chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: she miss the 6 month window; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on August 2023) and Twinrix (received 2nd dose on October 2023).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: she miss the 6 month window). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUL-2024 The reporter reported that he/she had a question about the Twinrix, if a patient missed the dose, she missed the 6-month window. The reporter asked if they did not have to restart and just wanted to take some kind of guidance if they had to restart the series or should he/she should go ahead for re-administer. The reporter reported that the first 2 doses were properly administrate it. She did not provide the specific dates for this and also, she did not have the batch number or expiration date of the previous vaccines. Also, when we asked about the follow up from the Safety team, her reply was not clear, she insisted that she had only this question and that she did not have time for this, due this situation. The reporter did not consent to follow-up. The vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix, which led to incomplete course of vaccination.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: patient is only given the diluent part; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9RP9M, expiry date 04-OCT-2025) for prophylaxis.   On 15-JUL-2024, the patient received Arexvy. On 15-JUL-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient is only given the diluent part) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-JUL-2024 The pharmacist called to inform that the Arexvy was 2 vials, right, the adjuvant as well as the powder, what happened if the patient was only given the diluent part.  The reporter confirmed that such thing had happened to a patient less than an hour ago, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: Shingrix was prescribed/recommended to her by four clinicians even though she is younger than age 50; This non-serious case was reported by a consumer via call center representative and described the occurrence of intercepted product prescribing error in a 42-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ophthalmic herpes zoster, eye swelling and nerve pain.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product prescribing error (Verbatim: Shingrix was prescribed/recommended to her by four clinicians even though she is younger than age 50). The outcome of the intercepted product prescribing error was unknown.   Additional Information: GSK Receipt Date: 15-JUL-2024 This case was reported by patient itself. The patient has a severe case of shingles of the eye causing her eye to be swollen shut and causing nerve pain. The patient has been out of work for six weeks due to shingles. She states that she has had 3 rounds of antivirals, but they did not work. Shingrix was prescribed or recommended to her by four clinicians even though she was younger than age 50 however the patient has not received Shingrix, which led intercepted product prescribing error. The patient did not have an immunodeficiency or immunosuppression due to known disease state or therapy. The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAPIPV, MENB
Symptoms: Product storage error
Clinical narrative: Bexsero and  Kinrix to an unknown number of patients after being exposed to 74.84F and above range for 95 hours; 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 an unspecified number of patients who received Men B NVS (Bexsero) (batch number en939, expiry date 21-OCT-2024) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis.   On an unknown date, the patient received Bexsero and Kinrix. On an unknown date, an unknown time after receiving Bexsero and Kinrix, the patient experienced incorrect storage of drug (Verbatim: Bexsero and  Kinrix to an unknown number of patients after being exposed to 74.84F and above range for 95 hours). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-JUL-2024 Medical assistant reported that she was sure they administered Bexsero and  Kinrix to an unknown number of patients after being exposed to 74.84F and above range for 95 hours but she'd have to get into the database to confirm details, which led to incorrect storage of product. Consented to follow up.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: mistakenly the adult dose was given the 1440 EL.U; Adult product administered to child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old male patient who received HAV (Havrix 1440 adult) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 11-JUL-2024, the patient received Havrix 1440 adult. On 11-JUL-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: mistakenly the adult dose was given the 1440 EL.U) and adult product administered to child (Verbatim: Adult product administered to child). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-JUL-2024 On the 11th of this month, it was suppose to be a pediatric dose of Hep A was to have been given, it was suppose to be Havrix PF 720 and mistakenly the adult dose was given the 1440 EL.U, which led to overdose and adult product used by child. They were  wondering.  They did not  knew the condition of the child because this was just brought to our attention.  So, basically looking for advice.  According to the HCP, that was the patient's 1st dose. Consented to follow up.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Intended vaccine to be given was Pediarix; Kinrix before recommended age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 8th August 2023).   On 12-JUL-2024, the patient received Kinrix. On 12-JUL-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix before recommended age). On an unknown date, the patient experienced wrong vaccine administered (Verbatim: Intended vaccine to be given was Pediarix ). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JUL-2024 Nurse called to report Kinrix was administered to a 15-month-old patient, before the recommended age which led to inappropriate age at vaccine administration. Intended vaccine to be given was Pediarix which led to wrong vaccine administered. Patient initials and lot number asked and declined.; Sender's Comments:  US-GSK-US2024089547:another patient/ same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1 year second dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a first dose of Shingrix one year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1 year second dose administration). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-JUL-2024 The pharmacist called to asking if a patient received a first dose of Shingrix one year ago, whether if that patient had to restart the series.  How much time had to last to start the series. During this call the pharmacist did not wanted to provide any Adverse event detail. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. Did not consent to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Single component of a two-component product administered, Underdose
