chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 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), 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 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) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient received treatment with Paxlovid from 04Mar2023 to 09Mar2023. 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: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of effect (vaccine did not provide coverage against infection and illness for at least 3 full months). Symptomatic 08Mar2023 and positive at-home test on Friday 10Mar2023; Lack of effect (vaccine did not provide coverage against infection and illness for at least 3 full months). Symptomatic 08Mar2023 and positive at-home test on Friday 10Mar2023.; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 41 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: "Raynaud's Syndrome" (unspecified if ongoing); "Seasonal Allergies" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: PATANOL; ATROVENT; ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]; ADALAT. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 08Mar2023, outcome "recovering", described as "Lack of effect (vaccine did not provide coverage against infection and illness for at least 3 full months). Symptomatic 08Mar2023 and positive at-home test on Friday 10Mar2023"; COVID-19 (medically significant) with onset 08Mar2023, outcome "recovering", described as "Lack of effect (vaccine did not provide coverage against infection and illness for at least 3 full months). Symptomatic 08Mar2023 and positive at-home test on Friday 10Mar2023.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Mar2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Facility type vaccine: Pharmacy or Drug Store. AE treatment: Motrin, Tylenol, Sudafed, Atrovent. Patient did not have COVID prior vaccination.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Nausea
Clinical narrative: metallic taste; nausea; 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.  An 80-year-old 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 but manufacturer unknown), for COVID-19 Immunization. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste"; NAUSEA (non-serious), outcome "unknown".  Additional information: Agent stated they have a 80 year old patient who took the Pfizer COVID 19 booster dose and is experiencing metallic taste and nausea. Per agent, caller wants to know why she is "still having COVID after taking the booster dose". (After providing this information, call went silent and agent was unable to hear the rest of the call, call disconnected due to technical issue)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; 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.  An 80-year-old 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; 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), outcome "not recovered"; SUSPECTED COVID-19 (medically significant), outcome "not recovered". Reportedly, Per agent, caller wants to know why she is "still having COVID after taking the booster dose".(After providing this information, call went silent and MI agent was unable to hear the rest of the call, call disconnected due to technical issue).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110033 same patient/drug, different events;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She mentioned that with the mRNA Pfizer COVID-19 Vaccine she kept getting COVID-19, and not only her, but her family and neighbors also; She mentioned that with the mRNA Pfizer COVID-19 Vaccine she kept getting COVID-19, and not only her, but her family and neighbors also; This is a spontaneous report received from a non-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 NOS), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She mentioned that with the mRNA Pfizer COVID-19 Vaccine she kept getting COVID-19, and not only her, but her family and neighbors also". Clinical course: She mentioned that with the mRNA Pfizer COVID-19 Vaccine she kept getting COVID-19, and not only her, but her family and neighbors also. Then she added that the only people she knew without COVID were people who didn't get the vaccine. She mentioned her question came because since she was about to get her yearly flu shot, she wanted to get the regular flu shot because it helped so a change of formula to mRNA had her scared. Caller was asking why Pfizer wants to turn flu shot to MRNA, knowing that the covid-19 vaccine was not working. She also mentioned that people did not take flu shots because they said that it did not work well.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Blue toe syndrome, Lymphadenopathy, Lymphoedema
Clinical narrative: 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS (ongoing). Vaccination history included: Bnt162b2 (Dose 1, primary series vaccines were Pfizer), for Covid-19 immunization; Bnt162b2 (Dose 2, primary series vaccines were Pfizer, I Had a rash on my arm after the 2nd dose of Pfizer. My doctor's office mentioned shingles.), for Covid-19 immunization, reaction(s): "shingles", "rash on my arm"; Moderna (Her 3rd vaccine dose was Moderna and she had no reaction), for Covid-19 immunization, reaction(s): "no reaction". The following information was reported: LYMPHOEDEMA (non-serious), outcome "unknown", described as "lymphedema"; BLUE TOE SYNDROME (non-serious), outcome "not recovered", described as "all my toes went blue and it resolved except the blue stayed in 2 of my toes"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "My lymph nodes in my throat and ankles have been swelling". Additional information: No PQC Present. Caller wanted to know about Comirnaty if it has something to do with lymphatic system. She has lymphedema following having the vaccine. Caller also wanted to know if the vaccine and also the Eliquis has corn in it. Caller states "Her lymph nodes in her throat and ankles have been swelling since she got the bivalent vaccine dose."