chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: none" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL topical, start date: May2021, stop date: 26Aug2023; OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL], start date: Jan2020, stop date: 28Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: 2 negative tests on days 8 and 10; (2023) Negative, notes: 2 negative tests on days 8 and 10. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received: Paxlovid from 28Aug2023 to 02Sep2023 as treatment of COVID-19 and Patient had no known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296511 same patient, different drug/event;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing); "Anxiety Medication" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for anxiety, start date: 15Jan2020. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 30Aug2023 to 04Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Myocarditis
Clinical narrative: Myocarditis; 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 received bnt162b2 (BNT162B2), on 15Jun2022 as dose 2, single (Lot number: FM0173) at the age of 50 years for COVID-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: she has had it for years. There were no concomitant medications. Vaccination history included: bnt162b2 (First Dose: 25May2022 Lot: FJ4989), administration date: 25May2022, when the patient was 50-year-old, for COVID-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization) with onset Oct2022, outcome "not recovered". The patient was hospitalized for myocarditis (start date: Oct2022, discharge date: Oct2022). The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; Unknown results. Therapeutic measures were taken as a result of myocarditis. Additional information: The reporter stated she developed, after she took the vaccine, myocarditis and was hospitalized. She got the vaccine in Jun2022, and shortly after that, she started having pains in her chest so then she thought she will watch it because sometimes maybe it is just pleuritic chest pain but then it kept going on and on and when she was walking outside, she would get short of breath with anything physical and she would be out of breath. She stated she couldn't understand how that would happen. One time she came to work, and it got harder to physically do stuff and then in Oct2022 she decided she was going to the ER (emergency room). She stated one Friday it got so bad, she said she was going to the hospital, so she went to the ER, and she got admitted and diagnosed with Myocarditis. She was hospitalized for 8 days. She also stated it hasn't resolved; it is ongoing. She was going about her business and going to work and coming home. She doesn't have a lot of activities and shopping and partying and all that stuff, she just goes to work and comes home. This year, in May2023, she ended up back in the hospital because of the same problems all over again. She went to the ER and it was the same thing again and she was admitted for 6 days in May2023. Even now she was having the same problems. It is persistent, she was just watching it. She is at work and at this point she has used up so much of her sick time, if she doesn't work, she won't get paid, she had to be watching it to see how long she can bear this. Treatment plan for the patient included hospitalization. They gave her a CAT scan and CT scan with dye, antibiotics, anti-Inflammatory in her IV (intravenous) line, pills, and they gave her medication in her IV. The reporter stated that the tests that they did at the hospital were done to come up with her diagnosis.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand other: J&J; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand other: J&J; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (04Sep2023) Negative; (06Sep2023) Negative; (08Sep2023) Negative; (10Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 79.0
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 79-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jun2023 at 13:15 as dose number unknown, single (Lot number: GJ3268) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "thyroid condition" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Meclyzine, reaction(s): "known allergies: Meclizine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (Sep2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Aug2023 to 02Sep2023. Clinical course: Negative test result 2days after last Paxlovid dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296484 Same reporter/patient, different drug/AE.;
Age: 68.0
Sex: M
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), on 06Oct2022 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. 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
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 16:45 as dose 4 (booster), single (Lot number: GH9697), in left arm and on 11Aug2023 at 17:00 as dose 5 (booster), single (Lot number: GK0923) at the age of 66 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Feb2021 at 16:30 as dose 1, single (Lot number: EN6198), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 18Jan2022 as dose 3 (booster), single (Lot number: FL3209), in left arm for covid-19 immunisation. The patient's relevant medical history included: "BMI>30" (unspecified if ongoing); "Known allergies: Nickel" (unspecified if ongoing). Concomitant medication(s) included: PHENTERMINE, start date: 11Aug2023, stop date: 24Aug2023; TOPIRAMATE, start date: 11Aug2023, stop date: 24Aug2023; NICOTINAMIDE, start date: 21Jul2023; CLOTRIMAZOLE, start date: 08Aug2023; FLUCONAZOLE, start date: 22Aug2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Never tested positive on day 6, 8, 10; symptoms decreased during 5 day treatment, but by day 6-7, started to have 2deg T surges (96.0-98.1, .2) sore throat, some nasal discharge. some coughing and sneezing.
