chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), 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: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "heart attack". The patient date of death was unknown. Reported cause of death: "heart attack".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: heart attack
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), 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: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "heart attack". The patient date of death was unknown. Reported cause of death: "heart attack". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: heart attack
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: an acute covid infection (PCR proven); an acute covid infection (PCR proven); This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 at 10:00 as dose 1, single (Lot number: EK5127), in left arm and on 15Dec2021 at 11:00 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 7 years, in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "recovered" and all described as "an acute covid infection (PCR proven)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Positive, notes: Infected by covid; (23Dec2022) Negative, notes: Upon presentation to (hospital name withheld) 23Dec2022, covid PCR negative.; Sender's Comments: A contributory role of BNT162B2 to event an acute covid infection (PCR proven) cannot be excluded based on temporal association and available information.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: tremor in her left hand; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "tremor in her left hand". The following information was reported: TREMOR (non-serious), outcome "unknown", described as "tremor in her left hand".  Additional information: Patient is a Registered Nurse and also a recipient of Pfizer Covid 19 vaccine shot and booster who had been watching the news for the past week and seeing people complaining about twitching from the vaccine. She is a nurse who works for a small pharmaceutical company who does drug discovery science, so she understands the background and is a complete supporter of the vaccine. She doesn't know if it's relevant but she got two boosters and the regular two shots since then she developed a tremor in her left hand for example she cannot eat a soup without falling off the spoon, her right arm is completely fine. She doesn't know if there's a real concern about tremor with the vaccine, but because she works in drug discovery she feels like it's important to have somebody who's reputable to talk about this. She thinks people are sensationalizing it in the media. She wanted to check if there are any studies or revealing a tremor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300017881 Same patient/drug/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: tremor in her left hand; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "tremor in her left hand"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "tremor in her left hand". The following information was reported: TREMOR (non-serious), outcome "unknown", described as "tremor in her left hand".  Additional information: Patient is a Registered Nurse and also a recipient of Pfizer Covid 19 vaccine shot and booster who had been watching the news for the past week and seeing people complaining about twitching from the vaccine. She is a nurse who works for a small pharmaceutical company who does drug discovery science, so she understands the background and is a complete supporter of the vaccine. She doesn't know if it's relevant but she got two boosters and the regular two shots since then she developed a tremor in her left hand for example she cannot eat a soup without falling off the spoon, her right arm is completely fine. She doesn't know if there's a real concern about tremor with the vaccine, but because she works in drug discovery she feels like it's important to have somebody who's reputable to talk about this. She thinks people are sensationalizing it in the media. She wanted to check if there are any studies or revealing a tremor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300017881 Same patient, drug and event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: tremor in her left hand; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: TREMOR (non-serious), outcome "unknown", described as "tremor in her left hand".  Additional information: Patient is a Registered Nurse and also a recipient of Pfizer Covid 19 vaccine shot and booster who had been watching the news for the past week and seeing people complaining about twitching from the vaccine. She is a nurse who works for a small pharmaceutical company who does drug discovery science, so she understands the background and is a complete supporter of the vaccine. She doesn't know if it's relevant but she got two boosters and the regular two shots since then she developed a tremor in her left hand for example she cannot eat a soup without falling off the spoon, her right arm is completely fine. She doesn't know if there's a real concern about tremor with the vaccine, but because she works in drug discovery she feels like it's important to have somebody who's reputable to talk about this. She thinks people are sensationalizing it in the media. She wanted to check if there are any studies or revealing a tremor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300017879 Same patient/drug/event, different dose;US-PFIZER INC-PV202300017880 Same patient/drug/event, different dose;US-PFIZER INC-PV202300015624 Same patient/drug/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My healthy 45 year old sister-in-law just died a few days before the Holiday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old 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 complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "My healthy 45 year old sister-in-law just died a few days before the Holiday". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Reporters healthy 45 year old sister-in-law just died a few days before the Holiday. She just got your new multi variant booster shot. Cause of death: Unknown! Reporters uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct.   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.; Reported Cause(s) of Death: My healthy 45 year old sister-in-law just died a few days before the Holiday
