chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Feeling abnormal, General physical health deterioration, Myalgia
Clinical narrative: muscle pain; fatigue; going downhill with her health; Her arm was sore with the covid vaccine; She's out of work and has been feeling so lousy/Feel horrible; 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 61-year-old female patient received BNT162b2 (COMIRNATY), on 18Mar2021 as dose 1, single (Lot number: ER2613), on 08Apr2021 as dose 2, single (Lot number: EW0153) and on 07Jan2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 61 years for COVID-19 immunization. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Comments: Fibromyalgia Diagnosed for 32 years; "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid arthritis Diagnosed at least 3 years ago or longer.; "compromised immune system" (unspecified if ongoing), notes: she has a compromised immune system. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "not recovered", described as "Her arm was sore with the covid vaccine"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "not recovered", described as "She's out of work and has been feeling so lousy/Feel horrible"; FATIGUE (non-serious) with onset Jan2022, outcome "not recovered"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset Jan2022, outcome "not recovered", described as "going downhill with her health"; MYALGIA (non-serious) with onset Jan2022, outcome "not recovered", described as "muscle pain". The events "muscle pain", "fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had not prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine. Patient family medical history relevant to AE(s) was none. Caller stated that she received her first booster dose of the Pfizer-Biontech COVID-19 vaccine on 07Jan2022. And ever since she has experienced muscle pain and fatigue. She wanted to know if these were common side effects due to the vaccine. Patient had the COVID booster shot; she has a compromised immune system. Ever since then, she has been going downhill with her health. She has been out of work for 3.5 weeks now. Symptoms were all in her muscles and she's fatigued. She felt like she can't function from the fatigue. She enquired that, this is a side effect, has this happened before? What should she do? Her muscles were in so much pain. She was out of work and has been feeling so lousy. She has not been doing much. Felt horrible.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pneumocystis jirovecii pneumonia, SARS-CoV-2 test
Clinical narrative: muscle pain; fatigue; going downhill with her health; Her arm was sore with the covid vaccine; She's out of work and has been feeling so lousy/Feel horrible; 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 61-year-old female patient received BNT162b2 (COMIRNATY), on 18Mar2021 as dose 1, single (Lot number: ER2613), on 08Apr2021 as dose 2, single (Lot number: EW0153) and on 07Jan2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 61 years for COVID-19 immunization. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Comments: Fibromyalgia Diagnosed for 32 years; "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid arthritis Diagnosed at least 3 years ago or longer.; "compromised immune system" (unspecified if ongoing), notes: she has a compromised immune system. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "not recovered", described as "Her arm was sore with the covid vaccine"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "not recovered", described as "She's out of work and has been feeling so lousy/Feel horrible"; FATIGUE (non-serious) with onset Jan2022, outcome "not recovered"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset Jan2022, outcome "not recovered", described as "going downhill with her health"; MYALGIA (non-serious) with onset Jan2022, outcome "not recovered", described as "muscle pain". The events "muscle pain", "fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had not prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine. Patient family medical history relevant to AE(s) was none. Caller stated that she received her first booster dose of the Pfizer-Biontech COVID-19 vaccine on 07Jan2022. And ever since she has experienced muscle pain and fatigue. She wanted to know if these were common side effects due to the vaccine. Patient had the COVID booster shot; she has a compromised immune system. Ever since then, she has been going downhill with her health. She has been out of work for 3.5 weeks now. Symptoms were all in her muscles and she's fatigued. She felt like she can't function from the fatigue. She enquired that, this is a side effect, has this happened before? What should she do? Her muscles were in so much pain. She was out of work and has been feeling so lousy. She has not been doing much. Felt horrible.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Product taste abnormal
Clinical narrative: strong metallic taste in his mouth; strong metallic taste in his mouth; 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.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2022 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. Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer: Unknown, Lot Number: Not provided), administration date: Sep2021, for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown, Lot Number: Not provided), administration date: Feb2021, for COVID-19 Immunization; Covid-19 vaccine (Dose: 1, Manufacturer: Unknown, Lot Number: Not provided), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: DYSGEUSIA (non-serious), PRODUCT TASTE ABNORMAL (non-serious) all with onset 28Apr2022, outcome "unknown" and all described as "strong metallic taste in his mouth".  Additional Information: The patient had strong metallic taste of all food whether it was ice cream or dill pickles, they all taste the same and this event was ongoing. Their family doctor could not see anything wrong in their mouth or tongue that could cause this. They called to check if this was a side effect of the Pfizer product Covid Booster Shot and if so how long it is expected to last if this was temporary or permanent. Caller was unwilling to complete this report, this is the 3rd department they have been given the number to call or transferred to and they just wanted their inquiry addressed.  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: Impaired gastric emptying
