chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, Immunisation reaction, Injection site reaction, Insomnia, Nausea
Clinical narrative: had a severe reaction with the Moderna vaccine; sick; Insomnia; shaking; Hurts a little bit you know at point of injection; throwing up; Nausea; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a severe reaction with the Moderna vaccine), ILLNESS (sick), INSOMNIA (Insomnia), TREMOR (shaking) and INJECTION SITE REACTION (Hurts a little bit you know at point of injection) in an 8-decade-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Batch-EM9810) on 06-Feb-2021, Pfizer (Dose 2, Batch-EL9266) on 28-Feb-2021, Pfizer (Dose 3, Batch-FF8841) on 01-Oct-2021, Pfizer (Dose 4 and Batch-FK9893) in April 2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Type 1 diabetes mellitus (type 1 diabetic). Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) and INSULIN NOS (INSULIN [INSULIN NOS]) for an unknown indication.   On 08-Jun-2022, the patient received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. 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 IMMUNISATION REACTION (had a severe reaction with the Moderna vaccine), ILLNESS (sick), INSOMNIA (Insomnia), TREMOR (shaking), INJECTION SITE REACTION (Hurts a little bit you know at point of injection), VOMITING (throwing up) and NAUSEA (Nausea). At the time of the report, IMMUNISATION REACTION (had a severe reaction with the Moderna vaccine), ILLNESS (sick), INSOMNIA (Insomnia), TREMOR (shaking), INJECTION SITE REACTION (Hurts a little bit you know at point of injection), VOMITING (throwing up) and NAUSEA (Nausea) outcome was unknown.            It was reported that the patient had taken the previous five Pfizer vaccines and had never experienced any adverse reactions to those five Pfizer vaccines. However, when the patient took the last vaccine in the fall of 2022, they experienced a severe adverse reaction with the Moderna vaccine including tongue reaction. The patient also reported that he would never take another Covid vaccine again and that he would rather have died of Covid than take another vaccine. No treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: had a severe reaction with the Moderna vaccine; sick; Insomnia; shaking; Hurts a little bit you know at point of injection; throwing up; Nausea; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a severe reaction with the Moderna vaccine), ILLNESS (sick), INSOMNIA (Insomnia), TREMOR (shaking) and INJECTION SITE REACTION (Hurts a little bit you know at point of injection) in an 8-decade-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Batch-EM9810) on 06-Feb-2021, Pfizer (Dose 2, Batch-EL9266) on 28-Feb-2021, Pfizer (Dose 3, Batch-FF8841) on 01-Oct-2021, Pfizer (Dose 4 and Batch-FK9893) in April 2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Type 1 diabetes mellitus (type 1 diabetic). Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) and INSULIN NOS (INSULIN [INSULIN NOS]) for an unknown indication.   On 08-Jun-2022, the patient received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. 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 IMMUNISATION REACTION (had a severe reaction with the Moderna vaccine), ILLNESS (sick), INSOMNIA (Insomnia), TREMOR (shaking), INJECTION SITE REACTION (Hurts a little bit you know at point of injection), VOMITING (throwing up) and NAUSEA (Nausea). At the time of the report, IMMUNISATION REACTION (had a severe reaction with the Moderna vaccine), ILLNESS (sick), INSOMNIA (Insomnia), TREMOR (shaking), INJECTION SITE REACTION (Hurts a little bit you know at point of injection), VOMITING (throwing up) and NAUSEA (Nausea) outcome was unknown.            It was reported that the patient had taken the previous five Pfizer vaccines and had never experienced any adverse reactions to those five Pfizer vaccines. However, when the patient took the last vaccine in the fall of 2022, they experienced a severe adverse reaction with the Moderna vaccine including tongue reaction. The patient also reported that he would never take another Covid vaccine again and that he would rather have died of Covid than take another vaccine. No treatment medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: extreme fatigue; low grade fever of 99-100 F; body aches; This spontaneous case was reported by a non-health professional and describes the occurrence of FATIGUE (extreme fatigue), PYREXIA (low grade fever of 99-100 F) and PAIN (body aches) in a 69-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 80777-0110-96) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 19-Sep-2024, the patient experienced FATIGUE (extreme fatigue), PYREXIA (low grade fever of 99-100 F) and PAIN (body aches). On 20-Sep-2024, FATIGUE (extreme fatigue), PYREXIA (low grade fever of 99-100 F) and PAIN (body aches) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2024, Body temperature: 99-100 F.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       Concomitant medication was not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ophthalmic migraine
