chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Immune system disorder
Clinical narrative: I know other two persons got the same after the vaccine/got ALS  from the vaccine; I know other two persons got the same after the vaccine/the vaccine damage my immune system healthy before the vaccine shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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: AMYOTROPHIC LATERAL SCLEROSIS (medically significant), outcome "unknown", described as "I know other two persons got the same after the vaccine/got ALS  from the vaccine"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "I know other two persons got the same after the vaccine/the vaccine damage my immune system healthy before the vaccine shot". 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-202201341350 same product/event, different patient;US-PFIZER INC-PV202200114181 same product/event, different patient;
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Jansen:Start date:24Mar2021/Pfizer / BioNTech start date:11Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "depression" (unspecified if ongoing); "dysthymia" (unspecified if ongoing), notes: dysthymia with intermittent anxiety; "intermittent anxiety" (unspecified if ongoing), notes: dysthymia with intermittent anxiety; "POIS (Post Orgasmic Illness Syndrome)" (unspecified if ongoing), notes: POIS (Post Orgasmic Illness Syndrome). Concomitant medication(s) included: NALTREXONE; ATOMOXETINE; DICLOFENAC. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Aug2021, outcome "unknown", described as "Jansen:Start date:24Mar2021/Pfizer / BioNTech start date:11Aug2021"; 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, 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: Arthralgia, Pruritus, Vaccination site swelling
Clinical narrative: itching / still has itching on her arms; received her Pfizer booster in her left arm and the second booster on her right arm and both of those left her with bumps; she has joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA426189.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "lost 50 pounds" (unspecified if ongoing), notes: The patient's past medical history included lost 50 pounds intentionally and had skin ulcers.; "skin ulcers" (unspecified if ongoing), notes: The patient's past medical history included lost 50 pounds intentionally and had skin ulcers. The patient's 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: PRURITUS (non-serious), outcome "not recovered", described as "itching / still has itching on her arms"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "received her Pfizer booster in her left arm and the second booster on her right arm and both of those left her with bumps"; ARTHRALGIA (non-serious), outcome "unknown", described as "she has joint pain". Therapeutic measures were taken as a result of pruritus.  Additional information: Treatment included was she was adding over the counter cream (unspecified) for she stated that she still had itching on her arms and not reported for other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she got a light case of covid in Jun2022.; she got a light case of covid in Jun2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "she got a light case of covid in Jun2022.". Patient got all her Pfizer vaccines, primary and 2 booster doses. Last booster dose on 06Apr2022. However, she had COVID 19 infection in Jun2022. Caller disconnected prior to transfer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Borderline HBP" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; METROPOLYN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Borderline, notes: Borderline HBP; SARS-CoV-2 test: (18Nov2022) Positive, notes: Took Paxlovid 5 days beginning 1st day of symptoms and positive antigen test; (23Nov2022) Negative, notes: Tested negative one day after completing treatment; (29Nov2022) Positive, notes: Tested positive 6 days later asymptomatic. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: burning pain in the elbow to wrist; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose number unknown (booster), single (Lot number: GH9697, Expiration Date: 15Dec2022) intramuscular for covid-19 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: BURNING SENSATION OF UPPER LIMB(medically significant) with onset 30Nov2022, outcome "not recovered", described as "burning pain in the elbow to wrist". Therapeutic measures were taken as a result of pain in extremity.  Clinical course: Patient given a shot (to deltoid unspecified if left or right) yesterday and is now complaining of burning pain in the elbow to wrist. Has been about 24 hours since the shot.  Didn't see anything on the package insert online other than extremity pain.  Wants to know how common it is, management, or other information. Patient started taking ibuprofen to treat it.  Doesn't know any further information other than what was on the text message he received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug. 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.
