chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Illness, SARS-CoV-2 test
Clinical narrative: she is losing her voice; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient 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 included: "covid" (unspecified if ongoing), notes: it took 5 days before she tested positive. The patient's concomitant medications were not reported. The following information was reported: APHONIA (non-serious) with onset Nov2023, outcome "unknown", described as "she is losing her voice"; ILLNESS (non-serious) with onset Nov2023, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section. Additional information included: the patient was losing her voice and said that she came from a trip on Saturday and her husband has covid and so does her old Father who is hospitalized for covid. She said that she had all the symptoms and had Paxlovid but she had not tested positive yet. She said that she had all the symptoms since Saturday and till now. She wanted to know if she should wait to be tested positive before taking the medication. The patient's husband was diagnosed with covid but had been feeling sick 4-5 days before.  She came from a trip on Saturday and is now feeling sick herself but she her covid test was negative.  In the past when she had covid, it took 5 days before she tested positive.  She has gotten Paxlovid in case she does test positive because she didn't think she would be able to get it over the Thanksgiving weekend. The caller wondered if she should take the Paxlovid even though she hasn't tested positive.  She doesn't want to transmit it to anyone and is concerned about her father. The doctor at the hospital, who is not her doctor, told her just to take it, but logic dictates she should not. She stated she had the recent Pfizer covid vaccine about a month ago. Should she take it even though she hasn't tested positive?  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: her brother is dieing from it at this moment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 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: IMMUNISATION REACTION (life threatening), outcome "unknown", described as "her brother is dieing from it at this moment".  Clinical information: Caller was "calling to find out if Pfizer was selling the mRNA vaccine to farms that are using it in feed for animals, which was indirectly being given to consumers who decided not to get the vaccine, such as herself." Attempted to confirm if caller was speaking about Comirnaty, the Pfizer COVID vaccine, in which they stated, "it was not a vaccine, it was a shot." Caller stated that she called Store and whom was unable to provide an answer on if their meat products have been injected with the vaccine. Caller stated that she "chose not to get this criminal shot and her brother was dieing from it at this moment." Caller stated "as soon as it was released, I knew it was a fraud and I don't want to get this indirectly from farm animals." Caller stated the only answer she was receiving from the grocery stores was that the meat products are by grass fed animals. Caller states that she was "getting garbage from Pfizer. You know nothing. Pfizer was going to get a class action suit. Pfizer was a criminal organization."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the vaccine do not protect you from Covid; the vaccine do not protect you from Covid; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "the vaccine do not protect you from Covid". Clinical course: So, Patient had concerns about drug safety and concern simply put is that there really was not any data that was vaccines doing much good anymore and keep reading more and more and more reports. However there was just more and more data now coming out showing that the inflammatory side effects of the vaccine are now surpassing the benefit and come sick with Covid, just got the vaccine last month and trying to explain them the Covid vaccine does not work.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: He got sick with the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 18-year-old male patient received bnt162b2 (BNT162B2), on 10Feb2022 as dose 1, single (Lot number: 33130BA) at the age of 16 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "He got sick with the first shot".  Additional information: Patient did not receive any other vaccines within 4 weeks prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300392914 same reporter/patient/drug, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: Can't use his left arm from his elbow down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: LIMB INJURY (non-serious), outcome "unknown", described as "Can't use his left arm from his elbow down". Additional information: Reporter stated he/she knew a boy that happened, that can't use his left arm from his elbow down, 9 days after he had it.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Diarrhoea, Fatigue, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: diarrhea; Expected sore arm; swollen lymph glands under arm; severe nausea; Easily exhausted with small efforts; Disrupted sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Eocinophilic Asthma" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "depression" (unspecified if ongoing), notes: Controlled; "high blood pressure" (unspecified if ongoing); "sleepiness" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing), notes: Sensitive. Concomitant medication(s) included: FASENRA; SYNTHROID; WELLBUTRIN; TRIAMTERENE; SYMBICORT; NUVIGIL. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "Nausea"; Bnt162b2 (Dose 2), for COVID-19 immunisation, reaction(s): "Nausea". The following information was reported: SLEEP DISORDER (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "Disrupted sleep"; FATIGUE (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "Easily exhausted with small efforts"; PAIN IN EXTREMITY (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "Expected sore arm"; DIARRHOEA (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "diarrhea"; NAUSEA (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "severe nausea"; LYMPHADENOPATHY (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "swollen lymph glands under arm". Therapeutic measures were not taken as a result of diarrhoea, pain in extremity, lymphadenopathy, nausea, fatigue, sleep disorder. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404908 same reporter and product, different dose and event .;US-PFIZER INC-202300404909 same reporter and product, different dose and event .;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Sleep disorder
