chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19: the patient received treatment with Paxlovid from 09Jan2024 to 14Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP .  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Lot number: HF9275) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "obesity" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "adhesive" (unspecified if ongoing); "ace inhibitors" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Moderna covid-19 vaccine, start date: 14Oct2022, stop date: 14Oct2022, for Covid-19 immunization, notes: DOSE 5 (BOOSTER), SINGLE lot no. 049D2214; Bnt162b2, start date: 17May2022, stop date: 17May2022, for Covid-19 immunization, notes: DOSE 4 (BOOSTER), SINGLE lot no. FM9992,; Bnt162b2, start date: 11Oct2021, stop date: 11Oct2021, for Covid-19 immunization, notes: DOSE 3 (BOOSTER), SINGLE lot no. FF2589; Bnt162b2, start date: 09Apr2021, stop date: 09Apr2021, for Covid-19 immunization, notes: DOSE 2, SINGLE lot no. EW0158; Bnt162b2, start date: 19Mar2021, stop date: 19Mar2021, for Covid-19 immunization, notes: DOSE 1, SINGLE lot no. ER2613; Neosporin, reaction(s): "Drug allergies:Neosporin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient took Paxlovid from 04Jan2024 to 06Jan2024.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Physician.  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), on 01Jun2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received treatment with Paxlovid from 11Jan2024 to 15Jan2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 31Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "allergies: Lobster" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid received from 09Jan2024 to 13Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: HG4629) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 5, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 08Jan2024 to13Jan2024.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism during pregnancy and early postpartum" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech (DOSE 3 (BOOSTER), SINGLE), administration date: 01Oct2022, when the patient was 34-year-old, for COVID-19 Immunization; moderna (DOSE 2, SINGLE), administration date: 28Oct2021, when the patient was 33-year-old, for COVID-19 Immunization; janssen (DOSE 1, SINGLE), administration date: 11Apr2021, when the patient was 33-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Negative, notes: after treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid received from 11Jan2024 to 15Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course details: Patient had no known allergies. Patient received treatment with Paxlovid from 16Jan2024 to 21Jan2024 for COVID-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose number unknown (boosters), Manufacturer Unknown), for COVID-19 Immunization; Flu, for Immunization; Rsv, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID". It was reported that the patient took all the doses and the patient was sick.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400016267 Same reporter/vaccine/events, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: my son and his lady friend got really sick; This is a spontaneous report received from a Consumer (parent) or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "my son and his lady friend got really sick".  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400021259 : Same product and event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really sick; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got really sick". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Waldenstrom's macroglobulinaemia
Clinical narrative: Right after the first booster right away she got thrombocytopenia, platelets were lowered; diagnosed with a rare uncurable lymphoma called 'waldensprom macroglobulinemia lymphoplasmacytic lymphoma; States her lymph nodes and her spleen is enlarged; States her lymph nodes and her spleen is enlarged; developed cancer on her leg which was removed; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 75-year-old female patient received BNT162b2 (COMIRNATY), on 12Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EN6198), administration date: 04Mar2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EN6208), administration date: 25Mar2021, when the patient was 73-year-old, for COVID-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant) with onset 18Nov2021, outcome "unknown", described as "developed cancer on her leg which was removed"; THROMBOCYTOPENIA (medically significant), outcome "unknown", described as "Right after the first booster right away she got thrombocytopenia, platelets were lowered"; WALDENSTROM'S MACROGLOBULINAEMIA (medically significant), outcome "unknown", described as "diagnosed with a rare uncurable lymphoma called 'waldensprom macroglobulinemia lymphoplasmacytic lymphoma"; LYMPHADENOPATHY (non-serious), SPLENOMEGALY (non-serious), outcome "unknown" and all described as "States her lymph nodes and her spleen is enlarged". The patient underwent the following laboratory tests and procedures: Platelet count: lowered. Therapeutic measures were taken as a result of neoplasm malignant. Additional information: States 6 days after receiving pfizer covid booster, she developed cancer on her leg which was removed. States a few months ago she was diagnosed with a rare uncurable lymphoma called 'waldensprom macroglobulinemia lymphoplasmacytic lymphoma. States her lymph nodes and her spleen is enlarged. States she has also had a couple of thrombocyopenia flareups since receving the vaccine. States she reported this in Mar2021 and received a form which she completed and sent back. States there was no data at that time.  She received the first shot in Mar2021, the first Pfizer Vaccine shot, confirmed as Covid 19 Vaccine and at the time right after developed as spelled out and confirmed, thrombocytopenia. She has heard some people have developed this after the vaccine, no additional details regarding these people. This is when platelet count goes down and can develop blood clots. Right after the first booster right away she got thrombocytopenia, platelets were lowered.  