(the 4th Covid Vaccine dose). Caller states her primary series vaccines were Pfizer, "She Had a rash on her arm after the 2nd dose of Pfizer. Her doctor's office mentioned shingles." Her 3rd vaccine dose was Moderna and she had no reaction. The caller then states she "had Covid for a week. She had Covid toe, all her toes went blue and it resolved except the blue stayed in 2 of her toes." On 13Mar2023 5:20pm ET: Outbound call placed. Outbound disclaimer provided. Voicemail left with number, hours of operation and Direct phone number. The caller said that she heard in the recording that Comirnaty could affect the lymphatic system and she had lymphedema on her leg following having the vaccine and was asking if it's the same thing. She also had three covid vaccines already. Medical Information and medical inquiry was forwarded. 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: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 78 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), 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 included: "Breast cancer", start date: 2014 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive any other medication in 2 weeks. The patient was treated with Paxlovid from 26Feb2023 to 02Mar2023. Patient did not had any known allergies.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110136 Same reporter/patient, different drug/AE.;
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 13:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 51 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), 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 included: "Anxiety" (unspecified if ongoing); "Gerd" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treatment with Paxlovid from 01Mar2023 till 05Mar2023. Patient had no allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110169 Same reporter/patient, different drug/AE.;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal operation
Clinical narrative: Back surgery; 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 71-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FJAA43) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Heart disorder" (unspecified if ongoing); "Prosthetic knee" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENTRESTO taken for cardiac disorder; NYQUIL taken for hypertension; TYLENOL taken for joint prosthesis user, arthritis. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EN6208), administration date: 11Mar2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EWA53), administration date: 08Apr2021, for Covid-19 Immunization, reaction(s): "Accident happened", "She had a disc that was ruptured", "She had a bruise", "Bang on the elbow and knee", "Elbow was losing strength"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: 330308D), administration date: 02Dec2021, for Covid-19 Immunization; Pneumonia shots, for Immunisation. The following information was reported: SPINAL OPERATION (medically significant) with onset Jul2022, outcome "recovered" (2022), described as "Back surgery". Clinical Course: She doesn't take flu shots, she has only taken pneumonia shots, she doesn't get sick, very seldom she gets sick, if she feels anything like a scratchy throat or runny nose she usually take that Blood pressure cold medicine Coricidin, she will take a couple of those and feel fine. No details were provided on patient's other conditions and investigations. Patient's weight was 160lbs-175lbs.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109929 same patient and product, different dose and events;
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Thrombosis
Clinical narrative: Diagnosed with blood clots; DVT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An adult male 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 complete;  unknown manufacturer), for COVID-19 immunisation. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Diagnosed with blood clots"; DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT". Therapeutic measures were taken as a result of thrombosis, deep vein thrombosis. Clinical course: Patient's wife confirmed if the DVTs which patient experienced was related to the recent vaccine booster. He took Eliquis which was very expensive. He was healthy, very active adult.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300048620 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Herpes zoster, Illness
Clinical narrative: Sick; Shingles; 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 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (not ongoing), notes: went through breast cancer and chemotherapy over 2 years but she still goes through blood work; "Chemotherapy" (not ongoing), notes: went through breast cancer and chemotherapy over 2 years but she still goes through blood work. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (hospitalization), outcome "unknown", described as "Sick"; HERPES ZOSTER (hospitalization), outcome "unknown", described as "Shingles". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results, notes: Over 2 years but she still goes through blood work. Patient got very sick with Pfizer COVID 19 1st vaccine which was 5 months after chemo. 1st vaccination gave her shingles 2 weeks later and had to go to the hospital at that time. They advised not to take the 2nd or if so wait 8 weeks. Patient waited 8 weeks and got the 2nd one that also put her in the hospital, and she lost 13 pounds and got so sick it was like she had COVID. Patient has not received the booster because of her reactions. Caller states she is hesitant about all these vaccines, they may work for people, but she does not want to put herself out there to get a problem she doesn't have. Not sure if the pneumonia vaccine would be a good fit for her. Caller no longer has breast cancer, but she still has side effects due to chemo treatments she was given.  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: Illness, Weight, Weight decreased
