chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was received from 13Jun2022 to 17Jun2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: had to be helicoptered to a medical facility for a massive heart attack after taking the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 2, 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 (Dose number: 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant), outcome "unknown", described as "had to be helicoptered to a medical facility for a massive heart attack after taking the vaccine.".  Clinical course: The patient had to be helicoptered to a medical facility for a massive heart attack after taking the vaccine. The patient had Covid-19 vaccine and was only alive because a helicopter took him to a hospital 200 miles away. He had a massive heart attack. He got second shot, the patient doesn't know but which vaccine and NDC/LOT/Expiration does not know.   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: Cerebrovascular accident
Clinical narrative: His friend has four friends that were in their early 50s that had mild strokes after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient in their 50's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "His friend has four friends that were in their early 50s that had mild strokes after the vaccine".  Clinical course: Case was assessed as non-serious by the reporter. The day after he could only bike 8 miles in two hours. He used to be able to bike up to 30 miles no problem, but now he struggles with short distances. His heart can't take it. If he does do a long bike ride, he has to sleep until 6pm the next day, he is just absolutely exhausted. He has been to the ER at least five times. He is scheduled to see a cardiologist but can't get an appointment until Aug. Now he has a nagging numbness that goes up and down from his elbow to his shoulder and then it'll go away. On the one year anniversary of the shot 04Jun2022 he had sharp pains to the heart. He thought he had severe asthma and that's why he wanted to get the vaccine. His friend had to be helicoptered to (withheld) for a massive heart attack after taking the vaccine. A friend of his, a 39 year old athlete, is having problems after the vaccine and the doctor says its all in her friend. His friend has four friends that were in their early 50s that had mild strokes after the vaccine.  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: Cerebrovascular accident
Clinical narrative: His friend has four friends that were in their early 50s that had mild strokes after the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "His friend has four friends that were in their early 50s that had mild strokes after the vaccine.".  Clinical course: Case was assessed as non-serious by the reporter. The day after he could only bike 8 miles in two hours.He used to be able to bike up to 30 miles no problem, but now he struggles with short distances. His heart can't take it. If he does do a long bike ride, he has to sleep until 6pm the next day, he is just absolutely exhausted. He has been to the ER at least five times. He is scheduled to see a cardiologist but can't get an appointment until Aug. Now he has a nagging numbness that goes up and down from his elbow to his shoulder and then it'll go away. On the one year anniversary of the shot 04Jun2022 he had sharp pains to the heart. He thought he had severe asthma and that's why he wanted to get the vaccine. His friend had to be helicoptered to (withheld) for a massive heart attack after taking the vaccine. A friend of his, a 39 year old athlete, is having problems after the vaccine and the doctor says its all in her friend. His friend has four friends that were in their early 50s that had mild strokes after the vaccine.  No follow-up attempts are possible. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: four friends that were in their early 50s that had mild strokes after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An adult 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "four friends that were in their early 50s that had mild strokes after the vaccine".  Clinical course: Case was assessed as non-serious by the reporter. The day after he could only bike 8 miles in two hours. He used to be able to bike up to 30 miles no problem, but now he struggles with short distances. His heart can't take it. If he does do a long bike ride, he has to sleep until 6pm the next day, he is just absolutely exhausted. He has been to the ER at least five times. He is scheduled to see a cardiologist but can't get an appointment until Aug. Now he has a nagging numbness that goes up and down from his elbow to his shoulder and then it'll go away. On the one year anniversary of the shot 04Jun2022 he had sharp pains to the heart. He thought he had severe asthma and that's why he wanted to get the vaccine. His friend S had to be helicoptered to (withheld) for a massive heart attack after taking the vaccine. A friend of his, a 39 year old runner, is having problems after the vaccine and the doctor says its all in her friend. His friend has four friends that were in their early 50s that had mild strokes after the vaccine.  The information on the batch/lot number for 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: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Feb2021 as dose 2, single (Lot number: EL1283) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jan2022 as dose 3 (booster), single (Lot number: 028k21a), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". 