chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't yet received dose 2; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, received first dose, 2 years ago with batch number 7BC47 and expiry date 09-Jun-2023).   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: hasn't yet received dose 2). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2024 The reporter reported that the patient received her first dose of Shingrix 2 years ago from reporting day and had not received the 2nd dose. The reporter consented to follow-up. Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been linked with the case US2024056882, reported by same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site swelling, Mobility decreased
Clinical narrative: left arm swollen like it had a grapefruit sitting on the side of it at the injection site; extremely dizzy; I could not get out of bed for 3 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 3 days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: left arm swollen like it had a grapefruit sitting on the side of it at the injection site), dizziness (Verbatim: extremely dizzy) and bedridden (Verbatim: I could not get out of bed for 3 days). The outcome of the injection site swelling, dizziness and bedridden were resolved.   It was unknown if the reporter considered the injection site swelling, dizziness and bedridden to be related to Shingrix.     It was unknown if the company considered the injection site swelling, dizziness and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2024 The patient self-reported this case for herself. The patient received Shingrix 1st dose in April 2024. She was unsure of exact date. However, the reporter stated her left arm was swollen like a grapefruit was sitting on it (sitting on the side of it at the injection site) and the swelling started going down one week after the injection.  At this time (the time of reporting) the left arm was resolved in 2024. The patient also complained of getting extremely dizzy for 3 days that now had resolved in 2024. The patient also stated that she could not get out of bed for 3 days due to dizziness. This had now been resolved in 2024. In 2024, after receiving Shingrix, the patient experienced injection site swelling, dizziness and bedridden. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Influenza, Pyrexia
Clinical narrative: Fever; Flu symptoms; This non-serious case was reported by a nurse via call center representative and described the occurrence of fever in a 30-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   The patient's past medical history included vaccination adverse reaction (generally had reactions to all vaccines).   On an unknown date, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced fever (Verbatim: Fever) and flu symptoms (Verbatim: Flu symptoms). The outcome of the fever and flu symptoms were unknown.   The reporter considered the fever and flu symptoms to be related to Tdap Vaccine.     The company considered the fever and flu symptoms to be related to Tdap Vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2024 The reporter had a patient who was on third trimester of pregnancy, who generally had reactions to all vaccines.  The patient just had 2 years ago (from reporting date) a Tdap vaccine (unknow brand name but HCP believes was Boostrix), and it did gave her a fever and flu symptoms.  The reporter was looking for someone to advice her whether or not the risk exceed the benefit of taking another Boostrix.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: wanted to get a 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 21-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose on 26th December 2023, batch 7MH25, expiry 7th December 2025).   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: wanted to get a late second dose). 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: 03-MAY-2024 Pharmacist explained a 21 year old patient received first of Engerix-B on December 26th 2023, and they wanted to get a late second dose now, which led to incomplete course of vaccination. Consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Aphasia, Back pain, Guillain-Barre syndrome, Hypoaesthesia, Limb injury
Clinical narrative: Guillain Barre syndrome; Tingling in Fingers and Toes; Deep Back Pain (Spasms); Motor Skills Affected (feels like she can't put sentences together properly); Losing feeling in fingers and toes; loss of feeling in toes; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a adult female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included latex allergy and allergy to chemicals.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant), tingling of extremity (Verbatim: Tingling in Fingers and Toes), back pain (Verbatim: Deep Back Pain (Spasms)), motor activity abnormal (Verbatim: Motor Skills Affected (feels like she can't put sentences together properly)), numbness in fingers (Verbatim: Losing feeling in fingers and toes) and sensory loss (Verbatim: loss of feeling in toes). The outcome of the guillain barre syndrome, tingling of extremity, back pain, motor activity abnormal, numbness in fingers and sensory loss were unknown.   It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, back pain, motor activity abnormal, numbness in fingers and sensory loss to be related to Boostrix.     It was unknown if the company considered the guillain barre syndrome, tingling of extremity, back pain, motor activity abnormal, numbness in fingers and sensory loss to be related to Boostrix.   Additional Information: GSK receipt date: 06-MAY-2024 and 07-MAY-2024 The reporter reported that a patient when travelling, stepped on rusty nail. The patient experienced tingling in fingers and toes, having deep back pain like spasms, feels like her motor skills was affected as did not feel she was putting sentences together well, loss of feeling in her fingers and toes and symptoms of Guillain Barr Syndrome after receiving Boostrix vaccine. The reporter did not provide any additional details about when the vaccine took place.
