chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; 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 patient received BNT162b2 (BNT162B2), on 29Jan2021 at 13:00 as dose 1, single (Lot number: EL92965), in left arm, on 20Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in left arm and on 28Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 at 13:00 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Sep2022, outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive, notes: Tested positive for COVID with antigen test 3 days after fifth day of taking Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: patient experienced a recurrence of COVID symptoms (a little milder than initial symptoms) and tested positive for COVID with antigen test 3 days after fifth day of taking Paxlovid. Patient was not taken any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received covid-19 vaccine.  No follow up attempts are possible, no further information expected.
Age: 69.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pulmonary" (unspecified if ongoing). The patient took concomitant medications. 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, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received vaccine. Patient received other medication in 2weeks. Patient had no known allergies. Patient received Paxlovid as COVID 19 Treatment from unspecified date in Sep2022 to unspecified date Sep2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1=Pfizer/BioNTech, Dose 2=Pfizer/BioNTech, Dose 3= Moderna; 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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 at 12:00 as dose 1, single (Lot number: EN6204), in right arm and on 01Apr2021 at 12:00 as dose 2, single (Lot number: EP7533) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Dec2021 as dose 3 (booster), single (Lot number: 070h21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 15Jul2021, stop date: 16Sep2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: 15Jul2021. Past drug history included: Amoxicillin for drug use for unknown indication, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2021 at 12:00, outcome "unknown", described as "Dose 1=Pfizer/BioNTech, Dose 2=Pfizer/BioNTech, Dose 3= Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Patient was treated for Covid-19 with anti-viral from Pfizer from 17Sep2022 to 21Sep2022. Patient reported Stroke in July2021 which was a rebound COVID after Paxlovid. Adverse event start date: 27Sep2022, with outcome Recovering. No treatment received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1=Pfizer/BioNTech, Dose 2=Pfizer/BioNTech, Dose 3= Moderna; 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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 at 12:00 as dose 1, single (Lot number: EN6204), in right arm and on 01Apr2021 at 12:00 as dose 2, single (Lot number: EP7533) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Dec2021 as dose 3 (booster), single (Lot number: 070h21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 15Jul2021, stop date: 16Sep2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: 15Jul2021. Past drug history included: Amoxicillin for drug use for unknown indication, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2021 at 12:00, outcome "unknown", described as "Dose 1=Pfizer/BioNTech, Dose 2=Pfizer/BioNTech, Dose 3= Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Patient was treated for Covid-19 with anti-viral from Pfizer from 17Sep2022 to 21Sep2022. Patient reported Stroke in July2021 which was a rebound COVID after Paxlovid. Adverse event start date: 27Sep2022, with outcome Recovering. No treatment received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 12:00 as dose 2, single (Lot number: EP7533) at the age of 45 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Stroke" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 10Mar2021, when the patient was 45-year-old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Jul2021, outcome "unknown", described as "Stroke". Clinical course: Patient received Dose 3 of Moderna (Lot number- 070h21a) in left arm on 31Dec2021. Other medication within 2 weeks of vaccination was reported as ruvastatin from 15Jul2021 to 16Sep2022 and Aspirin from 15Jul2021.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 12:00 as dose 2, single (Lot number: EP7533) at the age of 45 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Stroke" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 10Mar2021, when the patient was 45-year-old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Jul2021, outcome "unknown", described as "Stroke". Clinical course: Patient received Dose 3 of Moderna (Lot number- 070h21a) in left arm on 31Dec2021. Other medication within 2 weeks of vaccination was reported as ruvastatin from 15Jul2021 to 16Sep2022 and Aspirin from 15Jul2021.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 at 16:00 as dose 2, single (Lot number: En6203) at the age of 76 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not have any other medication in 2 weeks. The patient did not have known allergies. The patient started Paxlovid treatment from 29Sep2022 to 30Sep2022 for covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches; she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches; 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 female patient 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: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "For the first two she felt a little tired", "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "For the first two she felt a little tired", "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine"; Bnt162b2 (DOSE 3, SINGLE), for Covid-19 immunization, reaction(s): "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine". The following information was reported: PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches".  