chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Pulmonary function test
Clinical narrative: asthma, symptoms were more pronounced than usual; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 45-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Aug2024 at 09:50 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Asthma" (unspecified if ongoing); "Immune deficiency" (unspecified if ongoing), notes: slight, is not severe. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE; Lot number: unknown), administration date: Sep2022, for Covid-19 Immunization. The following information was reported: ASTHMA (non-serious) with onset 07Aug2024 at 11:20, outcome "recovering", described as "asthma, symptoms were more pronounced than usual". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthma.  Additional information: The patient received the covid 19 vaccine (Pfizer Comirnaty 2023-2024 product) today at 950am and about 1.5 hours later, she started getting asthma symptoms. She had chronic asthma as a pre-existing condition. It's probably coincidental and she was not sure it was related to the vaccine, but symptoms were more pronounced than usual. She stated that it was a little bit more pronounced at the time. Now, it was actually better. When having it, it was pronounced more than usual but, was better now, had improved since then. She had been fine with previous vaccines before. She doesn't think it's an allergy to product since it was getting better, not worse. The patient weighs around 219. No treatment was given. She took Prilosec for other issues. Did not take anything for this since she thinks it would conflict with this. She also just had pulmonary function testing recently and did not show anything. She does not know if that was relevant. When asked about Pfizer/BioNtech COVID-19 vaccine details, she does not remember names of any of them. She had full range, and this was the last of the series. The dates, NDC, lot number and expiration of previous covid vaccines were unknown. The last one she got was Sep2022. Discussed per PI and attached VR noting no specific information on use with Ventolin inhaler but shared information re: "Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to COMIRNATY." Also shared relevant data that no specific information on 'asthma' or use in patients with asthma but shared per CONS doc. Signs of a severe allergic reaction can include difficulty breathing and referred to HCP for further discussion or recommendations.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Redness at injection site; itchiness at injection site; bumps at injection site; This is a spontaneous report received from an Other HCP.  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Jul2024 at 10:00 as dose 1, single (Lot number: HL3888) at the age of 66 years, in left arm for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 24Jul2024, outcome "unknown", described as "Redness at injection site"; VACCINATION SITE RASH (non-serious) with onset 24Jul2024, outcome "unknown", described as "bumps at injection site"; VACCINATION SITE PRURITUS (non-serious) with onset 24Jul2024, outcome "unknown", described as "itchiness at injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pruritus, vaccination site rash.  Additional information: Treatment received for the adverse events included Cetirizine, Betamethasone Dipropionate 0.05 Percent. Patient had NKDA (No known drug allergy). The patient did not receive any other vaccines on the same date as the Prevnar 20 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the Prevnar 20 vaccine.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Redness, itchiness and bumps at the injection site; Redness, itchiness and bumps at the injection site; Redness, itchiness and bumps at the injection site; This is a spontaneous report received from an Other HCP.  A 65-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Lot number: HL3888), in left arm for immunisation. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: NKDA. There were no concomitant medications.  The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 29Jul2024, outcome "unknown" and all described as "Redness, itchiness and bumps at the injection site". Therapeutic measures were taken as a result of vaccination site mass, vaccination site erythema, vaccination site pruritus.  Additional information: Patient received vaccination on left upper arm. Vaccine was administered at doctor's office/urgent care. Patient did not receive any other vaccines on the same date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not take any other medications within 2 weeks of the event. Patient had received Cetirizine, Triamcinolone Acetonide 0.1% Cream as treatment for the adverse events. There was no hospitalization prolonged.