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: Guillain Barre syndrome; Tingling in Fingers and Toes; Deep Back Pain (Spasms); Motor Skills Affected (feels like she can't put sentences together properly); Losing feeling in fingers and toes; loss of feeling in toes; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a adult female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included latex allergy and allergy to chemicals.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant), tingling of extremity (Verbatim: Tingling in Fingers and Toes), back pain (Verbatim: Deep Back Pain (Spasms)), motor activity abnormal (Verbatim: Motor Skills Affected (feels like she can't put sentences together properly)), numbness in fingers (Verbatim: Losing feeling in fingers and toes) and sensory loss (Verbatim: loss of feeling in toes). The outcome of the guillain barre syndrome, tingling of extremity, back pain, motor activity abnormal, numbness in fingers and sensory loss were unknown.   It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, back pain, motor activity abnormal, numbness in fingers and sensory loss to be related to Boostrix.     It was unknown if the company considered the guillain barre syndrome, tingling of extremity, back pain, motor activity abnormal, numbness in fingers and sensory loss to be related to Boostrix.   Additional Information: GSK receipt date: 06-MAY-2024 and 07-MAY-2024 The reporter reported that a patient when travelling, stepped on rusty nail. The patient experienced tingling in fingers and toes, having deep back pain like spasms, feels like her motor skills was affected as did not feel she was putting sentences together well, loss of feeling in her fingers and toes and symptoms of Guillain Barr Syndrome after receiving Boostrix vaccine. The reporter did not provide any additional details about when the vaccine took place.
Sex: M
Vaccine: COVID19
Symptoms: Bladder cancer
Clinical narrative: bladder cancer; This spontaneous case was reported by a patient and describes the occurrence of BLADDER CANCER (bladder cancer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2024, the patient experienced BLADDER CANCER (bladder cancer) (seriousness criterion medically significant). At the time of the report, BLADDER CANCER (bladder cancer) had not resolved.            It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.  Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) event of bladder cancer. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, patient have been diagnosed with bladder cancer after receiving the second dose of the Moderna Vaccine. No further information about the event was provided. Considering the nature of event and lack of biological plausibility for causality the event of bladder cancer is considered as not related to mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: pain; swelling of injection site; tiredness; lethargy; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 04Dec2021 as dose 1, single (Lot number: ER8737, Expiration Date: 31Jul2021) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LETHARGY (non-serious) with onset Dec2021, outcome "unknown"; PAIN (non-serious) with onset Dec2021, outcome "unknown"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "slight fever"; VACCINATION SITE SWELLING (non-serious) with onset Dec2021, outcome "unknown", described as "swelling of injection site"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "tiredness". Additional information: Onset date of all events-within hours to 1 day from date of vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400033136 same patient, same drug, different dose/event;US-PFIZER INC-202400103387 same patient, same drug/event, different dose;US-PFIZER INC-202400103388 same patient, same drug/event, different dose;US-PFIZER INC-202400103389 same patient, same drug/event, different dose;US-PFIZER INC-202400103390 same patient, same drug/event, different dose;US-PFIZER INC-202400103391 same patient, same drug/event, different dose;
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: pain; swelling of injection site; tiredness; lethargy; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2021 as dose 2, single (Lot number: ER8735, Expiration Date: 31Jul2021) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Pennacillian" (unspecified if ongoing); "allergies:many miscellaneous food" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number: Er8737, expiration date: 31Jul2021, vaccine location: left arm), administration date: 12Apr2021, when the patient was 57-year-old, for Covid-19 immunisation, reaction(s): "pain", "swelling of injection site", "tiredness", "lethargy", "slight fever". The following information was reported: LETHARGY (non-serious) with onset May2021, outcome "unknown"; PAIN (non-serious) with onset May2021, outcome "unknown"; PYREXIA (non-serious) with onset May2021, outcome "unknown", described as "slight fever"; VACCINATION SITE SWELLING (non-serious) with onset May2021, outcome "unknown", described as "swelling of injection site"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "tiredness". Additional information: All events onset date was within hours to 1 day from date of each vaccine. Prior vaccinations within 4 weeks was NONE. Relevant test reported as NONE. Specific Relevant Test For Thromboembolic events with Thrombocytopenia reported as None.
