chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Was prescribed Paxlovid / Can this drug, Paxlovid, reduce the benefits of getting the Pfizer COVID-19 vaccine; was prescribed Paxlovid / Can this drug, Paxlovid, reduce the benefits of getting the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Was prescribed Paxlovid / Can this drug, Paxlovid, reduce the benefits of getting the Pfizer COVID-19 vaccine"; COVID-19 (medically significant), outcome "unknown", described as "was prescribed Paxlovid / Can this drug, Paxlovid, reduce the benefits of getting the Pfizer COVID-19 vaccine". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient asked if PAXLOVID could reduce the benefits of getting the Pfizer COVID-19 vaccine reported it was administered it 8 or 10 days ago.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm and on 01Sep2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; CENTRUM JR [MINERALS NOS;VITAMINS NOS]; GLUCOSAMINE; EMERGEN-C VITAMIN D & CALCIUM; FISH OIL; MUCINEX D, start date: 03Dec2022, stop date: 07Dec2022; NORGESTIMATE & ETHINYL ESTRADIOL; TYLENOL, start date: 01Dec2022, stop date: 05Dec2022; VITAMIN C [ASCORBIC ACID]. Past drug history included: Remicade for immunosuppressant, notes: taking immunosuppressant, Remicade. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Negative, notes: Tested negative on day 6 and felt better; (12Dec2022) Positive, notes: Rebound covid positive test on day 11. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was in other medication in 2weeks, took full course of Paxlovid Day1-5. Tested negative on day 6 and felt better. On day 9 feeling unwell. Rebound covid positive test on day 11 and COVID 19 treatment received with Paxlovid from 02Dec2022 to 06Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201369695 same patient/drug, different dose/AE;
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lymphadenopathy, Ultrasound testes
Clinical narrative: swollen lymph node under the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 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. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, She states she has the original covid vaccine and booster 3 and 4), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, She states she has the original covid vaccine and booster 3 and 4), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN, She states she has the original covid vaccine and booster 3 and 4), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN, She states she has the original covid vaccine and booster 3 and 4), for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node under the arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Female consumer states that she had the bivalent Pfizer Covid 19 vaccine on 27Oct. She states she has the original covid vaccine and booster 3 and 4. She recently had a monogram that showed a swollen lymph node under the arm. She states that she has never had this result before and now she was having to have more testing with includes as ultrasound and possibly a biopsy. She states that many women are having panic attached before they get the vaccines and they cause swollen lymph node and then when they have monograms they show up. States that shouldn't go to get a monograph until 2-3 month after vaccines. Also makes her wonder if it could cause cancer. States she was almost 5 weeks out from vaccine when she got the monogram and she wasnt told to wait.   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, SARS-CoV-2 test
Clinical narrative: still got covid; still got covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "still got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical details: Patient said she is a woman with covid and a prescription for Paxlovid. She asked what's the time interval between getting a recent Pfizer covid vaccine shot and starting Paxlovid. She stated that she had the bivalent Pfizer covid vaccine last month but still got covid now. She also mentioned that every after she got the Pfizer covid vaccine she experienced Guillain-Barre symptoms. Patient said she was taking immunoglobulin or IVIG (Gammagard) and would like to know if there is information for a possible drug interaction between Paxlovid and the IVIG. Patient said one of her doctors told her she could still take Paxlovid after the 5 day symptom onset but that it would not be as effective, and that her other doctors said that she should take it within the 5 day symptom onset. Patient asked what is Pfizer's recommendation on the matter since her doctors are giving contradictory information.  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: She developed a mild case of Covid on 09Sep2022, and tested positive 13Sep2022; She developed a mild case of Covid on 09Sep2022, and tested positive 13Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), 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 on 10Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Sep2022, outcome "unknown" and all described as "She developed a mild case of Covid on 09Sep2022, and tested positive 13Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Positive.  Clinical course: It was reported that patient was asking when she can get the booster dose of the Pfizer BioNTech Covid vaccine. She has had four previous boosters of the Pfizer Covid vaccines, the last being administered on 10Aug2022. She developed a mild case of Covid on 09Sep2022, and tested positive 13Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Full blood count, Investigation, Metabolic function test, SARS-CoV-2 test