Age: 64.0
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 a non-contactable reporter (Consumer). The reporter is the patient. A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: COVID 19 Treatment; (Nov2022) Positive, notes: Had Covid rebound 5 plus days and still testing positive with symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. which includes anti-viral Pfizer Covid 19 Treatment from 13Nov2022 to 18Nov2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201343089 Same patient, same drug/different dose, different AEs;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Iridocyclitis, Pain, Weight
Clinical narrative: Nongranulomatous anterior uveitis in the eye; Painful to move her eye or head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood thinner" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing), notes: Since she was a child and has been on since 18 years old. The patient's weight reported as 107 - 108 lbs. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single; ELIQUIS taken for anticoagulant therapy; LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: moderna (DOSE 1, Lot number: 038K20A or 038K26A), administration date: 21Jan2021, for Covid-19 immunization, reaction(s): "Hives"; moderna (DOSE 2, Lot number: 006M20A), administration date: 18Feb2021, for Covid-19 immunization, reaction(s): "Hives"; BNT162b2 (DOSE 3 (BOOSTER), Route of Administration: Intramuscular, Lot number: FJ1611), administration date: 16Dec2021, for Covid-19 immunization, reaction(s): "Hives", "Interchange of vaccine products". Within 3-4 days after COVID-19 Vaccine Bivalent, patient's eye got very red, white part got swollen, and was painful to move her eye or head. She could not see well. Because this happened during a holiday, she could not see her doctor till Monday. Her doctor said she developed non-granulomatous anterior uveitis in the eye. Her doctor prescribed her eye drops and steroids which helped with pain. She knows some people have gotten this shot and have gotten this reaction and her fear is that she will lose vision in her eye. She would like to know what the outcome of people has been who have had this side effect from this shot. She wishes she had not gotten the shot. The events were assessed as serious (medically significant). The outcome of the events was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 68-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation.  The patient had no relevant medical history. Concomitant medication included: ATORVASTATIN, stop date: 07Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID 19 Treatment".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Nov2022) Positive, notes: Home test positive on Day 6; (13Nov2022) Negative, notes: Tested negative on Day 7 & 8; (14Nov2022) Negative, notes: Tested negative on Day 7 & 8; (16Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (17Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (18Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (19Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (20Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (21Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (22Nov2022) Negative, notes: Tested negative on subsequent days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: treated with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jun2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing); (unspecified if ongoing); "asthma moderate to severe" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "low thyroid" (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 18Nov2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Nov2022) Positive; (18Nov2022) Positive; (27Nov2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Original positive test date 18Nov and positive result confirmed at Urgent Care Clinic on 19Nov2022. Finished full 5 day medication course of Paxlovid from 19Nov2022 to 23Nov2022 as prescribed. Tested negative, with symptom abatement, on 27Nov2022. Full return of Covid 19 Symptoms on 29Nov2022 and a positive Covid 19 rapid antigen home test 30Nov2022.   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: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Known allergies: shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
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; Interchange of vaccine products; 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), on 26Feb2021 as dose 1, single (Lot number: EN6203), on 19Mar2021 as dose 2, single (Lot number: EN6208) and on 09Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 02Oct2022 as dose 5 (booster), single (Lot number: 057F22A) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Apr2022 as dose 4 (booster), single (Lot number: 001M21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypogammaglobulinaemia" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: nutmeg" (unspecified if ongoing). Concomitant medication(s) included: OXCARBAZEPINE; SYNTHROID; VITAMIN D3. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Nov2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Nov2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient started Paxlovid (Lot number: 1919256A) on 15Nov2022 and stopped on 19Nov2022 for treatment of COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Deep vein thrombosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: tested Covid positive; tested Covid positive; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Dec2020 at 18:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jan2021 at 18:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Nov2022, outcome "not recovered" and all described as "tested Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Nov2022) positive; (22Nov2022) negative; (27Nov2022) positive. Therapeutic measures were taken as a result of covid-19. The patient tested COVID positive on 17Nov2022 in the afternoon with a sore throat, nasal congestion, cough, fever, and body aches. Although, the patient's Urgent Care physician did not think of her as a high-risk patient and did not initially plan to order Paxlovid for the patient, after her request, the physician ordered Paxlovid. The patient finished the 5 days of paxlovid treatment on 22Nov2022 morning. The Covid test on the 22Nov2022 afternoon was negative. The patient's symptoms seemed to be better at that moment. 3 days after finishing Paxlovid treatment, she gradually felt the nasal congestion got more severe, and the body aches got worse. The symptoms do not match the Covid negative result on 22Nov2022. Then on 27Nov2022, she did a Covid test again, then realized she turned back Covid positive again. She then started isolation again. She would like to find out why she got Covid rebound even though she was fully vaccinated, healthy, and even did paxlovid treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, the reported serious events vaccination Failure and covid-19 cannot be excluded for the suspect product(s).
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had covid 6 weeks ago; had covid 6 weeks ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 80's 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) all with onset 2022, outcome "recovered" and all described as "had covid 6 weeks ago". Therapeutic measures were taken as a result of suspected covid-19, received PAXLOVID and stated it worked unbelievably. Stated it stopped it in its tracks. Reported that its phenomenal; within hours she was feeling better. Patient wanted to get the Pfizer booster, reporter mentioned all went well with the prior COVID vaccines. Reporter asked if there was any issue with having COVID-19 booster 6 weeks after having COVID.  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, 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 (Consumer). 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 15Oct2022 at 14:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing), notes: Known allergies: Sulfa; "Blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes 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.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Blood pressure measurement, Body temperature, Breath sounds, Complement factor C4
Clinical narrative: delayed angioedema; This is a literature report.  A 33-year-old woman with a history of episodic idiopathic urticaria, asthma, venom hypersensitivity, and Cushing syndrome on long-term low-dose corticosteroids tolerated her first Pfizer-BioNTech COVID-19 mRNA vaccine without immediate complications. After 1 day, she developed a pruritic, erythematous rash on her chest, throat tightness, and dyspnea, and presented to the ED where she was noted to be normotensive, tachycardic, and mildly febrile. Physical examination revealed lip and tongue angioedema, urticaria involving arms and chest, muffled voice, and decreased breath sounds. Flexible laryngoscopy revealed edematous vocal cords. She was urgently intubated. Serum tryptase levels during symptoms were normal. She received 2 doses of 0.3-mg intramuscular epinephrine, 50-mg oral diphenhydramine, 125-mg intravenous methylprednisolone, and 20-mg oral famotidine. Owing to her symptom severity, she was started on a continuous intravenous epinephrine infusion, which was weaned after 8 hours, and her angioedema resolved by 14 hours. She was advised not to receive dose 2 of the Pfizer-BioNTech COVID-19 vaccine. She denied a previous history of angioedema and reported no further episodes in the subsequent 7 months.  Table 1: Overview of Cases of Delayed Angioedema After SARS-CoV-2 mRNA Vaccine Administration Age (y): 33; Sex: Female; Atopic history: Allergic rhinitis, intermittent asthma, venom hypersensitivity, chronic spontaneous urticaria, no previous history of angioedema; Miralax exposure: Unclear if ever taken; Vaccine administered: first dosage Pfizer-BioNTech COVID-19; Onset of symptoms: 26h post-vaccination; Symptoms: Urticaria, lip swelling, tongue swelling, vocal cord swelling, dysphonia, dysphagia, and dyspnea; Vitals on presentation to the emergency department: BP, 95/55; HR, 128; RR, 18; T, 100.6F; oxygen saturation 98% on RA; Treatment: IM epinephrine, IV epinephrine, corticosteroid, antihistamine; Serum tryptase (mcg/L) 2.2, normal; C4 level (mg/dL): 21.8, normal; Recurrence of angioedema to date: None.; Sender's Comments: Based on the available information in the case, the causal association between the event "angioedema" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200115083 Same drug/event and different patient.;US-PFIZER INC-202201343859 Same drug/event and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Laryngoscopy, Oxygen saturation, Physical examination, Respiratory rate
Clinical narrative: delayed angioedema; This is a literature report.  A 33-year-old woman with a history of episodic idiopathic urticaria, asthma, venom hypersensitivity, and Cushing syndrome on long-term low-dose corticosteroids tolerated her first Pfizer-BioNTech COVID-19 mRNA vaccine without immediate complications. After 1 day, she developed a pruritic, erythematous rash on her chest, throat tightness, and dyspnea, and presented to the ED where she was noted to be normotensive, tachycardic, and mildly febrile. Physical examination revealed lip and tongue angioedema, urticaria involving arms and chest, muffled voice, and decreased breath sounds. Flexible laryngoscopy revealed edematous vocal cords. She was urgently intubated. Serum tryptase levels during symptoms were normal. She received 2 doses of 0.3-mg intramuscular epinephrine, 50-mg oral diphenhydramine, 125-mg intravenous methylprednisolone, and 20-mg oral famotidine. Owing to her symptom severity, she was started on a continuous intravenous epinephrine infusion, which was weaned after 8 hours, and her angioedema resolved by 14 hours. She was advised not to receive dose 2 of the Pfizer-BioNTech COVID-19 vaccine. She denied a previous history of angioedema and reported no further episodes in the subsequent 7 months.  Table 1: Overview of Cases of Delayed Angioedema After SARS-CoV-2 mRNA Vaccine Administration Age (y): 33; Sex: Female; Atopic history: Allergic rhinitis, intermittent asthma, venom hypersensitivity, chronic spontaneous urticaria, no previous history of angioedema; Miralax exposure: Unclear if ever taken; Vaccine administered: first dosage Pfizer-BioNTech COVID-19; Onset of symptoms: 26h post-vaccination; Symptoms: Urticaria, lip swelling, tongue swelling, vocal cord swelling, dysphonia, dysphagia, and dyspnea; Vitals on presentation to the emergency department: BP, 95/55; HR, 128; RR, 18; T, 100.6F; oxygen saturation 98% on RA; Treatment: IM epinephrine, IV epinephrine, corticosteroid, antihistamine; Serum tryptase (mcg/L) 2.2, normal; C4 level (mg/dL): 21.8, normal; Recurrence of angioedema to date: None.; Sender's Comments: Based on the available information in the case, the causal association between the event "angioedema" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200115083 Same drug/event and different patient.;US-PFIZER INC-202201343859 Same drug/event and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Tryptase
Clinical narrative: delayed angioedema; This is a literature report.  A 33-year-old woman with a history of episodic idiopathic urticaria, asthma, venom hypersensitivity, and Cushing syndrome on long-term low-dose corticosteroids tolerated her first Pfizer-BioNTech COVID-19 mRNA vaccine without immediate complications. After 1 day, she developed a pruritic, erythematous rash on her chest, throat tightness, and dyspnea, and presented to the ED where she was noted to be normotensive, tachycardic, and mildly febrile. Physical examination revealed lip and tongue angioedema, urticaria involving arms and chest, muffled voice, and decreased breath sounds. Flexible laryngoscopy revealed edematous vocal cords. She was urgently intubated. Serum tryptase levels during symptoms were normal. She received 2 doses of 0.3-mg intramuscular epinephrine, 50-mg oral diphenhydramine, 125-mg intravenous methylprednisolone, and 20-mg oral famotidine. Owing to her symptom severity, she was started on a continuous intravenous epinephrine infusion, which was weaned after 8 hours, and her angioedema resolved by 14 hours. She was advised not to receive dose 2 of the Pfizer-BioNTech COVID-19 vaccine. She denied a previous history of angioedema and reported no further episodes in the subsequent 7 months.  Table 1: Overview of Cases of Delayed Angioedema After SARS-CoV-2 mRNA Vaccine Administration Age (y): 33; Sex: Female; Atopic history: Allergic rhinitis, intermittent asthma, venom hypersensitivity, chronic spontaneous urticaria, no previous history of angioedema; Miralax exposure: Unclear if ever taken; Vaccine administered: first dosage Pfizer-BioNTech COVID-19; Onset of symptoms: 26h post-vaccination; Symptoms: Urticaria, lip swelling, tongue swelling, vocal cord swelling, dysphonia, dysphagia, and dyspnea; Vitals on presentation to the emergency department: BP, 95/55; HR, 128; RR, 18; T, 100.6F; oxygen saturation 98% on RA; Treatment: IM epinephrine, IV epinephrine, corticosteroid, antihistamine; Serum tryptase (mcg/L) 2.2, normal; C4 level (mg/dL): 21.8, normal; Recurrence of angioedema to date: None.; Sender's Comments: Based on the available information in the case, the causal association between the event "angioedema" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200115083 Same drug/event and different patient.;US-PFIZER INC-202201343859 Same drug/event and different patient.;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1, 2, and 3: Moderna/Dose 4: Pfizer / Biontech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 17Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included (within 2 weeks of vaccination): CLARITIN [CLARITHROMYCIN], start date: 20May2019; MAGNESIUM, start date: 01Jan2021; NASACORT, start date: 22May2022; PROBIOTICS, start date: 01Jan2017; VITAMIN D [VITAMIN D NOS], start date: 01Jan2017; Postnatal vitamins, start date: 14Aug2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022 at 12:00, outcome "unknown", described as "Dose 1, 2, and 3: Moderna/Dose 4: Pfizer / Biontech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes using 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
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 a non-contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EH9899), on 25Jan2021 as dose 2, single (Lot number: EL3302) and on 01Nov2021 at 10:00 as dose 3 (booster), single (Lot number: ff2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac dz" (unspecified if ongoing); "reactive airway dz" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 21Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Nov2022) Positive. Therapeutic measures were taken as a result of covid-19, treatment failure. On day 1 took PAXLOVID 5 days (from 21Nov2022 to 25Nov2022) as COVID 19 Treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Hysterectomy, Infection, SARS-CoV-2 test
Clinical narrative: DVT's in both of my upper arms; Hysterectomy; infection; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient. A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EL1284), in left arm for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported.  Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL 9262, Location of injection: Arm Right), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: F63527, Location of injection: Arm Left), for COVID-19 immunization. The following information was reported: HYSTERECTOMY (medically significant) with onset 06Jun2022, outcome "unknown"; INFECTION (medically significant) with onset 06Jun2022, outcome "unknown"; DEEP VEIN THROMBOSIS (hospitalization, life threatening) with onset 10Jun2022, outcome "not recovered", described as "DVT's in both of my upper arms". The patient was hospitalized for deep vein thrombosis (hospitalization duration: 13 day(s)).  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive, notes: Nasal Swab.  Therapeutic measures were taken as a result of deep vein thrombosis includes Lovenox injections; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events 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: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Drug ineffective, Hypoglycaemia, Laboratory test, Suspected COVID-19
Clinical narrative: Have had Covid 2x; Have had Covid 2x; stroke; TIA; Hypoglycemic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I don't drink, smoke. Or do any drugs" (unspecified if ongoing); "I don't drink, smoke. Or do any drugs" (unspecified if ongoing); "I don't drink, smoke. Or do any drugs" (unspecified if ongoing). The patient's 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 "Have had Covid 2x"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA"; HYPOGLYCAEMIA (non-serious), outcome "unknown", described as "Hypoglycemic". The patient underwent the following laboratory tests and procedures: So many tests: unknown results, notes: to find out why stroke and TIA with no luck. Clinical course: Since having this vaccine patient had several other issues. Stated that the only thing that has been consistent was this COVID Vaccine. Mentioned that patient was very healthy before. Asked if there were many complaints of stroke.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Have had Covid 2x; Have had Covid 2x; stroke; TIA; Hypoglycemic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I don't drink, smoke. Or do any drugs" (unspecified if ongoing); "I don't drink, smoke. Or do any drugs" (unspecified if ongoing); "I don't drink, smoke. Or do any drugs" (unspecified if ongoing). The patient's 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 "Have had Covid 2x"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA"; HYPOGLYCAEMIA (non-serious), outcome "unknown", described as "Hypoglycemic". The patient underwent the following laboratory tests and procedures: So many tests: unknown results, notes: to find out why stroke and TIA with no luck. Clinical course: Since having this vaccine patient had several other issues. Stated that the only thing that has been consistent was this COVID Vaccine. Mentioned that patient was very healthy before. Asked if there were many complaints of stroke.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.