chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Is pregnant: Yes/delivery date: 30Dec2022; Nausea; Vomited; Diarrhea; Headache; Muscle ache; Tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 23Jun2022 at 16:30 as dose 3 (booster), single (Lot number: FP4554) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Date of last menstrual period: 27Mar2022. The patient was 13 weeks pregnant at the time of exposure to BNT162b2. The patient was 12 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30Dec2022. Concomitant medication(s) included: AMOXICILLIN. Vaccination history included: BNT162b2 (Dose 2, Location of injection: Arm Left, Vaccine Administration Time: 13:00), administration date: 27Jul2021, when the patient was 41-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Location of injection: Arm Left, Vaccine Administration Time: 13:00), administration date: 09Jun2021, when the patient was 41-year-old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Diarrhea"; HEADACHE (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022); MYALGIA (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Muscle ache"; NAUSEA (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022); FATIGUE (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Tired"; VOMITING (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Vomited"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Is pregnant: Yes/delivery date: 30Dec2022". Therapeutic measures were not taken as a result of nausea, vomiting, diarrhoea, headache, myalgia, fatigue. Additional information: 24 hours after the vaccine, she started getting strong nausea, she vomited and had diarrhea. Also headache, muscle ache and very tired. No known allergies reported. No other vaccine in four weeks. List of any other medications the patient received within 2 weeks of vaccination: Amoxicillin, Prenatal vitamins. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Device date: 25Jun2022.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: P220395-0021L), in left arm, on 14Jan2021 as dose 2, single (Lot number: P220395-0021L), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: P220395-0090L), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "menopause" (unspecified if ongoing); "mild arthritis in fingers and toes" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 31Dec2009; SANDOZ-ESTRADIOL, start date: 31Dec2009; CARLSON VITAMIN D3, start date: 31Dec2019; CALCIUM, start date: 31Dec2019; LYSINE, start date: 31Dec2019. Past drug history included: Known allergies: lactose, reaction(s): "Known allergies: Lactose", notes: Known allergies: Lactose. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information in the case narrative, a causal relationship between reported events and suspect BNT162B2 is possible.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EM9809), on 10Mar2021 as dose 2, single (Lot number: EN6204), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: FF2593) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 10Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive, notes: 10Jun2022 positive test; (16Jun2022) Negative, notes: 16Jun2022 negative test; (22Jun2022) Positive, notes: positive test; (22Jun2022) Negative, notes: negative test; (22Jun2022) Positive, notes: tested positive with more severe symptoms; (23Jun2022) Positive, notes: 23Jun2022 tested positive with more severe symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.Clinical course: No other medication in 2weeks. Product Paxlovid Treatment started on 15Jun2022 to Treatment stopped on 20Jun2022 for COVID 19 Treatment. 10Jun2022 positive test and treated with Paxlovid. 23Jun2022 tested positive with more severe symptoms. Congestion, coughing, headache, rash on right cheek, rash under left arm, rash/hives between fingers. Adverse events start date: 22Jun2022.
Age: 65.0
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: el9265), on 23Feb2021 as dose 2, single (Lot number: en6203), on 04Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) and on 19Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Jun2022 as dose 4 (booster), single (Lot number: 059m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) positive; (18Jun2022) Negative; (24Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive other medications in two weeks. She had her last covid booster on 09Jun2022. Tested positive home test on 14Jun2022. Started taking Paxlovid that evening for treatment of COVID-19 and finished on 19Jun2022. The patient tested negative with home test on 18Jun2022. On 24Jun202, she started having symptoms and tested Positive on that day. Adverse event start date: 23Jun2022. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 08:00 as dose 1, single (Lot number: En6201), in left arm, on 04Mar2021 at 08:00 as dose 2, single (Lot number: En6198), in left arm and on 25Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FC3183) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart arrhythmias" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: Apr2018; TOPROL XL, start date: 01May2018; ROSUVASTATIN, start date: 30Nov2021; TAMBOCOR, start date: 01May2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive, notes: I started taking Paxlovid on the day after I 1st tested positive, which was 07Jun2022; (20Jun2022) Positive, notes: I still tested positive 13 days after taking my first dose of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: I still tested positive 13 days after taking my first dose of Paxlovid. started taking Paxlovid on the day after I 1st tested positive, which was 07Jun2022.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: drug ineffective; 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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: 8120), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: 9893) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2022, outcome "unknown", described as "Treatment of COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Posiitve. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. Reported Event: COVID tested positive. Symptoms: congestion, major runny nose, coughing, watery eyes  No follow-up attempts are possible. No further information is expected.
