chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Nocturnal dyspnoea
Clinical narrative: Unable to catch breath at time, especially when trying to go to sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 13Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Liver Transplant" (unspecified if ongoing); "previous covid-19" (unspecified if ongoing); "high blood Pressure" (unspecified if ongoing); "kidney damage from tacrolimus" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies"; Tacrolimus, reaction(s): "kidney damage". The following information was reported: NOCTURNAL DYSPNOEA (non-serious) with onset 14Oct2023, outcome "recovered" (16Oct2023), described as "Unable to catch breath at time, especially when trying to go to sleep at night". Therapeutic measures were not taken as a result of nocturnal dyspnoea.  Additional information: The patient was unable to catch breath at time, especially when trying to go to sleep at night. That last about 3 days. The patient had no COVID prior vaccination (as reported) and the patient was not COVID tested post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Actor died from receiving a COVID-19 Vaccine from a specific lot number; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), as dose number unknown, single (Lot number: EN66208, Expiration Date: 30Jun2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Actor died from receiving a COVID-19 Vaccine from a specific lot number". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: A call from the reporter was received complaining about why Pfizer has not called patients back from receiving a COVID-19 vaccine from a specific lot number. Reporter was not the patient, she was just calling to complain. All she stated that why haven't Pfizer called, did a recall for the patients who received the COVID-19 Vaccine Lot# EN66208. Patients were dying and was stating that an actor died from receiving the shot (Clarified as Pfizer COVID-19 Vaccine) from this particular batch number. Reported COVID-19 Vaccine expiration date was 30Jun2021.; Reported Cause(s) of Death: Actor died from receiving a COVID-19 Vaccine from a specific LOT number
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 as dose 7 (booster), single (Lot number: GK1337), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug hypersensitivity". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures (Paxlovid treatment start date: 16Sep2023, stop date: 21Sep2023) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335847 same patient, different drug and event;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 40 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Apr2021 as dose 1, single (Lot number: EW0164), in left arm and on 14May2021 as dose 2, single (Lot number: EW0183), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nerve damage" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 11Oct2023 to 15Oct2023.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 82-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm and on 29Aug2023 at 10:30 as dose number unknown, single (Lot number: GL0087) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex"; Macrobid, reaction(s): "Known allergies: Macrobid"; Ciprofloxacin, reaction(s): "Known allergies: ciprofloxacin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 10Oct2023 to 15Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: inflammatory autoimmune disease known as demyelinating neuropathy; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001252.  A 78-year-old female patient received bnt162b2 (BNT162B2), in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: 2022, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "inflammatory autoimmune disease known as demyelinating neuropathy". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and absence of factors which may provide an alternative cause, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported event neuropathy peripheral. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: Covid-19 vaccine (Dose number unknown; manufacturer unknown), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, latency 8 days after the suspect product(s) administration, outcome "unknown" and all described as "Covid". Clinical course: Covid vaccine fall 2023, received and 8 days later came down with Covid in a crowded amusement park. Patient second Covid vaccine in 5 months. Never had Covid before.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Having had COVID 4 times and almost dying once; Having had COVID 4 times and almost dying once; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant, life threatening), COVID-19 (medically significant, life threatening), outcome "unknown" and all described as "Having had COVID 4 times and almost dying once". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient stated that as a COVID survivor she wants to thank Pfizer for the vaccine and for the Paxlovid. In his/her case it was a true lifesaver. Having had COVID 4 times and almost dying once, he/she truly believe that Pfizer have played a major role in his/her life. Now, he/she was questioning the increased in the price of Paxlovid and begs for reconsideration.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: They gave it to me on my arm and it hurts. They always gave it to me in my left arm because I have been dog bite in my right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EN6203) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anti-psychotics" (unspecified if ongoing); "seizure's" (unspecified if ongoing); "thyroid pill" (unspecified if ongoing); "cholesterol pill" (unspecified if ongoing); "anti depression pill" (unspecified if ongoing); "I have been dog bite in my right arm" (unspecified if ongoing). Concomitant medication(s) included: KEPPRA [LEVETIRACETAM]; DILANTIN [PHENYTOIN SODIUM]; SIMVASTATIN; ZOLOFT; LEVOXYL. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "They gave it to me on my arm and it hurts. They always gave it to me in my left arm because I have been dog bite in my right arm".