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 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (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), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: cipro, reaction(s): "Known allergies: Cipro". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid form 25Aug2023 to 30Aug2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 66.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 31Aug2023 to 05Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01May2021, stop date: 04Sep2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccine and medications in two weeks. Paxlovid was given as treatment for COVID-19 from 05Sep2023 to 08Sep2023 .Patient did not have any known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Vaccination site rash
Clinical narrative: Stomach ache; rash at injected site; Headache after taking vaccine after 5 hr it resolved.; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the parent.  A 26-year-old male patient received bnt162b2 (BNT162B2), on 14Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Headache after taking vaccine after 5 hr it resolved."; ABDOMINAL PAIN UPPER (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Stomach ache"; VACCINATION SITE RASH (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "rash at injected site". Therapeutic measures were not taken as a result of abdominal pain upper, vaccination site rash, headache.  Additional information: The patient has no known allergies. The patient thinks that 20,000 people experienced rash at injection site, pruritus, and itching after taking Pfizer vaccine.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 44.0
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 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 44 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 14Apr2021 as dose 2, single (Lot number: ER8731), in right arm and on 07Dec2021 as dose 3 (booster), single (Lot number: FG3527), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan1992. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Sep2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2023) positive, notes: Tested positive on 02Sep2023; (05Sep2023) negative, notes: Symptoms subsided quickly and tested negative for 4 days 05Sep-08Sep; (06Sep2023) negative, notes: Symptoms subsided quickly and tested negative for 4 days 05Sep-08Sep; (07Sep2023) negative, notes: Symptoms subsided quickly and tested negative for 4 days 05Sep-08Sep; (08Sep2023) negative, notes: Symptoms subsided quickly and tested negative for 4 days 05Sep-08Sep; (09Sep2023) positive, notes: Symptoms returned on 09Sep and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 71.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20May2023 at 11:00 as dose 5 (booster), single (Lot number: Gj6743) at the age of 71 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing), notes: now with treatment hypothyroid; "hyper cholesterolemia" (unspecified if ongoing); "depression" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "sinus congestion" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohns" (unspecified if ongoing), notes: Other medical history: Crohns; "RA" (unspecified if ongoing), notes: Other medical history: RA. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 1, single (Lot number: gj2524) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid treatment start date: 31Aug2023 to 05Sep2023. No known allergies.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300297617 same reporter, patient, and drug, different dose and event;
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 63-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 61 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), on 16Apr2021 as dose 2, single (Lot number: EP7533), on 24Nov2021 as dose 3 (booster), single (Lot number: FH8030) and on 03Jun2022 as dose 4 (booster), single (Lot number: FM7553) 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), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken (Paxlovid) as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 01Sep2023 to 06Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine bnt162b2, bnt162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 69.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: taking Paxlovid/had 3 Pfizer Covid-19 vaccine shot and came down with covid; taking Paxlovid/had 3 Pfizer Covid-19 vaccine shot and came down with covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "surgery a month ago" (unspecified if ongoing), notes: thinks she got the Covid from the surgery/ she had back surgery a month ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "taking Paxlovid/had 3 Pfizer Covid-19 vaccine shot and came down with covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: 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 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02May2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 69 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gluten allergy" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, patiet was treated with Paxlovid from 29Aug2023 to 03Sep2023.
Age: 68.0
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Aug2023 at 12:00 as dose number unknown (booster), single (Lot number: Gl2042) at the age of 68 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rybelsus, stop date: 01Aug2023; Pantoprazole, stop date: 01Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: (06Sep2023) Negative, notes: very faint line still negative; (08Sep2023) Positive, notes: positive again no symptom. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 31Aug2023 to 04Sep2023.
