chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 16Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "APS" (unspecified if ongoing). Concomitant medication(s) included: HEPARIN, start date: 26Jun2022, stop date: 26Jun2022. 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 lab 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. Clinical course: Treatment included Paxlovid (Lot: GC2897) started on 27Jun2022. Other medication details: Other medication: start date: 26Jun2022, stop date: 26Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 at 12:00 as dose 1, single at the age of 53 years, in right arm for covid-19 immunisation. The patient relevant medical history included: "Asthma" (unspecified if ongoing). The patient concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that patient received COVID-19 treatment with paxlovid drug (lot number: GC8236). It was also reported that the patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 25Mar2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEXAPRO; VITAMIN D [VITAMIN D NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Antigen test: (Jun2022) T on my atigen test that day came up quickly; SARS-CoV-2 test: (19Jun2022) Positive; (25Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received paxlovid to treat drug ineffective, covid-19. Treatment start date: 19Jun2022, stop date: 24Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 at 16:00 as dose 1, single (Lot number: EL9269), in left arm, on 24Feb2021 at 16:00 as dose 2, single (Lot number: EL9269), in left arm, on 05Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23May2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anemia" (unspecified if ongoing); "malabsorption syndrome" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "IBS" (unspecified if ongoing), notes: Other medical history:IBS. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: Report about covid treatment reported as Yes. If vaccine received reported as Yes. Other medication in 2 weeks reported as No. Anti-viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 28Jun2022, treatment stop date: 02Jul2022, Indication: Treatment of COVID-19. adverse event reported as The most horrible taste in mouth, with heartburn and regurgitation. Stopped taking Paxlovid on 2Jul2022. Last dose taken was seven out of ten.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2022 at 12:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 42 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Positive, notes: Positive antigen home test including congestion body aches fatigue; (22Jun2022) positive, notes: Initial positive test; (28Jun2022) Negative, notes: negative PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 36-year-old female patient received BNT162b2 (BNT162B2), as dose 2, 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: No other medication in 2 weeks. The patient was treated with anti-viral details for COVID 19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team.  A 69-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was a little sore". Therapeutic measures were not taken as a result of pain in extremity. Additional information: Patient received her fourth dose of the Pfizer BioNTech COVID 19 vaccine this past Tuesday. With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Dates Unknown. NDC, Lot, Expiration Unknown.), for Covid-19 Immunization, reaction(s): "With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: It was reported that, husband was calling on behalf of wife, aged 69 received her fourth dose of the Pfizer BioNTech COVID 19 vaccine this past Tuesday. "With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this". It didn't get all red or swell up. It was sore for a day or two and that was it. It was discolored and it was kind of a large area that got red. It had not gotten better. She did not seem to be running a fever but if she was it would be low grade. He did not know if it was hot to the touch. It looked inflamed and red. He did not think it was a rash. It looked like someone punched her in the arm. The area of inflammation was about the size of his fist. Investigations were reported as No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Dates Unknown. NDC, Lot, Expiration Unknown.), for Covid-19 Immunization, reaction(s): "With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this"; Bnt162b2 (Second Dose, Dates Unknown. NDC, Lot, Expiration Unknown.), for Covid-19 Immunization, reaction(s): "With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Caller stated he is calling for his wife and she had an adverse reaction to the fourth shot from the Covid, verified Pfizer COVID 19 Vaccine Fourth Dose or Second Booster. Caller stated his wife is experiencing injection site swelling, redness, and her arm hurts. Caller reports the injection site burns when the patient takes a shower, next day after the shot, her arm started to get all red and sore and then it got worse from there, his wife is not feeling well, her arm is sore, she wouldn't even let him touch it, there is swelling at the injection site and redness. With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this. It didn't get all red or swell up. It was sore for a day or two and that's it. Its discolored and it is kind of a large area that got red. It has not gotten better. She doesn't seem to be running a fever but if she is it would be low grade. He doesn't know if it's hot to the touch. It looks inflamed and red. He doesn't think it's a rash. It looks like someone punched her in the arm. The area of inflammation is about the size of his fist.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 at 14:00 as dose 2, single (Lot number: FK9893) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetic" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN. 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Three weeks after ending the Paxlovoid pills I have developed a severe case of itching, from head to toe. This condition has been going on from 26Jun2022 to present. I can find no relief for the constant itching. I have applied anti-itch creams and lotions plus soaked 30 mins per night in Oatmeal Bath. Nothing so far seems to help.
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE (other medication in 2 weeks). The following information was reported: DRUG INEFFECTIVE (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: (30Jun2022) Unknown results, notes: Post Paxlovid rebound starting on 30Jun2022; (01Jul2022) Negative, notes: the day after testing negative; (03Jul2022) Positive, notes: 3rd day of rebound and symptoms are beginning to subside. Testing positive gain. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Treated with Paxlovid from 20Jun2022 to 25Jun2022).  Additional information: Post Paxlovid rebound starting on 30Jun2022, the day after testing negative. 3rd day of rebound and symptoms are beginning to subside. Testing positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasopharyngitis
Clinical narrative: I am still very fatigue and tired.; I still have the headache.; I feel cold.; 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 patient received BNT162b2 (BNT162B2), on 29Jun2022 as dose number unknown (booster), single (Lot number: FM0173) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMSULOSIN; PREDNISONE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), FATIGUE (non-serious) all with onset 29Jun2022, outcome "unknown" and all described as "I am still very fatigue and tired."; NASOPHARYNGITIS (non-serious) with onset 29Jun2022, outcome "unknown", described as "I feel cold."; HEADACHE (non-serious) with onset 29Jun2022, outcome "unknown", described as "I still have the headache.". Therapeutic measures were taken as a result of fatigue, headache, nasopharyngitis, fatigue.  Additional information: The patient was receiving treatment with Tylenol.
Sex: M
Vaccine: MENB
Symptoms: Eosinophil count, Urticaria
Clinical narrative: localized hives between the elbows and shoulder, in the arm where he received the vaccine; This is a spontaneous report received from contactable reporter(s) (Physician).  A 17-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), in Dec2021 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "elevated eosinophils" (unspecified if ongoing); "hypersensitivity to chinchilla dust" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset Dec2021, outcome "unknown", described as "localized hives between the elbows and shoulder, in the arm where he received the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: At that time, patient had localized hives between the elbows and shoulder, in the arm where he received the vaccine. Reporter had stated that it wasn't redness, it was true hives. Caller states that she understands the contraindication when it is anaphylaxis. This was not anaphylaxis, it was localized hives. Caller states it was tough because she could not give clinical guidance.  Clarified that the caller was made aware of this event today, 1Jul2022. Caller received call from agency today, stating that reporter had contacted them, requesting Filed Medical request. Caller received the message at 9:02am, today, 1Jul2022 and called the reporter back at 3:00pm. Event Details: Localized hives between the elbows and shoulder, in the arm where he received the vaccine: Clarified this occurred Dec2021. Reporter was calling now about this now because it was time for the patient's second dose. Unknown which arm this occurred in. Seriousness Criteria: Caller didn't ask that and reporter knew for sure that it was not anaphylaxis, which would be serious. Caller asks if Pfizer will follow up with reporter. Caller advised that Pfizer may contact reporter for in need of further information.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6202), in right arm, on 31Mar2021 as dose 2, single (Lot number: EN6955), in right arm and on 06Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient took unspecified concomitant medication in 2 weeks of vaccination. The following information was reported: VACCINATION FAILURE (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: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient was treated with anti-viral drug Paxlovid (Treatment of COVID-19) which was started on 30Jun2022 (Lot no: GA8849).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID-19/Tested positive on 6/24/22; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EL3246) at the age of 66 years, in left arm, on 27Jan2021 as dose 2, single (Lot number: EL8982), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperparathyroidism" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL; ATORVASTATIN; COQ10; ASPRIN. Other medication in 2 weeks included Vitamin B complex with zinc and vitamin C. The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Jun2022, outcome "unknown", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset 24Jun2022, outcome "unknown", described as "COVID-19/Tested positive on 6/24/22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive; (30Jun2022) Negative; (03Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 at 12:00 as dose 1, single (Lot number: EL9262), in left arm, on 07Mar2021 at 12:00 as dose 2, single (Lot number: EL9269), in left arm, on 15Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 86 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: Relapse after testing Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not have any known allergies. No other medication in 2 weeks. The patient received anti-viral product for COVID 19 treatment with Paxlovid from 17Jun2022 to 21Jun2022. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid-19 Treatment; covid-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 26May2021 as dose 2, single (Lot number: EP6955), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: KF8841), in left arm and on 30Apr2022 at 15:15 as dose 4 (booster), single (Lot number: FJ4989) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "anxiety" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "covid-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Reported Event: Last dose of Paxlovid was taken Tuesday morning of 28Jun2022 and symptoms of coughing and nasal congestion had nearly completely resolved as of 26Jun2022. On Thursday 30Jun2022, coughing and congestion returned, and lethargy. Coughing is severe when carrying on a conversation, chest feels tight, but cough is not productive. Today, Saturday 2Jul2022, cough and tiredness continue.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 13May2022 at 17:00 as dose 4 (booster), single (Lot number: fp4554), 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: WELLBUTRIN, start date: Jan2018. The patient previously received a COVID-19 Vaccine. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Anti-viral details product-COVID 19 Treatment, brand-Paxlovid, treatment start date-01Jul2022, lot number-gc0603, indication-Treatment of COVID-19. Reported Event: dysgeusia: bitter taste in throat, started about an hour after first dose-thought I had swallowed a tabled wrong. The taste is persisting. Adverse events start date 01Jul2022. Adverse events start time 07:00 PM. Ae resulted in None of the above. If patient recovered Unknown. If treatment Ae was no.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years, 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: 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: Unknown results; negative, notes: Rebound case after testing 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.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Feeling abnormal, Investigation
Clinical narrative: erectile disfunction; brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 22May2021 at 07:15 as dose 2, single (Lot number: EW0170) at the age of 25 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ASHWAGANDHA. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. PFiZer EW0170, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 01May2021, when the patient was 25-year-old, for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 22May2021, outcome "not recovered", described as "brain fog"; ERECTILE DYSFUNCTION (medically significant) with onset 22May2021, outcome "not recovered", described as "erectile disfunction". The patient underwent the following laboratory tests and procedures: several health chekup: reports were fine. Therapeutic measures were not taken as a result of erectile dysfunction, feeling abnormal.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. He complained of brain fog and erectile disfunction soon after the second dose of vaccination, Pfizer COVID Vaccine. He went for several health check-up and the reports were fine. But the disfunction remained the same.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 13:00 as dose 1, single (Lot number: En9264), in left arm and on 27Feb2021 at 09:00 as dose 2, single (Lot number: En6203) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Dec2021 at 15:30 as dose 3 (booster), single (Lot number: 029h21b), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: anti viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 18Jun2022, treatment stop date: 22Jun2022.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "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) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 12:30 as dose 1, single (Lot number: EN6206), on 26Mar2021 at 12:00 as dose 2, single (Lot number: ER8730), on 27Oct2021 at 15:45 as dose 3 (booster), single (Lot number: FH8020) and on 23Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 59 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (ongoing); "hypothyroidism" (unspecified if ongoing); "atopic dermatitis" (unspecified if ongoing); "known allergies: Sulfonamides" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; AMLODIPINE; HYDROCHLOROTHIAZIDE; LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; LOSARTAN; OMEPRAZOLE; POTASSIUM CHLORIDE; MONTELUKAST; DUPIXENT, reported as other medication in 2weeks. Past drug history included: Cephalosporins, reaction(s): "known allergies: cephalosporins"; Neomycin, reaction(s): "known allergies: neomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid, treatment started on 08May2022 and treatment stopped on 12May2022. Clinical course was reported as, Rebound covid on 19May2022 after taking the full 5 day course of Paxlovid, patient was asymptomatic and tested negative. A short time later she began developing symptoms again, worse than when she was first diagnosed and tested positive again 10 days after finishing Paxlovid. Symptoms stopped on 31May2022. Patient not received any treatment for symptoms and was recovered from symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dysstasia, Hyperhidrosis, Presyncope
Clinical narrative: Anaphylactic reaction; She is going to pass out; Sweating; threw up; she couldn't stand up because she was so dizzy; she couldn't stand up because she was so dizzy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 30Jun2022 as dose 1, 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown"; PRESYNCOPE (non-serious), outcome "unknown", described as "She is going to pass out"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating"; VOMITING (non-serious), outcome "unknown", described as "threw up"; DIZZINESS (non-serious), DYSSTASIA (non-serious), outcome "unknown" and all described as "she couldn't stand up because she was so dizzy". The events "anaphylactic reaction", "she is going to pass out", "sweating", "threw up" and "she couldn't stand up because she was so dizzy" required physician office visit and emergency room visit. Clinical course: Reporter stated that reporter just wanted to ask a question, okay so the daughter received her first Pfizer vaccine on 30Jun2022 (Thursday) and she had an anaphylactic reaction, she was sweating, she was going to pass out and she threw up and she couldn't stand up because she was so dizzy. So, reporter called her doctor and her doctor said she didn't recommend getting the second dose unless it had done in half without studying because her reaction was so bad. The paramedics came because the person regarding they called the paramedics just to make sure she was okay. So reporter asked if Pfizer recommended her getting the second dose because reporter didn't know what to do and reporter didn't want to jeopardize her health. Reporter was requested to visit emergency room and consulted with doctor in case of emergency. Reporter further stated that patient was okay now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Anaphylactic reaction; She is going to pass out; Sweating; threw up; she couldn't stand up because she was so dizzy; she couldn't stand up because she was so dizzy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 30Jun2022 as dose 1, 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown"; PRESYNCOPE (non-serious), outcome "unknown", described as "She is going to pass out"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating"; VOMITING (non-serious), outcome "unknown", described as "threw up"; DIZZINESS (non-serious), DYSSTASIA (non-serious), outcome "unknown" and all described as "she couldn't stand up because she was so dizzy". The events "anaphylactic reaction", "she is going to pass out", "sweating", "threw up" and "she couldn't stand up because she was so dizzy" required physician office visit and emergency room visit. Clinical course: Reporter stated that reporter just wanted to ask a question, okay so the daughter received her first Pfizer vaccine on 30Jun2022 (Thursday) and she had an anaphylactic reaction, she was sweating, she was going to pass out and she threw up and she couldn't stand up because she was so dizzy. So, reporter called her doctor and her doctor said she didn't recommend getting the second dose unless it had done in half without studying because her reaction was so bad. The paramedics came because the person regarding they called the paramedics just to make sure she was okay. So reporter asked if Pfizer recommended her getting the second dose because reporter didn't know what to do and reporter didn't want to jeopardize her health. Reporter was requested to visit emergency room and consulted with doctor in case of emergency. Reporter further stated that patient was okay now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/first tested 06Jun and was positive.; Treatment of COVID-19/first tested 06Jun and was positive.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 at 17:00 as dose 3 (booster), single (Lot number: Ew0183) at the age of 40 years, in right arm for covid-19 immunization; 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 immunzation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19/first tested 06Jun and was positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Positive; (12Jun2022) Negative, notes: All 5 were negative; (13Jun2022) Negative, notes: All 5 were negative; (14Jun2022) Negative, notes: All 5 were negative; (15Jun2022) Negative, notes: All 5 were negative; (16Jun2022) Negative, notes: All 5 were negative; (02Jul2022) Positive, notes: tested. It was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Other medication were given in 2 weeks: Ibuprophen and tylenol. Patient received paxlovid for treatment of Covid-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 75.0
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) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POEMS Syndrome (a blood cancer)" (unspecified if ongoing), notes: POEMS Syndrome (a blood cancer). Concomitant medication(s) included: LEVOTHYROXINE SODIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Negative; (01Jun2022) Positive; (Jun2022) Positive, notes: Was positive for another 7 days. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment start date=18May2022, treatment stop date=23May2022]. Additional information: Received Paxlovid on 18May2022. Symptoms were mild. Tested negative on 24May2022 and for one week thereafter. Reoccurring symptoms and another positive test on 01Jun2022. Symptoms more severe this time. Was positive for another 7 days. known allergies No. other medication in 2weeks Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Gadolinium, reaction(s): "known allergies gadolinium", notes: known allergies gadolinium; Levaquin, reaction(s): "known allergies levaquin", notes: known allergies levaquin; Tobramycin, reaction(s): "known allergies tobramycin", notes: known allergies tobramycin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.