chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Nov2022) Negative; (06Nov2022) Positive; (08Nov2022) Positive; (10Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Oct2022 to 03Nov2022. It was unknown if patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High Blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Nov2022 at 10:00, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient previously receive a COVID-19 Vaccine. COVID vaccine details: vaccine brand=Pfizer/BioNTech, Vaccine administration time=09:00 AM, Vaccine dose number=4. Antiviral details, product=COVID-19 Treatment, brand=Pfizer, treatment start date=09Nov2022, treatment stop date=13Nov2022, lot number=GE7319, indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test, Weight
Clinical narrative: Tested positive for Covid; after Covid vaccines; Tested positive for Covid; after Covid vaccines; Pfizer Covid vaccine: states one vaccine, #4 of a total of 5 Covid vaccines; 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 58-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 58 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Oct2022 as dose 5 (booster), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Apr2022, outcome "unknown", described as "Pfizer Covid vaccine: states one vaccine, #4 of a total of 5 Covid vaccines"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Nov2022, outcome "not recovered" and all described as "Tested positive for Covid; after Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: still testing positive for Covid several days later; (03Nov2022) Positive; Weight: (03Nov2022) 115 lbs, notes: Weight: thinks about 115 pounds. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: developed A-Fib per EKG; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 90-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 90 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Transient ischemic attack" (unspecified if ongoing); "Chronic kidney disease" (unspecified if ongoing); "Old MI" (unspecified if ongoing); "Known allergy: PCN" (unspecified if ongoing), notes: Known allergy: PCN; "Known allergy: Sulfa" (unspecified if ongoing), notes: Known allergy: Sulfa. The patient took concomitant medications. Past drug history included: Plavix, reaction(s): "Known allergy: Plavix", notes: Known allergy: Plavix. Vaccination history included: Covid-19 vaccine (Primary series Immunization complete but Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (disability, medically significant) with onset 11Nov2022, outcome "not recovered", described as "developed A-Fib per EKG". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (11Nov2022) A-Fib. Therapeutic measures were taken as a result of atrial fibrillation. Additional information. The patient did not receive any other vaccine within four weeks of Pfizer vaccine. The patient received other medications (unspecified) with two weeks of covid vaccine. The patient was not diagnosed with covid prior vaccination. The patient was not tested with covid post vaccination.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event ATRIAL FIBRILLATION and BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2. 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: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness of the upper arm where the injection site occurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of the upper arm where the injection site occurred". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient mentioned that previously she already received 4 shots of Pfizer COVID -19 Vaccine, 2 doses of the primary series (captured as Pfizer COVID 19 Vaccine) and 2 booster shots (captured as COVID 19 vaccine booster). Consumer stated, it was between elbow and wrist, so the forearm and that was 3 days after the vaccination. So, patient had a typical reaction that had for the prior 4 Pfizer Vaccination for the symptoms, soreness of the upper arm where the injection site occurred. Height about 5 ft. 3.5 and weight about 105 pounds and weight is about 105 up to 110 but you can say 105. Other Medical Conditions and Other Medications: Consumer stated, Yes, but nothing neurological and nothing having to do with heart let back on you and talking about other medical condition, nothing having to do with heart or anything like that, only numbness in hand or fever anything like that. Consumer stated no treatment was received. No Investigations was conducted.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296272 same patient, different vaccine dose/event;US-PFIZER INC-202201296759 same patient/ event, different vaccine doses;US-PFIZER INC-202201296760 same patient/ event, different vaccine doses;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness of the upper arm where the injection site occurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Soreness of the upper arm where the injection site occurred"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Soreness of the upper arm where the injection site occurred". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of the upper arm where the injection site occurred".