chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
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 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "melanoma" (unspecified if ongoing); "thyroid cancer survivor" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lomotil, reaction(s): "Allergies: Lomotil"; Benzoin, reaction(s): "Allergies: benzoin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Feb2024) positive; (09Feb2024) Negative; (10Feb2024) Negative; (12Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid, from 03Feb2024 to 07Feb2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm 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 immunisation; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 5, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient took Paxlovid from 02Feb2024 to 06Feb2024 as treatment 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19; COVID 19; Dose 1, 2, 3, 4: Pfizer; Dose 5: Moderna; This is a spontaneous report received from an Other HCP.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), on 12Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Sep2023 as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: Jan2014. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2023, outcome "unknown", described as "Dose 1, 2, 3, 4: Pfizer; Dose 5: Moderna"; 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 information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 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 vaccination failure (CoVID-19) with the suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Age: 40.0
Sex: M
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 from product quality group.  A 41-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 at 13:00 as dose 1, single (Lot number: HG9725) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "NASH" (unspecified if ongoing); "Fatty liver disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Vaccine brand: Pfizer / BioNTech,, Vaccine lot number: 6H9694, Vaccine dose number: unknown,, Vaccine location: Left arm), administration date: 07Oct2022, when the patient was 39-year-old, for COVID-19 Immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Feb2024) Negative, notes: Tested negative days 7-9; (10Feb2024) Negative, notes: Tested negative days 7-9; (11Feb2024) Negative, notes: Tested negative days 7-9; (12Feb2024) Positive, notes: Testing positive on day 10. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 03Feb2024 to 08Feb2024.  No follow-up attempts are possible.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-1 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Manufacturer: Pfizer, 5th, 6th dose; Manufacturer: Moderna, 1st, 2nd, 3rd, 4th ,7th dose; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GJ2524), in left arm and on 15Jul2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Jan2021 as dose 1, single (Lot number: 039K20A), in left arm, on 03Feb2021 as dose 2, single (Lot number: 013M20A), in left arm, on 24Jan2022 as dose 3 (booster), single), in left arm, on 31Mar2022 as dose 4 (booster), single), in left arm and on 17Nov2023 as dose 7 (booster), single), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Oct2022, outcome "unknown", described as "Manufacturer: Pfizer, 5th, 6th dose; Manufacturer: Moderna, 1st, 2nd, 3rd, 4th ,7th dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (25Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received vaccine. The patient did not receive any other medication for the last 2weeks. After testing Covid + on 25Jan2024 the patient started Paxlovid and completed 5 days of treatment. Anti-viral details: product COVID 19 Treatment, brand Paxlovid, treatment start date 25Jan2024, treatment stop date 29Jan2024, indication Treatment of COVID-19. On 01Feb2024 the patient tested negative after symptoms resolved. On 03Feb2024, the patient had symptoms, tested Covid + and started Paxlovid for the 2nd time. The patient had a negative Covid test x 2. On 12Feb2024, the patient having symptoms again. Tested negative. The patient had been tested on the same type test. All within date. The patient was told she had rebound covid.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Lot number: FL9893) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Jan2021 as dose 1, single (Lot number: 011L20A), in left arm, on 02Feb2021 as dose 2, single (Lot number: 030L20A), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: 019F21A), in left arm, on 13Oct2022 as dose 5 (booster), single (Lot number: 060F22A), in left arm, on 15May2023 as dose 6 (booster), single (Lot number: 069H22A), in left arm and on 11Dec2023 as dose 7 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "SAIHD" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "lumbar stenosis" (unspecified if ongoing); "post prostatectomy (cancer, Gleason 9)" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "essential tremor" (unspecified if ongoing); "leaky heart valve" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing); "Known allergies: pollen" (unspecified if ongoing); "Known allergies: dust" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 02Mar2020; LEVOTHYROXINE, start date: 10Jun2014; BUPROPION, start date: 11Mar2019; LAMOTRIGINE, start date: 11Mar2019. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 31Jan2024 to 04Feb2024 as treatment of COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "BRCA 1 positive" (unspecified if ongoing), notes: positive; "metastatic breast cancer" (unspecified if ongoing); "connective tissue disease" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Clinical course was as follows: Adverse event: The patient tested negative five days after onset of Covid and completed all Paxlovid doses (treatment from 03Feb2024 to07Feb2024). Two-three days later she had severe congestion, then low grade fever. Other medications in 2weeks product=Losartan, Propanol, Monoxidil, Allegra D, Wellbutrin, and Famotidine. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.
