chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 infection (Confirmed); COVID-19 infection (Confirmed); This is a spontaneous report received from contactable reporter(s) (Physician).  A 50-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 13Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis", start date: 2013 (ongoing); "Psoriasis", start date: 2013 (unspecified if ongoing); "Hypothyroidism", start date: 1983 (ongoing), notes: Hypothyroid; "Tooth abcess", start date: 02Nov2020 (unspecified if ongoing); "non melanoma skin cancer" (unspecified if ongoing); "Former smoker" (unspecified if ongoing); "Migraine" (unspecified if ongoing), notes: Migraine. Concomitant medication(s) included: METHOTREXATE oral, start date: Jan2020 (ongoing); NARCOTINE (ongoing); LEVOTHYROXINE taken for hypothyroidism, start date: 20Aug2016 (ongoing); TOPIRAMATE taken for migraine, start date: 28Jul2016 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovered" (07Jan2022) and all described as "COVID-19 infection (Confirmed)". Patient's height was 64 inches, weight was 203 lbs. It was reported the patient had a confirmed COVID-19 infection on 01Jan2022, On that day, she was tested positive using a COVID- 19 real time PCR test. The patient had a runny nose and a sore throat during the event. The event did not require hospitalization and she did not receive any treatments for the infection. Prior to the event, the patient had low disease activity. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive. Therapeutic measures were not taken as a result of covid-19. The reporter did not attribute the COVID-19 infection to Xeljanz or any other medication.  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 available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.
Sex: U
Vaccine: COVID19
Symptoms: Thyroiditis acute
Clinical narrative: Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (FIRST DOSE), for covid-19 immunization. The following information was reported: THYROIDITIS ACUTE (medically significant), outcome "unknown", described as "Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of acute thyroiditis  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.,Linked Report(s) : US-PFIZER INC-202200710264 Same article/ Event/drug and different patient;US-PFIZER INC-202200710266 Same article/ Event/drug and different patient;US-PFIZER INC-202200710265 Same article/ Event/drug and different patient
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID-19; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 at 13:00 as dose 1, single (Lot number: En6205), in right arm and on 27Apr2022 at 13:00 as dose 2, single (Lot number: En6207) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Infertility" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: AIRBORNE ELDERBERRY, start date: 07May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Following my third dose of Paxlovid I began experiencing night terrors anytime I napped or slept in the evening. I have not had any prior experience with night terrors in my adult life. They were vivid and disturbing dreams. In addition since my first dose of Paxlovid I have had a grapefruit/ bitter soap taste in my mouth and mucus.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 20Jul2021 as dose 3 (booster), single (Lot number: P220395-0047L) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing), notes: Migraines; "GERD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Almost negative; (May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
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) from Regulatory Authority. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: En205), in right arm, on 26Mar2021 as dose 2, single (Lot number: Er8727), in right arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 3203080), in right arm and on 01Apr2022 as dose 4 (booster), single (Lot number: Fj9943) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: STATIN [ATORVASTATIN CALCIUM]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course-After the 5 day treatment the patient felt fine.Tested negative on day 6. 5 days after the 5 day treatment have a head full, sinus, cough. Sore throat. It was reported that, the patient taking other medications within 2 weeks of starting COVID-19 treatment. The patient previously also received a COVID-19 Vaccine. Device Date: 12May2022  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; currently pregnant; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 11Sep2021 as dose 3 (booster), single (Lot number: ff2588) 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. Relevant medical history included: "Drug allergy" (unspecified if ongoing). Date of last menstrual period: 03Sep2021. The patient was 1 weeks pregnant at the time of exposure to BNT162b2. The patient was 1 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 10Jun2022. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], start date: 04Aug2021.  The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (medically significant) with onset 11Sep2021, outcome "unknown", described as "currently pregnant"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive; (10May2022) highly positive, notes: day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 28Apr2022 to 02May2022. Clinical course: The patient completed Paxlovid treatment on day 5 from positive PCR, symptoms had completely resolved. On day 10, symptoms returned but much worse than prior. A repeat rapid antigen test remained highly positive on day 13. No hospitalization Prolongation. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 77.0
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) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: Dose: 4 Pfizer, Dose: 3, 2, 1 Moderna COVID-19 vaccine. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: (2022) Negative, notes: Tested negative day 6. Tested negative day 5. On day 9 symptoms returned and tested positive again; (2022) Negative, notes: Tested negative day 6. Tested negative day 5. On day 9 symptoms returned and tested positive again; (2022) Positive, notes: Tested negative day 6. Tested negative day 5. On day 9 symptoms returned and tested positive again. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Antiviral details product Paxlovid: COVID 19 Treatment. Treatment start date: 03May2022 and stop date: 08May2022. After finishing 2nd day dose pack symptoms improved. Tested negative day 6. Tested negative day 5. On day 9 symptoms returned and tested positive again. No known allergies. Device timestamp: 12May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Breast mass