Additional information: Caller mentioned that she usually have body and muscle ache after getting the vaccine. For the boosters she had body aches. NDC number of COVID-19 vaccine was not provided. Other Products was not provided. She doesn't have high blood pressure or heart issues or anything.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Respiratory disorder
Clinical narrative: kept getting bronchitis; kept getting respiratory issue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male 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: BRONCHITIS (non-serious), outcome "unknown", described as "kept getting bronchitis"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "kept getting respiratory issue".  Additional information: The reporter stated that one of her son was vaccinated and one son was not vaccinated. Her concern was the son that was vaccinated kept getting bronchitis over the other one who was not vaccinated. She asked why her son was who was vaccinated was the one getting sick all the time and other one was not. The reporter stated that his son (patient) was really healthy, he was a teen, he was an athlete and ever since he has got the shot he kept getting respiratory issue. The reporter was concerned if it was new because now the studies were coming out on TV and she read on the website that the vaccine does work but he was getting sick. The reporter asked why he was sick all the time now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Aug2022 as dose number unknown, single (Lot number: FP7137) at the age of 31 years for COVID-19 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications.  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: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Clinical course: The patient started Paxlovid on 29Sep2022 and end date not provided for the treatment of COVID-19. Other medications in two weeks were taken by the patient.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a 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 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: ,; "asthma" (unspecified if ongoing); "Known allergies: Shellfidmsh" (unspecified if ongoing); "Known allergies: cats" (unspecified if ongoing); "Known allergies: mold" (unspecified if ongoing); "Known allergies: tobacco and maybe caraway" (unspecified if ongoing); "Known allergies: tobacco and maybe caraway" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE, start date: 01Oct2010; OZEMPIC, start date: 01Oct2010; METFORMIN, start date: 01Oct2010; LISINOPRIL, start date: 01Oct2010; ATORVASTATIN, start date: 01Oct2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Other medication in 2weeks product: Jardiance, Ozempic, metformin, Lisinopril, atorvastatin. The patient received Paxlovid as COVID 19 Treatment from 23Sep2022 to 27Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Viral infection
Clinical narrative: sore throat; Viral fever; Viral fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 3-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization.  The following information was reported: VIRAL INFECTION (non-serious) with onset 30Sep2022, outcome "recovered", described as "Viral fever"; OROPHARYNGEAL PAIN (non-serious) with onset 30Sep2022, outcome "recovered", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient clarified that the patient was her son who was almost 4 years old. She clarified that he got 2 doses of Pfizer Covid-19 Vaccine. He was scheduled for his 3rd dose of Pfizer Covid-19 Vaccine on 28Sep2022, but they canceled that by mistake so he missed that dose; not because of patient's sore throat as provided by inbound transfer agent. He was then supposed to go on 30Sep2022 to get the third dose of Pfizer Covid-19 Vaccine; but that was the day he started having symptoms so they cancelled that dose because of his symptoms. They were afraid his symptoms were COVID, but they weren't. They tested him for COVID and strep throat, and it wasn't COVID, it was a viral fever. The patient has now been over 48 hours with no fever or symptoms and is negative 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: Death
Clinical narrative: she has known two people to get the EUA vaccine and 'drop dead'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  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: DEATH (death, medically significant), outcome "fatal", described as "she has known two people to get the EUA vaccine and 'drop dead'". The patient date of death was unknown. Reported cause of death: "she has known two people to get the EUA vaccine and 'drop dead'". It was not reported if an autopsy was performed.  Reporter stated she was being forced to get the vaccine or lose her job. She relayed that she had known two people to get the EUA vaccine and 'drop dead' she did not specify which Covid 19 vaccine these people had received.  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-202201201476 same reporter/drug/event, different patients;; Reported Cause(s) of Death: she has known two people to get the EUA vaccine and 'drop dead'
