chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: fever; Sore arm; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In SEP-2024, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick), fever (Verbatim: fever) and pain in arm (Verbatim: Sore arm). The outcome of the sickness was resolved (duration 1 day) and the outcome of the fever was not reported and the outcome of the pain in arm was resolved (duration 1 week).   It was unknown if the reporter considered the sickness, fever and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the sickness, fever and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-OCT-2024 This case was reported by a patient via interactive digital media. Consumer reported that he got the first Shingles vaccine shot back in Sept. And made him very sick for a day and had 103-degree fever. He had sore arm for about a week. He not getting the second one until March. The follow-up could not be possible as no contact details were available.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: joint/muscle pain in under left arm nearer to chest; joint/muscle pain in under left arm nearer to chest; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 63-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   On 18-OCT-2024, the patient received the 1st dose of FluLaval 2024-2025 season (left deltoid). On 18-OCT-2024, less than a day after receiving FluLaval 2024-2025 season, the patient experienced muscle pain (Verbatim: joint/muscle pain in under left arm nearer to chest) and joint pain (Verbatim: joint/muscle pain in under left arm nearer to chest). The outcome of the muscle pain and joint pain were not resolved.   It was unknown if the reporter considered the muscle pain and joint pain to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the muscle pain and joint pain to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 Consumer was the reporter who stated he had Flulaval administered on 18 October 2024 in his left deltoid. Consumer stated that later that evening he began to experience intermittent joint/muscle pain in under left arm nearer to chest. Consumer stated this morning the pain was intense. Consumer stated he did not have any other vaccines administered at that time.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: arm pain/painful to raise arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3re73, expiry date 16-NOV-2026) for prophylaxis.   Concurrent medical conditions included wound, laceration of leg and lymphoma.   On 07-OCT-2024 19:37, the patient received Boostrix (left arm). In OCT-2024, an unknown time after receiving Boostrix, the patient experienced pain in arm (Verbatim: arm pain/painful to raise arm). The outcome of the pain in arm was not resolved.   The reporter considered the pain in arm to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     The company considered the pain in arm to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter reported that she presented to the emergency department for a left knee laceration that resulted in a very bad wound.  While at the emergency department, the consumer reported that Boostrix was administered. The consumer stated that she was vaccinated with Boostrix in the left arm. The reporter stated that she had arm pain still present from the injection and was able to raise her arm but had pain when doing so. The injection site was not red or swollen. The reporter consented to follow up.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Infanrix expired dose administered; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received DTPa (Infanrix) (batch number 7hm5j, expiry date 13-SEP-2024) for prophylaxis.   On 21-OCT-2024, the patient received Infanrix. On 21-OCT-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix expired dose administered). The outcome of the expired vaccine used 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: 22-OCT-2024 Pediatrician called to report that an expired dose of Infanrix was administered to a 2 year and 9 months old patient which led to expired vacicne used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first Shingrix dose about 5 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years 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: received the first Shingrix dose about 5 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024 Pharmacist reported that a patient received the first Shingrix dose about 5 years ago and asked if the patient had to re start the series. The reporter did not provide information about first dose (lot number, expiration date). Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: experienced Bell's Palsy; This serious case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-SEP-2024, the patient received the 1st dose of Shingrix (left arm). On 26-OCT-2024, 37 days after receiving Shingrix, the patient experienced bell's palsy (Verbatim: experienced Bell's Palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.     The company considered the bell's palsy to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 13-NOV-2024 The registered pharmacist reported that her friend (patient) received the 1st dose of Shingrix vaccine and the patient experienced Bell's Palsy.  The reporter asked if there was a correlation between Bells Palsy and Shingrix.; Sender's Comments: Bell's palsy  is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: COVID19
