chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2
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 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 10Apr2021 as dose 2, single (Lot number: ER8732), in left arm and on 03Sep2021 as dose 3 (booster), single (Lot number: EW0179), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Mar2023) Positive, notes: Started Paxlovid 02Mar2023- same day I tested positive-; (07Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (08Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (09Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (15Mar2023) Positive, notes: Tested positive 15Mar2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2 weeks was reported as yes. The patient received Anti viral COVID-19 Treatment with Paxlovid from 02Mar2023 to 07Mar2023.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, Headache, Malaise, SARS-CoV-2 test positive
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 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 10Apr2021 as dose 2, single (Lot number: ER8732), in left arm and on 03Sep2021 as dose 3 (booster), single (Lot number: EW0179), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Mar2023) Positive, notes: Started Paxlovid 02Mar2023- same day I tested positive-; (07Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (08Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (09Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (15Mar2023) Positive, notes: Tested positive 15Mar2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2 weeks was reported as yes. The patient received Anti viral COVID-19 Treatment with Paxlovid from 02Mar2023 to 07Mar2023.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Throat irritation
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 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 10Apr2021 as dose 2, single (Lot number: ER8732), in left arm and on 03Sep2021 as dose 3 (booster), single (Lot number: EW0179), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Mar2023) Positive, notes: Started Paxlovid 02Mar2023- same day I tested positive-; (07Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (08Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (09Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (15Mar2023) Positive, notes: Tested positive 15Mar2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2 weeks was reported as yes. The patient received Anti viral COVID-19 Treatment with Paxlovid from 02Mar2023 to 07Mar2023.
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.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (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 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Mar2023) Positive; (06Mar2023) Positive; (07Mar2023) Positive; (08Mar2023) Positive; (09Mar2023) Positive; (10Mar2023) Positive; (11Mar2023) Positive; (12Mar2023) Negative; (13Mar2023) Negative; (14Mar2023) Positive; (15Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with paxilovid for COVID-19 from 05Mar2023 to 09Mar2023.  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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 at 16:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Paraseptal emphysema" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound after 2 days of testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medication in 2weeks: Yes. The patient received Paxlovid from 05Mar2023 to 09Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 after appropriately spaced doses of COVID-19 immunization is considered as vaccination failure of BNT162b2, BNT162b2 omi ba.4-5, and the Company cannot completely exclude the possible causality between the reported events and BNT162b2, BNT162b2 omi ba.4-5 administration.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, 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 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "severe asthma" (unspecified if ongoing), notes: Other medical history: severe asthma, hypertension, PVC heart issues; "Hypertension" (unspecified if ongoing), notes: Other medical history: severe asthma, hypertension, PVC heart issues; "PVC heart issues" (unspecified if ongoing), notes: Other medical history: severe asthma, hypertension, PVC heart issues; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Known allergies: walnut" (unspecified if ongoing), notes: Known allergies: walnut; "Known allergies: clove" (unspecified if ongoing), notes: Known allergies: clove. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Severe increase, notes: I had severe increase in blood pressure after the 3rd dose; 150/104, notes: My blood pressure went from 150/104 an hour after the 3rd dose to 220/135 3.5 hours later; 220/135, notes: My blood pressure went from 150/104 an hour after the 3rd dose to 220/135 3.5 hours later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated for COVID-19 with Paxlovid of brand Pfizer from 05Mar2023 to 06Mar2023.  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: 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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. 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 19Sep2022 as dose 4 (booster), single (Lot number: Gj2524) at the age of 71 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Lymphocytic lymphoma" (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 Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2weeks: Yes. The patient received Paxlovid from 03Mar2023 to 08Mar2023 for treatment of COVID-19. Known allergies: No.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Skin disorder, Urticaria
Clinical narrative: very bad case of blister; itching; quite a few things on my skin; hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 73-year-old 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.The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, I think its Pfizer, here is the Lot# EN6203, its the Lot# of Pfizer first one), for Covid-19 Immunization; Bnt162b2 (DOSE 2, Second dose is my Pfizer ER8730.), for Covid-19 Immunization. The following information was reported: BLISTER (non-serious), outcome "unknown", described as "very bad case of blister"; PRURITUS (non-serious), outcome "unknown", described as "itching"; SKIN DISORDER (non-serious), outcome "unknown", described as "quite a few things on my skin"; URTICARIA (non-serious), outcome "not recovered", described as "hives".   Additional information: She took the COVID-19 Vaccine and now she was having issues and its hives and she wanted to report this and she wanted to talk to someone, she wants to talk to someone about her experience. When paraphrased the concern Consumer stated, she was having a very serious problem. she was dealing with a dermatologist, a allergist, the doctors. she had a very bad case of blister, itching and quite a few things on her skin that she never had, she was 73 year old women and these things are happening. Consumer stated, she was experiencing now is it above 5 weeks now, she was 73 years old and her visiting doctors now, she still have the hives on her skin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes; "gout" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "CKD 3" (unspecified if ongoing), notes: Other medical history: CKD 3; "cancer" (unspecified if ongoing), notes: Other medical history: cancer; "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162B2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Developed blood clot in lower calves; It was in deep inside lower left calf; 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 received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 4 (booster), single (Lot number: GH9697) at the age of 69 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Patient route of administration: Intramuscular, Anatomical location: Left arm, lot number: PAA165969), administration date: 01Apr2021, when the patient was 68-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Patient route of administration: Intramuscular, Anatomical location: Left arm, 11:45), administration date: 22Apr2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Patient route of administration: Intramuscular, Anatomical location: Left arm, lot number: EW0150), administration date: 22Nov2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Developed blood clot in lower calves; It was in deep inside lower left calf". Therapeutic measures were taken as a result of thrombosis. Clinical course: The patient reported that she does not know if this was coincidence or what, had developed blood clot in lower calves. The patient stated she was very-very active, she just bike, runs, and walks. She was just very shocked to see that she had developed blood clot. So, she was on Eliquis, which is the extremely expensive drug. The patient have been on Eliquis about 3 weeks. So, she just started was very unusual that, she got blood clot. She had never have this in her life. So, she just wanted to call and report it and see if any one else has been calling in and to say that they have developed any kind of blood clot. Patient reported they did not put the time down for the vaccines but it was for dose 1 and dose 3 around 16, 16:30 in the afternoon.
