chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Pain; Headache; Chills; Joint pain; Muscle pain; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2022 at 18:15 as dose 4 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:03, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering"; FATIGUE (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering"; HEADACHE (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering", described as "Joint pain"; MYALGIA (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering", described as "Muscle pain"; PAIN (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering". Therapeutic measures were taken as a result of pain, headache, chills, arthralgia, myalgia, fatigue.  Additional information: Dose received: More than 3. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had no known allergies. Reported Event: Pain, Headache, Chills, Joint pain, Muscle pain, Fatigue. The patient received treatment of Acetaminophen. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; Headache; Chills; Joint pain; Muscle pain; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2022 at 18:15 as dose 4 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:03, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering"; FATIGUE (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering"; HEADACHE (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering", described as "Joint pain"; MYALGIA (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering", described as "Muscle pain"; PAIN (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering". Therapeutic measures were taken as a result of pain, headache, chills, arthralgia, myalgia, fatigue.  Additional information: Dose received: More than 3. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had no known allergies. Reported Event: Pain, Headache, Chills, Joint pain, Muscle pain, Fatigue. The patient received treatment of Acetaminophen. No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood Pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Rebound covid; (09Sep2022) Positive, notes: Rebound covid Positive test three days after completeing Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Adverse event: Rebound covid Positive test three days after completeing Paxlovid treatment. The patient did not have Known allergies. Patient did not receive any Other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "migraine" (unspecified if ongoing); "rosacea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Omeprazole, reaction(s): "Known allergies: Omeprazole", notes: Known allergies: Omeprazole; Amoxycillin, reaction(s): "Known allergies: Amoxycillin", notes: Known allergies: Amoxycillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical details: It was reported, COVID 19 Treatment, Paxlovid from 06Sep2022 to 08Sep2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 55.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER8736), in left arm and on 13Jan2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Acetaminophen" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient didn't taken other medication in 2 weeks. Patient received Paxlovid as treatment for Covid-19, started on 06Sep2022 and stopped on 11Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 24Jan2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Feb2021 at 13:00 as dose 2, single (Lot number: FL9267), in left arm, on 01Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 31035BA), in left arm and on 18May2022 at 15:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Milk protein A" (unspecified if ongoing). 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: At Home test became strongly positive after fading to almost gone; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical summary: Other medication in 2 weeks was None. Patient took Paxlovid, starting 31Aug2022 and Treatment stop date was 04Sep2022 for treatment of COVID-19. Adverse event was also reported as at home test became strongly positive after fading to almost gone on 10Sep2022 at 9:00 AM. It was unknown if patient recovered with no treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 12Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Aortic stenosis" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was treated with Paxlovid from 29Aug2022 to 02Sep2022. Patient did not have any Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure and covid 19 cannot be ruled out.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid19; tested positive for Covid19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Sep2022, outcome "unknown" and all described as "tested positive for Covid19". The patient underwent the following laboratory tests and procedures: Body temperature: (Sep2022) 101-103.1, notes: Caller states starting on 01Sep2022 through 04Sep2022, she ran a really high fever 101-103.1; SARS-CoV-2 test: (01Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Tested positive for Covid 19 on 01Sep2022 after receiving 3 doses of the Covid 19 Vaccine. Reporter stated she tested positive for Covid19 on Thursday 01Sep2022. Reporter stated she doesn't know how she got it, she wasn't even working at the school at the time, and she wears a mask everywhere and to the grocery store. Reporter also stated she has been vaccinated with the original Pfizer Covid Vaccines and the Booster Dose. There were no other conditions, other products and investigations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and Covid-19 cannot be ruled out.