chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dyspnoea, Extra dose administered, SARS-CoV-2 test
Clinical narrative: Severe back pain, between shoulder blades; difficulty breathing; Dose Number 4: 02Apr2022/ Dose Number 3: 02Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 02Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADAIR; SINGULAIR; VITAMIN B COMPLEX; VITAMIN D [COLECALCIFEROL]. Past drug history included: Composine, reaction(s): "Known allergies: Composine"; Keflex, reaction(s): "Known allergie: Keflex". Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: EXTRA DOSE ADMINISTERED (non-serious) with onset 02Apr2022, outcome "unknown", described as "Dose Number 4: 02Apr2022/ Dose Number 3: 02Apr2022"; BACK PAIN (hospitalization) with onset 02Apr2022 at 16:00, outcome "recovered" (2022), described as "Severe back pain, between shoulder blades"; DYSPNOEA (hospitalization) with onset 02Apr2022 at 16:00, outcome "recovered" (2022), described as "difficulty breathing". The patient was hospitalized for back pain, dyspnoea (hospitalization duration: 1 day(s)). The events "severe back pain, between shoulder blades" and "difficulty breathing" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Apr2022) Negative. Therapeutic measures were taken as a result of back pain, dyspnoea. Clinical course: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included prebiotic and citruce. Several breathing treatments and pain medication were received as a treatment of events dyspnoea and back pain. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Dec2020 as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no 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 suspected covid-19.  Clinical course: Seriousness criteria not Results in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect: No. On 28Apr2022 patient experienced Starting feeling sick again after feeling much better, Worse shortness of breath and cough, Extremely fatigued and headaches. Outcome of event at the time of last observation was Not resolved. The patient received COVID-19 treatment with Paxlovid (Date of start of drug: 12Apr2022, Date of last administration: 17Apr2022). The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. The patient received Ventolin treatment for the adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Magnetic resonance imaging, Neuralgia, Peripheral vascular disorder
Clinical narrative: Nerve pain with no history; Unexplained bruising; Circulation Problem/swelling; Circulation Problem/swelling; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 at 15:00 as dose 1, single (Lot number: ER8729) at the age of 37 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Pain" (unspecified if ongoing); "Inflammation" (unspecified if ongoing); "Nerve pain" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: MOTRIN [IBUPROFEN] taken for pain, inflammation, start date: Apr2021 (ongoing); CYMBALTA taken for neuralgia, start date: Apr2021 (ongoing); LORAZEPAM taken for anxiety, start date: Apr2021 (ongoing); PREDNISONE taken for inflammation, start date: Feb2022, stop date: Mar2022. The following information was reported: PERIPHERAL VASCULAR DISORDER (non-serious), SWELLING (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Circulation Problem/swelling"; NEURALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "Nerve pain with no history"; CONTUSION (non-serious) with onset Apr2021, outcome "unknown", described as "Unexplained bruising". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient took second dose (EW0172) on 30Apr2021 at 15:00 at hospital via an intramuscular route of administration. Patient took third dose (FM0698) on 28Feb2022at 15:00 at hospital via an intramuscular route of administration. Patient took booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Patient took first dose and medical issues began.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling, X-ray
Clinical narrative: Nerve pain with no history; Unexplained bruising; Circulation Problem/swelling; Circulation Problem/swelling; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 at 15:00 as dose 1, single (Lot number: ER8729) at the age of 37 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Pain" (unspecified if ongoing); "Inflammation" (unspecified if ongoing); "Nerve pain" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: MOTRIN [IBUPROFEN] taken for pain, inflammation, start date: Apr2021 (ongoing); CYMBALTA taken for neuralgia, start date: Apr2021 (ongoing); LORAZEPAM taken for anxiety, start date: Apr2021 (ongoing); PREDNISONE taken for inflammation, start date: Feb2022, stop date: Mar2022. The following information was reported: PERIPHERAL VASCULAR DISORDER (non-serious), SWELLING (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Circulation Problem/swelling"; NEURALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "Nerve pain with no history"; CONTUSION (non-serious) with onset Apr2021, outcome "unknown", described as "Unexplained bruising". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient took second dose (EW0172) on 30Apr2021 at 15:00 at hospital via an intramuscular route of administration. Patient took third dose (FM0698) on 28Feb2022at 15:00 at hospital via an intramuscular route of administration. Patient took booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Patient took first dose and medical issues began.