Age: 51.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in May2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received treatment with Paxlovid from 03Sep2023 to 07Sep2023.  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: Bronchial hyperreactivity
Clinical narrative: she had an airway reaction to the COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRONCHIAL HYPERREACTIVITY (non-serious), outcome "unknown", described as "she had an airway reaction to the COVID vaccine".  Additional information: A caller said she was calling about a flu vaccine that had Pfizers name on it. She called to schedule an appointment for a flu vaccine, and the providers name was Withheld Pfizer, and there was no name for the flu vaccine. When she read that, it sounded like the COVID vaccine, and she said she was supposed to get a flu vaccine. When she called the place, they said sometimes people get the COVID vaccine with their flu vaccines and mix them together, and she said that they cannot mix them together and had to give them separately. She wanted to get information about this because if it was part of the COVID vaccine, she did not want to go for a flu vaccine under the auspice of ending up with the COVID vaccine at the same time. She mentioned she had an airway reaction to the COVID vaccine.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Ocular vascular disorder
Clinical narrative: Eye stroke/ Occular vein occlusion -left eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GUAIFENESIN taken for fibromyalgia (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: FL247, Anatomical site of injection: Arm, Route of administration: Intramuscular), administration date: 15Jan2021, for Covid-19 immunization. The following information was reported: OCULAR VASCULAR DISORDER (medically significant) with onset Jul2021, outcome "not recovered", described as "Eye stroke/ Occular vein occlusion -left eye". The patient underwent the following laboratory tests and procedures: eye test: (Jul2021) eye stroke, notes: Test: Eye stroke. Date: Jul2021. Result: eye test. Therapeutic measures were taken as a result of ocular vascular disorder. Clinical course: "Eye stroke - Jul2021. Ocular vein occlusion - left eye. Back of eye - Have to get injections in my left eye."  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: probably killed my wife; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received bnt162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "probably killed my wife". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Pfizer is a nasty; vile; foul company that probably killed my wife since she was the only one in the household who had the Pfizer covid shot; but she died. We all lived. Reporter consider event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: probably killed my wife
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Feeling cold, Feeling hot, Headache, Injection site erythema
Clinical narrative: Approximately at 1am the morning after I received the rsv vaccine I became extremely cold and couldn't stop shaking .    This lasted for about 20 minutes.  Around 10 am I felt warm and thermometer showed 100.3.  There was a large knot at injection site and arm was red and felt hot to touch.  I also had a severe headache.  These symptoms lasted for approximately 24 hours.  Headache remained for approximately 48 hours and as of today 9/12/23 injection site is still slightly red and sore but other symptoms are gone.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site nodule, Injection site pain, Skin warm, Tremor
Clinical narrative: Approximately at 1am the morning after I received the rsv vaccine I became extremely cold and couldn't stop shaking .    This lasted for about 20 minutes.  Around 10 am I felt warm and thermometer showed 100.3.  There was a large knot at injection site and arm was red and felt hot to touch.  I also had a severe headache.  These symptoms lasted for approximately 24 hours.  Headache remained for approximately 48 hours and as of today 9/12/23 injection site is still slightly red and sore but other symptoms are gone.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Fall, Hypotension, Loss of consciousness, Sluggishness
Clinical narrative: Patient received both flu vaccine and HPV dose 2 today. After receiving his injections, he sat in the chair next to his mother while his sister received her immunization. He started to slump down and lay his head on his mother. He had LOC for about 30 seconds reported by nursing and became still in his body. He also had urinary incontinence. Physicians and nurses came in for aid and he was awake, yet sluggish. he was oriented to time, person, place. BP was mildly low.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Urinary incontinence
Clinical narrative: Patient received both flu vaccine and HPV dose 2 today. After receiving his injections, he sat in the chair next to his mother while his sister received her immunization. He started to slump down and lay his head on his mother. He had LOC for about 30 seconds reported by nursing and became still in his body. He also had urinary incontinence. Physicians and nurses came in for aid and he was awake, yet sluggish. he was oriented to time, person, place. BP was mildly low.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea, Electrocardiogram, Palpitations
Clinical narrative: 7 days after getting vaccine, I became short of breath & heart pounded hard whenever I exerted myself (even walking up stairs). It did go away in 3 to 4 weeks.
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Atrial fibrillation, Blood pressure increased, Headache, Pyrexia
Clinical narrative: Patient states that 2 hours after vaccination she had a splitting headache, this headache lasted  36 hours. She also developed a fever of 101. She then had her blood pressure increase and went into a-fib. She thought she was going to need a cardio conversion but she didn't. She feels that the horrible headache caused the a-fib and high blood pressure but she wanted me to report this. She stated she has had high dose flu vaccines in the past with no problems.
