chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: had five Pfizer COVID vaccinations most recent on Sept/tested positive for COVID; had five Pfizer COVID vaccinations most recent on Sept/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 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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) all with onset Nov2022, outcome "not recovered" and all described as "had five Pfizer COVID vaccinations most recent on Sept/tested positive for COVID". It was reported that patient has had 5 Pfizer vaccinations and the most recent was the Bivalent in Sep2022. He tested positive for COVID on an unspecified date in Nov2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, COVID-19, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: Omicron BA.1/BA.2 coinfection; Omicron BA.1/BA.2 coinfection; This is a literature report for the following literature source(s).  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic lymphocytic leukemia/small cell lymphocytic leukemia" (unspecified if ongoing); "chronic lymphocytic leukemia/small cell lymphocytic leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Chemotherapy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Omicron BA.1/BA.2 coinfection". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: 123, notes: (Approx 90 days post vaccination); Multiple fragment analysis: COVID-19 cases caused by coinfection with, notes: different SARS-CoV-2 variants (Delta/Omicron BA.1 and Omicron BA.1/BA.2); SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported COVID-19 positive after 3 doses of BNT162b2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202201307875 Same article, drug, event and different patient;
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Endometrial cancer, Uterine polypectomy
Clinical narrative: endometrial carcinoma / type 1 endometrial carcinoma; This is a spontaneous report received from a contactable reporter (Consumer (patient's husband)) from medical information team.  A 31-year-old (as reported) female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown) at the age of 30 years (as reported), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ENDOMETRIAL CANCER (medically significant), outcome "unknown", described as "endometrial carcinoma / type 1 endometrial carcinoma". The patient underwent the following laboratory tests and procedures: Uterine polypectomy: type 1 endometrial carcinoma. Therapeutic measures were taken as a result of endometrial cancer. Clinical course information: The reporter's wife took the Pfizer BioNTech COVID vaccine, the first and second dose a little under a year ago. Shortly after, she developed side effect symptoms and was recently diagnosed with endometrial carcinoma. The test was endometrial polypectomy. The result was type 1 endometrial carcinoma. The reporter would like to know how he can contact damages or settlement department.   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: Carpal tunnel syndrome, Hypoaesthesia
Clinical narrative: my two middle fingers on my right hand went permanently numb; had chiropractic appointments, hand specialist and finally Carpal Tunnel release surgery and my fingers are still numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 25Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 1st booster), for COVID-19 immunization. The following information was reported: CARPAL TUNNEL SYNDROME (medically significant) with onset 2022, outcome "unknown", described as "had chiropractic appointments, hand specialist and finally Carpal Tunnel release surgery and my fingers are still numb"; HYPOAESTHESIA (non-serious) with onset Jul2022, outcome "not recovered", described as "my two middle fingers on my right hand went permanently numb". The events "had chiropractic appointments, hand specialist and finally carpal tunnel release surgery and my fingers are still numb" and "my two middle fingers on my right hand went permanently numb" required physician office visit. Additional information: On 25Jul2022 patient second booster in right arm. The end of Jul2022 her two middle fingers on her right hand went permanently numb. Since then, She had chiropractic appointments, hand specialist and finally Carpal Tunnel release surgery and her fingers are still numb.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Dysstasia, Feeling cold, Seizure, Tremor
Clinical narrative: convulsing; joint pain; freezing; shaking; could not stand up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: SEIZURE (medically significant) with onset 17Nov2022 at 03:00, outcome "recovering", described as "convulsing"; DYSSTASIA (non-serious) with onset 17Nov2022 at 03:00, outcome "recovering", described as "could not stand up"; FEELING COLD (non-serious) with onset 17Nov2022 at 03:00, outcome "recovering", described as "freezing"; ARTHRALGIA (non-serious) with onset 17Nov2022 at 03:00, outcome "recovering", described as "joint pain"; TREMOR (non-serious) with onset 17Nov2022 at 03:00, outcome "recovering", described as "shaking". Yesterday (16Nov2022), patient got booster, 4th booster shot (Pfizer COVID-19 Vaccine) yesterday and patient was kind of a surprised because patient woke up at about 3 in the morning and patient was absolutely freezing and patient was convulsing, patient was shaking, patient could not stand up and the joint pain was unbearable and this was really bizarre because patient had experienced that sometime ago with the flu shot. (Medication name could not be clarified; Unspecified Flu Shot) But never with the COVID-19 shot. Patient must say that at the present time it had diminished quite a bit. Patient was just wondering why patient was experiencing that when patient never did before. Patient stated never mind, it subsided quite a bit. It was not as bad as it was. Patient was feeling a lot better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: Liver lymphoma; This is a spontaneous report received from a contactable nurse.  