chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller and his wife used a Paxlovid prescription back in 19Sep; Caller and his wife used a Paxlovid prescription back in 19Sep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller and his wife used a Paxlovid prescription back in 19Sep". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller and his wife used a Paxlovid prescription back in 19Sep and it worked perfectly with no problems and wanted to know how long to wait before getting the new Pfizer Vaccination for Covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300172112 same reporter/product/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot
Clinical narrative: dizzy; Whole body got hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Time of vaccination: 14:30, Anatomical Site of injection: Left upper arm, Batch/Lot number: EW0151, Route of administration: Intramuscular), administration date: 06Apr2021, for COVID-19 Immunization, reaction(s): "No adverse effect"; bnt162b2 (DOSE 2, SINGLE, Time of vaccination: 14:30, Anatomical Site of injection: Left upper arm, Batch/Lot number: EW0151, Route of administration: Intramuscular), administration date: 27Apr2021, for COVID-19 Immunization, reaction(s): "No adverse effect"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Time of vaccination: 16:00, Anatomical Site of injection: Left upper arm, Batch/Lot number: FL3197, Route of administration: Intramuscular), administration date: 29Nov2021, for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; FEELING HOT (non-serious), outcome "unknown", described as "Whole body got hot".  Additional Information: After receiving dose 4, patient was not asked to wait. She had no adverse reactions to doses 1-3. As she walked away she got dizzy and her whole body got hot, starting at the top, rolly down to my legs. She stopped and talked to the nurse about it but he didn't know what it was. He just printed her to a chair and said sit. No one checked on her about 15 mins later left fine so she feft that was the only time she had any reaction to the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296335 same patient/drug, different doses/AE (LOE);
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: after taking the new covid vaccine, he collapse while he was walking.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient 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: SYNCOPE (medically significant), outcome "unknown", described as "after taking the new covid vaccine, he collapse while he was walking.".  Clinical course: Caller calling in to report that he got a side effect after taking the new covid vaccine, he collapse while he was walking.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: a practice that i oversee gave a act-hib vaccination after the expiration date with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15-months-old and unknown gender patient who got a HIB (PRP/T) vaccine [ACT-HIB] vaccination after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2023, the patient received unknown expired dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ784AAA; expiry date: 07-Oct-2023) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (same day latency).  Reportedly, A practice that reporter oversee gave a Hib vaccination after the expiration date and reporter was hoping you could tell me if the dose should be repeated or if it will count as valid  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  No additional details.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old male patient to whom expired HIB (PRP/T) VACCINE [ACT-HIB] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Prophylactic vaccination (Immunization).  On 10-Oct-2023, the patient received 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE with no reported adverse event (expired product administered) (latency: same day) (Powder and solvent for solution for injection) Frequency = once, Strength = standard (lot UJ801AA and expiry date: 05-Oct-2023) via intramuscular route in the left thigh for immunization.   It was reported that "Physician wants to know what to do or how to proceed and if this will be harmful to the child. She wanted to know if there was a grace period.'  Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administration of expired ACTHIB to a patient with no adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who got administration of expired to a vaccine HIB (PRP/T) VACCINE [ACT-HIB] to patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Oct-2023, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot- UJ792AA and expiration date- 06-Oct-23) via unknown route in unknown administration site (dose, frequency, route, strength,: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Fluzone High-dose and was administered to a patient post-excursion with no reported adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 77 years old male patient and reporter reported that the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] was administered to a patient post-excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2023, the patient received a unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, expiry date, formulation: not reported and Frequency: once; lot UT8072AA) via intramuscular route in unknown administration site as immunization and was administered after post-excursion with no reported adverse event (poor quality product administered) (same day latency).  