Symptoms: Drug effect less than expected
Clinical narrative: My initial vaccine was Moderna and I had a poor response; This spontaneous case was reported by a consumer and describes the occurrence of DRUG EFFECT LESS THAN EXPECTED (My initial vaccine was Moderna and I had a poor response) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG EFFECT LESS THAN EXPECTED (My initial vaccine was Moderna and I had a poor response). At the time of the report, DRUG EFFECT LESS THAN EXPECTED (My initial vaccine was Moderna and I had a poor response) outcome was unknown.            Concomitant medication was not provided. Patient had at least 2 Pfizer COVID vaccines. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2024: Live follow-up received and added no new information.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Movement disorder, Myalgia
Clinical narrative: weakness; difficulty in moving; muscle pain; tiredness; chills; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), MOVEMENT DISORDER (difficulty in moving), MYALGIA (muscle pain), FATIGUE (tiredness) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Heart disorder in April 2023. Previously administered products included for Product used for unknown indication: Pfizer Covid vaccine (dose 3), Pfizer Covid vaccine (dose 1), Pfizer Covid vaccine (dose 2), Pfizer Covid vaccine (dose 2), Pfizer Covid vaccine (dose 2), Pfizer Covid vaccine (dose 2), Pfizer Covid vaccine (dose 3), Pfizer Covid vaccine (dose 3), Pfizer Covid vaccine (dose 3), Pfizer Covid vaccine (dose 3), Pfizer Covid vaccine (dose 1), Pfizer Covid vaccine (dose 1), Pfizer Covid vaccine (dose 1), Pfizer Covid vaccine (dose 1) and Pfizer Covid vaccine (dose 2). Past adverse reactions to the above products included Chills with Pfizer Covid vaccine, Pfizer Covid vaccine and Pfizer Covid vaccine; Movement disorder with Pfizer Covid vaccine, Pfizer Covid vaccine and Pfizer Covid vaccine; Muscle pain with Pfizer Covid vaccine, Pfizer Covid vaccine and Pfizer Covid vaccine; Tiredness with Pfizer Covid vaccine, Pfizer Covid vaccine and Pfizer Covid vaccine; and Weakness with Pfizer Covid vaccine, Pfizer Covid vaccine and Pfizer Covid vaccine.    On 14-Nov-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 14-Nov-2024, the patient experienced ASTHENIA (weakness), MOVEMENT DISORDER (difficulty in moving), MYALGIA (muscle pain), FATIGUE (tiredness) and CHILLS (chills). At the time of the report, ASTHENIA (weakness), MOVEMENT DISORDER (difficulty in moving), MYALGIA (muscle pain), FATIGUE (tiredness) and CHILLS (chills) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. She had several reactions which includes muscle pain, weakness, tiredness, chills, difficulty in moving. She was feeling a bit better on the day of reporting. She also mentioned that she had been vaccinated 3 times before (she couldn't remember exact dates) with Pfizer Covid vaccine and she always had the same reactions like this, that passed after some days. She also mentioned that last April she had a heart problem. Reporter causality was not reported. Treatment information was not provided.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Crying, Insomnia, Pyrexia
Clinical narrative: temperature of almost 101 F; freezing cold; couldn't sleep; was also extra weepy after the shot for a few days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INSOMNIA (couldn't sleep), CRYING (was also extra weepy after the shot for a few days), PYREXIA (temperature of almost 101 F) and CHILLS (freezing cold) in a 5-year-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Constipation, Sickness (was sick a lot last year), Flu and COVID-19.    On 11-Nov-2024, the patient received second dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (unknown route) 1 dosage form. On 12-Nov-2024,  after starting mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS), the patient experienced PYREXIA (temperature of almost 101 F). In November 2024, the patient experienced INSOMNIA (couldn't sleep), CRYING (was also extra weepy after the shot for a few days) and CHILLS (freezing cold). The patient was treated with Ibuprofen (Advil) at an unspecified dose and frequency. At the time of the report, INSOMNIA (couldn't sleep), CRYING (was also extra weepy after the shot for a few days), PYREXIA (temperature of almost 101 F) and CHILLS (freezing cold) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2024, Body temperature: almost 101 F.     For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was reported that in May had mono and gave it to her grandmother and her aunt. Patient had 1 previous COVID vaccine, but caller didn't know which one it was. The concomitant medication was not reported by reporter. Patient received the Moderna COVID injection on Monday and woke up Tuesday with a temperature of almost 101 F. They assumed it was from the COVID vaccine and called their pediatrician. They gave patient some Advil and she seemed a little better during the day. However, that night, and for the last four nights, patient goes to sleep, she's a very good sleeper overnight, and woke up around 2 am, 1:30 and was wide awake like it's daytime and GL was so upset because she was up for 2 hours and couldn't sleep.   This case was linked to US-MODERNATX, INC.-MOD-2021-015706, US-MODERNATX, INC.-MOD-2024-777412 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015706:Patient Sister case US-MODERNATX, INC.-MOD-2024-777412:Patient's brother
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Peripheral coldness
Clinical narrative: cold hands; little cranky; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIPHERAL COLDNESS (cold hands) and FEELING ABNORMAL (little cranky) in a 1-year-old male patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2024, the patient received first dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (unknown route) .25 milliliter. On 12-Nov-2024, the patient experienced PERIPHERAL COLDNESS (cold hands) and FEELING ABNORMAL (little cranky). At the time of the report, PERIPHERAL COLDNESS (cold hands) and FEELING ABNORMAL (little cranky) had not resolved.        The action taken with mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that the patient received his first COVID vaccine on Tuesday and was due for his second vaccine in a month, and they aren't sure if they feel comfortable and are debating whether to give him his next vaccine because they are so upset. Patient was a little cranky, also had other shots on Tuesday. Patient had very cold hands since his vaccine. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-015706, US-MODERNATX, INC.-MOD-2024-777361 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015706:Same Reporter different patient US-MODERNATX, INC.-MOD-2024-777361:Patient's brother
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain in extremity, Parosmia, SARS-CoV-2 test
Clinical narrative: Malaise/Up and down episodes of malaise, chills; chills/Up and down episodes of malaise, chills; felt a sore arm; alterations in taste an smell of food; alterations in taste an smell of food; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Malaise/Up and down episodes of malaise, chills), PAIN IN EXTREMITY (felt a sore arm), PAROSMIA (alterations in taste an smell of food), TASTE DISORDER (alterations in taste an smell of food) and CHILLS (chills/Up and down episodes of malaise, chills) in a 71-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 vaccine (some) and Pfizer (some). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine and Pfizer. Concurrent medical conditions included High cholesterol and Blood pressure high.    On 16-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On 16-Oct-2024, the patient experienced PAIN IN EXTREMITY (felt a sore arm), PAROSMIA (alterations in taste an smell of food) and TASTE DISORDER (alterations in taste an smell of food). On 18-Oct-2024, the patient experienced MALAISE (Malaise/Up and down episodes of malaise, chills) and CHILLS (chills/Up and down episodes of malaise, chills). The patient was treated with Paracetamol (Tylenol) in October 2024 at an unspecified dose and frequency. At the time of the report, MALAISE (Malaise/Up and down episodes of malaise, chills) and CHILLS (chills/Up and down episodes of malaise, chills) was resolving and PAIN IN EXTREMITY (felt a sore arm), PAROSMIA (alterations in taste an smell of food) and TASTE DISORDER (alterations in taste an smell of food) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2024, SARS-CoV-2 test: Negative.         Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Patient had a sore arm on vaccination day but approximately 2 days after the vaccine began to notice Malaise and chills. Since then, patient continues to have up and down episodes of malaise, chills (which were improved with Tylenol), alterations in taste and smell of food. Patient had a negative Covid test on 12NOV2024. Patient never had a fever, but he just does not feel like he felt before when he got the vaccine on the 16th. Reporter causality was not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Malaise/Up and down episodes of malaise, chills; chills/Up and down episodes of malaise, chills; felt a sore arm; alterations in taste an smell of food; alterations in taste an smell of food; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Malaise/Up and down episodes of malaise, chills), PAIN IN EXTREMITY (felt a sore arm), PAROSMIA (alterations in taste an smell of food), TASTE DISORDER (alterations in taste an smell of food) and CHILLS (chills/Up and down episodes of malaise, chills) in a 71-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 vaccine (some) and Pfizer (some). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine and Pfizer. Concurrent medical conditions included High cholesterol and Blood pressure high.    On 16-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On 16-Oct-2024, the patient experienced PAIN IN EXTREMITY (felt a sore arm), PAROSMIA (alterations in taste an smell of food) and TASTE DISORDER (alterations in taste an smell of food). On 18-Oct-2024, the patient experienced MALAISE (Malaise/Up and down episodes of malaise, chills) and CHILLS (chills/Up and down episodes of malaise, chills). The patient was treated with Paracetamol (Tylenol) in October 2024 at an unspecified dose and frequency. At the time of the report, MALAISE (Malaise/Up and down episodes of malaise, chills) and CHILLS (chills/Up and down episodes of malaise, chills) was resolving and PAIN IN EXTREMITY (felt a sore arm), PAROSMIA (alterations in taste an smell of food) and TASTE DISORDER (alterations in taste an smell of food) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2024, SARS-CoV-2 test: Negative.         Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Patient had a sore arm on vaccination day but approximately 2 days after the vaccine began to notice Malaise and chills. Since then, patient continues to have up and down episodes of malaise, chills (which were improved with Tylenol), alterations in taste and smell of food. Patient had a negative Covid test on 12NOV2024. Patient never had a fever, but he just does not feel like he felt before when he got the vaccine on the 16th. Reporter causality was not reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness between her legs; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRURITUS (itchiness between her legs) in an 86-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness between her legs). The patient was treated with Cetirizine hydrochloride (Zyrtec) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness between her legs) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Reporter reported that about the side effects that happened to her mom way back 27-October-2024 after taking the Moderna covid Vaccine. Her mom was experienced itchiness between her legs and its been ongoing for almost 3 weeks now and currently taking Zyrtec as prescribed by their doctor to relieve the itchiness.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Visual impairment
Clinical narrative: does not see good; hands are too twisted; This spontaneous case was reported by a patient and describes the occurrence of VISUAL IMPAIRMENT (does not see good) and LIMB DISCOMFORT (hands are too twisted) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (does not see good) and LIMB DISCOMFORT (hands are too twisted). At the time of the report, VISUAL IMPAIRMENT (does not see good) and LIMB DISCOMFORT (hands are too twisted) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that patient did not see good and that his hands are too twisted to deal with the internet.  Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19, FLUX, RVX
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 77-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years intramuscular, in arm for covid-19 immunisation; rsv vaccine (RSV VACCINE), on 24Sep2024 as dose number unknown, single), in arm for immunisation; influenza vaccine (FLU VACCINE VII), on 24Sep2024 as dose number unknown, single), in arm. The patient's relevant medical history included: "Stage IV kidney disease" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty, for COVID-19 Immunization, reaction(s): "no adverse effect". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: Patient said that she had a reaction to the COVID Vaccine for the first time and she said that every bone in her body was aching and they are hurting last 4 days and she also received an RSV vaccine and a Flu vaccine at the same time with the COVID Vaccine. Patient mentioned aving previous COMIRNATY doses and never experienced any AE. She did not know that a formulation administered was a new vaccine. She was unsure of a specific anatomical location of vaccination, probably left arm. In the following days patient did some lab work related to her chronic stage iv kidney disease and saw her neurologist (unrelated to vaccination).  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: two of my relatives were dead because of it (Pfizer-BioNTech COVID Vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "two of my relatives were dead because of it (Pfizer-BioNTech COVID Vaccine". The date and cause of death for the patient were unknown.  Clinical course: The reporter stated, 'two of my relatives were dead because of it (Pfizer-BioNTech COVID Vaccine)'. She specified that her brother-in-law took the BioNtech vaccine and died. The reporter wanted to get some answers and some explanation why her loved ones are dead from their (Pfizer) vaccine and why it is still on the market when it's killed 17 million people worldwide.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400303588 Same reporter/suspect vaccine/event; different patient;; Reported Cause(s) of Death: two of my relatives were dead because of it (Pfizer-BioNTech COVID Vaccine)
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain in extremity