A 62-year-old female patient received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Liver lymphoma"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Liver lymphoma". The following information was reported: LYMPHOMA (medically significant), outcome "unknown", described as "Liver lymphoma". The patient developed liver lymphoma after receiving both COVID-19 shots and booster. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event Hepatic lymphoma  and the suspect drug BNT162B2 cannot be excluded.  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-PV202200106296 Same patient, product, and event; different dose;
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: liver lymphoma; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 62-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; Lot number: unknown), for COVID-19 immunization, reaction(s): "liver lymphoma". The following information was reported: LYMPHOMA (medically significant), outcome "unknown", described as "liver lymphoma". Per clinical course, patient developed liver lymphoma after receiving both COVID-19 shots and booster. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event lymphoma and the suspect drug cannot be excluded. 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-PV202200106296 same patient/drug/event, different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Joint range of motion decreased, Neuralgia
Clinical narrative: nerve pain and couldn't move her arm; nerve pain and couldn't move her arm; 1st dose Pfizer COVID-19 Vaccine: Date Received: Apr2021/2nd dose Pfizer COVID-19 Vaccine: Date Received: 15Jul2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 15Jul2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: TAPAZOLE taken for thyroid disorder. Vaccination history included: Bnt162b2 (1st dose Pfizer COVID-19 Vaccine:, Date Received: Apr2021, Lot number: unknown, Route of Administration: Intramuscular), administration date: Apr2021, when the patient was 53 years old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Jul2021, outcome "unknown", described as "1st dose Pfizer COVID-19 Vaccine: Date Received: Apr2021/2nd dose Pfizer COVID-19 Vaccine: Date Received: 15Jul2021"; NEURALGIA (non-serious), outcome "unknown", JOINT RANGE OF MOTION DECREASED (non-serious), outcome "recovered" and all described as "nerve pain and couldn't move her arm". Additional Information: When she had the 2nd part of the 1st vaccine, the vaccine was put in her shoulder capsule and had nerve pain and couldn't move her arm. She did make sure she has padding on her shoulder and not feeling like that. She couldn't tell she couldn't move her left arm till the next morning.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: nerve pain and couldn't move her arm; nerve pain and couldn't move her arm; 1st dose Pfizer COVID-19 Vaccine: Date Received: Apr2021/2nd dose Pfizer COVID-19 Vaccine: Date Received: 15Jul2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 15Jul2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: TAPAZOLE taken for thyroid disorder. Vaccination history included: Bnt162b2 (1st dose Pfizer COVID-19 Vaccine:, Date Received: Apr2021, Lot number: unknown, Route of Administration: Intramuscular), administration date: Apr2021, when the patient was 53 years old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Jul2021, outcome "unknown", described as "1st dose Pfizer COVID-19 Vaccine: Date Received: Apr2021/2nd dose Pfizer COVID-19 Vaccine: Date Received: 15Jul2021"; NEURALGIA (non-serious), outcome "unknown", JOINT RANGE OF MOTION DECREASED (non-serious), outcome "recovered" and all described as "nerve pain and couldn't move her arm". Additional Information: When she had the 2nd part of the 1st vaccine, the vaccine was put in her shoulder capsule and had nerve pain and couldn't move her arm. She did make sure she has padding on her shoulder and not feeling like that. She couldn't tell she couldn't move her left arm till the next morning.   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, COVID19
Symptoms: Inappropriate schedule of product administration, Joint range of motion decreased, Neuralgia
Clinical narrative: got COVID; got COVID; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 15Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: 17Nov2023, NDC number: 59267-0304-2) intramuscular, in arm (reported as 'shoulder') for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE taken for thyroid disorder. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "got COVID". Clinical course: The patient got COVID in January and stated she presumes this wouldn't have happened had she got the Pfizer booster instead of the Moderna. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201309805 same patient/drug, different dose/event;
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: got COVID; got COVID; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 15Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: 17Nov2023, NDC number: 59267-0304-2) intramuscular, in arm (reported as 'shoulder') for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE taken for thyroid disorder. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "got COVID". Clinical course: The patient got COVID in January and stated she presumes this wouldn't have happened had she got the Pfizer booster instead of the Moderna. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201309805 same patient/drug, different dose/event;
