chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: Booster; I had all the Pfizer shots for the covid. But guess what? I got the Covid.; I had all the Pfizer shots for the covid. But guess what? I got the Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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 "I had all the Pfizer shots for the covid. But guess what? I got the Covid.". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore throat; Pain in arm/ sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Jul2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single and intramuscular, administration date 26Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 01Jan2019 (Batch/Lot number: unknown) at unk(citrate free) for rheumatoid arthritis; rituximab (RITUXAN) (Batch/Lot number: unknown); varicella zoster vaccine rge (cho) (SHINGRIX), administration date 05Jan2020 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: " humira not  working ", start date: 01Jan2020 (unspecified if ongoing); "Erythropapular rash", start date: 05Jan2021 (unspecified if ongoing) (events  of non-serious taking shingles vaccine and developing red raise rash from  armpit to elbow); "Allergic reaction to drug", start date: 01Feb2021 (unspecified if ongoing); "Throat swelling", start date: 01Feb2021 (unspecified if ongoing). The patient had no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (medically significant) with onset 05Jul2021, outcome "recovered" (2021), described as "Sore throat"; PAIN IN EXTREMITY (non-serious) with onset 05Jul2021, outcome "recovered" (2021), described as "Pain in arm/ sore arm". On 05Jul2021, the patient experienced taking covid vaccine and developing sore arm and sore throat. The action taken for rituximab was unknown. The action taken for adalimumab was dosage permanently withdrawn. The reporter's causality for the event(s) of taking covid vaccine and  developing sore arm and sore throat onset 05Jul2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of taking covid vaccine and  developing sore arm and sore throat onset 05Jul2021 with RITUXAN(RITUXIMAB) was not reported. The reporter's causality for the event(s) of taking covid vaccine and  developing sore arm and sore throat onset 05Jul2021 with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) was possible. The reporter's causality for the event(s) of taking covid vaccine and  developing sore arm and sore throat onset 05Jul2021 with SHINGRIX(VARICELLA ZOSTER VACCINE RGE (CHO))(VARICELLA ZOSTER VACCINE RGE (CHO)) was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Oropharyngeal pain and Pain in extremity and BNT162B2.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough infection - tested positive via Rapid on Monday, started quarantine.  PCR test done Monday, results Tuesday - Positive.; Breakthrough infection - tested positive via Rapid on Monday, started quarantine.  PCR test done Monday, results Tuesday - Positive.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from product quality group.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), intramuscular, administered in arm left, administration date 05Nov2021 13:00 (Lot number: 301358A) at the age of 40 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 24Feb2021 04:15 (Lot number: EN5318) as dose 2, single and intramuscular, administered in arm left, administration date 02Feb2021 04:45 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: XELJANZ; LEVOXYL. The following information was reported: VACCINATION FAILURE (medically significant) with onset 06Dec2021, outcome unknown, COVID-19 (medically significant) with onset 06Dec2021, outcome recovering, and all described as Breakthrough infection - tested positive via Rapid on Monday, started quarantine. PCR test done Monday, results Tuesday  Positive; IMMUNISATION (medically significant) with onset 05Nov2021 13:00, outcome unknown, described as booster. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (06Dec2021) positive, notes: Nasal Swab; sars-cov-2 test: (07Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with Covid-19 Prior to vaccination. The patient has the patient been tested for COVID-19, since the vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Decreased appetite, Immunisation, Lethargy, Myalgia
Clinical narrative: booster; Red swollen lump at injection site; blurred vision; lethargy; cognitive confusion; loss of appetite; muscle aches; wheezing; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Known allergies: Molds" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing); "Known allergies: some foods" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE MASS (non-serious) with onset Dec2021, outcome "recovering", described as "Red swollen lump at injection site"; VISION BLURRED (non-serious) with onset Dec2021, outcome "recovering", described as "blurred vision"; LETHARGY (non-serious) with onset Dec2021, outcome "recovering", described as "lethargy"; CONFUSIONAL STATE (non-serious) with onset Dec2021, outcome "recovering", described as "cognitive confusion"; DECREASED APPETITE (non-serious) with onset Dec2021, outcome "recovering", described as "loss of appetite"; MYALGIA (non-serious) with onset Dec2021, outcome "recovering", described as "muscle aches"; WHEEZING (non-serious) with onset Dec2021, outcome "recovering", described as "wheezing". Therapeutic measures were not taken as a result of vaccination site mass, vision blurred, lethargy, confusional state, decreased appetite, myalgia, wheezing.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No previous side effects from 1st 2 doses except very mild soreness at infection site. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vision blurred, Wheezing
