chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid from 11Oct2022 to 15Oct2022.  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: 73.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2824) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 at 12:00 as dose 1, single (Lot number: EN9581), in left arm, on 08Feb2021 at 12:00 as dose 2, single (Lot number: EL9267), in left arm, on 21Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 03Mar2022 at 12:00 as dose 4 (booster), single (Lot number: PK9894), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no known allergies. There were no concomitant medications. 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: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; 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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 11:30 as dose 1, single (Lot number: EP7534), in left arm, on 03Apr2021 at 11:00 as dose 2, single (Lot number: EW0151), in left arm, on 25Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 27Jul2022 at 11:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN (Brand: pharm), start date: 05Jul2010; GABAPENTIN (Brand: Aurobindo), start date: 01Apr2022, also reported as other medication in 2weeks. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin"; Dilaudid, reaction(s): "Known allergies: dilaudid". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Oct2022) Negative; (20Oct2022) Positive, notes: Tested positive for COVID-19 48 hours after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid, started on 10Oct2022 and stopped on 15Oct2022. Clinical course was reported as, Tested positive for COVID-19 on 20Oct2022 at 08:00, 48 hours after testing negative, 5 days after finishing full course of Paxlovid. Patient not received any treatment and was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: second shot: hole in retina of her eye (right eye); Had numbness in her toes; second shot: Blurred vision (distorted) right eye; second shot: tendonitis (constant ringing in the ears); autoimmune levels were up; 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), on 04Mar2021 at 13:30 as dose 2, single (Lot number: EN6198) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch lot no: EM9809), administration date: 04Feb2021, when the patient was 62-year-old, for Covid-19 immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset Jul2021, outcome "unknown", described as "autoimmune levels were up"; RETINAL TEAR (medically significant), outcome "not recovered", described as "second shot: hole in retina of her eye (right eye)"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Had numbness in her toes"; VISION BLURRED (non-serious), outcome "not recovered", described as "second shot: Blurred vision (distorted) right eye"; TENDONITIS (non-serious), outcome "not recovered", described as "second shot: tendonitis (constant ringing in the ears)". The event "second shot: tendonitis (constant ringing in the ears)" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: autoimmune levels up, notes: autoimmune levels were up. Is what the blood work showed. Therapeutic measures were not taken as a result of autoimmune disorder, hypoaesthesia, tendonitis.  Clinical Course: Reporter wanted to know where to go to report an injury from the Pfizer Covid 19 vaccine. Had numbness in her toes, hole in the retina of her eye and tendonitis (constant ringing in the ears). Wanted to go on record that she reported it and what happened to her. Event details: Two months after had the Pfizer Covid 19 vaccine everything started. Later clarified that about 5 weeks after she had the second shot that she had ringing in her ears. Later clarified that it was 4-5 weeks after the second shot that she had ringing in her ears. Few weeks after that she started having numbness in her toes and blurred vision in her right eye. Later clarified as numbness in toes of both feet but more in the right foot: no treatment. hole in retina of her eye. Was told they wanted to put a ball in her right eye. Took pictures of her eye and saw the hole in her retina. Had pictures within the last 30 days. tendonitis (constant ringing in the ears): Made an ear doctor appointment. No treatment. autoimmune levels were up: no treatment Product details: Had the second Pfizer Covid 19 vaccine at 1330. Had the first Pfizer Covid 19 vaccine on 04Feb2021 with lot number of EM9809. Investigations: Went to the doctor when she started having problems and was told that her autoimmune levels were up. Is what the blood work showed.
