chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Lacrimation increased, Oropharyngeal pain
Clinical narrative: 4 days after my last dose of Paxlovid my symptoms returned/I took a Covid antigen test when I took the last Paxlovid dose, and it was still positive; 4 days after my last dose of Paxlovid my symptoms returned/I took a Covid antigen test when I took the last Paxlovid dose, and it was still positive; runny nose; sore throat; sneezing; watery eyes; headache; fever; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 11:00 as dose 1, single (Lot number: EN6207), in left arm, on 06Apr2021 at 11:00 as dose 2, single (Lot number: EWD150), in left arm, on 12Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 06Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "melanoma" (unspecified if ongoing), notes: Other medical history: melanoma; "brain cavernoma" (unspecified if ongoing), notes: Other medical history: brain cavernoma. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06May2022, outcome "not recovered" and all described as "4 days after my last dose of Paxlovid my symptoms returned/I took a Covid antigen test when I took the last Paxlovid dose, and it was still positive"; COUGH (non-serious) with onset 2022, outcome "not recovered"; PYREXIA (non-serious) with onset 2022, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 2022, outcome "not recovered"; RHINORRHOEA (non-serious) with onset 2022, outcome "not recovered", described as "runny nose"; SNEEZING (non-serious) with onset 2022, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "not recovered", described as "sore throat"; LACRIMATION INCREASED (non-serious) with onset 2022, outcome "not recovered", described as "watery eyes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of rhinorrhoea, oropharyngeal pain, sneezing, lacrimation increased, headache, pyrexia, cough.  Clinical course: No known allergies reported. Device timestamp was 06May2022.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Sneezing, Vaccination failure
Clinical narrative: 4 days after my last dose of Paxlovid my symptoms returned/I took a Covid antigen test when I took the last Paxlovid dose, and it was still positive; 4 days after my last dose of Paxlovid my symptoms returned/I took a Covid antigen test when I took the last Paxlovid dose, and it was still positive; runny nose; sore throat; sneezing; watery eyes; headache; fever; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 11:00 as dose 1, single (Lot number: EN6207), in left arm, on 06Apr2021 at 11:00 as dose 2, single (Lot number: EWD150), in left arm, on 12Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 06Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "melanoma" (unspecified if ongoing), notes: Other medical history: melanoma; "brain cavernoma" (unspecified if ongoing), notes: Other medical history: brain cavernoma. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06May2022, outcome "not recovered" and all described as "4 days after my last dose of Paxlovid my symptoms returned/I took a Covid antigen test when I took the last Paxlovid dose, and it was still positive"; COUGH (non-serious) with onset 2022, outcome "not recovered"; PYREXIA (non-serious) with onset 2022, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 2022, outcome "not recovered"; RHINORRHOEA (non-serious) with onset 2022, outcome "not recovered", described as "runny nose"; SNEEZING (non-serious) with onset 2022, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "not recovered", described as "sore throat"; LACRIMATION INCREASED (non-serious) with onset 2022, outcome "not recovered", described as "watery eyes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of rhinorrhoea, oropharyngeal pain, sneezing, lacrimation increased, headache, pyrexia, cough.  Clinical course: No known allergies reported. Device timestamp was 06May2022.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: indication=Treatment of COVID-19; indication=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 51-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 3 (booster), single (Lot number: er8732) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received no other medication in 2 weeks.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: ff2590) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: None relevant medical history reported.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication treatment of COVID-19; indication treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EK9231), on 13Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 01Oct2021 as dose 3 (booster) single (Lot number: FE3592) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "prolactinoma" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: CABERGOLINE oral, start date: 01Feb2022; XYZAL oral, start date: 01Jan2017; COMBIGAN ophthalmic, start date: 01Jan2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "indication treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) positive again, notes: 10 days after finishing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient had no known allergies. COVID 19 was treated with PAXLOVID (Lot no: FY5657) oral, on 24Apr2022 and treatment was stopped on 28Apr2022. Other medication in 2weeks were CABERGOLINE, XYZAL and COMBIGAN. Patient experienced mild sore throat and tested positive again for COVID-19 on 08May2022 for which no treatment was provided (10 days after finishing PAXLOVID treatment).  No follow-up attempts are required: No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Lot number: 330268BD) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allergy: shellfish. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown".