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: In your shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days; I was so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "In your shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days"; ILLNESS (non-serious), outcome "unknown", described as "I was so sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was unknown. Patient had trouble with the 3 shots pt. had. Is there eggs, milk products and aluminum die. In patient shot. patient was so sick that  patient , scared to get a booster shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: Shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), till Mar2021 at 11 mg for rheumatoid arthritis. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing), notes: Hashimoto's thyroiditis; "Hyperparathyroidism" (unspecified if ongoing), notes: Hyperparathyroidism; "High blood pressure" (unspecified if ongoing); "stroke" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Manufacturer unknown), for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for tofacitinib citrate was temporarily withdrawn in Mar2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: urticaria; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown". Additional information: Patient reported developing urticaria after bivalent vaccine booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Blood glucose increased, Diabetes mellitus, Drug interaction, Feeling abnormal
Clinical narrative: I have diabetes too; I have verry hight sugar; I feel strange, without power.; The diabetes was... fatal.. verry bad.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2022-626780 (Mderna).  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: DIABETES MELLITUS (medically significant), outcome "unknown", described as "I have diabetes too"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "I have verry hight sugar"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel strange, without power."; DRUG INTERACTION (non-serious), outcome "unknown", described as "The combinacion con diabetes was... fatal.. verry bad.".  Clinical course: The attached reports concerning your product, PFIZER/BIONTECH VACCINE , was being forwarded to Pfizer on behalf of Moderna in compliance with the FDA regarding post-marketing adverse event reporting dated Mar1992 and posted 1998. Please be informed below provided email contains information of other manufacturer. Hence, Forwarded it to pifzer. Case created with system ID MOD-2022-626780. Kindly find the response received from the reporter upon follow-up for the case: MOD-2022- 626780.  Yes, Patient had verry high sugar (Patient had diabetes too).., Patient feel strange, without power.. After patient make Pfizer.. Now patinet try to recuper patient healed.. The combination with diabetes was... fatal.. very bad.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19-2
Symptoms: Administration site warmth, Drug hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: I have had a terrible reaction to this medication.; My arm has been terribly painful; My arm has been terribly painful, hot; arm swollen to the touch still as of today 30Sep2022; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset Sep2022, outcome "not recovered", described as "I have had a terrible reaction to this medication."; PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "not recovered", described as "My arm has been terribly painful"; ADMINISTRATION SITE WARMTH (non-serious) with onset Sep2022, outcome "not recovered", described as "My arm has been terribly painful, hot"; PERIPHERAL SWELLING (non-serious) with onset Sep2022, outcome "not recovered", described as "arm swollen to the touch still as of today 30Sep2022".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Menopause, Night sweats
Clinical narrative: horrible hot flashes; night sweats; menopause; 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 65-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious), outcome "unknown", described as "horrible hot flashes"; NIGHT SWEATS (non-serious), outcome "unknown"; MENOPAUSE (non-serious), outcome "unknown".  Additional Information- Patient received two Covid vaccines a year ago and had horrible hot flashes and night sweats since. Patient was 65 and through menopause, was also through with night sweats. she would like to know if there was anything she could do to made it stop. She was miserable asked for help.  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: Anxiety, Fear, Herpes zoster, Hypoacusis, Pain
Clinical narrative: I developed a severe case of facial shingles; suffered great pain; anguish; severe loss of hearing; fear of loss of vision; 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 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 (Primary series immunization complete but manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (1st booster), for COVID-19 Immunization; Both shingles boosters (I did previously have both shingles boosters in 2018), administration date: 2018. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "I developed a severe case of facial shingles"; PAIN (non-serious), outcome "unknown", described as "suffered great pain"; ANXIETY (non-serious), outcome "unknown", described as "anguish"; HYPOACUSIS (non-serious), outcome "unknown", described as "severe loss of hearing"; FEAR (non-serious), outcome "unknown", described as "fear of loss of vision". The events " i developed a severe case of facial shingles", "suffered great pain" and "anguish" required physician office visit.  Additional Information: patient stated that, after my 4th corona booster patient developed a severe case of facial shingles, suffered great pain, anguish, suffering. numerous visits to numerous doctor's fear of loss of vision and severe loss of hearing. Patient previously had both shingles boosters in 2018 and patients hearing was fair. Your vaccine was poison and causing great pain and suffering shame on Pfizer. immune from lawsuit Pfizer made billions in profits injuring people. your cure worse than the disease.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2, FLUX
