chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-year-old male patient received BNT162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). The patient took 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 11May2023 to 15May2023 as a treatment for the events. He received Multiple vitamins from Jan2023 to May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got 2nd shot and with in 2 weeks she is in hospital with COVID; Got 2nd shot and with in 2 weeks she is in hospital with COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: ER8730), in left arm and in Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary fibrosis", start date: 2019 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: chemo; "Lupus", start date: 2016 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "chronic migraines", start date: 2010 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "Fibromyalgia", start date: 2016 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "Chemo" (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: chemo. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Jul2021, outcome "unknown" and all described as "Got 2nd shot and with in 2 weeks she is in hospital with COVID". The patient was hospitalized for drug ineffective, covid-19 (start date: Jul2021, discharge date: 09Sep2021). The events "got 2nd shot and with in 2 weeks she is in hospital with covid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Had COVID. Therapeutic measures were taken as a result of covid-19. The following death information was reported, despite no fatal outcome. The patient date of death was 09Sep2021. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Clinical course: Got 2nd shot and within 2 weeks the patient was in hospital with COVID and was there from Jul2021 till 09Sep2021. She died 03:00 PM. Started feeling sick the next day. Heavy chest and fever, feeling bad. Started feeling bad over the next few days and went to doctor after about 10 days not feeling good. Had COVID. The patient was hospitalized from Mid Jul till 09Sep2021 died. Prior Vaccinations: None. The reporter stated that until she took the vaccines she was alive and not any more manned for 37 years with 2 questions and 4 grand kids second shot in Jul.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died/Dead
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Feeling abnormal, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Got 2nd shot and with in 2 weeks she is in hospital with COVID; Got 2nd shot and with in 2 weeks she is in hospital with COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: ER8730), in left arm and in Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary fibrosis", start date: 2019 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: chemo; "Lupus", start date: 2016 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "chronic migraines", start date: 2010 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "Fibromyalgia", start date: 2016 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "Chemo" (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: chemo. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Jul2021, outcome "unknown" and all described as "Got 2nd shot and with in 2 weeks she is in hospital with COVID". The patient was hospitalized for drug ineffective, covid-19 (start date: Jul2021, discharge date: 09Sep2021). The events "got 2nd shot and with in 2 weeks she is in hospital with covid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Had COVID. Therapeutic measures were taken as a result of covid-19. The following death information was reported, despite no fatal outcome. The patient date of death was 09Sep2021. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Clinical course: Got 2nd shot and within 2 weeks the patient was in hospital with COVID and was there from Jul2021 till 09Sep2021. She died 03:00 PM. Started feeling sick the next day. Heavy chest and fever, feeling bad. Started feeling bad over the next few days and went to doctor after about 10 days not feeling good. Had COVID. The patient was hospitalized from Mid Jul till 09Sep2021 died. Prior Vaccinations: None. The reporter stated that until she took the vaccines she was alive and not any more manned for 37 years with 2 questions and 4 grand kids second shot in Jul.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died/Dead
Age: 68.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Nov2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 68 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: "No" (unspecified if ongoing), notes: Known allergies: No, Other medical history: Looking at the patient's meds, you can probably figure it out. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product: COVID 19 Treatment, brand: Pfizer, from 20May2023 to 21May2023 orally.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other: Moderna, vaccine brand: Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Mar2022 as dose 4 (booster), single (Lot number: 069H21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: asthma. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "not recovered", described as "vaccine brand other: Moderna, vaccine brand: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had treatment with Paxlovid started on 13May2023 and stopped on 18May2023. known allergies: no.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Patient treated with Paxlovid from 12May2023.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: I started losing my hairs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FP7136) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "I started losing my hairs".  Additional information: The patient received the first dose on 14Apr, within 2 days she started losing her hairs and when she got second dose of it, it was almost all completely fallen out and right about quarter to a 3rd of hairs that was it. The patient stated that it increased hair loss and she had lost about almost well over half the 3 quarters of her hair from this. She had not changed any products that she used prior to this. It started falling out about 2 days after receiving the first Covid shot.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: when I get second dose of it, it is almost all completely fallen out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: GE1990) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot: FP7136, received the first dose on 14Apr), for COVID-19 immunization, reaction(s): "I started losing my hairs". The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "when I get second dose of it, it is almost all completely fallen out".  Additional information: Reporter was calling about the Covid Vaccine. She received the first dose on 14Apr, within 2 days she started losing her hairs and when she got second dose of it, it is almost all completely fallen out and right about quarter to a 3rd of hairs that was it. The reporter stated that it increased the hair loss, and she had lost about almost well over half the 3 quarters of her hair from this. She has not changed any products that she used prior to this and like she said, it started falling out about 2 days after receiving first Covid shot. She reported, this is the huge hair loss. Patient was asking does Pfizer do anything to reimburse because now the patient has to go to the Physician now. The patient stated, "Yes, I just said Is Pfizer is going to reimburse for anything that it is going to take from me to grow this hair back. Where there be hormone therapy or whatever because I have a doctor's appointment to go to. It is that bad."