Clinical narrative: ocular migraine followed by mild headache; nausea morning after vaccine; This spontaneous case was reported by a patient and describes the occurrence of OPHTHALMIC MIGRAINE (ocular migraine followed by mild headache) and NAUSEA (nausea morning after vaccine) in a 64-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 80777-0110-96) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 21-Sep-2024, the patient experienced OPHTHALMIC MIGRAINE (ocular migraine followed by mild headache) and NAUSEA (nausea morning after vaccine). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] (oral use) at a dose of 324 milligram. At the time of the report, OPHTHALMIC MIGRAINE (ocular migraine followed by mild headache) and NAUSEA (nausea morning after vaccine) was resolving.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that reactions were not severe (and may be unrelated to vaccine), but very rare for patient to have. The patient did not experience any additional symptoms/events. There were no lab data/results available.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Fever of 101.4; soreness in arm/ aches in extremities; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 101.4) and PAIN IN EXTREMITY (soreness in arm/ aches in extremities) in a 41-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 23-Sep-2024, the patient experienced PYREXIA (Fever of 101.4) and PAIN IN EXTREMITY (soreness in arm/ aches in extremities). At the time of the report, PYREXIA (Fever of 101.4) and PAIN IN EXTREMITY (soreness in arm/ aches in extremities) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2024, Body temperature: Fever of 101.4.         No concomitant and treatment medication were reported.  It was unknown if the patient experienced any additional symptoms/events.
Sex: U
Vaccine: COVID19
Symptoms: Device breakage
Clinical narrative: 1 vaccine broken in manufacturer box; The initial case was missing the following minimum criteria: identifiable event. Upon receipt of follow-up information on 18Sep2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse from product quality group.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LM2221, Expiration Date: 01Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 2024, outcome "unknown", described as "1 vaccine broken in manufacturer box".  Causality for "1 vaccine broken in manufacturer box" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).  Additional information: The reporter clarified no patient involvement with this product.
Sex: U
Vaccine: RSV
Symptoms: Dizziness, Headache, Malaise, Myalgia, Syncope
Clinical narrative: Fainting, I feel like I want to faint; I have had a vaccine (Abrysvo) yesterday and it was supposed to be a Moderna, but it is a Pfizer Vaccine (Abrysvo).; I don't do well; I just don't feel well; Headache; Muscle ache; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "Fainting, I feel like I want to faint"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "I have had a vaccine (Abrysvo) yesterday and it was supposed to be a Moderna, but it is a Pfizer Vaccine (Abrysvo)."; MALAISE (non-serious), outcome "unknown", described as "I don't do well; I just don't feel well"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: Fainting, I feel like I want to faint; I have had a vaccine (Abrysvo) yesterday and it was supposed to be a Moderna, but it is a Pfizer Vaccine (Abrysvo).; I don't do well; I just don't feel well; Headache; Muscle ache; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "Fainting, I feel like I want to faint"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "I have had a vaccine (Abrysvo) yesterday and it was supposed to be a Moderna, but it is a Pfizer Vaccine (Abrysvo)."; MALAISE (non-serious), outcome "unknown", described as "I don't do well; I just don't feel well"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache". Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19 after two days after taking the Pfizer vaccine shot; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An adult male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 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: COVID-19 (non-serious) with onset 2024, 2 days after the suspect product(s) administration, outcome "unknown", described as "tested positive for Covid 19 after two days after taking the Pfizer vaccine shot". Relevant laboratory tests and procedures are available in the appropriate section.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature labour, Uterine contractions during pregnancy
Clinical narrative: Premature contractions, 2 days after receiving the vaccine; This is a spontaneous report received from a Physician from a sales representative.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history included: "Unknown drug allergy" (unspecified if ongoing). The patient was 32 weeks pregnant at the event onset. The patient's concomitant medications were not reported.  The following information was reported: UTERINE CONTRACTIONS DURING PREGNANCY (non-serious), 2 days after the suspect product(s) administration, outcome "recovered", described as "Premature contractions, 2 days after receiving the vaccine". It was unknown if therapeutic measures were taken as a result of uterine contractions during pregnancy.  Additional information: Premature contractions, 2 days after receiving the vaccine.  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: RSV
