chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 09Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: ATIVAN; CITALOPRAM; CAPECITABINE; OMEPRAZOLE; VITAMIN D [VITAMIN D NOS]. Past drug history included: Paclitaxel, reaction(s): "Allergy".  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (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; Positive, notes: after completing treatment symptoms back and blazing positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  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: Cardiac disorder
Clinical narrative: Cardiac event; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Cardiac event".  Additional information: The reporter stated that the patient was her husband's friend who was a gastroenterologist, who also had a cardiac event after receiving the COVID vaccine. She does not know if he reported it. Neither one of them had heart issues. The patient said that should not have happened to him. They are approximately the same age and went to medical school.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with Covid; diagnosed with Covid; 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), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 14Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Chronic myeloid leukemia" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; FLONASE [FLUTICASONE PROPIONATE]; RED YEAST RICE; TAMSULOSIN; FLOMAX [MORNIFLUMATE]; IMATINIB taken for chronic myeloid leukaemia. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "unknown" and all described as "diagnosed with Covid".  Clinical course: It was reported that patient was diagnosed with Covid about 2 days ago. He did received Pfizer covid vaccine and 2 booster shots also. caller wanted to know about paxlovid, its prescribed to him but he has not started it. He has HTN takes Lisinopril for it, Flonase, red yeast rice, Tamsulosin, flomax, has chronic myeloid leukemia takes imatinib 400mg for it. Patient stated his Covid symptoms are not that bad and may be he should not take Paxlovid. Patient wanted to know about any interactions in medications he is taking and Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Asthma" (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: (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Adverse event - Rebound on day 14. Mild symptoms and a positive test the night of day 14. Anti-viral details :Product = COVID 19 Treatment, Brand-Paxlovid, Treatment start date : 10Jul2022, Treatment stop date : 07Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201005434 Same patient, different product and event;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I Tested positive by PCR on 11Jul2022; I Tested positive by PCR on 11Jul2022; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2020 at 12:00 as dose 1, single (Lot number: EH4899), in left arm, on 13Jan2021 at 12:00 as dose 2, single (Lot number: EL1283), in right arm, on 01Oct2021 at 18:00 as dose 3 (booster), single (Lot number: FD0810), in left arm and on 01Apr2022 at 17:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing), notes: Other medical history: Type 2 Diabetes; "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Jan2022; JARDIANCE, start date: 01Jan2022; METOPROLOL, start date: 01Jan2022; AMLODIPINE, start date: 01Jan2022; LEVOTHYROXINE, start date: 01Jan2022; HCTZ, start date: 01Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "recovering" and all described as "I Tested positive by PCR on 11Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) Positive, notes: I Tested positive by PCR on 11Jul2022,; (25Jul2022) Positive, notes: on vacation tested positive 25Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Tested positive by PCR on 11Jul2022, took Paxlovid for 5 days for cough runny nose mild body aches all very mild , got better went to work on day 6 worked two days went on vacation tested positive 25Jul2022 I did not test again after firt one, the symptoms sneezing and coughing did not take Paxlovid again today is day 3 of symptoms and no other symptoms so far.   No follow-up attempts are needed. No further information is expected.; 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 product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: en5318), in right arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 43 years, in right arm, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Jul2022 as dose 4 (booster), single (Lot number: 006M21A) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "recovering" and all described as "tested positive for Covid-19". The event "tested positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: tested positive for Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: en5318), in right arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 43 years, in right arm, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Jul2022 as dose 4 (booster), single (Lot number: 006M21A) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "recovering" and all described as "tested positive for Covid-19". The event "tested positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: tested positive for Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 47-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9266), in right arm and on 08Mar2021 as dose 2, single (Lot number: EL9264) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Dec2021 as dose 3 (booster), single (Lot number: 045J21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Anti-viral details: For COVID 19, patient was treated with Paxlovid. Treatment start date was 08Jul2022 and treatment stop date was 13Jul2022.  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: Patient received the Pfizer COVID 19 Vaccines. "I dont want to do us more harm by getting it after taking the paxlovid but I dont know if you can do that; Patient received the Pfizer COVID 19 Vaccines. "I dont want to do us more harm by getting it after taking the paxlovid but I dont know if you can do that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient received the Pfizer COVID 19 Vaccines. "I dont want to do us more harm by getting it after taking the paxlovid but I dont know if you can do that". 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.  Clinical course: She stated that would be their 2nd  booster as they never received that dose. Spent a long time searching the internet before calling. If you don't know then She knew her doctor does not know. They advised to not get the booster. If she would have gotten the booster she would not have gotten COVID so bad. Now she don't know what to do and don't know if its safe to go ahead and get one or if whether we should wait. Caller asked, "Other than her doctor, who led her the wrong way, who could she contact that might know? There was one website, it said something about don't get shot within 90 days after if you have had COVID. She don't know what to do and her husband was in the same boat so anyway. She had 2 doctors, separate who told them to wait for the new vaccine coming in the fall" so that is what her husband and her did. "That did not turn out so well. Now she don't know whether we can go ahead and get the 2nd booster and then the one in the fall due to the wait between, 4 or 6 months." Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), 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: "Meningioma surgery in 2020, fully recovered from that" (unspecified if ongoing), notes: Meningioma surgery in 2020, fully recovered from that; "health cold" (unspecified if ongoing); "flu relief" (unspecified if ongoing). Concomitant medication(s) included: VILAZODONE, start date: 15Oct2021. 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; Negative; Negative. 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.  Clinical course: Patient reported, I stopped paxlovid Thursday morning and just tested positive again today and symptoms returned. I tested negative Friday and Sunday after treatment. Sore throat, runny nose have returned.
Age: 54.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right 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: "Depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR taken for depression. The patient received other medications and antidepressant within 2 weeks after vaccination. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". 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; (Jul2022) Rebound covid, notes: Rebound covid post paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 14Jul2022 to 19Jul2022 as treatment for Covid-19.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As per limited available information the causality of the event drug ineffective and covid -19 can not be ruled out.it will be reassessed once more information received.
Sex: U
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 patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Oct2021 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". 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: The patient received other medication in 2weeks reported as Yes. The Paxlovid Treatment start date was 22Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: EW0169) at the age of 43 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: "hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypothyroidism, pcos, high blood pressure, obesity; "pcos" (unspecified if ongoing), notes: Other medical history: hypothyroidism, pcos, high blood pressure, obesity; "high blood pressure" (unspecified if ongoing), notes: Other medical history: hypothyroidism, pcos, high blood pressure, obesity; "obesity" (unspecified if ongoing), notes: Other medical history: hypothyroidism, pcos, high blood pressure, obesity; "bee venom" (unspecified if ongoing), notes: Known allergies: bee venom; "bee venom" (unspecified if ongoing), notes: Known allergies: bee venom; "salmon" (unspecified if ongoing), notes: Known allergies: salmon; "sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Drug allergy: keflex", notes: Known allergies: keflex; Cipro, reaction(s): "Drug allergy: cipro", notes: Known allergies: cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was unknown if the patient had other medication in 2 weeks. Covid symptoms returned and tested positive where previously tested negative about 5 days after last dose of Paxlovid was taken.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: First dose COVID-19 Vaccine: Arm hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 22Jun2021 as dose 1, single (Lot number: EW0178) at the age of 62 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Jun2021, outcome "unknown", described as "First dose COVID-19 Vaccine: Arm hurting". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Caller and husband got their COVID-19 vaccines together. Her husband got his COVID-19 Vaccines in the muscle because he was complaining about how long the needle was and it hurt when she was jamming the needle in there. With first COVID-19 Vaccine, complaining his left arm was hurting, which was where he got the shots. Caller figured it was just that. Patient only had two doses of COVID-19 Vaccine.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 23May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto Disease" (unspecified if ongoing), notes: other autoimmune disease in process of diagnosis; "obesity" (unspecified if ongoing); "tobacco user" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceclore for allergy, notes: known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Other Medication In 2weeks was reported as Yes with Hydroxychoroquine started on 15Sep2021 and Levothyroxine started on 17Mar2021, Liothyonine started on 16Feb2022, Prazosin started on 09May2022, Cymbalta started on 11Mar2022. 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 with anti-viral drug Paxlovid started on 13Jul2022 and stopped on 18Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- Known allergies: No. COVID 19 Treatment included anti-viral Paxlovid started from 24Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; vaccine brand other=Moderna, Vaccine dose number=1, vaccine dose number=2, vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine headache" (unspecified if ongoing). 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"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "vaccine brand other=Moderna, Vaccine dose number=1, vaccine dose number=2, vaccine brand=Pfizer / BioNTech". 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.  Clinical course included that recurrence of covid sx 2-8 days after completion of Paxlovid 5 day course and full resolution of symptoms. recurrence symptoms include headache/ diarrhea/ body aches and fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) (Other HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "Cardiomyopathy" (unspecified if ongoing); "OSA" (unspecified if ongoing); "low back pain" (unspecified if ongoing); "Known allergies : Antihistamines" (unspecified if ongoing), notes: Known allergies : Antihistamines. 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 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.  Clinical course: Patient received antiviral treatment for Covid-19 with Paxlovid from 13Jul2022 to 17Jul2022. Rebound symptoms after being done with paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient received the Pfizer COVID 19 Vaccines. "I dont want to do us more harm by getting it after taking the paxlovid but I dont know if you can do that; Patient received the Pfizer COVID 19 Vaccines. "I dont want to do us more harm by getting it after taking the paxlovid but I dont know if you can do that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient received the Pfizer COVID 19 Vaccines. "I dont want to do us more harm by getting it after taking the paxlovid but I dont know if you can do that". 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.  Clinical course: Patient and his wife were over 71 years old, and they finished the Paxlovid last weekend. Patient's wife was asking how soon after they finish the Paxlovid could get their 2nd booster shot. She stated this would be their 2nd booster as they never received that dose. She guesses there really was no information. Spent a long time searching the internet before calling. They advised to not get the booster. If she would have gotten the booster, she would not have gotten COVID so bad. Now she did not know what to do. She did not know if it was safe to go ahead and got one or if whether we should wait. She had looked on CDC website, hours looking on the internet for the question to not bother all, she knew busy. Caller asked other than her doctor, who led her the wrong way, who could she contact that might know. There was one website, it said something about dont get shot within 90 days after if you have had COVID. She did not know what to do and her husband was in the same boat so anyway. She had 2 doctors, separate who told us to wait for the new vaccine coming in the fall so that was what her husband and her did and that did not turn out so well. Now she did not know whether we could go ahead and got the 2nd booster and then the one in the fall due to the wait between, 4 or 6 months. Patient received the Pfizer COVID 19 Vaccines. He did not want to do us more harm by getting it after taking the paxlovid but he did not know if he could do that.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, 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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 at 08:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE, start date: 01Nov2020; VITAFUSION WOMEN'S; LEVOTHYROXINE; ACETAMINOPHEN; GABAPENTIN; VIACTIV CALCIUM PLUS VITAMIN D & K; OXYBUTYNIN; SLOW RELEASE IRON; HYALURONIC ACID; ZAFIRLUKAST; PANTOPRAZOLE; FLAXSEED; FISH OIL; SUPER B COMPLEX [VITAMIN B COMPLEX]; ZINC; ARNUITY ELLIPTA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : Patient received treatment for COVID-19 from 22Jul2022 to 25Jul2022 with Lot 1910754A.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Pruritus, 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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 at 08:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE, start date: 01Nov2020; VITAFUSION WOMEN'S; LEVOTHYROXINE; ACETAMINOPHEN; GABAPENTIN; VIACTIV CALCIUM PLUS VITAMIN D & K; OXYBUTYNIN; SLOW RELEASE IRON; HYALURONIC ACID; ZAFIRLUKAST; PANTOPRAZOLE; FLAXSEED; FISH OIL; SUPER B COMPLEX [VITAMIN B COMPLEX]; ZINC; ARNUITY ELLIPTA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : Patient received treatment for COVID-19 from 22Jul2022 to 25Jul2022 with Lot 1910754A.  The information on the batch/lot number for BNT162b2 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: 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 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALLEGRA 24 HOUR taken for hypersensitivity. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound symptoms several days after completing course of PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2021 as dose 2, single (Lot number: EW0141) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0178;  Anatomical location:right arm,), administration date: 22Jun2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "complaining his left arm was hurting". The following information was reported: CHEST PAIN (non-serious) with onset 13Jul2021, outcome "recovering". Therapeutic measures were not taken as a result of chest pain.  Additional information: The patient had chest pain in the left part of the chest between the breast and sternum bone. Seems like pain was there for an hours or two then resided. Patient can't explain if recovered completed or with lasting effects since patient didn't go to the doctors. Patient only had two doses of COVID-19 Vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8732), in left arm and on 26Apr2021 as dose 2, single (Lot number: EW0172) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HAILEY 24 FE taken for contraception, start date: Jan2020, stop date: 02Jul2022. 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; (09Jul2022) negative, notes: tested negative for COVID-19 on 09Jul2022; (12Jul2022) positive, notes: On 12Jul2022 (three days after my final dose of Paxlovid) I tested positive for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Antiviral details: Paxlovid for COVID 19 Treatment (Treatment start date: 03Jul2022 and Treatment stop date: 08Jul2022). Indication: Treatment of COVID-19. I was prescribed and began taking Paxlovid on the afternoon of 03Jul2022 and completed the course as directed on the morning of 08Jul2022. I experienced a resolution of COVID-19 symptoms (fever, aches, congestion) on 06Jul2022 and tested negative for COVID-19 on 09Jul2022. On 12Jul2022 (three days after my final dose of Paxlovid) I tested positive for COVID-19. I had not been in close contact with any other individual, so my presumption was that this was a rebound of my COVID-19 illness. I experienced symptoms, including aches, congestion, and fever that were worse than during my initial illness, through 17Jul2022. Other medications in 2 weeks product (Hailey 24 Fe): Birth control and Statin (Brand: Rosuvastatin), start date: Sep2021 and stop date: 02Jul2022. No known allergies. No other medical history.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contacted Covid; Contacted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 22May2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "recovered" and all described as "Contacted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.   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: COVID 19 Treatment; COVID 19 Treatment; 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), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Past drug history included: Lexapro, reaction(s): "Known allergies: Lexapro", notes: Known allergies: Lexapro. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment initiated with Paxlovid from 21Jul2022 to 26Jul2022. Other medication in 2 weeks product: lisinopril.  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 known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment/ Treatment of COVID-19; COVID 19 Treatment/ 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 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high bp" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN MEDOXOMIL, start date: 01Dec2020, stop date: 26Jul2022. Past drug history included: Norflex, reaction(s): "drug allergy"; Clindamycin, reaction(s): "drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID 19 Treatment/ Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included: Adverse event noted exhibited all symptoms of covid ba5 variant. Anti-Viral details noted as product noted as COVID 19 Treatment; brand noted as Paxlovid; treatment start date noted as 14Jul2022; treatment stop date noted as 19Jul2022; and indication noted as treatment of COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.