Age: 72.0
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 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Lot number: Hf9275) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient has not known allergies. Vaccination history included: moderna (DOSE 1; lot number: D41l20a), administration date: 24Feb2021, when the patient was 70-year-old, for COVID-19 immunisation; moderna (DOSE 2; lot number: 016b21a), administration date: 24Mar2021, when the patient was 70-year-old, for COVID-19 immunisation; moderna (DOSE 3 (BOOSTER); lot number: 077C218), administration date: 05Nov2021, when the patient was 70-year-old, for COVID-19 immunisation; moderna (DOSE 4 (BOOSTER); lot number: 002m21a), administration date: 21Apr2022, when the patient was 71-year-old, for COVID-19 immunisation; comirnaty (DOSE 5 (BOOSTER)), administration date: 03Oct2022, when the patient was 71-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 04Feb2024 until 08Feb2024.
Age: 53.0
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 54-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 09:30 as dose 1, single (Lot number: HF9275) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies (seasonal pollen and dust/mold)" (unspecified if ongoing); "Allergies (seasonal pollen and dust/mold)" (unspecified if ongoing); "Allergies (seasonal pollen and dust/mold)" (unspecified if ongoing); "Allergies (seasonal pollen and dust/mold)" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE HCL, start date: 01Feb2012, stop date: 13Feb2024. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Dose Number: 5, Batch/Lot No: GH9694, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 06Oct2022, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 4, Batch/Lot No: FL3197, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 24May2022, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FF8839, Location of injection: Arm Right, Vaccine Administration Time: 09:30 AM), administration date: 23Nov2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 03May2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 09:30 AM), administration date: 12Apr2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I tested positive again for COVID-19 on 13Feb2024; (13Feb2024) Positive, notes: I tested positive again for COVID-19 on 13Feb2024. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid for COVID-19 Treatment since 04Feb2024 to 08Feb2024. The patient received the vaccine. No known allergies.
Sex: U
Vaccine: COVID19
Symptoms: Hiccups
Clinical narrative: Hiccups; 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 (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HICCUPS (non-serious), outcome "unknown". The action taken for BNT162b2 omi xbb.1.5 was unknown.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Hot flush
Clinical narrative: burning up/return of hot flashes; burning up/return of hot flashes; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "burning up/return of hot flashes". Additional information: The patient was wondering for any reports of the return of hot flashes as a result of the Pfizer Covid vaccine. She was burning up and the Covid vaccine was the only thing she can think of that might be the cause.   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: I was vaccinated for COVID (Unspecified Vaccine) with Pfizer product; I got COVID rebound; I was vaccinated for COVID (Unspecified Vaccine) with Pfizer product; I got COVID rebound; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Left), administration date: 07Mar2021, when the patient was 67-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EP6935, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 67-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was vaccinated for COVID (Unspecified Vaccine) with Pfizer product; I got COVID rebound". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid as treatment for Covid-19 from 10Jan2024 to 14Jan2024. Patient's health care provider feel very strongly like she said she has been extremely ill from this. She started to feel well on Paxlovid and day 3 took a turn for the worse and has been sick beyond sick ever since, this was the sick she has been in her entire life. She was 67 and half year old and in very good health. She had 2 doses and had a booster, so she doesn't know if people are more reactive when they get it.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Headache, Investigation, Pyrexia
Clinical narrative: fatigue; headache; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Jan2024 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "T2 Diabetes mellitus", start date: 19Aug2017 (ongoing); "Long haul covid", start date: 26Mar2020 (ongoing); "Asthma", start date: 2002 (ongoing); "Arthritis from long Covid", start date: 30Mar2020 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6207, Left arm, at 09:30), administration date: 19Mar2021, when the patient was 64-year-old, for Covid-19 immunisation, reaction(s): "got sick for a week "with like, COVID symptoms"", "fatigue", "Headache", "Vomiting", "Fever / night fever", "Nausea", "a little legs pain"; BNT162b2 (DOSE 2, SINGLE, Lot number: EW0150, Left arm, at 09:30), administration date: 09Apr2021, when the patient was 64-year-old, for Covid-19 immunisation, reaction(s): "got sick for a week "with like, COVID symptoms"", "fatigue", "headache", "Vomiting", "Fever"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FH8027, Left arm), administration date: 15Nov2021, when the patient was 65-year-old, for Covid-19 immunisation, reaction(s): "got sick for a week "with like, COVID symptoms"~", "fatigue", "headache", "Fever". The following information was reported: FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "slight fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient received booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at-risk of serious covid-19 complications). Only because of aftereffects of original covid-19 illness. The patient reported that "I am a long hauler from severe covid-19 of Mar2020. It has caused me many medical issues. As for the Pfizer vaccines I was horrifically ill after the first 2- high fever, vomiting, severe fatigue, headaches for once a week each time. The 3 and 4 doses (which she just received 2 and half weeks before, on 13Jan2024) were a little less haul on me. But still had reactions of fatigue, headache, slight fever".