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Drug ineffective, Dyspnoea, Suspected COVID-19
Clinical narrative: Covid 19; Covid 19; Breathlessness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN9581), as dose 2, single (Lot number: EN6203) and as dose 3 (booster), single (Lot number: 30155BA) for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing); "I occasionally take anti-inflammatory" (unspecified if ongoing). Concomitant medication(s) included: VALTREX taken for herpes zoster; CELEBREX taken for inflammation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19"; DYSPNOEA (medically significant), outcome "unknown", described as "Breathlessness". The patient underwent the following laboratory tests and procedures: Blood test: I had blood work done to check my liver function, notes: because of taking Celebrex. I have not yet the result back but I am assuming in acceptable parameters because my Doctor hasn't called me yet. Therapeutic measures were taken as a result of suspected covid-19, dyspnoea.  Additional information :This is the second time patient have had COVID, she is fully vaccinated with the Pfizer vaccine and Booster one time with the Pfizer Booster COVID-19 Vaccine and she still had this breakthrough infection. she experienced breathlessness with COVID infection. Patient has no other medical condition, she only takes anti-viral Valtrex for a herpes that she had many years ago and she occasionally takes anti-inflammatory Celebrex.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: taking Paxlovid; taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "taking Paxlovid". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Batch/Lot number: unknown), on 16Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Undifferentiated connective tissue disease with scleroderma features" (unspecified if ongoing), notes: Undifferentiated connective tissue disease with scleroderma features. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: No. Anti-viral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=18Apr2022, Treatment stop date=23Apr2022, Indication=Treatment of COVID-19. Adverse event: Rebound of COVID symptoms 5 days after completing Paxlovid course.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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 contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 20Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 16Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 66 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "chronic cough" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "tinnitus" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL (Manufacturer: Aurobindo Pharma), start date: 31Aug2021; OMEPRAZOLE (Manufacturer: Aurobindo Pharma), start date: 31Jan2018. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Novocaine, reaction(s): "Known allergies: Novocaine". The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 19Apr2022, outcome "recovered" (06May2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive; (26Apr2022) Negative, notes: On 26Apr I tested for the first time, negative for Covid (home test), and all the symptoms diminished; (28Apr2022) Positive, notes: On 28Apr, most symptoms returned (no fever), running nose, headache, fatigue, congestion - home test turned positive; (02May2022) positive, notes: on 02May, my symptoms became worse, test still positive; (06May2022) negative, notes: 06May I tested first time negative. Therapeutic measures were taken as a result of covid-19. Clinical Course: The patient was tested positive for Covid on Tue 19Apr2022, with fever 100F, muscle pain, sore throat, running nose, fatigue. On 20Apr2022, a five-day treatment of Paxlovid was prescribed. During 5-day round of Paxlovid (Lot number: 300691085301) from 20Apr2022 to 24Apr2022, on 23Apr2022, the patient experienced severe migraine & high blood pressure (as 168/109), same on 24Apr2022. On 26Apr2022, the patient was tested for the first time, negative for Covid (home test), and all the symptoms diminished. On 28Apr2022, most symptoms returned (no fever), running nose, headache, fatigue, congestion - home test turned positive. The patient has been testing daily, her symptoms worsened - on 02May2022, the symptoms became worse, test still positive. On 03May2022, at 6am, the patient called local ER, they suggested to come to ER. She saw instead her Family doctor who examined and said that she had no pneumonia, prescribed Albuterol Sulfate. On 06May2022, the patient was tested first time negative. This was 17-day span of testing positive with some remnants of symptoms. A rebound after Paxlovid as reported.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: initially tested positive five days ago; initially tested positive five days ago; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 23Mar2021 as dose 1, single (Lot number: ER2613), in right arm at the age of 56 years, on 13Apr2021 as dose 2, single (Lot number: EW0153), in left arm at the age of 56 years, on 03Nov2021 as dose 3 (booster), single (Lot number: FF2593), in right arm at the age of 56 years and on 26Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FU9893) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "DVT", start date: 2004 (unspecified if ongoing), notes:not on blood thinners, now. The patient had no any known allergies. Concomitant medication(s) included (in 2weeks): ACYCLOVIR [ACICLOVIR], start date: 12Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "unknown" and all described as "initially tested positive five days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I retested positive; (03May2022) Positive, notes: I initially tested positive five days ago. Therapeutic measures were taken as a result of covid-19 with Paxlovid.