chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Laboratory test, Nausea, Skin irritation, Weight decreased
Clinical narrative: On 5/10/2025, the patient let the pharmacist know that patient had hallucination, irritation, sweating, headache, dizziness and nausea on the first night after the vaccination on 5/5/2025.   From 5/05/2025 to 5/10/2025, the patient lost some weight due to lack of sleep and bitter taste in the mouth, in addition to other side effects (irritation, headache and dizziness).  On 5/10/2025, patient decided to go to ER because she was afraid that she might have stroke.  ER doctors gave her medications to treat nausea, dizziness and anxiety.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Crying, Food refusal, Infant irritability, Lethargy, Pain
Clinical narrative: Per mom: She was incredibly fussy, lethargic, refused to eat, would cry out in pain when mom picked her up and also when she would put her down. This lasted for around 3 days post vaccine until mom essentially forced her to take a bottle and started improving.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 2 RED CIRCLE BELOW INJECTIONS  SITE, TENDER, 1 IS 1IN AND OTHER ABOUT 3IN IN DIAMTER- WARM TO TOUCH - NO TREAMENT
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Flushing, Vision blurred, Visual impairment
Clinical narrative: PATIENT REPORTED FLUSHED CHEEKS WITH VISUAL DISTURBANCES (BLURRED VISION AND "SPARKLES" IN FIELD OF VISION) SHORTLY AFTER RECEIVING IMMUNIZATION. PATIENT WAS ASKED TO SIT IN PHARMACY WAITING AREA FOR OBSERVATION. PATIENT WAS GIVEN A BOTTLE OF COLD WATER TO DRINK. AND ALLOWED TO REST WITH PHARMACY STAFF CHECKING ON HER FREQUENTLY. AFTER ABOUT 20 MINUTES, PATIENT FELT MUCH BETTER.  FLUSHED CHEEKS AND VISUAL DISTURBANCES RESOLVED.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Allergy to vaccine, Chills, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Fever muscle pain chills nausea injection site redness and swelling. Redness and swelling continuing to worsen as the days pass. Went to urgent care they added vaccine to allergy list prescribed steroids if  it gets worse. Took Zyrtec in am and Benadryl at h.s. Woke up to it more swollen and more red. Starting steroids today.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever muscle pain chills nausea injection site redness and swelling. Redness and swelling continuing to worsen as the days pass. Went to urgent care they added vaccine to allergy list prescribed steroids if  it gets worse. Took Zyrtec in am and Benadryl at h.s. Woke up to it more swollen and more red. Starting steroids today.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not report an adverse event- patient had already received both doses of a 2 dose series and received an unneeded third dose on 04/05/2025.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test positive, Bradycardia, Epstein-Barr virus test, Fatigue, Laboratory test
Clinical narrative: - Proliferation of Anti-bodies, multisystem inflammatory syndrome, weak limbs, POTS, Bradycardia, neurological impairment, neuropathy, fatigue, and list goes on and on.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Multisystem inflammatory syndrome, Muscular weakness, Nervous system disorder, Neuropathy peripheral, Postural orthostatic tachycardia syndrome
Clinical narrative: - Proliferation of Anti-bodies, multisystem inflammatory syndrome, weak limbs, POTS, Bradycardia, neurological impairment, neuropathy, fatigue, and list goes on and on.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan brain
Clinical narrative: - Proliferation of Anti-bodies, multisystem inflammatory syndrome, weak limbs, POTS, Bradycardia, neurological impairment, neuropathy, fatigue, and list goes on and on.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash
Clinical narrative: PATIENT NOTICED A RASH/ REDNESS OF SKIN NEAR THE INJECTION SITE.  SHE WENT TO THE DOCTOR AND HE DIAGNOSED CELLULITIS
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requests getting Tdap and Shingle vaccines. The 2 vaccines were administered with out any problem or adverse reaction.  Afterward our screening system indicated that patient already received another Tdap vaccine 2 months ago. This make the new vaccine was a dupplication of therapy .
