chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID on 15Nov2021; COVID on 15Nov2021; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9205), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 30125BA) at the age of 72 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "minor arrhythmia" (ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; CALCIUM + VITAMIN D3; METOPROLOL SUCCINATE taken for arrhythmia (ongoing). Past drug history included: Mynocin, reaction(s): "Allergies:mynocin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Nov2021, outcome "unknown" and all described as "COVID on 15Nov2021".Clinical course: Patient took dose 1, dose2, dose 3 in afternoon.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400031234 same patient/drug, different dose/events;
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: I took 2 pfizer Covid vaccines and 1 booster. They ruined my heart.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have never been a smoker" (unspecified if ongoing); "haven't had any alcohol since I was in my 20's" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (medically significant), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "I took 2 pfizer Covid vaccines and 1 booster. They ruined my heart.". Clinical course: Patient exercise on a regular basis and was not overweight. Patient never had any heart issues. Patient's father just passed last year at 95 and it was not due to his heart. Patient's mother was currently 91, living with dementia, but going strong.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: We both have had covid  3 times. The 1st time was 02Aug2021; We both have had covid  3 times. The 1st time was 02Aug2021; This is a spontaneous report and received from Consumer or other non HCPs.  A 67-year-old female patient received BNT162b2 (COMIRNATY), on 22Jan2021 as dose 1, single (Lot number: FL3302) and on 12Feb2021 as dose 2, single (Lot number: EL9263, Expiration Date: 31May2021) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 02Aug2021, outcome "unknown" and all described as "We both have had covid  3 times. The 1st time was 02Aug2021". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with monoclonal antibody treatments.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400087959 Same reporter, product , AE different patient;US-PFIZER INC-202400053123 Same patient /suspect product different dose;
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFib; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "AFib". Clinical course: Patient watched a video of a child involved in Pfizer covid vaccine and quite alarmed by it. It was on (withheld). Patient also had a covid vaccine provided by his employer that Pfizer created. Were can patient get risk assessment of what his afib could have been caused by it.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 0.25
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MENQUADFI was administered to a child < 2yrs of age with no reported adverse event; Initial information received on 08-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient who was administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] < 2yrs of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live oral 1V (Rotarix); diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid (Vaxelis); and pneumococcal vaccine CONJ 20V (CRM197) (pneumococcal vaccine CONJ 20V (CRM197)) all for Immunisation.  On an unknown date the patient was administered meningococcal A-C-Y-W135 (T CONJ) vaccine (lot: U7938AB; expiry date: 28-Feb-2025; frequency: once; strength; standard) at < 2yrs of age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) via unknown route in the right thigh for Immunisation.  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: 1.25
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: ADACEL  was administered to the patient of 15 months with no reported adverse event.; patient received adacel instead of daptacel with no adverse event; Initial information received on 11-Apr-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 15 months old female patient who was administered Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] instead of Daptacel with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB Vaccine CONJ (TET TOX) (ACT HIB) for Immunisation.  On 11-Apr-2024, the patient was administered 0.5 ml (dose 1) of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot U7905AA, expiry date: 03-Oct-2025, strength not reported) via intramuscular route in the right thigh instead of Daptacel with no adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency: same day) for Immunization.  Reportedly, Patient was supposed to receive her 4th dose of Daptacel.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered a Daptacel that expired on the 6th of April with no reported adverse event; Initial information received on 11-Apr-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age/gender patient who was administered a Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] that expired on the 6th of april 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 unknown dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) that expired on the 6th of april with no reported adverse event (expired product administered) (latency: same day) (lot number, expiry and strength not reported) via unknown route in unknown administration site for Immunization. Information regarding batch number will be requested in this case.  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: 53.0
Sex: F