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: fatigue; headache; slight fever; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Jan2024 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "T2 Diabetes mellitus", start date: 19Aug2017 (ongoing); "Long haul covid", start date: 26Mar2020 (ongoing); "Asthma", start date: 2002 (ongoing); "Arthritis from long Covid", start date: 30Mar2020 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6207, Left arm, at 09:30), administration date: 19Mar2021, when the patient was 64-year-old, for Covid-19 immunisation, reaction(s): "got sick for a week "with like, COVID symptoms"", "fatigue", "Headache", "Vomiting", "Fever / night fever", "Nausea", "a little legs pain"; BNT162b2 (DOSE 2, SINGLE, Lot number: EW0150, Left arm, at 09:30), administration date: 09Apr2021, when the patient was 64-year-old, for Covid-19 immunisation, reaction(s): "got sick for a week "with like, COVID symptoms"", "fatigue", "headache", "Vomiting", "Fever"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FH8027, Left arm), administration date: 15Nov2021, when the patient was 65-year-old, for Covid-19 immunisation, reaction(s): "got sick for a week "with like, COVID symptoms"~", "fatigue", "headache", "Fever". The following information was reported: FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "slight fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient received booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at-risk of serious covid-19 complications). Only because of aftereffects of original covid-19 illness. The patient reported that "I am a long hauler from severe covid-19 of Mar2020. It has caused me many medical issues. As for the Pfizer vaccines I was horrifically ill after the first 2- high fever, vomiting, severe fatigue, headaches for once a week each time. The 3 and 4 doses (which she just received 2 and half weeks before, on 13Jan2024) were a little less haul on me. But still had reactions of fatigue, headache, slight fever".  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: Ear discomfort
Clinical narrative: her ears were plugged; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 75-year-old patient received BNT162b2 (BNT162B2 NOS), 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: EAR DISCOMFORT (non-serious), outcome "unknown", described as "her ears were plugged".  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She received 4 doses (all from Pfizer) on 07May2021, 28May2021, 24Dec2021 and 30May2022 / home test for covid and tested positive; She received 4 doses (all from Pfizer) on 07May2021, 28May2021, 24Dec2021 and 30May2022 / home test for covid and tested positive; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Dec2023 as dose 1, single (Lot number: HM7010) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 07May2021, for COVID-19 immunization; BNT162b2 (Dose 2), administration date: 28May2021, for COVID-19 immunization; BNT162b2 (Dose 3), administration date: 24Dec2021, for COVID-19 immunization; BNT162b2 (Dose 4), administration date: 30May2022, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2023, outcome "unknown" and all described as "She received 4 doses (all from Pfizer) on 07May2021, 28May2021, 24Dec2021 and 30May2022 / home test for covid and tested positive". In the night of 24Dec2023, she experienced a very strong body ache and chills, without fever; these events lasted for 30 hours and then disappeared. After that she experienced sore throat and cough, she performed a home test for covid and tested positive on 27Dec2023, then tested negative on 04Jan2024. The diagnosis for covid was confirmed by her physician. Her husband got vaccinated the same day without any side effects and he tested negative for covid. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2023) Positive; (04Jan2024) Negative. No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300456001 Same patient, different doses/ AE;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Headache and no interference with activity; 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 Feb2024 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: HEADACHE (non-serious) with onset 01Feb2024, outcome "unknown", described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset 01Feb2024, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 01Feb2024, outcome "unknown", described as "Mild injection site tenderness (tender to touch)".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild injection site tenderness (tender to touch); This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), on 02Feb2024 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: VACCINATION SITE PAIN (non-serious) with onset Feb2024, outcome "unknown", described as "Mild injection site tenderness (tender to touch)".