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: Flu; pneumonia; Initial information received on 20-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves an Adult and unknown gender patient who had pneumonia and flu after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 02-Dec-2022, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with unknown formulation, strength, dose, route, lot number, expiration and at unknown administration site) for prophylactic vaccination(immunization) and flu(influenza).  ON 27-Dec-2022, the patient developed pneumonia and flu (influenza) (latency:25 days) following the administration of Influenza Vaccine.  No lab data were reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both events.  At time of reporting, the outcome was Unknown for both events.  Seriousness criteria: hospitalized for both events.; Sender's Comments: Sanofi company comment dated 25-Jan-2023: This case involves an Adult and unknown gender patient who had pneumonia and flu after receiving Influenza Vaccine. The time to onset was compatible with the role of vaccine. 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 on information provided, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia, Sepsis
Clinical narrative: got influenza A , pneumonia and sepsis in December and was hospitalized for 4 days; got influenza A , pneumonia and sepsis in December and was hospitalized for 4 days; got influenza A , pneumonia and sepsis in December and was hospitalized for 4 days; Initial information received on 24-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got influenza a , pneumonia and sepsis in december and was hospitalized for 4 days after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   In October 2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a serious event of got influenza a , pneumonia and sepsis in december and was hospitalized for 4 days (influenza, pneumonia) (latency): unknown following the administration of INFLUENZA VACCINE.   In Dec-2022 the patient developed a serious event of  got influenza a , pneumonia and sepsis in december and was hospitalized for 4 days (sepsis) (latency: approximately 3 months) following the administration of INFLUENZA VACCINE.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: Unknown  Seriousness criteria: Hospitalization, Medically significant for pneumnonia and Hospitalization for influenza, sepsis.; Sender's Comments: Sanofi company comment dated 30-Jan-2023: This case involves an unknown age and unknown gender patient who got influenza a, pneumonia and sepsis in december and was hospitalized for 4 days after receiving vaccine INFLUENZA VACCINE. The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, concomitant medication, clinical course, 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: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: The last time l got the flu shot l got horribly sick; Initial information received on 24-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got the flu shot and got horribly sick last time while receiving vaccine influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient had received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, frequency, route, formulation, strength, lot/batch number and expiration date: not provided) as Prophylactic vaccination.  On an unknown date the patient had developed a non-serious the last time l got the flu shot l got horribly sick (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken- Not applicable.  It was not reported if the patient received a corrective treatment for the event (Illness).  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Adverse reaction
Clinical narrative: had many different vaccines given at the same time and adversely reacted 2 separate times; Initial information was received on 24-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant and unknown gender of patient who reported that had many different vaccines given at the same time and adversely reacted 2 separate times after receiving vaccines Vaxelis and 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.  Concomitant medications included hepatitis b vaccine (HEPATITIS B VACCIN); POLIO VACCINE (POLIO); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); and HIB VACCINE (HIB).  On an unknown date, the patient received a unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date, the patient received a unknown dose of suspect Vaxelis (Injection) (not produced by Sanofi Pasteur)  (strength, expiry date, lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination(immunization).  On an unknown date the patient developed a non-serious event of had many different vaccines given at the same time and adversely reacted 2 separate times (adverse reaction) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and (unknown latency) following the administration of Vaxelis.  No lab data reported.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (had many different vaccines given at the same time and adversely reacted 2 separate times).  At time of reporting, the outcome was Recovered on an unknown date for the event had many different vaccines given at the same time and adversely reacted 2 separate times.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 24-Jan-2023 regarding an unsolicited valid Social Media non-serious case received via consumer.  This case involves an unknown age and unknown gender patient who had flu after receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported: I got my vaccine too and I'm on day 13 of the flu. The worst case I've ever had in 59 years. They missed it this time I'm afraid. So many flu cases here after the vaccine  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Age: 61.0
Sex: F
Vaccine: MNQ
Symptoms: Herpes zoster
Clinical narrative: an episode of shingles; Initial information was received on 24-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2023SA031061 and 2023SA029739 (CLUSTER).  This case involves a 61 years old female patient who experienced an episode of shingles while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical treatment included ACYCLOVIR with takes acyclovir daily prophylactically. The patient's past vaccination(s) included MMR in NOV-2022 and MENACTRA with on a 5 year cycle. The patient's past medical history and family history were not provided. At the time of the event, the patient had ongoing Asplenia with since JUN2012 and Diabetes mellitus with has had DM for two years.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 19-Jan-2023, the patient received total, 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U7459AE and expiry 03-Nov-24) ) (formulation and strength: unknown) via intramuscular route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious an episode of shingles (herpes zoster) (unknown latency) 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 event (an episode of shingles).  At time of reporting, the outcome was Unknown for the event an episode of shingles.