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 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 17:30 as dose number unknown (booster), single (Lot number: GJ6665), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Apr2022 as dose number unknown, single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's 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". 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 which included Paxlovid from 02Mar2023 to 07Mar2023. The patient never tested negative.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: take medication for it.; "high Cholesterol" (ongoing), notes: take medication for it. Concomitant medication(s) included: LISINOPRIL, start date: Jan2019; ROSUVASTATIN, start date: Jan2020, stop date: 27Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Feb2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Feb2023) Positive; (05Mar2023) Negative; (15Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. The patient caught Covid and tested positive on Monday 27Feb2023. By Sunday 05Mar2023 had largely recovered and tested negative. But then on Tuesday 07Mar2023 symptoms returned worse than they were the first time. It had taken until 15Mar2023 to test negative again and still felt quite tired. Paxlovid started from 27Feb2023 to 04Mar2023.  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: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arms; aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arms"; PAIN (non-serious), outcome "unknown", described as "aches".  Additional information: During Covid 19 questionnaire question of family medical history relevant to adverse events caller states her boys had aches. States sore arms and aches with Covid vaccine. She was sure it was probably reported.    The information on the batch/lot number for [BNT162B2 NOS], has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300115993 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300116007 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 13Feb2021, outcome "unknown", described as "Metallic taste". Additional information: The reporter's husband experienced metallic taste in his mouth after the Pfizer Covid shot. That was a long time ago, right after the immunization came out. It occurred right after the shot, within minutes. Her husband had 4 doses Covid 19 vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300116007 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300115780 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's 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 drug ineffective, covid-19 which included Paxlovid from 02Mar2023 to 06Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine product; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2021 at 15:00 as dose 1, single (Lot number: EW0185), in right arm and on 02Jul2021 at 14:00 as dose 2, single (Lot number: EW0198) at the age of 36 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Jan2022 at 16:00 as dose 3 (booster), single (Lot number: 084J21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE, start date: 01Sep2022, stop date: 15Mar2023; LAMOTRIGINE, start date: 01Dec2022, stop date: 15Mar2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Jan2022, outcome "unknown", described as "Interchange of vaccine product"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course:  Oral contraceptive from 01Nov2022 to 15Mar2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID; COVID; Moderna- 24Oct2021/ Pfizer- 30Mar2022/ Moderna- 06Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 06Sep2022 as dose 5 (booster), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Mar2022, outcome "unknown", described as "Moderna- 24Oct2021/ Pfizer- 30Mar2022/ Moderna- 06Sep2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jan2023, outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive; (06Feb2023) Negative; (08Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Ritonavir (Paxlovid) started on 30Jan2023. Paxlovid rebound started on 07Feb2023. No admission to hospital due to the event. Tested positive for covid-19 on 30Jan2023 and began a 5 day dose of Paxlovid on the same day, began feeling better by Feb, tested negative for Covid on 06Feb2023. Feeling bad again on 07Feb2023 and Covid symptoms (cough, fever, congestion, low energy) returned. Tested positive again on 08Feb2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from 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 03Feb2023 at 09:00 as dose 5 (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), 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); "sinus bradycardia" (unspecified if ongoing); "raised cholesterol" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Mar2023) Positive, notes: I continue to test positive, 8 days after ending dose. 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: 38.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). The patient took concomitant medications which include seasonable. The following information was reported: DRUG INEFFECTIVE (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: (09Mar2023) Negative, notes: Tested negative on Day 4 of taking Paxlovid; (14Mar2023) positive, notes: Then again tested positive 3 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient tested negative on Day 4 of taking Paxlovid, but then again tested positive 3 days after finishing Paxlovid. The patient received Paxlovid from 05Mar2023 to 10Mar2023. Patient was on other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300116349 same patient, different drug, different event;
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: 4554) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: Days 6 COVID Ag negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had no known allergies. The patient was treated with Paxlovid from 06Mar2023 to 10Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300116338 Same patient, different product, different event;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Developed blood clot in our lower calves; his started in his calf worked with ways up the leg and his was worse, his actually went to his lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 04:30 as dose 4 (booster), single (Lot number: GH9697) at the age of 66 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, 1st Pfizer COVID Vaccine LOT# and Expiration date: The very 1st one was PAA165969, Time for the 1st vaccine: It was around 11 in the morning, they were in the morning, Route of administration for the 1st vaccine: Reporter stated, "They were all intramuscular, all 4), administration date: 01Apr2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, 11:45 in the morning, Route of administration for the 1st vaccine: Reporter stated, "They were all intramuscular, all 4), administration date: 22Apr2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 3 (1st booster), Route of administration for the 1st vaccine: Reporter stated, "They were all intramuscular, all 4, LOT# for the 3rd dose: Reporter stated, "Its EW0150), administration date: 22Nov2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "Developed blood clot in our lower calves; his started in his calf worked with ways up the leg and his was worse, his actually went to his lungs". Therapeutic measures were taken as a result of thrombosis (Heparin for two days in the ICU at the local hospital and Eliquis).