Symptoms: Exposure during pregnancy, Off label use, Premature labour, Product use issue
Clinical narrative: Abrysvo: prescribed for patient 38 weeks gestation; Abrysvo: prescribed for patient 38 weeks gestation; Premature contractions, 2 days after receiving the vaccine.; This is a spontaneous report received from a Physician from a sales representative.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history included: "Unknown drug allergy" (unspecified if ongoing). The patient was 38 weeks pregnant at the event onset. The patient's concomitant medications were not reported. The following information was reported: PREMATURE LABOUR (non-serious), outcome "recovered", described as "Premature contractions, 2 days after receiving the vaccine."; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "Abrysvo: prescribed for patient 38 weeks gestation". It was unknown if therapeutic measures were taken as a result of premature labour.  Additional information: Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion. The patient did receive any other vaccines on the same date as the vaccine(s) for which you are reporting: Unknown. The patient did receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting: Unknown. The patient was taking any other medications within 2 weeks of the event starting: Unknown. Reported Event: Premature contractions, 2 days after receiving the vaccine.  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: RSV
Symptoms: Exposure during pregnancy, Premature labour
Clinical narrative: Premature contractions 2 days after receiving the vaccine; This is a spontaneous report received from a Physician from a sales representative.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history included: "Unknown" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Unknown, reaction(s): "Hypersensitivity". The following information was reported: PREMATURE LABOUR (non-serious), outcome "recovered", described as "Premature contractions 2 days after receiving the vaccine". It was unknown if therapeutic measures were taken as a result of premature labour.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Reactive Arthritis" (unspecified if ongoing); "Bee stings" (unspecified if ongoing); "Coconut" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bupropion, reaction(s): "Allergy: Bupropion". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown". Additional information: Have received Pfizer vaccine since start of Covid. Have gotten flu and Covid shot at the same time since Covid began. Other than fever and chills, have not had any other side effects. Patient received Pfizer vaccine since start of Covid. .   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400261257 same patient/product/event, different dose;
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Reactive Arthritis" (unspecified if ongoing); "Bee stings" (unspecified if ongoing); "Coconut" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bupropion, reaction(s): "Allergy: Bupropion". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "chills", "fever"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "chills", "fever"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "chills", "fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400261257 same patient and drug, different dose and event;
Age: 12.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Malaise, Oropharyngeal pain, Vomiting
Clinical narrative: Threw up on 9/24; Sore throat; Felt unwell on 9/23; This is a spontaneous report received from a Consumer or other non HCP.  A 12-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Sep2024 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 12 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 22Sep2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "OCD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; FLUOXETINE; ADDERALL; CLARITIN [LORATADINE]; IBUPROFEN. Past drug history included: Amoxicillin, reaction(s): "Amoxicillin allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 23Sep2024 at 05:00, outcome "recovering", described as "Felt unwell on 9/23"; OROPHARYNGEAL PAIN (non-serious) with onset 23Sep2024 at 05:00, outcome "recovering", described as "Sore throat"; VOMITING (non-serious) with onset 24Sep2024 at 05:00, outcome "recovering", described as "Threw up on 9/24". Therapeutic measures were not taken as a result of oropharyngeal pain, malaise, vomiting.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was taking other medications within 2 weeks of the event starting. The patient had sore throat and felt unwell on 23Sep2024 at 05:00 AM and threw up on 24Sep2024 at 05:00 AM.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Got covid in 2022; Got covid in 2022; This is a spontaneous report received from a Nurse.