Reportedly: Fluzone High-dose Quadrivalent was exposed to Low temperature reached: - 6.4°C. Duration out of labelled range: 3 hours and 50 minutes Human error was unknown, the extended stability data was not cover the excursion, Administered to a patient: YES, Previous excursion: None   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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: 90.0
Sex: M
Vaccine: FLU4
Symptoms: Aphasia, Memory impairment, Transient ischaemic attack
Clinical narrative: patient experienced transient ischemic attack; patient is still suffering from speech aphasia; memory recall issues; Initial information received on 11-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 90-year-old male patient who experienced transient ischemic attack, patient is still suffering from speech aphasia and memory recall issues after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccine included ABRYSVO vaccine.   On 26-Sep-2023 at 16:15 hours, the patient received a 0.7 ml total dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form, lot number, expiry date: unknown) via unknown route in upper arm for immunization.  On 26-Sep-2023 at 18:00 hours, the patient had an event of patient experienced transient ischemic attack (transient ischaemic attack) (latency: 1 hour 45 min) following the administration of influenza quadrival A-B high dose HV vaccine.   On an unknown date the patient had events of patient is still suffering from speech aphasia (aphasia) and memory recall issues (memory impairment) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  It was reported, that on 26September2023 at 16:15, the patient received a FLUZONE HIGH DOSE shot, and afterwards received ABRYSVO vaccine on the same arm. At 18:00, he states patient experienced transient ischemic attack and they immediately called an ambulance. He was rushed to the ER where he spent an entire night. When asked about the patient's condition now, he says that patient is still suffering from speech aphasia and memory recall issues,  It was unknown if any lab data/test results available.  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: unknown for all the events.  Seriousness criteria: event of  patient experienced transient ischemic attack was assessed as medically significant. The patient was hospitalized for this event.; Sender's Comments: Sanofi company comment dated 16-Oct-2023: This case involves a 90-year-old male patient who experienced transient ischemic attack, after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history,lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD QIV was administered to 5 years old patient with no reported adverse event; Initial information was received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA317318 and 2023SA317312.  This case involves a 5 years old male patient who was administered with influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2023, the patient received a 0.7 ml, once dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot U8138CA, expiry date: 30-Jun-2024, strength: standard) via intramuscular route in the left deltoid  for Immunization (product administered to patient of inappropriate age) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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: FLU4
Symptoms: Rash
Clinical narrative: patient had rashes after they received the vaccine; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case is linked to cases 2023SA314994 and 2023SA315554.  This case involves an unknown age and unknown gender patient who had rashes after they received the vaccine after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (with an unknown formulation, strength, expiry date and lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient had rashes after they received the vaccine (rash) (unknown latency).  It was reported, Caller does not have patient information as well as lot number and expiration as the reporter stated nurses just informed her with regards to the AE but no specific details provided. The reporter consented to follow up.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the reported events.  At time of reporting, the outcome was Unknown for the event patient had rashes after they received the vaccine.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 of their staff members received expired FLUZONE QIV NP with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient(s) who received expired Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] 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 of suspect Influenza quadrival a-b vaccine Suspension for injection (lot number: UT7731MA, Expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunization.  