Clinical narrative: diarrhea; Expected sore arm; swollen lymph glands under arm; severe nausea; Easily exhausted with small efforts; Disrupted sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Eocinophilic Asthma" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "depression" (unspecified if ongoing), notes: Controlled; "high blood pressure" (unspecified if ongoing); "sleepiness" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing), notes: Sensitive. Concomitant medication(s) included: FASENRA; SYNTHROID; WELLBUTRIN; TRIAMTERENE; SYMBICORT; NUVIGIL. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "Nausea"; Bnt162b2 (Dose 2), for COVID-19 immunisation, reaction(s): "Nausea". The following information was reported: SLEEP DISORDER (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "Disrupted sleep"; FATIGUE (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "Easily exhausted with small efforts"; PAIN IN EXTREMITY (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "Expected sore arm"; DIARRHOEA (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "diarrhea"; NAUSEA (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "severe nausea"; LYMPHADENOPATHY (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "swollen lymph glands under arm". Therapeutic measures were not taken as a result of diarrhoea, pain in extremity, lymphadenopathy, nausea, fatigue, sleep disorder. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404908 same reporter and product, different dose and event .;US-PFIZER INC-202300404909 same reporter and product, different dose and event .;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Nausea
Clinical narrative: diarrhea; Expected sore arm; swollen lymph glands under arm; severe nausea; Easily exhausted with small efforts; Disrupted sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Eocinophilic Asthma" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "depression" (unspecified if ongoing), notes: Controlled; "high blood pressure" (unspecified if ongoing); "sleepiness" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing), notes: Sensitive. Concomitant medication(s) included: FASENRA; SYNTHROID; WELLBUTRIN; TRIAMTERENE; SYMBICORT; NUVIGIL. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "Nausea"; Bnt162b2 (Dose 2), for COVID-19 immunisation, reaction(s): "Nausea". The following information was reported: SLEEP DISORDER (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "Disrupted sleep"; FATIGUE (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "Easily exhausted with small efforts"; PAIN IN EXTREMITY (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "Expected sore arm"; DIARRHOEA (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "diarrhea"; NAUSEA (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "severe nausea"; LYMPHADENOPATHY (non-serious) with onset 10Nov2023, outcome "recovered with sequelae", described as "swollen lymph glands under arm". Therapeutic measures were not taken as a result of diarrhoea, pain in extremity, lymphadenopathy, nausea, fatigue, sleep disorder. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404908 same reporter and product, different dose and event .;US-PFIZER INC-202300404909 same reporter and product, different dose and event .;
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Diarrhoea, Fatigue, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: very little nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Eosinophilic Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Hashimoto's Disease" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "controlled depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "controlled daytime sleepiness" (unspecified if ongoing). Concomitant medication(s) included: FASENRA; SYNTHROID; WELLBUTRIN; TRIAMTERENE; SYMBICORT; NUVIGIL taken for somnolence. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "very little nausea". Additional information: The initial Covid vaccines (2 spaced 3 weeks apart) were the least worst, very little nausea but still down for three days. The patient wonders if Fasenra injections are potentially making the Covid bivalent vaccine harder on his system.. The patient, prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, the patient hasn't been tested for COVID-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404909 same reporter, same vaccine, different dose (2nd) and same event;US-PFIZER INC-202300400454 same reporter and vaccine, different dose and event;
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Sleep disorder
Clinical narrative: very little nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Eosinophilic Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Hashimoto's Disease" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "controlled depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "controlled daytime sleepiness" (unspecified if ongoing). Concomitant medication(s) included: FASENRA; SYNTHROID; WELLBUTRIN; TRIAMTERENE; SYMBICORT; NUVIGIL taken for somnolence. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "very little nausea". Additional information: The initial Covid vaccines (2 spaced 3 weeks apart) were the least worst, very little nausea but still down for three days. The patient wonders if Fasenra injections are potentially making the Covid bivalent vaccine harder on his system.. The patient, prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, the patient hasn't been tested for COVID-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404909 same reporter, same vaccine, different dose (2nd) and same event;US-PFIZER INC-202300400454 same reporter and vaccine, different dose and event;