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: high fever; severe chills; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 30Sep2022 as unk, single (Batch/Lot number: unknown) for 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: PYREXIA (non-serious) with onset 01Oct2022, outcome "unknown", described as "high fever"; MYALGIA (non-serious) with onset 01Oct2022, outcome "unknown", described as "muscle aches"; CHILLS (non-serious) with onset 01Oct2022, outcome "unknown", described as "severe chills".  Additional information: Day before reporting patient received both the new Pfizer Bivalent and the Flu shot and had a violent reaction. High fever, severe chills and muscle aches and frankly patient thought he/ she was dying. It was irresponsible, deadly and assinine of Pfizer to tell the PUBLIC that was okay.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: she has experienced alterations to her menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the parent.  A 14-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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, DOSE 1; SINGLE), for COVID-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "she has experienced alterations to her menstrual cycle". The event "she has experienced alterations to her menstrual cycle" required physician office visit.  Additional information: Reporter's daughter (14yo) received the 2nd dose of the COVID vaccine late July and she has experienced alterations to her menstrual cycle (it gets lighter but it doesn't go away. Pediatrician mentioned that the vaccine was causing this types of alterations in some people. I need to receive information on this regard. I would like to know if this side effect will go away and when.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive; I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 28Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 30Sep2022, outcome "recovered" (01Oct2022) and all described as "I tested positive". The patient was hospitalized for drug ineffective, covid-19 (start date: 30Sep2022, discharge date: 01Oct2022, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive, notes: I received my fourth Covid vaccine on 28Sep. Due to a hospital visit two days later, I tested positive; (01Oct2022) Negative, notes: the next day before I was released, I tested negative.  Clinical course: Patient received fourth Covid vaccine on 28Sep. Due to a hospital visit two days later, patient tested positive. However, the next day before release, patient tested negative. Inquired if positive due to the recent vaccine shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: I tested positive; I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 28Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 30Sep2022, outcome "recovered" (01Oct2022) and all described as "I tested positive". The patient was hospitalized for drug ineffective, covid-19 (start date: 30Sep2022, discharge date: 01Oct2022, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive, notes: I received my fourth Covid vaccine on 28Sep. Due to a hospital visit two days later, I tested positive; (01Oct2022) Negative, notes: the next day before I was released, I tested negative.  Clinical course: Patient received fourth Covid vaccine on 28Sep. Due to a hospital visit two days later, patient tested positive. However, the next day before release, patient tested negative. Inquired if positive due to the recent vaccine shot.   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: Death
Clinical narrative: death(month died: Feb2022); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ5342) 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: DEATH (death, medically significant) with onset Feb2022, outcome "fatal", described as "death(month died: Feb2022)". The patient date of death was Feb2022. The reported cause of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death(month died: Feb2022)
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective, Haemodynamic instability, Hypoxia, Oxygen saturation decreased