Clinical narrative: Covid test/ Result: positive for Covid; Covid test/ Result: positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 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: "Guillain Barre syndrome" (unspecified if ongoing); "Myasthenia gravis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "over weight" (unspecified if ongoing); "Covid", start date: Mar2020 (unspecified if ongoing), notes: first symptoms of Covid Mar2020. having a Myasthenia flare up and also getting Guillain-Barre symptoms with it. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 09Dec2022, outcome "unknown", COVID-19 (medically significant) with onset 09Dec2022, outcome "unknown" and all described as "Covid test/ Result: positive for Covid". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) good, notes: everything was good; Flu test: (09Dec2022) Positive, notes: positive for Flu B; Unit: Not Provided; Metabolic function test: (unspecified date) good, notes: everything was good; SARS-CoV-2 test: (09Dec2022) Positive, notes: Result: positive for Covid; Unit: Not Provided.  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.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: Covid test/ Result: positive for Covid; Covid test/ Result: positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 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: "Guillain Barre syndrome" (unspecified if ongoing); "Myasthenia gravis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "over weight" (unspecified if ongoing); "Covid", start date: Mar2020 (unspecified if ongoing), notes: first symptoms of Covid Mar2020. having a Myasthenia flare up and also getting Guillain-Barre symptoms with it. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 09Dec2022, outcome "unknown", COVID-19 (medically significant) with onset 09Dec2022, outcome "unknown" and all described as "Covid test/ Result: positive for Covid". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) good, notes: everything was good; Flu test: (09Dec2022) Positive, notes: positive for Flu B; Unit: Not Provided; Metabolic function test: (unspecified date) good, notes: everything was good; SARS-CoV-2 test: (09Dec2022) Positive, notes: Result: positive for Covid; Unit: Not Provided.  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.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Full blood count, Guillain-Barre syndrome, Metabolic function test
Clinical narrative: Covid test/ Result: positive for Covid; Covid test/ Result: positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 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: "Guillain Barre syndrome" (unspecified if ongoing); "Myasthenia gravis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "over weight" (unspecified if ongoing); "Covid", start date: Mar2020 (unspecified if ongoing), notes: first symptoms of Covid Mar2020. having a Myasthenia flare up and also getting Guillain-Barre symptoms with it. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 09Dec2022, outcome "unknown", COVID-19 (medically significant) with onset 09Dec2022, outcome "unknown" and all described as "Covid test/ Result: positive for Covid". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) good, notes: everything was good; Flu test: (09Dec2022) Positive, notes: positive for Flu B; Unit: Not Provided; Metabolic function test: (unspecified date) good, notes: everything was good; SARS-CoV-2 test: (09Dec2022) Positive, notes: Result: positive for Covid; Unit: Not Provided.  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.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature, Body temperature fluctuation, Chest discomfort, Full blood count, Guillain-Barre syndrome
Clinical narrative: Covid test/ Result: positive for Covid; Covid test/ Result: positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 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: "Guillain Barre syndrome" (unspecified if ongoing); "Myasthenia gravis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "over weight" (unspecified if ongoing); "Covid", start date: Mar2020 (unspecified if ongoing), notes: first symptoms of Covid Mar2020. having a Myasthenia flare up and also getting Guillain-Barre symptoms with it. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 09Dec2022, outcome "unknown", COVID-19 (medically significant) with onset 09Dec2022, outcome "unknown" and all described as "Covid test/ Result: positive for Covid". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) good, notes: everything was good; Flu test: (09Dec2022) Positive, notes: positive for Flu B; Unit: Not Provided; Metabolic function test: (unspecified date) good, notes: everything was good; SARS-CoV-2 test: (09Dec2022) Positive, notes: Result: positive for Covid; Unit: Not Provided.  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.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Influenza, Metabolic function test, Pyrexia, Renal pain
