chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administration after a below temperature excursion of 29.9°F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: administration after a below temperature excursion of 29.9°F as the minimum reached.). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Shingrix, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 08 February 2024, with batch number XS27B and expiry date 17 March 2025).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: late second dose). The outcome of the incomplete course of vaccination was not applicable.   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: 16-MAY-2025 Medical Information Canada transferred a pharmacist that wanted to report an Engerix-B late second dose which led to incomplete course of vaccination. Pharmacist said, can the patient receive Twinrix since the patient wanted to have protection also for Hepatitis A? Which guidance can we have on this topic? Vaccination date, vaccine detail and patient demographics were obtained in this call.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number PC6573) for prophylaxis.   On 08-APR-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 19-MAY-2025 The health care professional reported that they got vaccines and did not know if they were familiar with that place or not but anyway.  They got the Shingrix vaccine normally, it was supposed to be frozen however, they have an employee that did not know that so, she put it on the refrigerator.  It have been refrigerated since we got it but it was not in frozen, so need to know if it was still be efficacy of it or they should get rid of it and order new and they have two people that were vaccinated with it, which led to incorrect storage of drug. Did they not, when it was not frozen, so need to you know if they need to be revaccinated. Besides the two patients reported, health care professional confirmed that no other patient was administered with Shingrix after being stored at non recommended temperatures. Medical information discussed with health care professional normal storage conditions for Shingrix. This case is linked with US2025062278, reported by same reporter.; Sender's Comments:  US-GSK-US2025062278:same reporter,Different patient
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number PC65Y3) for prophylaxis.   On 08-APR-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 19-MAY-2025 The health care professional reported that they got vaccines and did not know if they were familiar with that place or not but anyway.  They got the Shingrix vaccine normally, it was supposed to be frozen however, they have an employee that did not know that so, she put it on the refrigerator.  It have been refrigerated since we got it but it was not in frozen, so need to know if it was still be efficacy of it or they should get rid of it and order new and they have two people that were vaccinated with it, which led to incorrect storage of drug. Did they not, when it was not frozen, so need to you know if they need to be revaccinated. Besides the two patients reported, health care professional confirmed that no other patient was administered with Shingrix after being stored at non recommended temperatures. Medical information discussed with health care professional normal storage conditions for Shingrix. This case is linked with US2025062275, reported by same reporter.; Sender's Comments:  US-GSK-US2025062275:same reporter,Different patient
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 19-MAY-2025, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable.   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: 20-MAY-2025 Medical assistant called and reported an excursion for Kinrix vaccine a min. temperature of 31.8 degree F, for a cumulative 57 hours. Also mentioned they found out that it was given to a patient and asked what would happened if it was give it to a patient and do we need to give the patient the vaccine again. Patient received vaccine after temperature excursion, which led to incorrect storage of drug.
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unapproved age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received HAV (Havrix pediatric) (batch number DN273, expiry date 28-AUG-2026) for prophylaxis.   On 05-MAR-2025, the patient received the 1st dose of Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 16-MAY-2025 The Medical Assistant was calling regarding a vaccine that was given too early.  If there were any steps that were needed to be taken.  Hepatitis A, Havrix was received by the patient of 6 months at the time and Hepatitis a was given along with MMR and Varicella, which led to inappropriate age at vaccine administration. It was given on 5th March 2025, patient was six months at the time, patient is 8 months now.  No reactions or anything from it.  So, believed they do go back to normal schedule, give him again at twelve months but was there anything on our end that we need to watch for.