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EL0142, Expiration Date: Mar2021), in arm, on 31Jan2021 as dose 2, single (Lot number: EN5318, Expiration Date: May2021), in arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 79 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Has a bad back" (unspecified if ongoing); "back surgery" (not ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN oral taken for blood cholesterol abnormal. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Got covid in 2022". The event "got covid in 2022" required physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Reporter was a retired registered nurse. She was calling about the Covid Booster. She got the first two vaccinations and it was wonderful. Then when boosters came out she got them. She talked to her doctor they said same thing don't get anymore. If she got covid then can just take Paxlovid. Confirmed she did get covid, but it was very mild. Age of onset: Unknown. Sometime 2021 -2024 had three boosters. Initially provided they were a minimum of 6 months apart. Ill after first booster. Covid: Several attempts made to clarify when she had covid. She confirmed she had covid twice. Initially provided she got covid once she came home from a trip from withheld in Jun2023. She also mentioned she had a small case of covid when she went on a withheld, it was sometime 2022. It was a mild case. She got this during the trip and took Dayquil and Nyquil Seriousness Criteria- Not life threatening, she thought she had a cold. Initially confirmed she had 2 boosters then got covid. These vaccines was administered in her left arm, but she was not sure. She believed she got them all in her left arm. Route: Assuming it was subcutaneous or intramuscular. She later said she got a mild dose of covid this Summer Aug2024. Clarified further she only had covid after the Name in 2022 and when she came home from withheld in Aug2024 At end of call clarified and confirmed she did not have covid in Jun2023 when came home from withheld. She was currently taking a course on medications/adverse reactions course of studying and found number. No doctor has offered help. They just say do not get another booster, can take Paxlovid or something. Had covid twice and has received the Pfizer covid vaccine and Pfizer covid boosters. Had covid in 2022 and Aug2024.; Sender's Comments: Based on the known drug safety profile, the reported events Vaccination failure, Covid-19 are assessed as related to suspect drug .,Linked Report(s) : US-PFIZER INC-202400263123 same patient, different dose, different events;
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Illness, Movement disorder, Pyrexia, Ventilation/perfusion scan
Clinical narrative: Second Covid Booster-ill; It was back where could not move, really felt bad; fever; This is a spontaneous report received from a Nurse.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Feb2023 as dose 4 (booster), single (Lot number: GJ6743) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Has a bad back" (unspecified if ongoing); "She has had back surgery a few years ago" (unspecified if ongoing); "Covid", start date: 2022 (unspecified if ongoing), notes: after river cruise. Concomitant medication(s) included: PRAVASTATIN oral taken for blood cholesterol. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot: EL0142; Exp: Mar2021), administration date: 11Jan2021, when the patient was 78-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot: EN5318 ; Exp: May2021), administration date: 31Jan2021, when the patient was 78-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER); Lot: FC3183), administration date: 30Sep2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "First Covid Booster- Ill", "Her legs did not work", "Muscles were shocked". The following information was reported: MOVEMENT DISORDER (non-serious) with onset 10Feb2023, outcome "unknown", described as "It was back where could not move, really felt bad"; ILLNESS (non-serious) with onset 10Feb2023, outcome "unknown", described as "Second Covid Booster-ill"; PYREXIA (non-serious) with onset 10Feb2023, outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was a retired registered nurse calling about the Covid Booster.  She was a big person of vaccination and gets everything. She got the first two vaccinations, and it was wonderful. Then when boosters came out she got them. Confirmed as the Pfizer Covid Booster. Once she the first Covid Booster she got ill from the booster. Then time went on and being a steward of vaccinations she got the second vaccination, second booster when it was time, but got even sicker. She got the second Covid booster in the morning. She seemed to be okay during the day, but cannot remember specifically. During night she got sick again. It was back where could not move, really felt bad. This time felt like really really awful and much more scary and lasted longer. She thinks she had a fever. It was scary enough did not want to do again. Second time much more frightened than the first. She was calling asking why she was having these violent reactions to vaccination. Was it something she was allergic to in it that she does not know about. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400263123 same patient, different event/dose;
