chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
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) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6200), in right arm, on 13Nov2021 as dose 3 (booster), singe (Lot number: 30135BA), in left arm and on 19Jul2022 as dose 4 (booster), single (Lot number: 33036BD) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "lung issue" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication in two weeks. The patient had no know allergies. The patient took Paxlovid for covid-19 treatment from 24Sep2022 to 29Sep2022 with lot number NDC0069-0345-30.   No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Echocardiogram, Magnetic resonance imaging, Malaise
Clinical narrative: he took the first shot and didn't feel good after, but a couple of days later he was okay; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: ER6208) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 2006. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "he took the first shot and didn't feel good after, but a couple of days later he was okay". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197965 Same reporter/drug, different patients;US-PFIZER INC-202201201522 same reporter/drug, different patient/event;
Age: 60.0
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). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 14:00 as dose 4 (booster), single (Lot number: IM9992) at the age of 60 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: "Hypertension" (unspecified if ongoing); "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Penicillin; "Known allergies : Latex" (unspecified if ongoing), notes: Known allergies : Latex. There were no concomitant medications.  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: (27Sep2022) Negative; (20Sep2022) Positive, notes: Took Paxlovid from Sept 20-25 for positive COVID test with uri symptoms; (01Oct2022) Positive, notes: Symptoms returned on 01Oct2022 and retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19  cannot be completely excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Off label use, Product use issue
Clinical narrative: period started on 19Sep and it ended on 23Sep/ experienced cramps; My period started on 19Sep and it ended on 23Sep/ spotting; Other Vaccine on Same date product: Flu shot; Other Vaccine on Same date product: Flu shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: Gj2524) at the age of 34 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 17Sep2022 as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "Nocturnal epilepsy" (unspecified if ongoing), notes: Nocturnal epilepsy; "If COVID prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; NORETHINDRONE [NORETHISTERONE]. Vaccination history included: Bnt162b2 (DOSE 3, lot number: Fh8030, vaccine location: Arm), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURE UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURE UNKNOWN), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 17Sep2022, outcome "unknown" and all described as "Other Vaccine on Same date product: Flu shot"; INTERMENSTRUAL BLEEDING (non-serious) with onset 29Sep2022 at 13:00, outcome "recovered" (2022), described as "My period started on 19Sep and it ended on 23Sep/ spotting"; DYSMENORRHOEA (non-serious) with onset 29Sep2022 at 13:00, outcome "recovered" (2022), described as "period started on 19Sep and it ended on 23Sep/ experienced cramps". The events "period started on 19sep and it ended on 23sep/ experienced cramps" and "my period started on 19sep and it ended on 23sep/ spotting" required physician office visit. Therapeutic measures were not taken as a result of dysmenorrhoea, intermenstrual bleeding.  Additional information: Patient period started on 19Sep and it ended on 23Sep. On 29Sep, she experienced cramps and spotting. This was not normal for her. She never had spotting before. Patient received the COVID vaccine two weeks prior. AE resulted in Doctor or other healthcare professional office/clinic visit. COVID was not tested post vaccination. No known allergies.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Barrett's oesophagus" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; OMEPRAZOLE; METOPROLOL; LEVOTHYROXINE; unspecified probiotic and multivitamin. Known allergies: Not that patient know of. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (treatment start date: 29May2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 22.0
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) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3 (booster), single (Lot number: 330268D) at the age of 22 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 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: The patient received Paxlovid from 21Sep2022 to 25Sep2022 for treatment of COVID-19
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 14:00 as dose 1, single (Lot number: EL3247), in left arm, on 03Feb2021 at 14:00 as dose 2, single (Lot number: EL9769), in left arm, on 23Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FW0183), in left arm and on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Hypercholesterolemia" (unspecified if ongoing), notes: Other medical history: Hypercholesterolemia; "GERD" (unspecified if ongoing), notes: Other medical history: GERD. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, the patient received Paxlovid from 20Sep2022 to 25Sep2022, (batch/lot: 6E8702) for treatment of COVID-19. The patient did not received other medication in 2 weeks. No known allergies and other medical history: Hypertension, Hypercholesterolemia, GERD.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased, Malaise, Myocardial necrosis marker
