chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment/ Return of milder symptoms, body aches, mild fever, and nasal congestion.; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 05Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF2587), 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: "Long QT Syndrome" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 02Jan2006. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 15Jul2022, outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset 15Jul2022, outcome "not recovered", described as "COVID 19 Treatment/ Return of milder symptoms, body aches, mild fever, and nasal congestion.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (15Jul2022) positive, notes: Retested via rapid antigen test prior to an event on 15Jul and reverted to positive; SARS-CoV-2 test: (08Jul2022) Negative, notes: Negative COVID-19 tests; (09Jul2022) Negative, notes: Negative COVID-19 tests; (10Jul2022) Negative, notes: Negative COVID-19 tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 treated with Paxlovid started on 02Jul2022 and ended on 06Jul2022.  Clinical course: No known allergies.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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 complete; Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "mild injection site pain".  Additional information: The reporter wanted to know if it is okay for him to take Tylenol for mild injection site pain. It was nothing serious. She did not want to do a report.  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-202200966592 same reporter/drug/event; different patient.;
Age: 56.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received treatment for covid-19 with Paxlovid from 12may2022 to 16may2022. The patient also received fourth dose of moderna vaccine for covid-19 immuniation.  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 provided and plausible temporal association, the causality between the Vaccination failure and Covid-19 for the suspect vaccines cannot be excluded. However, the efficacy of a drug varies from patient to patient and can be affected by different factors.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 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 included: "Dm" (unspecified if ongoing), notes: Dm; "hyperlipidemia" (unspecified if ongoing), notes: hyperlipidemia; "depression" (unspecified if ongoing); "ptsd" (unspecified if ongoing), notes: ptsd. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine", notes: Known allergies: Compazine; Wellbutrin, reaction(s): "Known allergies: wellbutrin", notes: Known allergies: wellbutrin; Ozempic, reaction(s): "Known allergies: ozempic", notes: Known allergies: ozempic. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". 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.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity, SARS-CoV-2 test
Clinical narrative: upper right arm has been extremely sore/Lifting my arm brings the sore feeling; I can still lift or pull things but it is a little difficult; 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 31Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]. Patient did not other vaccine received in four weeks. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 30-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Right), administration date: 10Feb2021, when the patient was 30-year-old, for COVID-19 Immunization. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 22Jun2022, outcome "not recovered", described as "I can still lift or pull things but it is a little difficult"; PAIN IN EXTREMITY (non-serious) with onset 22Jun2022, outcome "not recovered", described as "upper right arm has been extremely sore/Lifting my arm brings the sore feeling". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, movement disorder.  Additional information: Patient had no known allergies. Patient did not receive any other vaccine within four weeks. Patient was not diagnosed with covid-19 prior vaccination. Case was reported as non-serious. Adverse event For the last few weeks, my upper right arm has been extremely sore. I can still lift or pull things but it is a little difficult (it is my dominant arm). Lifting my arm brings the sore feeling as well.