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: (10Jun2022) positive, notes: Positive antigen test 10Jun2022 after symptoms for 1 day,; (14Jun2022) negative, notes: negative test on 14Jun2022 symptoms resolved; (21Jun2022) positive, notes: HA developed and tested positive on 21Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing), notes: 7 year cancer survivor from Lymphoma. Concomitant medication(s) included: BENZONATATE, start date: 29May2022, stop date: 08Jun2022. 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: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After feeling better at the end of my Paxlovid treatment I felt well. Approx a week after I took the Paxlovid my symptoms returned. My symptoms were not as intense as my original symptoms. I had a runny nose and cough for Approx 5 days. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), 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: "Lung scarring" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: apples" (unspecified if ongoing); "Known allergies: cats" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Allergies: Morphine"; Erithromiacin, reaction(s): "Allergies: erithromiacin". 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: Negative, notes: rebound infection 15 days after finishing treatment, with 12 days of negative tests between positive tests; Positive, notes: rebound infection 15 days after finishing treatment, with 12 days of negative tests between positive tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, solution for injection), on 03Feb2022 at 11:00 as dose 1, single (Lot number: EL9261), on 24Feb2021 at 13:45 as dose 2, single (Lot number: EN6201), in left arm, on 29Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8762) and on 05Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Hypothyroidism" (unspecified if ongoing); "Chronic Lyme" (unspecified if ongoing); "Chronic Epstein Barr" (unspecified if ongoing); "Babesia" (unspecified if ongoing); "Known Allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; T3; ESTRIOL; TESTOSTERONE; PROGESTERONE; NALTREXONE. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin"; Serevent, reaction(s): "Known allergies: Serevent"; Ibuprofen, reaction(s): "Known allergies: Ibuprofen"; Bactrim ds, reaction(s): "Known allergies: Bactrim DS". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 13 days 10 hrs after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2021) Positive; (21Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events Drug ineffective, COVID-19 cannot be completely excluded based on temporal association.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nausea, Vaccination failure, Vomiting
Clinical narrative: sever nausea; vomiting; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: el3246), in left arm, on 09Feb2021 as dose 2, single (Lot number: el9269), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: ff2590), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: fk9893) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing). Concomitant medication(s) included: FISH OIL, stop date: 06Jun2022; VITAMIN C & ROSEHIP, stop date: 06Jun2022; IBUPROFEN, stop date: 06Jun2022; CALCIUM CITRATE, stop date: 06Jun2022; ACETAMINOPHEN, stop date: 06Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; NAUSEA (non-serious) with onset 18Jun2022, outcome "not recovered", described as "sever nausea"; VOMITING (non-serious) with onset 18Jun2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: COVID-19: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19, nausea.  Clinical information: After 4 doses, patient experienced sever nausea and vomiting. Dr. office suggested she was continue taking the product and try eating toast with it. She seem to experience the nausea pretty continuous, but only vomit after 5 hrs. After ingesting each dose of paxlovid. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 77-year-old female patient received the 1st, 2nd and 3rd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); all single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced ineffective drug (medically significant) and COVID-19 (medically significant), with outcome of unknown. "She had all her Pfizer COVID-19 vaccines including the booster and was surprised to get COVID-19 infection." The events required an emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr 14, 2022) positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: Patient called to ask about side effect from Paxlovid. She had all her Pfizer COVID-19 vaccines including the booster and was surprised to get COVID-19 infection. She took her first dose of Paxlovid this morning and 3 hours later, she developed diarrhea. She went to the ER this morning and was diagnosed with COVID-19. The ER doctor prescribed Paxlovid for her, but her regular doctor does not know if she started taking it. Information on the batch/lot number for BNT162B2 requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "htn" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). 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 "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: COVID 19 Treatment with Paxlovid on 08Jun2022 to 13Jun2022.  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 information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Information: No other medication in 2 weeks. It was reported that patient rebound Covid after taking Plaxovid.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, 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) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Previous bilateral pneumonia", start date: 2015 (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Tetanus toxoid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: Unknown results, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient did not receive any other medications within 2 weeks of vaccination.  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 in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 80.0