Clinical narrative: didn't feel good after; Elevated heart enzyme; Elevated heart rate; Felt like he was having a heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYOCARDIAL NECROSIS MARKER INCREASED (medically significant) with onset 10Oct2021, outcome "unknown", described as "Elevated heart enzyme"; HEART RATE INCREASED (non-serious) with onset 10Oct2021, outcome "unknown", described as "Elevated heart rate"; FEELING ABNORMAL (non-serious) with onset 10Oct2021, outcome "unknown", described as "Felt like he was having a heart attack"; MALAISE (non-serious), outcome "recovered", described as "didn't feel good after". The events "elevated heart enzyme", "elevated heart rate", "felt like he was having a heart attack" and "didn't feel good after" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (10Oct2021) Elevated; Myocardial necrosis marker: (10Oct2021) Elevated.  Clinical course: This report concerns the reporter's son. Reporter was father of the patient. The reporter states that he is calling about the first two shots of the Pfizer COVID Vaccines. States that he took the first shot and didn't feel good after, but a couple of days later he was okay. Caller states that his wife took the caller and the caller's son to the Emergency Room. The reporter's son had an elevated heart rate. The reporter states that they kept him and his son overnight for observation and then released them the next day. The reporter states that his son experienced an elevated heart rate and an elevated heart enzyme on 10Oct2021. The reporter's son was taken to the Emergency Room, kept overnight for observation, and released on 11Oct2021. The reporter states that his son said he felt like he was having a heart attack. The reporter denies any other medical conditions, medications, labs, testing, or treatments for his son relevant to these events. NDC number and Expiry Date of COVID Vaccine were not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197909 Same reporter/drug, different patients;
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker increased
Clinical narrative: didn't feel good after; Elevated heart enzyme; Elevated heart rate; Felt like he was having a heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYOCARDIAL NECROSIS MARKER INCREASED (medically significant) with onset 10Oct2021, outcome "unknown", described as "Elevated heart enzyme"; HEART RATE INCREASED (non-serious) with onset 10Oct2021, outcome "unknown", described as "Elevated heart rate"; FEELING ABNORMAL (non-serious) with onset 10Oct2021, outcome "unknown", described as "Felt like he was having a heart attack"; MALAISE (non-serious), outcome "recovered", described as "didn't feel good after". The events "elevated heart enzyme", "elevated heart rate", "felt like he was having a heart attack" and "didn't feel good after" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (10Oct2021) Elevated; Myocardial necrosis marker: (10Oct2021) Elevated.  Clinical course: This report concerns the reporter's son. Reporter was father of the patient. The reporter states that he is calling about the first two shots of the Pfizer COVID Vaccines. States that he took the first shot and didn't feel good after, but a couple of days later he was okay. Caller states that his wife took the caller and the caller's son to the Emergency Room. The reporter's son had an elevated heart rate. The reporter states that they kept him and his son overnight for observation and then released them the next day. The reporter states that his son experienced an elevated heart rate and an elevated heart enzyme on 10Oct2021. The reporter's son was taken to the Emergency Room, kept overnight for observation, and released on 11Oct2021. The reporter states that his son said he felt like he was having a heart attack. The reporter denies any other medical conditions, medications, labs, testing, or treatments for his son relevant to these events. NDC number and Expiry Date of COVID Vaccine were not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197909 Same reporter/drug, different patients;
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: enlarged lymph node; developed a decent amount of pain under his left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVXUS000003536 (Novavax).  A 39-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's family history included: "Heart disease" (unspecified if ongoing), notes: He had a history of heart disease in his family. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: Feb2021, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "It was reported that after the 1st dose his arm hurt and he was tired.", "It was reported that after the 1st dose his arm hurt and he was tired.". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph node"; AXILLARY PAIN (non-serious), outcome "unknown", described as "developed a decent amount of pain under his left arm". The events "enlarged lymph node" and "developed a decent amount of pain under his left arm" required physician office visit.  Additional information: On 16Sep2022, it was reported that a patient started treatment on Feb2021 with Pfizer BioNTech COVID-19 Vaccine of two doses for unspecified indication. It was reported that after the 1st dose his arm hurt and he was tired. After the 2nd dose, he developed a decent amount of pain under his left arm. He went to his doctor who said he had an enlarged lymph node. The pain was on and off and the same happened after the booster dose. It was concerning and he wanted to avoid it. He had a history of heart disease in his family. His doctor said getting the Novavax vaccine is a good idea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: The pain was on and off and the same happened after the booster dose; The pain was on and off and the same happened after the booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003536.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "Heart disease" (unspecified if ongoing), notes: He had a history of heart disease in his family. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunization, reaction(s): "It was reported that after the 1st dose his arm hurt and he was tired.", "It was reported that after the 1st dose his arm hurt and he was tired."; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "enlarged lymph node", "developed a decent amount of pain under his left arm". The following information was reported: PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "The pain was on and off and the same happened after the booster dose".  Additional information: Adverse Event Information: On 16Sep2022, it was reported that a patient started treatment on Feb2021 with Pfizer BioNTech COVID-19 Vaccine of two doses for unspecified indication. It was reported that after the 1st dose his arm hurt and he was tired. After the 2nd dose, he developed a decent amount of pain under his left arm. He went to his doctor who said he had an enlarged lymph node. The pain was on and off and the same happened after the booster dose. It was concerning and he wanted to avoid it. He had a history of heart disease in his family. His doctor said getting the Novavax vaccine is a good idea.