Clinical narrative: lump on breast bone; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4388586-00 (AbbVie).  A 58-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for psoriatic arthropathy. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BREAST MASS (medically significant), outcome "unknown", described as "lump on breast bone". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No Known allergies. The reporter's causality for the event(s) of LUMP ON BREAST BONE was not provided with HUMIRA. Abbvie's opinion is that the event of LUMP ON BREAST is not assessable.  The reporter's assessment of the causal relationship of "lump on breast bone" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: En6295), in left arm and on 19Apr2021 as dose 2, single (Lot number: Er8731) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Nov2021 as dose 3 (booster), single (Lot number: 033f21a), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: 028k21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dose:4, 3 Moderna/Dose:2, 1 Pfizer" (unspecified if ongoing), notes: Dose:4, 3 Moderna/ Dose:2, 1 Pfizer. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Negative; (11May2022) Positive; (10May2022) Inconclusive; (11May2022) Positive; (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Other medication in 2 weeks: No.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8733), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: F78762) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHALIDONE, start date: Jan2019; LISINOPRIL, start date: Jan2019; ATORVASTATIN, start date: Jan2019. Past drug history included: Solumedrol, reaction(s): "known allergies: solumedrol". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "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.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Ag; positive Ag/runny nose; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 31-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533) intramuscular, on 22Apr2021 as dise 2, single (Lot number: EW0171) and on 20Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11May2022, outcome "recovering", described as "positive Ag"; COVID-19 (medically significant) with onset 11May2022, outcome "recovering", described as "positive Ag/runny nose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive, notes: Positive Ag. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: runny nose allergy sx tested 11May positive Ag.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2  cannot be excluded for the reported events of covid-19 and vaccination failure.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Jan2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Dec2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Deep vein thrombosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies:- Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3249), on 09Feb2021 as dose 2, single (Lot number: Em9810), in right arm and on 21Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Apr2022 as dose 4 (booster), single (Lot number: 005m21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DESCOVY, start date: 26Jan2022; PANTOPRAZOLE; ROSUVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive; (May2022) Negative; (May2022) Negative; (May2022) Negative; (May2022) Negative. Therapeutic measures were taken as a result of covid-19.  Additional Information: Anti-viral details: Product=COVID 19 Treatment. Brand=Paxlovid. Treatment start date=30Apr2022.Treatment Stop date=04May2022.Indication=Treatment of COVID-19.Adverse event: Paxlovid Rebound.Adverse event country:. Adverse event start date: 10May2022.AE resulted in: None of the above.Not recovered.treatment AE: No.Other medical history: After taking Paxlovid for 5 days, I tested neg 4 times in 6 days and had no symptoms. 7 days after my last dose of paxlovid, I had new symptoms and tested positive again.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER730), in left arm, on 14Apr2021 as dose 2, single (Lot number: ER8734), in right arm and on 18Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Sep2015; SIMVASTIN, start date: Sep2016, stop date: 01May2022; CLARITINE, start date: Jun2017, stop date: 01May2022. The following information was reported: COVID-19 (medically significant) with onset 11May2022, outcome "not recovered", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (12May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti viral details: Product: COVID 19 Treatment, brand: Pfizer Paxlovid, treatment start date: 02May2022, treatment stop date: 07May2022. Patient received other medication in 2weeks was multi vitamin, start date: Jan2022 and stop date: 01May2022. Patient tested positive for COVID 12May2022 with runny nose and sneezing. Patient had no known allergies.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6206), in left arm and on 01Apr2021 as dose 2, single (Lot number: ER8730) at the age of 57 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 08Nov2021 as dose 3 (booster) single (Lot number: 033F214), in left arm for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MUCINEX, start date: 28Apr2022, stop date: 08May2022; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 28Apr2022, stop date: 08May2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive antigen and PCR; Positive; Positive, notes: tested positive antigen and PCR. Therapeutic measures were taken as a result of Covid-19. Clinical Course: stuffy nose started on Covid day 13. tested positive antigen and PCR.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid: Treatment of COVID-19; Paxlovid: 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 at 19:00 as dose 1, single (Lot number: EP7534) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Mar2015. Past drug history included: Percocet, reaction(s): "Known allergies:Percocet". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (10May2022) Negative, notes: Resurgence and worsening of Covid symptoms and a positive covid home test after a negative covid home test on day 14; (May2022) Positive, notes: Resurgence and worsening of Covid symptoms and a positive covid home test after a negative covid home test on day 14. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Cholesterol managed with medication" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Mar2022, stop date: May2022; EZETIMIBE, start date: Mar2022, stop date: May2022; DEPLIN [LEVOMEFOLIC ACID], start date: Mar2022, stop date: May2022; FISH OIL, start date: Mar2022, stop date: May2022; VITAMIN B COMPLEX, start date: Mar2022, stop date: May2022; COQ10 [UBIDECARENONE], start date: Mar2022, stop date: May2022; VITAMIN B 12 [CYANOCOBALAMIN], start date: Mar2022, stop date: May2022; VITAMIN D3, start date: Mar2022, stop date: May2022; MAGNESIUM, start date: Mar2022, stop date: May2022. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04May2022 at 14:30, outcome "unknown", described as "Paxlovid: Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 188/104. Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of Covid-19. Clinical course: Paxlovid was given for Covid-19 treatment on 01May2022 and stopped on 04May2022. Adverse event start date was 04May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid: COVID 19 Treatment; Paxlovid: 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 42-year-old male patient 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 was not reported. Concomitant medication(s) included: OMEPRAZOLE; LISINOPRIL; BENADRYL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of covid-19. Patient took a 5 day dose of paxlovid-his symptoms disappeared and after 5 days patient tested negative on rapid tests. Patient tested negative two other times and then 3 days later patient developed covid symptoms again-patient tested lsiirice on an antigen test on May 11th and again today on 12May2022.  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: Malaise
Clinical narrative: she is feeling sick today; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Dose 1 manufacturer unknown.), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series completed, Dose 2 manufacturer unknown.), for Covid-19 immunization; Covid-19 vaccine (First Booster dose (Dose 3), Manufacturer unknown.), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 12May2022, outcome "unknown", described as "she is feeling sick today".  Additional information: she mentioned that she is gone with her second dose of Pfizer COVID-19 Booster yesterday and she is feeling sick today and she would like to know if we can get her some recommendation of what is the next step for her to do."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Feeling abnormal, Off label use, Product use issue
Clinical narrative: Felt miserable the next day from the vaccines; she got both the covid vaccine booster and the shingles vaccine at the same time; she got both the covid vaccine booster and the shingles vaccine at the same time; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (141003). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing), notes: Diagnosis or Reason for Use:, Rheumatoid Arthritis. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Unknown Manufacturer.), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt miserable the next day from the vaccines"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "she got both the covid vaccine booster and the shingles vaccine at the same time".  Additional information: Patient reported she got both the covid vaccine booster and the shingles vaccine at the same time at the end of February (exact date unknown) and her MD advised her to stop taking xeljanz for 1 week after the vaccines. patient reported she felt miserable the next day from the vaccines but no change in rheumatoid arthritis symptoms were reported related to missed doses and patient has since restarted the medication. MD was aware.   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-202101638959 same reporter, patient; different drug/event
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out in hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "primary immunization: Pfizer/ Booster: Moderna" (unspecified if ongoing), notes: primary immunization: Pfizer/ Booster: Moderna. The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "broke out in hives".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOXYL; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 13May2022 at 09:00, outcome "recovering", described as "Exhaustion". Therapeutic measures were not taken as a result of fatigue. 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: Altered visual depth perception, Nausea, Vomiting
Clinical narrative: experienced issues with depth perception; nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: ALTERED VISUAL DEPTH PERCEPTION (non-serious), outcome "unknown", described as "experienced issues with depth perception"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown".  Additional information: Description of Event: Female nurse received 2nd dose of Pfizer COVID vaccine 2 months after having a baby. She experienced issues with depth perception, nausea, vomiting. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Liver function test, Liver function test increased
Clinical narrative: after completing first booster her labs were elevated; fatty liver disease / labs were elevated; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "diagnosis of fatty liver disease" (unspecified if ongoing), notes: Patient has a diagnosis of fatty liver disease due to a medication. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (completed primary series, DOSE 2), for COVID-19 immunization; Bnt162b2 (completed primary series, DOSE 1), for COVID-19 immunization. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "after completing first booster her labs were elevated"; LIVER FUNCTION TEST INCREASED (non-serious), outcome "unknown", described as "fatty liver disease / labs were elevated". The patient underwent the following laboratory tests and procedures: Liver function test: Result unknown, notes: completes labs for monitoring; no change, notes: After primary series; elevated, notes: After first booster.  