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: His wife had a sudden onset of a severe case of Psoriatic Arthritis shortly after receiving the booster or 3rd dose of the original Covid-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), 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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PSORIATIC ARTHROPATHY (disability), outcome "unknown", described as "His wife had a sudden onset of a severe case of Psoriatic Arthritis shortly after receiving the booster or 3rd dose of the original Covid-19 vaccine". Therapeutic measures were taken as a result of psoriatic arthropathy. Clinical Course: The reporter mentioned that his wife had a sudden onset of a severe case of Psoriatic Arthritis shortly after receiving the booster or 3rd dose of the original Covid-19 vaccine which she never had been diagnosed with prior to the vaccine. Wife is a physician. It was unknown if patient received other vaccine on same date or in four weeks and unknown if received other medications in two weeks.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Then had Covid a second time at the beginning of this year.; Then had Covid a second time at the beginning of this year.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: MEN6201), on 09Mar2021 as dose 2, single (Lot number: ENU199) and on 15Oct2021 as dose 3 (booster), single (Lot number: 30125BA) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: CC2M214) for covid-19 immunisation. The patient's relevant medical history included: "one kidney", start date: 2017 (unspecified if ongoing), notes: Caller has one kidney, sees kidney doctor, had tumor on it so had to have kidney removed; "tumor", start date: 2017 (unspecified if ongoing), notes: tumor was cancerous, sent to try to save but because was so large could not save the kidney. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Then had Covid a second time at the beginning of this year.". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Received multiple doses of Pfizer COVID vaccine, except one dose received was Moderna COVID vaccine. Unknown how many doses total had of Pfizer COVID vaccine because was told they were no longer writing down information on CDC vaccination card. Thinks probably had some doses of Pfizer COVID vaccine and Moderna COVID vaccine before having Covid. First had Covid when everybody had Covid, then had Covid a second time at beginning of this year, this is third time having Covid,  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I sit here at home today ill with COVID; I sit here at home today ill with COVID; This is a spontaneous report received from a Consumer or other non HCP.  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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I sit here at home today ill with COVID".  Clinical course: The patient stated that I have received all my COVID vaccines and yet I sit here at home today ill with COVID. This is disappointing.
Sex: F
Vaccine: COVID19, TD
Symptoms: Atrophy, Influenza like illness, Injected limb mobility decreased, Muscular weakness, Vaccination site pain
Clinical narrative: atrophied to lost full mobility of right upper arm to wrist; atrophied to lost full mobility of right upper arm to wrist; cannot carry and hold anything and has lowered; flu like sickness; arm has just started to subside from the pain/pain did not start until almost a week after shots; Initial information received on 02-Aug-2024 regarding an unsolicited valid serious case received from a physician.  This case involves an unknown age female patient who experienced atrophied to lost full mobility of right upper arm to wrist, cannot carry and hold anything and has lowered, flu like sickness and arm has just started to subside from the pain/pain did not start until almost a week after shots after receiving Comirnaty And Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac].  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 Glucose tolerance impaired, Fibromyalgia and Food allergy.  On 13-May-2024, the patient received 0.5 ml (dose 1) of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (with an unknown strength, expiry date, lot number) via intramuscular route in unknown administration site for immunization.  On 13-May-2024, the patient received 0.5 ml (dose 1) (Booster) of suspect Comirnaty not produced by Sanofi Pasteur (with an unknown strength, expiry date, lot number) via intramuscular route in unknown administration site for immunization.  On an unknown date in 2024, the patient developed atrophied to lost full mobility of right upper arm to wrist (atrophy) (injected limb mobility decreased), cannot carry and hold anything and has lowered (muscular weakness) (unknown latency). These events were leading to disability.  On an unknown date in 2024, the patient developed flu like sickness (influenza like illness) and arm has just started to subside from the pain/pain did not start until almost a week after shots (vaccination site pain) (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for the event vaccination site pain, was Unknown for the reported events; Sender's Comments: Sanofi company comment dated 12-Aug-2024: This case involves an unknown age female patient who experienced atrophied to lost full mobility of right upper arm to wrist, cannot carry and hold anything and has lowered, flu like sickness and arm has just started to subside from the pain/pain did not start until almost a week after shots after receiving Comirnaty And Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac]. Furthermore, information regarding condition at the time of vaccination excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 7.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of DAPTACEL to a patient belonging to a wrong age group (with no reported adverse event); Initial information received on 07-Aug-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 7 years old and unknown gender patient belonging to a wrong age group (with no reported adverse event) who was administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 05-Aug-2024, the patient received a unknown dose (dosage text: 1X) of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot 2CA77C1, Expiry date: 30-Sep-2025, strength was unknown) via unknown route in unknown administration site for Immunization and administration of daptacel to a patient belonging to a wrong age group (with no reported adverse event) (product administered to patient of inappropriate age) (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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: HIb powder was mixed with sterile water the solution that is used to dilute live virus vaccines (with no reported adverse event); Initial information received on 07-Aug-2024 regarding an unsolicited non-valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who had hib powder was mixed with sterile water the solution that is used to dilute live virus vaccines (with no reported adverse event) after receiving HIB (PRP/T) Vaccine [ACT-HIB].   On an unknown date, the patient received a unknown dose of suspect HIB (PRP/T) VACCINE (lot UK111AA , Expiry date: 31-Aug-2025, strength was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had hib powder was mixed with sterile water the solution that is used to dilute live virus vaccines (with no reported adverse event) (product preparation error) (unknown 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.
