chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: symptoms reappeared after day 6, and tested positive; symptoms reappeared after day 6, and tested positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 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: "HTN" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: bactrim for Known allergies: Bactrim. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "symptoms reappeared after day 6, and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (10Jun2022) Negative, notes: Tested negative after 4 days of Paxlovid; (22Jun2022) Positive, notes: tested positive for the next 16 days; (23Jun2022) Negative, notes: Symptoms abating, and tested negative on day 17. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti viral details COVID 19 Treatment, treatment start date: 07Jun2022,stop date: 11Jun2022, indication: Treatment of COVID-19. Adverse event: Very bad taste. Tested negative after 4 days of Paxlovid. Improving. Then symptoms reappeared after day 6, and tested positive for the next 16 days. Symptoms abating, and tested negative on day 17. Also flare up of gout while on Paxlovid. Adverse event start date: 08Jun2022 and stop date: Jun2022. outcome: Recovered with lasting effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 23Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 31Mar2022 at 14:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Known allergies: cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details for COVID 19 treatment started from 12Jun2022 to 15Jun2022. There was no other medications in two weeks
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Back pain, Bruxism, Chills, Hypersensitivity, Neck pain
Clinical narrative: Fever with chills; Clenched teeth; Neck and back pain; Neck and back pain; shaking; psychosomatic versus allergic reaction; psychosomatic versus allergic reaction; This is a spontaneous report received from contactable reporter (Nurse) from medical information team.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 23Jun2022 as dose number unknown, 0.5 ml single (Lot number: ER2622, Expiration Date: 31Jan2024) at the age of 16 years, in right deltoid for immunization; meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), on 23Jun2022 as dose number unknown, 0.5ml single (Lot number: U7299AC, Expiration Date: 04Aug2024), in left deltoid for immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BRUXISM (medically significant) with onset 23Jun2022, outcome "recovering", described as "Clenched teeth"; PYREXIA (medically significant) with onset 23Jun2022, outcome "recovering", described as "Fever with chills"; NECK PAIN (medically significant), BACK PAIN (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "Neck and back pain"; SOMATIC SYMPTOM DISORDER (medically significant), HYPERSENSITIVITY (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "psychosomatic versus allergic reaction"; TREMOR (medically significant) with onset 23Jun2022, outcome "recovering", described as "shaking". The events "fever with chills", "clenched teeth", "neck and back pain", "shaking" and "psychosomatic versus allergic reaction" required emergency room visit. Therapeutic measures were taken as a result of pyrexia, bruxism, neck pain, back pain, tremor, somatic symptom disorder, hypersensitivity which included Benadryl. They have a patient who was administered Trumenba and Menquadfi to yesterday. Two (2) and a half hours after receiving the vaccines the patient complained of severe neck and back pain, fever, clenched teeth and chills and shaking. So the patient went to the Emergency Room and was given Benadryl and all symptoms seem to resolve. She said the Emergency Room called this a psychosomatic versus allergic reaction.; Sender's Comments: There is a reasonable possibility that the events pyrexia and hypersensitivity were related to TRUMENBA based on known drug safety profile and close temporal relationship. Based on the close temporal relationship, the association between the other events with TRUMENBA can not be fully 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.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Somatic symptom disorder, Tremor
Clinical narrative: Fever with chills; Clenched teeth; Neck and back pain; Neck and back pain; shaking; psychosomatic versus allergic reaction; psychosomatic versus allergic reaction; This is a spontaneous report received from contactable reporter (Nurse) from medical information team.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 23Jun2022 as dose number unknown, 0.5 ml single (Lot number: ER2622, Expiration Date: 31Jan2024) at the age of 16 years, in right deltoid for immunization; meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), on 23Jun2022 as dose number unknown, 0.5ml single (Lot number: U7299AC, Expiration Date: 04Aug2024), in left deltoid for immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BRUXISM (medically significant) with onset 23Jun2022, outcome "recovering", described as "Clenched teeth"; PYREXIA (medically significant) with onset 23Jun2022, outcome "recovering", described as "Fever with chills"; NECK PAIN (medically significant), BACK PAIN (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "Neck and back pain"; SOMATIC SYMPTOM DISORDER (medically significant), HYPERSENSITIVITY (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "psychosomatic versus allergic reaction"; TREMOR (medically significant) with onset 23Jun2022, outcome "recovering", described as "shaking". The events "fever with chills", "clenched teeth", "neck and back pain", "shaking" and "psychosomatic versus allergic reaction" required emergency room visit. Therapeutic measures were taken as a result of pyrexia, bruxism, neck pain, back pain, tremor, somatic symptom disorder, hypersensitivity which included Benadryl. They have a patient who was administered Trumenba and Menquadfi to yesterday. Two (2) and a half hours after receiving the vaccines the patient complained of severe neck and back pain, fever, clenched teeth and chills and shaking. So the patient went to the Emergency Room and was given Benadryl and all symptoms seem to resolve. She said the Emergency Room called this a psychosomatic versus allergic reaction.; Sender's Comments: There is a reasonable possibility that the events pyrexia and hypersensitivity were related to TRUMENBA based on known drug safety profile and close temporal relationship. Based on the close temporal relationship, the association between the other events with TRUMENBA can not be fully 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.