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Injection site pain/Injection site tenderness; muscle pain; 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)), on 03Feb2024 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: VACCINATION SITE PAIN (non-serious) with onset Feb2024, outcome "unknown", described as "Injection site pain/Injection site tenderness"; MYALGIA (non-serious) with onset Feb2024, outcome "unknown", described as "muscle pain". Additional information: For injection site pain, the recorded worst pain that the patient experienced anytime during the 2 days after the patient's COVID-19 vaccination (which occurred on Sunday 04Feb2024 and Monday 05Feb2024) was: 2 - Moderate injection site pain interfering with activity. For injection site tenderness, the recorded worst tenderness that the patient experienced anytime during the 2 days after the patient's COVID-19 vaccination was: 1 - Mild injection site tenderness (tender to touch). For muscle pain, the recorded worst intensity of pain that the patient experienced anytime during the 2 days after the patient's COVID-19 vaccination was 1 - Mild muscle pain and no interference with activity.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Chest X-ray normal, Cough, Throat irritation
Clinical narrative: Violent Coughing; Throat irritation; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Covid-19", start date: Aug2022 (unspecified if ongoing), notes: Ever since having covid (Aug2022); "I've been hyper-sensitive to fall allergies" (unspecified if ongoing), notes: I've been hyper-sensitive to fall allergies; "Paint fumes (wive- done have projects) mold." (unspecified if ongoing), notes: Paint fumes (wive- done have projects) mold. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (I also have had the covid booster (Late Nov)), administration date: Nov2023, for COVID-19 immunization; Flu vaccine (the flu vaccine (Mid- Oct)), administration date: Oct2023, for Immunization. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Violent Coughing"; THROAT IRRITATION (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  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: Asthenia, Fall, Feeling abnormal, Nasal congestion, Pain
Clinical narrative: stuffed up nose; felt weak; unstable; fell; body aches; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier: NUS2023US129781_NS (Novartis).  A 63-year-old female patient received BNT162b2 (BNT162B2 NOS), in Jan2024 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. The following information was reported: NASAL CONGESTION (non-serious) with onset 08Feb2024, outcome "unknown", described as "stuffed up nose"; FALL (non-serious) with onset Feb2024, outcome "unknown", described as "fell"; ASTHENIA (non-serious) with onset Feb2024, outcome "unknown", described as "felt weak"; FEELING ABNORMAL (non-serious) with onset Feb2024, outcome "unknown", described as "unstable"; PAIN (non-serious) with onset 2024, outcome "recovered" (2024), described as "body aches".  Additional information: The patient stated after a Covid booster shot last month, she felt body aches for one week. Over the past weekend, she felt weak, unstable, and fell. On 08Feb2024, she woke up with a stuffed up nose.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid vaccines I am having issues with the effectiveness of the meds; Covid vaccines I am having issues with the effectiveness of the meds; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 203499.  A 57-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. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid vaccines I am having issues with the effectiveness of the meds".  Clinical information: Patient stated Pfizer is a brand and he was familiar with and well know. Covid vaccines patient was having issues with the effectiveness of the meds. If it was something else, patient would be willing to try. The reporter consider event as caused by suspect product.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: They did the Covid and it seems sketchy cause I got it and felt funny; They did the Covid and it seems sketchy cause I got it and felt funny; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 26-year-old female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "They did the Covid and it seems sketchy cause I got it and felt funny".  The reporter considered the event was caused by suspect product.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: cannot smell nor taste anything; cannot smell nor taste anything; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer unknown), for COVID-19 Immunisation. The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious), outcome "not recovered" and all described as "cannot smell nor taste anything". Additional information: Consumer stated that she cannot smell nor taste anything since she took her 2nd covid-19 vaccine (Pfizer) shot.  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-202200997042 Same patient, different dose/event;
Sex: M
Vaccine: DTAP, MEN
Symptoms: Asterixis, Brain injury, Encephalopathy, Head banging, Meningitis
