chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cataract, Influenza like illness
Clinical narrative: Bilateral cataracts; Flu like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4297958-00 (Agency).  A 79 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of Administration: Intramuscular), administration date: Jan2021, when the patient was 79 years old, for Covid 19 immunization. The following information was reported: CATARACT (medically significant), outcome "unknown", described as "Bilateral cataracts"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms". The action taken for adalimumab was unknown. The reporter considered "bilateral cataracts" and "flu like symptoms" related to bnt162b2.  Clinical course: On unknown dates, the patient experienced cataracts in both eyes and second vaccination and booster for covid-19 made felt like having flu. On an unknown date, second vaccination and Booster for covid-19 made felt like having flu resolved. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. Patient had began cataracts in both eyes on her 06Jan2022 visit. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of Cataracts in both eyes and second vaccination and Booster for Covid-19 made felt like having flu was not provided. for the drug Humira. there is no reasonable possibility that the events of Cataracts in both eyes and second vaccination and booster for covid-19 made felt like having flu are related to Humira (Adalimumab). The reporter's causality for the events of Bilateral cataracts and Flu like symptoms was possible for the drug bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events Influenza like illness , Cataract  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.,Linked Report(s) : US-PFIZER_INC-202200363826 same patient/drug, different vaccine dose
Sex: U
Vaccine: FLUX
Symptoms: Autopsy, Death, Myocardial infarction
Clinical narrative: suffered a fatal heart attack before the game; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp via social media.  This case involves patient of unknown demographics who suffered a fatal heart attack before the game, after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, frequency, formulation, route, lot number and expiry date were unknown) via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient suffered a fatal heart attack before the game (myocardial infarction) (latency: unknown). This event was assessed as medically significant and lead to death. The autopsy details were unknown at the time of report.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (suffered a fatal heart attack before the game).  At time of reporting, the outcome was Fatal for the event suffered a fatal heart attack before the game.  Based on information previously received, the following information (classification from non-case to non-valid case) has been amended  Based on information previously received, the following information case classification of non-valid case and justification  has been deleted; Sender's Comments: Sanofi company comment dated 27-Jan-2022: This case involves patient of unknown demographics who was suffered a fatal heart attack before the game (myocardial infarction) leading to death with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: suffered a fatal heart attack before the game
Sex: M
Vaccine: FLUX
Symptoms: Myocarditis
Clinical narrative: myocarditis; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp via social media.  This case involves a 21 years old male patient who had myocarditis while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (frequency, formulation, route, strength, lot number and expiry date were unknown) via unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient had myocarditis (latency: unknown). This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (myocarditis).  At time of reporting, the outcome was Unknown for the event myocarditis.; Sender's Comments: Sanofi company dated: 27-Jan-2022: This case involves 21-year-old male patient who had myocarditis with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Gait inability, Near death experience, Wheelchair user
Clinical narrative: I have a friend that just had a flu shot about 3 months ago and she almost died now she can't even walk she's in a wheelchair; I have a friend that just had a flu shot about 3 months ago and she almost died now she can't even walk she's in a wheelchair; Initial information received on 19-Feb-2022 regarding an unsolicited valid serious case from Social Media page as flu shot campaign received from a non-healthcare professional.  This case involves adult female patient who had a flu shot about 3 months ago and she almost died now she can't even walk she's in a wheelchair after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in November 2021, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for Prophylactic vaccination. Information on Batch number was requested.  On an unknown date she had a flu shot about 3 months ago and she almost died now she can't even walk she's in a wheelchair (near death experience) and (gait inability) (unknown latency) following the administration of influenza vaccine.  Seriousness was medically significant for near death experience and leading to disability for gait inability.  Action taken was not applicable  Corrective treatment was not reported for the events.   Outcome was Not Recovered for the events.; Sender's Comments: Company Comment dated 08-Mar-2022: This case adult female patient who had a flu shot about 3 months ago and she almost died now she can't even walk she's in a wheelchair while receiving influenza vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information the role of the individual suspect vaccine cannot be assessed.