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: tested positive for Covid19; tested positive for Covid19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Sep2022, outcome "unknown" and all described as "tested positive for Covid19". The patient underwent the following laboratory tests and procedures: Body temperature: (Sep2022) 101-103.1, notes: Caller states starting on 01Sep2022 through 04Sep2022, she ran a really high fever 101-103.1; SARS-CoV-2 test: (01Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Tested positive for Covid 19 on 01Sep2022 after receiving 3 doses of the Covid 19 Vaccine. Reporter stated she tested positive for Covid19 on Thursday 01Sep2022. Reporter stated she doesn't know how she got it, she wasn't even working at the school at the time, and she wears a mask everywhere and to the grocery store. Reporter also stated she has been vaccinated with the original Pfizer Covid Vaccines and the Booster Dose. There were no other conditions, other products and investigations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and Covid-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Nausea; I am nauseated; Feeling tired; Headache; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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: NAUSEA (non-serious), outcome "unknown", described as "Nausea; I am nauseated"; FATIGUE (non-serious), outcome "unknown", described as "Feeling tired"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain". Therapeutic measures were taken as a result of headache.  Additional information: NDC number of COVID-19 Vaccine, UPC number of COVID-19 Vaccine and Expiry Date of COVID-19 Vaccine was Unknown. Consumer stated, She was trying to find out if you had a side effect sort of from the shot (COVID-19 Vaccine) like nausea or you know feeling tired or headache, muscle pain can you take medication for that like Tylenol and nausea medication (Unspecified medication) or not. When probed to clarify if consumer already consumed the medications (Tylenol and Unspecified Medication): She want to know if you can take it. She did take Tylenol for the headache but now she was nauseated. Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information Department for the concern. Consumer was provided with the number of Pfizer Medical Information Department as (phone number), option 3 and timings as 8 am to 9 pm, Monday to Friday. In response to further probing, Consumer stated, She would rather want you to transfer. Attempt was made to transfer the call to Pfizer Medical Information Department however, it was unsuccessful. Consumer was requested to connect after some time to the department. Further probing could not be done. Hence, product details (LOT, Expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer (basal squamous)", start date: 2017 (ongoing); "Prostate cancer", start date: Nov2019, stop date: Jan2020, notes: Surgical removal Jan2020; "Surgery", start date: Jan2020 (unspecified if ongoing), notes: Surgical removal Jan2020; "Cholesterol" (ongoing); "Acid Reflux" (ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol abnormal (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (DOSE: 01, Time: 10: 00AM, Lot number: EN6198, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "injection site soreness"; BNT162b2 (DOSE: 02, Time: 10: 00AM, Lot number: EN6208, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 17Mar2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "injection site soreness"; BNT162b2 (DOSE: 03, Time: 10: 00AM, Lot number: FF2589, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 28Sep2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "injection site soreness". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness".  Additional information: Patient didn't experience any adverse effects following his previous (4) shots other than a little injection site soreness. vaccination facility type was pharmacy or drug store. Prior vaccination was none. vaccine administered at specific facility was reported as no.2 or 3 previous outpatient surgeries 1 recent radiation treatment (finally 20th treatment on 25Aug2022).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies and had taken no other medications in two weeks. She was treated with Paxlovid from 03Sep2022 to 07Sep2022 for the treatment of Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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. Concomitant medication(s) included: PROPRANOLOL, start date: 01May2018. The following information was reported: DRUG INEFFECTIVE (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: (unspecified date) Positive, notes: COVID-19 Treatment; (14Sep2022) Positive, notes: 6 days after finishing Paxlovid I have symptoms again and am positive on the test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral drug PAXLOVID was taken from 03Sep2022 to 08Sep2022 for the treatment of COVID-19   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