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Patient fainted 5 minutes after receiving vaccination. She sat for monitoring due to a history of fainting post vaccination secondary to a fear of needles. Upon getting up to leave the pharmacy assisted by her family member she began to get lightheaded and fainted and they lowered her gently to the floor so she could lie down.  Patient was able to sit up a few moments later and was alert and oriented.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: when the patient was at the pharmacy we looked up the state registry and it didn't have her for any HPV vaccines, the patient wasn't aware of ever getting one and received it, left and her parents informed her she did receive it already when she was around 10
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient came back to the pharmacy a few days after the second dose of Shingrix vaccine and reported breaking out into rash all over body. Patient was unsure if due to new medication or vaccine.
Age: 65.0
Sex: F
Vaccine: HEPAB, PNC21, VARZOS
Symptoms: Injection site bruising, Injection site pain, Pyrexia
Clinical narrative: vaccines was given on 04/30/2025  total 3 vaccines (1 on R arm and 2 vaccines on L arm)and on 05/18/2025 patient came to pharmacy and showed the right arm ( Twinrix) and had bruise on injection site. she said she had fever for 2 days on and off and had this bruise. No pain or itching at this time but hurts when touch.   Patient advised to go and get it checked with Doctor and patient agreed to see doctor.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: rash on left side of torso under arm and left side of back only.  Itches really bad and hurts.  Patient took hot showers, used peroxide, Cortisone 10,  calamine lotion , some spray for infection from the dollar store and Benadryl liquid gels.  She was not any better until she started taking Benadryl Saturday night the 10th.  She took 2 gel caps Saturday night and 2 Sunday morning the 11th and is doing much better.  The rash is not itching any more.  If the rash does not go away she is going back to the doctor's office to see if it may be Shingles.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Patient called stating that she has been having chills and asked if the vaccine can cause chills.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Arexvy immunization was given when not indicated as patient had received a single dose of Abrysvo in 2023 that he did not remember getting.
Age: 52.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Cardiac monitoring, Chest pain, Echocardiogram, Electrocardiogram, Inflammation
Clinical narrative: SWELLING/INFLAMMATION OF THE CHEST,  SEVERE CHEST PAIN, SWELLING OF THE LEFT ARM AROUND INJECTION SITE,. CURRENTLY WEARING A HEART MONITOR. WAS PRESCRIBED FAMOTIDINE RECENTLY
Age: 52.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Injection site swelling, Magnetic resonance imaging, Swelling
Clinical narrative: SWELLING/INFLAMMATION OF THE CHEST,  SEVERE CHEST PAIN, SWELLING OF THE LEFT ARM AROUND INJECTION SITE,. CURRENTLY WEARING A HEART MONITOR. WAS PRESCRIBED FAMOTIDINE RECENTLY
Age: 75.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient called 2 days after vaccine complaining of pain and stiffness in the shoulder/neck area of the right arm (opposite from injection site). Says pain relieved with rest, OTC APAP.  No other symptoms reported. Said has gotten better since awakening. Advised to continue rest/OTC therapy and seek further care if symptoms worsen or do not get better over the next few days.
Age: 54.0
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: patient developed a rash and cellulitis on the arm where the vaccine was administered; patient developed a rash and cellulitis on the arm where the vaccine was administered; The spontaneous report was received from a nurse referring to a 54-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant therapy, drug Reactions and allergies were not reported.  On 18-Apr-2025, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) Injection (CAPVAXIVE) 168 mcg/ml (vaccination scheme frequency, anatomical location, and dose were not reported) (lot #Z002626, expiration date was not reported, but upon internal validation established as 04-Sep-2026) administered by intramuscular (IM) route for prophylaxis.  Approximately 3 days after administration (on 21-Apr-2025), the patient developed a rash and cellulitis on the arm where the vaccine was administered. The reporter reported treatment was not necessary and the patient has now recovered from both events. No additional details reported.   The causal relationship between both events and Hepatitis B Vaccine (Recombinant) (CAPVAXIVE) was unknown.