Age: 73.0
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) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 at 12:00 as dose 3 (booster), single (Lot number: EW0177), in left arm and on 09Feb2022 at 12:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Liver cancer Rx Keytruda" (unspecified if ongoing), notes: Liver cancer Rx Keytruda. Concomitant medication(s) included: DOXAZOSIN, start date: Jun2017, stop date: 24Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Negative, notes: negative antigen test on 21Jun2022; (25Jun2022) Positive, notes: Positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medications within 2 weeks of vaccine.The device date was reported as 25Jun2022.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
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 a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN. 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: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 13Jun2022, Treatment stop date: 18Jun2022, Indication: Treatment of COVID-19.  Rebound Covid 5 days after finishing paxlovid treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Illness, Investigation, Renal impairment, SARS-CoV-2 test
Clinical narrative: feel ill; kidney function at 20%/Minimal Change Disorder/reduced over 3 months to zero mg/Kidney back up to 53%/kidney back down to 23%; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 at 11:00 as dose 3 (booster), single (Lot number: EW0173) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: QUINAPRIL; ATORVASTATIN; AMLODIPINE. Vaccination history included: BNT162b2 (Dose 2 at 11:45 AM on 24Feb2021, lot: EN6200, location: Right arm), administration date: 24Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose 1 at 11:45 AM on 31Jan2021, lot: EL9265, location: Right arm), administration date: 31Jan2021, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: RENAL IMPAIRMENT (medically significant) with onset 10Oct2021 at 12:00, outcome "not recovered", described as "kidney function at 20%/Minimal Change Disorder/reduced over 3 months to zero mg/Kidney back up to 53%/kidney back down to 23%"; ILLNESS (medically significant) with onset 11Oct2021, outcome "not recovered", described as "feel ill". The events "kidney function at 20%/minimal change disorder/reduced over 3 months to zero mg/kidney back up to 53%/kidney back down to 23%" and "feel ill" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy kidney: (07Dec2021) MCD, notes: Minimal Change Disorder; kidney function: (05Nov2021) kidney function at 20, notes: blood test showed kidney function at 20%; (16Mar2022) Kidney back up to 53, notes: Kidney back up to 53%; (25May2022) kidney back down to 23, notes: kidney back down to 23%; SARS-CoV-2 test: (02Dec2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of renal impairment, illness. Clinical course included 11Oct2021 started to feel ill. went through 2 rounds of antibiotics over next 3 weeks. 05Nov2021 blood test showed kidney function at 20%. After kidney biopsy 07Dec2021 showed MCD., Minimal Change Disorder. Beginning 14Dec2021 on 60mg Prednisone - reduced over 3 months to zero mg. Also took a diuretic during this time. Kidney back up to 53% by 16Mar2022. 25May2022 labs showed kidney back down to 23%. Beginning 02Jun2022 on Prednisone 20mg + diuretic + Tacrolimus 1mg twice a day. labs to be redone 01Jul2022. The patient was treated with prednisone, tacrolimus and diuretic. The patient had no other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected
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 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Symptom rebound and positive rapid test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Insomnia" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Symptom rebound and positive rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (25Jun2022) positive, notes: Symptom rebound and positive rapid test 5 days after ending treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
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 69-year-old male patient received BNT162b2 (BNT162B2), on 12May2022 as dose 4 (booster), single (Lot number: FK9729) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ESTRADIOL VALERATE; PROGESTERONE. The following information was reported: DRUG INEFFECTIVE (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: (unspecified date) Unknown results, notes: Treatment of COVID-19; (24Jun2022) Positive, notes: Recurrence of Covid symptoms 8 days after completion of Paxlovid treatment, including positive self-test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid treatment from 12Jun2022 to 16Jun2022 for Covid-19. other medication with two weeks of vaccination was Estradiol Valerate and Progesterone.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 24Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Anti viral details: product=COVID 19 Treatment, brand=Pfizer Paxlovid, treatment start date=20Jun2022, treatment stop date=23Jun2022, indication=Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