Sex: F
Vaccine: RSV
Symptoms: Abnormal behaviour
Clinical narrative: not being her normal self and her behavior is kind of 'Affect'; This is a spontaneous report received from a Pharmacist from medical information team.  An 80-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; denosumab (PROLIA) for bone densitometry. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "not being her normal self and her behavior is kind of 'Affect'". The action taken for denosumab was unknown.  Additional information: Caller stated that one of their elderly patients (80-years, Female) received an Abrysvo vaccination and the received a dose of Prolia injection for bone density the next day. Caller stated that the patient's daughter reported that the patient is not being her normal self and her behavior is kind of 'Affect' (behavior description is inaudible).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Back pain
Clinical narrative: The pain in the lower back that is going to the front part; The pain was in my joint, in the knee joint; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 57-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in 2023 as dose number unknown, single). The patient's relevant medical history included: "COVID", start date: 2022 (unspecified if ongoing), notes: got COVID in 2022. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 (it is more than five doses for the vaccine)), for COVID-19 immunisation; Bnt162b2 (DOSE 2 (it is more than five doses for the vaccine)), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (it is more than five doses for the vaccine)), for COVID-19 immunisation; Bnt162b2 (DOSE 4 (it is more than five doses for the vaccine)), for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "The pain in the lower back that is going to the front part"; ARTHRALGIA (non-serious), outcome "unknown", described as "The pain was in my joint, in the knee joint". Additional information included: Date of vaccination was last year, patient did not remember exactly. It was around Dec, she thought so Dec-Nov. The patient took it with the Flu vaccine. She think it was around Oct or Sep because she did together with the same Flu vaccine. It was Pfizer vaccine for the COVID, all patient's vaccinations was Pfizer. The patient had been so bad, it was more than five doses for the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400105024 same patient, different dose/event;US-PFIZER INC-202400105025 same patient, different dose/event;
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Mar2024 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing), notes: Controlled; "high blood pressure" (unspecified if ongoing), notes: Controlled. Patient had known no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 7 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "recovered" (2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Negative; (2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 29Apr2024 to 04May2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got COVID in 22 (2022); I got COVID in 22 (2022); This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 55-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I got COVID in 22 (2022)".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400105024 same patient, different dose/event;US-PFIZER INC-202400104765 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Brain fog, Gait disturbance
Clinical narrative: brain fog; wobbliness; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: Unknown), administration date: 17Feb2021, for COVID-19 immunisation, reaction(s): "Brain fog", "Gait distrurbance". The following information was reported: BRAIN FOG (non-serious), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "wobbliness".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400061607 same patient, different dose/event;US-PFIZER INC-202400105885 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Blood test, Cerebellar ataxia, Dysarthria
Clinical narrative: my balance was off; Ataxia Cerebellum; I am on a walker; slurred speech; I can't write; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number unknown), administration date: 17Feb2021, for COVID-19 immunisation, reaction(s): "Brain fog", "Gait disturbance"; BNT162b2 (DOSE 2, SINGLE, Lot number unknown), administration date: 12Mar2021, for COVID-19 immunisation, reaction(s): "Brain fog", "Gait disturbance". The following information was reported: BALANCE DISORDER (non-serious), outcome "unknown", described as "my balance was off"; CEREBELLAR ATAXIA (non-serious), outcome "unknown", described as "Ataxia Cerebellum"; WALKING AID USER (non-serious), outcome "unknown", described as "I am on a walker"; DYSARTHRIA (non-serious), outcome "unknown", described as "slurred speech"; DYSGRAPHIA (non-serious), outcome "unknown", described as "I can't write". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400105884 same patient, different dose/event;US-PFIZER INC-PV202400061607 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Dysgraphia, Magnetic resonance imaging, Magnetic resonance imaging head, Ophthalmological examination, Walking aid user