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: MENQUADFI that expired in February was administered to a patient, with no reported adverse event; Initial information received on 11-Apr-2024 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves a 53 years old female patient who was administered Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] that expired in February 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 Varicella Zoster Vaccine RGE (CHO) (Shingrix), Hepatitis A Vaccine INACT, Hepatitis B Vaccine RHBSAG (Yeast) (Twinrix) and Varivax for Prophylactic vaccination.  On 07-Apr-2024, the patient was administered 0.5 ml (dose1) of Meningococcal A-C-Y-W135 (T CONJ) Vaccine (Solution for injection) (lot U7046AA, frequency: once, strength: standard) via intramuscular route in the left arm that expired in 28-Feb-2024 with no reported adverse event (expired product administered) (latency: same day) for Immunization.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administered DAPTACEL instead of the prescribed ADACEL to an adult patient, with no reported adverse event; inadvertently administered DAPTACEL instead of the prescribed ADACEL to an adult patient, with no reported adverse event; Initial information received on 12-Apr-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves Adult unknown gender patient who was inadvertently administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] instead of the prescribed Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] 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 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) instead of prescribed adacel to an adult patient, with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day) (lot number, expiry and strength not reported) via unknown route in unknown administration site for Immunization. Information regarding batch number will be requested in this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a staff member inadvertently administered DAPTACEL instead of the prescribed ADACEL to an adult patient with no reported adverse event; Initial information received on 12-Apr-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves Adult and unknown gender patient who was inadvertently administered with Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] instead of the prescribed Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] 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 had inadvertently received (dose and units unknown) suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot number, strength and expiry date not reported) via unknown route in unknown administration site for immunization instead of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot number, strength and expiry date not reported) with no reported adverse event (wrong product administered) (latency: same day).  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: 4.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Product storage error; This spontaneous report was received from medical assistant (MA) (also reported as office coordinador), concerning a 4-year-old male. The patient had private insurance and facility was a public clinic.   The patient's medical history was not reported. The patient's concurrent conditions included  autism spectrum disorder,  cognitive disorder, and speech delay. Concomitant medications included vitamin d nos and cyproheptadine hydrochloride.  On 11-JAN-2024, the patient was vaccinated by MA with improperly stored of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, administered in the left thigh subcutaneously for prophylaxis (lot number W025567 has been verified to be valid, expiration date not reported but upon internal validation established as 14-AUG-2024) (albumin status recombinant human albumin). No other vaccines given on that same day or 4 weeks prior. No adverse event reported.   This is one of the several cases created from the same source.
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Product storage error; This spontaneous report was received from medical assistant (MA) (also reported as office coordinator), concerning a 13-month-old male. The facility was a public clinic.   The patient's medical history was not reported. The patient's concurrent conditions included  cradle cap.   On 05-JAN-2024 (conflicting information reported as 05-JAN-2023), the patient was vaccinated by MA with an improperly dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, unk, (lot #W028536, has been verified to be valid, expiration date: 12-MAY-2025), administered intramuscularly  in the left vastus lateralis (LVL) for prophylaxis (strength was not provided). On that same day, he received hepatitis a vaccine inact (HEP A IN VAC) and influenza vaccine (FLU VACCINE VII) (dose, frequency, route, anatomical location, lot number and expiration date were not reported) as prophylaxis. No adverse event reported.   This is one of the several cases created from the same source.
Sex: U
Vaccine: RSV
Symptoms: Insurance issue, Pulmonary hypertension
Clinical narrative: pulmonary hypertension; This serious case was reported by a consumer via interactive digital media and described the occurrence of pulmonary hypertension in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pulmonary hypertension (Verbatim: pulmonary hypertension) (serious criteria GSK medically significant). The outcome of the pulmonary hypertension was unknown.   It was unknown if the reporter considered the pulmonary hypertension to be related to Arexvy.     It was unknown if the company considered the pulmonary hypertension to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 The patient was suffering from pulmonary hypertension severely so he/she can get something to help get that back under control. It would help the patient in the long run because the outcome of it was not and the patient just not quite ready yet for the outcome. Medication was hard to come by right now. Patient's insurance company was fighting with the doctor on a prescription that the doctor says he/she mean it did not want to pay for it.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "Persistent moderate asthma" (unspecified if ongoing); "Intolerance to dairy" (unspecified if ongoing); "Hypothyroidism with removed thyroid" (unspecified if ongoing); "Hypothyroidism with removed thyroid" (not ongoing). The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Drug allergy"; Lidocaine, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "recovered" (07Apr2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2024) negative; (08Apr2024) negative; (09Apr2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 01Apr2024 to 05Apr2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5  in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiac sarcoidosis" (unspecified if ongoing); "Immunocompromised state" (unspecified if ongoing); "History of ventricular tachycardia" (unspecified if ongoing); "History of fibrillation" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Allergic to captopril, reaction(s): "Drug Allergies: Captopril"; Dapsone medications, reaction(s): "Drug allergies:Dapsone". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "recovered" (Apr2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Apr2024 to 09Apr2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate high blood pressure" (unspecified if ongoing); "Lactose intolerance" (unspecified if ongoing), notes: Not allergic. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 04Apr2024 to 08Apr2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Illness
Clinical narrative: Weakness; sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: The reporter is the patient. The patient complained of weakness and sick for days after receiving Pfizer vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event, Product preparation error
Clinical narrative: two-month-old baby received a double DTaP-IPV dose and then just one HIB component with no reported adverse event; 2-month-old was only given the dtap and ipol portion of vaccine, initially reported to HCP that they were only gave a Diluent, with no reported adverse event; Initial information received on 11-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 months old male patient who had received a double Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] dose and then just one hib component and was only given the dtap and ipol portion of vaccine, initially reported to hcp that they were only gave a diluent, 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 HEPATITIS B VACCINE; PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20); and ROTAVIRUS VACCINE.  On an unknown date, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (Frequency: twice, strength: standard and lot UJ849AA) via intramuscular route in the left thigh as immunization and received a double dtap-ipv dose and then just one hib component with no reported adverse event (extra dose administered); only given the dtap and ipol portion of vaccine, initially reported to hcp that they were only gave a diluent (product preparation error) (same day latency).   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: 1.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: None - gave Kinrix instead of Hep A
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blindness, Chest pain, Dizziness, Eye irritation, Headache
Clinical narrative: patient came to pharmacy reporting severe reaction to vaccine- headaches, dizziness, chest pain, runny nose, sore throat, fever, muscle aches all over body, and insomnia. patient stated his vision was almost gone and he could not even get up to take himself to hospital. patient seemed much better during visit but RPh could tell his eyes were irritating him . counseled him to see PCP ASAP
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Insomnia, Myalgia, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: patient came to pharmacy reporting severe reaction to vaccine- headaches, dizziness, chest pain, runny nose, sore throat, fever, muscle aches all over body, and insomnia. patient stated his vision was almost gone and he could not even get up to take himself to hospital. patient seemed much better during visit but RPh could tell his eyes were irritating him . counseled him to see PCP ASAP
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: red area on left deltoid. patient said it does not itch. she is not having trouble breathing. may be growing.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Electrocardiogram normal, Loss of consciousness, Musculoskeletal stiffness, Syncope
Clinical narrative: Patient had a syncopal episode and loss of consciousness approximately 5 minutes after receiving vaccines. Patient's body stiffened and she did not respond to verbal cues and physical touch. Patient was able to regain consciousness within less than a minute. Patient alert upon waking. Vital signs stable.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Administration site pain, Injection site pain, Pain in extremity
Clinical narrative: Patient called on 04/12/2024 to report of on-going  soreness in the area of administration for her HPV vaccine. She received her 1st dose of the Gardasil-9 on 08/13/2023. She states she experienced a bit of pain the days receiving the vaccine but nothing really bothersome to prevent her from receiving the 2nd dose (10/19/2023). She didn't report of the pain prior to her 2nd dose and proceeded to receive the 2nd dose in the same arm as before. She calls back after almost 6 months with a chief complaint of pain in the injection arm, particularly the injection site area. Experiences it more when she wakes up, possibly from sleeping on the side with the pain. She has tried several OTC options like motrin, tylenol, aleve, warm compress but to no avail. The site isn't swollen or red but just soreness that doesn't seem to go away. She's yet to see her PCP for treatment; she would update pharmacy when she does.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: PATIENT SAID IT STARTED ON SUNDAY 4/14/24 AND GRADUALLY INCREASED FOLLOWING SYMPTOMS IN LEFT LEG, NUMBNESS AND WEAKNESS.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hyperhidrosis, Pain, Productive cough, Pyrexia
Clinical narrative: Six days  following immunization patient phoned clinic to report within 24 hours of immunization fever 102F, sweating, headache, vomiting, some phlegm, body aches all over. Fever broke day 4. Pain and bodyaches continued with improvement day 6. Patient declined follow up visit.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Six days  following immunization patient phoned clinic to report within 24 hours of immunization fever 102F, sweating, headache, vomiting, some phlegm, body aches all over. Fever broke day 4. Pain and bodyaches continued with improvement day 6. Patient declined follow up visit.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Magnetic resonance imaging heart abnormal, Myocarditis