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Lymphadenopathy
Clinical narrative: swollen left lymphnode
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood glucose normal, COVID-19, Cirrhosis alcoholic, Coagulopathy
Clinical narrative: Patient Progress:   Status: Progress not as expected - plan revision underway     ICU END OF SHIFT SUMMARY   Nursing Primary Problem/Medical Diagnosis 1. Alcoholic Cirrhosis/Hepatitis 2. Coagulopathy     Significant Events and Nursing Interventions   Pt sedated on precedex gtt overnight. Weaned as tolerating this morning. Pt on 15L OFM, lung sounds w/ crackles. Lasix given. Developed SVT/ afib RVR, EKG, Amio bolus and gtt started. Pt converted to SR, developed hypotension. NE gtt started. Weaning as tolerated. Amio stopped. Large BM today, Remains confused and intermittently restless. Mother in law approved to come in and saw pt today.     Delirium Assessment CAM: Positive RASS: -1 Sedation: Low dose Precedex gtt   Mobility Care Plan Baseline level of function: 2 Last recorded mobility level: 1 Current Level of function: 1 Need for Physical Therapy? Not HD stable at this point.   Falls Prevention Care Plan Is the patient at risk for falls? Yes Are the necessary measures in place to promote patient safety? Yes Falls Care Plan documented? Yes   Restraints Care Plan Are restraints being utilized?Yes BUE soft limb restraints.  State reasons/medical necessity for use: to prevent pulling of tubes/lines Orders current and updated? Yes   DVT Prophylaxis: SCDS Isolation Precaution: COVID, enhanced resp and contact Blood sugar levels within acceptable range (less than 180 mg/dl)? Yes If not, is the patient on an insulin regimen?    Infection Prevention Strategies Central line in place: No Necessity/IV Drips:  Dressing change:    Urinary indwelling catheter in place: No Necessity:  Seal patent/ no loops/ off the floor:  Wounds present: Yes Nutrition: NPO   Plans and goals for patient recovery and care: Continue to wean NE as tolerating, safety, continue family updating/ discusions with family.       Note Details  Author (R.N.) File Time 9/12/2023  2:38 PM Author Type REGISTERED NURSE Status Addendum Last Editor (R.N.) Specialty GENERAL, OTHER Hospital Acct # Admit Date 9/4/2023  ED to Hosp-Admission (Current) on 9/4/2023  ED to Hosp-Admission (Current) on 9/4/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  09/04   Admitted from ED 2214 09/06   Code    Transferred to ICT-INTENSIVE CARE NURSE UNIT 1905 09/07   Transferred out of ICT-INTENSIVE CARE NURSE UNIT 1747 09/09   Rapid Response    Transferred to ICT-INTENSIVE CARE NURSE UNIT 0048  pt in house
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Electrocardiogram normal, Hepatitis alcoholic, Hypotension, Intensive care
Clinical narrative: Patient Progress:   Status: Progress not as expected - plan revision underway     ICU END OF SHIFT SUMMARY   Nursing Primary Problem/Medical Diagnosis 1. Alcoholic Cirrhosis/Hepatitis 2. Coagulopathy     Significant Events and Nursing Interventions   Pt sedated on precedex gtt overnight. Weaned as tolerating this morning. Pt on 15L OFM, lung sounds w/ crackles. Lasix given. Developed SVT/ afib RVR, EKG, Amio bolus and gtt started. Pt converted to SR, developed hypotension. NE gtt started. Weaning as tolerated. Amio stopped. Large BM today, Remains confused and intermittently restless. Mother in law approved to come in and saw pt today.     Delirium Assessment CAM: Positive RASS: -1 Sedation: Low dose Precedex gtt   Mobility Care Plan Baseline level of function: 2 Last recorded mobility level: 1 Current Level of function: 1 Need for Physical Therapy? Not HD stable at this point.   Falls Prevention Care Plan Is the patient at risk for falls? Yes Are the necessary measures in place to promote patient safety? Yes Falls Care Plan documented? Yes   Restraints Care Plan Are restraints being utilized?Yes BUE soft limb restraints.  