Age: 35.0
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 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 35 years 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: LABETALOL. 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: Positive, notes: Rebound covid positive with mild symptoms 2 days after testing negative via home rapid antigen test; Negative, notes: Rebound covid positive with mild symptoms 2 days after testing negative via home rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 08Nov2022 to 12Nov2022.  Additional information: Rebound covid positive with mild symptoms 2 days after testing negative via home rapid antigen test
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products: Moderna COVID-19 Vaccine (dose 1, 2, 4, and 5) and BNT162B2 (dose 3); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (initial pfizer dose), single (Lot number: FD0809) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 013M20A), in left arm, on 10Mar2021 as dose 2, single (Lot number: 001B21A), in left arm, on 15Apr2022 as dose 4 (booster), single (Lot number: 041J21A), in left arm and on 08Sep2022 as dose 5 (booster), single (Lot number: A57144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "none (besides ADHD)" (unspecified if ongoing), notes: Other medical history: none (besides ADHD). Concomitant medication(s) included: ADDERALL. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin; Azithromycin, reaction(s): "Known allergies: Azithromycin", notes: Known allergies: Azithromycin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Interchange of vaccine products: Moderna COVID-19 Vaccine (dose 1, 2, 4, and 5) and BNT162B2 (dose 3)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Nov2022) Positive, notes: initial positive test & symptoms were Day 0; (15Nov2022) Negative, notes: testing negative on Day 9 and Day 10; (16Nov2022) Negative, notes: testing negative on Day 9 and Day 10; (17Nov2022) Positive, notes: Tested positive for COVID on Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 08Nov2022 to 13Nov2022.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech - Dose Number: 3/Moderna - Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6203), on 25Mar2021 as dose 2, single (Lot number: ER8734), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Jul2022, outcome "unknown", described as "Pfizer / BioNTech - Dose Number: 3/Moderna - Dose Number: 4"; 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient used Paxlovid as treatment of COVID 19 from 08Nov2022 to 12Nov2022.
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 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 15:30 as dose 4 (booster), single (Lot number: GJ3275) 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 included: "Pre-diabetic" (unspecified if ongoing); "prior surgeries like gastric bypass in 2013. No other surgeries have lasting effects.", start date: 2013 (unspecified if ongoing). Concomitant medication(s) included: AMBIEN CR; ZOLPIDEM TARTRATE. Past drug history included: Roxicet, reaction(s): "known allergies: Roxicet". 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Skin sensitivity, bad taste in mouth, those both went away after completing Paxlovid treatment. Was starting to test negative but am now testing positive again. Had a slightly irritated throat. Patient received paxlovid for covid 19 treatment, started on 07Nov2022 and stopped on 12Nov2022.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is still sore/sore arm; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose number unknown (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 series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "not recovered", described as "arm is still sore/sore arm".  Additional information included as patient got the Pfizer BioNTech COVID booster and said one side effect was sore arm, received vaccine 25Oct2022, arm is still sore. She wanted to know how long will this last. She has an appointment shortly, calling to see how long these side effects last because has to go do bloodwork soon. Patient reported that she is having a sore arm since she received the Pfizer-BioNTech Covid 19 Vaccine booster shot (no formulation was specified).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Off label use, Pain, Product use issue, Sluggishness
Clinical narrative: Very tired; sluggish; groggy; Left arm is very sore at site of vaccination; body in general is relatively achy.; Location of injection for vaccine received same date: Flu Shot - Left arm; Location of injection for vaccine received same date: Flu Shot - Left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 15:45 as dose 4 (booster), single (Lot number: GH9702) at the age of 24 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 17Nov2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; SYMBICORT. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (Booster), Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 17Nov2022, outcome "unknown" and all described as "Location of injection for vaccine received same date: Flu Shot - Left arm"; VACCINATION SITE PAIN (non-serious) with onset 18Nov2022, outcome "recovering", described as "Left arm is very sore at site of vaccination"; FATIGUE (non-serious) with onset 18Nov2022, outcome "recovering", described as "Very tired"; PAIN (non-serious) with onset 18Nov2022, outcome "recovering", described as "body in general is relatively achy."; SOMNOLENCE (non-serious) with onset 18Nov2022, outcome "recovering", described as "groggy"; SLUGGISHNESS (non-serious) with onset 18Nov2022, outcome "recovering", described as "sluggish". Therapeutic measures were not taken as a result of fatigue, sluggishness, somnolence, vaccination site pain, pain.  