Clinical narrative: my balance was off; Ataxia Cerebellum; I am on a walker; slurred speech; I can't write; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number unknown), administration date: 17Feb2021, for COVID-19 immunisation, reaction(s): "Brain fog", "Gait disturbance"; BNT162b2 (DOSE 2, SINGLE, Lot number unknown), administration date: 12Mar2021, for COVID-19 immunisation, reaction(s): "Brain fog", "Gait disturbance". The following information was reported: BALANCE DISORDER (non-serious), outcome "unknown", described as "my balance was off"; CEREBELLAR ATAXIA (non-serious), outcome "unknown", described as "Ataxia Cerebellum"; WALKING AID USER (non-serious), outcome "unknown", described as "I am on a walker"; DYSARTHRIA (non-serious), outcome "unknown", described as "slurred speech"; DYSGRAPHIA (non-serious), outcome "unknown", described as "I can't write". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400105884 same patient, different dose/event;US-PFIZER INC-PV202400061607 same patient, different dose/event;
Sex: U
Vaccine: PNC20
Symptoms: Device issue
Clinical narrative: three of our Prevnar 20 vaccines have something floating in them; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown ,single (Lot number: HH9323) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "three of our Prevnar 20 vaccines have something floating in them".  Additional information: The reporter stated, "we get our vaccines from (withheld) and three of our Prevnar 20 vaccines have something floating in them". The reporter further stated that the particles did not dissipate after vigorous shaking. The vaccines were not administered to any patient.  Causality for "three of our prevnar 20 vaccines have something floating in them" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: inadvertently administered only the HIB component of PENTACEL with no reported adverse event; inadvertently administered only the HIB component of PENTACEL it was diluted with sterile water instead with no reported adverse event; Initial information received on 09-May-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who was inadvertently administered only the HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] it was diluted with sterile water instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient was inadvertently administered only the HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot number and expiry date not reported) via unknown route in unknown administration site Immunization (single component of a two-component product administered) it was diluted with sterile water instead with no reported adverse event (product preparation error) (unknown latency). There will be no information available on the batch number for this case.  She mentioned she does not have the patient's information on hand. She also mentioned she's reporting for a different clinic and was unsure if it's okay to follow up with the clinic for further information regarding the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Caller declined to respond to questions and refuses future follow-up.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: received a dose of acthib that was reconstituted with the sterile water that comes with the mmr product. hcp states the diluent that came with the acthib was not used with no reported ae; Initial information received on 09-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old female patient who experienced received a dose of HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with the sterile water that comes with the mmr product. hcp states the diluent that came with the acthib was not used with no reported Adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Prophylactic vaccination.  On 01-May-2024, the patient received 0.5 ml, total dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection  that was reconstituted with the sterile water that comes with the mmr product (product preparation error) (latency same day) (lot UJ965AA and expiry 18-11-24) via intramuscular route in the left thigh for Immunization.  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: 17.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Vaccination error