Clinical narrative: Constrictive pericarditis and myocarditis, progressive shortness of breath, chest pressure, fatigue, hospitalizations and is still present
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pericarditis constrictive
Clinical narrative: Constrictive pericarditis and myocarditis, progressive shortness of breath, chest pressure, fatigue, hospitalizations and is still present
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Abnormal behaviour, Blood culture negative, C-reactive protein increased, Chest X-ray abnormal, Culture urine negative
Clinical narrative: Patient received vaccines around 1:30p on 4/10/2024. The following evening, 4/11/2024, patient was "acting off", thus mother took temperature and reportedly was 104.9 rectally, and was taken to the ER d/t temperature
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Gastrointestinal tube insertion, Immunisation reaction, Liver function test normal, Pyrexia, Rotavirus test positive
Clinical narrative: Patient received vaccines around 1:30p on 4/10/2024. The following evening, 4/11/2024, patient was "acting off", thus mother took temperature and reportedly was 104.9 rectally, and was taken to the ER d/t temperature
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Thermometry abnormal, Urine analysis normal, Viral infection, White blood cell count increased
Clinical narrative: Patient received vaccines around 1:30p on 4/10/2024. The following evening, 4/11/2024, patient was "acting off", thus mother took temperature and reportedly was 104.9 rectally, and was taken to the ER d/t temperature
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Product storage error
Clinical narrative: MODERNA VACCINE BOOSTER GIVEN  14 DAY PAST FRIDGE EXPIRATION DATE, , VACCINE IS IN DATE TILL END OF APRIL BUT WAS IN FRIDGE FOR 14 DAYS PAST 30 DAY MARK WHEN MOVED FROM FREEZER
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Immune system disorder, Injection site reaction, Local reaction
Clinical narrative: Pt wanted to let us know that after her visit on 4/9/2024 when she returned home that evening she started to experience an adverse reaction to her Tdap vaccine. Pt went to UC on 4/13/2024 for chills, fever, swelling, tenderness, and redness that she had been experiencing for 5 days. UC notes states "Delayed local reaction along with immune response reaction to the Tdap vaccine. Reassured patient that this is unlikely to happen again as it is not a significant anaphylactic reaction. No sign of cellulitis on exam today. Recommend Tylenol and ibuprofen as needed for pain and inflammation. Recommend increasing fluid and rest. Can try cool compresses as well to the local site reaction. She will continue to monitor for secondary cellulitis and return for reevaluation if any concerning signs or symptoms occur. "   Pt reports she's feeling better, no fever, no chills, still a little sore, red, swollen, and warm to touch. Pt will call us if symptoms worsen.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Skin reaction, Skin warm, Swelling
Clinical narrative: Pt wanted to let us know that after her visit on 4/9/2024 when she returned home that evening she started to experience an adverse reaction to her Tdap vaccine. Pt went to UC on 4/13/2024 for chills, fever, swelling, tenderness, and redness that she had been experiencing for 5 days. UC notes states "Delayed local reaction along with immune response reaction to the Tdap vaccine. Reassured patient that this is unlikely to happen again as it is not a significant anaphylactic reaction. No sign of cellulitis on exam today. Recommend Tylenol and ibuprofen as needed for pain and inflammation. Recommend increasing fluid and rest. Can try cool compresses as well to the local site reaction. She will continue to monitor for secondary cellulitis and return for reevaluation if any concerning signs or symptoms occur. "   Pt reports she's feeling better, no fever, no chills, still a little sore, red, swollen, and warm to touch. Pt will call us if symptoms worsen.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Pt wanted to let us know that after her visit on 4/9/2024 when she returned home that evening she started to experience an adverse reaction to her Tdap vaccine. Pt went to UC on 4/13/2024 for chills, fever, swelling, tenderness, and redness that she had been experiencing for 5 days. UC notes states "Delayed local reaction along with immune response reaction to the Tdap vaccine. Reassured patient that this is unlikely to happen again as it is not a significant anaphylactic reaction. No sign of cellulitis on exam today. Recommend Tylenol and ibuprofen as needed for pain and inflammation. Recommend increasing fluid and rest. Can try cool compresses as well to the local site reaction. She will continue to monitor for secondary cellulitis and return for reevaluation if any concerning signs or symptoms occur. "   Pt reports she's feeling better, no fever, no chills, still a little sore, red, swollen, and warm to touch. Pt will call us if symptoms worsen.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Vaccination error
Clinical narrative: Box of Rotarix had all diluent syringes gone, but 1 vial vaccine left in box can not rule out that this patient received 1st dose of 2 dose series of rotarix
Age: 0.42
Sex: F
Vaccine: RV1
Symptoms: Vaccination error
Clinical narrative: Box of Rotarix has all diluent syringes gone, but 1 vial vaccine left in box. Can not rule out that this patient received 2nd dose of 2 dose series. Did receive 1st dose @ 2months
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Unevaluable event
Clinical narrative: Box of rotarix had all diluent syringes gone, but 1 vial vaccine left in box. cant rule out that this patient received 1st dose of 2 dose series. Did receive 2nd dose 1/5/2024
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommende by the CDC.