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 37-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 14:00 as dose 1, single (Lot number: EJ1686), on 04Feb2021 at 14:00 as dose 2, single (Lot number: EN5318), on 12Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FE3594) and on 25May2022 at 10:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Vitiligo" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, 6 days 22 hrs after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, 6 days 22 hrs after the suspect product(s) administration, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) positive; (14Jun2022) negative; (15Jun2022) negative; (16Jun2022) negative; (21Jun2022) positive; (22Jun2022) positive; (23Jun2022) positive; (24Jun2022) positive; (26Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: I have muscle twitching after the second Pfizer shot and more than a year still twitching not went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Lot number: Er8729), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Er8733, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 23Mar2021, when the patient was 40-year-old, for Covid-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 26Apr2021 at 10:00, outcome "not recovered", described as "I have muscle twitching after the second Pfizer shot and more than a year still twitching not went away".  Additional information: : Patient had muscle twitching after the second Pfizer shot and more than a year still twitching did not got away.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Testing positive after having recovered 6 days ago and testing negative. Symptoms include cough and congestion; Positve, notes: Testing positive after having recovered 6 days ago and testing negative. Symptoms include cough and congestion.. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti-viral Paxlovid from 14Jun2022 to 19Jun2022.  Clinical course: Anti-viral Paxlovid from 14Jun2022 to 19Jun2022 for Treatment of COVID-19. On 24Jun2022, testing was positive after having recovered 6 days ago and testing negative. Symptoms include cough and congestion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: 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) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Oct2021 as dose number unknown, single (Lot number: FF2593) at the age of 67 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. Other medication in 2 weeks reported as no. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, 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: I have a rebound of covid. Symptoms started 5 -6 days after finishing paxlovid and testing negative; (23Jun2022) strong positive, notes: Tested again 9 days after finishing paxlovid and tested strong positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that, anti-viral details: product-COVID 19 Treatment, brand-Pfizer, treatment start date was on 10Jun2022 and treatment stop date was on 14Jun2022, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Covid 19 and Drug ineffective and suspect drug BNT162B2 cannot be excluded.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 10 days after starting paxlovid (same day as positive covid test); 10 days after starting paxlovid (same day as positive covid test); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 31Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. 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), outcome "not recovered" and all described as "10 days after starting paxlovid (same day as positive covid test)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient did not received any other medication within 2 weeks prior vaccination. The patient received treatment from 05Jun2022 to 06Jun2022 as a treatment for the events. It was reported that, the 10 days after starting paxlovid (same day as positive COVID-19 test), the patient had rebound symptoms of runny nose, cough, chills, fatigue. which were worse than original symptoms. The patient had no known allergies. The patient had no other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pruritus, Sensitive skin, Urticaria