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: No adverse event; patient received improperly stored vaccine; This Spontaneous Safety Report with reference number:02789391 was received by a partner on 16-APR-2025 and forwarded on 16-APR-2025 from a medical assistant.  Due to the nature of the event, the causality between the event "patient received improperly stored vaccine" and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by MCM on 14-MAY-2025 from a healthcare professional. The case is maintained as non-serious.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events.   Due to the nature of the event, the causality between the event "patient received improperly stored vaccine" and Vaxelis was not applicable.  No further information is expected
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: heart failure; Safety information originally reported under manufacturer case PV202500058845 has been nullified and re-entered under this new manufacturer report number 202500104046.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for covid-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (16May2025): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. Updated information: Reporter and patient's name updated.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (19May2025): This is a follow-up report to notify that the cases PV202500058845 and 202500104046 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202500104046.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance, Hypotonia
Clinical narrative: Can't walk; hard to walk; Losing muscle tone; hard to make a fist; Arthritis; This is a spontaneous report received from a consumer from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), in 2023 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: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Can't walk; hard to walk"; HYPOTONIA (non-serious), outcome "unknown", described as "Losing muscle tone; hard to make a fist"; ARTHRITIS (non-serious), outcome "unknown". The events "can't walk; hard to walk", "losing muscle tone; hard to make a fist" and "arthritis" required physician office visit and emergency room visit.  Additional Information: The patient would like to know the side effects to the Pfizer COVID-19 vaccine (Comirnaty 12+). After providing the side effects, the patient states she can't walk, and she is losing muscle tone. It is her whole right side; it is hard to make a fist, and it is hard to walk. The patient doesn't know if her symptoms have to do with the vaccine, but she didn't have problems before. The patient has been to her doctor, but they are telling her it is arthritis, but she had to go to the ER, and they were telling her they didn't see any arthritis. The patient got the shot 2 years ago, hopefully it is not from shot. The patient asked for the time frame that people are reporting things after getting the Pfizer COVID-19 vaccine, if they report having side effects that start a year or two later. The patient was also asking if there are any reports or studies on what she is experiencing.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She also stated that she has gastroenterology problems and whenever she has had the Pfizer vaccine booster it always fixed her gastroenterology flares.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing); "gastroenterology problems" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation; Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "She also stated that she has gastroenterology problems and whenever she has had the Pfizer vaccine booster it always fixed her gastroenterology flares.". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: The Pfizer one made me sicker than COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not 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: ILLNESS (non-serious), outcome "unknown", described as "The Pfizer one made me sicker than COVID". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: It made me less sick afterwards then the Pfizer; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna COVID-19 vaccine (Dose number unknown, lot number unknown), for COVID-19 immunisation, reaction(s): "sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "It made me less sick afterwards then the Pfizer".  Additional information: the patient specified that he/she prefers to receive Moderna because it made him/her less sick afterwards then the Pfizer.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: left facial paralysis (bells palsey)
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Unevaluable event
Clinical narrative: none
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness to Left upper thigh measures 12.5cm x 13.75cm, firm and warm to palpation.  cellulitis also noticed.  no fever noted the onset started the evening the vaccine was received.  patient started on clindamycin 75mg/5ml solution take 18mls po every 8 hrs x 7 days. Tylenol or ibuprofen recommended if needed.