Clinical narrative: booster; Red swollen lump at injection site; blurred vision; lethargy; cognitive confusion; loss of appetite; muscle aches; wheezing; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Known allergies: Molds" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing); "Known allergies: some foods" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE MASS (non-serious) with onset Dec2021, outcome "recovering", described as "Red swollen lump at injection site"; VISION BLURRED (non-serious) with onset Dec2021, outcome "recovering", described as "blurred vision"; LETHARGY (non-serious) with onset Dec2021, outcome "recovering", described as "lethargy"; CONFUSIONAL STATE (non-serious) with onset Dec2021, outcome "recovering", described as "cognitive confusion"; DECREASED APPETITE (non-serious) with onset Dec2021, outcome "recovering", described as "loss of appetite"; MYALGIA (non-serious) with onset Dec2021, outcome "recovering", described as "muscle aches"; WHEEZING (non-serious) with onset Dec2021, outcome "recovering", described as "wheezing". Therapeutic measures were not taken as a result of vaccination site mass, vision blurred, lethargy, confusional state, decreased appetite, myalgia, wheezing.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No previous side effects from 1st 2 doses except very mild soreness at infection site. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Crying, Feeling abnormal, Hair growth abnormal, Hormone level abnormal
Clinical narrative: covid_test_result=Positive; covid test result=Positive; All hair follicles removed by laser hair removal procedure no longer effective; hormone increases; crying for no reason; feel more hormonally unstable.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2021 12:00 (Lot number: EM9810) at the age of 27 years as dose 2, single and administration date 20Jan2021 12:00 (Lot number: EL3249) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prothrombin G20210A" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Zofran, reaction(s): "Known allergies: Zofran". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Sep2021, outcome "unknown" and all described as "covid_test_result=Positive"; HAIR GROWTH ABNORMAL (non-serious) with onset 12Feb2021, outcome "unknown", described as "All hair follicles removed by laser hair removal procedure no longer effective"; HORMONE LEVEL ABNORMAL (non-serious) with onset 12Feb2021, outcome "unknown", described as "hormone increases"; CRYING (non-serious) with onset 12Feb2021, outcome "unknown", described as "crying for no reason"; FEELING ABNORMAL (non-serious) with onset 12Feb2021, outcome "unknown", described as "feel more hormonally unstable.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Sep2021) positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of hair growth abnormal, hormone level abnormal, crying, feeling abnormal.  Clinical information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid_test_result=Positive; covid test result=Positive; All hair follicles removed by laser hair removal procedure no longer effective; hormone increases; crying for no reason; feel more hormonally unstable.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2021 12:00 (Lot number: EM9810) at the age of 27 years as dose 2, single and administration date 20Jan2021 12:00 (Lot number: EL3249) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prothrombin G20210A" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Zofran, reaction(s): "Known allergies: Zofran". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Sep2021, outcome "unknown" and all described as "covid_test_result=Positive"; HAIR GROWTH ABNORMAL (non-serious) with onset 12Feb2021, outcome "unknown", described as "All hair follicles removed by laser hair removal procedure no longer effective"; HORMONE LEVEL ABNORMAL (non-serious) with onset 12Feb2021, outcome "unknown", described as "hormone increases"; CRYING (non-serious) with onset 12Feb2021, outcome "unknown", described as "crying for no reason"; FEELING ABNORMAL (non-serious) with onset 12Feb2021, outcome "unknown", described as "feel more hormonally unstable.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Sep2021) positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of hair growth abnormal, hormone level abnormal, crying, feeling abnormal.  Clinical information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Melanocytic naevus, Skin cancer, Vaccination complication, Vaccination site pain
Clinical narrative: Skin cancer; Mole of skin; Vaccination adverse reaction; Vaccination site pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4185039-00.  A 64 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single and intramuscular, administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN CANCER (medically significant), outcome "unknown", described as "Skin cancer"; MELANOCYTIC NAEVUS (non-serious), outcome "recovering", described as "Mole of skin"; VACCINATION COMPLICATION (non-serious) with onset 2021, outcome "recovered" (2021), described as "Vaccination adverse reaction"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Vaccination site pain". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the events "Mole of skin and Skin cancer "with the suspect product was not provided at the time of this report and causal relationship of the events "Vaccination adverse reaction  and Vaccination site pain "with the suspect product was provided as not related at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events vaccination complication, vaccination site pain cannot be totally excluded and events skin cancer, melanocytic naevus is mostly unrelated to suspect product BNT162B2.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bursitis, Joint injury
Clinical narrative: Hip bursitis; Hip injury;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4188084-00 (Company).  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 74 years as dose number unknow, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) at 15 DF 1x/day for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURSITIS (medically significant), outcome "not recovered", described as "Hip bursitis"; JOINT INJURY (medically significant), outcome "not recovered", described as "Hip injury". The action taken for upadacitinib was dosage not changed. Therapeutic measures were taken as a result of bursitis. The patient had reported that she had new bursitis and something torn in her hip that required a steroid injection. Her orthopedic did not think it had anything to do with Rinvoq. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of HIP BURSITIS and TORN IN HIP with RINVOQ(UPADACITINIB) was no reasonable possibility. Causality for BNT162B2: The reporter's causality for the event(s) of HIP BURSITIS and TORN IN HIP with BNT162B2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Bursitis, hip injury and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness, Loss of personal independence in daily activities, Pain in extremity, Wrong technique in product usage process