Clinical narrative: gastroparesis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), 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 Immunization. The following information was reported: IMPAIRED GASTRIC EMPTYING (medically significant) with onset 01Nov2021, outcome "unknown", described as "gastroparesis". Clinical course included: Caller wants to know if she could develop gastroparesis after receiving the Pfizer COVID-19 vaccine. She also wants to know if her husband could give her COVID if he receives the second booster shot and she does not. Caller wants to know if she can switch to a different COVID-19 vaccine (like Moderna or Johnson) to receive her second booster shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; The initial case was missing the following minimum criteria: AE reporting - Medical Information. Upon receipt of follow-up information on (20May2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 66-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 mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient reported as he was looking for information related to Paxlovid, and other antivirals. "I've got covid in my 3rd of symptoms". I got the Paxlovid this afternoon, should I wait until the morning to start the 5-day regimen. Patient was vaccinated for COVID-19 then tested positive yesterday, so he was prescribed Paxlovid and he wanted to know: how does a doctor determine what to give to patients in regards he prescribed him Paxlovid, and if Remdesivir was a Pfizer product. he has not taken the drug Paxlovid yet, so he doesn't know if he be of any help, since he just got it within the last half hour from the pharmacy and has been reading thru the information for it. he wanted to get some antivirals and called his doctor who doesn't take call right away so he had to wait on him and talked to his nurse and he saw Paxlovid listed on the internet as an antiviral and he knows there were other medicines. He says when he talked to him, his doctor called in Paxlovid for him without him knowing about it. He says he sees that Remdesivir was approved by the FDA as a medicine, so he would like to know. was it a Pfizer drug, and he asked the prior representative and she didn't know.   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: Alopecia
Clinical narrative: significant, rapid hair loss; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (medically significant), outcome "unknown", described as "significant, rapid hair loss". Clinical course was reported as, Reporter was asking for any information that is available about alopecia suspected to be caused by Comirnaty as reporter have a colleague (patient) who has significant, rapid hair loss since she received the vaccine, and she has concerns that her hair loss was caused by the vaccine.  Reporter just want to provide her with any information that is available.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported event and the suspect product BNT162B2 cannot be ruled out.  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.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive 20May; Tested positive 20May; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "penicillin Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "not recovered" and all described as "Tested positive 20May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "unknown" and all described as "I have all the Pfizer shots, booster but ended up contracting COVID, tested positive on Tuesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: Contracting COVID, tested positive on Tuesday. Clinical course: Caller stated, "I have all the Pfizer shots, booster but ended up contracting COVID, tested positive on Tuesday, I started having symptoms late Sunday night in the Monday morning. I'm trying to get this, I tried yesterday and the doctor's office told me that I'm outside of my window for this antiviral pill to work. I spoke to a nurse on our hotline and she said that I should still be within my window to use antiviral pill." Caller asked, "can you tell me yes or no whether it would help if I got this or not?" Caller wanted to know if Paxlovid would still be helpful for him if he get this today. Caller knew that the medication is being given within 5 days. Caller clarified that he tried to get the Paxlovid yesterday and finally got back to him today. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was vaccinated with the COVID-19 vaccine and booster that positive for COVID-19; was vaccinated with the COVID-19 vaccine and booster that positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "was vaccinated with the COVID-19 vaccine and booster that positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Warm transfer from agent withheld Paxlovid Call Center IVR CEP has a healthcare professional who has a patient that was vaccinated with the COVID-19 vaccine and booster that positive for COVID-19. Is using Paxlovid. Asked if there is a time interval to get the second booster shot of COVID-19 vaccine after completing the dose of Paxlovid. Information confirmed as provided. Wanted to know if there was a suggested time of completion after Paxlovid with no symptoms. Wanted to know if it is 30 or 90 days or has it been established yet. Description of Product Complaint: Description of complaint: PC#1: COVID-19 vaccine: Is positive for COVID-19. PC#2: COVID-19 vaccine (booster): Is positive for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 27Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 08Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO, start date: Jun2014; ALBUTEROL [SALBUTAMOL] nasal, start date: Jan2015; ATIVAN, start date: Jun2013, stop date: 09May2022; FLOVENT nasal, start date: Feb2018. Past drug history included: Minocyclin, reaction(s): "Known allergies:Minocyclin", notes: known allergies : Minocyclin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I had a return of COVID symptoms and a new positive antigen test 5 days after completing the course of Paxlovid. Therapeutic measures were taken as a result of covid-19.  Additional information: Adverse event: I had a return of COVID symptoms and a new positive antigen test 5 days after completing the course of Paxlovid.