Clinical narrative: Nurse said that an expired MenQuadfi vaccine was administered to a male patient 30 minutes prior to the call, with no reported adverse event; Initial information received on 09-May-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 17 years old male patient where nurse said that an expired meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] vaccine was administered to a male patient 30 minutes prior to the call, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-May-2024, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot number not reported via unknown route in unknown administration site (dose, strength, lot/batch number: not provided) for Immunisation (expired product administered) (latency- same day). Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursions that occurred for GARDASIL-9.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.; Confirmed no symptomatic adverse events were reported.; This spontaneous report has been received from a registered nurse and refers to a patient who is currently 12-year-old of unknown gender. Information regarding the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  Multiple temperature excursions occurred for a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as follows: on 07-JUN-2023, at 33 degrees Fahrenheit (F) for 3 hours; on 13-JUN-2023, at 60 F for 4 hours and 30 minutes and from that date until 23-JUN-2023, at 34.10 F for 240 hours; on 30-NOV-2023, at 52 F for 5 hours and 45 minutes; from 01-DEC-2023 to 09-DEC-2023, at 51.78 F for 192 hours. However, on an unknown date, the patient was vaccinated with that dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dose, route of administration and anatomical location were not provided; lot number W010663 has been verified to be valid, expiration date 11-MAR-2024) (product storage error). There was no data logger involved.  No symptomatic adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2404USA008890:MSD US-009507513-2404USA008641:MSD US-009507513-2404USA008637:MSD US-009507513-2404USA008692:MSD US-009507513-2404USA008715:MSD US-009507513-2404USA008807:MSD US-009507513-2404USA008815:MSD US-009507513-2404USA008820:MSD US-009507513-2404USA008840:MSD US-009507513-2404USA008853:MSD US-009507513-2404USA008863:MSD US-009507513-2404USA008925:MSD
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; patient inadvertently received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 08-AUG-2023; This spontaneous report was received from an office manager regarding to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not provided. Concomitant medications included sterile diluent.  On 08-AUG-2023, the patient inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, at a dose of 0.5 milliliter (ml)/dose, lot number U022175 (lot number U022175 had been verified to be valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [M-M-R II], expiration date was reported as 14-JUL-2023) (strength, vaccination scheme, route of administration and anatomical injection site were not provided) (expired product administered); nonetheless, the sterile diluent used for reconstitution was not expired. No symptoms reported. No additional adverse event (AE)/product quality complaint (PQC) reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.; a temperature excursion (TE) for GARDASIL 9 (2014790 04/22/2026) that occurred on 05/07/2024 and then was inadvertently administered to a patient on 05/09/2024; This spontaneous report has been received from a nurse referring a 11-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.    On 07-MAY-2024, HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of -0.4C for 4 hours 51 minutes 0 seconds. No previous temperature excursion reported.  On 09-MAY-2024, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), at a dose of 0,5 milliliter (mL), once, lot number 2014790 with expiration date 22-APR-2026 that has been verified to be valid, administered for prophylaxis (strength, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error) No adverse event reported.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Cerebrovascular accident, Chest X-ray, Feeling abnormal