Clinical narrative: lost 13 pounds; got so sick it was like she had COVID; 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 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 included: "breast cancer" (not ongoing), notes: she still has side effects due to chemo treatments she was given; "chemotherapy" (not ongoing), notes: she still goes through blood work. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Lot number: unknown), for COVID-19 immunisation, reaction(s): "shingles", "very sick". The following information was reported: WEIGHT DECREASED (hospitalization), outcome "unknown", described as "lost 13 pounds"; ILLNESS (hospitalization), outcome "unknown", described as "got so sick it was like she had COVID". The patient underwent the following laboratory tests and procedures: Weight: she lost 13 pounds. Clinical course: Patient waited 8 weeks (since first vaccination) and got the 2nd one that also put her in the hospital, and she lost 13 pounds and got so sick it was like she had COVID. She has not received the booster because of her reactions. Patient stated she was hesitant about all these vaccines, they may work for people, but she did not want to put herself out there to get a problem she didn't have.   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: Cytogenetic analysis, Drug ineffective, Suspected COVID-19
Clinical narrative: lost 13 pounds; got so sick it was like she had COVID; 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 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 included: "breast cancer" (not ongoing), notes: she still has side effects due to chemo treatments she was given; "chemotherapy" (not ongoing), notes: she still goes through blood work. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Lot number: unknown), for COVID-19 immunisation, reaction(s): "shingles", "very sick". The following information was reported: WEIGHT DECREASED (hospitalization), outcome "unknown", described as "lost 13 pounds"; ILLNESS (hospitalization), outcome "unknown", described as "got so sick it was like she had COVID". The patient underwent the following laboratory tests and procedures: Weight: she lost 13 pounds. Clinical course: Patient waited 8 weeks (since first vaccination) and got the 2nd one that also put her in the hospital, and she lost 13 pounds and got so sick it was like she had COVID. She has not received the booster because of her reactions. Patient stated she was hesitant about all these vaccines, they may work for people, but she did not want to put herself out there to get a problem she didn't have.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Weight, Weight decreased
Clinical narrative: it was like she had COVID; it was like she had COVID; 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 62-year-old female patient received BNT162b2 (BNT162B2), on 30May2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (not ongoing), notes: over 2 years but she still goes through blood work; "chemotherapy" (unspecified if ongoing), notes: over 2 years but she still goes through blood work. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "it was like she had COVID". The patient underwent the following laboratory tests and procedures: Cytogenetic analysis: negative, notes: all genetics for cancer was negative, including breast cancer. Clinical course: After Dose 2 she got so sick it was like she had COVID. Does not have cancer gene in her DNA. Does not know how that happened. The oncologist said there was so much medication, she couldn't begin to tell what gave her that. Patient had family history of hypertension and no family history of breast cancer.  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-202300110131 same reporter/patient, different drug/event;US-PFIZER INC-202300110727 same reporter/patient, different dose/event;US-PFIZER INC-202300110726 same reporter/patient, different dose/event;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cytogenetic analysis, Drug ineffective, Suspected COVID-19
Clinical narrative: it was like she had COVID; it was like she had COVID; 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 62-year-old female patient received BNT162b2 (BNT162B2), on 30May2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (not ongoing), notes: over 2 years but she still goes through blood work; "chemotherapy" (unspecified if ongoing), notes: over 2 years but she still goes through blood work. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "it was like she had COVID". The patient underwent the following laboratory tests and procedures: Cytogenetic analysis: negative, notes: all genetics for cancer was negative, including breast cancer. Clinical course: After Dose 2 she got so sick it was like she had COVID. Does not have cancer gene in her DNA. Does not know how that happened. The oncologist said there was so much medication, she couldn't begin to tell what gave her that. Patient had family history of hypertension and no family history of breast cancer.  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-202300110131 same reporter/patient, different drug/event;US-PFIZER INC-202300110727 same reporter/patient, different dose/event;US-PFIZER INC-202300110726 same reporter/patient, different dose/event;