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.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 80 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: "High Blood pressure" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "Heart (ICD)" (unspecified if ongoing); "Known allergies: Iodine Contrast dyes" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: Jan2010, stop date: 21Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Negative, notes: Felt much better by 13Jun2022 tested negative 14Jun2022; (20Jun2022) Positive, notes: 19Jun2022 started having coughing return and Tested positive on 20Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course:  Symptoms were identical to the first infection.AE treatment: Benzonatate 200mg, Prednisone 20mg, Albuterol HFA.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-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 28Oct2021 as dose 3 (booster), single (Lot number: 059E21A) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient started treatment for COVID-19 on 05Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200874401 Same patient, different product and event;
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid (using a home test) 24 hours after having symptoms. Currently is sick with congestion, cough, and fatigue. No fever yet.; Tested positive for Covid (using a home test) 24 hours after having symptoms. Currently is sick with congestion, cough, and fatigue. No fever yet.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 09Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 14Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 58 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022 at 17:00, outcome "not recovered" and all described as "Tested positive for Covid (using a home test) 24 hours after having symptoms. Currently is sick with congestion, cough, and fatigue. No fever yet.". No known allergies. No covid prior vaccination. No other vaccine in four weeks and no other medications in two weeks. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Negative, notes: Nasal Swab; (20Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 75.0
Sex: M
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 11Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 23Sep2021 as dose 3 (booster) single (Lot number: 30135BA), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9093) at the age of 75 years, in left arm for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (14Jun2022) Negative; (15Jun2022) Negative; (16Jun2022) Negative; (17Jun2022) Negative; (18Jun2022) Negative; (22Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
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) (Nurse).  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Batch/Lot number: unknown), on 03May2021 as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Codeine: Drug allergy"; Erythromycin, reaction(s): "Erythromycin: 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: Patient experienced vomiting, diarrhea and metallic taste in mouth within 8 hours of taking first dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 2, single) and second regimen (Batch/Lot number: unknown) at single (dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID 19 Treatment/ I first tested positive on 13Jun; COVID 19 Treatment/ I first tested positive on 13Jun; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EK4176), in left arm, on 08Feb2021 as dose 2, single (Lot number: EM6201), in left arm and on 31Aug2021 as dose 3, (booster), single (Lot number: FC3182) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "CVID" (ongoing); "fibromyalgia" (unspecified if ongoing); "undifferentiated connective tissue disease" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; SPIRIVA; SKELAXIN [CLONIXIN LYSINATE]; HIZENTRA. Past drug history included: Bactrim valtrex, reaction(s): "Allergy", notes: Known allergies: Bactrim Valtrex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment/ I first tested positive on 13Jun". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (13Jun2022) Positive, notes: I first tested positive on 13Jun; (17Jun2022) Negative, notes: I tested negative starting on 17Jun. I tested negative for three days; (22Jun2022) Positive, notes: I went back to work on 21Jun. I woke up with a sore throat on 22Jun and decided to retest myself since I knew about Paxlovid rebound. I tested with the (Withheld) antigen test. It was very strongly positive. Therapeutic measures were taken as a result of covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 at 12:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04May2021 at 12:15 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Nov2021 at 17:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Known allergies: no, reaction(s): "Drug Allergy". The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After testing positive for Covid on 10Jun2022; After testing positive for Covid on 10Jun2022; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 2, single (Lot number: ER7523), in left arm, on 24Aug2021 as dose 3 (booster), single (Lot number: FA7485), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypopituitarism" (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 10Jun2022, outcome "not recovered" and all described as "After testing positive for Covid on 10Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (10Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: After testing positive for Covid on 10Jun2022 took by the drug, Paxlovid  for five days following which I tested negative.  