Clinical narrative: BELL'S PALSY; STROKE LIKE SYMPTOMS; PANIC ATTACKS; BODY BUZZ; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient experienced vision changes when treated with covid-19 vaccine nrvv ad26 (dose series 1) (JNJ 78436735) for covid-19 prophylaxis. The patient received covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, intramuscular, batch number: 1822811) dose was not reported, administered on 29-OCT-2021 for covid-19 prophylaxis. Concomitant medications included metformin for long covid symptoms. It was reported that after second vaccine, the consumer reported 2 weeks post second vaccine on 29-Oct-2021, he had onset of numbness, tingling, and pain, shortly after onset went to the Emergency room with stroke like symptoms (dose series 2) and was diagnosed with Bell's Palsy (dose series 2), He stated his doctor refused to report his symptoms. From that point symptoms persisted for over a year with worsening intensity, he reported panic attacks, "Body Buzz" (dose series 2) related to something with his Neurological system, 2 hospitalizations with stroke-like symptoms, Multiple doctor visits, Consumer reported all diagnostic tests and blood work was all negative, Took Prednisone treatment when hospitalized the second time, Consumer reported to be undergoing Hyperbaric chamber Treatments, and he states that anytime he undergoes physical activity, he has an exacerbation of his symptoms. Consumer provided Lot number of first and second vaccine, as reported in this report, however stated expiration date unavailable, Agent asked for NDC, UDI, Serial number, GTIN, and prescription number and reported these to be unavailable, Email not asked for during this call. Consumer voiced his desire to discuss this report with Janssen safety department in further detail, informed Consumer this agents role is just for intake and to submit global complaint to our safety department. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke like symptoms, and the outcome of bell's palsy, panic attacks and body buzz was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20240517690 (dose series 1 case).; Sender's Comments: V0:  Bell's palsy; The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration. Cerebrovascular accident; The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Panic attack
Clinical narrative: BELL'S PALSY; STROKE LIKE SYMPTOMS; PANIC ATTACKS; BODY BUZZ; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient experienced vision changes when treated with covid-19 vaccine nrvv ad26 (dose series 1) (JNJ 78436735) for covid-19 prophylaxis. The patient received covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, intramuscular, batch number: 1822811) dose was not reported, administered on 29-OCT-2021 for covid-19 prophylaxis. Concomitant medications included metformin for long covid symptoms. It was reported that after second vaccine, the consumer reported 2 weeks post second vaccine on 29-Oct-2021, he had onset of numbness, tingling, and pain, shortly after onset went to the Emergency room with stroke like symptoms (dose series 2) and was diagnosed with Bell's Palsy (dose series 2), He stated his doctor refused to report his symptoms. From that point symptoms persisted for over a year with worsening intensity, he reported panic attacks, "Body Buzz" (dose series 2) related to something with his Neurological system, 2 hospitalizations with stroke-like symptoms, Multiple doctor visits, Consumer reported all diagnostic tests and blood work was all negative, Took Prednisone treatment when hospitalized the second time, Consumer reported to be undergoing Hyperbaric chamber Treatments, and he states that anytime he undergoes physical activity, he has an exacerbation of his symptoms. Consumer provided Lot number of first and second vaccine, as reported in this report, however stated expiration date unavailable, Agent asked for NDC, UDI, Serial number, GTIN, and prescription number and reported these to be unavailable, Email not asked for during this call. Consumer voiced his desire to discuss this report with Janssen safety department in further detail, informed Consumer this agents role is just for intake and to submit global complaint to our safety department. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke like symptoms, and the outcome of bell's palsy, panic attacks and body buzz was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20240517690 (dose series 1 case).; Sender's Comments: V0:  Bell's palsy; The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration. Cerebrovascular accident; The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: pain; swelling of injection site; tiredness; lethargy; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 59 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pennacillian allergy" (unspecified if ongoing); "many miscellaneous food allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8737, EXP: 31Jul2021, Intramuscular, Anatomical site of injection: Left arm), administration date: 