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 72-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "In remission from SLL/CLL" (unspecified if ongoing), notes: In remission from SLL/CLL; "In remission from SLL/CLL" (unspecified if ongoing), notes: In remission from SLL/CLL. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; METOPROLOL. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Unknown Results, notes: Test: COVID-19 Antigen test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Rebound Covid 29 antigen test three days after completing the 5 day course of Paxlovid. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date: 20May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder
Clinical narrative: Texture and taste of food changed - can barely taste and texture is like chewing on a wet sponge - terrible - has not gone away; Texture and taste of food changed - can barely taste and texture is like chewing on a wet sponge - terrible - has not gone away; This is a spontaneous report received from a 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 07Apr2022 at 13:00 as dose 4 (booster), single (Lot number: Fk9893) at the age of 64 years, in left arm 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: Cr8730, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 24Mar2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0162, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 14Apr2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: 320308d, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 25Oct2021, when the patient was 64-year-old, for Covid-19 Immunization. The following information was reported: DYSGEUSIA (non-serious), TASTE DISORDER (non-serious) all with onset 07Apr2022 at 13:00, outcome "not recovered" and all described as "Texture and taste of food changed - can barely taste and texture is like chewing on a wet sponge - terrible - has not gone away". Therapeutic measures were not taken as a result of dysgeusia, taste disorder.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "increased cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: Jan2006, stop date: 10May2022. Vaccination history included: Covid-19 vaccine (Dose 1, Single), administration date: Feb2021, for Covid-19 immunisation; Covid-19 vaccine (Dose 2, Single), administration date: Mar2021, for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported event and the suspect product BNT162B2 cannot be ruled out.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID rebound; COVID rebound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 at 03:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. 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 "COVID rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: COVID rebound. Therapeutic measures were not taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound symptoms and a positive covid test a week after treatment finished/ COVID 19 Treatment; Rebound symptoms and a positive covid test a week after treatment finished/ COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER2613), in left arm and on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D [VITAMIN D NOS]; GLUCOSAMINE; LIPITOR; AREDS 2 VISUAL ADVANTAGE; COQ10 [UBIDECARENONE]; PSEUDOPHED. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Rebound symptoms and a positive covid test a week after treatment finished/ COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive, notes: a week after treatment finished. Therapeutic measures were taken as a result of covid-19. Clinical course: COVID 19 Treatment: Paxlovid, treatment start date: 09May2022 and stop date: 13May2022. On 18May2022, Rebound symptoms and a positive covid test a week after treatment finished. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8734), on 21Apr2021 as dose 2, single (Lot number: EW0169), in right arm and on 20Dec2021 at 17:00 as dose 3 (booster), single (Lot number: FE3594) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing), notes: Known Allergies: Penicillin. Concomitant medication(s) included: SERTRALINE, start date: 01Apr2021, stop date: 20May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical course: Started Paxlovid on day I test positive for COVID. Had runny nose, cough, moderate body aches/chills. Symptoms immediately improved. Terrible, soapy taste in mouth during treatment with paxlovid; intensified as the 5 days went on but stopped as soon as I stopped treatment. Test negative for COVID on day 5. Now on day 10/11, I have significant nasal congestion, headache & mucus, with slight headache.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: a joint transplant in my toe; 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 male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYTIGA, start date: Mar2021. The following information was reported: LIMB INJURY (medically significant), outcome "unknown", described as "a joint transplant in my toe". Therapeutic measures were taken as a result of limb injury.  Clinical course: Is the reporter's contact information available to you or a sub-contracted party reported as yes. Patient reported "I recently had a joint transplant in my toe. I have a titanium rod put in". Covid vaccine: Pfizer 2 shots & booster- Fall 2021. Patient did not provide any further details about the joint transplant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills so severe; Fever, chills so severe; Body pain lasted 48 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "Fever, chills so severe"; PAIN (non-serious), outcome "recovered", described as "Body pain lasted 48 hours". Therapeutic measures were taken as a result of pyrexia, chills.  Additional information: Clinical course: It was reported that patient second covid vaccine and booster were what would call severe. Fever, chills so severe had 4 layers plus a winter coat and heating pad. Body pain lasted 48 hours. For the 4th booster, patient switched to Moderna and lost another two days with a worse reaction. Patient legs cramped and were so weak, struggled to get of the toilet. If there are no breathing problems, it's all dismissed. Patient know another booster will come in the future.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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 (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 48 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Pulmonary Sarcoidosis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "previous breast cancer" (unspecified if ongoing), notes: previous breast cancer; "previous spinal cord tumor" (unspecified if ongoing), notes: previous spinal cord tumor; "Sulfa allergy" (unspecified if ongoing), notes: Sulfa allergy; "penicillin allergy" (unspecified if ongoing), notes: penicillin allergy. Concomitant medication(s) included: METHOTREXATE, start date: 26Dec2021, stop date: 20May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19. It was reported that patient also received Paxlovid from 10May2022 to 14May2022 for the indication of treatment of Covid-19.