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) (Nurse). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 30 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: "Asthma" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Known allergies: Honey" (unspecified if ongoing); "Known allergies: raspberry" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: TOPAMAX, start date: 13Jun2010; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; VITAMIN D [VITAMIN D NOS]; NEXPLANON. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received vaccine and other medications were received in 2 weeks. Anti-viral details included Product for COVID 19 Treatment, Brand was Pfizer. Treatment start date was on 10Sep2022. Treatment stop date was on 14Sep2022. Indication was for Treatment of COVID-19.   No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded
Age: 44.0
Sex: F
Vaccine: COVID19, 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single at the age of 44 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: "Autoimmune disease" (unspecified if ongoing); "Moderate to severe asthma" (unspecified if ongoing); "significant small nerve fiber damage" (unspecified if ongoing), notes: significant small nerve fiber damage; "Dysautonomia" (unspecified if ongoing); "Executive dysfunction" (unspecified if ongoing); "Eosinophilic esophagitis" (unspecified if ongoing); "PTSD" (unspecified if ongoing). Concomitant medication(s) included: PROZAC, start date: 01Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test rebound 7 days after last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment included Paxlovid (Treatment start date: 01Sep2022, Treatment stop date: 06Sep2022). Adverse event included symptoms and positive test rebound 7 days after last dose of 5 days course of Paxlovid and the patient had long Covid that led to disability and PTSD and this rebound was traumatic (adverse start date: 12Sep2022 15:00 PM).  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, FLUX
Symptoms: Menstruation irregular
Clinical narrative: Menstrual cycle started early, 1 or 2 days after vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2022 at 11:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 09Sep2022 (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. 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: 1st Booster), for COVID-19 immunization.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 10Sep2022, outcome "unknown", described as "Menstrual cycle started early, 1 or 2 days after vaccine.". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: Dose received: More than 3. If other vaccine in four weeks: No. other medications in two weeks: No The patient not had covid prior vaccination and not tested covid post vaccination. Patient had no known allergies.  The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years 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 was not reported. Concomitant medication(s) included: ESTROGEN; PROGESTERONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: Patient was received Paxlovid for treatment of Covid-19 from 31Aug2022 to 05Sep2022. The patient received other medications which included Hormone replacement therapy (Estrogen patches and progesterone pills) in 2weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Fatigue, Hypertension, Malaise
Clinical narrative: She states she is having the side effects of feeling unwell; tired; blood pressure elevated; some chills; 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 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), 15 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer.), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "She states she is having the side effects of feeling unwell"; FATIGUE (non-serious), outcome "unknown", described as "tired"; HYPERTENSION (non-serious), outcome "unknown", described as "blood pressure elevated"; CHILLS (non-serious), outcome "unknown", described as "some chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Dose/Dosage Form was Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than or equal 12 years - 15/15 mcg per dose. Patient had received Booster dose yesterday of Pfizer COVID 19 Bivalent vaccines and had the side effects of feeling unwell, tired, blood pressure elevated, some chills. Consumer stated that she knows these are normal side effects according to the information they gave and asked how long will the side effects to last? What patient can take for the side effects?  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: Echocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Myocarditis; This is a literature report for the following literature source(s):   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 1; Manufacturer unknown, ), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: unknown result; Decreased LVEF, notes: in 3 cases; Rt. ventricular dysfunction, notes: in 3 cases; Echocardiogram: LVEF 33; Magnetic resonance imaging heart: unknown result; Enhancement, notes: pericardial in 3 cases; Enhancement (diffuse and global) with myocardial, notes: edema; T1: increased globalnative T1 value.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201127030 Same article/drug/ event; different patient;US-PFIZER INC-202201127029 Same article/drug/ event; different patient.;