Sex: M
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: consumer receiving an expired yf-vax with no reported adverse event; Initial information received on 07-Aug-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age male patient receiving an expired yellow fever vaccine - [YF-VAX] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s)and family history were not provided.  On 07-Aug-2024, the patient received a 0.5 ml dose of suspect yellow fever vaccine -, Solution for injection (strength: unknown) (lot: UJ830AC, expiry date: 30-Jul-2024) via unknown route in unknown administration site as immunization and consumer receiving an expired yf-vax with no reported adverse event (expired 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: 56.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering an expired dose of tenivac to patients with no reported adverse event; Initial information received on 08-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked with several case Ids.  This case involves a 56 years old female patient who got administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Jan-2024, the patient received 0.5 ml booster dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (strength- standard) (lot- U7183AA and expiration date- 24-SEP-2023) via intramuscular route in the left deltoid (frequency: not provided) for Immunisation (expired 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: 67.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered with no reported adverse event; Initial information received on 08-Aug-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case Ids- 2024SA237418, 2024SA237469, 2024SA237702 and 2024SA237436  This case involves a 67 years old male patient to whom expired 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 05-Feb-2024, the patient received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT 0.5 ml TOTAL, Suspension for injection lot U7183AA expiry- 24-Sep-2023 via intramuscular route in the left deltoid for Immunization (strength unknown) with no reported adverse event (expired 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.; Sender's Comments:  US-SA-2024SA237418: US-SA-2024SA237469: US-SA-2024SA237702: US-SA-2024SA237436:
Age: 82.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of expired dose of TENIVAC with no adverse event; Initial information received on 08-Aug-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with case Ids- 2024SA237469, 2024SA237702, 2024SA237436  This case involves a 82 years old female patient with administration of expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Jun-2024, the patient received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, 0.5 ml TOTAL, Suspension for injection  lot U7183AA expiry- 24-Sep-2023 via intramuscular route in the left deltoid for Immunization (strength unknown) with no adverse event (expired 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.; Sender's Comments:  US-SA-2024SA237702: US-SA-2024SA237436: US-SA-2024SA237643:
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient came in for the routine vaccination and was given an expired menquadfi vaccine with no reported adverse event; Initial information received on 08-Aug-2024 regarding an unsolicited valid non-serious case received via nurse.  This case involves a 18-year-old male patient came in for the routine vaccination and was given an expired meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] vaccine with no reported adverse event.  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 meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (strength: unknown) (lot: U7299AB, expiry date: 04-Aug-2024) via unknown route in unknown administration site as immunization and patient came in for the routine vaccination and was given an expired menquadfi vaccine with no reported adverse event (expired 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: 3.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: inappropriate use due to the ACT-HIB that was diluted with just sterile water was administered to a patient with no adverse event; inappropriate use due to the ACT-HIB that was diluted with just sterile water was administered to a patient with no adverse event; Initial information received on 08-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient with inappropriate use due to the HIB (PRP/T) VACCINE [ACT-HIB] that was diluted with just sterile water was administered to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Aug-2024, the patient received HIB (PRP/T) VACCINE, 0.5 ml TOTAL, Powder and solvent for solution for injection lot UK111AA expiry- 31-Aug-2025 via intramuscular route in the right thigh for Immunization (strength unknown) that was diluted with just sterile water was administered to a patient with no adverse event (product preparation error) (poor quality 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: DTAPIPVHIB
Symptoms: Cough, Peripheral swelling, Urticaria
Clinical narrative: The child had swelling of the arm affected and hives. He also had a severe cough and I was concerned about airway compromise. I am concerend that receiving another dose will cause him more harm and possible futher allergic reaction.