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Drug ineffective, Eczema, Interchange of vaccine products, Skin burning sensation
Clinical narrative: the patient got COVID-19; the patient got COVID-19; autoimmune skin disease; eczema; burning skin; Feb2021 with dose 2, and Aug2021 with dose 3 (booster) of Moderna COVID-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001258 (NOVAVAX).  A 72-year-old female patient received bnt162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Aug2021 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. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Aug2021, outcome "unknown", described as "Feb2021 with dose 2, and Aug2021 with dose 3 (booster) of Moderna COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "the patient got COVID-19"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune skin disease"; ECZEMA (non-serious), outcome "unknown"; SKIN BURNING SENSATION (non-serious), outcome "unknown", described as "burning skin". The events "autoimmune skin disease", "eczema" and "burning skin" required physician office visit. Clinical course: It was reported after the Pfizer booster, on unreported dates, the patient got COVID-19. She also got a weird eczema and burning skin. She went to the dermatologist. The dermatologist stated she now has an autoimmune skin disease and was seeing more of this in her medical practice. She also stated she thinks the mRNA vaccines were the cause.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: the patient got COVID-19; the patient got COVID-19; autoimmune skin disease; eczema; burning skin; Feb2021 with dose 2, and Aug2021 with dose 3 (booster) of Moderna COVID-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001258 (NOVAVAX).  A 72-year-old female patient received bnt162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Aug2021 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. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Aug2021, outcome "unknown", described as "Feb2021 with dose 2, and Aug2021 with dose 3 (booster) of Moderna COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "the patient got COVID-19"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune skin disease"; ECZEMA (non-serious), outcome "unknown"; SKIN BURNING SENSATION (non-serious), outcome "unknown", described as "burning skin". The events "autoimmune skin disease", "eczema" and "burning skin" required physician office visit. Clinical course: It was reported after the Pfizer booster, on unreported dates, the patient got COVID-19. She also got a weird eczema and burning skin. She went to the dermatologist. The dermatologist stated she now has an autoimmune skin disease and was seeing more of this in her medical practice. She also stated she thinks the mRNA vaccines were the cause.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair line has been receding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: ALOPECIA (non-serious), outcome "unknown", described as "hair line has been receding".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: significant repository issues; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A patient (no qualifiers provided) 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: RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "significant repository issues". Additional information: The reporter called regarding assistance with the ABRYSVO vaccine. During the call, the reporter stated that the primary care was very anxious about the patient getting a RSV shot and that was because the patient have been diagnosed with significant repository issues, the patient gotten COVID shot, "and by the way got your COVID shot".   The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: will she have another series of acid reflux again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "will she have another series of acid reflux again". Additional information: Patient was asking if she will be vaccinated of the Pfizer covid19 vaccine again, will she have another series of acid reflux again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: BNT162B2 NOS/ MODERNA COVID-19 VACCINE; She had COVID in Aug; She had COVID in Aug; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP).  A 62-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pauciarticular Juvenile Rheum Arthritus" (unspecified if ongoing); "Allergies: D.Farinae Mite Extract" (unspecified if ongoing); "Dog Epithelium Extract 1:10 Vial" (unspecified if ongoing); "Casein 1:100 Vial" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" and all described as "She had COVID in Aug"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "BNT162B2 NOS/ MODERNA COVID-19 VACCINE". Clinical course: She had covid in Aug and had to hold her doses for 10 days.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Considering interchange of vaccine, the role of company suspect drug BNT162b2 to all the reported events Drug ineffective and COVID19 cannot be excluded completely. However the contribution of Moderna to the events cannot be excluded,Linked Report(s) : US-PFIZER INC-202200846805 same patient, different drug/event;
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Nasal congestion, Nasopharyngitis, Rhinitis, Sputum discoloured, Upper respiratory tract infection