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in each arm and both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), 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: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy in each arm and both hands".  Clinical course: After receiving a Pfizer vaccine in each arm I now have neuropathy in each arm and both hands. I don't have diabetes or any other issues I think I need to be compensated for this horrible heath issue.   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-PV202300093283 same patient, same vaccine, different doses, same events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ6796), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received Paxlovid treatment for COVID 19 from 15May2023 to 19May2023, patient received other medication in 2weeks product Nyquil, Tylenol, probiotics, ester C, vitamin D, Patient did not have Known allergies.  No follow-up attempts are possible. No further information is expected.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old 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 was not reported. Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE], start date: 01Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment: Paxlovid: Treatment start date 15May2023 till treatment stop date 20May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bladder dysfunction, Platelet count, Platelet count increased
Clinical narrative: Pain in every joint; Loss of bladder function; Blood platelet count went to 636,000; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: EN5318) at the age of 82 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, At 11:00, Batch/lot number: EL3246, Anatomical location: Left arm), administration date: 2021, for COVID-19 Immunisation. The following information was reported: PLATELET COUNT INCREASED (caused and prolonged hospitalization, disability, life threatening) with onset 25Dec2021 at 01:00, outcome "recovered with sequelae", described as "Blood platelet count went to 636,000"; BLADDER DYSFUNCTION (caused and prolonged hospitalization, disability, life threatening) with onset 25Dec2021 at 01:00, outcome "recovered with sequelae", described as "Loss of bladder function"; ARTHRALGIA (caused and prolonged hospitalization, disability, life threatening) with onset 25Dec2021 at 01:00, outcome "recovered with sequelae", described as "Pain in every joint". The patient was hospitalized and prolonged hospitalization for arthralgia, bladder dysfunction, platelet count increased (hospitalization duration: 52 day(s)). The events "pain in every joint", "loss of bladder function" and "blood platelet count went to 636,000" required emergency room visit. The patient underwent the following laboratory tests and procedures: Platelet count: went to 636,000, notes: high. Therapeutic measures were taken as a result of arthralgia, bladder dysfunction, platelet count increased. Clinical course: Patient had pain in every joint which felt like when cutting with razor or knife and loss of bladder function. He was hospitalized for 2 months. He had two surgeries on bladder spine nerves. He recovered with lasting effects. He received many treatments. Patient did not received other vaccine in four weeks, not received other medications in two weeks.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna, Vaccine dose number=4 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: Fe3590) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Apr2022 as dose 4 (booster), single (Lot number: 059M21A), in right arm and on 01Nov2022 at 12:15 as dose 5 (booster), single (Lot number: 049022H), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Apr2022, outcome "unknown", described as "Vaccine brand other=Moderna, Vaccine dose number=4 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Other medication in 2weeks: Yes, Other medication details: Other medication in 2weeks product=Losartin. Anti-viral details: Product=COVID 19 Treatment, Treatment start date=12May2023, Treatment stop date=17May2023.