Sex: U
Vaccine: COVID19
Symptoms: Motor dysfunction
Clinical narrative: I can't use my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  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: MOTOR DYSFUNCTION (non-serious), outcome "unknown", described as "I can't use my arm".  Additional information: The patient stated, he/she did not want to hear, wanted to talk to somebody, they gave him/her down the shots and he/she could not use his/her arm. Patient was not a healthcare professional.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She had all 4 shots so far and had 1 mild case of covid; She had all 4 shots so far and had 1 mild case of covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 83-year-old patient received BNT162b2 (BNT162B2), 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 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 "She had all 4 shots so far and had 1 mild case of covid". Patient called in with questions about a letter the patient received from the program informing the patient their HCP state license number was missing for their enrolment in the program. When asked by the call agent to confirm the name of the medication the patient was calling about. The patient stated. Tikosyn 125mg. Patient later stated the following about the Pfizer-BioNTech COVID-19 Vaccine. Tell she has been very grateful for all their vaccines they helped keep her going through all this crazy stuff, she has had all 4 shots so far and had 1 mild case of covid.  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: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: 3 doses of the Moderna Covid-19 vaccine and one dose of Pfizer.; his wife and himself had Covid mid Aug2022 after getting 3 doses of the Moderna Covid-19 vaccine and one dose of Pfizer; his wife and himself had Covid mid Aug2022 after getting 3 doses of the Moderna Covid-19 vaccine and one dose of Pfizer; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): MOD22-022731 (MODERNA), 147942 (MODERNA).  A female patient received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Lot number: 011M20A), on 05Mar2021 as dose 2, single (Lot number: 002A21A) and on 08Nov2021 as dose 3(booster), single (Lot number: 065F21A) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "his wife and himself had Covid mid Aug2022 after getting 3 doses of the Moderna Covid-19 vaccine and one dose of Pfizer"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "3 doses of the Moderna Covid-19 vaccine and one dose of Pfizer.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) positive.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling extreme fatigue that remained until around 6:00 PM; 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 number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization completed), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "feeling extreme fatigue that remained until around 6:00 PM".  Additional information: It was reported that on the next day, the patient woke up feeling extreme fatigue that remained until around 18:00. Event took place after use of product.  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: Antibody test, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Bacterial test, Blood folate
Clinical narrative: Acute Immune-mediated Demyelinating Polyneuropathy; This is a literature report for the following literature source(s).  A 36-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "progressive bilateral paresthesia" (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: DEMYELINATING POLYNEUROPATHY (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "Acute Immune-mediated Demyelinating Polyneuropathy". The patient underwent the following laboratory tests and procedures: Antibody test: unremarkable; unremarkable; unremarkable; unremarkable; negative, notes: for serum and CSF; Antineutrophil cytoplasmic antibody: unremarkable; Antinuclear antibody: unremarkable; positive; Bacterial test: which included hepatitis, notes: serologies,Campylobacter jejuni serology, Lyme atb, CMV atb, EBV atb were all negative; Blood folate: Normal; Cytomegalovirus test: negative, notes: for serum and CSF; Double stranded DNA antibody: unremarkable; Electromyogram: showed evidence of acute diffuse sensorimotor, notes: neuropathy with mixed axonal and demyelinating features; Epstein-Barr virus antibody: negative, notes: For serum and CSF; Helicobacter test: negative, notes: in serum and CSF; Hepatitis viral test: negative, notes: in serum and CSF; clinical features: not suggestive of Sjogren's Syndrome.; unremarkable; which included hepatitis, notes: serologies,Campylobacter jejuni serology, Lyme atb, CMV atb, EBV atb were all negative; not suggestive of Sjogren's Syndrome.; Magnetic resonance imaging head: showed small scattered foci of increased FLAIR, notes: signal in the white matter, suggesting an underlying inflammatory process; Neurological examination: normal; Orthopaedic examination: normal; Physical exam: was notable for decreased distal sensation to, notes: touch and pain in all 4 limbs, otherwise, the rest of her neurological and musculoskeletal evaluation was normal; Rheumatoid factor: unremarkable; Vitamin B1: Normal; Vitamin B12: normal. Therapeutic measures were taken as a result of demyelinating polyneuropathy.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events DEMYELINATING POLYNEUROPATHY and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Cytomegalovirus test, Demyelinating polyneuropathy, Double stranded DNA antibody, Electromyogram, Epstein-Barr virus antibody