Age: 54.0
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: patient developed a rash and cellulitis on the arm where the vaccine was administered; patient developed a rash and cellulitis on the arm where the vaccine was administered; The spontaneous report was received from a nurse referring to a 54-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant therapy, drug Reactions and allergies were not reported.  On 18-Apr-2025, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) Injection (CAPVAXIVE) 168 mcg/ml (vaccination scheme frequency, anatomical location, and dose were not reported) (lot #Z002626, expiration date was not reported, but upon internal validation established as 04-Sep-2026) administered by intramuscular (IM) route for prophylaxis.  Approximately 3 days after administration (on 21-Apr-2025), the patient developed a rash and cellulitis on the arm where the vaccine was administered. The reporter reported treatment was not necessary and the patient has now recovered from both events. No additional details reported.   The causal relationship between both events and Hepatitis B Vaccine (Recombinant) (CAPVAXIVE) was unknown.
Age: 33.0
Sex: F
Vaccine: YF, YF
Symptoms: Chills, Cough, Dyspnoea, Headache, Vomiting
Clinical narrative: cough; problems breathing kind of like when she was younger with her asthma; chills; patient vomited once, and symptoms seems to be getting worst; patient vomited once, and symptoms seems to be getting worst; developed intermittent headache a couple of hours after receiving the shot for the last 3 days; Initial information received on 29-Apr-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 33 year old female patient who developed intermittent headache a couple of hours after receiving the shot for the last 3 days, cough, problems breathing kind of like when she was younger with her asthma, chills and patient vomited once, and symptoms seems to be getting worst after receiving Yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma and Dyspnoea.   On 25-Apr-2025, the patient received a 0.5ml to 2ml dose 1 of suspect yellow fever vaccine - Solution for injection standard strength (lot UK133AB, expiry date-31-Oct-2025) via intramuscular route in the right arm for Immunization.  On 25-Apr-2025 the patient developed intermittent headache a couple of hours after receiving the shot for the last 3 days (headache) (latency-few hours).  On an unknown date the patient developed cough, breathing kind of like when she was younger with her asthma (dyspnoea), chills and vomited once, and symptoms seems to be getting worst (vomiting) and (condition aggravated) (latency-unknown).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 33.0
Sex: F
Vaccine: YF, YF
Symptoms: Asthma, Chills, Condition aggravated, Cough, Dyspnoea
Clinical narrative: cough; problems breathing kind of like when she was younger with her asthma; chills; patient vomited once, and symptoms seems to be getting worst; patient vomited once, and symptoms seems to be getting worst; developed intermittent headache a couple of hours after receiving the shot for the last 3 days; Initial information received on 29-Apr-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 33 year old female patient who developed intermittent headache a couple of hours after receiving the shot for the last 3 days, cough, problems breathing kind of like when she was younger with her asthma, chills and patient vomited once, and symptoms seems to be getting worst after receiving Yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma and Dyspnoea.   On 25-Apr-2025, the patient received a 0.5ml to 2ml dose 1 of suspect yellow fever vaccine - Solution for injection standard strength (lot UK133AB, expiry date-31-Oct-2025) via intramuscular route in the right arm for Immunization.  On 25-Apr-2025 the patient developed intermittent headache a couple of hours after receiving the shot for the last 3 days (headache) (latency-few hours).  On an unknown date the patient developed cough, breathing kind of like when she was younger with her asthma (dyspnoea), chills and vomited once, and symptoms seems to be getting worst (vomiting) and (condition aggravated) (latency-unknown).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 33.0
Sex: F
Vaccine: YF, YF
Symptoms: Headache, Vomiting
Clinical narrative: cough; problems breathing kind of like when she was younger with her asthma; chills; patient vomited once, and symptoms seems to be getting worst; patient vomited once, and symptoms seems to be getting worst; developed intermittent headache a couple of hours after receiving the shot for the last 3 days; Initial information received on 29-Apr-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 33 year old female patient who developed intermittent headache a couple of hours after receiving the shot for the last 3 days, cough, problems breathing kind of like when she was younger with her asthma, chills and patient vomited once, and symptoms seems to be getting worst after receiving Yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma and Dyspnoea.   On 25-Apr-2025, the patient received a 0.5ml to 2ml dose 1 of suspect yellow fever vaccine - Solution for injection standard strength (lot UK133AB, expiry date-31-Oct-2025) via intramuscular route in the right arm for Immunization.  On 25-Apr-2025 the patient developed intermittent headache a couple of hours after receiving the shot for the last 3 days (headache) (latency-few hours).  On an unknown date the patient developed cough, breathing kind of like when she was younger with her asthma (dyspnoea), chills and vomited once, and symptoms seems to be getting worst (vomiting) and (condition aggravated) (latency-unknown).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Sex: M