Age: 61.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: bee stings" (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 "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient took Paxlovid Treatment from 15May2023 to 19May2023.  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Gait inability, Hyperacusis
Clinical narrative: Drug Ineffective; COVID-19; vertigo; unable to walk; extreme fatigue; light sensitivity; noise sensitivity; nonstop migraines; nausea; This is a spontaneous report received from 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 02Apr2021 as dose 1, single (Lot number: ER9733) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (disability) with onset 04Apr2021, outcome "not recovered", described as "extreme fatigue"; PHOTOPHOBIA (disability) with onset 04Apr2021, outcome "not recovered", described as "light sensitivity"; NAUSEA (disability) with onset 04Apr2021, outcome "not recovered"; HYPERACUSIS (disability) with onset 04Apr2021, outcome "not recovered", described as "noise sensitivity"; MIGRAINE (disability) with onset 04Apr2021, outcome "not recovered", described as "nonstop migraines"; GAIT INABILITY (disability) with onset 04Apr2021, outcome "not recovered", described as "unable to walk"; VERTIGO (disability) with onset 04Apr2021, outcome "not recovered"; COVID-19 (disability, medically significant) with onset 01Jan2022, outcome "not recovered"; DRUG INEFFECTIVE (disability, medically significant) with onset 01Jan2022, outcome "not recovered". The events "vertigo", "unable to walk", "extreme fatigue", "light sensitivity", "noise sensitivity", "nonstop migraines" and "nausea" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive. Therapeutic measures were taken as a result of vertigo, gait inability, fatigue, photophobia, hyperacusis, migraine, nausea which includes Specialists, care of concierge doc. Clinical course: Patient reports that fatigue was ongoing and that becomes extreme after any strenuous activity; periodic vertigo; loud noises cause vertigo and nausea. Patient did not experienced COVID prior vaccination. Patient  tested COVID positive post vaccination. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and received treatment.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Photophobia, SARS-CoV-2 test, Vertigo
Clinical narrative: Drug Ineffective; COVID-19; vertigo; unable to walk; extreme fatigue; light sensitivity; noise sensitivity; nonstop migraines; nausea; This is a spontaneous report received from 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 02Apr2021 as dose 1, single (Lot number: ER9733) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (disability) with onset 04Apr2021, outcome "not recovered", described as "extreme fatigue"; PHOTOPHOBIA (disability) with onset 04Apr2021, outcome "not recovered", described as "light sensitivity"; NAUSEA (disability) with onset 04Apr2021, outcome "not recovered"; HYPERACUSIS (disability) with onset 04Apr2021, outcome "not recovered", described as "noise sensitivity"; MIGRAINE (disability) with onset 04Apr2021, outcome "not recovered", described as "nonstop migraines"; GAIT INABILITY (disability) with onset 04Apr2021, outcome "not recovered", described as "unable to walk"; VERTIGO (disability) with onset 04Apr2021, outcome "not recovered"; COVID-19 (disability, medically significant) with onset 01Jan2022, outcome "not recovered"; DRUG INEFFECTIVE (disability, medically significant) with onset 01Jan2022, outcome "not recovered". The events "vertigo", "unable to walk", "extreme fatigue", "light sensitivity", "noise sensitivity", "nonstop migraines" and "nausea" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive. Therapeutic measures were taken as a result of vertigo, gait inability, fatigue, photophobia, hyperacusis, migraine, nausea which includes Specialists, care of concierge doc. Clinical course: Patient reports that fatigue was ongoing and that becomes extreme after any strenuous activity; periodic vertigo; loud noises cause vertigo and nausea. Patient did not experienced COVID prior vaccination. Patient  tested COVID positive post vaccination. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and received treatment.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antibody test, Antinuclear antibody, Aspartate aminotransferase, Blood immunoglobulin G
Clinical narrative: a case of acute onset of hepatitis and following covid 19 initial vaccine; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Patient has never had alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEPATITIS (medically significant), 3 days after the suspect product(s) administration, outcome "recovered", described as "a case of acute onset of hepatitis and following covid 19 initial vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 446; 622, notes: peaked at day 20; Antibody test: negative; negative; Antinuclear antibody: negative; Aspartate aminotransferase: 212; 232, notes: peaked at day 20; Blood immunoglobulin G: negative; Cytomegalovirus test: negative; Epstein-Barr virus test: negative; Gamma-glutamyltransferase: 101; autoimmune markers: negative; Investigation normal: was positive for hepatomegaly; Viral test: negative.  Clinical course: Case of hepatitis with symptoms lasting for 4-5 weeks following covid 19 initial vaccine and an accidental booster dose.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202300197814 Same article/patient/drug and different event/dose;
Sex: M
Vaccine: COVID19
Symptoms: Cytomegalovirus test, Epstein-Barr virus test, Gamma-glutamyltransferase, Hepatitis, Investigation
Clinical narrative: a case of acute onset of hepatitis and following covid 19 initial vaccine; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Patient has never had alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEPATITIS (medically significant), 3 days after the suspect product(s) administration, outcome "recovered", described as "a case of acute onset of hepatitis and following covid 19 initial vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 446; 622, notes: peaked at day 20; Antibody test: negative; negative; Antinuclear antibody: negative; Aspartate aminotransferase: 212; 232, notes: peaked at day 20; Blood immunoglobulin G: negative; Cytomegalovirus test: negative; Epstein-Barr virus test: negative; Gamma-glutamyltransferase: 101; autoimmune markers: negative; Investigation normal: was positive for hepatomegaly; Viral test: negative.  Clinical course: Case of hepatitis with symptoms lasting for 4-5 weeks following covid 19 initial vaccine and an accidental booster dose.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202300197814 Same article/patient/drug and different event/dose;
Sex: M
Vaccine: COVID19
Symptoms: Investigation normal, Viral test
Clinical narrative: a case of acute onset of hepatitis and following covid 19 initial vaccine; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Patient has never had alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEPATITIS (medically significant), 3 days after the suspect product(s) administration, outcome "recovered", described as "a case of acute onset of hepatitis and following covid 19 initial vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 446; 622, notes: peaked at day 20; Antibody test: negative; negative; Antinuclear antibody: negative; Aspartate aminotransferase: 212; 232, notes: peaked at day 20; Blood immunoglobulin G: negative; Cytomegalovirus test: negative; Epstein-Barr virus test: negative; Gamma-glutamyltransferase: 101; autoimmune markers: negative; Investigation normal: was positive for hepatomegaly; Viral test: negative.  Clinical course: Case of hepatitis with symptoms lasting for 4-5 weeks following covid 19 initial vaccine and an accidental booster dose.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202300197814 Same article/patient/drug and different event/dose;
Age: 50.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Cellulitis, Hypersensitivity, Rash, Skin warm
Clinical narrative: allergic reaction; cellulitis/arm had a rash and was hot it continued to grow until I was admitted to the hospital; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 25Feb2017 as dose number unknown, single (Lot number: R12276, Expiration Date: 01Feb2018) at the age of 50 years intramuscular, in left deltoid for immunisation; pneumococcal vaccine (PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE]), on 25Feb2017 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "SLL lymphoma", start date: 20Jan2017 (unspecified if ongoing), notes: diagnosed 20Jan2017, no treatments; "Immunocompromised" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CELLULITIS (hospitalization, intervention required) with onset 25Feb2017, outcome "recovered", described as "cellulitis/arm had a rash and was hot it continued to grow until I was admitted to the hospital"; HYPERSENSITIVITY (hospitalization, intervention required) with onset 2017, outcome "unknown", described as "allergic reaction". The patient was hospitalized for cellulitis (hospitalization duration: 2 day(s)). The events "cellulitis/arm had a rash and was hot it continued to grow until i was admitted to the hospital" required emergency room visit. Therapeutic measures were taken as a result of cellulitis.  Clinical course: The patient had cellulitis on 25Feb2017 and was admitted to the hospital due to the event. The patient received treatment and was fine now. The reported issue occurred after the use of the Pfizer product. The patient reported that soon after receiving vaccination, her arm had a rash and was hot and it continued to grow until she was admitted to the hospital. She was there 2 days. In 2017, the patient received oral antibiotics from her internist, had no relief at ER provided antibiotic shot in the tush, and next day she was admitted with IV antibiotics. She only had cellulitis after receiving pneumonia vaccination. She would like to know the ingredients to potentially rule out an allergic reaction. She thought she had an allergic reaction, as she ended up with cellulitis. The patient had no other products that were taken together with those indicated above.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Autoimmune hepatitis, Bilirubin conjugated, Blood alkaline phosphatase
Clinical narrative: VS were normal, physical examination was remarkable for jaundice and mild RUQ tenderness; This is a literature report.