Clinical narrative: Haemodynamic instability; Respiratory distress; Hypoxia; Pneumothorax; COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer). A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Aug2022 as dose 4 (booster), single (Lot number: FK9894) for COVID-19 immunization; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL9269), as dose 2, single (Lot number: EN6198) and as dose 3 (booster), single (Lot number: FH8028) for COVID-19 immunization. The patient's relevant medical history included: "Seronegative RA" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had positive SARS-CoV-2 IgG (Anti-Spike) on 23Aug2022. The patient had COVID-19 pneumonia in 2022 (positive SARS-COV-2 antibody test) presented for worsening shortness of breath (SOB). In the emergency room (ER), the patient was hypoxic requiring high flow nasal cannula (HFNC) 100% with Fi02/50 L and a nonrebreather maintaining SP02 in the early 90s. A significant increase in work of breathing was noted and patient was intubated. On 28Aug2022, the patient developed respiratory distress. Patient had a needle decompression and then chest tube placement for right sided tension pneumothorax. Patient was unable to be weaned off ventilator and on 05Sep2022 had a drop in Sp02 with increased WOB. The patient required multiple pressors for hemodynamic instability. She was then transitioned to comfort care and passed peacefully that evening of 06Sep2022. The reported cause of death: "COVID-19 pneumonia", "Haemodynamic instability", "Hypoxia", "Pneumothorax", "Respiratory distress". It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; Haemodynamic instability; Hypoxia; Pneumothorax; Respiratory distress
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumothorax, Respiratory distress, SARS-CoV-2 antibody test
Clinical narrative: Haemodynamic instability; Respiratory distress; Hypoxia; Pneumothorax; COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer). A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Aug2022 as dose 4 (booster), single (Lot number: FK9894) for COVID-19 immunization; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL9269), as dose 2, single (Lot number: EN6198) and as dose 3 (booster), single (Lot number: FH8028) for COVID-19 immunization. The patient's relevant medical history included: "Seronegative RA" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had positive SARS-CoV-2 IgG (Anti-Spike) on 23Aug2022. The patient had COVID-19 pneumonia in 2022 (positive SARS-COV-2 antibody test) presented for worsening shortness of breath (SOB). In the emergency room (ER), the patient was hypoxic requiring high flow nasal cannula (HFNC) 100% with Fi02/50 L and a nonrebreather maintaining SP02 in the early 90s. A significant increase in work of breathing was noted and patient was intubated. On 28Aug2022, the patient developed respiratory distress. Patient had a needle decompression and then chest tube placement for right sided tension pneumothorax. Patient was unable to be weaned off ventilator and on 05Sep2022 had a drop in Sp02 with increased WOB. The patient required multiple pressors for hemodynamic instability. She was then transitioned to comfort care and passed peacefully that evening of 06Sep2022. The reported cause of death: "COVID-19 pneumonia", "Haemodynamic instability", "Hypoxia", "Pneumothorax", "Respiratory distress". It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; Haemodynamic instability; Hypoxia; Pneumothorax; Respiratory distress
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003553 (Novavax). A female patient received BNT162b2 (BNT162B2, Lot #: Not reported, Exp. Date: Not reported), in May2021 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 "COVID-19". Adverse event information: On 19Sep2022, it was reported that a patient started treatment on an unreported date in May2021 with Pfizer-BioNTech COVID-19 Vaccine at an unspecified dose/frequency for an unspecified indication. It was reported the patient got COVID-19.   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: Death
Clinical narrative: My mom died the next morning after administration of the bivalent vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster; bivalent), single (Lot number: GJ5342) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Alzheimer" (unspecified if ongoing), notes: Alzheimer; "Anxiety/depression" (unspecified if ongoing); "Anxiety/depression" (unspecified if ongoing); "High BP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Severe arthritis" (unspecified if ongoing). Concomitant medication(s) included: VALPROIC ACID; SERTRALINE; LOSARTAN; TYLENOL; ATENOLOL. Vaccination history included: Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant) with onset 14Sep2022, outcome "fatal", described as "My mom died the next morning after administration of the bivalent vaccine". The patient date of death was 14Sep2022. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Clinical information: Patient's age was reported as 83 (unit not reported). Vaccine was administered by public. The event did not result in emergency room or office visit.   No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: My mom died the next morning after administration of the bivalent vaccine
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Cataplexy, Fatigue, Sleep paralysis
Clinical narrative: cataplexy attacks; hallucinatory dreams; sleep paralysis; extreme tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003551.  A female patient received BNT162b2 (BNT162B2), on 19Sep2022 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: CATAPLEXY (medically significant), outcome "unknown", described as "cataplexy attacks"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "hallucinatory dreams"; SLEEP PARALYSIS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "extreme tiredness". Clinical course: It was reported that the patient started treatment with Pfizer BioNTech COVID-19 Vaccine for COVID-19 immunization. It was reported the patient had 5 days of cataplexy attacks, hallucinatory dreams, sleep paralysis, and extreme tiredness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.