Clinical narrative: Covid test/ Result: positive for Covid; Covid test/ Result: positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 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: "Guillain Barre syndrome" (unspecified if ongoing); "Myasthenia gravis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "over weight" (unspecified if ongoing); "Covid", start date: Mar2020 (unspecified if ongoing), notes: first symptoms of Covid Mar2020. having a Myasthenia flare up and also getting Guillain-Barre symptoms with it. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 09Dec2022, outcome "unknown", COVID-19 (medically significant) with onset 09Dec2022, outcome "unknown" and all described as "Covid test/ Result: positive for Covid". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) good, notes: everything was good; Flu test: (09Dec2022) Positive, notes: positive for Flu B; Unit: Not Provided; Metabolic function test: (unspecified date) good, notes: everything was good; SARS-CoV-2 test: (09Dec2022) Positive, notes: Result: positive for Covid; Unit: Not Provided.  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.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Urinary tract infection
Clinical narrative: Covid test/ Result: positive for Covid; Covid test/ Result: positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 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: "Guillain Barre syndrome" (unspecified if ongoing); "Myasthenia gravis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "over weight" (unspecified if ongoing); "Covid", start date: Mar2020 (unspecified if ongoing), notes: first symptoms of Covid Mar2020. having a Myasthenia flare up and also getting Guillain-Barre symptoms with it. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 09Dec2022, outcome "unknown", COVID-19 (medically significant) with onset 09Dec2022, outcome "unknown" and all described as "Covid test/ Result: positive for Covid". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) good, notes: everything was good; Flu test: (09Dec2022) Positive, notes: positive for Flu B; Unit: Not Provided; Metabolic function test: (unspecified date) good, notes: everything was good; SARS-CoV-2 test: (09Dec2022) Positive, notes: Result: positive for Covid; Unit: Not Provided.  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.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: flare up of her guillain-barre; flare up of her guillain-barre; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia Gravis" (ongoing), notes: Comments: Myasthenia Gravis, Also reports hx of Myasthenia Gravis; "Hashimoto's disease" (unspecified if ongoing), notes: Comments: Hashimoto's disease; "Guillain Barre syndrome" (ongoing), notes: Comments: Guillain Barre syndrome; "COVID", start date: Mar2020 (unspecified if ongoing), notes: Had first symptoms of Covid Mar2020.; "over weight" (unspecified if ongoing). Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis (ongoing). Vaccination history included: Bnt162b2 (First Dose: Apr2021, she thinks, when they came out), administration date: Apr2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Has autonomic dysfunction and had an increase of that as well", "balance was off", "Her eyes, she had the miller fisher variant and her eyes got really wonky again", "flareup of her guillain-barre", "after the first vaccine, her reflexes went away and that was it"; Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "flare up of her guillain-barre". The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), CONDITION AGGRAVATED (medically significant), outcome "recovered" and all described as "flare up of her guillain-barre". The event "flare up of her guillain-barre" required physician office visit. The patient underwent the following laboratory tests and procedures: Full blood count: that came back good, everything was good; Metabolic function test: that came back good, everything was good. Therapeutic measures were taken as a result of guillain-barre syndrome, condition aggravated. Clinical course: Patient had first symptoms of Covid Mar2020. Was having a Myasthenia flare up and also getting Guillain-Barre symptoms with it. Then, was on a low dose, 2mg for and with the Covid, they bumped it up to 4mg and has stayed at 4mg since then. Now, because of what is going on, they will bump it up for just a week to 10mg. Will start the 10mg dose today. Just talked to doctor about it. Had physician appointment after the first time, for sure. went again this May2022 and was symptomatic then, as well. Then, had surgery in Jun2022 and had more symptoms then. Hard to know which caused the symptoms. Got a flareup of Guillain-Barre and hadn't had a flareup for 30 years. They did an IVIG, intravenous immunoglobulin treatment. She just finished the series last week. Clarified this treatment as the Gamma Gard infusion which was previously mentioned that she believes she had a reaction to.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 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: "Diabetes" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Barrett's esophagus" (unspecified if ongoing), notes: Other medical history: Hx of Barrett's esophagus. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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) Negative, notes: Patient had 2 negative tests prior to rebound symptoms; (unspecified date) Negative, notes: Patient had 2 negative tests prior to rebound symptoms; (Dec2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 02Dec2022 to 07Dec2022. Clinical Course: It was unknown if he received other medication in 2weeks. No known allergies. Rebound COVID-19 symptoms and positive test after treatment with Paxlovid. Patient had 2 negative tests prior to rebound symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the reported events and BNT162B2.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer Covid Vaccines: Covid positive after 5 vaccines; Pfizer Covid Vaccines: Covid positive after 5 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Anxiety" (unspecified if ongoing), she has not been diagnosed, but she knows she has anxiety. Stated that it was not a new condition for her; "she hasn't slept well" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing), notes: 25 years ago. Concomitant medication(s) included: TRAZODONE taken for sleep disorder (ongoing). The patient stated that the 5 shots she mentioned receiving were 5 doses of the Pfizer Covid Vaccines. She got her first ones back before anyone else because the hospital her daughter works at offered them to the families of nurses.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer Covid Vaccines: Covid positive after 5 vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2022) Positive; (12Dec2022) Negative. Patient mentioned that she tested positive for Covid last Tuesday (08Dec2022) and tested negative in the morning of 12Dec2022 with a home test. She called the doctor. Her husband had tested positive on Monday or Tuesday. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 06Dec2022 to 10Dec2022 at 3 tablets twice a day by mouth. 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-202201372357 same patient and suspect drug, different event and dose;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: Pfizer Covid Vaccines: Covid positive after 5 vaccines; Pfizer Covid Vaccines: Covid positive after 5 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Anxiety" (unspecified if ongoing), she has not been diagnosed, but she knows she has anxiety. Stated that it was not a new condition for her; "she hasn't slept well" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing), notes: 25 years ago. Concomitant medication(s) included: TRAZODONE taken for sleep disorder (ongoing). The patient stated that the 5 shots she mentioned receiving were 5 doses of the Pfizer Covid Vaccines. She got her first ones back before anyone else because the hospital her daughter works at offered them to the families of nurses.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer Covid Vaccines: Covid positive after 5 vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2022) Positive; (12Dec2022) Negative. Patient mentioned that she tested positive for Covid last Tuesday (08Dec2022) and tested negative in the morning of 12Dec2022 with a home test. She called the doctor. Her husband had tested positive on Monday or Tuesday. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 06Dec2022 to 10Dec2022 at 3 tablets twice a day by mouth. 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-202201372357 same patient and suspect drug, different event and dose;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: achy; nauseous; weak stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Anxiety" (unspecified if ongoing); "she hasn't slept" (unspecified if ongoing), notes: Caller states that she takes this medication to help her sleep because she hasn't slept well since her hysterectomy 25 years ago; "hysterectomy" (unspecified if ongoing), notes: Caller states that she takes this medication to help her sleep because she hasn't slept well since her hysterectomy 25 years ago; "Sleep" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE [TRAZODONE HYDROCHLORIDE] taken for sleep disorder (ongoing). The following information was reported: PAIN (non-serious), outcome "recovered", described as "achy"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "weak stomach". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter states that the 5 shots she mentioned receiving were 5 doses of the Pfizer Covid Vaccines. States that she got her first ones back before anyone else because the hospital her daughter works at offered them to the families of nurses. Dates and Lot Numbers for the reporter's 5 doses of the Pfizer Covid Vaccines are unknown. States all she knows was there were 5 of them and they were all Pfizer. Reporter states she thought about switching to Moderna but didn't because she knew what she was going to get with Pfizer. States she had no side effects from any of the shots. She might have just been achy for 12-20 hours. States that she also had a weak stomach and gets nauseous that was normal for her. Trazodone: reporter states that she had been taking this medication for 20-30 years.  