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer BioNTech Vaccine administered (patient also took paxlovid for covid-19 treatment after received BNT162b2).; Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2).; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 at 14:15 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "acquired hypothyroidism" (unspecified if ongoing); "borderline hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: CYTOMEL; SYNTHROID; PRAVASTATIN. Vaccination history included: Covid-19 vaccine (Dose 1 (manufacturer unknown)), for COVID-19 immunization; Covid-19 vaccine (Dose 2 (manufacturer unknown)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2).". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (02May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (03May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (04May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (05May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (06May2022) Strongly Positive, notes: strongly positive on rapids for 6 days in a row now; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid anti-viral details product for covid 19 Treatment. The patient started treatment on 19Apr2022, and treatment stopped on 24Apr2022. The patient previously received a COVID-19 Vaccine. Patient had not known allergies. Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. After paxlovid course, patient had 4 negative rapid tests, and then 4 days after that he had a positive rapid test and have been strongly positive on rapids for 6 days in a row now. He had mild symptoms of cough, congestion, fatigue and muscle soreness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Blood test, Contusion, Magnetic resonance imaging, Neuralgia
Clinical narrative: nerve pain with no histrory; unexplained bruising; swelling; circulation problems; MRI abnormal (L5, SI, lowerback); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2022 at 15:00 as dose 3 (booster), single (Lot number: FM0698) at the age of 38 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Inflammation" (unspecified if ongoing); "Nerve pain" (unspecified if ongoing). Concomitant medication(s) included: MOTRIN [IBUPROFEN] taken for pain, inflammation, start date: Apr2021 (ongoing); CYMBALTA taken for neuralgia, start date: Apr2021 (ongoing); LORAZEPAM taken for anxiety, start date: Apr2021 (ongoing); PREDNISONE taken for inflammation, start date: Feb2022, stop date: Mar2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 03:00 PM, Site and route of injection: # hospital, Anatomical Site and route of injection: # hospital, Intramuscular, Batch/Lot number: ER8279), administration date: 09Apr2021, when the patient was 37-year-old, for COVID-19 immunization, reaction(s): "Nerve pain with no history", "Unexplained bruising", "Circulation Problem", "swelling"; BNT162b2 (DOSE 2, SINGLE, Time: 03:00 PM, Site and route of injection: # hospital, Anatomical Site and route of injection: # hospital, Intramuscular, Batch/Lot number: EW0172), administration date: 30Apr2021, when the patient was 37-year-old, for COVID-19 immunization, reaction(s): "Blood high(lipo protein)".  The following information was reported: ARTHROPATHY (non-serious) with onset 04Mar2022, outcome "unknown", described as "MRI abnormal (L5, SI, lowerback)"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain with no histrory"; CONTUSION (non-serious), outcome "unknown", described as "unexplained bruising"; SWELLING (non-serious), outcome "unknown"; PERIPHERAL VASCULAR DISORDER (non-serious), outcome "unknown", described as "circulation problems". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not had covid-19, prior vaccinations within 4 weeks.Booster dose was administered due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications).  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral vascular disorder, SARS-CoV-2 test, Swelling, X-ray
Clinical narrative: nerve pain with no histrory; unexplained bruising; swelling; circulation problems; MRI abnormal (L5, SI, lowerback); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2022 at 15:00 as dose 3 (booster), single (Lot number: FM0698) at the age of 38 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Inflammation" (unspecified if ongoing); "Nerve pain" (unspecified if ongoing). Concomitant medication(s) included: MOTRIN [IBUPROFEN] taken for pain, inflammation, start date: Apr2021 (ongoing); CYMBALTA taken for neuralgia, start date: Apr2021 (ongoing); LORAZEPAM taken for anxiety, start date: Apr2021 (ongoing); PREDNISONE taken for inflammation, start date: Feb2022, stop date: Mar2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 03:00 PM, Site and route of injection: # hospital, Anatomical Site and route of injection: # hospital, Intramuscular, Batch/Lot number: ER8279), administration date: 09Apr2021, when the patient was 37-year-old, for COVID-19 immunization, reaction(s): "Nerve pain with no history", "Unexplained bruising", "Circulation Problem", "swelling"; BNT162b2 (DOSE 2, SINGLE, Time: 03:00 PM, Site and route of injection: # hospital, Anatomical Site and route of injection: # hospital, Intramuscular, Batch/Lot number: EW0172), administration date: 30Apr2021, when the patient was 37-year-old, for COVID-19 immunization, reaction(s): "Blood high(lipo protein)".  The following information was reported: ARTHROPATHY (non-serious) with onset 04Mar2022, outcome "unknown", described as "MRI abnormal (L5, SI, lowerback)"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain with no histrory"; CONTUSION (non-serious), outcome "unknown", described as "unexplained bruising"; SWELLING (non-serious), outcome "unknown"; PERIPHERAL VASCULAR DISORDER (non-serious), outcome "unknown", described as "circulation problems". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not had covid-19, prior vaccinations within 4 weeks.Booster dose was administered due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications).  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 with home test on 06-May-2022.; Tested positive for COVID-19 with home test on 06-May-2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955), on 10Apr2021 as dose 2, single (Lot number: EP6955), on 08Dec2021 as dose 3 (booster), single (Lot number: FJ8762) and on 11Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 58 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Vit D deficiency" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing), notes: Osteoarthritis (knee) all controlled with meds/supplements; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN; CALCIUM VIT D; VITAMIN D [COLECALCIFEROL]. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant) with onset 06May2022, outcome "unknown", COVID-19 (medically significant) with onset 06May2022, outcome "not recovered" and all described as "Tested positive for COVID-19 with home test on 06-May-2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: No other vaccine in four weeks. Tested positive for COVID-19 with home test on 06May2022. Symptom of runny nose began 05May2022. Additional symptoms experienced beginning 06May2022: cough, congestion, loss of sense of taste, headache, low grade fever.  treatment ae include Phenylephrine, Benzonatate, Diphenhydramine, Luden's cough drops. No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19 / the test was positive; Treatment of COVID-19 / the test was positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 at 19:00 as dose 3 (booster), single (Lot number: 301358A) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01May2022 at 08:00, outcome "unknown", COVID-19 (medically significant) with onset 01May2022 at 08:00, outcome "not recovered" and all described as "Treatment of COVID-19 / the test was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Negative, notes: at 8:00 am; (01May2022) Positive, notes: at 8:00 am. Clinical course: Patient received any other medications within two weeks of vaccination was reported as no. Patient took a 5-day course of Paxlovid for treatment of COVID-19 with start date as 22Apr2022 and stop date as 27Apr2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2).; Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 31May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04May2022, outcome "unknown", COVID-19 (medically significant) with onset 04May2022, outcome "recovering" and all described as "PAXAES report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2).". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: Testing positive for Covid again. Therapeutic measures were not taken as a result of covid-19.Clinical course :other medication in 2weeks was reported as no. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive Covid test on 22Apr2022; Positive Covid test on 22Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 22Apr2022, outcome "unknown" and all described as "Positive Covid test on 22Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22Apr2022) Positive; (28Apr2022) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: There was no other medication in 2 weeks. Reported Event: After a positive COVID test on 22Apr2022 I took Paxlovid for the 5 day treatment. I took another COVID test on 28Apr2022 and tested negative (PCR). On Day 13, I started experiencing COVID symptoms again and took another COVID test and it came up positive again. There was no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): (Novartis).  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown". Additional information: They therefore forwarded the information below relating to our product which was obtained by one of their employees during the normal course of business.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cystitis, Drug ineffective, Musculoskeletal disorder, Pain
Clinical narrative: dose 1 in 01-Feb-2022, dose 2 in 22-Feb-2022; COVID; Bladder infection; Sinus infection; Aches; Neck issue; Neck issue during the time of the COVID vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4186728-00 (Company).  A 79-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years and on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1139174) at 40 mg (40 mg, (citrate free, 1 in 2 wk)) and second regimen (Lot number: 1155993) at 40 mg (40 mg, (citrate free, 1 in 2 wk)), all subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISORDER (non-serious) with onset Feb2021, outcome "unknown", described as "Neck issue"; VACCINATION COMPLICATION (non-serious) with onset Feb2021, outcome "unknown", described as "Neck issue during the time of the COVID vaccine"; COVID-19 (medically significant), outcome "recovered", described as "COVID"; VACCINATION FAILURE (medically significant), outcome "recovered", described as "dose 1 in 01-Feb-2022, dose 2 in 22-Feb-2022"; CYSTITIS (non-serious), outcome "unknown", described as "Bladder infection"; SINUSITIS (non-serious), outcome "recovering", described as "Sinus infection"; PAIN (non-serious), outcome "unknown", described as "Aches". The action taken for adalimumab was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "covid", "dose 1 in 01-feb-2022, dose 2 in 22-feb-2022", "bladder infection", "sinus infection" and "aches" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "neck issue" and "neck issue during the time of the covid vaccine" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Vaccination complication
Clinical narrative: dose 1 in 01-Feb-2022, dose 2 in 22-Feb-2022; COVID; Bladder infection; Sinus infection; Aches; Neck issue; Neck issue during the time of the COVID vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4186728-00 (Company).  A 79-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years and on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1139174) at 40 mg (40 mg, (citrate free, 1 in 2 wk)) and second regimen (Lot number: 1155993) at 40 mg (40 mg, (citrate free, 1 in 2 wk)), all subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISORDER (non-serious) with onset Feb2021, outcome "unknown", described as "Neck issue"; VACCINATION COMPLICATION (non-serious) with onset Feb2021, outcome "unknown", described as "Neck issue during the time of the COVID vaccine"; COVID-19 (medically significant), outcome "recovered", described as "COVID"; VACCINATION FAILURE (medically significant), outcome "recovered", described as "dose 1 in 01-Feb-2022, dose 2 in 22-Feb-2022"; CYSTITIS (non-serious), outcome "unknown", described as "Bladder infection"; SINUSITIS (non-serious), outcome "recovering", described as "Sinus infection"; PAIN (non-serious), outcome "unknown", described as "Aches". The action taken for adalimumab was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "covid", "dose 1 in 01-feb-2022, dose 2 in 22-feb-2022", "bladder infection", "sinus infection" and "aches" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "neck issue" and "neck issue during the time of the covid vaccine" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He already have his first 2 doses and 1st booster dose however he is still got Covid/being positive with Covid; He already have his first 2 doses and 1st booster dose however he is still got Covid/being positive with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He already have his first 2 doses and 1st booster dose however he is still got Covid/being positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he is asking for the best time he can get his 2nd booster dose after being positive with Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   69-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FF2S90) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Lot number: 028L20A), in left arm and on 06Mar2021 as dose 2, single (Lot number: 027A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol, controlled with statin; "Interchange of vaccines" (unspecified if ongoing). No known allergies. There were no concomitant medications. No other medication in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Antiviral details included product: COVID 19 treatment, brand: Paxlovid, treatment start date: 24Apr2022, treatment stop date: 28Apr2022, indication: treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Covid test; positive Covid test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-month-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 03Sep2021 as dose 3 (booster), single (Lot number: Fc3184) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: other medical history: Lupus; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure; "obese" (unspecified if ongoing), notes: other medical history:obese. The patient's concomitant medications were not reported. Past drug history included: Known allergies: codeine (iv), reaction(s): "Known allergies: Codeine (IV)", notes: Known allergies: Codeine (IV). The following information was reported: VACCINATION FAILURE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovering" and all described as "positive Covid test". Serious: No, Seriousness criteria-results in death: No, Seriousness criteria-life threatening: No, Seriousness criteria- caused/prolonged hospitalization: No, Seriousness criteria- disabling/incapacitating: No, Seriousness criteria-congenital anomaly/birth defect: No, Other medication in 2 weeks was reported as Yes. Other medication details: Other medication in 2 weeks product=Metoprolol Tartrate, Valsartan, Methotrexate, Hydroxychloroquine, Folic Acid, Pantoprazole, Montelukast, Alloporinal, D-3, B-12. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 18Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2022) Positive; (23Apr2022) Negative; (05May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional Information: The patient did not receive any other medications within 2 weeks of starting COVID-19 treatment. The patient was previously received a COVID-19 Vaccine. Reported Event: Return of Covid symptoms and testing positive after taking Paxlovid and testing negative and feeling better. Retest on Day 17 05May2022 positive after first positive test 18Apr2022 and negative test on 23Apr2022. start of reaction/event: 02May2022. The patient had no known allergies. Outcome of event was not recovered. The patient did not receive treatment. Adverse Event resulted in None of the above  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, 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). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Benzonate" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "overweight" (unspecified if ongoing); "sensitive stomach" (unspecified if ongoing), notes: sensitive stomach. Concomitant medication(s) included: FAMOTIDINE; ROSUVASTATIN; SYMBICORT; MONTELUKAST; VITAMIN D [VITAMIN D NOS]; ZINC. Past drug history included: Known allergies: clarithromycin, reaction(s): "Known allergies: Clarithromycin". Paxlovid gives patient very unpleasant adverse events. It starts with a lasting metallic taste 30 min after patient took it, and it progresses to stomach ache (epigastric pain), abdominal discomfort, nausea, overall sensation of feeling unwell, occasional headache, tingling sensations, weird hallucinatory smells (urine), and a feeling of being somewhat slightly sedated. These effects last for more than 3 hours after each those with the metallic taste, which is very strong, lasting even longer. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 17Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Herniated discs" (unspecified if ongoing); "Known Allergies: Oysters" (unspecified if ongoing), notes: Known Allergies: Oysters; "Known Allergies: Scallops" (unspecified if ongoing), notes: Known Allergies: Scallops; "Known Allergies: latex" (unspecified if ongoing); "Known Allergies: Sulfa drugs" (unspecified if ongoing), notes: Known Allergies: Sulfa drugs. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL], start date: Jan2022, stop date: 07May2022; PRESERVISION, start date: Feb2022, stop date: May2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: on day four and all better by day 7 with a negative. antigen test day 7; Positive, notes: day 10 from initial onset of symptoms and the first positive test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: Yes Did you/the patient previously receive a COVID-19 Vaccine?: Yes Reported Event: Had a metallic bitter taste in mouth for five days but felt better on day four and all better by day 7 with a negative antigen test day 7 and day 10 from initial onset of symptoms and the first positive test, but on day 13 started to have a lot of congestion, sneezing, headache, body aches, cough and fatigue. that lasted another 7 days getting somewhat better by day 18. Some aches and post nasal drip cough still occurring on day 21. Date of start of reaction/event: 01May2022 (12:00AM) Outcome of reaction/event at the time of last observation: Recovering/resolving Hospitalization Prolonged : No AE resulted in :None of the above Device Date : 07May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 15:00 as dose 1, single (Lot number: EN6200), in left arm, on 25Mar2021 at 15:45 as dose 2, single (Lot number: EP7534), in left arm and on 18Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Autoimmune disease" (unspecified if ongoing), notes: Autoimmune disease. Concomitant medication(s) included: VALSARTAN; LEVOTHYROXINE. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 07May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Negative; (07May2022) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: It was reported that patient took paxlovid. Started feeling better. Stopped May 1st and by evening started getting fever again at 99 to 100. Next morning got black eye from bruise from just wiping gently on left eye the sleep dust in morning. Then went to ER to check on platelets. All bloodwork was good so went home. Then tested negative on rapid on Thursday 05May2022 and then started having symptoms of red eye, sore throat, postnasal drip, and nerve pain in hands starting on Thursday and Friday 05May and 06May. Tested again on Saturday, 07May2022 and was very dark line positive.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); Report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 20:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 10Aug2021, stop date: 07May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Report with Pfizer BioNTech Vaccine administered (patient also took paxlovid for covid-19 treatment after received BNT162b2)". Therapeutic measures were taken as a result of drug ineffective, covid-19. The treatment start date was reported as 27Apr2022 and stop date was reported as 01May2022. The patient took Zoloft as the other medication in 2weeks. The start date for Zoloft was reported as 10Aug2021 and stop date was reported as 07May2022. The adverse event Rebound of symptoms was 4 days following cessation of medication. Device Date was 07May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Relevent test: covid test; 03Jan2022; positive; Relevent test: covid test; 03Jan2022; positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 15Apr2021 as dose 2, single (Lot number: EW0169), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 03Jan2022, outcome "unknown", VACCINATION FAILURE (medically significant), with onset 03Jan2022, outcome "unknown" and all described as "Relevent test: covid test; 03Jan2022; positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2021) Negative; (09Nov2021) Negative; (03Jan2022) Positive.  Batch and lot tested and found within specifications checked. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer bioNTech COVID-19 vaccine lot EW0169 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0169, fill lot EP8700, and the formulated drug product lot EP8602. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer bioNTech COVID-19 injectable lot EN6205 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200013081 same reporter/patient, dose number, different event