Clinical narrative: Acute Immune-mediated Demyelinating Polyneuropathy; This is a literature report for the following literature source(s).  A 36-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "progressive bilateral paresthesia" (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: DEMYELINATING POLYNEUROPATHY (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "Acute Immune-mediated Demyelinating Polyneuropathy". The patient underwent the following laboratory tests and procedures: Antibody test: unremarkable; unremarkable; unremarkable; unremarkable; negative, notes: for serum and CSF; Antineutrophil cytoplasmic antibody: unremarkable; Antinuclear antibody: unremarkable; positive; Bacterial test: which included hepatitis, notes: serologies,Campylobacter jejuni serology, Lyme atb, CMV atb, EBV atb were all negative; Blood folate: Normal; Cytomegalovirus test: negative, notes: for serum and CSF; Double stranded DNA antibody: unremarkable; Electromyogram: showed evidence of acute diffuse sensorimotor, notes: neuropathy with mixed axonal and demyelinating features; Epstein-Barr virus antibody: negative, notes: For serum and CSF; Helicobacter test: negative, notes: in serum and CSF; Hepatitis viral test: negative, notes: in serum and CSF; clinical features: not suggestive of Sjogren's Syndrome.; unremarkable; which included hepatitis, notes: serologies,Campylobacter jejuni serology, Lyme atb, CMV atb, EBV atb were all negative; not suggestive of Sjogren's Syndrome.; Magnetic resonance imaging head: showed small scattered foci of increased FLAIR, notes: signal in the white matter, suggesting an underlying inflammatory process; Neurological examination: normal; Orthopaedic examination: normal; Physical exam: was notable for decreased distal sensation to, notes: touch and pain in all 4 limbs, otherwise, the rest of her neurological and musculoskeletal evaluation was normal; Rheumatoid factor: unremarkable; Vitamin B1: Normal; Vitamin B12: normal. Therapeutic measures were taken as a result of demyelinating polyneuropathy.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events DEMYELINATING POLYNEUROPATHY and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Helicobacter test, Hepatitis viral test, Investigation, Magnetic resonance imaging head, Neurological examination
Clinical narrative: Acute Immune-mediated Demyelinating Polyneuropathy; This is a literature report for the following literature source(s).  A 36-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "progressive bilateral paresthesia" (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: DEMYELINATING POLYNEUROPATHY (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "Acute Immune-mediated Demyelinating Polyneuropathy". The patient underwent the following laboratory tests and procedures: Antibody test: unremarkable; unremarkable; unremarkable; unremarkable; negative, notes: for serum and CSF; Antineutrophil cytoplasmic antibody: unremarkable; Antinuclear antibody: unremarkable; positive; Bacterial test: which included hepatitis, notes: serologies,Campylobacter jejuni serology, Lyme atb, CMV atb, EBV atb were all negative; Blood folate: Normal; Cytomegalovirus test: negative, notes: for serum and CSF; Double stranded DNA antibody: unremarkable; Electromyogram: showed evidence of acute diffuse sensorimotor, notes: neuropathy with mixed axonal and demyelinating features; Epstein-Barr virus antibody: negative, notes: For serum and CSF; Helicobacter test: negative, notes: in serum and CSF; Hepatitis viral test: negative, notes: in serum and CSF; clinical features: not suggestive of Sjogren's Syndrome.; unremarkable; which included hepatitis, notes: serologies,Campylobacter jejuni serology, Lyme atb, CMV atb, EBV atb were all negative; not suggestive of Sjogren's Syndrome.; Magnetic resonance imaging head: showed small scattered foci of increased FLAIR, notes: signal in the white matter, suggesting an underlying inflammatory process; Neurological examination: normal; Orthopaedic examination: normal; Physical exam: was notable for decreased distal sensation to, notes: touch and pain in all 4 limbs, otherwise, the rest of her neurological and musculoskeletal evaluation was normal; Rheumatoid factor: unremarkable; Vitamin B1: Normal; Vitamin B12: normal. Therapeutic measures were taken as a result of demyelinating polyneuropathy.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events DEMYELINATING POLYNEUROPATHY and the suspect drug cannot be excluded. The case will be reassessed once new information is available.