Age: 1.92
Sex: M
Vaccine: COVID19
Symptoms: Injection site injury, Overdose, Product administered to patient of inappropriate age, Product use complaint
Clinical narrative: a 23 month old child was inadvertently administered 0.2 mL of the Pfizer Covid vaccine gray cap adult vaccine; a 23 month old child was inadvertently administered 0.2 mL of the Pfizer Covid vaccine gray cap adult vaccine; it is very, very tiny on the bottle; injury; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 23-month-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose number unknown, 0.2 ml single (Lot number: FP7135, Expiration Date: 30Nov2022) at the age of 23 months, in left thigh for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 24Jun2022, outcome "unknown" and all described as "a 23 month old child was inadvertently administered 0.2 mL of the Pfizer Covid vaccine gray cap adult vaccine"; INJECTION SITE INJURY (non-serious) with onset 24Jun2022, outcome "unknown", described as "injury"; PRODUCT USE COMPLAINT (non-serious) with onset 24Jun2022, outcome "unknown", described as "it is very, very tiny on the bottle".  Additional information: It was reported that she called to advice that they have administered an adult dose grey cap Pfizer COVID-19 Vaccine to 23 months old baby. They have given 0.2 ml of the dose to the patient. She told that she handed the vaccine to the provider and it was checked by the provider but it was the provider who administered the COVID-19 Vaccine and also reported that he grabbed the needle as reporter stuck his leg, the dad didn't have his arms and when he grabbed it when the needle came out, it scratched his leg a little bit. So, but reporter didn't inject anything he grabbed it as soon as reporter stuck in reporter didn't get to put the plunger down. So, he got stuck again with the wrong and had the injury. Reporter grabbed the needle out of his hand and reporter just stuck him again, the provider was holding his legs down.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test, Syncope, Vomiting
Clinical narrative: Fainted; Didn't know what had happened.; vomited; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Aug2021 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: other medical history: Allergies; "anxiety about Covid-19" (unspecified if ongoing), notes: other medical history: anxiety about Covid-19; "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts. Concomitant medication(s) included: ZYRTEC ALLERGY taken for multiple allergies; ASMANEX. Past drug history included: Cephalosporins, reaction(s): "Known allergies: Cephalosporins", notes: Known allergies: Cephalosporins. The following information was reported: FEELING ABNORMAL (non-serious) with onset 04Aug2021 at 14:30, outcome "unknown", described as "Didn't know what had happened."; SYNCOPE (medically significant) with onset 04Aug2021 at 14:30, outcome "unknown", described as "Fainted"; VOMITING (non-serious) with onset 04Aug2021 at 14:30, outcome "unknown", described as "vomited". The events "fainted", "didn't know what had happened." and "vomited" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of syncope, feeling abnormal, vomiting. Clinical Information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks included Zyrtec for allergies, Asmanex daily inhaler. The patient had no covid prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Exfoliative rash, Rash
Clinical narrative: Rash to bilateral buttocks, very painful, raw, sensitive, scaly; Rash to bilateral buttocks, very painful, raw, sensitive, scaly; Rash to bilateral buttocks, very painful, raw, sensitive, scaly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 at 17:00 as dose 1, single (Lot number: FK5227) at the age of 7 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DERMATITIS ACNEIFORM (non-serious), RASH (non-serious), EXFOLIATIVE RASH (non-serious) all with onset 16Nov2021 at 16:00, outcome "recovered" and all described as "Rash to bilateral buttocks, very painful, raw, sensitive, scaly". Therapeutic measures were not taken as a result of dermatitis acneiform, rash, exfoliative rash. Additional information: The patient did not had any known allergies. The patient did not received any treatment adverse event. No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pericarditis, SARS-CoV-2 test