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: gh9694) at the age of 46 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Mar2023, outcome "recovering" and all described as "COVID-19". The event "covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Mar2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; Covid symptoms returned; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 35-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Covid symptoms returned". Clinical course: Reporter Contact Information: (city name withheld). Patient not wanted to report name. Seemed better then had Moderna booster and Covid symptoms returned. No better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine, cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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-PV202300048756 Same patient/product, different dose/events;
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Paraplegia
Clinical narrative: paralyzed from the waist down; Guillen Barre/ Guillain-Barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:.  A male patient received BNT162b2, BNT162b2 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 complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PARAPLEGIA (medically significant), outcome "not recovered", described as "paralyzed from the waist down"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillen Barre /Guillain-Barre syndrome". Clinical course: The reporter had 4 male patients, who had been paralyzed due to Guillen Barre from the Pfizer COVID 19 Vaccine. She stated one of them was paralyzed from the neck down and the others from the waist down. The treatment had been different based on income. She reported one could not do anything financially due to income. The other was getting neurological shots that worked from the brain down to re-insulate his nerves to get more movement in the body. The shots were done in a series of shots and he had to be able to afford the shots to get better. If the patient did not have the money to pay for that, they were sitting in the hospital or at home. She stated they did therapy with them to get them moving as much as possible but they still had a long road to recovery. The reporter stated the most recent patient's seemed to be fine before the contracted Guillen Barre, they may have had arthritis or something but they were working full time and everything.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110001 same reporter/drug, different patients/events.;US-PFIZER INC-202300110873 same reporter/drug, different patients/events.;
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: paralyzed from the waist down; Guillen Barre; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2, BNT162b2 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 completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: PARALYSIS (medically significant), outcome "not recovered", described as "paralyzed from the waist down"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "not recovered", described as "Guillen Barre". Clinical course: the reporter had 4 male patients, who have been paralyzed due to Guillen Barre from the Pfizer COVID 19 Vaccine. She states one of them is paralyzed from the neck down and the others from the waist down. The treatment has been different based on income. She reports one can't do anything financially due to income. The other is  getting neurological shots that work from the brain down to re-insulate his nerves to get more movement in the body. The shots are done in a series of shots and he has to be able to afford the shots to get better. If the patient doesn't have the money to pay for that, they are sitting in the hospital or at home. She states they do therapy with them to get them moving as much as possible but they still have a long road to recovery. One patient's Guillen Barre was in 2021 and he has recovered completely, but the other 3 never recovered. One is paralyzed from the neck down and the other 2 the waist down. One patient got his a month ago and nowhe is paralyzed from the waist down and he is working on the road to recovery. It is almost like a stroke. The reporter stated the most recent patient's seemed to be fine before the contracted Guillen Barre, they may have had arthritis or something but they were working full time and everything.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110001 same reporter/drug/event, different patients;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GLJ2524) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Lot number: 031A21A), in left arm, on 22Apr2021 as dose 2, single (Lot number: 019B21A), in left arm and on 29May2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient had no relevant medical history (No chronic health problems, No known allergies). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110129 same patent, different drug/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: Interchange of vaccine products; had Covid for a week. I had Covid toe, all my toes went blue and it resolved except the blue stayed in 2 of my toes; had Covid for a week. I had Covid toe, all my toes went blue and it resolved except the blue stayed in 2 of my toes; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "had Covid for a week. I had Covid toe, all my toes went blue and it resolved except the blue stayed in 2 of my toes".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300111129 same patient/drug, different dose number/event;US-PFIZER INC-202300110146 same patient/drug, different dose number/event;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 15Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 28Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Non Hodgins Lymphoma survivor" (unspecified if ongoing); "Chemo" (unspecified if ongoing), notes: Chemo 10Jul to 4Aug then 20-days of radiation.; "Hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing), notes: GERD from a flap that doesn't always close correctly.; "Herpes virus" (ongoing), notes: also have the Herpes virus living in my spine that I take acyclovir daily for. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR] taken for herpes virus infection, start date: 01Jan2010 (ongoing); SYNTHROID, start date: 01Jan2012; OMEPRAZOLE, start date: 01Jan2018. Past drug history included: Leviquin, reaction(s): "rip up my stomach"; Bioxin, reaction(s): "rip up my stomach". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive for Covid in the ER; (28Feb2023) Positive, notes: initially tested positive; (08Mar2023) Negative, notes: was negative and felt fine. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient was treated with Paxlovid.  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-202300109979 same patient, different drug/event;US-PFIZER INC-202300111511 same patient, different drug/event;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accident, Contusion, Intervertebral disc protrusion, Joint injury, Muscular weakness