Additional information: Patient had a diagnosis of fatty liver disease due to a medication. She completed labs for monitoring. She completed primary series and no change in labs but after completing first booster her labs were elevated. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she is feeling sick all day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Second Dose, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Third Dose (1st booster), Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 12May2022, outcome "unknown", described as "she is feeling sick all day".  Additional information: Caller said she did her second booster dose of the Pfizer Covid19 vaccine yesterday however she is feeling sick all day today and was asking for a recommendation for the next step she can do. Caller refused to provide personal information. Resolutions: Submitted manual AE form- Regulatory Authority  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: On her first booster she got a sore arm; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed , unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "On her first booster she got a sore arm".  Additional Information: From: withheld  Reporter Name: withheld  Reported by: Nurse Reporter Contact Information: withheld  Patient Name: withheld  Description of Event: It was reported that, the withheld told me she received the Pfizer-Biontech covid19 vaccine. On her first booster she got a sore arm. She did not have any other symptoms. Name of Product: Pfizer-BioNTech Covid-19 vaccine Awareness Date: 12May2022 Country of Occurrence: United States. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: headache; fatigue; Up all night with dry heaves; Dizziness; just not feeling well at all; Achiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 80 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL; ASPIRIN 81; ZETIA; STATIN [ATORVASTATIN CALCIUM]. Vaccination history included: BNT162b2 (Suspect Products: Pfizer Covid 19 Vaccines, Third Dose or First Booster Dose: 01Dec2021 Lot: FH8030), administration date: 01Dec2021, when the patient was 80-year-old, for COVID-19 Immunization; BNT162b2 (Suspect Products: Pfizer Covid 19 Vaccines, Second Dose: 04Mar2021 Lot: EN6205), administration date: 04Mar2021, when the patient was 80-year-old, for COVID-19 Immunization, reaction(s): "Headache", "Fatigue"; BNT162b2 (Caller states he has had the 4 Pfizer Shots for Covid, Suspect Products: Pfizer Covid 19 Vaccines, First Dose: 11Feb2021 Lot: EL9266), administration date: 11Feb2021, when the patient was 80-year-old, for COVID-19 Immunization, reaction(s): "Headache", "Fatigue".  The following information was reported: PAIN (life threatening) with onset 11May2022, outcome "recovered" (14May2022), described as "Achiness"; DIZZINESS (non-serious) with onset 11May2022, outcome "recovered" (14May2022); RETCHING (non-serious) with onset 11May2022, outcome "recovered" (14May2022), described as "Up all night with dry heaves"; MALAISE (non-serious) with onset 11May2022, outcome "recovered" (14May2022), described as "just not feeling well at all"; FATIGUE (non-serious) with onset 12May2022, outcome "recovered" (13May2022); HEADACHE (non-serious) with onset 12May2022, outcome "recovered" (13May2022). Therapeutic measures were not taken as a result of pain, headache, fatigue, retching, dizziness, malaise.  Clinical course was reported as: Caller states he has had the 4 Pfizer Shots for Covid and the first 3 went fine but the 4th one he had a problem with. Caller states he was talking to his doctor's nurse about it and she said he should report it. Caller states he had a severe reaction to the fourth vaccine. Caller states he had a headache and fatigue which he had with the first 3 too but this one he was up all night long with dry heaves, dizziness, achiness and just not feeling well at all. Caller states he had Covid before any of the vaccines were available so he knows it is not a good thing to have. Treatment: Stayed in bed a lot. Did any AE(s) require a visit to: Emergency Room? No; Physician Office? No, but he called and she was going to get him in the next day, but he was feeling better by then so he didn't go.  It was None patient receive any other vaccines within four weeks prior to the vaccination. It was None patient had AE(s) following prior vaccinations. Family Medical History was none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200720141 Same patient, same event, different dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Coronary artery disease, Electrocardiogram
Clinical narrative: acute myocardial infarction and subsequent diagnosis of multi-vessel coronary disease suggesting silent presence of the disease prior to vaccination
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Pain, Pyrexia, Tinnitus
Clinical narrative: After my 2nd vaccine of Moderna, I had a 102 fever and my entire left side of my body was in pain, so much so that I could not sleep on my left side.  The booster (information above) I also had a fever of 101 and pain at the point of entry. I was also lethargic for two days. My brother and my nephew also had similar symptoms, even from the 2nd initial vaccine of Moderna.  I have progressively noticed a loud ringing in my right ear, which seems to ring up to the crown of my head. It's quite noticeable especially when I am not engaged in any activity. It must mention that my mother had Johnson Steven's Syndrome.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Severe, Systemic: severe body aches-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Unable to Sleep-Severe, Additional Details: pt states that a few hours after the receiving the vaccine, she experienced severe body aches, severe
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Pain, Sleep disorder
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Severe, Systemic: severe body aches-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Unable to Sleep-Severe, Additional Details: pt states that a few hours after the receiving the vaccine, she experienced severe body aches, severe
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Echocardiogram, Ischaemic stroke, Magnetic resonance imaging head, Thrombotic stroke
Clinical narrative: acute thrombotic ischemic stroke in the sylvian branch of left middle cerebral artery
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-