Age: 20.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient had a vasovagal syncope 3-4 minutes after Anthrax and Typhoid was administered on the right arm. Patient states that he felt lightheaded before passing out, declines shortness of breath, throat swelling, numbness and/or tingling  sensation. Patient was unconscious for less than 10 seconds. Vitals were all normal.
Age: 13.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: DIFFUSE BODY RASH
Age: 1.25
Sex: F
Vaccine: PNC15
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose accidentally given. No side effects noted per parents. No fever or extra irritability. Appears to be her normal self now. Family worried about possible long term side effects of getting an extra dose.
Age: 59.0
Sex: M
Vaccine: YF
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: mild fever,nausea vomtting after 3 days
Age: 55.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a 3rd dose in what should have been a 2-dose series. Patient reports that he is fine at this time and has been instructed to contact us to report any side effects.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Parent reports 40mm in diameter, red, raised, painful lump at MMR II injection site. Vaccine was administered in subcutaneous tissue between left lateral thigh and buttock with 25G 1/2" needle. Patient Tmax 101 F on Saturday 8/10/24, relieved by Tylenol and Motrin. Provider recommended antihistamine therapy with Zyrtec or Benadryl combined with ice therapy to site. Plan of care reviewed with parent including: s/s worsening condition, return precautions, and when to go to ER. all parties verbalize understanding.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Laboratory test
Clinical narrative: Patient reported next day in the morning rapid heat beat so went to local ER and after multiple tests were ran, nothing wrong with heart adverse reaction to vaccine
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deafness unilateral, Magnetic resonance imaging normal, Tinnitus, Vertigo
Clinical narrative: Vertigo (24 hrs), tinnitus and unilateral hearing loss in RT ear, 2 rounds of oral steroids, 3 steroid injections, continued tinnitus and hearing loss
Age: 4.0
Sex: F
Vaccine: DTPPVHBHPB, MMRV
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: After about 24 hours swollen red and hard at I section site accompanied by fever and itchiness at injection site. Stayed the same until 72 hours it turned into a spotty rash at injection site and throught now 96 hours has stayed rhe same with the itch and spotty rash at injection site
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal mass, Uterine mass
Clinical narrative: Abdomina/uterine mass
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain oedema
Clinical narrative: was prescribed Paxlovid for Covid 19; was prescribed Paxlovid for Covid 19; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 06Aug2024, this case now contains all required information to be considered valid.   This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group, Program ID:.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), on 20Jan2021 as dose 2, single (Lot number: EL0140, Expiration Date: 31Mar2021), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "was prescribed Paxlovid for Covid 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: Caller wanted to know if there would be any interaction or reaction to taking paxlovid now as it happened before with the Covid vaccine. Patient was taking the Pfizer COVID shot. She took the Pfizer vaccine, the COVID shot and she said on the fourth one she did get an adverse event and that her brain swelled and she had go to the ER and she was wondering if she can, if it was still okay to take the Paxlovid, she was prescribed it. Patient did not received any other Vaccine on the same date and four weeks prior to COVID Vaccine. Lot EL0140 was captured in COMPLAINT 742251. Lot has been updated to Unknown. Originally reported lot numbers FJ9989 and EK973 does not appear to be a valid lot for the COVID vaccine. Lot has been updated to valid lot EL0140. Originally reported lot number FJ9989 does not appear to be a valid lot for the COVID vaccine. Lot has been updated to capture lot EK9730. Investigation Summary and Conclusion: (withheld) For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  Follow-up (06Aug2024 and 07Aug2024): This is a spontaneous follow-up report received from the same Consumer. Updated Information: Patient details, Relevant medical history, Suspect details, events added.