Age: 57.0
Sex: M
Vaccine: TTOX
Symptoms: Arthropathy, Muscle discomfort, Nervousness, Pain
Clinical narrative: Attack muscles and joints throughout body, in constant pain; Contracted covid; Initial information received on 04-Mar-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp(health care professional).  This case involves a 57 years old male patient who experienced attack muscles and joints throughout body, in constant pain and contracted covid while receiving vaccine Tetanus Toxoid.  The patient's past medical history, concomitant drugs, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID (strength, dose, and route: unknown) produced by unknown manufacturer lot number not reported in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious "attack muscles and joints throughout body, in constant pain" (pain)(unknown latency) and "contracted covid (covid-19)" (unknown latency) following the administration of TETANUS TOXOID.  It was reported that "I think I contracted covid twice since October 2019 and September 2022. I am not vaccinated. In January 2019, I recieved a TDap booster that has attack my muscles and joints throughout my body. i am in constant pain. I was on steroids until February 2022. I take Naprosyn for pain. I would like to become vaccinated. But I am extremely nervous. I dont want to have a double bad reaction and maybe pass away. What do u think I should do ? "  Action taken: Unknown for both the events.  It was not reported if the patient received a corrective treatment for the event (Contracted covid) and received a corrective treatment naproxen (Naprosy) for the event Attack muscles and joints throughout body, in constant pain  At time of reporting, the outcome was Unknown for both the events
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Colitis, Condition aggravated, Milk allergy
Clinical narrative: colitis; Condition worsened; made her allergy to milk worse; Initial information received from courtesy contact via Pfizer on 04-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 3 years old female patient who experienced colitis, made her allergy to milk worse and condition worsened while receiving vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Milk allergy.   On an unknown date, the patient received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer)(strength, dosage, batch number,route, administration site and expiry date: unknown for  the suspect) for Prophylaxis.  On an unknown date the patient developed  non-serious event colitis,allergy to milk worse (milk allergy), condition worsened (condition aggravated)  (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (colitis, made her allergy to milk worse, Condition worsened).  At time of reporting, the outcome was Unknown for all the events.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion was 67F worst case scenario; total time of excursion was 8 days with no reported adverse event; Initial information received on 14-Jan-2022 regarding an unsolicited valid non-serious case  from a other health professional.  This case a 67 years old female patient who involves a temperature excursion was 67f worst case scenario; total time of excursion was 8 days with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MCR5)/HIB(PRP/T) vaccine (Pentacel).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect suspension for injection Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MCR5)/HIB(PRP/T) (strength, dose, route, expiry date: unknown) lot UJ577AAA in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious "temperature excursion was 67f worst case scenario; total time of excursion was 8 days with no reported adverse event (intercepted product storage error)" (unknown latency) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MCR5)/HIB(PRP/T) vaccine.  It was reported that "temperature excursion for PENTACEL due to it being left on the counter; temperature excursion was 67F worst case scenario; total time of excursion was 8 days; confirms product was not administered post excursion. Medical assistant asks for stability information".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion was 67F worst case scenario; total time of excursion was 8 days with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion was 67f worst case scenario; total time of excursion was 8 days 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.  Additional information received on 03-Mar-2022 regarding an unsolicited valid non-serious case  from  other health professional.  Case updated to valid case and patient's demographics added.
Age: 0.33
Sex: U
Vaccine: MNQ
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: mistakenly the facility gave MENACTRA to a 4 month old child with no reported adverse event; Initial information received on 01-Mar-2022 regarding an unsolicited valid non-serious case from other health professional via call center.  This case involves a 4months old patient of unknown gender who was mistakenly administered Menactra by the facility with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Feb-2022, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine (formulation, strength, dose, batch number, route, administration site : unknown) for immunization. Information on batch number was requested.  On 28-Feb-2022, the patient was mistakenly administered Menactra by the facility with no reported adverse event (product administered to patient of inappropriate age) following the administration of Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the events (product administered to patient of inappropriate age).  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: 11.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Off label use
Clinical narrative: potential AE because of use against local labelling with no reported adverse event; Initial information received on 01-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves a 11 years old female patient who experienced potential AE because of use against local labelling with no reported adverse event while receiving vaccine Diphtheria-15/tetanus/5 hybrid ac pertussis/IPV (MRC5) vaccine [Quadracel] and Measles vaccine, mumps vaccine, rubella vaccine [MMR].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking measles vaccine, mumps vaccine, rubella vaccine (strength, dose, route, formulation, batch number and expiry date: unknown) and diphtheria-15/tetanus/5 hybrid ac pertussis/IPV (MRC5) vaccine (strength, dose, route, formulation, batch number and expiry date: unknown) in unknown administration site all for Immunisation.  On an unknown date the patient developed a non-serious potential AE because of use against local labelling with no reported adverse event (off label use) (latency:unknown) following the first dose intake measles vaccine, mumps vaccine, rubella vaccine and diphtheria-15/tetanus/5 hybrid ac pertussis/IPV (MRC5) vaccine.  