chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory disorder, Wrong product administered
Clinical narrative: Did not get a second dose, but got a bivalent booster dose; Having breathing issues; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Jan2023 as dose 2, single (Lot number: GL0447) for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1), administration date: 18Mar2022, for COVID-19 Immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 31Jan2023, outcome "unknown", described as "Did not get a second dose, but got a bivalent booster dose"; RESPIRATORY DISORDER (non-serious) with onset 2023, outcome "unknown", described as "Having breathing issues". The event "having breathing issues" required physician office visit. Additional information: Caller was asking for guidance after an administration error. On 18Mar2022, a 61-year-old female patient got her first dose of the vaccine, and did not get a second dose, but got a bivalent booster dose on 31Jan2023. She has been having breathing issues and has had to see pulmonologist after that.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Pfizer was making people sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Pfizer was making people sick".  Additional information: Age Group was reported as adult (18 to less than 65 years).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: muscle pain; low grade fever; flu like symptoms; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient in their 60's received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Lot number: EN6206) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LIALDA oral taken for crohn's disease (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); LIOTHYRONINE oral taken for hypothyroidism (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical site of Injection: Arm, Route of administration: Intramuscular, Lot number: EN6201), administration date: 11Feb2021, for Covid-19 Immunization, reaction(s): "muscle pain", "low grade fever", "flu like symtoms", "tiredness", "COVID-19". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "flu like symptoms"; PYREXIA (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "low grade fever"; MYALGIA (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "muscle pain"; FATIGUE (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, influenza like illness, fatigue.  Additional information: Mild reaction to all covid vaccines including muscle pain, low grade fever, flu like symptoms, tiredness.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: giving the wrong dosage of the Pfizer Covid 19 vaccine 4 to 11 years old/Covid vaccine it was the 5 to 11-year-old dose; This case has been considered invalid as Unspecified AE.  This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID: (004756; 159558).  A young patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), described as "giving the wrong dosage of the Pfizer Covid 19 vaccine 4 to 11 years old/Covid vaccine it was the 5 to 11-year-old dose". Additional information: The verbatim of the caller was, it was the Covid vaccine it was the 5 to 11-year-old dose.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.  Follow-up (03Feb2023): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included:  Updated information included: dose description updated. The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Cytokine test, Investigation, Myocarditis, Troponin T
Clinical narrative: Myocarditis; elevated cardiac troponin T; This is a literature report for the following literature source(s):   An adolescent patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown"; TROPONIN T INCREASED (hospitalization), outcome "unknown", described as "elevated cardiac troponin T". The patient underwent the following laboratory tests and procedures: Antibody test: asymptomatic, notes: Results were compared with those from 45 healthy, asymptomatic, age-matched vaccinated control subjects; Cytokine test: asymptomatic, notes: Results were compared with those from 45 healthy, asymptomatic, age-matched vaccinated control subjects; SARS-CoV-2-specific T-cell analysis: asymptomatic, notes: Results were compared with those from 45 healthy, asymptomatic, age-matched vaccinated control subjects; Troponin T: increased, notes: (median, 260 ng/L; interquartile range, 215-1114 ng/L; upper limit of normal, 14 ng/L) and C-reactive protein (CRP) levels (median, 29.75 mg/L; interquartile range, 15.53-50.58 mg/L; upper limit of normal, 8 mg/L).  