Clinical narrative: hives; sensitive skin; itchy; nauseous; Some brain fog; Weight loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2022 as dose 3 (booster), single (Lot number: 330258D) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (dose number 2, Prev dose product - COVID 19, Prev dose brand - Pfizer Bio Tech, Prev dose lot number - EN6202, vaccine location - Left leg,), administration date: 11Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (dose number 1, Prev dose product - COVID 19, Prev dose brand - Pfizer Bio Tech, Prev dose lot number - EN6201, vaccine location - Left arm), administration date: 18Feb2021, when the patient was 68-year-old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 07Feb2022, outcome "unknown", described as "Some brain fog"; WEIGHT DECREASED (non-serious) with onset 07Feb2022, outcome "unknown", described as "Weight loss"; URTICARIA (non-serious) with onset 07Feb2022, outcome "unknown", described as "hives"; PRURITUS (non-serious) with onset 07Feb2022, outcome "unknown", described as "itchy"; NAUSEA (non-serious) with onset 07Feb2022, outcome "unknown", described as "nauseous"; SENSITIVE SKIN (non-serious) with onset 07Feb2022, outcome "unknown". Therapeutic measures were taken as a result of urticaria, sensitive skin, pruritus, nausea, feeling abnormal, weight decreased.  Adverse event: With recent vaccine, a month after consumer began having hives after eating. She have been tested for the foods and don't have an allergy. She also began having very sensitive skin, very itchy. Sometimes feel nauseous. Some brain fog. Weight loss due to the unknown problem with food. Ae treatment: Have seen many doctors, on Claritin Pepcid.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: hives; sensitive skin; itchy; nauseous; Some brain fog; Weight loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2022 as dose 3 (booster), single (Lot number: 330258D) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (dose number 2, Prev dose product - COVID 19, Prev dose brand - Pfizer Bio Tech, Prev dose lot number - EN6202, vaccine location - Left leg,), administration date: 11Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (dose number 1, Prev dose product - COVID 19, Prev dose brand - Pfizer Bio Tech, Prev dose lot number - EN6201, vaccine location - Left arm), administration date: 18Feb2021, when the patient was 68-year-old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 07Feb2022, outcome "unknown", described as "Some brain fog"; WEIGHT DECREASED (non-serious) with onset 07Feb2022, outcome "unknown", described as "Weight loss"; URTICARIA (non-serious) with onset 07Feb2022, outcome "unknown", described as "hives"; PRURITUS (non-serious) with onset 07Feb2022, outcome "unknown", described as "itchy"; NAUSEA (non-serious) with onset 07Feb2022, outcome "unknown", described as "nauseous"; SENSITIVE SKIN (non-serious) with onset 07Feb2022, outcome "unknown". Therapeutic measures were taken as a result of urticaria, sensitive skin, pruritus, nausea, feeling abnormal, weight decreased.  Adverse event: With recent vaccine, a month after consumer began having hives after eating. She have been tested for the foods and don't have an allergy. She also began having very sensitive skin, very itchy. Sometimes feel nauseous. Some brain fog. Weight loss due to the unknown problem with food. Ae treatment: Have seen many doctors, on Claritin Pepcid.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2021 as dose 1, single (Lot number: EN5318), in left arm, on 12May2021 as dose 2, single (Lot number: ER8735), in left arm and on 12Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NATURE'S BOUNTY, start date: 10Jun2022, stop date: 12Jun2022; PHARMACA, start date: 10Jun2022, stop date: 25Jun2022; INSIGHT PHARMACEUTICALS, start date: 10Jun2022, stop date: 25Jun2022.  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: Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Medication did not eliminate the virus but probable lessening of symptoms. After 5 days, on June 11th I felt bad so returned to urgent care where they took my pulse & O2 levels - 95 & 95. Was sent home to rest. Home tested 12Jun, strong line indicating covid. Began immune enhancing treatments in full (had taken less during the Paxlovid). Now, after Paxlovid, I am worse with the body & throat pain, brain-fog confusion, apathy, tiredness, and congested upper respiratory tract returning as before and worsening. One night, 24Jun, had breathing difficulties but was ok in the morning so did not go to urgent care. However, NOTE I was a scuba diving instructor for a long time and my regular breathing remains more deep and full than the average person (good for me in this case I am sure). I have not had fever. Am airing my small sailboathome completely, weather permitting, using HEPA air filter now at night and day in bad weather. NOTE-all dates entered populate 1 day early this form.
Age: 49.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 at 14:00 as dose 1, single (Lot number: ER8727), in left arm, on 01May2021 at 11:30 as dose 2, single (Lot number: ER8731), in right arm and on 21Dec2021 at 15:30 as dose 3 (booster), single (Lot number: FJ1611) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mitrovalve prolapse" (unspecified if ongoing); "kidney donor (1 Kidney)" (unspecified if ongoing); "partial thyroidectomy" (unspecified if ongoing); "obesity" (unspecified if ongoing); "GERD" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "dust mites allergy" (unspecified if ongoing); "Pollen allergy" (unspecified if ongoing); "mold allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; SERTRALINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022 at 09:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Negative, notes: Tested negative 19Jun2022 with home rapid antigen test; (26Jun2022) Positive, notes: On 26Jun2022 took another Rapid Antigen test at home and it was positive again. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Cerebrovascular accident, Drooling, Dysarthria, SARS-CoV-2 test
Clinical narrative: stroke; Bells Palsy; Developed severe left sided facial droop involving eye and mouth with drooling; slurred speech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mentally disabled" (unspecified if ongoing); "HTN" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (disability, medically significant) with onset 11Aug2021 at 08:00, outcome "recovered with sequelae", described as "Bells Palsy"; DROOLING (disability) with onset 11Aug2021 at 08:00, outcome "recovered with sequelae", described as "Developed severe left sided facial droop involving eye and mouth with drooling"; DYSARTHRIA (disability) with onset 11Aug2021 at 08:00, outcome "recovered with sequelae", described as "slurred speech"; CEREBROVASCULAR ACCIDENT (disability, medically significant) with onset 11Aug2021 at 08:00, outcome "recovered with sequelae", described as "stroke". The events "stroke", "bells palsy", "developed severe left sided facial droop involving eye and mouth with drooling" and "slurred speech" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident, bell's palsy, drooling, dysarthria.  Additional information:  Developed severe left sided facial droop involving eye and mouth with drooling and slurred speech. Aide thought was a stroke, taken to ER and diagnosed with Bells Palsy. Adverse event resulted in: (Emergency room/department or urgent care, Disability or permanent damage). Patient received treatment with unspecified medication. Patient did not have Covid prior vaccination and patient tested with Covid post vaccination with nasal swab. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 56 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 included: "Asthma" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (19Jun2022) Negative; (23Jun2022) Positive; (26Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody 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 72-year-old patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Mar2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial flutter" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Dec2017, stop date: 13Jun2022; XARELTO, start date: Mar2022, stop date: 13Jun2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (21Jun2022) Negative, notes: Symptoms resolved, and tested negative for COVID-19 antibodies; (23Jun2022) Positive, notes: Symptoms returned, and tested positive for COVID-19 antibodies. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient recieved anti viral Paxlovid from 15Jun2022 to 19Jun2022 for treatment of COVID-19. Symptoms resolved, and tested negative for COVID-19 antibodies, 2 days after completion of Paxlovid treatment. Symptoms returned, and tested positive antibodies for COVID-19 on 23Jun2022, 5 days after completion of Paxlovid treatment. No known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 at 13:00 as dose 1,single (Lot number: EL3302), in right arm, on 02Mar2021 at 11:00 as dose 2, single (Lot number: EN6200), in right arm and on 06Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 301308A) at the age of 74 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Jun2022 at 13:00 as dose 4 (booster), single (Lot number: 058A22-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing), notes: arthritis, osteoporosis, migrains, vertigo,uterine cancer (10 years ago); "osteoporosis" (unspecified if ongoing), notes: arthritis, osteoporosis, migrains, vertigo,uterine cancer (10 years ago); "migrains" (unspecified if ongoing), notes: arthritis, osteoporosis, migrains, vertigo,uterine cancer (10 years ago); "vertigo" (unspecified if ongoing), notes: arthritis, osteoporosis, migrains, vertigo,uterine cancer (10 years ago); "uterine cancer" (unspecified if ongoing), notes: arthritis, osteoporosis, migrains, vertigo,uterine cancer (10 years ago); "covid" (unspecified if ongoing), notes: Second time getting COVID in 7, months. Concomitant medication(s) included: LEVOTHYROXINE, start date: May1985; VITAMIN D3, start date: May2018; VITAMIN B12 [CYANOCOBALAMIN], start date: May2020. Past drug history included: Vancomycin, reaction(s): "Known allergies: vancomycin"; Cypro flaxen, reaction(s): "Known allergies: cypro flaxen". 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.