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 non-contactable reporter(s) (Physician).  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 was not reported. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other medication in 2weeks. The patient has taken Paxlovid antiviral for the treatment of COVID-19 from 10Oct2022 to 15Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 31.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DESVENLAFAXINE; TRAZODONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: received COVID 19 Treatment; (Oct2022) Positive, notes: positive test 5 days after treatment with paxlovid ended. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Anti-viral for Covid-19 from 11Oct2022 to 16Oct2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Caller mentioned that she had all her Pfizer COVID-19 Vaccine shots and boosters. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Aug2022 at 09:00 as dose 5 (booster), single (Lot number: Fp7140) at the age of 39 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: "Known allergy: Penicillin" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "autoimmune disorder" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "gerd" (unspecified if ongoing); "chronic pain" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 08Oct2022, stop date: 15Oct2022. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: After finishing Paxlovid symptoms seemed to improve for a few days, a d I testosterone negative for covid; (20Oct2022) Positive, notes: today I am again testing positive despite staying isolated. Therapeutic measures were taken as a result of drug ineffective, covid-19. After finishing Paxlovid symptoms seemed to improve for a few days, a d I testosterone negative for covid. Six days after finishing Paxlovid I started experiencing congestion and sneezing which worsened, and today I am again testing positive despite staying isolated.treatment start date 08Oct2022, and treatment end date.13Oct2022 of Paxlovid.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, Drug ineffective
Clinical narrative: She got Omicron; She got Omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 44-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney problem" (unspecified if ongoing), notes: She has kidney and heart problems; "heart problem" (unspecified if ongoing), notes: She has kidney and heart problems. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "She got Omicron". The patient underwent the following laboratory tests and procedures: Blood test: damper on her heart and kidneys, notes: Omicron put a damper on her heart and kidneys that showed up on bloodwork; COVID-19: Positive, notes: she had Omicron really bad. Clinical course: Report 3 of 3 on caller's daughter. Caller doesn't know if she is in the right spot. She got the last booster, the 2nd booster of Omicron/something and had horrible side effects. She has called on the last 3, every time she got one she called to tell us side effects. During report caller states her daughter has a lot of problems. She has kidney and heart problems, has 4 kids, has EDS and just a lot of problems. She got Omicron variety and had gotten all her shots except the 2nd booster. Omicron put a damper on her heart and kidneys that showed up on bloodwork. Doesn't have details of the vaccines. Has reported on her in the past and she is 43. Had originally called and asked why it would bother her kidneys so bad, it made her hurt more. Had the Pfizer Covid 19 vaccines but not the last one because they told her to wait. She doesn't know if it's because she got Covid. Is that true you build immunity? Her daughter said she has so much built up, she had Omicron really bad. She felt like passing out and wanted to sleep and sleep and sleep. Caller states it affected it kidneys and heart after getting Omicron. She had 3 Pfizer Covid 19 vaccines. Does have where her right leg turns purple due to her heart, and they did blood work. She went to the hospital when she had Covid and the tests found it was affecting her heart and kidneys and showed damage to both.   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: A contributory role of BNT162B2 to event She got Omicron cannot be excluded based on temporal association and available information.,Linked Report(s) : US-PFIZER INC-202201246587 same patient, different vaccine dose/events;
Age: 60.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 17:00 as dose 1, single (Lot number: El3246), in left arm, on 19Feb2021 at 17:00 as dose 2, single (Lot number: El9267), in left arm and on 21Nov2021 at 12:00 as dose 3 (booster), single (Lot number: Fh8027) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 01Jan2019; LISINOPRIL, start date: 01Jan2019; HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative (home test) on day 9; positive, notes: again Day 11. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient taking other medications/products within 2 weeks of starting COVID-19 treatment was Yes. Patient took plaxlovid for the full five days. Seemed to be better by day 7. No symptoms and tested negative (home test) on day 9. On day 11, COVID symptoms returned (5 days after completing plaxlovid) and tested positive again.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
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; Name of Drug as Reported: Moderna, Dose number: 04; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6206), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 46 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Sep2022 at 05:00 as dose 4 (booster), single (Lot number: AS7140C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "perimenopause" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "migraine" (unspecified if ongoing); "non specific joint/connective tissue disorder with similarities to, but lacking diagnostic criteria for, EDS, Marfan's" (unspecified if ongoing), notes: non specific joint/connective tissue disorder with similarities to,; "known allergies:Sulfa" (unspecified if ongoing), notes: known allergies:Sulfa; "known allergies:penicillin" (unspecified if ongoing), notes: known allergies:penicillin; "known allergies:latex" (unspecified if ongoing), notes: known allergies:latex. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022, outcome "unknown", described as "Name of Drug as Reported: Moderna, Dose number: 04"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2022) Negative, notes: Tested negative for COVID (after taking Paxlovid) on antigen test Friday, Saturday, Sunday; (15Oct2022) Negative, notes: Tested negative for COVID (after taking Paxlovid) on antigen test Friday, Saturday, Sunday; (16Oct2022) Negative, notes: Tested negative for COVID (after taking Paxlovid) on antigen test Friday, Saturday, Sunday; (17Oct2022) Positive, notes: Monday - tested positive for COVID again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: It was reported that other medications in two weeks reported as yes. Patient started treatment for COVID 19 with Paxlovid on 09Oct2022 and stopped on 13Oct2022.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID test Positive; COVID test Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 30Mar2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 27Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies penicillin" (unspecified if ongoing), notes: known allergies penicillin. Concomitant medication(s) included: SIMVASTATIN; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab.  Clinical Information: Patient received no other vaccine in four weeks. Other medications in two weeks included simvastatin, omeprazole and multivitamin. Patient had no COVID prior vaccination. The patient was COVID tested post vaccination.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Cataract, Pain in extremity, SARS-CoV-2 test