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 62-year-old male patient received BNT162b2 (BNT162B2 NOS), on 10Nov2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown), in right 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: "Heart stent" (not 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 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment with Paxlovid from 09Mar2023 till 13Mar2023. 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-202300116496 same reporter/patient, different product/AE;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; 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 71-year-old female patient received BNT162b2 (BNT162B2 NOS), on 01Sep2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left 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: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient had no known allergies. Patient received Paxlovid as treatment of COVID-19 from 05Mar2023 to 09Mar2023. Patient also received Acetaminophen from 05Mar2023 to 07Mar2023.  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-202300116551 Same patient, different product and event;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 09Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 07Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "possible lupus" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Reglan, reaction(s): "known allergies: reglan"; Compazine, reaction(s): "known allergies: compazine"; Imitrex, reaction(s): "known allergies: imitrex". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 05Mar2023 to 09Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300116589 same reporter/patient, different product/event;
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 30-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for influenza immunisation as dose number unknown, single (seqirus). The following information was reported: COVID-19 (medically significant) with onset 13Mar2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 13Mar2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Positive, notes: Nasal Swab. Clinical course: Patient received vaccine at Workplace clinic. Viral sx cough rhinorrhea HA body aches mild 13Mar2023.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and other HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: FD0809) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (13Mar2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Mar2023) Negative; (16Mar2023) positive, notes: with mild symptoms. Therapeutic measures (paxlovid) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300116720 same reporter/patient, different product/AE;
Age: 33.0
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) (Nurse). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 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: "Migraines" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing) and had no known allergies. There were no concomitant medications. 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started taking paxlovid treatment on 15Mar2023.  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 possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202300116764 Same patient, different product, different event;
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Feeling abnormal
Clinical narrative: first one took me months to recoup from but symptoms were not nearly as bad as the symptoms from this vaccine; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. Other Case identifier(s): MOD-2023-714901 (Moderna).  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Small intestine carcinoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "first one took me months to recoup from but symptoms were not nearly as bad as the symptoms from this vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 14Jan2023 patient woke up with the usual big body aches, Fatigue, nausea and vomiting and watery diarrhea, near migraine headache. Non painful Blood coming from rectum for two days that soaked through clothing. Stopped abruptly the 3rd day. Still having significant headaches/migraines, nausea, vomiting and watery diarrhea fatigue. Patient had lost close to 20 lbs in this time frame. Miss-ing work at times. Mostly forging through. Poor quality of life. Patient had viral syndrome. Patient had history of carcinoma of Small bowel. Patient was told patient was one of 3% of people who had these kind of symptoms. Patient was only wanting to know if there was anything to help feel better. Patient was only on medication for hypothyroidism. Stopped supplements other than multivitamin and apple cider vinegar capsules to help tummy. Patient had yearly CT for carcinoma and that was completely clear. Patient never had COVID. Patients first 3 vaccines were Pfizer- first one took me months to recoup from but symptoms were not nearly as bad as the symptoms from this vaccine. This last vaccine was Moderna. Due to the way patient was right now- patient was strongly thinking that patient will not vaccinate again for COVID. At the very least not with Moderna.   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: Drug hypersensitivity
Clinical narrative: she is allergic to one of the ingredients of the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "she is allergic to one of the ingredients of the vaccine".  Additional information: Caller wanted to know if she should take her 3rd shot because she stated that she was allergic to one of the ingredients of the vaccine. Created manual AE form because she already had previous vaccines prior to the 3rd one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.