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Nausea
Clinical narrative: very little nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Eosinophilic Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Hashimoto's Disease" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "controlled depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "controlled daytime sleepiness" (unspecified if ongoing). Concomitant medication(s) included: FASENRA; SYNTHROID; WELLBUTRIN; TRIAMTERENE; SYMBICORT; NUVIGIL taken for somnolence. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "very little nausea". Additional information: The initial Covid vaccines (2 spaced 3 weeks apart) were the least worst, very little nausea but still down for three days. The patient wonders if Fasenra injections are potentially making the Covid bivalent vaccine harder on his system.. The patient, prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, the patient hasn't been tested for COVID-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404909 same reporter, same vaccine, different dose (2nd) and same event;US-PFIZER INC-202300400454 same reporter and vaccine, different dose and event;
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Headache, Myalgia
Clinical narrative: chronic pain all entire head; severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult male patient received bnt162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Lot number: EP7534) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Chronic depression", start date: Jan2018 (ongoing); "anxiety", start date: Jan2018 (ongoing); "OCD", start date: Jan2018 (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; FLUOXETINE; NORTRIPTYLINE. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot number: EN9581, Arm Right), administration date: 24Feb2021, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "chronic pain all entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered". The events "chronic pain all entire head", "severe muscle ache and joint pain", "extreme fatigue", "chest pain" and "nausea" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400483 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-PV202300192087 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-PV202300180183 Same Reporter/Patient/Drug, Different Vaccine Dose/Event;
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: chronic pain all entire head; severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult male patient received bnt162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Lot number: EP7534) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Chronic depression", start date: Jan2018 (ongoing); "anxiety", start date: Jan2018 (ongoing); "OCD", start date: Jan2018 (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; FLUOXETINE; NORTRIPTYLINE. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot number: EN9581, Arm Right), administration date: 24Feb2021, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "chronic pain all entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered". The events "chronic pain all entire head", "severe muscle ache and joint pain", "extreme fatigue", "chest pain" and "nausea" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400483 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-PV202300192087 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-PV202300180183 Same Reporter/Patient/Drug, Different Vaccine Dose/Event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 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 and concomitant medications were not reported. Past drug history included: Zithromax, reaction(s): "Allergies: Zithromax". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 06Nov2023 until 10Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Monoplegia, Sensory loss
Clinical narrative: Arm Paralysis/9 days later, he lost the (feeling) extremities on his left arm; 9 days later, he lost the (feeling) extremities on his left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 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: MONOPLEGIA (medically significant), 9 days after the suspect product(s) administration, outcome "unknown", described as "Arm Paralysis/9 days later, he lost the (feeling) extremities on his left arm"; SENSORY LOSS (medically significant), 9 days after the suspect product(s) administration, outcome "unknown", described as "9 days later, he lost the (feeling) extremities on his left arm". Clinical course: Reporter knew a boy in (city) that had his (vaccine) and 9 days later, he lost the (feeling) extremities on his left arm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300392914 Same reporter, Drug / Different Adverse event, Different Patient;US-PFIZER INC-202300400979 Same reporter, Drug / Different Adverse event, Different Patient;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Jul2023 as dose 5 (booster), single (Lot number: GK1337), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart issues" (unspecified if ongoing); "known allergies: no, just sticking plasters" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Feb2002, stop date: 04Nov2023; ESCITALOPRAN, start date: Apr2023, stop date: 16Nov2023; FLOWMAX, start date: Apr2023, stop date: 04Nov2023; METOPROLOL, start date: Feb2023, stop date: 16Nov2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) close to negative, notes: After the series 5 doses, I felt well and tested close to negative, last night I felt unwell, and tested strongly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment from 06Nov2023 to 10Nov2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300377377 same patient, different drug and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) 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 included: "Hypercholesterolaemia" (unspecified if ongoing); "Macrobid allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid start date 30Oct2023, stop date 04Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300377383 same patient, different drug and event;