Clinical narrative: She passed out for 10-15 minutes, and had her head between her knees.; Caller reports that with her first dose of the purple cap Pfizer Covid-19 vaccine that her side effects included sore arm and fatigue; Caller reports that with her first dose of the purple cap Pfizer Covid-19 vaccine that her side effects included sore arm and fatigue; Laid up for a few days; She was administered the purple cap Pfizer Covid-19 vaccine with the smaller needle because she is thin size.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "recovered" (2021), described as "She passed out for 10-15 minutes, and had her head between her knees."; FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "unknown" and all described as "Caller reports that with her first dose of the purple cap Pfizer Covid-19 vaccine that her side effects included sore arm and fatigue"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Laid up for a few days"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 2021, outcome "unknown", described as "She was administered the purple cap Pfizer Covid-19 vaccine with the smaller needle because she is thin size." The patient stated that she received her primary series of the purple cap Pfizer Covid-19 vaccine back in Spring 2021. The patient states that her vaccination provider and the longer needle and the shorter needle. Clinical comment: The patient reports that she was administered the purple cap Pfizer Covid-19 vaccine with the smaller needle because she is thin size and she had all the side effects.She reported that her first dose of the purple cap Pfizer Covid-19 vaccine that her side effects included sore arm and fatigue, laid up for a few days, that when she got home after getting the purple cap Pfizer Covid-19 vaccine that she passed out for 10-15 minutes, and had her head between her knees.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (13Dec2021): Follow-up activities closed. Batch/lot number not available.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: I began to develop a fever since early morning of 13 Dec 2021.; My left arm, where the injection took place, was exceedingly sore; I felt pressure in my stomach as if the food I ate was stuck there and not being digested; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 12Dec2021 at 12:30 (Lot number: FD0809) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Bowel obstruction" (unspecified if ongoing); "Thyroid nodule" (unspecified if ongoing), notes: Thyroid nodules; "Circumcision" (unspecified if ongoing) and "Allergy to antibiotic" (unspecified if ongoing), notes: Known allergies: Cephalosporins. The patient did not take any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL3247), administration date: 09Mar2021, when the patient was 34 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955), administration date: 30Mar2021, when the patient was 34 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021 at 12:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 13Dec2021 at 01:00, outcome "recovering", described as "I began to develop a fever since early morning of 13 Dec 2021"; PAIN IN EXTREMITY (non-serious) with onset 13Dec2021 at 01:00, outcome "recovering", described as "My left arm, where the injection took place, was exceedingly sore"; ABDOMINAL DISCOMFORT (non-serious) with onset 13Dec2021 at 01:00, outcome "recovering", described as "I felt pressure in my stomach as if the food I ate was stuck there and not being digested". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity and abdominal discomfort.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the fever lasted through the day, and in the evening his body temperature was still 99.5 F. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Drug ineffective, Illness, Suspected COVID-19
Clinical narrative: developed covid when she got out of the hospital; developed covid when she got out of the hospital; hair was falling; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single 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 "developed covid when she got out of the hospital"; ALOPECIA (non-serious), outcome "unknown", described as "hair was falling"; ILLNESS (non-serious), outcome "unknown", described as "sick". Clinical information: Caller stated that last Jun (year was not specified) she was only supposed to undergo a medical check. Caller stated that they put her in isolation for 10 days in the hospital and performed all kinds of tests ("tortured me, continued to torture me") and developed covid when she got out of the hospital. She was put in a mental hospital, put tags on her and her hair was falling was falling out. Caller suspects that the hospital might have administered Pfizer BioNTech Covid-19 vaccine during its clinical trial phase. Caller also mentioned that she would like to have this escalated to the president since the vaccine was administered to her without her consent. Description of complaint: Attempted transfer for a caller reporting that she is in the COVID vaccine trial and she has gotten COVID 3 times, she only provided two dates to the transfer agent as being in Mar and Jul (unspecified year). The caller also mentioned that they gave her COVID without her knowing and that was when she went to the trial. Inquired if transfer agent knew if the caller was speaking in regards to the COVID virus or the COVID vaccine specifically and the transfer agent states that the caller just said that she was in the COVID vaccine trial. Product strength and count size dispensed: Unable to obtain Additional lot numbers: Unable to obtain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling cold, Immunisation, Lymphadenopathy, Lymphocyte count increased