She also developed cancer on the leg. She got the shot in left arm and cancer developed in left leg. 3 months ago she was diagnosed with a rare uncommon incurable lymphoma which is attributed to thrombocytopenia.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got a COVID vaccine from Pfizer (Pfizer COVID-19 Vaccine); I get COVID; I got a COVID vaccine from Pfizer (Pfizer COVID-19 Vaccine); I get COVID; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got a COVID vaccine from Pfizer (Pfizer COVID-19 Vaccine); I get COVID".  Clinical course: The patient reported that they got a covid vaccine from Pfizer this was in Oct2023 and they have covid now so, they were just wondering how did they got it. They just got a vaccine about 3 months ago and how did they catch covid and stated that the vaccine was supposed to protect. Patient was asking if it was because of the variants.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Dizziness, Feeling abnormal
Clinical narrative: temperature of 101; Dizzy; started to feel bad; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Jan2024 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 20Jan2024, outcome "unknown", described as "Dizzy"; FEELING ABNORMAL (non-serious) with onset 20Jan2024, outcome "unknown", described as "started to feel bad"; BODY TEMPERATURE INCREASED (non-serious) with onset 20Jan2024, outcome "unknown", described as "temperature of 101". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient wanted to report a possible reaction. Patient took COVID booster "yesterday" (19Jan2024) and had a temperature of 101. Patient was dizzy and did not think it was anything serious but patient just wanted to report the reactions. Patient started having reaction in the afternoon.  Batch/lot number is not provided, and it cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 17:15 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pacemaker" (unspecified if ongoing); "lungs compromised from valley fever" (unspecified if ongoing); "lungs compromised from valley fever" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 4 (booster), single; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (booster), single; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, single; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1, single; Manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid treatment from 12Jan2024 to 16Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HH7545) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "known allergies: some trees" (unspecified if ongoing); "known allergies: bees" (unspecified if ongoing); "nickel and cobalt allergy" (unspecified if ongoing); "hydroperoxides allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LUMIGAN. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE; Batch/Lot No: GH9694; Location of injection: Arm Left), administration date: 10Sep2022, when the patient was 68-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary immunization series completed; manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid treatment from 09Jan2024 to13Jan2024.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single), as dose 4 (booster), single) and as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SIMPONI, start date: 04Jan2024. Past drug history included: Levothyroxine, stop date: 01Mar2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid treatment from 13Jan2024 to 17Jan2024. No known allergies.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Weight
Clinical narrative: she had pain in her chest; anxiety in her chest; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pfizer/biontech COVID-19 (DOSE 1, Lot: Unknown, Expiry: Unknown , Site: Left arm), administration date: 03Feb2021, when the patient was 74-year-old, for Covid-19 immunization; pfizer/biontech COVID-19 (DOSE 2, Lot: EN6200, Expiry: Unknown, Site: Left arm), administration date: 24Feb2021, when the patient was 74-year-old, for Covid-19 immunization. The following information was reported: CHEST DISCOMFORT (non-serious) with onset Nov2021, outcome "not recovered", described as "anxiety in her chest"; CHEST PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "she had pain in her chest". The events "she had pain in her chest" and "anxiety in her chest" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, chest discomfort.  Additional Information: The patient is a consumer calling about the Pfizer Covid-19 Vaccine and said that she would like to report a side effect. She wanted to report that after she got the shot, she had pain in her chest. Heart doctor said that there was nothing wrong with her heart. They sent her to a doctor for anxiety in her chest, and they gave her some medication and the medication they gave her is not helping. She feels like she has anxiety in her chest. Before that she was as healthy as she could be. Weight: 107-108lbs. Chest pain started not long after her covid shot. She got all 3 shots. She clarified that her chest pain started after she received a 3rd shot. No NDC or Expiry date on her vaccination card for her 3rd dose.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: mild injection site pain; fatigued; muscle aches; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Jan2024 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic autoimmune urticaria" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient diagnosed with COVID-19. Concomitant medication(s) included: PROBIOTICS; SPIRONOLACTONE; ALLI. The patient also took other concomitant therapy. Vaccination history included: Pfizer covid vaccine (DOSE 1, SINGLE, Batch/Lot not reported), for COVID-19 Immunization; Pfizer covid vaccine (DOSE 2, SINGLE, Batch/Lot not reported), for COVID-19 Immunization; Pfizer covid vaccine (DOSE 3 (BOOSTER), SINGLE, Batch/Lot not reported), for COVID-19 Immunization; Pfizer covid vaccine (DOSE 4 (BOOSTER), SINGLE, Batch/Lot not reported), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 20Jan2024 at 09:00, outcome "recovered" (21Jan2024), described as "fatigued"; VACCINATION SITE PAIN (non-serious) with onset 20Jan2024 at 09:00, outcome "recovering", described as "mild injection site pain"; MYALGIA (non-serious) with onset 20Jan2024 at 09:00, outcome "recovered" (21Jan2024), described as "muscle aches". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, myalgia.  Additional Information: Patient did not receive other vaccines within 4 weeks prior to COVID vaccine. Patient's Concomitant medications (received within 2 weeks of vaccination) included: MVI. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies. Patient received a Pfizer COVID booster on 19Jan2024. And had received 4 previous Pfizer COVID vaccines. On 20Jan2024, patient had mild injection site pain, and felt fatigued and had muscle aches. The fatigue and muscle aches had resolved by the time patient woke up on 21Jan2024. Mild injection site pain is persisting as of 21Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose number unknown (boosters), Manufacturer Unknown), for COVID-19 Immunization; Flu, for Immunization; Rsv, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID". It was reported that the patient took all the doses and the patient was sick.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400016267 Same reporter/vaccine/events, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose number unknown (boosters), Manufacturer Unknown), for COVID-19 Immunization; Flu, for Immunization; Rsv, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID". It was reported that the patient took all the doses and the patient was sick.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400016267 Same reporter/vaccine/events, different patient;
Sex: F
Vaccine: PNC20
Symptoms: Deafness
Clinical narrative: hearing loss; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 18Jan2024, 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.   A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), 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: DEAFNESS (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "hearing loss". Clinical course: This time the patient was figuring out what caused it, patient tried if that was Prevnar 20 but she found that was not the case.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: I did experience some shoulder and back soreness; I did experience some shoulder and back soreness; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US011082_NC (Novartis).  A 53-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "I did experience some shoulder and back soreness".  Additional information: Patient says "I did experience some shoulder and back soreness after a few days of receiving my Covid vaccination."  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in the deltoid muscle it was administered in; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown), in arm 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain in the deltoid muscle it was administered in". Additional information: Patient received every Covid vaccine and boosters that have been recommended by the CDC and my physician. Since patient's last booster, over a year ago, not the most recent vaccine patient received late this summer/early fall, patient have had pain in the deltoid muscle it was administered in. The pain was worse with the use of that arm, ie swimming or lifting light objects. Patient wanted to know if there were others with this same side effect and what the company recommended as a treatment. It continued to get worse.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Myalgia
Clinical narrative: Covid; Covid; sore muscles; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; MYALGIA (non-serious), outcome "unknown", described as "sore muscles". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 13.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: were accidentally given ipol instead of menveo with no adverse event; Initial information received  from Country on 19-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 years old male patient who were accidentally given IPV (VERO) [IMOVAX POLIO] instead of Menveo with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Prophylactic vaccination; and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Prophylactic vaccination.  On 09-Jan-2024, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (lot V1A021M,Expiry date :17-Feb-2024, strength was unknown) via intramuscular route in left deltoid for Prophylactic vaccination (Immunization). On an unknown date, the patient received a unknown dose of suspect MENVEO not produced by Sanofi Pasteur (strength, expiry date, formulation, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization).  On 09-JAN-2024 the patient were accidentally given ipol instead of menveo with no adverse event (wrong product administered) (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 and Module of the 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: F
Vaccine: FLUX
Symptoms: Chest discomfort, Chills, Dyspnoea, Pain, Pyrexia
Clinical narrative: blotchy rash; chills; feverish; aches; shortness of breath; heavy chest; Initial information was received on 19-Jan-2024 regarding an unsolicited valid non-serious Courtesy case received from Biogen case received from a physician.  This case involves Adult female patient who experienced blotchy rash, chills, feverish, aches, shortness of breath and heavy chest after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylatcic vaccination (Immunization). There will be no information available on batch number for this case.  On an unknown date the patient developed blotchy rash (rash macular), chills, feverish (pyrexia) ,  aches (pain), shortness of breath (dyspnoea) and heavy chest (chest discomfort) (unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (blotchy rash, chills, feverish, aches, shortness of breath, heavy chest).  At time of reporting, the outcome was Unknown for all the events.