Age: 70.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 at 16:45 as dose 1, single (Lot number: EL1284), in left arm, on 14Jan2021 at 15:15 as dose 2, single (Lot number: EL3302), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 06Mar2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "stable ascending aortic aneurysm" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "ongoing weight loss" (unspecified if ongoing); "Gi problems", start date: Oct2021 (unspecified if ongoing), notes: Gi problems since Oct2021. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 09Jul2022, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 09Jul2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (09Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about covid treatment reported as Yes. If Vaccine received and Other medication in 2 weeks reported as Yes. Anti-viral details: product: COVID 19 Treatment, brand=Paxlovid, Treatment start date: 30Jun2022, Treatment stop date: 05Jul2022, Indication: Treatment of COVID-19. Adverse event reported as rebound symptoms and positive home test 4 days after completing 5 days of Paxlovid 100-300. I tested negative on two different days and was symptom free during the 4 days. Known allergies reported as No.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prediabetes" (unspecified if ongoing), notes: Other medical history: Prediabetes; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile the event Drug ineffective and Covid-19  is assessed as related to the suspect drug BNT162b2.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Malaise, Pain in extremity
Clinical narrative: Chills; Not feeling good; Diarrhea; Didn't feel like eating; Arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 89-year-old female patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 4 (booster), single (Lot number: FP4554, Expiration Date: 31Oct2022) at the age of 89 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EP6955), administration date: 22Mar2021, when the patient was 88-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot Number: 5EL1016), administration date: 14Apr2021, when the patient was 88-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot Number: FJ110112.R), administration date: 15Dec2021, when the patient was 89-year-old, for COVID-19 Immunization; Shingles (With the shingles shot she had a very sore arm for a few days. The first one was at the end of Feb.), administration date: Feb2022, for Immunization, reaction(s): "sore arm"; Shingles (With the shingles shot she had a very sore arm for a few days. The 2nd one was at the end of May), administration date: May2022, for Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Jul2022, outcome "recovered" (Jul2022), described as "Arm was sore"; CHILLS (non-serious) with onset 14Jul2022, outcome "recovered" (Jul2022); DIARRHOEA (non-serious) with onset 14Jul2022, outcome "recovered" (Jul2022), described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 14Jul2022, outcome "recovered" (Jul2022), described as "Didn't feel like eating"; MALAISE (non-serious) with onset 14Jul2022, outcome "recovered" (Jul2022), described as "Not feeling good".  Additional information: It was reported that the events happened the before day and it has all resolved now (as of report). The patient did not receive any vaccination within the last 4 weeks. There was no family medical history. No relevant lab tests were done. The patient had no other conditions and medical history.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL1283), in Feb2021 as dose 2, single (Lot number: EL9265), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial Fib" (unspecified if ongoing), notes: Atrial Fib. No known allergies. Concomitant medication(s) included: METOPROLOL, start date: Jan2018, stop date: Jul2022; ELIQUIS, start date: Jan2018, stop date: Jul2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 Treatment with Paxlovid from Jul2022 to FY4422. Patient had unusual taste. Diarrhea started on day two. Would not stop. Doctor discontinued Paxlovid on day 4. Leg cramps, continued through day 6. Diarrhea continued through day 6. Patient received treatment: OTC Imodium for Diarrhea, Pedialyte for cramps.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood homocysteine, COVID-19, 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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 04:00 as dose 1, single (Lot number: EL9265), in left arm, on 04Mar2021 at 11:00 as dose 2, single (Lot number: EN6198), in left arm, on 27Oct2021 at 17:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 29Mar2022 at 17:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Liver hyper metabolism" (unspecified if ongoing), notes: Liver hyper metabolism; "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "Prothrombin mutation G20210A" (unspecified if ongoing), notes: prothrombin 20210a heterogeneous, C677T. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood homocysteine: Unknown results, notes: Result: Unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 at 15:00 as dose 3 (booster), single (Lot number: EW0196) at the age of 41 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's relevant medical history included: "known allergies: sesame" (unspecified if ongoing); "known allergies: tropical fruits" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN. Past drug history included: Biaxin, reaction(s): "Allergy: Biaxin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Events treatment included paxlovid (lot number: 6C4762), treatment start date was 12Jul2022. The patient previously receives a COVID-19 Vaccine.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: Patient had no other medication in 2 weeks.