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Dose_number=3 date=29Sep2021; COVID 19 Treatment; Dose_number=3 date=29Sep2021; 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 52-year-old male patient received BNT162b2 (BNT162B2), on 29Sep2021 at 13:00 as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Nsaids, reaction(s): "Allergy_NSAIDS". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Dose_number=3 date=29Sep2021; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Negative; (08May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Dose number=3 date=01Nov2021; COVID 19 Treatment; Dose number=3 date=01Nov2021; 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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: Jan2021, stop date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 30Apr2022, outcome "not recovered" and all described as "Dose number=3 date=01Nov2021; COVID 19 Treatment". The patient received other medication Bupropion in 2 weeks. First positive test/onset of symptoms was 30Apr2022. First dose of Paxlovid as treatment of COVID-19 taken 30Apr2022 in the evening. Last dose taken on 05May2022 in the morning. Negative at home antigen test result received on 06May2022. Rebound of covid viral load occurred on day 3 after completing Paxlovid treatment. Positive antigen test result received on 08May2022 11:00 am. Confirmed with 2 at home antigen tests. Rebound happened on day 8 of Covid (starting from first positive test date). The patient was recovering and no treatment was reported. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Positive; (06May2022) Negative; (08May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: dose number=3 date=24Oct2021; COVID 19 Treatment; dose number=3 date=24Oct2021; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 01Jan2018; METOPROLOL TARTRATE, start date: 01Jan2018; ROSUVASTATIN, start date: 01Jan2018, stop date: 27Apr2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: 01Jan2018.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "dose number=3 date=24Oct2021; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) fainter; (06May2022) fainter; (08May2022) Positive; (Apr2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Apr2022 to 02May2022.  The patient was taking other (unspecified) medications/products within 2 weeks of starting COVID-19 treatment. It was reported that last dose of Paxlovid was taken on the morning of 03May2022, and antigen results were getting fainter on 05May2022 and 06May2022, have had runny nose for a few days and antigen test (same type, taken under same conditions) was now strongly positive today 08May2022, so it seems like the virus has rebounded. The patient had no Known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: She said, she is still having extreme hair loss; She was like bald-head; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "She was like bald-head"; ALOPECIA (non-serious) with onset Dec2021, outcome "unknown", described as "She said, she is still having extreme hair loss".  Additional information: Reporter stated that, she went to have a doctor's Ophthalmology test last week, she was talking to a girl that was checking my vision and she do not know how we got talking about that but patient told  that she have had a Covid infection and she said that her hair has started to fall out and you know while she was having Covid she was having terrible loss of hair, she was like bald head and after she got better with Covid infection she said that she went took the Covid vaccine, reporter do not know she had Pfizer or Moderna, reporter did not thought to ask her that but she said after she had the Covid infection and then she went and had vaccinated and she said she is still having extreme hair loss after having Covid infection and then having her Covid vaccination after having had a Covid infection.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies penicillin" (unspecified if ongoing). Concomitant medication(s) included: LATANAPROST, start date: Mar2014, stop date: May2022. Vaccination history included: Covid-19 vaccine (Primary immunization completed.), for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 29Apr2022, outcome "not recovered" and all described as "I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive; (04May2022) Negative, notes: I completed the full course of treatment and tested negative; (08May2022) Positive, notes: I tested positive for Covid again but do not have any symptoms yet,. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Other medication in 2 weeks was Yes. Anti viral details:product=COVID 19 Treatment, brand=Paxlovid, treatment start date was 29Apr2022,treatment stop date was 04May2022,indication was treatment of COVID-19.I tested positive for Covid on the morning of 29Apr2022 and started Paxlovid that evening. my symptoms of fever, scratchy throat, and fatigue lasted until 01May2022. I completed the full course of treatment and tested negative for Covid on 04May2022. On 08May2022 I tested positive for Covid again but do not have any symptoms yet. Adverse event start date was 08May2022. Adverse event start time was 06:00 PM . If patient recovered was not recovered. If treatment ae was no  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: have had 5 of my wife's friends who had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "have had 5 of my wife's friends who had miscarriages". Clinical course includes, As per call with reporter: Reporter thinks the real world data right now, rather than