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, 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 56-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing), notes: Other medical history: CAD; "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 Aug2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Continued to test positive for a week and a half; (2022) Negative, notes: Got negative test after about 2 1/2 weeks total; (Aug2022) Positive, notes: Now again symptomatic and positive for COVID about three weeks later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID treatment was reported as yes. Other medication in 2 weeks reported as Yes. Antiviral product for COVID 19 Started on date 23Aug2022 and stop date given as 28Aug2022. Other medication in 2 weeks product reported as Atorvastatin. Rebound COVID. Finished Paxlovid course. Got mild rebound in symptoms. Patient had no Known allergies  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 3 (booster), single (Lot number: GH9703) at the age of 66 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 included: "asthma" (unspecified if ongoing); "aplastic anemia" (unspecified if ongoing); "celiac disease" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 21Sep2022 at 12:00, outcome "recovering", described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  Additional information: Patient received other medication in 2 weeks. On 21 Sep2022, patient was having bad cough and sore throat. Patient received Paxlovid from 22Sep2022 to 27Sep2022 for the treatment of Covid-19 and received benzononate as treatment.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 28Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 11Jun2022 as dose 4 (booster), single (Lot number: PM7553) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "osteopenia/porosis" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "almonds" (unspecified if ongoing); "soy" (unspecified if ongoing); "gluten" (unspecified if ongoing); "dairy" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; RESTASIS; ESTRIOL topical; VITAMIN D3; FISH OIL; MAGNESIUM. Past drug history included: Known allergy: ciprofloxacin, reaction(s): "Known allergy: ciprofloxacin"; Known allergy: levaquin, reaction(s): "Known allergy: levaquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Tested negative twice over ensuing days; (13Sep2022) Positive, notes: COVID 19 Treatment; (25Sep2022) Positive, notes: Symptoms returned 25Sep and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid from 14Sep2022 to 19Sep2022 for treatment of COVID-19. Other medication in 2 weeks product was Estriol topical lotion. Symptoms began 13Sep2022, started Paxlovid 14Sep2022 and finished course. Tested negative twice over ensuing days. Symptoms returned 25Sep2022 and tested positive. Rheumatologist prescribed Paxlovid for a second course 27Sep2022 (currently taking).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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. Concomitant medication(s) included: BUPROPION. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 including PAXLOVID from 24Sep2022 to 28Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
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) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "polymyalgia rheumatica" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ATENOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Sep2022, outcome "not recovered", COVID-19 (medically significant) with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: COVID rebound. I tested negative, and then positive again five days later, with return of symptoms; Positive, notes: COVID rebound. I tested negative, and then positive again five days later, with return of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient not had any known allergies. Other medication in 2 weeks was Yes. Paxlovid was used for treatment of covid-19 from 22Sep2022 to 27Sep2022. Adverse events start date was again reported as 30Sep2022 and was not recovered without treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 59.0
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 59-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6021), on 25Mar2021 as dose 2, single (Lot number: FR2613), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 3C1308A), in left arm and on 10Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "Degenerative Disc Disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergies : penicillin" (unspecified if ongoing), notes: Known allergies : penicillin; Sulfa; "Known allergies : Sulfa" (unspecified if ongoing), notes: Known allergies : penicillin; Sulfa. Concomitant medication(s) included: LIPITOR; NYQUIL; SUDAFED 12 HOUR. The following information was reported: VACCINATION FAILURE (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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Other medication in 2weeks reported as Lipitor, Nyquill and Sudafed. Patient received Paxlovid treatment from 23Sep2022 to 28Sep2022.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dos 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose1, 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: "Hypothyroidism" (unspecified if ongoing); "HBP" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; LIOTHYRONINE; HCTZ; MONTELUKAST; UNITHROID. Past drug history included: Met metformin, reaction(s): "known allergy: Metformin"; Red color in benadryl, reaction(s): "Known allergies: red color in Benadryl". 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: (28Sep2022) Positive, notes: I tested positive for Covid-19 again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: Patient received other medications in two weeks Atenolol, Liothyronine of brand Zydus, HCTZ, Montelukast of brand, Unithroid of brand in two weeks. After isolating for 12 days and recovering, she went back to work. Two days later, 5 days since stopping Paxlovid, she developed a fever, cough and sore throat again. She tested positive for covid again same night. Now, she have had the same initial symptoms for 3 days, stuffy nose, cough, sore throat, and fever.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 at 14:00 as dose 1, single (Lot number: ER8133), in left arm and on 24Apr2021 at 14:00 as dose 2, single (Lot number: ES0164) at the age of 46 years, in right arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 071F2A1), in right arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma - using albuterol and Flovent inhalers. Concomitant medication(s) in 2 weeks included: AIRBORNE, start date: 01Jun2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Apr2022. The patient had any known allergies was reported as none known. The patient was not pregnant at the time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Negative, notes: Tested negative twice; (26Sep2022) Negative, notes: Tested negative twice -Second time 3pm Monday 26Sep; (28Sep2022) Positive, notes: Out of sheer curiosity retested on 28Sep and tested strongly positive, again on 29Sep; (29Sep2022) Positive, notes: Out of sheer curiosity retested on 28Sep and tested strongly positive, again on 29Sep; (01Oct2022) Positive, notes: again on 10Oct. Strongly positive on all tests. Therapeutic measures were taken as a result of covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 20Sep2022 and stopped on 24Sep2022, Indication: Treatment of COVID-19. It was reported that, completed Paxlovid series on Saturday 24Sep.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Breast enlargement, Lymphadenopathy
Clinical narrative: My lymph nodes and my breast are very enlarged; My lymph nodes and my breast are very enlarged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: LYMPHADENOPATHY (non-serious), BREAST ENLARGEMENT (non-serious), outcome "unknown" and all described as "My lymph nodes and my breast are very enlarged".  Additional Information: It was reported that the patient had vaccine on Tuesday and lymph nodes and breast were very enlarged and patient wanted to know what should be done or should go to a doctor for this because it was now 4 days, 5 days after the vaccine, 4 days after the vaccine and it had not gone away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jul2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 at 09:00 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) 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: "Inflammatory arthritis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: NORVASC, start date: 01Feb2019; BUPROPION, start date: 01Nov2014; LISINOPRIL, start date: 01Jun1998; HYDROXYCHLOROQUINE, start date: 01Feb2014; FOLIC ACID, start date: 01Mar2021; MELOXICAM, start date: 01Jan2018; VITAMIN C [ASCORBIC ACID], start date: 01Jan2022; VITAMIN D [VITAMIN D NOS], start date: 01May2009; ELDERBERRY [SAMBUCUS NIGRA], start date: 01Oct2020. Past drug history included: Fluconazole, reaction(s): "known allergies:Fluconazole".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication: Covid-19 treatment; (Sep2022) Positive, notes: Covid positive tests following the completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the patient was got infected with COVID/again the last one was about three weeks ago; the patient was got infected with COVID/again the last one was about three weeks ago; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (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 Sep2022, outcome "unknown" and all described as "the patient was got infected with COVID/again the last one was about three weeks ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: last one was about three weeks ago. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has had 4 COVID-19 vaccines from Pfizer. Then, the patient was got infected with COVID and took antiviral treatment for 5 days (could not confirm the identity of this treatment). Caller wanted to know how long after the treatment, the patient should wait to get the fifth dose of the vaccine. The patient has had four vaccine from Pfizer and then the patient has been exposed to COVID and the patient got infected so, the patient has took the anti-viral treatment for five days. The patient was exposed twice to COVID and he got very sick so, once was about Dec2021 and again the last one was about three weeks ago. The patient has the symptoms very very very bad symptoms, somehow that medication did not do the effect, did not work.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect products  BNT162B2,BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 59-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EA6206), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8730), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: EW0180), in left arm and on 17May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENZONATATE, start date: 18Sep2022, stop date: 27Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: treatment of COVID-19; (23Sep2022) Negative, notes: home test; (30Sep2022) Positive, notes: home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 18Sep2022 to 22Sep2022.
Age: 58.0
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 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 was not reported. Concomitant medication(s) included: LEXAPRO. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Antiviral treatment for COVID-19 with paxlovid from 19Sep2022 to 23Sep2022. No known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: my wife got a little nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose number unknown (booster), single (Lot number: GH9693) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: NERVOUSNESS (non-serious), outcome "unknown", described as "my wife got a little nervous".  Additional information: Reporter stated that "my wife and I both got the, that what we thought was the Pfizer, the Bivalent COVID-19 Vaccine and then my wife just started asking me she was a little concerned if we get the right thing. So, we got the batch number. Yeah, I am it is right but my wife got a little nervous. You know, because the first we got it and she said that is what it is. Okay, what is that number".   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Booster Dose (dose 2/3/4) pfizer covid 19 vaccine and Dose 1 JANSSEN covid 19 vaccine; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Oct2021 as dose 2 (booster), single (Batch/Lot number: unknown), in left arm and on 01Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Booster Dose (dose 2/3/4) pfizer covid 19 vaccine and Dose 1 JANSSEN covid 19 vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Positive, notes: Continued to test positive on day 3 of isolation; (28Sep2022) Positive, notes: Tested positive 8 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 15Sep2022 to 20Sep2022). Clinical course: Patient had no known allergies. Tested positive 8 days after finishing Paxlovid, after having tested negative twice. Started isolation again. Continued to test positive on day 3 of isolation. Sinus symptoms continued but did not worsen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.