On an unknown date, the patient(s) received expired Influenza Quadrival A-B Vaccine with no reported adverse event (expired product administered) (latency: same day).  It was reported, Nurse explains that they share a building with another program; explains that the other program had been storing FLUZONE QIV NP that was past expiration date, and the other program had sent the expired product to them; states that 2 staff members were given expired FLUZONE QIV NP. He asks if there is any extension on the expiration date; asks if it is safe to use: No additional information available at time of call; caller declined to respond to questions and has accepted follow-up. This situation is reported as a medication error due to expired product was administered.  Action taken: not applicable.   Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 43.0
Sex: M
Vaccine: FLUC3
Symptoms: Discomfort, Injection site pain, Pain in extremity
Clinical narrative: Soreness in my upper right arm (arm the injection was received in); Slight discomfort; This spontaneous case was received on 10-Oct-2023 from a pharmacist (reference number: SEQW23-03201) with additional information received on the same date (being processed together) and concerned a 43-year-old male patient.  The patient's medical history included blood pressure and acid reflux. The patient's concomitant medications included amlodipine used for blood pressure, and pantoprazole used for acid reflux.  On 09-Oct-2023, at approximately 8:30 am, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; anatomical location: right arm, route of administration: not reported) for active immunization against influenza disease. The batch number was not reported.  On 10-Oct-2023, one day after receiving Flucelvax Quadrivalent, the patient experienced a very mild soreness in upper right arm (arm the injection was received in).  On an unspecified date in Oct-2023, the patient experienced slight discomfort.  On 10-Oct-2023, the patient recovered from event ' Painful R arm '.  At the time of reporting, on 10-Oct-2023, the outcome of event 'discomfort' was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 43-year-old patient experienced pain in upper right arm and discomfort within one day after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 43-year-old patient experienced pain in upper right arm and discomfort within one day after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Age: 3.0
Sex: M
Vaccine: FLUC3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Showed large red areas around the injection site/ Redness covered most of their upper arm from the elbow to shoulder; The red area was warmer to the touch than other areas of the skin; The red area was somewhat swollen; This spontaneous case was received on 16-Oct-2023 from other non-healthcare professional (reference number SEQW23-03428) and concerned a 3-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 14-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent vaccine (influenza vaccine inact sag 4v;  anatomical location reported as 'arm', dose, and route of administration: not reported) as influenza immunization. The batch number was not reported.  On 15-Oct-2023, approximately 32 hours after receiving Flucelvax Quadrivalent vaccine, the patient experienced large red areas around the injection site. The redness covered most of his upper arm from the elbow to shoulder. The red area was warmer to the touch than other areas of the skin and were somewhat swollen.  The outcome of the events was not reported.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  This case is linked with the case 202305219 (the same reporter).  Company comment: A 3-year-old patient was vaccinated with Flucelvax Quadrivalent vaccine. One day after receiving the suspect vaccine, the patient experienced erythema, skin warm and swelling. Causality is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 3-year-old patient was vaccinated with Flucelvax Quadrivalent vaccine. One day after receiving the suspect vaccine, the patient experienced erythema, skin warm and swelling. Causality is assessed as possibly related, due to plausible temporal relationship.
Age: 3.0
Sex: M
Vaccine: FLUC3
Symptoms: Swelling
Clinical narrative: Showed large red areas around the injection site/ Redness covered most of their upper arm from the elbow to shoulder; The red area was warmer to the touch than other areas of the skin; The red area was somewhat swollen; This spontaneous case was received on 16-Oct-2023 from other non-healthcare professional (reference number SEQW23-03428) and concerned a 3-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 14-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent vaccine (influenza vaccine inact sag 4v;  anatomical location reported as 'arm', dose, and route of administration: not reported) as influenza immunization. The batch number was not reported.  On 15-Oct-2023, approximately 32 hours after receiving Flucelvax Quadrivalent vaccine, the patient experienced large red areas around the injection site. The redness covered most of his upper arm from the elbow to shoulder. The red area was warmer to the touch than other areas of the skin and were somewhat swollen.  