Clinical narrative: potential administration of only the liquid component of Menveo; potential administration of only the liquid component of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A, expiry date 31-DEC-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: potential administration of only the liquid component of Menveo) and inappropriate dose of vaccine administered (Verbatim: potential administration of only the liquid component of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-JUL-2024 The nurse called and informed that they were under an investigation to see whether or not they had an error. The reporter asked for guidance with the three different lot numbers of Menveo components to see what they gave. The reporter mentioned that they had a mismatch left in the box, only the powder, but no liquid vial to correspond with and which means that there were investigating if there was a potential administration of only the liquid component of Menveo, which led inappropriate preparation of medication and inappropriate dose of vaccine administered In the facility there was an investigation about did they lose it or had a vaccine error (for the liquid vial).  The reporter also mentioned that they already had information on what to do if they determined it was an error, and that the recommendation that they had was to repeat the dose. The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: patient that received a first dose in 2021 she wants to know if the patient has to restart the dose scheme or what does she have to do; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received only 1st dose in 2021, on an unknown date).   On an unknown date, the patient did not receive 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: patient that received a first dose in 2021 she wants to know if the patient has to restart the dose scheme or what does she have to do). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JUL-2024 The pharmacist reported that she had a question related to administration schedule for a patient that received only 1st dose of Engerix B vaccine (specific date not specified) and she wanted to knew if the patient had to restart the dose scheme or what does she had to do. The pharmacist did not provide further detail (demographics or details about the administered vaccine) about the event. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Age: 58.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient received 2 liquid portions + 1 powder portion; patient received 2 liquid portions + 1 powder portion; patient received 2 liquid portions + 1 powder portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA984A, expiry date 30-SEP-2024) for prophylaxis.   On 02-MAY-2024, the patient received Menveo. On 02-MAY-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received 2 liquid portions + 1 powder portion), inappropriate dose of vaccine administered (Verbatim: patient received 2 liquid portions + 1 powder portion) and wrong technique in product usage process (Verbatim: patient received 2 liquid portions + 1 powder portion). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and wrong technique in product usage process were unknown.   Additional Information: GSK Receipt Date: 23-JUL-2024 The pharmacist reported that they had an issue at the clinic basically one of the nurses there administered the Menveo vaccine to one of the patient and they only gave them the liquid part of the Menveo, which he/she thought had 3 strains and then he thought it was the diluent, so he went and mixed the 2nd part and another liquid part of the Menveo and administer it and so basically, he got 2 parts of the vial that contain the CYW strain and 1 part of the A strain, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and wrong technique in product usage process. The reporter really don't know what happened, or if we are supposed to reported, or was there any effects or anything. The reporter confirmed that the patient received first only the liquid portion, and when they realize this, the also administer the vaccine properly reconstitute, so the patient received 2 liquid portions and 1 powder portion. The reporter consent to follow-up.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first dose of Twinrix on 23 May 2022 and did not return for another dose until 20 Jul 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 23-MAY-2022, batch number 4F3YY, expiry date 01-JAN-2023).   On 20-JUL-2024, the patient received the 2nd dose of Twinrix. On 20-JUL-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received first dose of Twinrix on 23 May 2022 and did not return for another dose until 20 Jul 2024). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JUL-2024 The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: 24 hours of misery; This spontaneous case was reported by a physician and describes the occurrence of DISCOMFORT (24 hours of misery) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknwon.     In 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (24 hours of misery). At the time of the report, DISCOMFORT (24 hours of misery) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  The patient hesitated to get a booster of last year's formulation because any mRNA vaccine gives 24 hours of misery, and there was a likelihood that if patient got a booster now, Medicare would deny another later in the fall.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2024: Live non-significant follow-up received: Reference id added.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinusitis
Clinical narrative: patient received covid booster at drug store on 7/8/24 and came down with covid mild rhino sinus on 7/16/24; patient received covid booster at drug store on 7/8/24 and came down with covid mild rhino sinus on 7/16/24; This spontaneous case was reported by a pharmacist and describes the occurrence of SINUSITIS (patient received covid booster at drug store on 7/8/24 and came down with covid mild rhino sinus on 7/16/24) and COVID-19 (patient received covid booster at drug store on 7/8/24 and came down with covid mild rhino sinus on 7/16/24) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation.    On 08-Jul-2024, the patient received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Jul-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced SINUSITIS (patient received covid booster at drug store on 7/8/24 and came down with covid mild rhino sinus on 7/16/24). On an unknown date, the patient experienced COVID-19 (patient received covid booster at drug store on 7/8/24 and came down with covid mild rhino sinus on 7/16/24). At the time of the report, SINUSITIS (patient received covid booster at drug store on 7/8/24 and came down with covid mild rhino sinus on 7/16/24) and COVID-19 (patient received covid booster at drug store on 7/8/24 and came down with covid mild rhino sinus on 7/16/24) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) 2nd or 3rd covid test positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 64.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: The caller is a 64-year-old male received Trumenba/Only approved for use for individuals checked in to 25 years of age, patient is 64 years old; Little painful in the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 64-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 16Jul2024 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for immunisation. The patient's relevant medical history included: "Spleen removal surgery", start date: 1981 (unspecified if ongoing); "Triglycerides high" (unspecified if ongoing); "surgical asplenic" (unspecified if ongoing). Concomitant medication(s) included: FENOFIBRATE taken for blood triglycerides increased. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "The caller is a 64-year-old male received Trumenba/Only approved for use for individuals checked in to 25 years of age, patient is 64 years old"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Little painful in the injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: The patient inquired if the dose of meningococcal group b Rlp2086 he received was enough or it should be a series. As of 17Jul2024, the patient had a dose of Trumenba vaccine yesterday and he was asking if the dosage that he received is already enough. However, upon checking the indication and usage for Trumenba, it is only approved for use for individuals checked in to 25 years of age, patient is 64 years old. When asked if the patient had any adverse reaction, the patient stated, "Yes, but it is mostly when the pharmacist had the shot ready, he said relax your arm and I went for relaxing and he pushed into the muscle so, little painful in the injection site."  The information on the batch/lot number for meningococcal group b Rlp2086  will be requested and submitted if and when received.  Follow-up (17Jul2024): This is a spontaneous follow-up report received from a Consumer (patient). Updated information: medical history, event (added vaccination site pain), and narrative.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Disorientation, Fatigue, Myalgia, Nerve injury
Clinical narrative: tired; she feels like her every nerve ending was hyperextended her body does not work normal; joint and muscle pain; joint and muscle pain; is disorientated; pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 11Jul2024 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevenar 13 (no side effects), administration date: 2018, for immunization. The following information was reported: DISORIENTATION (non-serious) with onset Jul2024, outcome "unknown", described as "is disorientated"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset Jul2024, outcome "unknown" and all described as "joint and muscle pain"; PAIN (non-serious) with onset Jul2024, outcome "unknown"; NERVE INJURY (non-serious) with onset Jul2024, outcome "unknown", described as "she feels like her every nerve ending was hyperextended her body does not work normal"; FATIGUE (non-serious) with onset Jul2024, outcome "unknown", described as "tired". Additional information: She took that shot she was tired went to bed she feels like her every nerve ending was hyperextended, her body does not work normal.  She probably got it on the right arm she also has a question if she can take Benadryl for pain. Caller confirmed she had the Prevnar 20 on 11Jul2024, stated she had no extreme effect on 2018 when she took the Prevnar 13. Caller added aside from feeling tired, having joint and muscle pain, she is disorientated, caller looking for what could have caused the side effects she experienced. Caller asking can take Benadryl for pain.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: tired; she feels like her every nerve ending was hyperextended her body does not work normal; joint and muscle pain; joint and muscle pain; is disorientated; pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 11Jul2024 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevenar 13 (no side effects), administration date: 2018, for immunization. The following information was reported: DISORIENTATION (non-serious) with onset Jul2024, outcome "unknown", described as "is disorientated"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset Jul2024, outcome "unknown" and all described as "joint and muscle pain"; PAIN (non-serious) with onset Jul2024, outcome "unknown"; NERVE INJURY (non-serious) with onset Jul2024, outcome "unknown", described as "she feels like her every nerve ending was hyperextended her body does not work normal"; FATIGUE (non-serious) with onset Jul2024, outcome "unknown", described as "tired". Additional information: She took that shot she was tired went to bed she feels like her every nerve ending was hyperextended, her body does not work normal.  