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 65-year-old female patient (not pregnant) 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 included: "PMR" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE. 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: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical course: This is a positive event. Patient had PMR. The Paxlovid stopped the Covid symptoms but also took away her PMR pain and felt better than had in a long time. Patient had finished the Paxlovid and now her symptoms were starting to return. She checked with other people who has PMR and taken Paxlovid and they felt great after taking this medication. Have you documented that this helps with PMR? treatment start date=10Jul2022, treatment stop date=15Jul2022,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: a little bit of fever; aching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: CJ1686) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "a little bit of fever"; PAIN (non-serious), outcome "unknown", described as "aching".  Additional information: No Investigations were performed. It was reported that the patient received no other vaccines. Patient stated that with the first two vaccines she had the basic reactions of a little bit of fever and aching, took a nap never takes naps. The patient did not visit to ER or DR due to the events. Stated she is a 64-year-old athlete. It was reported that with the first two doses the symptoms only lasted about a day and Exact dates not provided.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and on 19May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild/sports induced asthma" (unspecified if ongoing), notes: Mild/sports induced asthma. The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim; Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet; Vicodin, reaction(s): "Known allergies: Vicodin", notes: Known allergies: Vicodin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had 2 Pfizer's first then 2 modernas. Anti-viral details product-COVID 19 Treatment, brand-Paxlovid, treatment start date-05Jul2022, treatment stop date-09Jul2022, indication-Treatment of COVID-19. The patient did not receive other medication in 2weeks. Adverse event-Began to cough and remained winded with chest tightness. Then congested, aches, sweats, chills, and slamming headache. Adverse events start date: 13Jul2022, AE resulted in: [None of the above]. If patient recovered was not Recovered. If treatment Ae was yes. Ae treatment: Consult.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Aching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: EP6955) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: CJ1686), administration date: 12Mar2021, when the patient was 62-year-old, for Covid-19 Immunisation, reaction(s): "Fever", "Aching". The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered", described as "Aching"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "Fever".  Additional information: The patient stated that with the first two vaccines she had the basic reactions to the first two, a little bit of fever and aching, took a nap never takes naps. Patient stated that with the first two doses the symptoms only lasted about a day. No other vaccines received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EJ1685), on 09Jan2021 as dose 2, single (Lot number: EL128), on 30Oct2021 as dose 3 (booster), single (Lot number: FF8841) and on 21May2022 as dose 4 (booster), single (Lot number: WA7478) at the age of 53 years for Covid-19 immunisation. The patient's relevant medical history included: "Asthma, that is why I took Paxlovid in the first place" (unspecified if ongoing), notes: Asthma, that is why I took Paxlovid in the first place; "Allergies: Sulfa" (unspecified if ongoing), notes: Allergies: Sulfa. Concomitant medication(s) included: Breo Ellipta; Montelukast; Prilosec [Omeprazole]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Negative, notes: I had a negative test on Day 5 after starting the medication; (09Jul2022) Positive, notes: On day 11, my test was positive again; (15Jul2022) Negative, notes: I am finally negative today on Day 7 after my rebound. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: I had a negative test on Day 5 after starting the medication and went on with life. On day 10, I started to feel badly again. On day 11, my test was positive again. (Rebound). I was much sicker than the original illness (bad cold so not serious) I am finally negative today on Day 7 after my rebound. The patient received treatment for the event with Paxlovid on 29Jun2022, stopped on 03Jul2022. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Nasopharyngitis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EJ1685), on 09Jan2021 as dose 2, single (Lot number: EL128), on 30Oct2021 as dose 3 (booster), single (Lot number: FF8841) and on 21May2022 as dose 4 (booster), single (Lot number: WA7478) at the age of 53 years for Covid-19 immunisation. The patient's relevant medical history included: "Asthma, that is why I took Paxlovid in the first place" (unspecified if ongoing), notes: Asthma, that is why I took Paxlovid in the first place; "Allergies: Sulfa" (unspecified if ongoing), notes: Allergies: Sulfa. Concomitant medication(s) included: Breo Ellipta; Montelukast; Prilosec [Omeprazole]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Negative, notes: I had a negative test on Day 5 after starting the medication; (09Jul2022) Positive, notes: On day 11, my test was positive again; (15Jul2022) Negative, notes: I am finally negative today on Day 7 after my rebound. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: I had a negative test on Day 5 after starting the medication and went on with life. On day 10, I started to feel badly again. On day 11, my test was positive again. (Rebound). I was much sicker than the original illness (bad cold so not serious) I am finally negative today on Day 7 after my rebound. The patient received treatment for the event with Paxlovid on 29Jun2022, stopped on 03Jul2022. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: the original illness (bad cold so not serious); Asthma; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA; MONTELUKAST; PRILOSEC [OMEPRAZOLE]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1685), administration date: 19Dec2020, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 2, Batch/Lot No: EL1283), administration date: 09Jan2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841), administration date: 30Oct2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: ASTHMA (non-serious) with onset 2022, outcome "unknown"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "the original illness (bad cold so not serious)". Therapeutic measures were taken as a result of asthma. Additional information:Asthma, that is why I took paxlovid in the first place The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Nasopharyngitis