Clinical narrative: chills; sore arm; feels a little blah and needs to lay down; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Jan2021, outcome "unknown"; MALAISE (non-serious) with onset Jan2021, outcome "unknown", described as "feels a little blah and needs to lay down"; PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "sore arm".  Batch/lot number is not provided, and it cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; The initial case was missing the following minimum criteria: Unspecified Product. Upon receipt of follow-up information on [13Nov2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 46-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Aug2024 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Comirnaty nos (DOSE NUMBER UNKNOWN), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Nov2024, outcome "not recovered" and all described as "COVID-19". The clinical course was reported as follows: The patient's husband wanted to know if the patient could take nirmatrelvir/ritonavir (PAXLOVID) at this point of her infection. The patient was vaccinated, was on her 10th day of the COVID infection and feeling worse with symptoms such as the lingering cough, chest congestion/compression and then nausea. This was the patient's first time with COVID. The patient had been coughing and had sore throats for 7-10 days and it was like with any cold and she had that more so with COVID. The patient's symptoms began last Monday night 04Nov2024 and the chest congestion, nausea, cough are the remaining symptoms and her symptoms started with the standard cold and grew into fever, fatigue and then sore throat and cough and they tested her on 07Nov2024 so found that out a little later even though she was staying at home. The patient had not started or taken nirmatrelvir/ritonavir (PAXLOVID. The patient's vaccinations were Pfizer and took place in Aug2024 and was whatever the last vaccination that was provided at that date; he was not sure how often it was but it was a two part Pfizer COVID vaccine that she received. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Nov2024) COVID-19 infection.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: two of my relatives were dead because of it (Pfizer-BioNTech COVID Vaccine); This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "two of my relatives were dead because of it (Pfizer-BioNTech COVID Vaccine)". The date and cause of death for the patient were unknown.  Clinical course: The reporter stated, 'two of my relatives were dead because of it (Pfizer-BioNTech COVID Vaccine)'. The reporter wanted to get some answers and some explanation why her loved ones are dead from their (Pfizer) vaccine and why it is still on the market when it's killed 17 million people worldwide.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400303577 Same reporter/suspect vaccine/event; different patient;; Reported Cause(s) of Death: two of my relatives were dead because of it (Pfizer-BioNTech COVID Vaccine)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Hordeolum, Swelling of eyelid
Clinical narrative: Swollen eyelid/Most likely recurring style on inside of upper lid; Swollen eyelid/Most likely recurring style on inside of upper lid; This happen last fall when she took the booster as well; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Nov2024 at 18:00 as dose 1, single (Lot number: UM2221) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Swollen eyelid", start date: 2023 (unspecified if ongoing), notes: when she took the (unspecified) booster; "style on inside of upper lid", start date: 2023 (unspecified if ongoing), notes: when she took the (unspecified) booster. There were no concomitant medications. 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, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 4, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 5, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 6, manufacturer unknown), for COVID-19 immunisation. The following information was reported: SWELLING OF EYELID (non-serious), HORDEOLUM (non-serious) all with onset 13Nov2024 at 19:00, outcome "not recovered" and all described as "Swollen eyelid/Most likely recurring style on inside of upper lid"; DISEASE RECURRENCE (non-serious) with onset 13Nov2024 at 19:00, outcome "not recovered", described as "This happen last fall when she took the booster as well". Therapeutic measures were not taken as a result of swelling of eyelid, hordeolum, disease recurrence.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400303731 same reporter/patient/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT; This is a spontaneous report received from an Other HCP from a sales representative.  A 63-year-old female patient (not pregnant) 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: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT". The vaccine was reported to have been administered on "05May2020". It was unknown if therapeutic measures were taken as a result of deep vein thrombosis.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162b2 (BNT162B2 NOS) cannot be excluded for the reported event. Information on details surrounding patient complete medical history, concomitant medications and clinical course would aid in comprehensive medical assessment. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: F
Vaccine: TTOX
Symptoms: Optic neuritis, Paraesthesia, Vision blurred
Clinical narrative: Optic neuritis; paresthesia of the arm; blurred vision; Initial information received on 13-Nov-2024 regarding an unsolicited valid  serious case received from a physician.  This case involves Adult female patient who had optic neuritis, paresthesia of the arm and blurred vision after receiving tetanus toxoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received tetanus toxoid produced by unknown manufacturer via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, formulation, dose, batch and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient had optic neuritis, paresthesia of the arm (Paresthesia upper limb) and blurred vision (vision blurred) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events  Seriousness criteria-Medically significant for optic neuritis.; Sender's Comments: Sanofi Company Comment dated 19-Nov-2024: This case involves Adult female patient who had optic neuritis, paresthesia of the arm and blurred vision after receiving tetanus toxoid.Further information regarding concurrent condition during vaccination, previous vaccination, past medical history, medical treatment, family history  concomitant medication and 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