State reasons/medical necessity for use: to prevent pulling of tubes/lines Orders current and updated? Yes   DVT Prophylaxis: SCDS Isolation Precaution: COVID, enhanced resp and contact Blood sugar levels within acceptable range (less than 180 mg/dl)? Yes If not, is the patient on an insulin regimen?    Infection Prevention Strategies Central line in place: No Necessity/IV Drips:  Dressing change:    Urinary indwelling catheter in place: No Necessity:  Seal patent/ no loops/ off the floor:  Wounds present: Yes Nutrition: NPO   Plans and goals for patient recovery and care: Continue to wean NE as tolerating, safety, continue family updating/ discusions with family.       Note Details  Author (R.N.) File Time 9/12/2023  2:38 PM Author Type REGISTERED NURSE Status Addendum Last Editor (R.N.) Specialty GENERAL, OTHER Hospital Acct # Admit Date 9/4/2023  ED to Hosp-Admission (Current) on 9/4/2023  ED to Hosp-Admission (Current) on 9/4/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  09/04   Admitted from ED 2214 09/06   Code    Transferred to ICT-INTENSIVE CARE NURSE UNIT 1905 09/07   Transferred out of ICT-INTENSIVE CARE NURSE UNIT 1747 09/09   Rapid Response    Transferred to ICT-INTENSIVE CARE NURSE UNIT 0048  pt in house
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Rales, Restlessness, Supraventricular tachycardia
Clinical narrative: Patient Progress:   Status: Progress not as expected - plan revision underway     ICU END OF SHIFT SUMMARY   Nursing Primary Problem/Medical Diagnosis 1. Alcoholic Cirrhosis/Hepatitis 2. Coagulopathy     Significant Events and Nursing Interventions   Pt sedated on precedex gtt overnight. Weaned as tolerating this morning. Pt on 15L OFM, lung sounds w/ crackles. Lasix given. Developed SVT/ afib RVR, EKG, Amio bolus and gtt started. Pt converted to SR, developed hypotension. NE gtt started. Weaning as tolerated. Amio stopped. Large BM today, Remains confused and intermittently restless. Mother in law approved to come in and saw pt today.     Delirium Assessment CAM: Positive RASS: -1 Sedation: Low dose Precedex gtt   Mobility Care Plan Baseline level of function: 2 Last recorded mobility level: 1 Current Level of function: 1 Need for Physical Therapy? Not HD stable at this point.   Falls Prevention Care Plan Is the patient at risk for falls? Yes Are the necessary measures in place to promote patient safety? Yes Falls Care Plan documented? Yes   Restraints Care Plan Are restraints being utilized?Yes BUE soft limb restraints.  State reasons/medical necessity for use: to prevent pulling of tubes/lines Orders current and updated? Yes   DVT Prophylaxis: SCDS Isolation Precaution: COVID, enhanced resp and contact Blood sugar levels within acceptable range (less than 180 mg/dl)? Yes If not, is the patient on an insulin regimen?    Infection Prevention Strategies Central line in place: No Necessity/IV Drips:  Dressing change:    Urinary indwelling catheter in place: No Necessity:  Seal patent/ no loops/ off the floor:  Wounds present: Yes Nutrition: NPO   Plans and goals for patient recovery and care: Continue to wean NE as tolerating, safety, continue family updating/ discusions with family.       Note Details  Author (R.N.) File Time 9/12/2023  2:38 PM Author Type REGISTERED NURSE Status Addendum Last Editor (R.N.) Specialty GENERAL, OTHER Hospital Acct # Admit Date 9/4/2023  ED to Hosp-Admission (Current) on 9/4/2023  ED to Hosp-Admission (Current) on 9/4/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  09/04   Admitted from ED 2214 09/06   Code    Transferred to ICT-INTENSIVE CARE NURSE UNIT 1905 09/07   Transferred out of ICT-INTENSIVE CARE NURSE UNIT 1747 09/09   Rapid Response    Transferred to ICT-INTENSIVE CARE NURSE UNIT 0048  pt in house