chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: 4 negative covid antigen tests; (unspecified date) Negative, notes: 4 negative covid antigen tests; (unspecified date) Negative, notes: 4 negative covid antigen tests; (unspecified date) Negative, notes: 4 negative covid antigen tests; (22Aug2022) Positive, notes: tested positive again; (Aug2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; METOPROLOL; PANTOPRAZOLE. Past drug history included: Sulfur, reaction(s): "Known allergies: Sulfur". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (from 06Aug2022 to 11Aug2022).  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: Bedridden, Fatigue, Feeling abnormal, Mental disorder, Myalgia
Clinical narrative: 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 04Dec2021 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. Vaccination history included: BNT162b2 (Dose: 1), administration date: 26Apr2021, for COVID-19 immunization; BNT162b2 (Dose: 2), administration date: 10May2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "not recovered"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness"; BEDRIDDEN (non-serious), outcome "unknown", described as "I was in bed for a few days"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "gained weight"; MENTAL DISORDER (non-serious), outcome "unknown", described as "struggling with my mental health and feeling motivated". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patients 1st injection: 26Apr2021 At a nursing home. 2nd injection: 10May2021 at a pharmacy. Both were Pfizer injections. Patients 3rd dose of a booster was on 04Dec2021 at a doctor's office. This was also a Pfizer injection. Patient got COVID in mid-May2022. The biggest things patient dealt with during that time were fatigue, brain fog, and muscle soreness. Patient was in bed for a few days. Since then, patient still experience fatigue and brain fog and my anti-depressants stopped working. Patient gained weight. It isn't fun and I've been struggling with patients mental health and feeling motivated. Patient stated, I'm not taking any more boosters from anyone until you all figure this out. I see how pharma is making more money by requiring more injections. But I'm not taking any additional injections from Pfizer or any other company until we know that they are both safe for humans long term and effective long term-effective as in preventing getting COVID completely, and suffering from it's symptoms. 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: SARS-CoV-2 test, Weight increased
Clinical narrative: 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 04Dec2021 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. Vaccination history included: BNT162b2 (Dose: 1), administration date: 26Apr2021, for COVID-19 immunization; BNT162b2 (Dose: 2), administration date: 10May2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "not recovered"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness"; BEDRIDDEN (non-serious), outcome "unknown", described as "I was in bed for a few days"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "gained weight"; MENTAL DISORDER (non-serious), outcome "unknown", described as "struggling with my mental health and feeling motivated". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patients 1st injection: 26Apr2021 At a nursing home. 2nd injection: 10May2021 at a pharmacy. Both were Pfizer injections. Patients 3rd dose of a booster was on 04Dec2021 at a doctor's office. This was also a Pfizer injection. Patient got COVID in mid-May2022. The biggest things patient dealt with during that time were fatigue, brain fog, and muscle soreness. Patient was in bed for a few days. Since then, patient still experience fatigue and brain fog and my anti-depressants stopped working. Patient gained weight. It isn't fun and I've been struggling with patients mental health and feeling motivated. Patient stated, I'm not taking any more boosters from anyone until you all figure this out. I see how pharma is making more money by requiring more injections. But I'm not taking any additional injections from Pfizer or any other company until we know that they are both safe for humans long term and effective long term-effective as in preventing getting COVID completely, and suffering from it's symptoms. 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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613), in right arm and on 08Apr2021 as dose 2, single (Lot number: ER8729), in right arm for covid-19 immunisation. The patient's relevant medical history included: "DM type 2" (unspecified if ongoing), notes: Other medical history: DM type 2; "HTN" (unspecified if ongoing), notes: Other medical history:HTN; "ITP" (unspecified if ongoing), notes: Other medical history: ITP; "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: TRULICITY; METFORMIN; METOPROLOL; VALSARTAN; EXTRA STRENGTH TYLENOL PM; TUMS EXTRA STRENGTH; IMODIUM. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro; Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor; Minocyclene, reaction(s): "Known allergies: Minocyclene", notes: Known allergies: Minocyclene; Advil, reaction(s): "Known allergies: Advil", notes: Known allergies: Advil; Aleve, reaction(s): "Known allergies: Aleve", notes: Known allergies: Aleve; Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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.The patient was treated with  Paxlovid from 17Aug2022 to 22Aug2022 for the treatment Covid- 19.The patient received Multivitamins.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
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 55-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 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: "Endolymphic Hydrops or MD" (unspecified if ongoing). Concomitant medication(s) included: HCTZ, start date: 01Apr2021. 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: (Aug2022) Negative, notes: PCR test, got better and tested at home negative; (unspecified date) Positive; (Aug2022) Positive, notes: Tested positive at home a day after symptoms restarted. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid rebound Took Paxlovid 2 days after + PCR test, got better and tested at home negative. 3 days after stopping Paxlovid got sick again. Tested positive at home a day after symptoms restarted. Symptoms were similar but rebound did not have a fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; off label use; Dose 4 booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 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 was not reported. Concomitant medication(s) included: NP THYROID, start date: Jan2021. The following information was reported: IMMUNISATION (medically significant) with onset Feb2021, outcome "unknown", described as "Dose 4 booster"; OFF LABEL USE (medically significant) with onset Feb2021, outcome "unknown"; 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: (unspecified date) Positive, notes: COVID 19 Treatment; (15Aug2022) Negative, notes: tested negative at end and for 3 more days; (19Aug2022) Positive, notes: but tested positive again on the 4th day. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient was treated with Antiviral treatment with Paxlovid from date: 11Aug2022 to 15Aug2022. Patient received other medication within 2 weeks is NP Thyroid from Jan2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 10:00 as dose 1, single (Lot number: EL9264), in left arm, on 19Feb2021 at 11:30 as dose 2, single (Lot number: EL9264), in left arm, on 24Sep2021 at 16:00 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 31Mar2022 at 16:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "heart failure" (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: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.Treatment of Anti-viral details for COVID 19 Treatment: Treatment start date10Aug2022 and Treatment stop date15Aug2022. Patient had no known allergy.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech- start date: 4Apr2021/ Treatment of COVID-19- start date: 15Aug2022; Pfizer / BioNTech- start date: 4Apr2021/ Treatment of COVID-19- start date: 15Aug2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Insulin resistance" (unspecified if ongoing), notes: Other medical history: Insulin resistance/heart palpitations; "Known allergies: Coconut" (unspecified if ongoing), notes: Known allergies: Coconut; "Known allergies: sulfur" (unspecified if ongoing), notes: Known allergies: sulfur; "heart palpitations" (unspecified if ongoing), notes: Other medical history: heart palpitations. Concomitant medication (Other medication in 2weeks product)(s) included: METFORMIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech- start date: 4Apr2021/ Treatment of COVID-19- start date: 15Aug2022". 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 drug ineffective, covid-19 of Paxlovid from 15Aug2022 to 20Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Age: 28.0
Sex: F
Vaccine: COVID19
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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 at 16:00 as dose 1, single (Lot number: EN6206), in left arm, on 11Apr2021 at 16:30 as dose 2, single (Lot number: ER2613), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: WEGOVY; SPIRONOLACTONE, Multivitamin. The following information was reported: VACCINATION FAILURE (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: Negative, notes: I tested negative on an antigen test 8 days after showing symptoms; Positive, notes: My symptoms started to return and I was testing positive again; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: vaccine was received. There was other medication in 2 weeks. Patient had COVID rebound after taking paxlovid. She tested negative on an antigen test 8 days after showing symptoms, but then 2 days later, her symptoms started to return and she was testing positive again, with the symptoms actually worse than the original case. With the symptoms actually worse than the original case.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech start date: 25Apr2022 / Treatment of COVID-19 start date: 14Aug2022; Pfizer / BioNTech start date: 25Apr2022 / Treatment of COVID-19 start date: 14Aug2022; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 70 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: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; EZETIMIBE; REPATHA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech start date: 25Apr2022 / Treatment of COVID-19 start date: 14Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2022) Positive; (unspecified date) Positive; (23Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Recurrence of positive test, antigen and pcr with mild symptoms 4 days after completion of 5 day course of Paxlovid. Other medical history: hypertension, hyperlipidemia. Product: COVID 19 Treatment, paxlovid, Treatment start date: 14Aug2022, stop date: 19Aug2022,; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective/ COVID-19 cannot be ruled out
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Autoimmune thyroiditis, Burning sensation, Lymphadenopathy
Clinical narrative: 3 miscarriages; Hashimoto; several swollen lymph nodes; My arms and legs are burning; 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 (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "3 miscarriages"; AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "Hashimoto"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "several swollen lymph nodes"; BURNING SENSATION (non-serious), outcome "unknown", described as "My arms and legs are burning". The pregnancy resulted in spontaneous abortion.  Clinical course: Since receiving 2 Covid 19 Pfizer vaccines and a booster, her health has taken a dive. She have several swollen lymph nodes that hurt & haven't gone away for over a year and more are appearing. Her arms and legs are burning, she have had 3 miscarriages, and she have been diagnosed with Hashimoto's. Is there a way to flush my body of the vaccine.  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-202201087034 similar report from same reporter;US-PFIZER INC-202201087035 similar report from same reporter;
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "cancer" (unspecified if ongoing). The patient took concomitant medications. 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; Positive, notes: Tested positive for Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient had no known allergies. Patient received COVID 19 Treatment Paxlovid from 17Aug2022 to 22Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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 included: "Sarcoidosis" (unspecified if ongoing); "Chronic UTI" (unspecified if ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]. 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.  Clinical information: The patient had no known allergies. The patient received Nexium medication in 2 weeks. On 12Aug2022, the patient received Paxlovid for treatment of COVID-19 and stop on 16Aug2022. The patient finished the medicine. 3 days later, the patient was sick again. First time while taking the med the patient was tired for 2 days with headache and nauseous then fine. Rebound, the patient was coughing a lot with a headache. The patient was on day 4. Adverse event start time: 10:00 PM, which resulted in none of the above and was recovering with no treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech / Treatment of COVID-19 start date: 18Jul2022; Pfizer / BioNTech / Treatment of COVID-19 start date: 18Jul2022; Vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 13Jan2021 as dose 2, single (Lot number: EL3249), in left arm and on 31Aug2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24May2022 as dose 4 (booster), single (Lot number: 054A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 24May2022, outcome "unknown", described as "Vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech / Treatment of COVID-19 start date: 18Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The Patient had taken Paxlovid from 18July2022 to 23July2022 for the treatment of covid-19. The patient had no known allergies.
Age: 32.0
Sex: M
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) (Other HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: 027L20A) and on 09Feb2021 as dose 2, single (Lot number: 016M20A) 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) all with onset 09Aug2022, 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: indication: Treatment of COVID-19; (09Aug2022) positive, notes: I tested positive for COVID on 09Aug; (17Aug2022) Negative, notes: continued to show improvement and tested negative from 17Aug-20Aug; (18Aug2022) Negative, notes: continued to show improvement and tested negative from 17Aug-20Aug; (19Aug2022) Negative, notes: continued to show improvement and tested negative from 17Aug-20Aug; (20Aug2022) Negative, notes: continued to show improvement and tested negative from 17Aug-20Aug; (22Aug2022) positive, notes: I got tested on 22Aug and subsequently resulted as COVID positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies: No. patinet tested positive for COVID on 09Aug2022. He started taking Paxlovid on 10Aug2022 and finished the series on 14Aug2022. He continued to show improvement and tested negative from 17Aug2022-20Aug2022. On 21Aug2022, he woke up with COVID symptoms. He got tested on 22Aug2022 and subsequently resulted as COVID positive.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Overdose, Pain in extremity, Product preparation error
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. A 5-year-old male patient received BNT162b2 (BNT162B2), on 22Aug2022 at 17:00 as dose 1 (orange cap), 0.2 ml single (Lot number: FL8094, Expiration Date: 22Sep2022) at the age of 5 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FEELING HOT (non-serious) with onset 22Aug2022, outcome "recovered" (23Aug2022), described as "felt hot"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 22Aug2022 at 17:00, outcome "unknown" and all described as "a dose of the Pfizer BioNTech COVID-19 orange cap vaccine to a 5-year-old male without dilution"; PAIN IN EXTREMITY (non-serious) with onset 23Aug2022, outcome "not recovered", described as "Pain in arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Vaccine was not Administered at Military Facility. Prior vaccinations within 4 weeks and adverse event following prior vaccinations were reported as none. The caller reported that they administered the vaccine to a 5-year-old male without the diluting the vaccine. The caller said that nothing bad occurred. This was the first dose. The patient has no allergies or conditions. The only thing is the patient felt a little bit hot yesterday, the patient's mom took the patient's temp, but he had no fever. The patient complained about pain in the arm this morning. The patient does not feel hot and had no fever this morning according to the mother.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Autoimmune thyroiditis, Burning sensation, Lymphadenopathy
Clinical narrative: 3 miscarriages; Hashimoto's; several swollen lymph nodes; My arms and legs are burning; 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 (pregnant) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. 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): "3 miscarriages", "Hashimoto's", "My arms and legs are burning", "several swollen lymph nodes". The patient was pregnant at time of vaccination. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "3 miscarriages"; AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "Hashimoto's"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "several swollen lymph nodes"; BURNING SENSATION (non-serious), outcome "unknown", described as "My arms and legs are burning". The pregnancy resulted in spontaneous abortion.  Clinical course: Since receiving 2 Covid-19 Pfizer vaccines and a booster, her health had taken a dive. Stated that, she had several swollen lymph nodes that hurt and amp; hadn't gone away for over a year and more are appearing. Stated that, her arms and legs are burning. Stated that, she have had 3 miscarriages and she had been diagnosed with Hashimoto's. Enquired that, was there a way to flush her body of the vaccine. A way to detox from it. A way to reverse all of these negative effects it's been having on her body.  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-202201086574 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Autoimmune thyroiditis, Burning sensation, Lymphadenopathy
Clinical narrative: 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 (pregnant) received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (Dose-1), for Covid-19 immunization, reaction(s): "3 miscarriages", "Hashimoto", "arms and legs are burning", "several swollen lymph nodes"; Bnt162b2 (Dose-2), for Covid-19 immunization, reaction(s): "3 miscarriages", "Hashimoto", "arms and legs are burning", "several swollen lymph nodes". The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "3 miscarriages"; AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "Hashimoto"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "several swollen lymph nodes"; BURNING SENSATION (non-serious), outcome "unknown", described as "arms and legs are burning". The pregnancy resulted in spontaneous abortion.  Clinical course: Since receiving 2 Covid 19 Pfizer vaccines and a booster, her health has taken a dive. She have several swollen lymph nodes that hurt & haven't gone away for over a year and more are appearing. Her arms and legs are burning, she have had 3 miscarriages, and she have been diagnosed with Hashimoto's. Was there a way to flush her body of the vaccine.  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-202201086574 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood thyroid stimulating hormone, Electrocardiogram, Full blood count, Heart rate
Clinical narrative: This is a literature report for the following literature source(s): "A CASE OF POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME AFTER MRNA COVID-19 VACCINE", Journal of General Internal Medicine, 2022. A 31-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: "History is negative for tobacco smoking" (unspecified if ongoing); "History is negative for drug use" (unspecified if ongoing); "History is negative for alcohol use" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pfizer Covid vaccine for COVID-19 immunisation, notes: DOSE 1, SINGLE. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 3 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Minimal change; 125/71; 144/108; Blood thyroid stimulating hormone: Unremarkable; Electrocardiogram: Normal sinus rhythm; Full blood count: Unremarkable; Heart rate: Increase in HR by 30 beats; 77; 137; Loop-recorder: Revealed presence of patient triggered episodes of, notes: sinus tachycardia upon standing; Normal; Metabolic function test: Unremarkable; Physical examination: Notable for moist mucous membranes; Tilt table test: Within 8 minutes of upright tilting, HR was 137 f, notes: rom a baseline of 77, and BP was 144/108 from 125/71; Vital signs measurement: Remarkable for an increase in HR by 30 beats with, notes: minimal change in BP. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome. Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or Comirnaty in triggering the onset of postural orthostatic tachycardia syndrome cannot be 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.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Metabolic function test, Physical examination, Postural orthostatic tachycardia syndrome, Tilt table test
Clinical narrative: This is a literature report for the following literature source(s): "A CASE OF POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME AFTER MRNA COVID-19 VACCINE", Journal of General Internal Medicine, 2022. A 31-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: "History is negative for tobacco smoking" (unspecified if ongoing); "History is negative for drug use" (unspecified if ongoing); "History is negative for alcohol use" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pfizer Covid vaccine for COVID-19 immunisation, notes: DOSE 1, SINGLE. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 3 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Minimal change; 125/71; 144/108; Blood thyroid stimulating hormone: Unremarkable; Electrocardiogram: Normal sinus rhythm; Full blood count: Unremarkable; Heart rate: Increase in HR by 30 beats; 77; 137; Loop-recorder: Revealed presence of patient triggered episodes of, notes: sinus tachycardia upon standing; Normal; Metabolic function test: Unremarkable; Physical examination: Notable for moist mucous membranes; Tilt table test: Within 8 minutes of upright tilting, HR was 137 f, notes: rom a baseline of 77, and BP was 144/108 from 125/71; Vital signs measurement: Remarkable for an increase in HR by 30 beats with, notes: minimal change in BP. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome. Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or Comirnaty in triggering the onset of postural orthostatic tachycardia syndrome cannot be 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.
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: This is a literature report for the following literature source(s): "A CASE OF POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME AFTER MRNA COVID-19 VACCINE", Journal of General Internal Medicine, 2022. A 31-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: "History is negative for tobacco smoking" (unspecified if ongoing); "History is negative for drug use" (unspecified if ongoing); "History is negative for alcohol use" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pfizer Covid vaccine for COVID-19 immunisation, notes: DOSE 1, SINGLE. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 3 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Minimal change; 125/71; 144/108; Blood thyroid stimulating hormone: Unremarkable; Electrocardiogram: Normal sinus rhythm; Full blood count: Unremarkable; Heart rate: Increase in HR by 30 beats; 77; 137; Loop-recorder: Revealed presence of patient triggered episodes of, notes: sinus tachycardia upon standing; Normal; Metabolic function test: Unremarkable; Physical examination: Notable for moist mucous membranes; Tilt table test: Within 8 minutes of upright tilting, HR was 137 f, notes: rom a baseline of 77, and BP was 144/108 from 125/71; Vital signs measurement: Remarkable for an increase in HR by 30 beats with, notes: minimal change in BP. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome. Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or Comirnaty in triggering the onset of postural orthostatic tachycardia syndrome cannot be 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.
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 contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EK9231), on 01Feb2021 as dose 2, single (Lot number: EL3249), on 25Sep2021 as dose 3 (booster), single (Lot number: FC3184) and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; LEVOTHYROXINE; ROSUVASTATIN, start date: Mar2022, stop date: 04Aug2022. 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. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Paxlovid was received as a therapeutic measures for the adverse events. Covid rebound symptoms began 15Aug2022 which was five days after completion of paxlovid. mild symptom course. Rebound symptoms still resolving 9 days later. also had significant metallic taste in mouth throughout treatment course. worsened 1-2 hours after each dose. Resolved with end of paxlovid course. present 05Aug-10Aug2022. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information in the case the reported events Vaccination failure and Covid 19 are assessed as related to suspect drug .
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 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's relevant medical history included: "Remission from lymphoma", start date: 2005 (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral. 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 antibody test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: Antigen test had been negative; (23Aug2022) Positive, notes: symptoms returned and antigen test again became positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks included lisinopril. There were no Known allergies. Anti-viral details: Product for COVID 19 Treatment included Brand: Paxlovid, treatment start date 12Aug2022, treatment stop date 17Aug2022 by oral route for treatment of COVID-19.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events covid 19 and Drug ineffective and the suspect product BNT162B2cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201087377 Same reporter/patient, different drug, different event.;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Received Pfizer / BioNTech / Treatment of COVID-19 start date: 11Aug2022; Received Pfizer / BioNTech / Treatment of COVID-19 start date: 11Aug2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 13Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 07May2022 as dose 4 (booster), single (Lot number: FK9853) at the age of 70 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing), notes: high cholesterol. Concomitant medication(s) included: FLONASE ALLERGY RELIEF; ZYRTEC ALLERGY (other medication in 2weeks). Past drug history included: Fluconazole, reaction(s): "Allergy"; Aspirin, reaction(s): "Allergy"; Ibuprofen, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Received Pfizer / BioNTech / Treatment of COVID-19 start date: 11Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included Paxlovid from 11Aug2022 to 15Aug2022.