The outcome of the events was not reported.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  This case is linked with the case 202305219 (the same reporter).  Company comment: A 3-year-old patient was vaccinated with Flucelvax Quadrivalent vaccine. One day after receiving the suspect vaccine, the patient experienced erythema, skin warm and swelling. Causality is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 3-year-old patient was vaccinated with Flucelvax Quadrivalent vaccine. One day after receiving the suspect vaccine, the patient experienced erythema, skin warm and swelling. Causality is assessed as possibly related, due to plausible temporal relationship.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles on 10/16/23. No additional illness or specific life stressors noted in an otherwise healthy 37 yom.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: itchy red dots all over body starting about 24 hours after the shot. Symptoms are improving but still having some today
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Dizziness, Dyspnoea, Erythema, Feeling abnormal, Hypersomnia
Clinical narrative: Patient contacted pharmacy the following day to inform us of a reaction. Patient stated that she started to feel off (itching hands and feet) when she was driving home.  States around 10am was having some difficulty breathing. Patient states difficulty breathing continued and around 12pm felt like she was blacking out but was able to use her albuterol inhaler at home (estimates 4 to 6 inhalations). Patient reported she lost consciousness and had urinary incontinence. Patient slept a lot the remaining of the day. Patient states has recovered.  Reports right arm is currently red, swollen, and appears bumpy.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Loss of consciousness, Peripheral swelling, Pruritus, Rash, Urinary incontinence
Clinical narrative: Patient contacted pharmacy the following day to inform us of a reaction. Patient stated that she started to feel off (itching hands and feet) when she was driving home.  States around 10am was having some difficulty breathing. Patient states difficulty breathing continued and around 12pm felt like she was blacking out but was able to use her albuterol inhaler at home (estimates 4 to 6 inhalations). Patient reported she lost consciousness and had urinary incontinence. Patient slept a lot the remaining of the day. Patient states has recovered.  Reports right arm is currently red, swollen, and appears bumpy.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: (R) arm pain + discomfort w slight swelling Pt reported fever Recommended tylenol PRN, ice application, apt w provider offered, hydration
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Mother calls to report patient was seen at urgent care due to rash/hives on bilateral arms, chest & back
Age: 1.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAIABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23LATER AFTERNOON.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9/.12.23 LATE AFTERNOON.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINE ERROR, ADMNISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEVIED 9.12.23 LATER AFTERNOON.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: Vaccine error, Administered After available Date to be used. Notification of Pfizer Bivalent to end received 9/12/23 late afternoon.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICANTION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATER AFTERNOON.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMRV, PNC13
Symptoms: Wrong product administered
Clinical narrative: Received 2 vaccines in error, PCV13 and Hib.
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient inadvertently received the 5-11 year old Pfizer vaccine instead of the 6m - 4yr Pfizer vaccine for her 3rd dose. This vaccine will count as the third dose of the series. Patient counceled on possible adverse events. Per mother on 9/12/22, patient experienced no adverse events/side effects
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, FLUR4
Symptoms: Death
Clinical narrative: NONE, PATIENT HAS BEEN A RESIDENT AT THE FACILITY SINCE DECEMBER 2020, BEEN RECEIVING PALLIATIVE CARE. SHE EXPIRED IN HOUSE 11-24-22 WHICH WAS EXPECTED.
Age: 50.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: -Localized swelling, redness, itchy to (R) subcutaneous region -(+) tingling (R) arm.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event. Will inform parents inadvertently administered MMR/Varicella and Varicella instead of separate MMR only noted at 2yr check-up when saw extra vaccine on vaccine list.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Urticaria
Clinical narrative: Hives all over body
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Extra dose administered
Clinical narrative: one MA gave flu shot before doctor examined. Another MA gave Men B, Menveo, and another flu shot #2 same day
Age: 87.0
Sex: F
Vaccine: FLUX, RSV