Age: 41.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 14:30 as dose 1, single (Lot number: HH7595) at the age of 41 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: EW0153), administration date: 10Apr2021, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/Lot number: EW0167), administration date: 01May2021, for COVID-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: 069H21A), administration date: 08Dec2021, for COVID-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: GH9693, Anatomical location: Left arm), administration date: 14Oct2022, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID-19 Treatment". 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 which included Paxlovid from 08Nov2023 to 12Nov2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300380633 same patient, different drug/events;
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN-6198), in left arm, on 20Mar2021 as dose 2, single (Lot number: EP-7534), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: Ff2588) at the age of 50 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 084J21A), in left arm, on 02Sep2022 as dose 5 (booster), single (Lot number: AS7144B) and on 09Sep2023 at 16:00 as dose 6 (booster), single (Lot number: 3030371), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing); "goat cheese" (unspecified if ongoing); "Hypertension (treated)" (unspecified if ongoing); "multiple orthopedic injuries" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Nov2023 to 12Nov2023. Clinical course: Patients other medical history included daily statin.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300377250 same patient, different drug and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 14Dec2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ketoconazole, reaction(s): "Known Allergies: Ketoconazole". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 07Nov2023 to 12Nov2023.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300385099 same reporter/patient, different drug/event;
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthralgia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "reflux" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, 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 from 08Nov2023 to 12Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384536 Same reporter/ patient; different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE, start date: 05Jun2022. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from 07Nov2023 to 11Nov2023. Clinical course: The patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384534 same reporter/patient, different drug/event;
Age: 31.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HD9876) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polycystic ovary syndrome" (unspecified if ongoing); "Allergy to sulfas" (unspecified if ongoing). Concomitant medication(s) included: CYCLOSPORINE, start date: Feb2021. 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 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid therapy start date: 08Nov2023, stop date: 12Nov2023) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384632 same  patient/reporter, different drug/AE;
Age: 71.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CALCIUM, start date: Jul1995; RALOXIFENE, start date: Nov1995; OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL], start date: Mar2017; VITAMIN D3, start date: Mar2019; LUTEIN, start date: Mar2019; AREDS. 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, 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 from 03Nov2023 to 08Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384539 same patient, different drug and event;
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 88-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 88 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 06Nov2023 to 11Nov2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381298 same reporter/patient, different drug/event;
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), on 01Mar2021 at 13:15 as dose 1, single (Batch/Lot number: unknown), in right arm and on 01Oct2021 at 13:15 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid started from 09Nov2023 to 14Nov2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384563 same patient, different drug and event;US-PFIZER INC-202300404912 same patient/vaccine, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old male patient received bnt162b2 (BNT162B2), on 04Aug2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Jan2021; LATANOPROST, start date: 01Jul2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from an unknown date to 10Nov2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency. However, a contributory role of BNT162b2 to the events Drug Ineffective and Covid-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300384540 same patient, different drug and event;
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single, in left arm 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 2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 Treatment with Paxlovid, treatment start date was on 01Nov2023, treatment stop date was on 06Nov2023.