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296760 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296757 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296758 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296272 same patient, different vaccine doses/event;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness of the upper arm where the injection site occurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "soreness of the upper arm where the injection site occurred"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "soreness of the upper arm where the injection site occurred"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "soreness of the upper arm where the injection site occurred". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of the upper arm where the injection site occurred".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296272 same patient, different vaccine doses/event;US-PFIZER INC-202201296757 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296758 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296759 same patient/event, different vaccine doses/event;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 14:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 at 13:15 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Dec2021 at 14:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 2 negative Covid tests and no symptoms after 5 days of paxlovid; Negative, notes: 2 negative Covid tests and no symptoms after 5 days of paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies and no other medical history. The patient received COVID 19 Treatment with Paxlovid from 29Oct2022 to 02Nov2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune hemolytic anemia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medications in 2 weeks. Anti-viral details: product: COVID 19 treatment, brand=Paxlovid, treatment start date was 03Nov2022 and treatment stop date was 08Nov2022, indication was treatment of COVID-19. Device timestamp was reported as 13Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: she is experiencing mild body aches; I feel this a little bit achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "she is experiencing mild body aches; I feel this a little bit achy".  Additional information: The patient stated she just got her COVID-19 vaccine Bivalent (Clarified as Pfizer COVID-19 Bivalent Vaccine) yesterday and she is experiencing mild body aches and she is asking if it is okay to take Advil. While confirming the name, Consumer stated, "I can't understand a thing you are saying, nothing. I just needed a simple question, can I take Tylenol (Later clarified as Advil) because I feel this a little bit achy but I will just wait and I will call the pharmacy when they open but thank you anyways."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 71 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Dec2020 as dose 1, single (Lot number: 025J202A), in left arm, on 23Jan2021 as dose 2, single (Lot number: 027L20A), in left arm, on 02Nov2021 at 10:00 as dose 3 (booster), single (Lot number: CUS9086), in left arm and on 19Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 48L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "controlled mild HTN" (unspecified if ongoing), notes: Other medical history: controlled mild HTN; "surgical removal of thyroid" (unspecified if ongoing), notes: Other medical history: surgical removal of thyroid. Concomitant medication(s) included: ESTRING, start date: Feb2022; HYDROCHLOROTHIAZIDE, start date: Aug1981; LEVOTHYROXINE, start date: Apr1994; SPIRONOLACTONE, start date: Feb1997. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Oct2022 at 11:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound Covid infection 7 days after finishing course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not had any allergies.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Interchange of vaccine products, drug ineffective, COVID-19 cannot be ruled out.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 14Apr2021 as dose 2, single (Lot number: 9W0151), in right arm and on 19Nov2021 as dose 3 (booster), single (Lot number: 302308D) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "history of congestive heart failure" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: 01Jun1997; ASMANEX, start date: 01Mar2016; FLONASE [FLUTICASONE PROPIONATE], start date: 01Aug2016. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 28Oct2022 to 01Nov2022.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Mar2021 at 10:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Right Bundle Branch Block" (unspecified if ongoing); "heart murmer" (unspecified if ongoing); "high cardiac artery calcium" (unspecified if ongoing); "low back pain" (unspecified if ongoing), notes: manageable with exercise; "burning mouth syndrome" (unspecified if ongoing); "Known allergies: Have a skin reaction to adhesive tape" (unspecified if ongoing); "Known allergies: Have a skin reaction to adhesive tape" (unspecified if ongoing). Concomitant medication(s) included: HYDRALAZINE, start date: May2021; LISINOPRIL, start date: 28Jul2020; SIMVASTATIN, start date: 13Oct2021, stop date: 08Sep2022; HYDROCHLOROTHIAZIDE, start date: Jul2003. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 09Sep2022 to 13Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone, Blood test, Body height, Pain in extremity, Platelet count