Age: 61.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: took Menactra in the past on a 5 year cycle with no reported adverse event; Initial information was received on 24-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case is linked to cases 2023SA031067 and 2023SA029739.  This case involves 61 years old female patient who took meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] in the past on a 5 year cycle with no reported adverse event.  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 Shingles, Asplenia with since Jun-2012 and Diabetes mellitus (has had DM for two years).  Concomitant medications included Aciclovir (Acyclovir [Aciclovir]) for Prophylaxis; pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation; and measles vaccine, MUMPS VACCINE, rubella vaccine (MMR) for Immunisation.  On an unknown date, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection (lot number, expiry date, dose, frequency, strength- not reported) via unknown route in unknown administration site for Immunisation.  On an unknown date the patient took meningococcal a-c-y-w135 (d conj) vaccine.in the past on a 5 year cycle with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  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.
Sex: U
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: a child that is less-than-7 years-old receives a dose of ADACEL instead of DTAP with no reported adverse event; Initial information received on 25-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a child patient that is less-than-7 years-old receives a dose of Adacel (diphtheria-2/tetanus/5 ac pertussis vaccine) instead of dtap 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 diphtheria-2/tetanus/5 ac pertussis vaccine suspension for injection (lot number, strength, expiry date, dosage not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the child that is less-than-7 years-old receives a dose of adacel instead of dtap with no reported adverse event (wrong product administered) (unknown latency)  A Medical Assistant (MA,) from Texas Health, asked if there are any concerns if a child that is less-than-7 years-old receives a dose of ADACEL instead of "DTAP?"  RA informed that since an AE occurred, I would like to gather additional information from her to document the call and submit an Adverse Event report to SANOFI PV Team  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: 60.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Off label use, Product availability issue
Clinical narrative: patient was originally supposed to receive Menquadfi however due to availability the patient received Menveo/ patient's PCP wrote a prescription for a 2 dose primary vaccination 8 weeks apart and a booster dose with no reported AE.; Initial information received on 25-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 60 years old male patient who was originally supposed to receive MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] however due to availability the patient received MENVEO/ patient's pcp wrote a prescription for a 2 dose primary vaccination 8 weeks apart and a booster dose 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 MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE(Solution for injection) (lot number, expiry date, strength, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation).   On an unknown date, the patient received an unknown dose of suspect MENVEO not produced by Sanofi Pasteur (lot number, expiry date, strength, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation).   On an unknown date the patient was originally supposed to receive menquadfi however due to availability the patient received menveo/ patient's pcp wrote a prescription for a 2 dose primary vaccination 8 weeks apart and a booster dose with no reported ae. (off label use) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and (unknown latency) following the administration of MENVEO.  Action taken: not applicable.  Outcome: Unknown
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: patient was administered an extra dose of fluzone high dose qiv with no reported adverse event; Initial information received on 25-Jan-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 79 years old female patient where patient was administered an extra dose of fluzone high dose qiv with no reported adverse event while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 26-Oct-2022 patient received 0.7 ml daily (QD) dose of suspect influenza quadrival a-b high dose hv vaccine (batch number- UJ933AC) via intramuscular route in the left arm (formulation, strength and expiration date: not provided) as Immunization and on 17-Nov-2022, the patient also received same vaccine lot number not reported via intramuscular route in the right arm.   On 17-Jan-2023 the patient was administered an extra dose of fluzone high dose qiv with no reported adverse event (incorrect dose administered) 2 months 22 days following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken- Not applicable.  At time of reporting, the 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.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: DTaP-IPV component of PENTACEL was administered without the Hib component with no reported adverse event; DTaP-IPV component of PENTACEL was administered without the Hib component with no reported adverse event; Initial information was received on 25-Jan-2023 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 18 months old male patient, the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was administered without the hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2023, the patient received a booster 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine without the hib component (lot number: UJ841AA, expiry date: 19-Feb-2024) via intramuscular route in the right thigh for immunisation with no reported adverse event (product preparation error) and (incorrect dose administered) (latency: same day)  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01462770:
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of TENIVAC was administered ,with no reported adverse event; Initial information received on 25-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old female patient tp whom expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac] was administered ,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2023, the patient received a expired 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) with no reported adverse event (expired product administered) (lot U6922AA, expiry date: 25-JAN-2023 and strength not reported) via intramuscular route in left deltoid as immunization.  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 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: 66.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired TENIVAC was administered with no reported AE; Initial information received on 26-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 66 years old male patient who experienced expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] was administered with no reported AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jan-2023, the patient received a 0.5 ml (frequency: once), dose of expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with no reported AE (strength and formulation: unknown, expiry date: 22-Jan-2023, lot U6922AA) via intramuscular route in the left deltoid as immunization (expired product administered).  No lab data was reported.  Action taken:  not applicable.  It was not reported if the patient received a corrective treatment for the event.  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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 042J21A and 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Feb-2022, received third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live non significant Follow up received; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    Concomitant medication was not provided. Treatment medication was not provided   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live  Non significant Follow up received: no new medically significant information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Immunisation reaction, Insomnia
Clinical narrative: Covid signs and symptoms as Cough, Headache, Fatigue which are all ongoing; strong Reaction to it / Reaction to Covid vaccine; Insomnia; Generalized Weakness; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid signs and symptoms as Cough, Headache, Fatigue which are all ongoing), IMMUNISATION REACTION (strong Reaction to it / Reaction to Covid vaccine), INSOMNIA (Insomnia) and ASTHENIA (Generalized Weakness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis and Vertigo.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid signs and symptoms as Cough, Headache, Fatigue which are all ongoing), IMMUNISATION REACTION (strong Reaction to it / Reaction to Covid vaccine), INSOMNIA (Insomnia) and ASTHENIA (Generalized Weakness). At the time of the report, COVID-19 (Covid signs and symptoms as Cough, Headache, Fatigue which are all ongoing), IMMUNISATION REACTION (strong Reaction to it / Reaction to Covid vaccine), INSOMNIA (Insomnia) and ASTHENIA (Generalized Weakness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient had a strong reaction to covid vaccine which delayed her getting her Ocrevus Infusion. She described the symptoms of the reaction as being worse than having Multiple Sclerosis. The HCP wanted her to go ahead and get another covid vaccine, but she was unsure if she would get another one or not and would discuss it when she sees the Doctor again. The patient also had chills, but they have resolved. Patient stated that she felt she just needed a good night's sleep and would feel some better.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2023: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 176th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Hyperhidrosis, Immediate post-injection reaction, Presyncope, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Near syncopal event immediately after injection, pt was assisted to lye down with feet up and observed in clinic for 30 minutes. Pt. recovered without issue and was ambulatory and reported feeling better upon leaving clinic. BP was 100/70, heart rate 80.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Near syncopal event immediately after injection, pt was assisted to lye down with feet up and observed in clinic for 30 minutes. Pt. recovered without issue and was ambulatory and reported feeling better upon leaving clinic. BP was 100/70, heart rate 80.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Headache, Lethargy, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Brief < 10 second syncope episode after flu vaccine administration today. EMS activated, patient able to recover in clinic after approximately 15 minutes. Discharged home in stable condition. Patient refused EMS transport to hospital.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 91.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Computerised tomogram head normal, Confusional state, Cough
Clinical narrative: COVID+ 1/21/2023.  Vaccination Status - Moderna x2, Pfizer x1 + Pfizer BIVALENT Booster x1 Admission Date: 1/21/2023 Discharge Date: Jan 27, 2023   Active Hospital Problems   Diagnosis Date Noted POA ? COVID-19 01/21/2023 Yes ? Dysarthria 07/06/2019 Yes ? Mild vascular dementia without behavioral disturbance, psychotic disturbance, mood disturbance, or anxiety 03/21/2019 Yes ? History of stroke 01/01/2009 Yes  DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Slurred speech  Hypoxia  COVID-19 virus infection  COVID-19    HOSPITAL COURSE: 91 year-old male. history of vascular dementia, CVAs, HLD, and dysphagia (from CVAs) who is a long-term care patient.  presented with cough and confusion as well as slurred speech and nausea with retching. he was noted to be hypoxic, requiring 2-3 L nasal cannula. COVID test was positive. he was admitted, started on remdesivir and decadron. on admission patient noted to have increasing confusion which quickly improved to baseline mental status. CT head without acute deficits and evaluated by neurology without further neurological workup. symptoms improved and he was able to be weaned down to 1L. patient cleared for discharge, requiring 1L with his only complaint being an improving cough and some debility. patient's daughter disputed discharge primarily because she did not want the patient to go back to his previous facility as she had issues with the facility but also did not want him to go back to a COVID unit where she was concerned he might get sicker; it was re-iterated that from e medical standpoint the patient remained medically cleared and that his discharge plan was felt to be safe and sufficient. patient finished his course of remdesivir and was discharged on the remainder of his ten day course of decadron; daughter had mentioned during one of numerous calls to our CM that she was under the impression a patient had to stay inpatient for decadron, she was told this is not the case. patient's discharge was delayed because daughter disputed discharge, citing she did not want him to go back to that facility, patient was discharged 1/27. CONSULTS:   neurology (neuro)