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered an HPV vaccine after at age 46 years old and the cut off for this vaccine is 45 years of age. Patient left office prior to realizing this nurse administered it by mistake so I was unable to monitor for any adverse reactions.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Asthenia, Blood thyroid stimulating hormone increased, Chest pain, Electrocardiogram abnormal
Clinical narrative: Have gone to ER for shooting muscle pains. Feel like I've aged 10 years in 4 since the vax. Fatigue and lack of energy namely. Stamina loss and Heart arrythmia. Immune system has severely decreased. I had a persistent chest pain for 3 months that would flare up at different times that only subsided after months of max supplementing potassium in my diet. I have changed all the variables of my lifestyle in favor of my health and yet my immune system is worse than it was when I was treating it like crap pre-vaccine. Pain continues at random points in legs, exact location varies as well. Ultrasound on right leg was negative.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fibrin D dimer normal, Full blood count normal, Hypertension, Immune system disorder
Clinical narrative: Have gone to ER for shooting muscle pains. Feel like I've aged 10 years in 4 since the vax. Fatigue and lack of energy namely. Stamina loss and Heart arrythmia. Immune system has severely decreased. I had a persistent chest pain for 3 months that would flare up at different times that only subsided after months of max supplementing potassium in my diet. I have changed all the variables of my lifestyle in favor of my health and yet my immune system is worse than it was when I was treating it like crap pre-vaccine. Pain continues at random points in legs, exact location varies as well. Ultrasound on right leg was negative.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Ultrasound scan normal
Clinical narrative: Have gone to ER for shooting muscle pains. Feel like I've aged 10 years in 4 since the vax. Fatigue and lack of energy namely. Stamina loss and Heart arrythmia. Immune system has severely decreased. I had a persistent chest pain for 3 months that would flare up at different times that only subsided after months of max supplementing potassium in my diet. I have changed all the variables of my lifestyle in favor of my health and yet my immune system is worse than it was when I was treating it like crap pre-vaccine. Pain continues at random points in legs, exact location varies as well. Ultrasound on right leg was negative.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. Just reporting it as it is an extra dose.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Flushing, Urticaria
Clinical narrative: After receiving HPV 9 vaccine at 4:54 PM, approximately 5-10min later patient reported having hives and was flush in the face.  Charge Nurse checked on patient and informed Provider of symptoms and then she evaluated patient.   Provider then ordered Benadryl 12.5 mg/5ml oral elixir 25mg and it was given at 5:19 PM.  Patient was better and denied any other symptoms by 5:30 PM.   Patient discharged by 5:40 PM with caregiver.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Oropharyngeal pain, Vasodilatation
Clinical narrative: Swollen neck veins, exhaustion, and sore throat.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: See printed 05/08/2025 and 05/09/2025 medical / clinical notes / documentation.   Phone call w/father. Last night, applied hot & cold compress to child's left forearm. At 7pm last night, father said child was able to feel a little below her left elbow. Father said while he was working today at 6:30am, child's mother called him & told him child's left forearm is able to feel again. Father also said he and child's mother does not want child to receive the 2nd HPV vaccination.   After leaving our office after examination & vaccination, child opened the car door and was unable to feel w/her left forearm, from her left elbow to her fingers (HPV vaccination was admin in her left deltoid). Child returned to Dr's office. Dr. examined child. Child was able to move her upper left extremity but was unable to feel below her left elbow to her fingers. 4:23PM, 2 ibuprofen 200mg tablets given PO, 4:40PM, there was no change to child's left forearm. Dr recommended hot & cold compress during the night and to call her PRN.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Large local reaction (R) upper arm
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site bruising
Clinical narrative: Bruising at injection site. Noticed after shower 2 days after injection. Not painful or bothersome to patient.
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: the patient involved did not experience any medical concerns after the  GARDASIL 9 was inadvertently administered; The wrong vaccine was pulled from the refrigerator and administered  because of human error; a 2 month old patient was  inadvertently administered a dose of GARDASIL 9 today, 5/5/2025, during a routine vaccination appointment when the patient was  ordered to receive a dose of VAXNEUVANCE; This spontaneous report was received from an administrator (also reported as "health business professional [HBP]") concerning a 2-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On 05-May-2025 (also reported as "today"), the patient was inadvertently administered a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), batch/lot number Y015180 has been verified to be a valid batch/lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal verification established as 28-Jan-2027, dose number 1, 0.5 mL administered as prophylaxis (anatomical location and route of administration were not reported) during a routine vaccination appointment when the patient was ordered to receive a dose of 15-Valent Pneumococcal Conjugate Vaccine (CRM197) suspension for injection (VAXNEUVANCE) 0.5 mL as single or four dose series (wrong product administered). Reporter confirmed the patient involved did not experience any medical concerns after Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was inadvertently administered (no adverse event). It was also stated that "the wrong vaccine was pulled from the refrigerator and administered because of human error" (product selection error.)  No additional information provided.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Stress, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the vaccine and I still have flare ups; Stress brings mine on; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (I have had so many flare ups).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got the vaccine and I still have flare ups) and stress (Verbatim: Stress brings mine on). The outcome of the vaccination failure, shingles and stress were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and stress to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-MAY-2025 This case was reported by a patient via interactive digital media. Patient indicated that he/she would not wish Shingles on anybody. Patient have had so many flare ups. Patient know when the pain starts. Patient got the vaccine and still had flare ups. Also indicated that they don't last as long and are less painful than before the shot but they were still painful. Patient stated that stress bring patient's on. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles, insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: DTAP, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: inadvertent administration of ActHib and Daptacel to patient after temperature excursion with no reported adverse event; temp. excursion of ActHib and daptacel occured at 9.6 C for 4 hrs with no reported adverse event; Initial information received on 19-May-2025 regarding an unsolicited valid non-serious Courtesy case received via Merck national service center from a other health professional.  This case involves an unknown age and unknown gender patient who had inadvertent administration of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] And Hib (Prp/T) Vaccine [Act-Hib] after temperature excursion at 9.6 c for 4 hrs, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2025 the suspects acthib and daptacel were exposed at 9.6 celsius for 4 hrs with no reported adverse event (product storage error) and on 19-May-2025 patient received an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (strength: not reported) (lot number, expiry date: not reported) via unknown route in unknown administration site and on same day patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (strength: not reported) (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization), with no reported adverse event (poor quality product administered) (latency: same day).  Information on batch number and expiration date corresponding to the one at time of event occurrence could not be 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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: reports that the Pentacel was given to patient past the expiration date with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from other health professional.  This case was linked to other case US-SA-2025SA146684.  This case involves a 4 months old male patient who received expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] date with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 14-May-2025, the patient received 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (Unknown strength) with lot UK023AA and 30-Apr-2025 via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (Latency same day)  Reportedly, the pentacel was given to 3 different patients past the expiration date. The first injection occurred on 30-Apr-2025, the second on 12-MAY-2025 and the last injection was on 14-MAY-2025.  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-2025SA146684:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 months old male patient who administered expired 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 12-May-2025, the patient received a dose of 0.5 ml of expired suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UK023AA and expiry date 30-Apr-2025) (strength not reported) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (Latency: same day).  Reportedly, Caller reported that pentacel was given to 3 different patients past the expiration date. The first injection occurred on 30-Apr-2025, the second on 12-May-2025 and the last injection was on 14-May-2025.  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-2025SA142769:
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administration of diluent from the pentacel without the dry mix/lyophilized component with no reported adverse event; Initial information received on 19-May-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 administrered diluent from the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] without the dry mix/lyophilized component with no reported adverse event. Information on the batch number was requested corresponding to the one at time of event occurrence  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 diluent  of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization and without the dry mix/lyophilized component with no reported adverse event (single component of a two-component product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence  Reportedly, The patient also got the HIB vaccine that same day. Caller asked about re-vaccination of pentacel or recommendations after only diluent was 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: 12.0
Sex: M
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administration of a menquadfi dose too early with no reported adverse event; Initial information received on 20-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who received meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] too early with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis a vaccine and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation.  On 13-Sep-2023, the patient received a dose 1  of suspect meningococcal a-c-y-w135 (t conj) vaccine, and   on 14-May-2024 also received an extra dose 2 of same vaccine, both with formulation:Solution for injection, lot U7939AB,expiry date :31-Mar-2026, lot number : U7827AD,expiry date: 30-Sep-2025, strength :standard, frequency: twice,  via unknown route in unknown administrative site for immunization, too early with no reported adverse event (extra dose administered) (latency: same day).  Reportedly, The first MENQUADFI dose was given on 13-Sep-2023 and then the second one was administered on 14-May-2024. Physician assistant asks if they still needs to give a third dose to the patient or if that second one already counts the full series. Both dose of vaccine were administered by different providers.  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: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: received the injection that had sterile water instead of diluent with no reported adverse event; Initial information received on 21-May-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 received HIB (PRP/T) Vaccine [Act-Hib] that had sterile water instead of diluent with no reported adverse event while receiving vaccine.  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 Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization, that had sterile water instead of diluent with no reported adverse event (product preparation error) (Latency Same day).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  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: 34.0
Sex: F
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Abdominal distension, Infrequent bowel movements
Clinical narrative: Per phone call from patient she is experiencing bloating causing her stomach to come over the waistline of her pants and decreased bowel movements since approximately March 30, 2025.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal distension, Infrequent bowel movements
Clinical narrative: ** Please note that Item 5 would not allow me to enter the date the patient reported because it was before this vaccine.  She reported that she noticed the bloating about two weeks after the first vaccines one 3/18/2025 and about two weeks before the second appointment on 4/22/2025, so I entered 4/2025.**    Patients reports bloating causing her stomach to come over the waistband of her pants and decreased bowel movements.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Antibody test, Body temperature increased, Urticaria
Clinical narrative: Hives all over body, lasted on and off for a month. Was given steroid injection twice, daily Benadryl/Zyrtec. Was prescribed an Epi pen just in case. It started around his forehead with an elevated temperature then it spread.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Minor was administered COVID 19 vaccine for 6 to 12 years old dose; minor received half a dose.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Patient was due for DTAP and was given a combination vaccine. No treatment needed, and patient's parents were notified
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Malaise, Pain, Pyrexia
Clinical narrative: Experienced high fever on the evening of the vaccine around 6 pm and took aspirin to treat pain and fever. On the following day, the patient experienced swelling of the lips and malaise.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Swelling of eyelid, Urticaria
Clinical narrative: patient developed hives, eyelid swelling, chest tightness that occurred the morning after the vaccination
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash
Clinical narrative: Patient ended up with a rash on left shoulder cap; above injection site
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Confusional state, Dizziness, Loss of consciousness, Syncope
Clinical narrative: On the evening on May 5, 2025, the donor began to feel lightheaded and had a syncope episode. Donor was unsure of what time or how long she exactly was unconscious for. Donor stated she woke up on the floor and was confused as to what happened. Donor did not have any injuries related to this event, and did not call 911 or receive any outside medical care. Donor stated she felt fine afterwards and continued as normal. Donor was evaluated on May 10, 2025, no injuries or symptoms were present. The donors' immunization injection site appeared to be healed, with no signs of swelling, infection, or bruising. Donor did not have any pain on the injection site. Donor later stated that she has a history of syncope episodes. however, she was unsure if previous syncope episodes were caused by donations or other unrelated factors.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: NUMBNESS IN LEFT HAND/FINGERS, NO PAIN, DIFFICULT TO MAKE FIST, STARTED SAME DAY AS VACCINE
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine administered IM rather than SQ as recommended.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Balance disorder, Blood testosterone free, Blood thyroid stimulating hormone, Brain fog
Clinical narrative: Loss of balance, brain fog, vision issues (inability to focus when moving), headache, spatial disorientation, Neck/back pain
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Differential white blood cell count, Disorientation, Electrocardiogram, Full blood count, Glycosylated haemoglobin
Clinical narrative: Loss of balance, brain fog, vision issues (inability to focus when moving), headache, spatial disorientation, Neck/back pain
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lipids, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test
Clinical narrative: Loss of balance, brain fog, vision issues (inability to focus when moving), headache, spatial disorientation, Neck/back pain
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Scan with contrast, Ultrasound Doppler, Vision blurred, Vitamin B12
Clinical narrative: Loss of balance, brain fog, vision issues (inability to focus when moving), headache, spatial disorientation, Neck/back pain
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Severe body pain and headache
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Father came in with patient to receive 4 year old vaccines to start school. Pulled up Vaccine Registry and reviewed due vaccinations. I mis- interpreted a date on the vaccine schedule. During the visit I read and interpreted needing 4th dose of polio, 5th dose of Dtap, and 2nd dose for MMR and Varicella. I did not properly check that last dose of Dtap was given 2/21/25. I gave child 5th dose of Dtap too close to prior dose resulting in an invalid dose. I was not sure why Vaccine Registry was not counting the vaccine, it was not until I verified with a resource that I understood where I had made my mistake. Contacted parent and advised that an additional dose will be needed to complete the series.
Age: 73.0
Sex: M
Vaccine: PNC21, RSV, TDAP, VARZOS
Symptoms: Meningitis
Clinical narrative: patient's family came back after about a month and saying that patient was admitted to a hospital for a week and was discharged the day before. Patient's family member believed that the patient got meningitis because he received 4 vaccines at the same time a month prior to
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Was given triple the dose that was recommended and it was not diluted
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Rash
Clinical narrative: anaphylaxis, diffuse rash,
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Electromyogram, Epstein-Barr virus infection reactivation, Fatigue
Clinical narrative: Herpes lesions upper lip and mouth and extreme fatigue the next day.   Activation Epstein Barr diagnosed April 8, 2025.  Severe neuropathy diagnosed April 23, 2025.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Oral herpes
Clinical narrative: Herpes lesions upper lip and mouth and extreme fatigue the next day.   Activation Epstein Barr diagnosed April 8, 2025.  Severe neuropathy diagnosed April 23, 2025.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein, Full blood count normal, Injection site mass, Laboratory test normal, Metabolic function test normal
Clinical narrative: When seen on May 22, 2024, almost one month from the date of vaccine, patient still has a visible raised nodule at the site of the vaccine, approximately 3x3 cm (photo taken).  She also has had tingling and a fine tremor below her left eye and of her left arm from shoulder to fingers that began about 2 weeks after vaccine administration
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Tremor
Clinical narrative: When seen on May 22, 2024, almost one month from the date of vaccine, patient still has a visible raised nodule at the site of the vaccine, approximately 3x3 cm (photo taken).  She also has had tingling and a fine tremor below her left eye and of her left arm from shoulder to fingers that began about 2 weeks after vaccine administration
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse events noted.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: SHE HAD NO ADVERSE SYMPTOMS WHEN WE CHECKED WITH HER.
Age: 79.0
Sex: F
Vaccine: HEPAB
Symptoms: Injury associated with device
Clinical narrative: Needlestick injury due to incorrect use of safety device after administration. Individual immunizing was the only one injured.
Age: 20.0
Sex: M
Vaccine: UNK
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram ST segment abnormal, Electrocardiogram ST segment elevation, Headache
Clinical narrative: Experienced sudden onset L side chest pain radiating down L arm, and L eye vision changes at around 0630 in the AM after receiving Southern Hemisphere Flu shot the afternoon prior. SX intermittent. He had a concerning EKG showing sinus bradycardia and nonspecific changes.  Repeat EKGs were consistent. He went to the ER twice for these SX. on 20MAY and 22MAY. He went back the second time due to added SX of headache. Chest Xray was unremarkable. Troponin 18-- >13. Given these findings consulted cardiology who evaluated patient and advised symptoms are most likely due to  benign ventricular repolarization, with pertinent J point elevations and concave ST segments present.  Cardiology recommended follow-up with PCP and if symptoms are persistent to consider outpatient cardiac work-up including Holter monitor, stress test, and echocardiogram.
Age: 20.0
Sex: M
Vaccine: UNK
Symptoms: Sinus bradycardia, Troponin, Visual impairment
Clinical narrative: Experienced sudden onset L side chest pain radiating down L arm, and L eye vision changes at around 0630 in the AM after receiving Southern Hemisphere Flu shot the afternoon prior. SX intermittent. He had a concerning EKG showing sinus bradycardia and nonspecific changes.  Repeat EKGs were consistent. He went to the ER twice for these SX. on 20MAY and 22MAY. He went back the second time due to added SX of headache. Chest Xray was unremarkable. Troponin 18-- >13. Given these findings consulted cardiology who evaluated patient and advised symptoms are most likely due to  benign ventricular repolarization, with pertinent J point elevations and concave ST segments present.  Cardiology recommended follow-up with PCP and if symptoms are persistent to consider outpatient cardiac work-up including Holter monitor, stress test, and echocardiogram.