Clinical narrative: she had a disc that was ruptured; she had a bruise; Bang on the elbow and knee; elbow was losing strength; accident happened; 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 71-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Lot number: EWA53) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "heart disorder" (unspecified if ongoing); "Prosthetic knee" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENTRESTO taken for cardiac disorder; NYQUIL taken for hypertension; TYLENOL taken for joint prosthesis user, arthritis. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot no.EN6208), administration date: 11Mar2021, for Covid-19 immunization; Pneumonia shots, for Immunisation. The following information was reported: ACCIDENT (medically significant) with onset 16Jun2021, outcome "unknown", described as "accident happened"; INTERVERTEBRAL DISC PROTRUSION (medically significant), outcome "unknown", described as "she had a disc that was ruptured"; CONTUSION (medically significant), outcome "unknown", described as "she had a bruise"; JOINT INJURY (medically significant), outcome "unknown", described as "Bang on the elbow and knee"; MUSCULAR WEAKNESS (medically significant), outcome "unknown", described as "elbow was losing strength". Therapeutic measures were taken as a result of accident, intervertebral disc protrusion, contusion, joint injury, muscular weakness. Clinical Course: She did not take flu shots, she had only taken pneumonia shots, she did not get sick, very seldom she got sick, if she felt anything like a scratchy throat or runny nose she usually took Blood pressure cold medicine Coricidin, she would take a couple of those and feel fine. No details were provided on patient's other conditions and investigations. Patient's weight was 160lbs-175lbs. She had back surgery, in September they cut in the stomach, because she had this accident with 2 guys, the guy ran in the back, spun her around, she thought she just walked away but she had a bruise, bang on the elbow and knee. Her elbow was losing strength, it was the nerve, she had a disc that was ruptured, it was Spinal pressure, the accident happened 16Jun2021, but the Surgery was 24Sep2022 that was the first surgery, the second surgery on 26Sep2022, they couldn't do both in one day because of long hours, they had to go in back and put the trinkets in the back with 2 screws. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109929 same patient and product, different dose and events.;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Fatigue, Illness, Immune system disorder, Lymph node pain
Clinical narrative: Severe arm pain about a week after second shot; It got worse and froze my shoulder; Severe brain fog; tiredness all the time; My lymph nodes still swell occasionally; lymph nodes painful/are painful to this day; My immune system was compromised and I was sick all the time.; My immune system was compromised and I was sick all the time.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 2, single (Lot number: EW0158) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "I was diagnosed with Epstein Barr Virus" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing), notes: Known allergies: Sulfur. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (lot number: EL9267, dose 1, right arm), administration date: 22Mar2021, when the patient was 55-year-old, for Covid-19 Immunization. The following information was reported: PERIARTHRITIS (disability) with onset 23Apr2021, outcome "recovering", described as "It got worse and froze my shoulder"; IMMUNE SYSTEM DISORDER (disability), ILLNESS (disability) all with onset 23Apr2021, outcome "recovering" and all described as "My immune system was compromised and I was sick all the time."; LYMPHADENOPATHY (disability) with onset 23Apr2021, outcome "recovering", described as "My lymph nodes still swell occasionally"; PAIN IN EXTREMITY (disability) with onset 23Apr2021, outcome "recovering", described as "Severe arm pain about a week after second shot"; FEELING ABNORMAL (disability) with onset 23Apr2021, outcome "recovering", described as "Severe brain fog"; LYMPH NODE PAIN (disability) with onset 23Apr2021, outcome "recovering", described as "lymph nodes painful/are painful to this day"; FATIGUE (disability) with onset 23Apr2021, outcome "recovering", described as "tiredness all the time". The events "severe arm pain about a week after second shot", "it got worse and froze my shoulder", "severe brain fog", "tiredness all the time", "my lymph nodes still swell occasionally", "lymph nodes painful/are painful to this day" and "my immune system was compromised and i was sick all the time." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of pain in extremity, periarthritis, feeling abnormal, fatigue, lymphadenopathy, lymph node pain, immune system disorder, illness.   Patient also received dose 3, right arm on 01Jul2022 (lot number: FM7753). Patient did not have COVID prior vaccination and was COVID tested post vaccination.