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400231235 same patient, different dose/events;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: was prescribed Paxlovid for Covid 19; was prescribed Paxlovid for Covid 19; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 06Aug2024, this case now contains all required information to be considered valid.   This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group, Program ID:.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), on 20Jan2021 as dose 2, single (Lot number: EL0140, Expiration Date: 31Mar2021), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "was prescribed Paxlovid for Covid 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: Caller wanted to know if there would be any interaction or reaction to taking paxlovid now as it happened before with the Covid vaccine. Patient was taking the Pfizer COVID shot. She took the Pfizer vaccine, the COVID shot and she said on the fourth one she did get an adverse event and that her brain swelled and she had go to the ER and she was wondering if she can, if it was still okay to take the Paxlovid, she was prescribed it. Patient did not received any other Vaccine on the same date and four weeks prior to COVID Vaccine. Lot EL0140 was captured in COMPLAINT 742251. Lot has been updated to Unknown. Originally reported lot numbers FJ9989 and EK973 does not appear to be a valid lot for the COVID vaccine. Lot has been updated to valid lot EL0140. Originally reported lot number FJ9989 does not appear to be a valid lot for the COVID vaccine. Lot has been updated to capture lot EK9730. Investigation Summary and Conclusion: (withheld) For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  Follow-up (06Aug2024 and 07Aug2024): This is a spontaneous follow-up report received from the same Consumer. Updated Information: Patient details, Relevant medical history, Suspect details, events added.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400231235 same patient, different dose/events;
Age: 0.42
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Injection site reaction, Polymerase chain reaction positive, Rash, Rash papular, Skin lesion
Clinical narrative: again developed multiple lesions over the body / Rash type papulovesicular; developed lesions on leg / Rash type papulovesicular; HCP reports patient received VARIVAX on 9/26/2023 and developed lesions on leg in 1/2024. HCP reports those lesions had a pcr that was positive for Varicella Virus.; This spontaneous report was received from a physician referring to a 17-month-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 26-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, lot # X010531, expiration date not reported but upon internal validation established as 11-APR-2025, in the right thigh (strength and route of administration were not reported), as Immunization.    On 19-JAN-2024, the patient experienced rash papulovesicular (rash papular) in his leg. The patient's body temperature was 98.1 degrees Fahrenheit.  On an unspecified date in 2024, a polymerase chain reaction (PCR) was positive for Varicella virus (varicella virus test positive). No treatment was given to the patient. On an unreported date in 2024, the patient recovered from the events.   On 08-APR-2024, he was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) 0.5 mL, Lot # 05-JAN-2025 expiration date not reported but upon internal validation established as 05-JAN-2025, in the left thigh, as Immunization (strength and route of administration were not reported).    On 20-JUL-2024, the patient again developed multiple lesions scattered over body (rash papular). It was reported that there were more than 10 lesions including 3 in right elbow, 2 in his right leg, 2 lesions at forehead, 5 lesions in the right side and 1 lesion in the left side. Additionally, it was reported that the child had lesions on the right and left side of the forehead, described as a cluster of papular vesicles; also, had lesions on left forearm, right nasal crease and the skin had sluffed off the lesions. No itching was reported. A sample was collected on 24-JUL-2024 from a vesicle/lesion and papule. No treatment was given to the patient. On an unspecified date in 2024, the patient recovered from the event.           The causality assessment between the events and the suspect vaccines was not provided.