Age: 9.0
Sex: U
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: product administered to patient of inappropriate age with no reported adverse event; Initial information received on 11-Nov-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to other case 2024SA334721.  This case involves a 9-year-old and unknown gender patient who received influenza trivalent recombinant vaccine [flublok TIV].   The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient under the age of 18 may have received unknown dose of suspect influenza trivalent recombinant vaccine Solution for injection (Unknown strength) with lot U8440AA and expiry date: 30-Apr-2025 via unknown route in unknown administration site for infuenza with no reported adverse event (product administered to patient of inappropriate age) (latency same day)   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA334721:Patient 1 02300959
Age: 14.0
Sex: U
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under the age of 18 may have received FLUBLOK; Initial information received on 11-Nov-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to other case US-SA-2024SA334781.  This case involves a 14 year old and unknown gender patient who received influenza trivalent recombinant vaccine [flublok TIV].   The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient under the age of 18 may have received unknown dose of suspect influenza trivalent recombinant vaccine Solution for injection (Unknown strength and expiry date) with lot U8440AA via unknown route in unknown administration site for prophylactic vaccination (immunization) (product administered to patient of inappropriate age) (latency same day)   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA334781:Patient 1 02300959
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patients under 65 received FLUZONE HD; Initial information received on 12-Nov-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case was linked to other case US-SA-2024SA334813 and US-SA-2024SA334990.  This case involves a 40 years old female patient who received influenza USP trival A-B high dose subvirion vaccine [fluzone HD].   The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength) with lot U8429CA and expiry date 30-Jun-2025 via unknown route in unknown administration site for influenza (product administered to patient of inappropriate age) (latency same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA334813:02302474 (Patient 3) US-SA-2024SA334990:02302471 (Patient 2)
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inadvertently administered only the liquid portion of the PENTACEL vaccine, as they forgot to reconstitute it with the lyophilized Hib component with no reported adverse event; Initial information received on 12-Nov-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 months old female patient who inadvertently got administered only the liquid portion of the diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] vaccine, as they forgot to reconstitute it with the lyophilized hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Oct-2023 patient received dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection and on 21-Dec-2023 she also received a dose 2 and on 08-Feb-2024, the patient received a dose 3 and on 12-Nov-2024, the patient received 0.5 ml dose 4 of (lot- UK041AA) via intramuscular route in the right thigh (strength, lot/batch number and expiration date: not provided) for Immunisation and inadvertently administered only the liquid portion of the pentacel vaccine, as they forgot to reconstitute it with the lyophilized hib component with no reported adverse event (single component of a two-component product administered) (latency- same day).  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence 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: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received a 4th dose of PENTACEL one month earlier than the recommended 6-month interval between the 3rd and 4th doses with no reported adverse event; Initial information received on 12-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown demographics who received a 4th dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] one month earlier than the recommended 6-month interval between the 3rd and 4th doses with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose (dose 4) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization one month earlier than the recommended 6-month interval between the 3rd and 4th doses with no reported adverse event (inappropriate schedule of product administration) (latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is 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.