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ulcerative colitis" (ongoing), notes: on home sulfasalazine. Concomitant medication(s) included: SULFASALAZINE taken for colitis ulcerative (ongoing). The following information was reported: AUTOIMMUNE HEPATITIS (hospitalization, medically significant), outcome "unknown", described as "VS were normal, physical examination was remarkable for jaundice and mild RUQ tenderness". The events "vs were normal, physical examination was remarkable for jaundice and mild ruq tenderness" required emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1476 IU/l; Aspartate aminotransferase: 1621 IU/l; Bilirubin conjugated: 4.5 mg/dl; Blood alkaline phosphatase: 167 IU/l; Blood bilirubin: 6.0 mg/dl; C-reactive protein: 3.40 mg/dl; Endoscopic ultrasound: diffuse abnormal echotexture, notes: in the visualized portion of the liver; Gamma-glutamyltransferase: 339; reactive oxygen species: Negative; Magnetic resonance imaging: unremarkable; Pathology test: No significant ductal pathology; physical examination: was remarkable for jaundice and mild RUQ tendernes; Red blood cell sedimentation rate: 99, notes: mm; Ultrasound abdomen: unremarkable; Vital signs measurement: Normal. Therapeutic measures were taken as a result of autoimmune hepatitis. Clinical course: The patient with ulcerative colitis on home sulfasalazine who presented to the emergency department (ED) with complaints of a vague, non-cramping, and dull RUQ abdominal pain for 3 weeks duration. The patient's social history is unremarkable. No recent travel, occupational exposures, herbal supplements use, or acetaminophen use. He received 2 doses of Pfizer COVID -19 vaccines, last dose was around 21 days before admission. The patient was treated with azathioprine and prednisone 60 mg daily with slow tapering and with continuation of his home dose sulfasalazine.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Autoimmune hepatitis and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin, C-reactive protein, Endoscopic ultrasound, Gamma-glutamyltransferase, Investigation
Clinical narrative: VS were normal, physical examination was remarkable for jaundice and mild RUQ tenderness; This is a literature report.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ulcerative colitis" (ongoing), notes: on home sulfasalazine. Concomitant medication(s) included: SULFASALAZINE taken for colitis ulcerative (ongoing). The following information was reported: AUTOIMMUNE HEPATITIS (hospitalization, medically significant), outcome "unknown", described as "VS were normal, physical examination was remarkable for jaundice and mild RUQ tenderness". The events "vs were normal, physical examination was remarkable for jaundice and mild ruq tenderness" required emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1476 IU/l; Aspartate aminotransferase: 1621 IU/l; Bilirubin conjugated: 4.5 mg/dl; Blood alkaline phosphatase: 167 IU/l; Blood bilirubin: 6.0 mg/dl; C-reactive protein: 3.40 mg/dl; Endoscopic ultrasound: diffuse abnormal echotexture, notes: in the visualized portion of the liver; Gamma-glutamyltransferase: 339; reactive oxygen species: Negative; Magnetic resonance imaging: unremarkable; Pathology test: No significant ductal pathology; physical examination: was remarkable for jaundice and mild RUQ tendernes; Red blood cell sedimentation rate: 99, notes: mm; Ultrasound abdomen: unremarkable; Vital signs measurement: Normal. Therapeutic measures were taken as a result of autoimmune hepatitis. Clinical course: The patient with ulcerative colitis on home sulfasalazine who presented to the emergency department (ED) with complaints of a vague, non-cramping, and dull RUQ abdominal pain for 3 weeks duration. The patient's social history is unremarkable. No recent travel, occupational exposures, herbal supplements use, or acetaminophen use. He received 2 doses of Pfizer COVID -19 vaccines, last dose was around 21 days before admission. The patient was treated with azathioprine and prednisone 60 mg daily with slow tapering and with continuation of his home dose sulfasalazine.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Autoimmune hepatitis and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pathology test, Physical examination, Red blood cell sedimentation rate, Ultrasound abdomen
Clinical narrative: VS were normal, physical examination was remarkable for jaundice and mild RUQ tenderness; This is a literature report.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ulcerative colitis" (ongoing), notes: on home sulfasalazine. Concomitant medication(s) included: SULFASALAZINE taken for colitis ulcerative (ongoing). The following information was reported: AUTOIMMUNE HEPATITIS (hospitalization, medically significant), outcome "unknown", described as "VS were normal, physical examination was remarkable for jaundice and mild RUQ tenderness". The events "vs were normal, physical examination was remarkable for jaundice and mild ruq tenderness" required emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1476 IU/l; Aspartate aminotransferase: 1621 IU/l; Bilirubin conjugated: 4.5 mg/dl; Blood alkaline phosphatase: 167 IU/l; Blood bilirubin: 6.0 mg/dl; C-reactive protein: 3.40 mg/dl; Endoscopic ultrasound: diffuse abnormal echotexture, notes: in the visualized portion of the liver; Gamma-glutamyltransferase: 339; reactive oxygen species: Negative; Magnetic resonance imaging: unremarkable; Pathology test: No significant ductal pathology; physical examination: was remarkable for jaundice and mild RUQ tendernes; Red blood cell sedimentation rate: 99, notes: mm; Ultrasound abdomen: unremarkable; Vital signs measurement: Normal. Therapeutic measures were taken as a result of autoimmune hepatitis. Clinical course: The patient with ulcerative colitis on home sulfasalazine who presented to the emergency department (ED) with complaints of a vague, non-cramping, and dull RUQ abdominal pain for 3 weeks duration. The patient's social history is unremarkable. No recent travel, occupational exposures, herbal supplements use, or acetaminophen use. He received 2 doses of Pfizer COVID -19 vaccines, last dose was around 21 days before admission. The patient was treated with azathioprine and prednisone 60 mg daily with slow tapering and with continuation of his home dose sulfasalazine.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Autoimmune hepatitis and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.