Clinical narrative: I developed pericarditis after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6205) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: PERICARDITIS (medically significant) with onset 04Mar2021, outcome "not recovered", described as "I developed pericarditis after receiving the vaccine". The event "i developed pericarditis after receiving the vaccine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Diagnostic tests: Unknown results, notes: Diagnostic tests; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of pericarditis with Diagnostic tests and colchicine medication.  Clinical Course: Product- COVID 19, Brand: Pfizer, Lot number: EP7534, administration date: 18Mar2021, Dose number: 2. Patient had not taken other vaccine in four weeks. Patient did not have covid prior vaccination. Patient had covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Investigation, Vaccination site rash, Vaccination site warmth
Clinical narrative: Left upper arm Red at the site hard and hot, about the size of a lime; Left upper arm Red at the site hard and hot, about the size of a lime; Left upper arm Red at the site hard and hot, about the size of a lime; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jun2022 at 11:30 as dose 3 (booster), single (Lot number: FJ4991) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "latex: allergy" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE; LEVOCETIRIZINE; LEVOTHYROXINE; OLMESAR. Vaccination history included: BNT162b2 (Dose 2, Batch/Lot No: FG3527, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 09Nov2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Batch/Lot No: FF2590, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 12Oct2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE RASH (non-serious), ERYTHEMA (non-serious) all with onset 21Jun2022 at 12:00, outcome "not recovered" and all described as "Left upper arm Red at the site hard and hot, about the size of a lime". The events "left upper arm red at the site hard and hot, about the size of a lime" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site warmth, vaccination site rash, erythema.  Additional information: The patient had not received other vaccine in 4 weeks. Patient had other medications in 2 weeks with famotidine, levocetirizine, levothyroxine and olmesar. The patient was visited to doctor or other healthcare professional office/clinic visit for adverse event. The patient had no covid prior vaccination and covid tested post vaccination. Patient had latex allergy and no food allergies.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Loss of consciousness, Pallor, Vomiting
Clinical narrative: lost consciousness; went pale; chest pain; vomited; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 9-year-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 at 13:00 as dose 3 (booster), single (Lot number: FL8094) at the age of 9 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 2, Single, Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01Dec2021, when the patient was 9-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, Single, Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 10Nov2021, when the patient was 8-year-old, for Covid-19 immunization.  The following information was reported: CHEST PAIN (non-serious) with onset 24Jun2022 at 13:00, outcome "unknown"; LOSS OF CONSCIOUSNESS (medically significant) with onset 24Jun2022 at 13:00, outcome "recovered" (24Jun2022), described as "lost consciousness"; VOMITING (non-serious) with onset 24Jun2022 at 13:00, outcome "unknown", described as "vomited"; PALLOR (non-serious) with onset 24Jun2022 at 13:00, outcome "unknown", described as "went pale". The events "lost consciousness", "went pale", "chest pain" and "vomited" required emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (Jun2022) Unknown results, notes: given an EKG. Therapeutic measures were not taken as a result of loss of consciousness, pallor, chest pain, vomiting. Clinical course: It was reported that, the other vaccine in four weeks and other medications in 2 weeks was None. Adverse event:  Moments after receiving the shot, he went pale, had chest pain then lost consciousness. Paramedics were called. He was unconscious for a minute of two and when he woke, he vomited. Upon sitting up, he vomited again. Under paramedic advice, he was taken to the ER where he was observed, given an EKG and sent home. Covid prior vaccination and Covid tested post vaccination was None. No Known allergies reported and other medical history was None.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Paxlovid was given on start date of 14Jun2022 and stop date of 19Jun2022 with Indication of Treatment of COVID-19. Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient was previously received a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 at 16:00 as dose 4 (booster), single (Lot number: PP4554) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The other medications the patient received within 2 weeks of vaccination. The device date was reported as 25Jun2022.  No follow-up attempts are possible. No further information is expected..