Action taken:unknown.  It was not reported if the patient received a corrective treatment for the event (off-label use).  At time of reporting, the outcome was Unknown for the event off-label use.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: received her first dose of MENACTRA when she was 10 years and 8 months old, the patient received a second dose of MENACTRA when she was 14 years and 7 months old, with no reported adverse event.; received her first dose of MENACTRA when she was 10 years and 8 months old, the patient received a second dose of MENACTRA when she was 14 years and 7 months old, with no reported adverse event.; Initial information received on 02-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 years old female patient who received her first dose of meningococcal a-c-y-w135 (d conj) vaccine [MENACTRA] when she was 10 years and 8 months old, the patient received a second dose of menactra when she was 14 years and 7 months old, 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 a dose of suspect Meningococcal a-c-y-w135 (d conj) vaccine ( Strength, dose, formulation, lot number and expiry number: not reported) via unknown route in unknown administration site and on an unknown dates 1 other doses were administered for suspect meningococcal a-c-y-w135 (d conj) vaccine ( Strength, dose, formulation, lot number and expiry number: not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient received her first dose of menactra when she was 10 years and 8 months old, the patient received a second dose of menactra when she was 14 years and 7 months old, with no reported adverse event (Drug use in unapproved age group)  (Drug use for unapproved schedule) following the administration of Meningococcal a-c-y-w135 (d conj) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event Drug use in unapproved age group and Drug use for unapproved schedule.  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: 0.67
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error
Clinical narrative: Administered the 3rd dose of Pentacel 9 days too soon with no reported adverse event; Initial information received received on 02-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 months old female patient who was administered the 3rd dose of pentacel 9 days too soon with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2021, the patient received a first dose (dose-1) and on 10-Feb-2022 the patient received a second dose (dose-2) (dosage, form, route, administration site, strength: unknown); the patient received a third dose (3rd dose) 01-Mar-2022 of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (dose 0.5 ml to 2 ml via intramuscular route in left thigh); all with lot UJ474AAA and expiry date 09-Jul-2022 for prophylactic vaccination.  On 01-Mar-2022 the patient was administered the 3rd dose of pentacel 9 days too soon with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken was not applicable  Outcome was 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.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired doses of IPOL was administered to 3 patients after 25 days of expiration of the vaccine with no reported adverse event; Initial information received on 02-Mar-2022 regarding an unsolicited valid  non-serious case received from a health professional via call center.  This case involves 3 patients of unknown age and unknown gender to whom expired doses was administered after 25 days of expiration of the vaccine with no reported adverse event of vaccine poliomyelitis vaccine (inactivated) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 3 patients received a  dose of suspect poliomyelitis vaccine (inactivated), suspension for injection, once (dose, route, strength : unknown) ( lot R1F971M, expiration date:03-OCT-2021) at unknown administration site for immunization after 25 days of expiration of the vaccine with no reported adverse event (expired product administered). It was asked what to do and if the patients required booster moving forward.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event expired doses of ipol was administered to 3 patients after 25 days of expiration of the vaccine 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: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered MENACTRA which expired on 18Feb2022 to a patient, with no reported AE; Initial information was received on 02-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 21 years old male patient who was administered menactra which expired on 18feb2022 to a patient, with no reported AE (adverse event) while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 02-Mar-2022, the patient received 0.5 ml dose once of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine (formulation, strength, route: unknown) (Batch lot U6827BB, expiry date: 18-Feb-2022  ) via intramuscular route in unknown administration site for immunization.  On 02-MAR-2022 the patient was administered Menactra which expired on 18-Feb-2022, with no reported AE (expired product administered) (Latency: same day) following the administration of Meningococcal A-C-Y-W135 (D CONJ) Vaccine.  Action take: 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: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Medication error, No adverse event
Clinical narrative: ordered a 15 month old to have DTap and ActHIB separately but the person gave the child, Pentacel and Acthib( another brand) today, with no reported adverse event; Initial information received on 02-Mar-2022 regarding an unsolicited valid  non-serious case received from a nurse practitioner.  This case involves a 15 months old male patient for whom nurse practitioner ordered to have dtap and acthib separately but the person gave the child diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] and HIB vaccine CONJ (TET TOX) [Acthib] (another brand) today, 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) (Prevenar 13) and HIB vaccine CONJ (TET TOX) (Acthib) for Immunisation.  On 02-Mar-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, suspension for injection (lot U7013AA, expiration date: 10-Sep-2022) unknown strength via intramuscular route in the right thigh for immunization and on same day nurse practitioner reported that she ordered to have dtap and acthib separately but the person gave the child, pentacel and acthib( another brand) today, with no reported adverse event (wrong product administered). The caller asked what to do.  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: 74.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received the pentacel vaccine today instead of the tetanus shot with no reported adverse event; 74 years old took Pantacel vaccine with no reported adverse event; Initial information was received on 03-Mar-2022 regarding an unsolicited non-valid non-serious case received from a health professional via call center.   