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-month-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in right arm and on 29May2021 as dose 2, single (Lot number: EW0164) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 22Nov2021 as dose 3 (booster), single (Lot number: 012H21B), in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Dose 3 Moderna/ Dose 1 and Dose 2 Pfizer" (unspecified if ongoing), notes: Dose 3 Moderna/ Dose 1 and Dose 2 Pfizer. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03May2022, outcome "unknown", COVID-19 (medically significant) with onset 03May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive; (08May2022) Negative; (18May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No allergies reported.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-month-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in right arm and on 29May2021 as dose 2, single (Lot number: EW0164) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 22Nov2021 as dose 3 (booster), single (Lot number: 012H21B), in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Dose 3 Moderna/ Dose 1 and Dose 2 Pfizer" (unspecified if ongoing), notes: Dose 3 Moderna/ Dose 1 and Dose 2 Pfizer. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03May2022, outcome "unknown", COVID-19 (medically significant) with onset 03May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive; (08May2022) Negative; (18May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No allergies reported.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: On 19May2022 I had cold like symptoms; tested positive for COVID with a home test; tested positive for COVID with a home test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 71 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. 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) all with onset May2022, outcome "unknown" and all described as "tested positive for COVID with a home test"; NASOPHARYNGITIS (non-serious) with onset 19May2022 at 01:00, outcome "not recovered", described as "On 19May2022 I had cold like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of nasopharyngitis. It was reported that patient also received Paxlovid from 07May2022 to 12May2022 for the Indication treatment of Covid-19.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 05Apr2021 as dose 2, single (Lot number: ER8734), in right arm and on 03Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; OMEPRAZOLE; BUPROPION; TURMERIC [CURCUMA LONGA]. The following information was reported: VACCINATION FAILURE (medically significant) with onset 09May2022, outcome "unknown", COVID-19 (medically significant) with onset 09May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The event "covid-19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Negative; (09May2022) Positive; (13May2022) Positive; (15May2022) Negative; (20May2022) Positive. Therapeutic measures were taken as a result of vaccination failure. Therapeutic measures were not taken as a result of covid-19. Clinical course included patient started having symptoms Friday 06May2022. Rapid test resulted in a negative test. patient took another test Monday 09May2022 which came back positive. After consult with my Doctor Paxlovid was prescribed for me. Took first dose Monday 09May2022 evening. Last dose was taken Friday 13May2022, however patient still had a positive rapid test although I was feeling better. patient  took another test Sunday 15May2022 and it came back negative. Mon thru most of Friday (16May2022 - 20May2022) patient felt fine. Friday 20May2022, patient started getting similar symptoms from the original onset (Stuffy / Runny nose, Sore throat, Random (infrequent) cough. Patient did another rapid test Friday 20May2022, and it showed a positive test.
Age: 65.0
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 66-year-old male patient received BNT162b2 (BNT162B2), on 25Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Known allergies: fluoroquinolones" (unspecified if ongoing), notes: Known allergies: fluoroquinolones. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Home COVID test is now negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Anti-viral details: Product: COVID 19 Treatment (Pfizer), Treatment start date: 08May2022 and stop date: 012May2022, Indication is used for treatment of COVID-19. Other medication in 2weeks product: Alfuzosin, start date: 01May2022 and stop date: 08May2022. The patient had known allergies to Sulfa drugs and fluoroquinolones. Adverse event experienced on 20May2022 at 09:00 AM. The outcome of event not recovered. The patient did not receive treatment. Seem to have a rebound of COVID symptoms 7 days after completing Paxlovid treatment - fatigue and congestion. Home COVID test is now negative.  Follow-Up (24May2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller states his father is fully vaccinated; Caller states his father is fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 77-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. 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 "Caller states his father is fully vaccinated". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller states his father finished taking his Paxlovid but continues to feel weak, although he has gotten better. Caller states he wants to know if his father should have an Monoclonal infusion treatment and/or do a continuation of Paxlovid?  Caller states his father is fully vaccinated. Caller goes on to say his father 78-year-old fiance was prescribed Paxlovid but was unable to take more than two and a half days of it due to diarrhea,(going to the bathroom 20 times per day) chills, shaking and her just not feeling well. Caller states, so she got off it and she ended up having a Monoclonal infusion, although it was not recommended by her doctor, but she wanted to provide some sort of protection to herself. Caller says he has spoken with his fathers health care provider but he did not recommended the monoclonal infusion but caller believes this is only due to not wanting to be held liable since there is limited information in regards to Paxlovid and Monoclonal infusions. Caller says there are walk-in clinics in (withheld) in which you can get Paxlovid and Monoclonal infusions and they will also give Monoclonal infusions to those who have had Paxlovid prior, so some doctors must be Okay with it. Caller states he understand the CEO of Pfizer to have said that if you take Paxlovid and you don't feel better you should take more, but the FDA disagreed with that statement.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.