just the data from Pfizer and early on, I mean, there its-its awful, is just awful Murry, what they saw. Reporter started referring to a document that was regarding breast feeding and pregnant women. Reporter spoke for a while and then summarized and asked about information regarding breastfeeding and pregnancy with the Pfizer COVID19 vaccine. He mentioned both he and his wife are not vaccinated. Early on, Reporter had 5 of his wife friends who had miscarriages. They had the COVID vaccine. All of their friends who had no COVID vaccine had a normal, healthy baby. So 5 out of 5 that were vaccinated had miscarriages in their third trimester and then-well one had a still born birth so he guessed that's 4 out of 5. No doctor linked any of that to the COVID vaccine and all those doctors-all those women were told, cause we actually we're in the same church and they- there obviously were very mentally upset-but all their doctors, OBGYN, all of them recommended that they get the COVID vaccine because they were told that 'your baby is gonna get COVID or you could get COVID during it and your baby would die reporter meant, they didn't give any data and that scared those women into getting the shot. They didn't provide anything. So any questions that were asked, they said 'no you have to, you need to get it. 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-202200677408 mother/baby case
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Influenza, Vertigo
Clinical narrative: tiredness the next day; flu symptoms; have dizziness like you know whenever my head down and get up you know I get dizzy.; It's like a vertigo.; 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), as dose 4 (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 (Dose: 3, Manufacturer: Unknown, Lot Number: Not Provided), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown, Lot Number: Not Provided), for COVID-19 immunization; Covid-19 vaccine (Dose: 1, Manufacturer: Unknown, Lot Number: Not Provided), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness the next day"; INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms"; DIZZINESS (non-serious), outcome "unknown", described as "have dizziness like you know whenever my head down and get up you know I get dizzy."; VERTIGO (non-serious), outcome "unknown", described as "It's like a vertigo.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Feeling abnormal, Headache, Multiple sclerosis relapse
Clinical narrative: Relapsing Remitting Multiple Sclerosis; chills; severe headache; felt terrible; had no urinary control; fell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4615551.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 07May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (ongoing); "ear infections" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS; COPAXONE. Past drug history included: Morphine sulfate, reaction(s): "allergic to morphine sulfate". Vaccination history included: Tetanus shots (bad reaction to Tetanus shots), for Immunization, reaction(s): "bad reaction to Tetanus shots". The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant), outcome "unknown", described as "Relapsing Remitting Multiple Sclerosis"; CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt terrible"; URINARY INCONTINENCE (non-serious), outcome "unknown", described as "had no urinary control"; FALL (non-serious), outcome "unknown", described as "fell". On unknown date, it was reported that patient experienced: chills, severe headache, felt "terrible," had no urinary control and fell.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Relapsing Remitting Multiple Sclerosis; chills; severe headache; felt terrible; had no urinary control; fell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4615551.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 07May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (ongoing); "ear infections" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS; COPAXONE. Past drug history included: Morphine sulfate, reaction(s): "allergic to morphine sulfate". Vaccination history included: Tetanus shots (bad reaction to Tetanus shots), for Immunization, reaction(s): "bad reaction to Tetanus shots". The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant), outcome "unknown", described as "Relapsing Remitting Multiple Sclerosis"; CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt terrible"; URINARY INCONTINENCE (non-serious), outcome "unknown", described as "had no urinary control"; FALL (non-serious), outcome "unknown", described as "fell". On unknown date, it was reported that patient experienced: chills, severe headache, felt "terrible," had no urinary control and fell.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pruritus
Clinical narrative: Patient may have received vaccine subcutaneously rather than IM.; Experienced mild local reaction including itching; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Patient may have received vaccine subcutaneously rather than IM."; PRURITUS (non-serious), outcome "unknown", described as "Experienced mild local reaction including itching".  Additional Information: Patient may have received vaccine subcutaneously rather than IM. Experienced mild local reaction including itching. Pharmacist had already reported this to VAERS.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heart rate reported by pt; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EP5445) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: en5318), for Covid-19 immunization; Bnt162b2 (Dose 2, Batch/Lot No: el0142), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart rate reported by pt".