Then, 3 days I began I became symptomatic And tested positive again for Covid. I continue to be very ill with symptoms including fever cough congestion.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 16:30 as dose 1, single (Lot number: EL9266), in left arm, on 04Mar2021 at 16:30 as dose 2, single (Lot number: EN6205), in left arm and on 05Jan2022 at 12:00 as dose 3 (booster), single (Lot number: FL3198) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Other medication in 2weeks was unknown. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/ I tested positive on Saturday 11Jun; COVID 19 Treatment/ I tested positive on Saturday 11Jun; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 27 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Mar2021 as dose 1, single (Lot number: 046A21A), in left arm and on 20Apr2021 as dose 2, single (Lot number: 001C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate/severe asthma" (unspecified if ongoing); "allergies to dust" (unspecified if ongoing); "pollen" (unspecified if ongoing); "mold" (unspecified if ongoing); "pet dander" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; SINGULAIR; CETIRIZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/ I tested positive on Saturday 11Jun". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jun2022) Positive, notes: I tested positive; (21Jun2022) Positive, notes: Tuesday June 21 I tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 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 a contactable reporter(s) (Physician).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic allergic sinusitis" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications. He did not receive any other medication within 2 weeks of vaccination.  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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.   The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 30.0
Sex: M
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 31-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient did not receive any other medication in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (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: (15Jun2022) Negative, notes: after testing negative antigen on the 15th; (17Jun2022) Positive, notes: rebound Covid Stuffy nose, lethargy, brain fog, slight cough returned on 17Jun along with positive tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid for the treatment of covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Birth Control" (unspecified if ongoing). Concomitant medication(s) included: OCELLA taken for contraception. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.Antiviral details, Paxlovid for COVID 19 Treatment, from 13Jun2022 to 18Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 16:45 as dose 2, single (Lot number: EW/017218) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Deafness neurosensory, SARS-CoV-2 test, Tinnitus
Clinical narrative: tinnitus; Exactly 2 weeks after my second shot, I lost hearing in my left ear; A few days later when I went to the ENT, he diagnosed me with sudden sensorineutral hearing loss (SSHL); 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 received BNT162b2 (BNT162B2), on 21Oct2021 as dose 2, single (Lot number: 30155BA) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FH8020), administration date: 11Nov2021, for COVID-19 immunization. The following information was reported: DEAFNESS NEUROSENSORY (disability, medically significant) with onset 25Nov2021, outcome "recovering", described as "A few days later when I went to the ENT, he diagnosed me with sudden sensorineutral hearing loss (SSHL)"; DEAFNESS (disability, medically significant) with onset 25Nov2021, outcome "recovering", described as "Exactly 2 weeks after my second shot, I lost hearing in my left ear"; TINNITUS (non-serious), outcome "unknown". The events "exactly 2 weeks after my second shot, i lost hearing in my left ear" and "a few days later when i went to the ent, he diagnosed me with sudden sensorineutral hearing loss (sshl)" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination- Yes. Therapeutic measures were taken as a result of deafness, deafness neurosensory. Clinical source:Thankfully, steroids helped me regain some of my hearing. However, it is not perfect and now I have tinnitus.Doctor or other healthcare professional officeclinic visit, Emergency roomdepartment or urgent care, Disability or permanent damage.Patient oose not had covid prior vaccination and covid tested post vaccination.  Follow-Up (24Jun2022): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sleep paralysis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 at 15:00 as dose 1, single (Lot number: FW0171) at the age of 60 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "COPD(Emphysema)" (unspecified if ongoing); "Pre-Diabetic" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Sinusitis" (unspecified if ongoing); "Hayfever" (unspecified if ongoing); "HFpEF" (unspecified if ongoing); "Known allergies: sulfites" (unspecified if ongoing). Concomitant medication(s) included: SPIRIVA; PROAIR HFA; IPRATROPIUM. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: SLEEP PARALYSIS (non-serious) with onset 22Apr2021 at 02:00, outcome "unknown", described as "About 2 am my eyes popped open out of a dead- sleep and I couldn't move my entire right side. It lasted less than a minute". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of sleep paralysis. Additional information: Patient believe the rush of adrenal from the shock of not being able to move stopped the paralysis.