Clinical narrative: few months ago about the encephalopathy i experienced after your tdap; meningitis vax left me with severe brain damage w/all classic signs of meningitis; muscle spasms galore, spasticity; risus sardonicus; flapping,head banging; toe walking; Initial information received on 06-Feb-2024 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (healthcare professional).  This case involves an unknown age male patient who had few months ago about the encephalopathy after tdap, meningitis vax left with severe brain damage w/all classic signs of meningitis, muscle spasms galore, spasticity, risus sardonicus, flapping,head banging and toe walking after receiving meningococcal vaccine and diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel].  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received diphtheria-15/tetanus/5 ac pertussis vaccine, Suspension for injection and meningococcal vaccine produced by unknown manufacturer via unknown route in unknown administration site for immunization. Information on the batch number was requested.  On an unknown date the patient had few months ago about the encephalopathy i experienced after your tdap (encephalopathy),  meningitis vax left me with severe brain damage w/all classic signs of meningitis (brain injury), muscle spasms galore, spasticity (muscle spasms), risus sardonicus, flapping,head banging (head banging) and toe walking (unknown latency).  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events  Seriousness criteria- medically significant for encephalopathy and brain injury; Sender's Comments: Sanofi Company Comment dated 13-Feb-2024: This case involves an unknown age male patient who had few months ago about the encephalopathy after tdap, meningitis vax left with severe brain damage w/all classic signs of meningitis, muscle spasms galore, spasticity, risus sardonicus, flapping,head banging and toe walking after receiving meningococcal vaccine and diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: M
Vaccine: DTAP, MEN
Symptoms: Muscle spasms, Muscle spasticity, Risus sardonicus, Toe walking
Clinical narrative: few months ago about the encephalopathy i experienced after your tdap; meningitis vax left me with severe brain damage w/all classic signs of meningitis; muscle spasms galore, spasticity; risus sardonicus; flapping,head banging; toe walking; Initial information received on 06-Feb-2024 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (healthcare professional).  This case involves an unknown age male patient who had few months ago about the encephalopathy after tdap, meningitis vax left with severe brain damage w/all classic signs of meningitis, muscle spasms galore, spasticity, risus sardonicus, flapping,head banging and toe walking after receiving meningococcal vaccine and diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel].  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received diphtheria-15/tetanus/5 ac pertussis vaccine, Suspension for injection and meningococcal vaccine produced by unknown manufacturer via unknown route in unknown administration site for immunization. Information on the batch number was requested.  On an unknown date the patient had few months ago about the encephalopathy i experienced after your tdap (encephalopathy),  meningitis vax left me with severe brain damage w/all classic signs of meningitis (brain injury), muscle spasms galore, spasticity (muscle spasms), risus sardonicus, flapping,head banging (head banging) and toe walking (unknown latency).  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events  Seriousness criteria- medically significant for encephalopathy and brain injury; Sender's Comments: Sanofi Company Comment dated 13-Feb-2024: This case involves an unknown age male patient who had few months ago about the encephalopathy after tdap, meningitis vax left with severe brain damage w/all classic signs of meningitis, muscle spasms galore, spasticity, risus sardonicus, flapping,head banging and toe walking after receiving meningococcal vaccine and diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt given duplicate vaccine dose with no reported adverse event; Initial information received on 09-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who was given duplicate vaccine dose with no reported adverse event with MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection via intramuscular route in unknown administration site for immunization (strength, dose, batch number and expiry date- unknown) given duplicate vaccine dose with no reported adverse event (extra dose administered) (latency same day). Information on the batch number was requested.   There were no lab data/results available  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: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Rash, Skin warm, Swelling
Clinical narrative: patient developed localized rash; swelling; redness; hot to touch; patient also received ADACEL when she was pregnant; Initial information received on 08-Feb-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Adult female patient who patient developed localized rash, swelling, redness, hot to touch and patient also received adacel when she was pregnant. Data regarding this pregnancy were received retrospectively, i.e. after pregnancy outcome was known.   The gestation period at onset and gestation period at exposure, last menstrual period, estimated due date actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Latex allergy. The patient had unknown previous pregnancy/ies.  On an unknown date, the patient received suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection via unknown route in unknown administration site for immunization (strength, dose, batch number and expiry date- unknown)  (exposure during pregnancy) (latency same day). Information on the batch number was requested.  On an unknown date the patient developed localized rash (vaccination site rash), swelling (vaccination site swelling), redness (vaccination site erythema), hot to touch (vaccination site warmth) (unknown latency)..  Relevant prenatal testing after exposure was not reported  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events  At time of reporting, the outcome was Unknown for all the events.  Additionally, at time of reporting, the outcome of the pregnancy was reported as Unknown and fetal outcome was reported as Unknown