Symptoms: Arthralgia, Gait inability, Inflammatory marker increased, Joint swelling, Neck pain
Clinical narrative: SEVERE PAINS ACROSS SHOULDER, IN ALL JOINTS, NECK, KNEES ANKLES, WRISTS FINGERS, FEET AND SWELLING IN THOSE AREAS UNABLE TO WALK 9/22/2023 ON RISING FOR SEVERAL DAYS FLU ON 9/15/2023
Age: 87.0
Sex: F
Vaccine: FLUX, RSV
Symptoms: Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: SEVERE PAINS ACROSS SHOULDER, IN ALL JOINTS, NECK, KNEES ANKLES, WRISTS FINGERS, FEET AND SWELLING IN THOSE AREAS UNABLE TO WALK 9/22/2023 ON RISING FOR SEVERAL DAYS FLU ON 9/15/2023
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Pfizer Covid-19 5-11 yo vial was not diluted prior to vaccine administration. Patient received incorrect dosing per recommendation. Provider on site aware.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: No adverse event
Clinical narrative: No adverse reactions.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions physically occured for the patient. vaccines were given too early.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Patient received Pfizer COVID-19 5-11 yo vaccine in office for Boosters. After investigation, the COVID vaccine vial was not properly diluted. Provider on site made aware.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: Vaccine Error, Administered after available date to be used. Notification of Pfizer Bivalent to end received 9.12.23 late afternoon.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.1223 LATE AFTERNOON.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: NONE PATIENT RECEIVED PREVIOUS VACCINATION PRIOR TO ADMISSION TO NURSING HOME. SHE RECIVED PFIZER , WHICH WAS HER NUMBER TWO BOOSTER ON 6-8-22  ADMINISTERD BY PHARMACIST  PATIENT WAS RECEIVING HOSPICE CARE SERVICES WHEN SHE EXPIRED 6-20-22. SHE DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THE PFIZER COVID VACCINE ON 6-8-22
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 0 Adverse reactions physically accured for the patient. Vaccines were given to early
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Neck pain, Pain, Pain in extremity
Clinical narrative: shooting pain from left shoulder to fingers if reaching to pick something up. went to clinic, Dr, could not detect any major problems after going to clinic it was gone in a day or two. But as of yet I still get shooting sensation in shoulder area up back of my neck. They last as long as for instance, a bug bite etc. I had MRI in June to see if I had a pinched nerve , but I guess nothing was found-
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Patient received Pfizer Covid-19 5-11 yo vaccine in office for Boosters. After investigation, the covid vaccine vial was not properly diluted. Provider on site made aware.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Loss of personal independence in daily activities, Malaise, Pain
Clinical narrative: On 8/25/22 resident c/o not feeling well, unable to perform normal activities due to lethargy, Temp 101.9, Pulse rate 144, c/o body aches. On 8/26/22 symptoms improving.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Ear swelling, Erythema, Eye swelling, Injection site erythema, Tachypnoea
Clinical narrative: Ears, lips, and eyes swelling; hives scattered patchy erythema bilateral thighs ad torse of varying sizes;  tachypnea mom gave a dose of Zyrtec and took child to the ER child was assessed and given prednisoLONE (PRELONE) 15 mg/5mL oral solution 9.69 mg oral once  discharged on the following medications: HYROXYZINE (ATARAX) 10 MG/5ML SYRUP    Take 2.5 mLs (5 mg total) by mouth 3 (three) times daily  for 5 days PREDNISOLONE (ORAPRED) 15 MG/5ML ORAL SOLUTION   Take 3.23 mLs (9.69 mg total) by mouth  every 12 (twelve) hours for 5days
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Ears, lips, and eyes swelling; hives scattered patchy erythema bilateral thighs ad torse of varying sizes;  tachypnea mom gave a dose of Zyrtec and took child to the ER child was assessed and given prednisoLONE (PRELONE) 15 mg/5mL oral solution 9.69 mg oral once  discharged on the following medications: HYROXYZINE (ATARAX) 10 MG/5ML SYRUP    Take 2.5 mLs (5 mg total) by mouth 3 (three) times daily  for 5 days PREDNISOLONE (ORAPRED) 15 MG/5ML ORAL SOLUTION   Take 3.23 mLs (9.69 mg total) by mouth  every 12 (twelve) hours for 5days
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.29 LATE AFTERNOON.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 17.0
Sex: F
Vaccine: HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions physically occured for the patient. Vaccines were given too early
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER  BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED, NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER  BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATER AFTERNOON.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Vaccination error