Clinical narrative: the original illness (bad cold so not serious); Asthma; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA; MONTELUKAST; PRILOSEC [OMEPRAZOLE]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1685), administration date: 19Dec2020, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 2, Batch/Lot No: EL1283), administration date: 09Jan2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841), administration date: 30Oct2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: ASTHMA (non-serious) with onset 2022, outcome "unknown"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "the original illness (bad cold so not serious)". Therapeutic measures were taken as a result of asthma. Additional information:Asthma, that is why I took paxlovid in the first place The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: EW0178) at the age of 66 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: "benign hyper-tension" (unspecified if ongoing), notes: benign hyper-tension; "cancer" (unspecified if ongoing), notes: cancer history (7 years remission). Concomitant medication(s) included: LISINOPRIL. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Bactrin, reaction(s): "Known allergies: Bactrin"; Biaxin, reaction(s): "Known allergies: Biaxin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid, treatment start date=06Jul2022, treatment stop date=10Jul2022, indication=Treatment of COVID-19.
Age: 62.0
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0151), in right arm, on 29Apr2021 as dose 2, single (Lot number: EW0175), in right arm and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8038) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive, notes: The next day I tested and my result was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that no other medication in 2weeks. patient had no known allergies.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 breakthrough infection; COVID 19 breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6203), on 23Mar2021 as dose 2, single (Lot number: EN6203) and on 25Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 49 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Acid Reflux" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; PRAVASTATIN; FAMOTIDINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jul2022 at 18:00, outcome "recovering" and all described as "COVID 19 breakthrough infection". The event "covid 19 breakthrough infection" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, the patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. No known allergies. The patient also received other medication in two weeks which were reported as multivitamin and CPAP.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 21Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex; "interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO, start date: 01Oct2018; VYVANSE, start date: 01Jun2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. 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: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: Tested negative at Day 9; (Jul2022) Positive, notes: tested positive again at Day 15. Therapeutic measures were taken as a result of covid-19, drug ineffective. No known allergies reported for the patient.  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 available information , there is reasonable possibility of causal association between the events Drug Ineffective , COVID 19 and the suspect drug BNT162b2.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 1 day and as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications within in 2weeks after vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". On 02Jul2022, the patient had experienced bitter taste. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 02Jul2022 to 06Jul2022 for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 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. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: SERTRALINE, start date: Jan2007. Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment reported as yes. The patient previously received a COVID-19 Vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 and treatment included Paxlovid from 06Jul2022 to 10Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID Breakthrough Infection; COVID Breakthrough Infection; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). A 13-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 23May2021 as dose 1, single (Lot number: EW0177), on 13Jun2021 as dose 2, single (Lot number: EW0178) and on 24Mar2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 13 years, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Covid was not diagnosed prior vaccination. There was no other vaccine in four weeks of vaccination. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "recovering" and all described as "COVID Breakthrough Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive, notes: test type: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 75.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 at 10:00 as dose 1, single (Lot number: EL9267), in left arm, on 03Mar2021 at 12:00 as dose 2, single (Lot number: EN0205), in left arm, on 28Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 05Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 75 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), 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.  Clinical information: Anti viral details product COVID 19 Treatment, brand Pfizer, treatment start date 06Jul2022,treatment stop date 10Jul2022,indication. Treatment of COVID-19,COVID vaccine details vaccine brand=Pfizer / BioNTech, Adverse event: Fever, sore throat, congestion , cough, Adverse event start date: 14Jul2022,Adverse event start time: 04:00 PM. NO other medication in 2weeks.Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. AE resulted in: None of the above, If patient recovered: Recovering,If treatment Ae: No