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, SARS-CoV-2 test
Clinical narrative: injection site pain - pain in right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 4-year-old male patient received BNT162b2 (COMIRNATY), on 22Jun2022 at 17:15 as dose 1, single (Lot number: FT9142) at the age of 4 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "known allergis: Tree nuts" (unspecified if ongoing), notes: known allergies: Tree Nuts, Eggs; "known allergis: Eggs" (unspecified if ongoing), notes: known allergies: Tree Nuts, Eggs; "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. Concomitant medication(s) included: CHILDREN'S ZYRTEC. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 22Jun2022 at 20:30, outcome "recovered" (Jun2022), described as "injection site pain - pain in right arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of injection site pain.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 14:30 as dose 1, single (Lot number: En6201), in left arm, on 04Mar2022 at 14:30 as dose 2, single (Lot number: En6206), in left arm, on 10Sep2021 at 13:30 as dose 3 (booster), single (Lot number: Fe3593), in left arm and on 24May2022 at 13:15 as dose 4 (booster), single (Lot number: FJ4992) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2022, outcome "unknown", described as "COVID-19 Treatment"; VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: 9 days after testing negative; Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient started the treatment on 12Jun2022 to 16Jun2022 for COVID-19. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received COVID-19 Vaccine. There was COVID-19 rebound. The patient tested positive on an antigen test 9 days after testing negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I received two doses of the vaccine plus the booster and I just tested positive for the Covid-19; I received two doses of the vaccine plus the booster and I just tested positive for the 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 46-year-old patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), on 18Mar2021 as dose 2, single (Lot number: EL3247) and on 22Nov2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRUVADA. The following information was reported: VACCINATION FAILURE (medically significant) with onset 23Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 23Jun2022, outcome "not recovered" and all described as "I received two doses of the vaccine plus the booster and I just tested positive for the Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: "I do not lab test, I took home antigen test on Tuesday evening and it was negative and then I took another home antigen test today and it was positive."; (23Jun2022) positive, notes: "I do not lab test, I took home antigen test on Tuesday evening and it was negative and then I took another home antigen test today and it was positive.". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient reported that, patient took home antigen test on Tuesday evening and it was negative and then took another home antigen test today and it was positive. Patient also reported that, started taking just Niclo and Declo yesterday because patient thinks it was over because patient had the negative test on Tuesday but just re-tested and was positive.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown), on 13Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Lichen sclerosis" (unspecified if ongoing), notes: Lichen sclerosis; "Glaucoma" (unspecified if ongoing); "uterine cancer" (unspecified if ongoing); "Melanoma" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 Treatment: Paxlovid start date 08Jun2022 stop date 12Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown), on 25Feb2021 as dose 2, single (Batch/Lot number: unknown), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "GERD" (unspecified if ongoing), notes: GERD; "HRT" (unspecified if ongoing), notes: HRT; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication in 2 weeks of vaccination. Anti viral details: Paxlovid for treatment of COVID-19, from 13Jun2022 to 17Jun2022; Administrator route=Oral. 7 days after completion of Paxlovid renal dose she was again symptomatic and again tested positive on a rapid antigen COVID test, previously in the week had tested negative using the same home.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "High cholesterol" (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 25Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Positive, notes: New positive test. 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: fr2613), in left arm, on 12Apr2021 as dose 2, single (Lot number: fr0150), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: ff2593) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma and no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: continued to test positive on home tests every two days; (Jun2022) Positive, notes: Symptoms and positive tests are continuing. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started on 14Jun2022 and stopped on 19Jun2022.   Clinical course was reported as, after finishing the full five days of Paxlovid, patient felt great (no symptoms) but continued to test positive on home tests every two days.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (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 Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 of Paxlovid from 14Jun2022 to 19Jun2022.  Clinical course: The patient did not taken any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Tested negative on day 9 with elimination of Covid symptoms and then tested positive again on day 12 with re-onset of symptoms. There were no known allergies.  No follow-up attempts were possible. No further information was expected.
Age: 1.92
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Started running fever oof 102 about 48 hours after vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 23-month-old male patient received BNT162b2 (BNT162B2), on 23Jun2022 as dose 1, single (Lot number: FT9142) at the age of 23 months 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: PYREXIA (non-serious) with onset 25Jun2022, outcome "not recovered", described as "Started running fever oof 102 about 48 hours after vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER8733), in left arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 310308A) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORATADINE, start date: Aug2018; ESOMEPRAZOLE, start date: Dec2009; LISINOPRIL, start date: Dec2021; SUCRALFATE, start date: Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Negative, notes: Have tested negative since 16Jun2022; (25Jun2022) Positive, notes: positive test on 25Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 66-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 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 was not reported. Concomitant medication(s) included: LIPITOR, start date: 31Dec2020, stop date: 20Jun2022. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin", notes: known allergies: Aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 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: "Asthma" (unspecified if ongoing); "known allergies: Mango" (unspecified if ongoing), notes: known allergies: Mango; "known allergies: Latex" (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 Jun2022, 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.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 RNA, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/Was having headache, lost taste, smell, sneezing, terrible dry cough.Tested positive for Covid; COVID 19 Treatment/Was having headache, lost taste, smell, sneezing, terrible dry cough.Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Diabetes" (unspecified if ongoing); "Obesity" (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 06Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment/Was having headache, lost taste, smell, sneezing, terrible dry cough.Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 RNA: (Jun2022) Positive; SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taken other medication in 2 weeks was methotrexate, levothyroxine, folic Acid, Tresiba, lisinopril, viibryd, atorvastatin and farxiga. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Reported Event: Was having headache, lost taste, smell, sneezing, terrible dry cough. Tested positive for COVID. Started Paxlovid got better was regaining taste and smell cough still there but much better. Symptoms came back worse than before on 21Jun2022. Took home test and was positive again for COVID. The treatment was  received for the adverse event was Paxlovid. Hospitalization Prolonged: No Device timestamp: 25Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: PAA156051), in right arm, on 30Mar2021 as dose 2, single (Lot number: ER8272), in right arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in right arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive; (23Jun2022) Negative; (25Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.