Clinical information: Additional information: Vaccinated control (n=44) and myocarditis (n=16) cohorts. Antigen data corresponding to all individuals who received the BNT162b2 vaccine (n=59) and those who received the Moderna vaccine (n=2). Postvaccine myocarditis (n=16): Age at enrollment, average (minimum, maximum), y: 16 (12, 21) Male, n (%) 13 (81). Our cohorts were not evenly balanced between the BNT162b2 and mRNA-1273 vaccines: all of our adolescent control cohort and the majority of our myocarditis cohort received the BNT162b2 vaccine (n=15). In the postvaccine myocarditis cohort, most of the individuals (n=12 of 16; 75%) developed myocarditis after the second dose, although 2 experienced symptoms of myocarditis after the first dose and 2 after the third booster dose. All patients presented with chest pain, and all were found to have elevated cardiac troponin T (median, 260 ng/L; interquartile range, 215-1114 ng/L; upper limit of normal, 14 ng/L) and C-reactive protein (CRP) levels (median, 29.75 mg/L; interquartile range, 15.53-50.58 mg/L; upper limit of normal, 8 mg/L). Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Troponin T increased
Clinical narrative: Myocarditis; elevated cardiac troponin T; This is a literature report for the following literature source(s):   An adolescent patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown"; TROPONIN T INCREASED (hospitalization), outcome "unknown", described as "elevated cardiac troponin T". The patient underwent the following laboratory tests and procedures: Antibody test: asymptomatic, notes: Results were compared with those from 45 healthy, asymptomatic, age-matched vaccinated control subjects; Cytokine test: asymptomatic, notes: Results were compared with those from 45 healthy, asymptomatic, age-matched vaccinated control subjects; SARS-CoV-2-specific T-cell analysis: asymptomatic, notes: Results were compared with those from 45 healthy, asymptomatic, age-matched vaccinated control subjects; Troponin T: increased, notes: (median, 260 ng/L; interquartile range, 215-1114 ng/L; upper limit of normal, 14 ng/L) and C-reactive protein (CRP) levels (median, 29.75 mg/L; interquartile range, 15.53-50.58 mg/L; upper limit of normal, 8 mg/L).  Clinical information: Additional information: Vaccinated control (n=44) and myocarditis (n=16) cohorts. Antigen data corresponding to all individuals who received the BNT162b2 vaccine (n=59) and those who received the Moderna vaccine (n=2). Postvaccine myocarditis (n=16): Age at enrollment, average (minimum, maximum), y: 16 (12, 21) Male, n (%) 13 (81). Our cohorts were not evenly balanced between the BNT162b2 and mRNA-1273 vaccines: all of our adolescent control cohort and the majority of our myocarditis cohort received the BNT162b2 vaccine (n=15). In the postvaccine myocarditis cohort, most of the individuals (n=12 of 16; 75%) developed myocarditis after the second dose, although 2 experienced symptoms of myocarditis after the first dose and 2 after the third booster dose. All patients presented with chest pain, and all were found to have elevated cardiac troponin T (median, 260 ng/L; interquartile range, 215-1114 ng/L; upper limit of normal, 14 ng/L) and C-reactive protein (CRP) levels (median, 29.75 mg/L; interquartile range, 15.53-50.58 mg/L; upper limit of normal, 8 mg/L). Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: muscle pain; low grade fever; flu like symtoms; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201) at the age of 67 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: LIALDA oral taken for crohn's disease (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); LIOTHYRONINE oral taken for hypothyroidism (ongoing).  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 12Feb2021, outcome "recovered" (13Feb2021), described as "flu like symtoms"; PYREXIA (non-serious) with onset 12Feb2021, outcome "recovered" (13Feb2021), described as "low grade fever"; MYALGIA (non-serious) with onset 12Feb2021, outcome "recovered" (13Feb2021), described as "muscle pain"; FATIGUE (non-serious) with onset 12Feb2021, outcome "recovered" (13Feb2021), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, influenza like illness, fatigue.  Additional information: Adverse events: AE term: 24 hours, Onset date: ABT 12Feb2021, Seriousness criteria: Not serious, AE outcome: Recovered.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: 2 days after the vaccine I woke up extremely sick and I have been sick ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), on 26Dec2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 28Dec2022, outcome "not recovered", described as "2 days after the vaccine I woke up extremely sick and I have been sick ever since".  Additional information: 26Dec2022 at Privacy pharmacy in Withheld the patient reported it was against the patient's better judgement patient got primary COVID vaccine. Today is 07Feb2023 approximately 6 weeks after the vaccine. 2 days after the vaccine patient woke up extremely sick and have been sick ever since. A vaccine that is supposed to prevent from illness has caused illness for 6 Withheld weeks. Shame on you for conforming to harm the citizens.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Interchange of vaccine products
Clinical narrative: a person had 2 Moderna shots and that they got the Pfizer booster and made them sick; a person had 2 Moderna shots and that they got the Pfizer booster and made them sick; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna shots (Dose 1), for COVID-19 Immunization; Moderna shots (Dose 2), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "a person had 2 Moderna shots and that they got the Pfizer booster and made them sick".  Additional information: I over heard that a person had 2 Moderna shots and that they got the Pfizer booster and made them sick   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia totalis
Clinical narrative: My wife has lost all her hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 3, unknown manufacturer), for COVID-19 immunization. The following information was reported: ALOPECIA TOTALIS (non-serious), outcome "unknown", described as "My wife has lost all her hair". The event "my wife has lost all her hair" required physician office visit. Additional information: the patient specified that his wife has lost all her hair. She started just after she got the fourth Covid shot. First part of November she had a full head of hair. Now nothing. They've seen doctors with no answers.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: IPV
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: 11 doses were given from a 10 dose vial with no reported adverse event; Initial information received on 03-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown age and gender and it was reported that 11 doses were given from a 10 dose vial of ipv (vero) [Ipol] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect ipv (vero) (formulation: Suspension for injection) (strength; lot number; expiry date not reported) via unknown route in unknown administration site for immunization.  On an unknown date 11 doses were given from a 10-dose vial of ipv (vero) with no reported adverse event (incorrect dose administered) (latency: same day).  It was reported, "10 dose vial, would the 11th dose be considered a valid dose? If not valid, would it need to be repeated?"  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: 56.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Ipol 0.1ml was given instead of Tubersol with no reported adverse event; nitial information was received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA043808 and 2023SA043813.  This case involves 56 years old female patient who experienced ipol 0.1ml was given instead of tubersol with no reported adverse event while receiving vaccine ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 31-Jan-2023, the patient received a dose of suspect ipv (VERO) Suspension for injection at 0.1ml lot W1A191M at expiry of 16-Feb-2025 via intradermal route in the left forearm for immunization.  On 31-Jan-2023 the patient developed a non-serious event of ipol 0.1ml was given instead of tubersol with no reported adverse event (wrong product administered) following the administration of ipv (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (Ipol) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Ipol 0.1ml was given instead of Tubersol with no reported adverse event).  At time of reporting, the outcome was Unknown for the event ipol 0.1ml was given instead of tubersol with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received an extra dose of TDAP (BOOSTRIX) and MENQUADFI with no reported adverse event; ended up receiving extra dose of menquadfi and boostrix with no reported AE; Initial information was received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 years old female patient who experienced patient received an extra dose of tdap (boostrix) and menquadfi with no reported adverse event and ended up receiving extra dose of menquadfi and boostrix with no reported ae while receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (Boostrix) for Prophylactic vaccination; and althaea officinalis root, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL).  On 08-Dec-2022, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine lot U7576AB via intramuscular route in unknown administration site for Immunisation.  On 11-Jan-2023 the patient developed a non-serious event of patient received an extra dose of tdap (boostrix) and menquadfi with no reported adverse event (extra dose administered) 1 month 3 days following the administration of meningococcal a-c-y-w135 (t conj) vaccine. On 11-Jan-2023 the patient developed a non-serious event of ended up receiving extra dose of menquadfi and boostrix with no reported ae (incorrect dose administered) 1 month 3 days following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  It was not reported if the patient received a corrective treatment for the events (patient received an extra dose of TDAP (Boostrix) and Menquadfi with no reported adverse event, ended up receiving extra dose of menquadfi and boostrix with no reported AE).  At time of reporting, the outcome was Unknown for the event patient received an extra dose of tdap (boostrix) and menquadfi with no reported adverse event and was Unknown for the event ended up receiving extra dose of menquadfi and boostrix 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: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product storage error, Wrong technique in product usage process
Clinical narrative: medication error due to the inappropriate administration of FLUZONE QIV MDV that was no longer suitable for use post excursion with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 30 years old female patient who experienced medication error due to the inappropriate administration of fluzone qiv mdv that was no longer suitable for use 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 06-Feb-2023, the patient received 0.5 ml (frequency: once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ879AA and expiry date: 30-JUN-2023) (strength: standard) via intramuscular route in the deltoid (unsure which arm) for Immunization.  On 06-FEB-2023 the patient had medication error due to the inappropriate administration of fluzone qiv mdv that was no longer suitable for use post excursion with no reported adverse event (product storage error) (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: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error, Wrong technique in product usage process
Clinical narrative: the powder portion of Pentacal was incorrectly diluted with sterile water diluent and the diluent that was erroneously used with no reported adverse event; the liquid portion of Pentacel was not administered with no reported adverse event; Initial information was received on 07-Feb-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 2 months old female patient and reported that the powder portion of pentacal was incorrectly diluted with sterile water diluent and the diluent that was erroneously used and the liquid portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was not administered 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 (Rotavirus vaccine) for prophylactic vaccination; pneumococcal vaccine 13v (Pneumococcal 13 valent vaccine) for prophylactic vaccination; and hepatitis b vaccine (Hepatitis b vaccine) for Prophylactic vaccination.  On 07-Feb-2023, the patient was received the powder portion of the suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine was incorrectly diluted with sterile water diluent and the diluent that was erroneously used with no reported adverse event (product preparation error) (latency: same day) (lot number: UJ788ABA, expiration date: 18-Sep-2023, dose, formulation, strength: Unknown) via unknown route in the right upper thigh for Immunization (Immunisation) and the liquid portion of pentacel was not administered with no reported adverse event (wrong technique in product usage process) (latency: same day).  It was reported that "The powder mixed with sterile water and then administered is lot UJ788ABA. The liquid portion, not administered, is lot U7440BA. She commented that the liquid vial has a smudge on the lot number and she is unsure if the zero is a zero or the letter D. The carton is lot UJ788ABA."   No lab data reported.  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: 0.33
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: was administered Pentacel that was reconstituted with sterile water diluent instead of the supplied Pentacel diluent (HIb portion) with no reported adverse event; was administered Pentacel that was reconstituted with sterile water diluent instead of the supplied Pentacel diluent (HIb portion) with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 3-month-old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that was reconstituted with sterile water diluent instead of the supplied pentacel diluent (hib portion) 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 7V (CRM197) (Prevnar), rotavirus vaccine live reassort oral 5V (ROTATEQ) and Hepatitis B Vaccine (Hepatitis B [Hepatitis B Vaccine]) all for Prophylactic vaccination.  On 06-Feb-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml once (lot UJ789AA, expiry date: 18-Sep-2023) via intramuscular route in the right thigh for prophylactic vaccination (immunisation).  On 06-Feb-2023 the patient developed a non-serious was administered pentacel that was reconstituted with sterile water diluent instead of the supplied pentacel diluent (hib portion) with no reported adverse event (product preparation error, single component of a two-component product administered, latency: same day).  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 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: 58.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was administered expired tenivac with no reported adverse event; Initial information was received on 08-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 58 years old male patient who was received expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant medications included tozinameran (Pfizer biontech covid-19 vaccine) for Immunisation.  On 08-Feb-2023, the patient was received expired suspect of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (strength: standard, formulation: Unknown) at dose of 0.5 ml once (lot: U6922AA, expiry date: 22-Jan-2023) via intramuscular route in the right deltoid for Immunisation with no reported adverse event (expired product administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event patient was administered expired tenivac with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 9.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: student accidentally received two FLUZONE QIV NP vaccinations from pre-filled syringes instead of the intended FLUZONE QIV NP and Hep B vaccines with no reported adverse event; student accidentally received two FLUZONE QIV NP vaccinations from pre-filled syringes instead of the intended FLUZONE QIV NP and Hep B vaccines with no reported adverse event; Initial information received on 08-Feb-2023 regarding an unsolicited valid non-serious case from a physician.  This case involves a 9-year-old male patient who accidentally received two INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] vaccinations from pre-filled syringes instead of the intended fluzone qiv np and HEPATITIS B VACCINE with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 26-Jan-2023, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at a dose of 0.5 ml twice (lot UT7752MA, expiry date: 30-Jun-2023 via intramuscular route in the right and left deltoid for Influenza (Influenza immunisation).   On 26-Jan-2023 the patient accidentally received two fluzone qiv np vaccinations from pre-filled syringes instead of the intended fluzone qiv np and hep b vaccines with no reported adverse event (wrong product administered, extra dose administered, latency same day).  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 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: 75.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was administered expired Tenivac with no reported adverse event; Initial information received on 08-Feb-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 75 years old female patient who was administered expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Feb-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) (frequency: once) (Strength: standard)  [lot C5779AA and expiry date: 02-Oct-2022) via intramuscular route in the left deltoid for Immunization.  On 08-Feb-2023 the patient was administered expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult with no reported adverse event (expired 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 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: 47.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Redness, swelling, warmth, and itching at injection site. Symptoms developed 36 hours after injection and continued for over six days. Virtual physician visit advised localized allergic reaction Treated with Acetaminophen for pain, loratadine for histamine reaction (one every 24 hours) beginning on day two of symptoms; Triamcinolone Acetonide cream (.1%) beginning on day 3 or 4 of symptoms. After beginning treatment symptoms slowly subsided. Some residual redness and soreness remained one week after injection.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Neuralgia
Clinical narrative: I started to have rt neck nerve pain 2/1/2023 (thinking it was the way I slept). It is hard to wear clothes touching my neck, collarbone, a little under my collarbone, and my right shoulder. It is a sensation of my nerve.  I also notice this morning 2/10/2023 that it hurts to comb/brush my hair because that same sensation is also now on the Left side of my face and head.  Side note I had a trigeminal nerve issue in my face on the rt side about 2013-2015 (approximate year). I don't remember. And this is the same sensation I am having now.
Age: 0.42
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Developmental regression, Fatigue, Irritability
Clinical narrative: Fatigue, fussy, yelling, crying lasted a week after being vaccinated. Months later he still yells and has some regression in actions.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Acute kidney injury, Angiogram, Anticoagulant therapy, Arthralgia
Clinical narrative: After second injection severe pain began in left lower quad of abd, then to left back, thinking it was sciatica, multiple epidural injections and ablations with little to no relief. Pain continues,disability to walk, run or move. Limited ROM to Left leg,  After injection severe pain down side of Left leg, then into hip, then crept into calf with redness swelling that became so bad, I sought treatment in Er hospital. Pain with "extensive DVT" Left leg" from left retroperitoneal edema in left pelvis, left iliac vein, external iliac vein and femoral. DVT left popiteal, femoral, common femoral and iliac veins related to COVID vaccine. High grade occlusion.  5 days in ICU, stent and IVC filter, Eliquis, IVC filter removal 2/10/23
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest X-ray, Coagulation factor, Computerised tomogram spine, Deep vein thrombosis
Clinical narrative: After second injection severe pain began in left lower quad of abd, then to left back, thinking it was sciatica, multiple epidural injections and ablations with little to no relief. Pain continues,disability to walk, run or move. Limited ROM to Left leg,  After injection severe pain down side of Left leg, then into hip, then crept into calf with redness swelling that became so bad, I sought treatment in Er hospital. Pain with "extensive DVT" Left leg" from left retroperitoneal edema in left pelvis, left iliac vein, external iliac vein and femoral. DVT left popiteal, femoral, common femoral and iliac veins related to COVID vaccine. High grade occlusion.  5 days in ICU, stent and IVC filter, Eliquis, IVC filter removal 2/10/23
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disability, Epidural injection, Erythema, Gait inability, Intensive care
Clinical narrative: After second injection severe pain began in left lower quad of abd, then to left back, thinking it was sciatica, multiple epidural injections and ablations with little to no relief. Pain continues,disability to walk, run or move. Limited ROM to Left leg,  After injection severe pain down side of Left leg, then into hip, then crept into calf with redness swelling that became so bad, I sought treatment in Er hospital. Pain with "extensive DVT" Left leg" from left retroperitoneal edema in left pelvis, left iliac vein, external iliac vein and femoral. DVT left popiteal, femoral, common femoral and iliac veins related to COVID vaccine. High grade occlusion.  5 days in ICU, stent and IVC filter, Eliquis, IVC filter removal 2/10/23
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Laboratory test, Mobility decreased, Pain in extremity, Pelvic venous thrombosis
Clinical narrative: After second injection severe pain began in left lower quad of abd, then to left back, thinking it was sciatica, multiple epidural injections and ablations with little to no relief. Pain continues,disability to walk, run or move. Limited ROM to Left leg,  After injection severe pain down side of Left leg, then into hip, then crept into calf with redness swelling that became so bad, I sought treatment in Er hospital. Pain with "extensive DVT" Left leg" from left retroperitoneal edema in left pelvis, left iliac vein, external iliac vein and femoral. DVT left popiteal, femoral, common femoral and iliac veins related to COVID vaccine. High grade occlusion.  5 days in ICU, stent and IVC filter, Eliquis, IVC filter removal 2/10/23
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Retroperitoneal oedema, Stent placement, Ultrasound Doppler, Ultrasound scan
Clinical narrative: After second injection severe pain began in left lower quad of abd, then to left back, thinking it was sciatica, multiple epidural injections and ablations with little to no relief. Pain continues,disability to walk, run or move. Limited ROM to Left leg,  After injection severe pain down side of Left leg, then into hip, then crept into calf with redness swelling that became so bad, I sought treatment in Er hospital. Pain with "extensive DVT" Left leg" from left retroperitoneal edema in left pelvis, left iliac vein, external iliac vein and femoral. DVT left popiteal, femoral, common femoral and iliac veins related to COVID vaccine. High grade occlusion.  5 days in ICU, stent and IVC filter, Eliquis, IVC filter removal 2/10/23
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vena cava filter insertion, Venogram, Venous occlusion
Clinical narrative: After second injection severe pain began in left lower quad of abd, then to left back, thinking it was sciatica, multiple epidural injections and ablations with little to no relief. Pain continues,disability to walk, run or move. Limited ROM to Left leg,  After injection severe pain down side of Left leg, then into hip, then crept into calf with redness swelling that became so bad, I sought treatment in Er hospital. Pain with "extensive DVT" Left leg" from left retroperitoneal edema in left pelvis, left iliac vein, external iliac vein and femoral. DVT left popiteal, femoral, common femoral and iliac veins related to COVID vaccine. High grade occlusion.  5 days in ICU, stent and IVC filter, Eliquis, IVC filter removal 2/10/23
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy skin abnormal, Dermatitis bullous, Mouth ulceration, Rash vesicular, Skin exfoliation
Clinical narrative: Pt developed a severe urticaria, bollous - large open ulcers all over the body including oral cavity, skin peeling,feet and toes blistering rash. This patient is now going on 4 months duration of this occurance.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin ulcer, Urticaria
Clinical narrative: Pt developed a severe urticaria, bollous - large open ulcers all over the body including oral cavity, skin peeling,feet and toes blistering rash. This patient is now going on 4 months duration of this occurance.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Back pain, Dizziness, Gait inability, Headache
Clinical narrative: Shot 1 - 12/20/20 - no adverse effects  Shot 2 -1/10/21 - 18 hours post vax became very suddenly sick w/ flu like symptoms for about 24 hours then just as quickly symptoms were gone. Right hip where hx of laberal tear repair continued to ache for about 6 weeks. Aprox 3 weeks later 2/1/21 had shingles outbreak that took 3 weeks of antiviral meds to clear.   Shot 3 - 2/8/22 - 12 hours post vax suddenly very very ill, worse then last time, horrible body aches, especially hips/knees/ankles/low back/shoulders were throbbing with horrible pain that was not relieved with Tylenol or Ibuprofen, nausea, dizzy, headache, fever.  lasted about 48 hours then suddenly gone.  right hip with laberal tear repair continued to ache consistently for about a months.  April 2022 woke up with bilateral knee pain and swelling, no trauma.  Continued increasing stiffness when swelling went away. Knees and lower extremities continued to be very sore/painful/stiff and would swell randomly then get better. By June i could not go up/down more then 3 stairs.   Saw Dr. of sports medicine. He had me start twice dialy Diclofenac which immediately made me almost better.  Continued for 2 months total along with exercises to help strengthen,  then dropped to 1x per day.  continued a few weeks then stopped Diclofenac.  Within a week  could not walk, lower extremity (hips/knees/ankles/feet) pain, swelling and stiffness so bad had to start up Diclofenac again.  Began to feel better within days.  Theory: we know the vax immunocompromised me leading to shingles twice.  while immunocompromised triggered an inflammatory response that my body cant get rid of.   PCP ran more labs, all normal.   referred to Rheumatologist as well as Immunologist. First appointment with Rheumatology was 2 weeks ago, intake, xrays, extensive labs drawn.  f/u appointment 2/13/23 to discuss results/whats wrong with me?  Intake/1st appointment with immunology 3/1/23.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Immunodeficiency, Joint swelling, Laboratory test normal, Malaise
Clinical narrative: Shot 1 - 12/20/20 - no adverse effects  Shot 2 -1/10/21 - 18 hours post vax became very suddenly sick w/ flu like symptoms for about 24 hours then just as quickly symptoms were gone. Right hip where hx of laberal tear repair continued to ache for about 6 weeks. Aprox 3 weeks later 2/1/21 had shingles outbreak that took 3 weeks of antiviral meds to clear.   Shot 3 - 2/8/22 - 12 hours post vax suddenly very very ill, worse then last time, horrible body aches, especially hips/knees/ankles/low back/shoulders were throbbing with horrible pain that was not relieved with Tylenol or Ibuprofen, nausea, dizzy, headache, fever.  lasted about 48 hours then suddenly gone.  right hip with laberal tear repair continued to ache consistently for about a months.  April 2022 woke up with bilateral knee pain and swelling, no trauma.  Continued increasing stiffness when swelling went away. Knees and lower extremities continued to be very sore/painful/stiff and would swell randomly then get better. By June i could not go up/down more then 3 stairs.   Saw Dr. of sports medicine. He had me start twice dialy Diclofenac which immediately made me almost better.  Continued for 2 months total along with exercises to help strengthen,  then dropped to 1x per day.  continued a few weeks then stopped Diclofenac.  Within a week  could not walk, lower extremity (hips/knees/ankles/feet) pain, swelling and stiffness so bad had to start up Diclofenac again.  Began to feel better within days.  Theory: we know the vax immunocompromised me leading to shingles twice.  while immunocompromised triggered an inflammatory response that my body cant get rid of.   PCP ran more labs, all normal.   referred to Rheumatologist as well as Immunologist. First appointment with Rheumatology was 2 weeks ago, intake, xrays, extensive labs drawn.  f/u appointment 2/13/23 to discuss results/whats wrong with me?  Intake/1st appointment with immunology 3/1/23.