Clinical narrative: VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick).  The outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.     The company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 9-Oct-2023 The reporter was elderly.  She stated that she could not remember the details.   She had two female friends, she could not even remember who, who each got a shingles shot (she did not know if it was Shingrix or Zostavax) and both of them got sick. She did not provide any further details. She provided limited information. Did not consent to follow-up. The case was linked with case US2023138508, reported by the same reporter for different patients.; Sender's Comments:  US-GSK-US2023138508:same reporter different patient
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Patient alleged pain and swelling at injection site, followed by pain and weakness radiating down the left arm and eventually pain and weakness unilaterally down the left side of the body.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Sleep disorder
Clinical narrative: Patient alleged pain and swelling at injection site, followed by pain and weakness radiating down the left arm and eventually pain and weakness unilaterally down the left side of the body.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hemiparesis, Injection site pain, Injection site swelling, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Patient alleged pain and swelling at injection site, followed by pain and weakness radiating down the left arm and eventually pain and weakness unilaterally down the left side of the body.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient alleged pain and swelling at injection site, followed by pain and weakness radiating down the left arm and eventually pain and weakness unilaterally down the left side of the body.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Bone pain, Fatigue, Injection site pain, Magnetic resonance imaging abnormal
Clinical narrative: Patient alleged pain and swelling at injection site, followed by pain and weakness radiating down the left arm and eventually pain and weakness unilaterally down the left side of the body.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Magnetic resonance imaging joint, Pain, Pain in extremity, Periarthritis, Sleep disorder
Clinical narrative: Patient alleged pain and swelling at injection site, followed by pain and weakness radiating down the left arm and eventually pain and weakness unilaterally down the left side of the body.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium, Full blood count, Metabolic function test, Syncope
Clinical narrative: Patient wasn't feeling well the evening of the vaccine (10/07/2023) so went to bed early and didn't sleep well.  The next day (10/08/2023) she felt sick to stomach, felt overheated, head rolled back, eyes rolled back in head, white as paper, excessive sweating, other people said the patient passed out, and when they came to they threw up. She lives at a retirement community and the nurse checked her out and recommended she go to the hospital, but she decided to wait.  She saw her doctor on 10/09/2023 for a full work up and everything came back normal. She had physical therapy later in the day and still felt unwell, but the physical therapist occasionally took her pulse and blood pressure and it was normal. Doctor believes it was a vasovagal response.  She felt back to normal by the third day 10/10/2023.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Echocardiogram normal, Eye movement disorder, Feeling hot, Hyperhidrosis
Clinical narrative: Patient wasn't feeling well the evening of the vaccine (10/07/2023) so went to bed early and didn't sleep well.  The next day (10/08/2023) she felt sick to stomach, felt overheated, head rolled back, eyes rolled back in head, white as paper, excessive sweating, other people said the patient passed out, and when they came to they threw up. She lives at a retirement community and the nurse checked her out and recommended she go to the hospital, but she decided to wait.  She saw her doctor on 10/09/2023 for a full work up and everything came back normal. She had physical therapy later in the day and still felt unwell, but the physical therapist occasionally took her pulse and blood pressure and it was normal. Doctor believes it was a vasovagal response.  She felt back to normal by the third day 10/10/2023.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Malaise, Nausea, Pallor, Poor quality sleep
Clinical narrative: Patient wasn't feeling well the evening of the vaccine (10/07/2023) so went to bed early and didn't sleep well.  The next day (10/08/2023) she felt sick to stomach, felt overheated, head rolled back, eyes rolled back in head, white as paper, excessive sweating, other people said the patient passed out, and when they came to they threw up. She lives at a retirement community and the nurse checked her out and recommended she go to the hospital, but she decided to wait.  She saw her doctor on 10/09/2023 for a full work up and everything came back normal. She had physical therapy later in the day and still felt unwell, but the physical therapist occasionally took her pulse and blood pressure and it was normal. Doctor believes it was a vasovagal response.  She felt back to normal by the third day 10/10/2023.