This case involves a 74 years old female patient who reported that received the pentacel vaccine today instead of the tetanus shot with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Mar-2022, the patient received a dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine suspension for injection(strength: unknown)at dose of 0.5ml (lot UJ523AA and expiry date:22-jul-2022) via intramuscular route in the right deltoid for immunization.  On 03-MAR-2022, a 74years old patient reported that she received the pentacel vaccine today instead of the tetanus shot with no reported adverse event (incorrect dose administered)and (product administered to patient of inappropriate age) (latency: same day) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action taken:not applicable.  At time of reporting, the outcome was unknown for the event incorrect dose administration and product administered to patient of inappropriate age.    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: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RVX
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received their 3rd dose of PENTACEL 2 weeks after their 2nd dose with no reported adverse event; Initial information received  on 03-Mar-2022 regarding an unsolicited valid non-serious case received from a physician via call center.  This case involves a 6 months old female patient who had experienced patient received their 3rd dose of pentacel 2 weeks after their 2nd dose with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar); and rotavirus vaccine (Rotavirus Vaccine) both for Prophylactic vaccination.  On 29-Oct-2021, the patient received a 0.5 ml third dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (frequency: once, Strength: standard) (formulation: unknown) lot UJ494AAA via intramuscular route in the right thigh.  On 29-OCT-202, the patient developed a non-serious event patient received their 3rd dose of pentacel 2 weeks after their 2nd dose with no reported adverse event (inappropriate schedule of product administration) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (inappropriate schedule of product administration).  At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.  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: 1.83
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: QUADRACEL was administered to a 22 month old infant with no reported adverse event; Initial information received  on 03-Mar-2022 regarding an unsolicited valid non-serious case received from the health professional.  This case involves a 22 months old infant patient of unknown gender, wo was administered with diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Quadracel) with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient was administered with diphtheria-15/tetanus/5 hybrid AC pertussis/ipv (mrc5) vaccine (strength, formulation, dosage, route, administration site, lot number and expiry not reported) for prophylactic vaccination (Product administered to patient of inappropriate age) (latency: same day).  No adverse event 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 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: MENB, MNQ
Symptoms: Expired product administered, Medication error
Clinical narrative: how soon they can give another dose of MENACTRA to a patient that was given an expired dose today.; Initial information received on 04-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old male patient who experienced how soon they can give another dose of Menactra to a patient that was given an expired dose today while receiving vaccine meningococcal A-C-Y-W135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine b rfhbpa/fhbpb (Trumenba) for Immunisation.  On 04-Mar-2022, the patient received 0.5 ml of suspect meningococcal A-C-Y-W135 (d conj) vaccine(formulation unknown) via intramuscular route in the right deltoid (batch number: U6827BA and expiry date :18-Feb-2022) for immunization.   On 04-Mar-2022 (latency: same day)the patient developed a non-serious event of how soon they can give another dose of menactra to a patient that was given an expired dose today(expired product administered) following the administration of meningococcal A-C-Y-W135 (d conj) vaccine   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.  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: 13.0
Sex: M
Vaccine: DTAP, HPVX, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of Menactra, with no reported adverse event; Initial information was received on 04-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.  This case involves a 13years old male patient who received an expired dose of menactra, with no reported adverse event after receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV Vaccine (HPV Vaccine) and Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) as Prophylactic vaccination.  On 03-Mar-2022, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine (formulation, strength: unknown) at a dose of 0.5 ml once (batch number: U6877BA; expiration date: 28-Feb-2022) via intramuscular route in left arm  for immunization.  On 03-Mar-2022, the patient received an expired dose of menactra, with no reported adverse event (expired product administered) (latency: same day) following the administration of Meningococcal A-C-Y-W135 (D CONJ) Vaccine.  Action Taken: not applicable  At time of reporting, the outcome was Unknown for the event (expired 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: 21.0
Sex: M
Vaccine: RAB, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who started the rabies series but did not follow up, just returned and wants to follow up with the series with no adverse event; Initial information received on 06-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 21 year old male patient started the rabies series but did not follow up, just returned and wants to follow up with the series with no adverse event while receiving diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) and rabies (hdc) vaccine (Imovax Rabies).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Feb-2022, the patient received once a day of dose 0.25 to 2 ml of suspect rabies (hdc) vaccine (strength, lot number, expiry date: unknown) via intramuscular route in the right deltoid; boostrix not produced by Sanofi Pasteur (strength, route, frequency, dose, administration site, lot number, expiry date: unknown) for immunization.  On 25-Feb-2022 the patient started the rabies series but did not follow up, just returned and wants to follow up with the series with no adverse event (inappropriate schedule of product administration) (Latency: same day).  Action taken was not applicable  Outcome was 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.