Additional information: No other vaccine in four weeks. Patient was very tired, sluggish, and groggy the day after the vaccine. Left arm was very sore at site of vaccination and body in general was relatively achy. No Covid prior vaccination. Patient was not tested for Covid post vaccination. No known allergies.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Very tired; sluggish; groggy; Left arm is very sore at site of vaccination; body in general is relatively achy.; Location of injection for vaccine received same date: Flu Shot - Left arm; Location of injection for vaccine received same date: Flu Shot - Left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 15:45 as dose 4 (booster), single (Lot number: GH9702) at the age of 24 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 17Nov2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; SYMBICORT. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (Booster), Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 17Nov2022, outcome "unknown" and all described as "Location of injection for vaccine received same date: Flu Shot - Left arm"; VACCINATION SITE PAIN (non-serious) with onset 18Nov2022, outcome "recovering", described as "Left arm is very sore at site of vaccination"; FATIGUE (non-serious) with onset 18Nov2022, outcome "recovering", described as "Very tired"; PAIN (non-serious) with onset 18Nov2022, outcome "recovering", described as "body in general is relatively achy."; SOMNOLENCE (non-serious) with onset 18Nov2022, outcome "recovering", described as "groggy"; SLUGGISHNESS (non-serious) with onset 18Nov2022, outcome "recovering", described as "sluggish". Therapeutic measures were not taken as a result of fatigue, sluggishness, somnolence, vaccination site pain, pain.  Additional information: No other vaccine in four weeks. Patient was very tired, sluggish, and groggy the day after the vaccine. Left arm was very sore at site of vaccination and body in general was relatively achy. No Covid prior vaccination. Patient was not tested for Covid post vaccination. No known allergies.
Age: 40.0
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 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, Electrocardiogram, SARS-CoV-2 test
Clinical narrative: Because I got Covid twice between them. I had Covid at least three time since I had the Vaccine; Because I got Covid twice between them. I had Covid at least three time since I had the Vaccine; Because I got Covid twice between them. I had Covid at least three time since I had the Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 24Jul2021 as dose 1, single (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 46 years and on 22Dec2021 as dose 2, single (Lot number: FL3197, Expiration Date: Jun2022) 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), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Because I got Covid twice between them. I had Covid at least three time since I had the Vaccine". The patient underwent the following laboratory tests and procedures: Electrocardiogram: Results unknown, notes: EKG because all I can get help because all I have is the health problem."; SARS-CoV-2 test: Positive, notes: Because I got Covid twice between them. I had Covid at least three time since I had the Vaccine.  Clinical Information: Patient had never been diagnosed with diabetes. Patient did not take regular medication. Patient did not take anything daily. Patient got one at the hospital and one at (withheld). Because got Covid twice between them. Patient had Covid at least three time since the Vaccine. So, it do not stop Covid. Patient reported that he did not take any vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201313252 same reporter, different event;
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: a lot of itchiness all over body; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 series completed; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "a lot of itchiness all over body".  Additional information: The patient got the Pfizer Booster vaccine and had a reaction, she had lot of itchiness all over her body and she did not know what to do. The patient was referred to HCP for medical recommendations, but caller disconnected abruptly and was unable to collect further information. This report was not serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Extrasystoles, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: my heart rate is really fast and like strong in my chest; had the heart beat at the skip and she pace out some time; patient received it on 24Jul2021 and the next one she received on 22Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 2, single (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 47 years. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: FL3197, Expiration date: Jun2022), administration date: 24Jul2021, when the patient was 46-year-old, for COVID-19 Immunization. The patient had never been diagnosed with diabetes. She did not take regular medication and did not take anything daily. The patient received it on 24Jul2021 and the next one she received on 22Dec2021. The patient stated she had a life threatening side effect from it. The patient had real speeding heart rate and she never had it before until she got the vaccine. She did not stop drinking coffee and drank water and still cannot stop the racing heart. On her first thought, she thought it was anxiety so she took anxiety medicine but her heart still racing. She just got on 'medicine' because of her heart and she had to stop working and now I was trying to get her disability. She just had the heart beat at the skip and she pace out some time. The patient reported heart rate was really fast and like strong in her chest, it did not hurt yet but it was like she got a pain 'even on' but her heart beat is beating really fast. Before that, she had never had these problems. The patient underwent the following laboratory tests and procedures: Electrocardiogram: unknown results. Therapeutic measures were taken as a result of heart rate increased, extrasystoles.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201313200 same reporter, different event;
Age: 69.0
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) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EN6198), in left arm, on 23Mar2021 at 11:00 as dose 2, single (Lot number: ER2613), in right arm and on 03Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 002M21D), in right arm and on 07Sep2022 at 13:00 as dose 5 (booster), single (Lot number: AS7140C), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Oct2022, outcome "recovered" (03Nov2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2022) Positive, notes: Tested Positive for COVID with antigen test 28Oct2022; (03Nov2022) Negative, notes: Tested Negative on 03Nov2022 and 05Nov2022; (05Nov2022) Negative, notes: Tested Negative on 03Nov2022 and 05Nov2022; (08Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (10Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (11Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (13Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (15Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (17Nov2022) Positive, notes: Tested Positive on 08Nov2022, 10Nov 11Nov, 13Nov, 15Nov, 17Nov2022; (18Nov2022) Negative, notes: Tested Negative on Friday 18Nov2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Tested Positive for Covid with antigen test 28Oct2022 Started Paxlovid same day taken for 5 days.  Clinical course: vaccine received and no other medication with in 2 weeks.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive on Monday for the COVID-19;  I got my booster and everything back in Aug; I tested positive on Monday for the COVID-19;  I got my booster and everything back in Aug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: I do have Asthma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I tested positive on Monday for the COVID-19;  I got my booster and everything back in Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Nov2022) Positive, notes: I tested positive on Monday for the COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient called because patient tested positive on Monday for the COVID-19 (Captured conservatively). This is the second 'dose', is it. I got it an year ago. I got my booster and everything back in August. So I have done everything, so I do have Asthma (Intent: Medical history) and all of that but my doctor put me on Paxlovid on Wednesday. I took two days' worth, but on the very first dose almost immediately, I noticed a funny taste in my mouth and I have not been able to get rid of it. It's just like on my tongue, it's just bad taste. I just thought, I don't know what it is. It's not like, I ever lost my sense of taste with Covid or anything like that. I have a decent appetite but I can't get rid of this awful taste and I can't help but think, Is this is Paxlovid? I mean, I brush my teeth and everything and I cannot get rid of the, it's just an awful taste. It taste like, I had a bad, bad medicine. It's just gross and I didn't take my this morning dose. Yeah, I just don't want to take it. It's taste like I have really bad breath or something, it's hideous. So I don't know if it have to do with the Paxlovid. Well, I wanted to know if this is a side effect of the Paxlovid."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Ventricular extrasystoles
Clinical narrative: my Heart PVCs are close to 50000; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VENTRICULAR EXTRASYSTOLES (medically significant) with onset 2021, outcome "unknown", described as "my Heart PVCs are close to 50000". The patient took Pfizer vaccine one year before. Recently found out that Heart PVCs are close to 50000. They couldn't find any other reason for recent changes so doctor said vaccine could be a reason. The patient underwent the following laboratory tests and procedures: PVC: are close to 50000. 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: Hypersensitivity
Clinical narrative: if an allergic reaction concerning arteries is a side effect from the vaccine; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GL0446) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "if an allergic reaction concerning arteries is a side effect from the vaccine".  Additional information: Reporter in regard to Pfizer biontech covid vaccine bivalent for adults, if an allergic reaction concerning arteries is a side effect from the vaccine. Reporter states that his reaction seems to be moving around the body. He has some kind of reaction going on and wants to know if it's related to the vaccine. Reporter clarified reaction that occurred to be similar to an allergic reaction, it's not a normal allergic reaction as it seems to concern the arteries. Reporter commented it is not easy being sick.