Age: 0.42
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: again developed multiple lesions over the body / Rash type papulovesicular; developed lesions on leg / Rash type papulovesicular; HCP reports patient received VARIVAX on 9/26/2023 and developed lesions on leg in 1/2024. HCP reports those lesions had a pcr that was positive for Varicella Virus.; This spontaneous report was received from a physician referring to a 17-month-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 26-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, lot # X010531, expiration date not reported but upon internal validation established as 11-APR-2025, in the right thigh (strength and route of administration were not reported), as Immunization.    On 19-JAN-2024, the patient experienced rash papulovesicular (rash papular) in his leg. The patient's body temperature was 98.1 degrees Fahrenheit.  On an unspecified date in 2024, a polymerase chain reaction (PCR) was positive for Varicella virus (varicella virus test positive). No treatment was given to the patient. On an unreported date in 2024, the patient recovered from the events.   On 08-APR-2024, he was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) 0.5 mL, Lot # 05-JAN-2025 expiration date not reported but upon internal validation established as 05-JAN-2025, in the left thigh, as Immunization (strength and route of administration were not reported).    On 20-JUL-2024, the patient again developed multiple lesions scattered over body (rash papular). It was reported that there were more than 10 lesions including 3 in right elbow, 2 in his right leg, 2 lesions at forehead, 5 lesions in the right side and 1 lesion in the left side. Additionally, it was reported that the child had lesions on the right and left side of the forehead, described as a cluster of papular vesicles; also, had lesions on left forearm, right nasal crease and the skin had sluffed off the lesions. No itching was reported. A sample was collected on 24-JUL-2024 from a vesicle/lesion and papule. No treatment was given to the patient. On an unspecified date in 2024, the patient recovered from the event.           The causality assessment between the events and the suspect vaccines was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no symptomatic adverse events; HCP calling to report a temperature excursion on 30-APR-2024; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The information regarding the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 30-APR-2024, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# X015245, expiry date 22-NOV-2024 underwent a temperature excursion (3 days and 23 hours at 74.4 Fahrenheit (F), with minimum temperature of 39.02 F and maximum temperature 74.84 F).  On 28-JUN-2024, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot# X015245, expiry date 22-NOV-2024, for prophylaxis (dose, route of administration and anatomical location were not reported) (product storage error). No previous temperature excursion was reported; and data logger was involved. Additionally, no symptomatic adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA013069:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse calling to report adverse event regarding improperly stored and administered dose of PROQUAD.  Nurse stated that the PROQUAD was exposed to multiple temperature excursions dating back to May 2024, and the dose was administered to a patient on 8; This spontaneous report was received from a nurse regarding to a 5-years-old patient of unspecified gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 02-AUG-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, at a dose of 0.5 milliliter (mL)/ two dose series (lot number X023400 had been verified to be valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [PROQUAD]), expiration date 20-MAR-2025; route of administration and anatomical injection site was not provided) for prophylaxis (product storage error). It was reported that the vaccine was previously exposed to multiple temperature excursions (on an unknown day in May 2024). No additional adverse event (AE)s or product quality complaint (PQC) reported (no adverse event).
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse calling to report adverse event regarding improperly stored and administered dose of PROQUAD.  Nurse stated that the PROQUAD was exposed to multiple temperature excursions dating back to May 2024, and the dose was administered to a patient on 8; This spontaneous report was received from a nurse regarding to a 5-years-old patient of unspecified gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 02-AUG-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection (lot number X023400 had been verified to be valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [PROQUAD]), expiration date 20-MAR-2025; dose, vaccination scheme, route of administration and anatomical injection site was not provided) for prophylaxis (product storage error). It was reported that the vaccine was previously exposed to multiple temperature excursions (on an unknown day in May 2024). No additional adverse event (AE)s or product quality complaint (PQC) reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP reported VARIVAX was administered after a temperature excursion to one patient. Date of administration: Aug 7, 2024. No further information provided. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): VAR; This spontaneous report was received from a registered nurse and refers to a unspecified age and gender patient.   No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 07-AUG-2024, the patient was vaccinated with an improper storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, once, lot #Y006524, expiration date: 25-MAR-2026 (upon internal validation it was assessed as valid lot number), administered for prophylaxis (strength, and route of administration were not provided). Vaccine was administered with a temperature of 68 degrees Fahrenheit with a time frame of 16 hours 15 minutes. There was no information about previous temperature excursion (product storage error). No adverse events reported.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediarix vaccine was given to an adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Pediarix vaccine was given to an adult). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-AUG-2024 The reporter called to report the following: The reporter was calling to get information regarding that Pediarix vaccine was given to an adult, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up. The reporter did not count with further information because she was not in the clinic where the adverse event occurred.