Sex: F
Vaccine: FLUX
Symptoms: Rash macular
Clinical narrative: blotchy rash; chills; feverish; aches; shortness of breath; heavy chest; Initial information was received on 19-Jan-2024 regarding an unsolicited valid non-serious Courtesy case received from Biogen case received from a physician.  This case involves Adult female patient who experienced blotchy rash, chills, feverish, aches, shortness of breath and heavy chest after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylatcic vaccination (Immunization). There will be no information available on batch number for this case.  On an unknown date the patient developed blotchy rash (rash macular), chills, feverish (pyrexia) ,  aches (pain), shortness of breath (dyspnoea) and heavy chest (chest discomfort) (unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (blotchy rash, chills, feverish, aches, shortness of breath, heavy chest).  At time of reporting, the outcome was Unknown for all the events.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site cellulitis
Clinical narrative: developed cellulitis in the right arm after receiving the dose; Initial information received on 16-Jan-2024 from United states regarding an unsolicited valid serious case received from a physician.  This case involves a 3-year-old (3 years and 2 months) female patient who had developed cellulitis in the right arm after receiving the dose with influenza quadrival A-B multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant: No other vaccines  On 04-Jan-2024, the patient received 0.5 mL dose of suspect influenza quadrival A-B multidose vaccine preserved, Suspension for injection (Frequency: Once; Strength: standard) (lot number: U8049AA; expiry date: 01-Jun-2024) via intramuscular route in the right arm for Immunization.  On an unknown date the patient had developed cellulitis in the right arm after receiving the dose (vaccination site cellulitis) (unknown latency) following the administration of influenza quadrival A-B multidose vaccine preserved.   Reportedly, there was no mention of off-label use. Patient was hospitalized two days later after receiving the vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (developed cellulitis in the right arm after receiving the dose).  At time of reporting, the outcome was Unknown for the event developed cellulitis in the right arm after receiving the dose.  Seriousness criteria: The patient was hospitalized for the event vaccination site cellulitis from 06-Jan-2024.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: two temperature excursions/20OCT2023 for 45 minutes with the highest temperature of 52.1 F 13NOV2023 for 1 hour with the highest temperature of 52.8 F with no reported AE; punctured IPOL that is deemed not suitable for use anymore was given to a patient after the excursion with no reported AE; Initial information received on 19-Jan-2024 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 4 years old male patient who experienced two temperature excursions/20oct2023 for 45 minutes with the highest temperature of 52.1 f 13nov2023 for 1 hour with the highest temperature of 52.8 f with no reported ae and punctured IPV (VERO) [IPOL] that is deemed not suitable for use anymore was given to a patient after the excursion with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (infanrix), influenza vaccine inact split 4v (fluzone quadrivalent) and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 03-Jan-2024, the patient received 0.5 ml (TOTAL) dose of suspect IPV (VERO) Suspension for injection (lot V1B891M & expiration date- 01-Jun-2024) via subcutaneous route in the right thigh (strength: not provided) for Immunisation (product storage error) and (poor quality product administered) (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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Device breakage
Clinical narrative: their left breast implant ruptured; Initial information received on 19-Jan-2024 regarding an unsolicited valid  non-serious case received from a consumer/ non-healthcare professional.  This case involves a 65 years old female patient who reported their left breast implant ruptured after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Jan-2024, the patient received 0.7 ml of suspect Influenza Quadrival A-B High Dose Hv Vaccine (Strength: High dose) (Frequency: once) (with an unknown lot number, formulation and expiry date) via unknown route in the left arm for immunization.  On 14-Jan-2024, the patient reported  their left breast implant ruptured (device breakage) (latency: 2 days).   It was reported, Patient who was a nurse called to report that on 12JAN2024, they had a shot of FLUZONE HIGH DOSE and 2 days after that, on 14JAN2024, their left breast implant ruptured and patient mentioned that they were also administered with the vaccine on their left side. Caller wanted someone to reach out to them and stated that the emergency room cannot do anything for them and they might as well contact their lawyer.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (their left breast implant ruptured).  At time of reporting, the outcome was Unknown for the event their left breast implant ruptured.
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: accidentally given ipol instead of menveo with no reported adverse event; Initial information received on 19-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old male patient where reporter reported that accidentally given IPV (vero) [IPOL] instead of menveo with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (boostrix) and hpv vaccine vlp rl1 4v (yeast) (gardasil) for Immunisation.  On 09-Jan-2024, the patient received 0.5 ml (TOTAL) dose of suspect IPV (VERO) Suspension for injection (lot- V1A021M & expiration date- 17-Feb-2024) via intramuscular route in the left deltoid (strength: not provided) for Immunisation ((wrong product administered) (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.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia = Streptococcus pneumoniae pneumonia; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) regarding an adult male patient (reported as between 55-59 years old). Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided.  On unknown dates, the patient received 2 doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection administered as prophylaxis (doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported).  On an unknown date in 2020, the patient experienced Streptococcus pneumoniae pneumonia (Pneumonia pneumococcal); streptococcus pneumoniae serotyping was reported as Not available. At the time of reporting, the outcome of the event was not known.   The causal relationship between Streptococcus pneumoniae pneumonia and suspect vaccine was not reported.  Upon internal review Streptococcus pneumoniae pneumonia was considered a medically significant event.