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 24May2021 as dose 1, single (Lot number: ER8737) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "medical condition with the lungs", start date: 2017 (ongoing), notes: medical condition with the lungs. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296249 Same patient and vaccine, different event /dose number;US-PFIZER INC-202201296888 Same patient and vaccine, different event /dose number;US-PFIZER INC-202201296889 Same patient and vaccine, different event /dose number;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Scan, Weight
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 24May2021 as dose 1, single (Lot number: ER8737) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "medical condition with the lungs", start date: 2017 (ongoing), notes: medical condition with the lungs. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296249 Same patient and vaccine, different event /dose number;US-PFIZER INC-202201296888 Same patient and vaccine, different event /dose number;US-PFIZER INC-202201296889 Same patient and vaccine, different event /dose number;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone, Blood test, Body height, Investigation, Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter (Consumer), Program ID. A 67-year-old male patient received BNT162b2 (BNT162B2), on 14Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "medical condition with the lungs", start date: 2017 (ongoing); "wheelchair" (ongoing); "he has a paralyzed lung that has been stable" (unspecified if ongoing); "has oxygen" (unspecified if ongoing), notes: the lungs that he had already in 2017 and has oxygen for that and that was stable. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; lot number: ER8737), administration date: 24May2021, when the patient was 66-year-old, for Covid-19 immunization, reaction: "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: He has other underlying health conditions that are under control. The patient received a third and fourth dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Scan, Weight
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter (Consumer), Program ID. A 67-year-old male patient received BNT162b2 (BNT162B2), on 14Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "medical condition with the lungs", start date: 2017 (ongoing); "wheelchair" (ongoing); "he has a paralyzed lung that has been stable" (unspecified if ongoing); "has oxygen" (unspecified if ongoing), notes: the lungs that he had already in 2017 and has oxygen for that and that was stable. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; lot number: ER8737), administration date: 24May2021, when the patient was 66-year-old, for Covid-19 immunization, reaction: "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: He has other underlying health conditions that are under control. The patient received a third and fourth dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 11:30 as dose 5 (booster), single (Lot number: 59267-0304-02) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Sulfa Drugs" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM, start date: Oct2022, stop date: Nov2022; CYCLOBENZAPRINE, start date: Oct2022, stop date: Nov2022; ATOVAQUONE/PROGUANIL MYLAN, start date: 17Oct2022, stop date: 02Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test four days after completing Paxlovid series. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received medication in 2weeks. Patient received the treatment of Paxlovid.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Barrett's esophagus" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: 100.8 Fahrenheit, notes: fever of 100.8 F; SARS-CoV-2 test: Positive, notes: tested positive with an at-home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication in 2 weeks. It was reported that patient had mild covid symptoms and tested positive with an at-home test. The patient is doing well and will receive a PCR test shortly. S/sx: -headache -myalgia -joint pain -cough -runny nose -fever of 100.8 F.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; BNT61b2 (dose 1 and dose 2) and Moderna (dose 3 and dose 4 and dose 5); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 26Mar2021 as dose 2, single (Lot number: ER8727) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Sep2021 as dose 3 (booster), single (Lot number: 048F21A), in left arm, on 18Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm and on 11Oct2022 at 15:00 as dose 5 (booster), single (Lot number: 057F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "bronchiectasis" (unspecified if ongoing); "constipation" (unspecified if ongoing). Concomitant medication(s) included: TRULANCE, start date: Sep2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2021, outcome "unknown", described as "BNT61b2 (dose 1 and dose 2) and Moderna (dose 3 and dose 4 and dose 5)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Anti-viral details, Product=COVID 19 Treatment, brand=Pfizer, Paxlovid, treatment start date=04Nov2022, Treatment stop date=10Nov2022. Patient reported she is on day 11. 02Nov2022 was my first day of symptoms. Although she improved after taking Paxlovid, she have never stopped having symptoms. She continue to sneeze, have extra snot and phlegm, sometimes cough, sometimes ear pressure, and She is still testing positive. Today is the first day her symptoms were a little increased but no new symptoms.
Age: 54.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Malaise, Off label use, Product use issue
Clinical narrative: just didn't feel good; Pfizer COVID-19 Bivalent Booster last Friday and also had flu shot as well; Pfizer COVID-19 Bivalent Booster last Friday and also had flu shot as well; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose number unknown (booster), single (Lot number: GJ6738, Expiration Date: 30Jun2023) at the age of 54 years, in right deltoid for COVID-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Nov2022, outcome "unknown" and all described as "Pfizer COVID-19 Bivalent Booster last Friday and also had flu shot as well"; MALAISE (non-serious) with onset 05Nov2022, outcome "not recovered", described as "just didn't feel good".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296261 Same reporter/patient/drug, different event/dose;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 4th dose got Moderna; 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 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 24Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LEVOTHYROXINE; OMEGA-3-ACID ETHYL ESTER. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Apr2022, outcome "unknown", described as "4th dose got Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (2022) Positive, notes: Rebound of symptoms plus positive Covid test 8 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). 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 20Sep2022 as dose 4 (booster), single (Lot number: 1920150A) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included: The patient not received other medication in 2 weeks. Received Paxlovid treatment from 09Nov2022 to 13Nov2022. The patient allergies and other medical history reported as none. The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162b2, BNT162b2 omi ba.4-5 immunization is considered ineffective of BNT162b2, BNT162b2 omi ba.4-5, and the Company cannot completely exclude the possible causality between the reported events and BNT162b2, BNT162b2 omi ba.4-5  administration.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EM9809), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Anxiety" (unspecified if ongoing); "high colesterol" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: Mar2021; METOPROLOL, start date: Jan2013; ROSUVASTATIN, start date: Sep2022, stop date: 02Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient had a horrible very bitter taste in her mouth and was badly interfered with her ability to sleep. She had to suck Cepacol and make sure to numb my tongue to overcome the taste at night. The numb tongue only lasted for a short time and then she had to repeat to get back to sleep. She had very little sleep and feel drained, exhausted, and eat very little because food tastes terrible. In the daytime the patient discovered sipping constantly on milk helps. It was like torture at night. she had a relief after about 10 hours and it restarts about 2 hours after the next dose. The patient had no known allergies.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG, start date: 13Jun2007; LEVOTHYROXINE, start date: 17Jun2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Nov2022) Negative, notes: tested negative; (11Nov2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2022 at 16:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "I have Irritable Bowl Syndrome  but no serious or chronic health conditions that I know of" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 01Nov2022 to 05Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, SARS-CoV-2 test, Vaccination site mass
Clinical narrative: This patient has a large mass - likely scar tissue - at the site of the second vaccination; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 15 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Sep2021, when the patient was 15 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 11Nov2022, outcome "not recovered", described as "This patient has a large mass - likely scar tissue - at the site of the second vaccination". The event "this patient has a large mass - likely scar tissue - at the site of the second vaccination" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass.  Additional information: This patient has a large mass likely scar tissue at the site of the second vaccination. Started as a small lump at the time of vaccination, started to grow after the patient contracted covid post-vaccination. The mass was now 4-5 inches in diameter. The patient reported to this ED. The patient had no known allergies. Patient had no COVID prior vaccination. Patient was tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PPV
Symptoms: Adverse event following immunisation
Clinical narrative: She reacted badly once to pneumo vax and was hospitalized.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ADVERSE EVENT FOLLOWING IMMUNISATION (hospitalization), outcome "unknown", described as "She reacted badly once to pneumo vax and was hospitalized.". The clinical course was reported as follows: During the phone call received, Name (withheld) stated: "We have a patient referred to us as immunologist for a Prevnar 20 challenge. For reaction. She reacted badly once to pneumo vax and was hospitalized. So. it's recommended that she have a drug challenge." The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Post COVID Rehabilitation; Post COVID Rehabilitation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Post COVID Rehabilitation". Clinical course: The patient was attributing ongoing GI and neurologic symptoms to the Pfizer COVID-vaccine received in Dec2020-Jan2021 (as reported) timeframe, for which the patient was continuing to seek care.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.