Clinical narrative: bad cold; upper respiratory infection; rhinitis; nose was severely congested; greenish phlegm; Initial information was received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 72 years old male patient who experienced bad cold, upper respiratory infection, rhinitis, nose was severely congested and greenish phlegm 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 30-Sep-2023, the patient received a 0.5 ml, total dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot number, expiry date, strength, was unknown) via intramuscular route in unknown administration site for Immunization. The information on the batch number was requested.  On 07-Oct-2023 the patient had bad cold (nasopharyngitis), upper respiratory infection (upper respiratory tract infection) (Latency: 7 days)following the administration of influenza quadrival A-B high dose HV vaccine. On an unknown date in oct-2023  the patient had  rhinitis, nose was severely congested (nasal congestion) and greenish phlegm (sputum discoloured) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  It was reported"Patient called to report that he experienced a bad cold and upper respiratory infection 7 days after receiving FLUZONE HIGH DOSE QUADRIVALENT on September 30, 2023. He also inquired whether the vaccine contains inactivated flu strains, as his son suggested confirming this because they suspect it might be the reason for the flu-like symptoms he experienced if the vaccine contained an activated virus. He mentioned having greenish phlegm, a bad cold, and rhinitis but did not experience a fever. He stated that he was prescribed Doxycycline 100mg, to be taken 2 times a day for 10 days, for his upper respiratory infection and is still taking it up until now. He mentioned that his nose was severely congested during the first 2 days of treatment but has since reduced to 80-90% congestion due to the antibiotic. He also stated that he is still experiencing the symptoms but they have largely reduced."  Action taken: not applicable.  The patient was treated with doxycycline for event upper respiratory tract infection ,nasal congestion and was not known if corrective treatment was received or not for other events.  At time of reporting, the outcome was Recovering / Resolving for all the events.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administration of expired Tenivac to a patient with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] to a patient 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 total (1 X) of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA, Expiry date: 24-Sep-2023) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was administered expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult to a patient with no reported adverse event (expired product administered) (latency: same day).  It was reported, Pharmacist requests to confirm the expiration date for TENIVAC. Is it the day, month, year! HCP reports that the tenivac was administered past expiration. The caller declined to provide additional information about the administration of expired Tenivac to a patient.   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: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: PENTACEL was given to a patient but the patient was not able to get the HIB component of the vaccine with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves pentacel was given to a patient but the patient was not able to get the hib component of the vaccine 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 suspect diphtheria/tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine via unknown route in unknown administration site for Immunization (strength, dose, batch number and expiry date: unknown) was given to a patient but the patient was not able to get the hib component of the vaccine with no reported adverse event (single component of a two-component product administered) (latency same day). Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event single component of a two-component product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient was administered a vaccine post-excursion (with no reported adverse event); Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 18 years old female patient who was administered a IPV (VERO) (IPOL) vaccine 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 an unknown date, the patient previously had an oral Polio dose from outside the country and on 18-Sep-2023, the patient received dose 2 of 0.5 ml of suspect IPV (VERO) Suspension for injection (Batch number: W1A101M, expiry date: 10-Feb-2025, strength: standard) via intramuscular route in the left deltoid as Immunization  On 18-SEP-2023 the patient was administered a vaccine post-excursion (with no reported adverse event) (poor quality product administered) (Latency: same day)  It was reported" A doctor is reporting a temperature excursion that occurred one month ago and was advised to call us to determine if the vaccines are still viable for use. He also stated that the vaccines were used for three patients after the temperature excursion. Product/s: IPOL was Opened products and the reason: unknown Max temperature reached: 47.1°F Duration out of labelled range: 15 minutes Human error was unknown. The extended stability data did not cover the excursion. 3 patients were involved. Previous excursion: None. The patients were fine, and the reporter did not report any side effects."  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient had been administered with an expired FLUZONE HIGH DOSE with no reported adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from  a other health professional.  