Vaccine: YF, MMR, YF
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: yf-vax was administered 2 weeks after another live vaccine (mmr) with no reported ae; Initial information received on 06-May-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age male patient to whom YELLOW FEVER VACCINE - [YF-VAX] was administered 2 weeks after another live vaccine (MMR) with no reported ae (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 YELLOW FEVER VACCINE - Solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for  Immunization 2 weeks after another live vaccine (mmr) with no reported ae (inappropriate schedule of product administration) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Reportedly, they were not given 4 weeks apart, they were only given 2 weeks apart  Action taken: not applicable.   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: F
Vaccine: DTAPHEPBIP
Symptoms: Immune system disorder, Nervous system disorder
Clinical narrative: she has neuro and immune problems; she has neuro and immune problems; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of immune disorder (nos) in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced immune disorder (nos) (Verbatim: she has neuro and immune problems) and neurological disorder nos (Verbatim: she has neuro and immune problems). The outcome of the immune disorder (nos) and neurological disorder nos were not reported.   It was unknown if the reporter considered the immune disorder (nos) and neurological disorder nos to be related to Pediarix and Pediarix Pre-Filled Syringe Device.     It was unknown if the company considered the immune disorder (nos) and neurological disorder nos to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-APR-2025 The patient's parents reported this case. The patient (daughter) received Pediarix and stated that she was convinced it's why she had neuro and immune problems.  The reporter loved to see more data comparing them to other schedules and they all were toxic, but there's something up with GSK
Vaccine: FLUR4
Symptoms: Vaccination failure
Clinical narrative: During the market research interview participant mentioned that Flublok was seen to not to be as efficacious as it was before; Initial information received on 22-Apr-2025 regarding an unsolicited valid  serious case received from a other health professional.  This case involves market research interview participant mentioned that Influenza quadrivalent recombinant vaccine [Flublok QIV] was seen to not to be as efficacious as it was before.  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 quadrivalent recombinant vaccine (lot number, formulation and strength-unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) and was seen to not to be as efficacious as it was before (Suspected clinical vaccine failure).  Action taken was not applicable.  Seriousness Criteria-The event is assessed as medically significant.; Sender's Comments: Sanofi company comment dated 29-APR-2025: This case involves market research interview participant mentioned that Influenza quadrivalent recombinant vaccine [Flublok QIV] was seen to not to be as efficacious as it was before. Further information regarding regarding allergic history, medical history, concomitant medication and tolerance,  laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached: 8.5 °C to 8.8 °CDuration: 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2025SA112035 (Master case)  This case involves a 31 years old female patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] which was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone] Suspension for injection (once) (strength- standard, expiry date- 20-Jun-2025and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event (product storage error).   On 10-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the right deltoid for immunization.  Reportedly, reason: Monthly cycle count, inventory checking. There was no previous excursion. Human error was involved. Product was administered post excursion.   Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA114290: US-SA-2025SA113170: US-SA-2025SA112035:master case
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of ADACEL to an elderly patient (72-year-old patient ) with no adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 72 years old elderly male patient who had administration of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation.  On 21-Apr-2025, the 72-year-old patient received a standard dose of 0.5 ml once of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot U8115AA, expiry date- 31-MAR-2026) via intramuscular route in the left deltoid for Immunization; with no adverse event (product administered to patient of inappropriate age) (latency- same day).  Action taken was not applicable.  Reportedly, Reporter asked if it would be accounted for the patient because the information only says it is up to 64 years of age. She asked if we have recommendations on how they should proceed from here. No Treatment was received.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Product was administered after the excursion with no adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case was linked to other case US-SA-2025SA116224.  This case involves an unknown age male patient who received diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [tenivac] after the excursion with no adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Mar-2025, the patient received 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection of standard strength with lot U8491AA and expiry date 31-Mar-2027 once via intramuscular route in the left deltoid for immunisation after the excursion with no adverse event (poor quality product administered) (Latency same day)  Reportedly, Duration of temperature excursion: 55 days, Maximum/minimum temperature reached:  11 °C. Extended stability data did not cover the excursion. Human error not involved. Fridge malfunction.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA116224:
Sex: F
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Product was administered after the excursion with no adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to other case US-SA-2025SA117087  This case involves an unknown age female patient who received diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [tenivac] after the excursion with no adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 27-Mar-2025, the patient received 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection of standard strength with lot U8491AA and expiry date 27-Mar-2027 once via intramuscular route in the left deltoid for immunisation after the excursion with no adverse event (poor quality product administered) (Latency same day)  Reportedly, Duration of temperature excursion: 55 days, Maximum/minimum temperature reached:  11 °C. Extended stability data did not cover the excursion. Human error not involved. Fridge malfunction  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA117087:
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired FLUZONE NP was administered with no reported adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and gender patient who got administered expired Influenza usp trival a-b subvirion no preservative vaccine [Fluzone] NP with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an expired dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Influenza (immunization) with no reported adverse event (expired product administered) (latency- same day).  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  Action taken- not applicable.  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.
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: HCP states that one of their medical assistants administered ACT-HIB using a sterile water instead of the one provided with it with no reported adverse event; Initial information received on 22-Apr-2025 regarding an unsolicited valid  non-serious case received from a consumer/Non-Healthcare Professional.  This case involves an unknown age and unknown gender patient for whom  hcp (Healthcare Professional) stated that one of their medical assistants administered HIB (PRP/T) Vaccine [ACT-HIB] using a sterile water instead of the one provided with it 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, hcp stated that one of their medical assistants administered HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Immunization using a sterile water instead of the one provided with it with no reported adverse event (product preparation error) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Action taken: not applicable.  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: 2.0
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 2-year-old QUADRACEL with DAPTACEL, so patient received two DTap with no reported adverse event; Initial information received on 22-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who had received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine [Quadracel (Vero)] And Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], so the patient received two dtap with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Apr-2025, the patient received doses with dosage 0.5 ml of suspects Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine Suspension for injection (lot U8009AB, Expiry: 31-Jan-2026) and Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot 3CA11C1, Expiry: 31-DEC-2025) (Strength: Standard) via unknown route in unknown administration site as immunization, so patient received two dtap with no reported adverse event (extra dose administered) (Latency: same day).  Reportedly, Reporter is calling to make there is no reaction or anything.    Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA119219:
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: inappropriate use due to the administration of 1 mL of IPOL to a patient instead of 0.5 mL with no reported adverse event; Initial information received on 22-Apr-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case involves a 4 years old male patient who had inappropriate use due to the administration of 1 ml of IPV (VERO) [Ipol] to a patient instead of 0.5 ml 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 Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap); and Varicella zoster vaccine (Varicella vaccine) for Immunisation.  On 22-Apr-2025, the patient received 1 ml Dose 4 of suspect IPV (VERO) Suspension for injection lot X1D141M and expiry date- 31-OCT-2026 via intramuscular route in the right thigh for Immunisation instead of 0.5 ml with no reported adverse event (extra dose administered) (latency- same day).  Reportedly, the patient did not show any adverse events.  Action taken- not applicable.  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.
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: inappropriate use due to providing an early dose of pentacal with no reported adverse event; Initial information received on 23-Apr-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient with unknown age and gender who was inappropriately given an early dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization and inappropriately used due to providing an early dose of pentacal with no reported adverse event (inappropriate schedule of product administration).  Reportedly, Pentacal was inappropriately used due to providing an early dose which was not in accordance with the product labeling. Patient got the first dose and received the second dose 22 days later. They're trying to see if that would be considered a dose or an error and that dose should be repeated.  Action taken was not applicable.  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: 16.0
Sex: F
Vaccine: RAB
Symptoms: Rash
Clinical narrative: brushed against her head and it may have been a bat, and now the daughter has two bumps where it touched her; Initial information received on 24-Apr-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (mother).  This case involves a 16 years old female patient who had brushed against her head and it may have been a bat, and now the daughter has two bumps where it touched her after receiving rabies (HDC) vaccine [Imovax Rabies].  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 rabies (HDC) vaccine; Powder and solvent for suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  Information on the batch number was requested corresponding to the one at time of event occurrence.  On an unknown date the patient developed brushed against her head and it may have been a bat, and now the daughter has two bumps where it touched her (swelling) (unknown latency).  Reportedly: Her daughter had received several vaccines of Imovax Rabies and she is wondering if receiving frequent dose of Imovax Rabies would make it less effective or maybe causing potential problem  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.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered ACTHIB diluent that was not mixed with the lyophilized powder with no reported adverse event; Initial information received on 25-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 months old female patient who was administered with HIB (PRP/T) Vaccine [ACT-HIB] diluent that was not mixed with the lyophilized powder 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 (Tdap) for Immunisation.  On 25-Apr-2025, the patient received 0.5ml of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK198AA, expiry date 31-Mar-2026, strength standard, frequency once) via intramuscular route in the right thigh for Immunisation.  On an unknown date, the patient was administered with acthib diluent that was not mixed with the lyophilized powder with no reported adverse event (single component of a two-component product administered).  Action taken was not applicable.  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.
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion: estimated less than 24 hours/temperature reached: 82 °F/unsuitable product administered with no reported adverse event; Initial information received on 25-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had temperature excursion: estimated less than 24 hours/temperature reached: 82 °f/unsuitable product administered with no reported adverse event after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  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 diphtheria-2/tetanus/5 AC pertussis vaccine; Suspension for injection with unknown strength (lot 3CA30C1 with expiry date 30-APR-2026) via unknown route in unknown administration site for Immunization; temperature excursion: estimated less than 24 hours/temperature reached: 82 °f/unsuitable product administered with no reported adverse event (poor quality product administered).  Action taken was not applicable.  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: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 28-Apr-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 years old male patient with inappropriate use due to administration of an expired vaccine (HIB (PRP/T) VACCINE [ACT-HIB]) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Apr-2025, the patient received a dose 4 of suspect HIB (PRP/T) VACCINE dose 0.5 ml 1x(once) Powder and solvent for solution for injection (strength -standard) lot UJ995AA expiry date-28-Feb-2025  via intramuscular route in right leg for Immunization, inappropriate use due to administration of an expired vaccine with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.   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: 16.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: ship date on shipping label is more than two days prior to receiving the vaccine and one dose was administered with no reported adverse event; Initial information received on 28-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 years old male patient who received one dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [menquadfi] and ship date on your shipping label is more than two days prior to receiving 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 28-Apr-2025, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (lot UA493AA) (strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and ship date on shipping label is more than two days prior to receiving the vaccine with no reported adverse event (poor quality product administered) (Latency: same day).  Reportedly, The medical assistant reported that they received a shipment of 10 vials of MENQUADFI  today, 28 April 2025, at 9:00 AM. The medical assistant noted that the vaccines were still cold upon arrival, and the doctor and the nurse stated that the vaccine looks fine.  Action taken was not applicable.   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.