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: They had a fever but only after taking the covid shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2020US016115 (Norvatitis).  A 53-year-old female patient received BNT162b2 (BNT162B2), 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: PYREXIA (non-serious), outcome "unknown", described as "They had a fever but only after taking the covid shot". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: I had fever; I have body aches; Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (Pfizer-BioNTech COVID-19), on 05May2022 as dose 3 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I had fever"; PAIN (non-serious), outcome "unknown", described as "I have body aches"; CHILLS (non-serious), outcome "unknown".  Additional information: So yesterday I (patient) had I got my Booster first dose and I had some symptoms like a side effects, I had fever, I have body aches and chills. Lot number also reported as USW113 (Not clarified).  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive on a rapid and PCR for COVID; sore throat; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2 (COMIRNATY), on 01May2022 as dose 1, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious) with onset 06May2022, outcome "unknown", described as "fever"; OROPHARYNGEAL PAIN (non-serious) with onset 06May2022, outcome "unknown", described as "sore throat"; SARS-COV-2 TEST POSITIVE (non-serious) with onset 06May2022, outcome "unknown", described as "tested positive on a rapid and PCR for COVID". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: turned 5 on (Birth date) and got his first Comirnaty vaccine in 01May. He woke up 06May with a sore throat and fever and tested positive on a rapid and PCR for COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: then got Covid and ignored it and they passed away; then got Covid and ignored it and they passed away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: COVID-19 (death, medically significant), DRUG INEFFECTIVE (death, medically significant), outcome "fatal" and all described as "then got Covid and ignored it and they passed away". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Her friend was vaccinated (did not specify what vaccine) and then got Covid and ignored it and they passed away. The patient date of death was unknown. Reported cause of death: "then got Covid and ignored it and they passed away". It was not reported if an autopsy was performed. Clinical course: Caller stated she received Moderna vaccine, she tested positive for Covid 19 and has been taking Paxlovid for 4 days now. She has experienced water like diarrhea for 4 days now. She states that when she woke up in the morning she had to run from the bed to the toilet. and then she was fine the rest of the day. She had also experienced a metallic taste in her mouth. She would like to know if these two side effects were normal. Consumer was 78 year old female who described herself as a very healthy individual for her age and stated she did not have any breathing problems or anything. Caller also mentioned that her friend was vaccinated (did not specify what vaccine) and then got Covid and ignored it and they passed away. Proprietary medicinal product name was Paxlovid.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Reported Cause(s) of Death: then got Covid and ignored it and they passed away; then got Covid and ignored it and they passed away
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) 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: 01, Unknown manufacturer.), for Covid-19 Immunization. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite".  Additional Information: Forwarded as an Adverse Event by the team on 09May2022 Reporter provided verification of contact address on 06May2022. Customer Verbatim: I received two initial and then the booster. I have been left with a metallic salty taste in my mouth. I have no appetite since the second one. Is there anything I can do  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Orthostatic hypotension, Thinking abnormal
Clinical narrative: I get short of breath; Weak; Tired all the time; Orthostatic hypotension; My thinking is not like it should be; not able to think properly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2, Solution for injection), as dose 1, single (Lot number: EL3246) and as dose 2, single (Lot number: EL9263) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "I get short of breath"; ASTHENIA (non-serious), outcome "unknown", described as "Weak"; FATIGUE (non-serious), outcome "unknown", described as "Tired all the time"; ORTHOSTATIC HYPOTENSION (non-serious), outcome "unknown"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "My thinking is not like it should be; not able to think properly". Therapeutic measures were not taken as a result of dyspnoea, asthenia, fatigue, orthostatic hypotension, thinking abnormal. Additional information: When probed for adverse effects, consumer stated, "I get short of breath, weak, tired all the time and my thinking is not like it should be. I have orthostatic hypotension, short of breath and not able to think properly." Prior vaccinations(within 4 weeks): Consumer stated, "No".
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: hearing loss; This is a spontaneous report received from non-contactable reporter(s) (Nurse), Program ID: (175794).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss". The causality was reported as related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported event hearing loss and BNT162b2 cannot be excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.