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitation for almost a month, never went to ER; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Feb2023 as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Oral Cancer" (unspecified if ongoing), notes: survivor; "SIBO" (unspecified if ongoing); "IBS-C" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Epstein Barr virus" (unspecified if ongoing); "drug allergy" (unspecified if ongoing), notes: too many to list. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 immunisation; Covid-19 vaccine (dose 2), for COVID-19 immunisation. The following information was reported: PALPITATIONS (non-serious) with onset 19Feb2023, outcome "recovered" (31Mar2023), described as "heart palpitation for almost a month, never went to ER". Therapeutic measures were not taken as a result of palpitations.  Additional information: The patient informed that the facility where vaccine was administered was in the doctor's office/urgent care. The patient did not receive any other vaccines on the same date and within 4 weeks prior to the vaccines for which she was reporting.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Food allergy, Guillain-Barre syndrome, Radiculitis brachial
Clinical narrative: Guillain Barre Syndrome; brachial neuritis; Anaphylactic reaction; Post event, post vaccine yes to many foods; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jun2021 as dose 1, single (Lot number: EW0181) at the age of 24 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing), notes: previous to first vaccine. Concomitant medication(s) included: PREDNISONE; BENADRYL. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, disability, life threatening) with onset 2021, outcome "not recovered"; GUILLAIN-BARRE SYNDROME (hospitalization, disability, life threatening) with onset 2021, outcome "not recovered", described as "Guillain Barre Syndrome"; RADICULITIS BRACHIAL (hospitalization, disability, life threatening) with onset 2021, outcome "not recovered", described as "brachial neuritis"; FOOD ALLERGY (non-serious), outcome "unknown", described as "Post event, post vaccine yes to many foods". The patient was hospitalized for guillain-barre syndrome, radiculitis brachial, anaphylactic reaction (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of guillain-barre syndrome, radiculitis brachial, anaphylactic reaction. Clinical course: Facility type vaccine was Pharmacy or Drug Store. Patient administered with Pfizer BioNTech Vaccine on 13Jul2021 (lot number: Ew0168) as dose 2, single, Vaccine location: Upper Left deltoid, Facility type vaccine: Hospital. Patient received no other vaccine same date or in four weeks. Ae treatment was Steroids, epinephrine, morphine, blood thinners. Known allergies: Post event, post vaccine yes to many foods.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400263439 same patient/product, different events/dose;
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Fatigue; soreness at point of injection; muscle aches over whole body; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Sep2024 at 14:00 as dose 1, single (Batch/Lot number: unknown), in upper right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUCELVAX, on 19Sep2024 as dose number un known, single. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER)), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 24Sep2024 at 06:00, outcome "not recovered"; MYALGIA (non-serious) with onset 24Sep2024 at 06:00, outcome "not recovered", described as "muscle aches over whole body"; VACCINATION SITE PAIN (non-serious) with onset 24Sep2024 at 06:00, outcome "not recovered", described as "soreness at point of injection". Therapeutic measures were not taken as a result of fatigue, vaccination site pain, myalgia.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 39.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Exposure during pregnancy
Clinical narrative: Dizziness; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 24Sep2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years for maternal immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 13Feb2024. The patient was 32 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 33 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 13Nov2024. Concomitant medication(s) included: TDAP taken for immunisation as dose number unknown, single. The following information was reported: DIZZINESS (non-serious) with onset 24Sep2024 at 20:00, outcome "recovering". Therapeutic measures were not taken as a result of dizziness.  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
Symptoms: Psoriasis
Clinical narrative: psoriasis; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: PSORIASIS (medically significant) with onset 2022, outcome "not recovered". Therapeutic measures were taken as a result of psoriasis. Clinical course: In 2022, patient received a covid booster and about two weeks later she developed psoriasis. Patient did not give it a thought until now. She was on Otezla for almost a year and her psoriasis went into remission. Query response received as Date Reported to Pfizer 23Sep2024 and date received to their email box 22Sep2024. Unfortunately, for the onset date they did not have much information because this was randomly sent to them via email.  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-202400263160 same patient/product, different event/dose;
Sex: U
Vaccine: RSV
Symptoms: Drug ineffective, Malaise, Respiratory syncytial virus infection
Clinical narrative: RSV; RSV; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization), DRUG INEFFECTIVE (hospitalization), outcome "unknown" and all described as "RSV". The patient was hospitalized for respiratory syncytial virus infection, drug ineffective, illness (start date: Feb2024). The patient was in the hospital in Feb2024, and had RSV, really, really sick. So, patient can't afford to get it again.  The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V] will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (respiratory syncytial virus infection) with the suspect product RSV VACCINE PROT.SUBUNIT PREF 2V cannot be fully excluded.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness at the injection site; Warm sensation at the injection site; Cellulitis; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number GK2AZ, expiry date 21-APR-2026) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at the injection site), injection site warmth (Verbatim: Warm sensation at the injection site) and cellulitis (Verbatim: Cellulitis). The outcome of the injection site erythema, injection site warmth and cellulitis were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and cellulitis to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site warmth and cellulitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2024 A pharmacist mentioned that a patient had a reaction following the administration of the first dose of Shingrix. Symptoms included redness and warm sensation at the injection site. The reporter also mentioned that the patient developed cellulitis and asked if it was recommended for this patient to receive the second dose. First dose was given 2 months ago.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Behaviour disorder, Ear infection, Ear tube insertion, Malaise, Nasopharyngitis
Clinical narrative: Patient was never sick tell 1 week after he got vaccine. First he got a cold, then it turned into a sinus and ear infection, he got a fever of 101. I ended up taking him to urgent care because i couldnt get the fever to go down. I beleive it went up to almost 104. It was awhile ago i cant remember all the details. All I know is now and since the vaccine I have gotten hardly any answers of what all is wrong with patient. He had tubes put in his ears, they did not help. He has had ear infections with the tubes in. The Dr said he has childrens Fever Syndrome now because he gets fevers over everything.  A tiny cut on his hand. fever. He now has asthma and allergies also bad. Hes contantly is sick. i need help. His dr refuses to accept that all this is from the vaccine. Also patient now is beging tested for ADHD and has Atistic behaviors
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis, Treatment failure
Clinical narrative: Patient was never sick tell 1 week after he got vaccine. First he got a cold, then it turned into a sinus and ear infection, he got a fever of 101. I ended up taking him to urgent care because i couldnt get the fever to go down. I beleive it went up to almost 104. It was awhile ago i cant remember all the details. All I know is now and since the vaccine I have gotten hardly any answers of what all is wrong with patient. He had tubes put in his ears, they did not help. He has had ear infections with the tubes in. The Dr said he has childrens Fever Syndrome now because he gets fevers over everything.  A tiny cut on his hand. fever. He now has asthma and allergies also bad. Hes contantly is sick. i need help. His dr refuses to accept that all this is from the vaccine. Also patient now is beging tested for ADHD and has Atistic behaviors
Age: 12.0
Sex: M
Vaccine: FLU3, HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Bexero given instead of menveo.
Age: 1.0
Sex: F
Vaccine: MMR, PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: left leg, inner thigh swollen and red, 12 cm big
Age: 85.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Muscular weakness
Clinical narrative: Patient received both flu and COVID vaccine on 9/16/24.  The patient's wife called the pharmacy on 9/26/24 to say that 4 days following her husband's shots  that he began to exhibit weakness in his legs.  He was still able to walk, but was weak.  The wife indicated that the weakness lasted approximately 18 hours at which time the patient returned to normal.
Age: 85.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Asthenia, Wheelchair user
Clinical narrative: Patient received both flu and COVID vaccine on 9/16/24.  The patient's wife called the pharmacy on 9/26/24 to say that 4 days following her husband's shots  that he began to exhibit weakness in his legs.  He was still able to walk, but was weak.  The wife indicated that the weakness lasted approximately 18 hours at which time the patient returned to normal.