Clinical narrative: COVID test Positive; COVID test Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 30Mar2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 27Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies penicillin" (unspecified if ongoing), notes: known allergies penicillin. Concomitant medication(s) included: SIMVASTATIN; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab.  Clinical Information: Patient received no other vaccine in four weeks. Other medications in two weeks included simvastatin, omeprazole and multivitamin. Patient had no COVID prior vaccination. The patient was COVID tested post vaccination.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Full blood count, Haemoglobin, Laboratory test
Clinical narrative: Had a mild case of COVID; Had a mild case of COVID; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team and product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), on 12Jan2021 as dose 2, single (Lot number: EL1284) and on 26Sep2021 as dose 3 (booster), single (Lot number: FF2888) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Had surgery in the left arm" (unspecified if ongoing), notes: Had surgery in the left arm; "Chronic back issues" (unspecified if ongoing), notes: Chronic back issues; "Back pain and sleep" (unspecified if ongoing), notes: back pain and sleep; "Back pain and sleep" (unspecified if ongoing), notes: back pain and sleep; "Allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: LORTAB [LORATADINE] taken for back pain, insomnia, musculoskeletal discomfort; FINASTERIDE; FLUTICASONE taken for rhinitis allergic; VITAMIN D [COLECALCIFEROL]; B12 [CYANOCOBALAMIN] oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had a mild case of COVID". The patient underwent the following laboratory tests and procedures: Full blood count: ok, notes: All blood counts and chemistry counts have been ok; Haemoglobin: very slight low hemoglobin but not much, notes: Had very slight low hemoglobin but not much; Chemistry count: chemistry counts have been ok, notes: All blood counts and chemistry counts have been ok.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm and on 24Mar2021 as dose 2, single (Lot number: ER8732) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid for years" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2013. Past drug history included: Warfarin, reaction(s): "drug allergy"; Lovenox, reaction(s): "drug allergy"; Tetracyclines, reaction(s): "drug allergy". 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: Unknown results, notes: Called Dr. on Saturday night re:symptoms was told it was COVID take Immodium. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 37 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 25Jan2021 as dose 1, single (Lot number: 028L20A), in left arm, on 23Feb2021 as dose 2, single (Lot number: 030M20A), in left arm and on 03Sep2022 as dose 4 (booster), single (Lot number: AS7140C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "History of blood pressure issues on and off" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing); "Known allergies: mild food allergy to jalepeno peppers" (unspecified if ongoing); "Known allergies: lactose intolerant" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Oct2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Positive, notes: rapid antigen test - x2; (10Oct2022) Negative, notes: Negative PCR; (12Oct2022) Negative, notes: Negative Rapid antigen; (13Oct2022) Negative, notes: Negative Rapid antigen; (20Oct2022) Positive, notes: Positive rapid antigen. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient tested positive (rapid antigen test - x2) for COVID-19 on 10Oct2022. Started Pavloxid on 11Oct2022. Final dose on 15Oct2022. Negative PCR on 10Oct2022, negative rapid antigen on 12Oct2022 and 13Oct2022. Symptom free 13Oct2022. Re-developed symptoms on 20Oct2022. Positive rapid antigen test on 20Oct2022.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: beard literally started falling off/Alopecia started on my scalp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male 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: ALOPECIA (non-serious), outcome "unknown", described as "beard literally started falling off/Alopecia started on my scalp". Therapeutic measures were taken as a result of alopecia.  Additional information: The patient had never suffered from any hair loss. There was no history of hair loss in his family. A few weeks following Pfizer Covid vaccine by beard literally started falling off. The patient underwent costly and painful treatments to recover his beard. About 2 months back, the alopecia started on his scalp. The costly and painful process continues. Patient never had COVID. It was reported that getting the Pfizer vaccine was a decision the patient regrets for the rest of his life.  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: Oral pain, Ranula
Clinical narrative: After the second booster dose, her sister experienced boils under her tongue and within her mouth 7 days later.; boils under her tongue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: ORAL PAIN (non-serious), outcome "not recovered", described as "After the second booster dose, her sister experienced boils under her tongue and within her mouth 7 days later."; RANULA (non-serious), outcome "not recovered", described as "boils under her tongue". Therapeutic measures were taken as a result of oral pain, ranula.  Additional information: Event took place after use of product. Heart meds treat Hypertension. Patient's sister's doctor changed heart medications, but the boils persisted for at least 10 weeks, despite treatment with oral steroids.  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 has moderate covid; she has moderate covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 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 "she has moderate covid". Clinical course: Reporter mother who was 81 received the booster bivalent vaccine about a month ago, and she had moderate covid.  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: Alopecia, Drug ineffective, Myalgia, Skin reaction, Suspected COVID-19