This case involves 75 years old female patient who had been administered with an expired influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Oct-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot UJ928AA, Expiry date : 30-Jun-2023, Frequency : Total, formulation, strength was unknown) via intramuscular route in the arm not otherwise specified for Immunization and had been administered with an expired fluzone high dose with no reported adverse event (expired product administered) (latency : same day) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event a patient had been administered with an expired fluzone high dose with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: small pinpoint, raised, itchy red bumps; small pinpoint, raised, itchy red bumps; redness at the site post injection; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 51 years old female patient who experienced small pinpoint, raised, itchy red bumps, and redness at the site post injection after receiving Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2023, the patient received 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT8076NA) (Expiry date: 30-Jun-2024) (Strength: Standard) (Frequency: once) via intramuscular route in the right deltoid for immunization.  On an unknown date, the patient developed small pinpoint, raised, itchy red bumps (rash papular) (rash pruritic) and redness at the site post injection (vaccination site erythema)  (unknown latency).  It was reported, Caller reporting 4 of their employees have experienced reactions after receiving FLUZONE QIV PFS, administered at their clinic as part of employee health. Caller reporting 3 patients have complained of ongoing arm discomfort and one patient experienced redness around the injection site. Caller reporting, she is concerned about continuing to use this batch of vaccines, she reports they have given over 70 FLUZONE QIV PFS and 4 have experienced reactions. Caller did not have any information as far as time frame of onset of symptoms. Caller also with question on whether we have any information we can send as administration guide as a reference for administration. Caller reports redness at the site post injection, unknown as far as time of onset, she thinks the following day after injection. Caller reports employee (patient) experienced small pinpoint, raised, itchy red bumps. Caller reports area is improving, no longer itchy and most of the red bumps have resolved on their own, patient does have a few small red bumps.  Action taken: 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 events; Sender's Comments:  US-SA-2023SA322206:
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: experiencing prolonged arm pain at injection site post administration; complained of difficulty lifting her arm because of the pain; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 27 years old female patient who had prolonged arm pain at injection site post administration and complained of difficulty lifting her arm because of the pain after receiving influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or other vaccines: NO  On 03-Oct-2023, the patient received a standard dose of suspect influenza quadrival A-B vaccine Suspension for injection at a dose of 0.5 ml total (lot UT8076NA, expiry date- 30-JUN-2024) via intramuscular route in the right deltoid for Immunization.  On an unknown date in OCT-2023, (unknown latency), the patient developed prolonged arm pain at injection site post administration (vaccination site pain) and complained of difficulty lifting her arm because of the pain (injected limb mobility decreased) following the administration of influenza quadrival A-B vaccine.  Action taken was not applicable.  Treatment: Patient went to Urgent Care last week, prescribed steroids  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.; Sender's Comments:  US-SA-2023SA322148:Patient #2: US-SA-2023SA322445:Patient #4:
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever for 3 days; muscle aches; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 91 years old female patient who experienced fever for 3 days and muscle aches 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 0.7 ml 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 influenza.  On an unknown date, the patient developed fever for 3 days (pyrexia) and muscle aches (myalgia (unknown latency).  It was reported, Caller wants to find out where she can get the FLUBLOK in her area. She says that she had a bad reaction to the FLUZONE QIV a few years ago.. Caller is attempting to find the availability of FLUBLOK. Caller states she has called all over the area and cannot find the product anywhere and thinks it is "ridiculous to still have commercials advertising this shot when it can't be found." Caller states that she had a reaction to the FLUZONE HIGH-DOSE administered a few years ago and "had a fever for 3 days and severe muscle aches." She questions if there are any information about any anaphylactic reactions to the Fluzone and states, "I can deal with a little side effects, I am 91 and just do not want to get the flu."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (fever for 3 days, muscle aches).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event fever for 3 days and was Recovered / Resolved on an unknown date for the event muscle aches.