She probably got it on the right arm she also has a question if she can take Benadryl for pain. Caller confirmed she had the Prevnar 20 on 11Jul2024, stated she had no extreme effect on 2018 when she took the Prevnar 13. Caller added aside from feeling tired, having joint and muscle pain, she is disorientated, caller looking for what could have caused the side effects she experienced. Caller asking can take Benadryl for pain.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Physician.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". It was reported that the patient got COVID after getting the booster dose.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Sex: U
Vaccine: DTAP
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; Initial information received on 20-Jul-2024 regarding an unsolicited valid Social Media serious case received from a Patient.  This case involves an unknown age and unknown gender patient who experienced stroke after receiving vaccine Diphtheria-2/tetanus/5 ac pertussis 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 a Booster dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection in pre-filled syringe (lot- 3CA07C1 and expiry date- 31-Dec-2025) via unknown route in unknown administration site (strength, dosage: not provided) for Immunisation.  On an unknown date the patient developed stroke (cerebrovascular accident) (unknown latency). This event was assessed as medically significant. The patient was hospitalized for this event.  Reportedly, I am recovering at home from a stroke last week caused by your tetanus booster , requiring two hospitalisations  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovering / Resolving for the event.; Sender's Comments: Sanofi Company Comment dated 24-Jul-2024: This case involves an unknown age and unknown gender patient who experienced stroke after receiving vaccine Diphtheria-2/tetanus/5 ac pertussis vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, 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 individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic events were reported. No additional AE; HCP called to report that the patient was inadvertently administered an expired dose of ROTATEQ.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 16-JUL-2024, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml / series, lot #1947648, expiration date reported and confirmed as 21-JUN-2024 (strength was not provided) administered orally for prophylaxis (Expired product administered). No symptomatic events were reported. Confirmed the product did not suffer a previous temperature excursion. No further information was provided. No additional adverse event (AE) or product quality complaint (PQC).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported VAQTA administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.        ?    Names of vaccines involved (including lot/exp) VAQTA X025482  4/12/2025        ?    Temperature  57.9F; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 22-JUL-2024, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot number X025482, expiration date 12-APR-2025 (dose and route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 57.9 degrees Fahrenheit for 2 hours and 12 minutes. No previous excursions were detected.
Sex: U
Vaccine: MENB
Symptoms: Haemolysis, Laboratory test
Clinical narrative: Acute symptomatic hemolysis; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMOLYSIS (medically significant), outcome "unknown", described as "Acute symptomatic hemolysis". The patient underwent the following laboratory tests and procedures: Lab test: Unknown results. The reporter stated the event acute symptomatic hemolysis was a serious adverse event reaction and it was related to meningococcal group b rlp2086.  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid again; Covid again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 80-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid again". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: He did get the vaccines and boost in April. Had done everything could possibly do and now after paxlovid, unfortunately, this was the third time, he had had it three times before, this would be the most severe than others.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of MENQUADFI was mistakenly administered with no reported adverse event; Initial information received on 18-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who was mistakenly administered an expired dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] 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 hpv vaccine and tetanus vaccine both for Prophylactic vaccination.  On 16-Jul-2024, the patient received 0.5 ml total  dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot number: U7294AB) (Strength: standard) (Frequency: once) (expiry date: unknown) via intramuscular route in the right deltoid for immunization.  On 16-JUL-2024,  the patient was mistakenly administered an expired dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine with no reported adverse event (expired product administered) (latency: same day).  Reportedly, This situation is pre-assessed as a medication error/an inappropriate use due to the administration of an expired vaccine.  The caller wants to know if the dose is valid and if they need to monitor the patient for any adverse reactions.  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: 66.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: Patient reported vomiting, chills, and diarrhea
Age: 47.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 31.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event noted.
Age: 34.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Seizure
Clinical narrative: PATIENT HAD 2 SEIZURES BACK TO BACK ABOUT 5 MINUTES AFTER VACCINES WERE ADMINISTERED.
Age: 18.0
Sex: F
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 51.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individual beyond use date of 8 weeks after vaccine had been thawed. The individual has been notified of this error and offered to be revaccinated per guidelines. Our local Department of Public Health has been notified of this vaccination administration error.
Age: 67.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain started 2 hours after the shot followed by decreased range of motion and had sharp, stabbing pain for the first 5 days and from then on it started to getting better. She felt the shot was too close to the shoulder.
Age: 73.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individual beyond use date of 8 weeks after vaccine had been thawed. The individual has been notified of this error and offered to be revaccinated per guidelines. Our local Department of Public Health has been notified of this vaccination administration error.
Age: 11.0
Sex: M
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Pallor, Syncope, Tremor
Clinical narrative: patient faint after vaccination administration. pale, eyes rolled back and shaking a little.  Laid him down, took vitals, cool compress applied to forehead. Notified provider and placed under observation.
Age: 32.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Prostate cancer
Clinical narrative: prostate cancer
Age: 0.75
Sex: M
Vaccine: PNC15
Symptoms: Injection site erythema, Injection site warmth, Irritability
Clinical narrative: Patient was in office for a 9 month physical date of service 07/22/2024. Mother states no symptoms or fevers day and night of vaccine given. 07/23/2024 still no symptoms or changes to the site. 07/24/2024 Mother states she did notice redness at 8:00am to the injection site warm to the touch, slightly fussy no fever or other symptoms. She was in for a sick office visit 07/24/2024. Treatment plan discussed with mother will be benadryl/ ibprofen and observation. We will contact mother 07/26/2024 to see how patient is recovering and schedule a follow up apt.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt presented, alongside her daughter, presented to the pharmacy to complain about an injection site reaction from shingles vaccine received on 07/23/24. Per pt, the site has been very tender and swollen. Upon examining the site, there was visible redness and tenderness.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Blister, Decreased appetite, Injection site erythema, Pain, Pyrexia
Clinical narrative: Fever along with redness and swelling at vaccination site that appeared day after vaccination. Everything worsen with third degree blisters developing and continued high fever along with loss of appetite and pain.  Her leg gradually improved but continued to have fever for close to a month.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Vaccination site swelling
Clinical narrative: Fever along with redness and swelling at vaccination site that appeared day after vaccination. Everything worsen with third degree blisters developing and continued high fever along with loss of appetite and pain.  Her leg gradually improved but continued to have fever for close to a month.
Age: 0.58
Sex: F
Vaccine: HIBV, PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Large redness around vaccine injection area, hard bump, hot to touch, fussy
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out upon exiting pharmacy immunization room
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Heart rate increased, Sleep disorder, Tachycardia
Clinical narrative: Symptoms started about 9 hours after taking the second dose of the Pfizer COVID19 vaccine. I was sleeping and I woke up with extremely fast heart rate, difficulty breathing with the sensation on my breathing and muscles stopping for seconds from my diaphragm up.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Attention deficit hyperactivity disorder, Disorientation, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: Swollen red leg at site of injection. that then led to lethargy and disorientation. He was then placed on two separate rounds of antibiotics when the first didn?t seem to help. All the while he fell more and more ill. It took some time to get well again. Then once well we noticed ADHD type behaviors, which only increased over time. Then he started having ticks. Facial and vocal ticks. another huge struggle. This has been an ongoing struggle that we have tried our best to help him through to this day.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Malaise, Tic
Clinical narrative: Swollen red leg at site of injection. that then led to lethargy and disorientation. He was then placed on two separate rounds of antibiotics when the first didn?t seem to help. All the while he fell more and more ill. It took some time to get well again. Then once well we noticed ADHD type behaviors, which only increased over time. Then he started having ticks. Facial and vocal ticks. another huge struggle. This has been an ongoing struggle that we have tried our best to help him through to this day.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired dose of PROQUAD administered; This spontaneous report was received from a health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JUL-2024, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) injection, 0.5 milliliter, lot #W035468, expiration date: 06-MAY-2024, administered intramuscularly for prophylaxis (strength and anatomical location were not provided) (Expired product administered).  No additional adverse events were reported.