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-202201372270 same patient and suspect drug, different event and dose;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: achy; nauseous; weak stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Anxiety" (unspecified if ongoing); "she hasn't slept" (unspecified if ongoing), notes: Caller states that she takes this medication to help her sleep because she hasn't slept well since her hysterectomy 25 years ago; "hysterectomy" (unspecified if ongoing), notes: Caller states that she takes this medication to help her sleep because she hasn't slept well since her hysterectomy 25 years ago; "Sleep" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE [TRAZODONE HYDROCHLORIDE] taken for sleep disorder (ongoing). The following information was reported: PAIN (non-serious), outcome "recovered", described as "achy"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "weak stomach". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter states that the 5 shots she mentioned receiving were 5 doses of the Pfizer Covid Vaccines. States that she got her first ones back before anyone else because the hospital her daughter works at offered them to the families of nurses. Dates and Lot Numbers for the reporter's 5 doses of the Pfizer Covid Vaccines are unknown. States all she knows was there were 5 of them and they were all Pfizer. Reporter states she thought about switching to Moderna but didn't because she knew what she was going to get with Pfizer. States she had no side effects from any of the shots. She might have just been achy for 12-20 hours. States that she also had a weak stomach and gets nauseous that was normal for her. Trazodone: reporter states that she had been taking this medication for 20-30 years.  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-202201372270 same patient and suspect drug, different event and dose;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 23May2020 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Intractable back pain." (unspecified if ongoing). Concomitant medication(s) included: MORPHINE oral, start date: 01Jan2020. Past drug history included: Neurontin for known allergies: neurontin, notes: known allergies: neurontin; Gabapentin for known allergies: Gabapentin, notes: known allergies: Gabapentin; Nsaids for known allergies: Nsaids, notes: known allergies: Nsaids.  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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: product COVID 19 Treatment brand Paxlovid treatment start date: 11Dec2022, treatment stop date: 13Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19-2
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).  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (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), 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: "rheumatoid arthritis" (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 "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Covid-19 Test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID taken orally from 04Dec2022 to 09Dec2022.  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: 61.0
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 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 09:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 61 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: "Seizure" (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 as a result of drug ineffective, covid-19.  Clinical course: The vaccine received was yes. Other medication in 2weeks was unknown. COVID 19 Treatment, brand Pfizer, Treatment start date was 30Nov2022, Treatment stop date was 05Dec2022, indication was treatment of COVID-19.
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. 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 13Oct2022 at 14:00 as dose 5 (booster), single (Lot number: 59267030402) at the age of 69 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's relevant medical history included: "Moderate cholesterol" (unspecified if ongoing), notes: Other medical history: Moderate cholesterol; "Glaucoma" (unspecified if ongoing), notes: Other medical history: Glaucoma. Concomitant medication(s) included: ATORVASTATIN, start date: 14Oct2022, stop date: 27Nov2022. Past drug history included: Percodan, reaction(s): "Known allergies: Percodan", notes: Known allergies: Percodan. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 13:00 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's relevant medical history included: "Hashimoto l" (unspecified if ongoing); "Epstein Bar" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT, start date: 06Feb2014. Past drug history included: Compazine, reaction(s): "known allergies: Compazine". 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: Patient was in other medication in 2weeks, and received COVID-19 treatment with Paxlovid from 01Dec2022 to 07Dec2022.  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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had the 3 of them already and I still got the COVID; I had the 3 of them already and I still got the COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 and concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "allergic to Sulfur", notes: I am allergic to Sulfur. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had the 3 of them already and I still got the COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient's doctor prescribed the patient one medication called PAXLOVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.