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of Pentacel was administered to a patient (with no reported adverse event); Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient to whom expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] 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 16-Oct-2023, the patient received 4th dose of expired 0.5 mL dose of suspect suspension for injection of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Batch number: UJ786AA, expiry date: 12-Oct-2023) via intramuscular route in the left thigh as immunization (expired product administered; Latency: same day)   The caller was not aware of any adverse reactions, treatment, Doctor or Emergency Room visit necessary post administration.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached: Negative 0.2C Duration out of labelled range: 96 Hours with no adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited non-valid non-serious case received from a other health professional.  This case is linked to cases 2023SA322724(CLUSTER) and 2023SA324260(CLUSTER).  This case involves temperature excursion with max/low temperature reached: negative 0.2c duration out of labelled range: 96 hours was administered with no adverse event with 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 a  dose of suspect influenza quadrival A-B high dose HV vaccine via unknown route in unknown administration site for Immunization (strength, formulation ,batch, dose and expiry date: unknown) max/low temperature reached: negative 0.2c duration out of labelled range: 96 hours was administered to patient with no adverse event (poor quality product administered) (latency same day). Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired TENIVAC with no adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 60 years old female patient who was administered expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult [Tenivac] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown expired dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult Suspension for injection of lot U7189AA and expiry: 30-Sep-2023 via unknown route in unknown administration site for Immunization, with no adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient's current age is due for Pfizer Pediatric COVID vaccine, however, immunizer gave patient the Toddler vaccine which is for patient age 6months to <5 years old.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Cough, Nausea, Pyrexia
Clinical narrative: FEVER, CHILLS, NAUSEA, COUGH
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Erythema, Headache, Pain in extremity, Peripheral coldness
Clinical narrative: Injection was given Wednesday 10/18/23.  Arm was sore 10/19/23.  Late evening 10/20/23  had a chill for 2-3 hours,  hands very cold, headache, runny nose,  congested sinus, very cold hands.  Headache lasted 3 days-took tylenol to lessen it and eventually it went away.  Arm continued to be sore but very light;  then noted on  Saturday 10/21/23 band of pinkness accross my left arm where injection had been given-this was very pronounced and very warm.  This lasted till today 10/24/23
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, Sinus congestion, Skin warm
Clinical narrative: Injection was given Wednesday 10/18/23.  Arm was sore 10/19/23.  Late evening 10/20/23  had a chill for 2-3 hours,  hands very cold, headache, runny nose,  congested sinus, very cold hands.  Headache lasted 3 days-took tylenol to lessen it and eventually it went away.  Arm continued to be sore but very light;  then noted on  Saturday 10/21/23 band of pinkness accross my left arm where injection had been given-this was very pronounced and very warm.  This lasted till today 10/24/23
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Headache Fever 100.1 F Chills Sore throat   Sore throat began first, then chills, then fever, finally headache. All started approx 22.5 hours after vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site bruising, Injection site indentation
Clinical narrative: Adverse: 1. Injection site bruising 2. The area of the skin where the injection was administered has sunk. It was indented.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, Needle issue, No adverse event, Underdose
Clinical narrative: needle was not properly attached to the syringe, so it only injected part of the dose with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown age and demographics who was injected part of the dose of Influenza Quadrival A-B vaccine [Fluzone Quadrivalent] as needle was not properly attached to the syringe, so it only injected part of the dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received only a part of the dose of suspect Influenza Quadrival A-B vaccine Suspension for injection (strength, lot number and expiry: not reported) via unknown route in unknown administration site for immunization, as the needle was not properly attached to the syringe, so it only injected part of the dose with no reported adverse event (incorrect dose administered) (latency: same day). Information on the batch number was requested.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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.   Additional information was received on 17-Oct-2023 from Other healthcare professional: Case was upgraded from non-case to valid case and event of incorrect dose administered was added. Text amended accordingly.