Clinical narrative: fatigue symptoms associated with long Covid; fatigue symptoms associated with long Covid; severe tinnitus; continued hair loss; severe skin reaction; severe muscle aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003714 (Novavax).  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 "fatigue symptoms associated with long Covid"; TINNITUS (non-serious), outcome "unknown", described as "severe tinnitus"; ALOPECIA (non-serious), outcome "unknown", described as "continued hair loss"; SKIN REACTION (non-serious), outcome "unknown", described as "severe skin reaction"; MYALGIA (non-serious), outcome "unknown", described as "severe muscle aches". Clinical course: On 04Oct2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine at an unspecified dose and frequency for COVID-19 immunization. It was reported the patient experienced severe tinnitus, continued hair loss, severe skin reaction, severe muscle aches, fatigue symptoms associated with long Covid. It was reported that no further follow-up was anticipated.  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: Tinnitus
Clinical narrative: fatigue symptoms associated with long Covid; fatigue symptoms associated with long Covid; severe tinnitus; continued hair loss; severe skin reaction; severe muscle aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003714 (Novavax).  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 "fatigue symptoms associated with long Covid"; TINNITUS (non-serious), outcome "unknown", described as "severe tinnitus"; ALOPECIA (non-serious), outcome "unknown", described as "continued hair loss"; SKIN REACTION (non-serious), outcome "unknown", described as "severe skin reaction"; MYALGIA (non-serious), outcome "unknown", described as "severe muscle aches". Clinical course: On 04Oct2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine at an unspecified dose and frequency for COVID-19 immunization. It was reported the patient experienced severe tinnitus, continued hair loss, severe skin reaction, severe muscle aches, fatigue symptoms associated with long Covid. It was reported that no further follow-up was anticipated.  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: Influenza like illness, Muscle twitching, Vaccination site pain
Clinical narrative: twitching on left cheek/Periodic facial twitching on left side of face; pain at injection site; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 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 completed but manufacturer unknown), for COVID-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching on left cheek/Periodic facial twitching on left side of face"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms".  Additional information: Periodic facial twitching on left side of face began a few hours after booster shot and continues into the next day. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was diagnosed with Covid; I was diagnosed with Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booter), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "scleroderma" (unspecified if ongoing), notes: I have limited scleroderma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was diagnosed with Covid". 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: . I was diagnosed with Covid and on second day of Covid symptoms started Paxlovid which helped to reduce my symptoms within two days.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got positive result; I got positive result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 17Oct2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I got positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2022) Positive, notes: BinaxNOW Covid-19 Antigen Self Test kit to test myself. I got positive result. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness, Neuralgic amyotrophy, Paralysis
Clinical narrative: paralysis; lost 100 percent use of my left bicep; Parsonage Turner Syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: NEURALGIC AMYOTROPHY (non-serious) with onset 04May2021, outcome "unknown", described as "Parsonage Turner Syndrome"; PARALYSIS (medically significant), outcome "unknown"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "lost 100 percent use of my left bicep".  Clinical course: It was reported that, their COVID 19 vaccine gave the patient Parsonage Turner Syndrome on 04May2021. Stated that, patient had all the medical records to back up claims. Enquired, what did Pfizer intend to do about the paralysis caused by their drug. Patient had lost 100 percent use of left bicep. What was their official statement about this?  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: Pulmonary embolism
Clinical narrative: presumed pulmonary embolism; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (COMIRNATY), 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, reaction(s): "No adverse event, patient was presumed healthy prior to Covid booster". The following information was reported: PULMONARY EMBOLISM (death), outcome "fatal", described as "presumed pulmonary embolism". The patient date of death was unknown. Reported cause of death: "presumed pulmonary embolism". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported event Pulmonary Embolism 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; Reported Cause(s) of Death: presumed pulmonary embolism
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: a week later broke out with shingles on her forehead; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-Oct-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter saw a lady (patient) yesterday (day before reporting) who got the Shingles vaccine and a week later broke out with shingles on her forehead.  The reporter stated so much for vaccines. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Aug2019, 2nd Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2019).   In August 2022, the patient received the 2nd dose of Shingrix. In August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's Comments: The pharmacist reported that the patient received second dose of Shingrix in August 2022. The reporter reported that two patients were relatives (reporter´s parents) who received Shingrix the same month. The reporter consented to follow up. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. This case was one of the 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022149871:Same reporter
Age: 89.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal chest pain
Clinical narrative: Moderna Bivalent 051D22A on October 21, 2022 at 4:30 p.m. in left arm. Patient experienced a lot of pain on right side by rib cage.  Never had that pain before. She took one Extra-StrengthTylenol afternoon of Oct. 24; took two Extra-StrengthTylenol morning of Oct. 25.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe