chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 immunization. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: cucumbers" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "allergies" (unspecified if ongoing), notes: allergies; "anxiety" (unspecified if ongoing); "migraine" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; MONTELUKAST; BUSPIRONE. Past drug history included: Known allergies: codeine, reaction(s): "Known allergies: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient took other medications in two weeks. The patient was given COVID-19 treatment with anri viral drug from 19Jun2022.  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: Therapeutic response unexpected
Clinical narrative: first Covid-19 Vaccine last Mar2021. On May2021, she has "absolutely no symptoms" of rheumatoid arthritis; 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 76-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis", start date: 2018 (unspecified if ongoing), notes: diagnosed with rheumatoid arthritis last 2018. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset May2021, outcome "unknown", described as "first Covid-19 Vaccine last Mar2021. On May2021, she has "absolutely no symptoms" of rheumatoid arthritis".  Additional information: Caller is reporting a "good news" regarding the Pfizer BioNTech Covid-19 Vaccine. Caller mentioned that she has been diagnosed with rheumatoid arthritis last 2018. She has been taking Methotrexate injectables since then. She had her first Covid-19 Vaccine last Mar2021. On May2021, she has "absolutely no symptoms" of rheumatoid arthritis. Her rheumatologist took her off of her Methotrexate. Her rheumatoid arthritis has been on remission for a year now. She has no medical questions, she just wants to check if the shot could have caused her remission. She thinks that her rheumatoid arthritis remission might be a coincidence with the Methotrexate. If it were the COVID shot, she suggests Pfizer to investigate on it. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 21Jun2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for Covid-19 Immunization.  The following information was reported: DIARRHOEA (non-serious) with onset 21Jun2022, outcome "recovered" (Jun2022), described as "diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  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: had the 4 Pfizer Covid19 vaccines/ still tested positive for Covid; had the 4 Pfizer Covid19 vaccines/ still tested positive for 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 75-year-old female 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 as dose 4 (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 "had the 4 Pfizer Covid19 vaccines/ still tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller states that she had the 4 Pfizer Covid19 vaccines but she still tested positive for Covid on Monday and her Covid symptoms started last Wednesday and today is day 8 of her Covid infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient called for information on Paxlovid. She stated that she had the 4 Pfizer Covid19 vaccines but she still tested positive for Covid on Monday and her Covid symptoms started last Wednesday and today was day 8 of her Covid infection. Caller (patient) stated that she had been feeling worse and not better. Caller stated that, she asked her primary doctor to be placed on Paxlovid but she was reluctant to give it to her. Caller asked "even though Paxlovid works best within 5 days of Covid symptoms, it should still be effective if it is given after the 5 days right?" and "can my doctor still give it to me or should I go to the ER to get it there?" Caller stated, "my friend's Covid symptoms cleared up after taking Paxlovid."  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: Diarrhoea, Investigation, Scan, Weight, Weight decreased
Clinical narrative: lost about 22-25 pounds; chronic diarrhea; 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 female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBSD" (unspecified if ongoing), notes: States she does have a history of IBSD but this is beyond the that. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 3 (Booster)), for COVID-19 Immunization; Bnt162b2 (Dose:2), for COVID-19 Immunization; Bnt162b2 (Dose:1), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 2022, outcome "not recovered", described as "chronic diarrhea"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost about 22-25 pounds". The event "chronic diarrhea" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter states she has had this for a long time and has not find real answers, so she thinks the COVID Vaccine could be a real possibility of the cause but she doesn't know for sure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 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 included: "Asthma" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Negative; (22Jun2022) Positive; (unspecified date) Unknown Result. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 23Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 13May2022 at 13:00 as dose 4 (booster), single (Lot number: 057MZIA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "previous breast cancer" (unspecified if ongoing); "penicillin" (unspecified if ongoing), notes: Allergic to penicillin and penicillin related antibiotics. Concomitant medication(s) included: OLMESARTAN; EFFEXOR; HYDROCHLOROTHIAZIDE; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN D [COLECALCIFEROL]; ZIRTEC. Patient also received Multi-vitamin in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 21Jun2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: (Jun2022) Positive, notes: Still test positive at day 15. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID 19; Positive COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 19Feb2021 as dose 2, single (Lot number: EL9263), in right arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 26Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOVASTATIN, stop date: 06Jun2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 07Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 07Jun2022, outcome "not recovered" and all described as "Positive COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive; (16Jun2022) Negative; (21Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Tested Positive COVID19 07Jun2022, took Paxlovid 5 days 08Jun2022 to 12Jun2022. Tested negative 16Jun2022. On 21Jun2022 not feeling well tested Positive COVID 19 again. Milder symptoms.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 24Jan2022. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: The patient received other medication in 2weeks. The patient took Paxlovid for COVID 19 treatment. The treatment start date was reported as 20Jun2022 (lot number: GC0490). The patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment/ first positive test; COVID 19 Treatment/ first positive test; This is a spontaneous report received from a non-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 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 12May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "acid refulx" (unspecified if ongoing); "Allergy:penicillin" (unspecified if ongoing). Concomitant medication(s) included: VAGIFEM, start date: Dec2009 and also reported as patient took other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022 at 21:00, outcome "not recovered" and all described as "COVID 19 Treatment/ first positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 12 days after my first positive test, and 7 days after my last dose of Paxlovid, I tested positive for Covid. I have rebound Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (lot number: 980227470407) started on 09Jun2022 and stopped on 12Jun2022. No treatment received for symptoms and patient was not recovered from symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 at 19:00 as dose 3 (booster), single (Lot number: EW0198) at the age of 50 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: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure. Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE. Past drug history included: Atorvastatin, reaction(s): "Allergy", notes: also take Atorvastatin, but have spotted taking it, while I am on the Paxlovid site to avoid interactions. 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 anti-viral Paxlovid treatment from 13Jun2022 for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Lot number: Fe3594) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Apr2021 as dose 1, single (Lot number: 028a21a), in left arm and on 05May2021 as dose 2, single (Lot number: 016c21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. 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) Unknown result; (18Jun2022) Negative; (22Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Product Paxlovid treatment started on 12Jun2022 to 17Jun2022 for indication to Treatment of COVID-19.  Clinical course: No known allergies. Other medication in 2weeks: Yes.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positvie covid test; positvie covid test; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: el9262), in right arm, on 19Feb2021 as dose 2, single (Lot number: en6201), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: 30135ba) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "not recovered" and all described as "positvie covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Indication: Treatment of COVID-19; (20Jun2022) Negative, notes: 2 days after completing Paxlovid; (22Jun2022) Positive, notes: 4 days after completing Paxlovid. Therapeutic measures were taken as a result of covid-19.  Clinical information: No allergies; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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 "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 13Jun2022 to 18Jun2022.  Clinical Course: Reported as, Felt fine after day 4 of the treatment, and then on day 3 after patient ended the treatment patient developed congestion, runny nose, and headache with occasional sneezes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: indication=Treatment of COVID-19; indication=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 04Mar2021 at 12:30 as dose 1, single (Lot number: EN6206), in left arm, on 25Mar2021 at 12:00 as dose 2, single (Lot number: EP7534), in left arm and on 04Oct2021 at 09:30 as dose 3 (booster), single (Lot number: FC3183) at the age of 58 years, in left arm for COVID-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Apr2022 at 13:15 as dose 4 (booster), single (Lot number: 066K21A), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing); "Hashimoto' disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; EFFEXOR; LISINOPRIL; ALLEGRA ALLERGY; NASACORT; FAMOTIDINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient had received anti-viral medication; Paxlovid as COVID 19 Treatment. Treatment started on 11Jun2022 and stop date was 16Jun2022.
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone, Free thyroxine index, Histology, Physical examination
Clinical narrative: subacute thyroiditis; This is a literature report.  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: THYROIDITIS SUBACUTE (medically significant), 20 days after the suspect product(s) administration, outcome "unknown", described as "subacute thyroiditis". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: negative; negative; Blood thyroid stimulating hormone: 0.07 MiU/mL, notes: Low; Free thyroxine index: 3.04 ng/dL, notes: elevated; Histology: A heterogeneous and swol len thyroid, without, notes: nodules; Physical examination of thyroid: A heterogeneous and swol len thyroid, without, notes: nodules; Thyroid stimulating immunoglobulin: negative; Tri-iodothyronine: 200 ng/dL, notes: elevated; Ultrasound scan: A heterogeneous and swollen thyroid, without, notes: nodules. Therapeutic measures were taken as a result of thyroiditis subacute.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200008403 Same article/drug/event and Different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Thyroid stimulating immunoglobulin, Thyroiditis subacute, Tri-iodothyronine, Ultrasound scan
Clinical narrative: subacute thyroiditis; This is a literature report.  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: THYROIDITIS SUBACUTE (medically significant), 20 days after the suspect product(s) administration, outcome "unknown", described as "subacute thyroiditis". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: negative; negative; Blood thyroid stimulating hormone: 0.07 MiU/mL, notes: Low; Free thyroxine index: 3.04 ng/dL, notes: elevated; Histology: A heterogeneous and swol len thyroid, without, notes: nodules; Physical examination of thyroid: A heterogeneous and swol len thyroid, without, notes: nodules; Thyroid stimulating immunoglobulin: negative; Tri-iodothyronine: 200 ng/dL, notes: elevated; Ultrasound scan: A heterogeneous and swollen thyroid, without, notes: nodules. Therapeutic measures were taken as a result of thyroiditis subacute.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200008403 Same article/drug/event and Different patient.;
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received 4 vaccinations of Pfizer Biontech Covid 19 vaccine and has recently tested positive for Covid 19; received 4 vaccinations of Pfizer Biontech Covid 19 vaccine and has recently tested positive for Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL8982), on 19Feb2021 as dose 2, single (Lot number: EL9264), as dose 3 (booster), single (Lot number: FE3592) and on 02Jun2022 as dose 4 (booster), single (Lot number: FM2293) at the age of 85 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (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 "received 4 vaccinations of Pfizer Biontech Covid 19 vaccine and has recently tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: recently tested positive for Covid 19. Bebtelavimab may be name of infusion caller received but is not sure. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Caller has received 4 vaccinations of Pfizer Biontech Covid 19 vaccine and has recently tested positive for Covid 19. The patient had each dose in different arm and was rotated.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he received 2 initial Pfizer-BioNTech Covid vaccines and then the booster in Dec2021. He got covid in April; he received 2 initial Pfizer-BioNTech Covid vaccines and then the booster in Dec2021. He got covid in April; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Dec2021 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 "he received 2 initial Pfizer-BioNTech Covid vaccines and then the booster in Dec2021. He got covid in April". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Unknown results, notes: He got covid in April. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The caller stated he has already been on the phone for 24 minutes. He thought it would be quick but he called and got transferred to me from someone else. Request Name. Product: PAXLOVID. Question: The caller wanted to know how soon after taking Paxlovid can you get a covid vaccine booster. He stated he received 2 initial Pfizer-BioNTech Covid vaccines and then the booster in Dec2021. He got covid in April and took Paxlovid starting on 16Apr for 5 days. Now he is wondering when he can get his second booster after taking the Paxlovid. The caller did not have time to speak with at this time but consented to be contacted if there were additional questions. He provided his physicians contact information but he stated that he did not receive this from him.  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: Body temperature, COVID-19, Product administered to patient of inappropriate age, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for COVID; A little bit of fever last night and then today or this morning, she has a higher fever around 101; Daughter is 2 and a half years old; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A child female patient of age 2 and a half year-old received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FT9142) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "Tested positive for COVID"; PYREXIA (non-serious), outcome "unknown", described as "A little bit of fever last night and then today or this morning, she has a higher fever around 101"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Daughter is 2 and a half years old". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Transferring agent stated, I have a caller on the other line. His daughter received, his daughter was 2 and a half years old (not confirmed and clarified) and just received the first shot last night and she had a fever, a little bit of fever/ low grade fever last night and then today or this morning, she had a higher fever around 101. Caller wanted to know if the vaccine can cause a false positive result. On confirming if the reporter only wants to report or needs any information transferring agent stated, he would like to report that adverse event as well as his daughter tested positive as well for COVID. So he wants to know if the vaccine can cause the COVID-19. On paraphrasing the concern reporter stated, that was correct and she also, we just tested her and she did come up positive for the test. So I am just curious if that is possibly positive from the vaccine shot or it is actually a Covid test.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic steatosis, Rheumatoid arthritis
Clinical narrative: Having symptoms associated with rheumatoid arthritis and fatty liver; Having symptoms associated with rheumatoid arthritis and fatty liver; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 43-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization.  The following information was reported: RHEUMATOID ARTHRITIS (medically significant), HEPATIC STEATOSIS (non-serious), outcome "unknown" and all described as "Having symptoms associated with rheumatoid arthritis and fatty liver". It was unknown if therapeutic measures were taken as a result of rheumatoid arthritis, hepatic steatosis.  Clinical Course: Reporter  told that a 43-year-old woman reported having symptoms associated with rheumatoid arthritis and fatty liver after having received the COVID-19 vaccine. The report is second hand through a friend who is her counselor. I've shared the reporting website with the counselor and have urged her to share it with the woman who has been experiencing the symptoms. Patient was recovered or not: unknown. If patient had  COVID prior vaccination: Unknown. If patient was COVID tested post vaccination: Unknown. If patient had received treatment: unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body tinea
Clinical narrative: Ringworm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "hypoactive thyroid" (ongoing), notes: she has no thyroid function and was initially diagnosed with hyperactive thyroid at age 24; "Sjogren's disease" (ongoing), notes: Sjogren's disease has Sjogrens disease and symptoms started approximately 20 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Lot Number: EL9263), administration date: 26Feb2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, Lot Number: EN6198), administration date: 19Mar2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: BODY TINEA (non-serious) with onset 10Jun2022, outcome "not recovered", described as "Ringworm". Therapeutic measures were taken as a result of body tinea.  Additional information: The patient had ringworm and started taking an antifungal cream on 11Jun2022 and that was when noticed it and had the HCP through telehealth when asked about allergies gave the caller a topical treatment to use for that but only on legs and not on arms and the ringworm began on 10Jun2022; stated it was distressing that cannot find the antifungal cream and needs to find it before the end of the day. Caller stated the topical antifungal cream was Ketoconazole to apply topically daily to affected areas for two weeks and to keep it on as often as possible; stated the Ketoconazole had lot 637121, expiry date Jan2024 and also had NDC 00093-3219-92; stated the Ketoconazole was to be put on the two spots of ringworm and was still getting ringworm and took Ketoconazole still and this morning she had a 2nd location where it was starting and started using the antifungal cream for that.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase abnormal, Incorrect dose administered
Clinical narrative: 3rd booster of the Pfizer-BioNTech COVID-19 Vaccine; fluctuating Creatinine Kinase (CK) levels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for Covid-19 Immunization; Covid-19 vaccine (Dose 4), for Covid-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "3rd booster of the Pfizer-BioNTech COVID-19 Vaccine"; BLOOD CREATINE PHOSPHOKINASE ABNORMAL (non-serious), outcome "unknown", described as "fluctuating Creatinine Kinase (CK) levels". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller stated that the Patient just got his 3rd booster of the Pfizer-BioNTech COVID-19 Vaccine, and reported "fluctuating Creatinine Kinase (CK) levels". Caller wanted to know if this is a reported side effect.  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: 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 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Apr2022 as dose 4 (booster), single (Lot number: 057M21H), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Elevated Cholesterol" (unspecified if ongoing), notes: Elevated Cholesterol; "acid reflux" (unspecified if ongoing); "elevated A1c" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Covid-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.
Age: 60.0
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 17:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Mar2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 05Oct2021 at 09:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Apr2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hepatic steatosis" (unspecified if ongoing), notes: Fatty liver; "lactose intolerant" (unspecified if ongoing), notes: I am lactose intolerant. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergy: Erythromycin", notes: Erythromycin. 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". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6199), as dose 2, single (Lot number: ER8733) and on 30Nov2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 15Jun2022 to 20Jun2022 for COVID 19 Treatment.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, 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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer" (unspecified if ongoing); "BMI" (unspecified if ongoing), notes: BMI 27-28. Concomitant medication(s) included: METOPROLOL TARTRATE, start date: 14Mar2013. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 27-28, notes: BMI 27-28; SARS-CoV-2 test: (unspecified date) Unknown results; (13Jun2022) Negative, notes: after testing negative for 3 day, 13Jun-15Jun; (14Jun2022) Negative, notes: after testing negative for 3 day, 13Jun-15Jun; (15Jun2022) Negative, notes: after testing negative for 3 day, 13Jun-15Jun; (22Jun2022) Positive, notes: positive test. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was treated with Paxlovid for covid-19 from 13Jun2022 to 17Jun2022. Rebound 5 days after treatment completed, mild symptoms plus positive test on 22Jun2022, after testing negative for 3 days, 13Jun2022 to 15Jun2022. Event was not recovered and no treatment received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
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 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 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol. Concomitant medication(s) included: WELLBUTRIN XL, start date: Jun2008; LIPITOR, start date: Feb2009; AMLODIPINE, start date: Dec2009. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Reaction to the last COVID injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4444009-00 .  A 71-year-old patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 01, Intramuscular), administration date: 28Jan2021, when the patient was 70-year-old, for COVID-19 Vaccination. The following information was reported: IMMUNISATION REACTION (non-serious) with onset 2021, outcome "unknown", described as "Reaction to the last COVID injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.