12Apr2021, when the patient was 57-year-old, for COVID-19 immunisation, reaction(s): "Pain", "swelling of injection site", "Tiredness", "Lethargy", "Slight fever"; BNT162b2 (DOSE 2, SINGLE, Lot number: ER8735, EXP: 31Jul2021, Intramuscular, Anatomical site of injection: Right arm), administration date: 04May2021, when the patient was 57-year-old, for COVID-19 immunisation, reaction(s): "Pain", "swelling of injection site", "Tiredness", "Lethargy", "Slight fever"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 3203080, Intramuscular, Anatomical site of injection: Right arm), administration date: 03Dec2021, when the patient was 58-year-old, for COVID-19 immunisation, reaction(s): "Pain", "swelling of injection site", "Tiredness", "Lethargy", "Slight fever". The following information was reported: LETHARGY (non-serious) with onset Jun2022, outcome "unknown"; PAIN (non-serious) with onset Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset Jun2022, outcome "unknown", described as "slight fever"; VACCINATION SITE SWELLING (non-serious) with onset Jun2022, outcome "unknown", described as "swelling of injection site"; FATIGUE (non-serious) with onset Jun2022, outcome "unknown", described as "tiredness". Additional information: Onset date of all events-within hours to 1 day from date of vaccination. Prior vaccinations within 4 weeks was NONE. Relevant test reported as NONE. Specific Relevant Test For Thromboembolic events with Thrombocytopenia reported as None.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400103328 same patient, same drug/event, different dose;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: pain; swelling of injection site; tiredness; lethargy; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Lot number: Oj5346), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pennacillian allergy" (unspecified if ongoing); "many miscellaneous food allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8737, EXP: 31Jul2021, Intramuscular, Anatomical site of injection: Left arm), administration date: 12Apr2021, when the patient was 57-year-old, for COVID-19 immunisation, reaction(s): "Pain", "swelling of injection site", "Tiredness", "Lethargy", "Slight fever", "Pain"; BNT162b2 (DOSE 2, SINGLE, Lot number: ER8735, EXP: 31Jul2021, Intramuscular, Anatomical site of injection: Right arm), administration date: 04May2021, when the patient was 57-year-old, for COVID-19 immunisation, reaction(s): "swelling of injection site", "Tiredness", "Lethargy", "Slight fever"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 3203080, Intramuscular, Anatomical site of injection: Right arm), administration date: 03Dec2021, when the patient was 58-year-old, for COVID-19 immunisation, reaction(s): "Slight fever", "Lethargy", "Tiredness", "swelling of injection site", "Pain"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: FM0173, Intramuscular, Anatomical site of injection: Right arm), administration date: 18Jun2022, when the patient was 59-year-old, for COVID-19 immunisation, reaction(s): "Slight fever", "Lethargy", "Tiredness", "swelling of injection site", "Pain". The following information was reported: LETHARGY (non-serious) with onset Nov2022, outcome "unknown"; PAIN (non-serious) with onset Nov2022, outcome "unknown"; PYREXIA (non-serious) with onset Nov2022, outcome "unknown", described as "slight fever"; VACCINATION SITE SWELLING (non-serious) with onset Nov2022, outcome "unknown", described as "swelling of injection site"; FATIGUE (non-serious) with onset Nov2022, outcome "unknown", described as "tiredness". Additional information: Onset date of all events-within hours to 1 day from date of vaccination. Prior vaccinations within 4 weeks was NONE. Relevant test reported as NONE. Specific Relevant Test For Thromboembolic events with Thrombocytopenia reported as None.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400103328 same patient, same drug/event, different dose;
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Condition aggravated, Deep vein thrombosis, Detoxification, Electrocardiogram
Clinical narrative: PFIZER #1 4/13/2021  PFIZER #2 5/6/2021 DEVELOPED EXTENSIVE RIGHT LEG DVT WITH PULMONARY EMBOLISM.  UNPROVOKED.  FACTOR 5 LEIDEN POSITIVE.  ALSO DEVELOPED WORSENED TRIGEMINAL NEURALGIA REQUIRING EXTENSIVE MULTIPLE CONSULTATIONS AND THERAPIES INCLUDING ORAL MIGRAINE, INJECTIBLE MIGRAINE THERAPIES, JAW APPLIANCES, AND CONSIDERATION FOR TRIGEMINAL VASCULAR SURGERY.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION WITH XARELTO AND TRIGEMINAL NEURALGIA MEDICATIONS INCLUDING FLEXERIL, GABAPENTIN, BOTOX, AMOVIG, KETOROLAC, PERCHORLPERAZINE, CYMBALTA, .