Age: 44.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Fracture, Loss of consciousness, Road traffic accident, Skin laceration
Clinical narrative: Patient reports that shortly after leaving the pharmacy where she received the vaccines, she passed out while she was driving her car, causing a car accident.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not report any adverse event. This submission is because patient did receive RSV vaccine on 9/24/24 after already receiving this vaccine the previous year on 8/28/23. Vaccines is currently recommended as a one- dose vaccination.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not report any adverse events. this submission is because the patient received RSV vaccine on 9/24/24 after already receiving this vaccine the previous year on 8/28/23. Vaccine is currently recommended as a one-dose vaccination.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Chills, Discomfort
Clinical narrative: Spikevax caused me to have chest pain, with pressure on my chest. Shortness of breath caused trouble breathing, and I had to sit up all night. Pronounced irregular heartbeat with discomfort bordering on pain. I had fatigue, headache, muscle pain, joint pain, chills, fever, and nausea which came and went.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Heart rate irregular, Myalgia
Clinical narrative: Spikevax caused me to have chest pain, with pressure on my chest. Shortness of breath caused trouble breathing, and I had to sit up all night. Pronounced irregular heartbeat with discomfort bordering on pain. I had fatigue, headache, muscle pain, joint pain, chills, fever, and nausea which came and went.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Spikevax caused me to have chest pain, with pressure on my chest. Shortness of breath caused trouble breathing, and I had to sit up all night. Pronounced irregular heartbeat with discomfort bordering on pain. I had fatigue, headache, muscle pain, joint pain, chills, fever, and nausea which came and went.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: The guardian of the patient stated she noticed a red rash on the patient's thigh when changing the patient's diaper on 09/25/2024. The patient entered the clinic on 09/25/2024 at 1705 and a 50mm x 70mm area of redness was noted at the injection site. The area was not hard, warm, or raised. The patient did not seem to be in distress and was acting normally per guardian. The guardian was instructed to use a cold compress and Bendaryl. The guardian was instructed to monitor the area and report to the emergency department if the area worsens.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient was given HIB with sterile water diluent instead of the active diluent that comes in the box.  Per our pharmacist, patient will need re-vaccination.  No adverse reactions noted to date.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling of thigh around site of injection; treatment with ibuprofen, cool compress
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: no adverse event to report at this time. the patient researched the RSV vaccine on cdc and because it did not specify a duration decided to make an appointment and get a second dose. He received Arexvy 10/09/2023. I failed to notice the vaccine in the system report and he told me about it after the injection.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fear, Hypersensitivity, Lip swelling, Pruritus, Rash
Clinical narrative: Patient had what she described as an allergic reaction in which the upper trunk region of her body was itching intensely. She also said that the sides of her torso below her armpits were broken out in a red rash. Her lips and face were swollen and she said she was very scared because she had never experienced anything like this. She said that she got into the shower, got out, and rubbed cream all over including her face and lips. She then contacted the pharmacy and spoke to our pharmacy technician, who came to ask me what to tell her because I was giving another person a vaccination. I told her that she should go to an urgent care or ER and have her symptoms evaluated. She came in  the pharmacy about an hour or so later and bought diphenhydramine, which is what the ER doctor recommended. She stated that by the time she got to the ER, her symptoms had resolved. I called her around 7:00pm this evening and she stated that she was feeling much better. That she was going to rub some cream on her arm and go to bed.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash erythematous, Swelling face
Clinical narrative: Patient had what she described as an allergic reaction in which the upper trunk region of her body was itching intensely. She also said that the sides of her torso below her armpits were broken out in a red rash. Her lips and face were swollen and she said she was very scared because she had never experienced anything like this. She said that she got into the shower, got out, and rubbed cream all over including her face and lips. She then contacted the pharmacy and spoke to our pharmacy technician, who came to ask me what to tell her because I was giving another person a vaccination. I told her that she should go to an urgent care or ER and have her symptoms evaluated. She came in  the pharmacy about an hour or so later and bought diphenhydramine, which is what the ER doctor recommended. She stated that by the time she got to the ER, her symptoms had resolved. I called her around 7:00pm this evening and she stated that she was feeling much better. That she was going to rub some cream on her arm and go to bed.