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was immunocompromised and was supposed to have two doses administered 8 weeks apart. However, the second administration occurred after only 4 weeks with no reported adverse event; Initial information received on 07-Mar-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 45 years old female patient who experienced patient was immunocompromised and was supposed to have two doses administered 8 weeks apart. however, the second administration occurred after only 4 weeks with no reported adverse event while receiving meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Immunocompromised.   On 04-Mar-2022, the patient received 0.5ml  of suspect meningococcal a-c-y-w135 (d conj) vaccine solution for injection lot U7273BAwith unknown expiration date via unknown route in the right deltoid.  on the same day (04-MAR-2022)  the Pharmacist reported that a patient received a dose meningococcal a-c-y-w135 (d conj) vaccine of at an earlier interval than prescribed. The patient was immunocompromised and was supposed to have two doses administered 8 weeks apart. However, the second administration occurred after only 4 weeks (inappropriate schedule of product administration) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  it was reported "The first administration occurred on 04FEB2022 and the second on 04MARCH2022".  Action taken: Not applicable for the event.  corrective treatment: not reported.  outcome: 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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Janssen given on 3/12/2022. Patient verbally consented/confirmed, he had not received previous COVID-19 vaccination. After vaccination, discovered patient received a dose of Moderna on 2/15/2022 at a different pharmacy.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and painful lymph node in left armpit.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Vision blurred
Clinical narrative: 2/23/2022 at 14:30-Left forearm numbness that progressed to  At 1600: Left lower extremity,  At 2100: Left eye blurry vision
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: About 5 minutes after receiving her pfizer booster the patient fainted.  She fell forward off of her chair onto the ground, she remained unconscious for about 60 seconds.  Upon awakening she reported that she felt like she hit her head.  She claimed that she was feeling fine, other than the small bump on her head.  She was monitored for about 20 minutes before a friend picked her up to take her home.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Hyperaesthesia, Mechanical urticaria, Skin abrasion, Urticaria
Clinical narrative: I got triple Moderna for vaccines. About 2 weeks after getting my booster shot, I started breaking-out in full body hives. I was extremely sensitive to all touch/abrasion. February 2022, I saw a dermatologist, and she diagnosed me with dermatographia. Now I have to take Claritin daily to prevent the hives. It has been over 2 months now and symptoms still persist (if I do not take Claritin daily).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fibrin D dimer increased, Hypoaesthesia, Menstrual disorder
Clinical narrative: Altered menstruation, a lot of lower back pain without being able to feel the legs, high D-dimers.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Every other period is twice as long since this shot. Normally my periods last 4-5 days, whereas now, one of them lasts 10+ days. This has continued since the second Covid shot, which I took 5+ months ago.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Polymyalgia rheumatica onset 08/2021. Treatment since then with prednisone (ongoing).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid Heartbeat from Covid 19 vaccine J&J
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Pain in extremity, X-ray
Clinical narrative: I have continuous pain in my right heel and it is the same type of paid I had when I took the levaquin.  Have tried heel pads and acupuncture but nothing alleviates the pain.  No one has been able to determine the cause of the pain.  Last week I was thinking about the medicines I had been taking before and after the covid shot and the only new medicine was the shot.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia areata, Blood thyroid stimulating hormone normal, Haemoglobin decreased, Laboratory test, Red blood cell count normal
Clinical narrative: 1st dose of Pfizer Covid vaccine received on December 2, 2021. 2nd dose of Pfizer Covid vaccine received on December 23, 2021. After 3 weeks of 2nd dose (around January 13, 2022), we (parents) noticed patient's aggressive hair fall. After the 2nd Covid shot, the vaccine triggered his underlying condition (alopecia arreata) and after the immense weekly hair fall, it has caused complete - ABSOLUTE - hair loss and balding within 1.5 months (mid January-February 2022). This had NEVER HAPPENED BEFORE.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thyroxine free, White blood cell count normal
Clinical narrative: 1st dose of Pfizer Covid vaccine received on December 2, 2021. 2nd dose of Pfizer Covid vaccine received on December 23, 2021. After 3 weeks of 2nd dose (around January 13, 2022), we (parents) noticed patient's aggressive hair fall. After the 2nd Covid shot, the vaccine triggered his underlying condition (alopecia arreata) and after the immense weekly hair fall, it has caused complete - ABSOLUTE - hair loss and balding within 1.5 months (mid January-February 2022). This had NEVER HAPPENED BEFORE.