Age: 2.5
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was imprperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended bu the CDC.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 0.25
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 1.17
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Reported Symptoms: Narrative: Other Relevant HX: Other:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Left atrial appendage closure implant, Palpitations, Pneumonia, Pruritus
Clinical narrative: Reported Symptoms: 10033556:PALPITATION; 10037087:PRURITUS; 10037844: RASH; 10040047:SEPSIS; Narrative: The patient received 4 doses of Moderna COVID 19 Vaccine (Feb/Mar/Nov 2021 and May 2022) and one dose Moderna Mar 2024. The patient experienced a rash and itching after receiving the Moderna COVID 19 vaccine, which was documented on 14 March 2024. On 21 March 2024, the patient presented to the Emergency Department with atrial fibrillation, sepsis, and pneumonia. The patient was admitted to the hospital and treated with diltiazem, antibiotics, and inhalers. The patient was discharged in stable condition, but with persistent atrial fibrillation status post watchman device. Other Relevant HX: Other: sepsis
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Sepsis
Clinical narrative: Reported Symptoms: 10033556:PALPITATION; 10037087:PRURITUS; 10037844: RASH; 10040047:SEPSIS; Narrative: The patient received 4 doses of Moderna COVID 19 Vaccine (Feb/Mar/Nov 2021 and May 2022) and one dose Moderna Mar 2024. The patient experienced a rash and itching after receiving the Moderna COVID 19 vaccine, which was documented on 14 March 2024. On 21 March 2024, the patient presented to the Emergency Department with atrial fibrillation, sepsis, and pneumonia. The patient was admitted to the hospital and treated with diltiazem, antibiotics, and inhalers. The patient was discharged in stable condition, but with persistent atrial fibrillation status post watchman device. Other Relevant HX: Other: sepsis
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Mobility decreased, Respiratory distress
Clinical narrative: Reported Symptoms: 10028411:MYALGIA; 10038687:RESPIRATORY DISTRESS; Narrative: Patient stated that his knees were so painful after vaccine administration that he was unable to walk for 2 days and had to remain in bed. Other Relevant HX: Other: ACUTE RESPIRATORY DISTRESS
Sex: F
Vaccine: RSV
Symptoms: Device connection issue, No adverse event
Clinical narrative: Reported Symptoms: 10067482:NO ADVERSE EVENT; Narrative: Received via email: One of the nurses here at the facility was giving an RSV vaccine (Lot #HM9851) and the hub came apart and would not stay intact. She discarded the vaccine and obtained another one to administer to the pt. Other Relevant HX: Other: NONE
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: Reported Symptoms: 10003658:ATRIAL FIBRILLATION; 10033556:PALPITATION; Narrative: The patient received 3 Pfizer COVID 19 vaccines (Jan/Feb 2021 and Apr 2022) and 1 Moderna COVID 19 Vaccine 11/13/23. After receiving the Moderna COVID 19 Vaccine, the patient experienced atrial fibrillation within 24hours. The patient's heart rate was 155. He went to the Hospital Emergency Department. The Cardiology physician started the patient on propafenone, which did not work as well to maintain sinus rhythm. The patient was changed to amiodarone 200mg daily. Other Relevant HX: Other: Atrial fib
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Electroencephalogram normal, Pruritus, Seizure
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10049604:SHORTNESS OF BREATH; Narrative:  Patient received influenza vaccine 3/26/24. PT experienced itching and convulsions and was prescribed diphenhydramine and famotidone 20mg po BID to help with itching. EEG was performed and no seizures were detected. In ED pt receved methylprednisolone 125mg IV and famotidine 20g IV and diphenhydramine 25mg IV. Other Relevant HX: Other: SHORTNESS OF BREATH
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX:
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Reported Symptoms: 10002424:ANGIOEDEMA; Narrative: Other Relevant
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paresis, Hypoaesthesia, Muscular weakness
Clinical narrative: Reported Symptoms: 10028411:MYALGIA; 10029829:NUMBNESS; Narrative: The patient received Pfizer COVID 19 Vaccine on 8/9/21 and 8/31/21. The patient presented to the clinic on 16 September 2021 complaining of muscle weakness and facial weakness to the left side. The patient again went to the hospital 12 Oct 2021 for the same symptoms. The patient described the feeling like novocaine. The patient continues to have numbness potentially due to the COVID 19 vaccines in his left hand and face since Sep 2021, and is currently seen by neurology. Other Relevant HX: Other: left face and hand numbness