Clinical narrative: booster; I might have cancer; the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy); extreme coldness; freezing to my extremities/My hands are like ice; elevated lymphocytes; short of breath; 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 63 year-old female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)", "I might have cancer"; Bnt162b2 (DOSE 1), for COVID-19 Immunization, reaction(s): "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)", "I might have cancer". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I might have cancer"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)"; FEELING COLD (non-serious), outcome "unknown", described as "extreme coldness"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "freezing to my extremities/My hands are like ice"; LYMPHOCYTE COUNT INCREASED (non-serious), outcome "unknown", described as "elevated lymphocytes"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath".The patient had extreme coldness, and freezing to her extremities, this has never happened before, until now when she took the booster. Her hands are like ice, if touch someone they jump back. She had to raise the temperature up in her house. She also want to report something that has happened to me every time she took the shot, and she tired of the Doctors not believing her when she tells them. The radiologist was telling, she might have cancer. She kept telling him that the nodules that form in her breast, only happens after she took the vaccine, and then it goes away, she wants to report this so that Pfizer can document, and people know that this is happening, and I am not the only one. Her doctor told me that she has elevated lymphocytes, which could mean that her immune system is very active. She was feeling short of breath, so much so, that she has to rest when she climb stairs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant, Peripheral coldness
Clinical narrative: booster; I might have cancer; the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy); extreme coldness; freezing to my extremities/My hands are like ice; elevated lymphocytes; short of breath; 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 63 year-old female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)", "I might have cancer"; Bnt162b2 (DOSE 1), for COVID-19 Immunization, reaction(s): "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)", "I might have cancer". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I might have cancer"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)"; FEELING COLD (non-serious), outcome "unknown", described as "extreme coldness"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "freezing to my extremities/My hands are like ice"; LYMPHOCYTE COUNT INCREASED (non-serious), outcome "unknown", described as "elevated lymphocytes"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath".The patient had extreme coldness, and freezing to her extremities, this has never happened before, until now when she took the booster. Her hands are like ice, if touch someone they jump back. She had to raise the temperature up in her house. She also want to report something that has happened to me every time she took the shot, and she tired of the Doctors not believing her when she tells them. The radiologist was telling, she might have cancer. She kept telling him that the nodules that form in her breast, only happens after she took the vaccine, and then it goes away, she wants to report this so that Pfizer can document, and people know that this is happening, and I am not the only one. Her doctor told me that she has elevated lymphocytes, which could mean that her immune system is very active. She was feeling short of breath, so much so, that she has to rest when she climb stairs.  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, Immunisation, Influenza like illness, Pain, Pyrexia
Clinical narrative: feeling like I have the flu; fever; aches; chills; received my COVID-19 booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 14Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE number unknown, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "received my COVID-19 booster"; INFLUENZA LIKE ILLNESS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "feeling like I have the flu"; PYREXIA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 15Dec2021, outcome "not recovered", described as "aches"; CHILLS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "chills". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lymphadenopathy, Neoplasm malignant
Clinical narrative: I might have cancer; the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy); shortness of breath; 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 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I might have cancer"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". The events "i might have cancer" and "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)" were evaluated at the physician office visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance, Illness, Immunisation, Muscle atrophy
Clinical narrative: LOST MUSCLE; ARTHRITIS; LACK OF CONTROL; SICK; Booster; This is a spontaneous report received from contactable reporter (Physician).  A female patient received bnt162b2 (Batch/Lot number: unknown) as dose 3, single 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 immunisation; COVID-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MUSCLE ATROPHY (non-serious), outcome "unknown", described as "LOST MUSCLE"; ARTHRITIS (non-serious), outcome "unknown", described as "ARTHRITIS"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "LACK OF CONTROL"; ILLNESS (non-serious), outcome "unknown", described as "SICK"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". Additional information: *On an unspecified date, the patient was administered with Covid-19 vaccine for Covid-19 immunization at unknown dose and route of administration. The patient was sick shortly after taking the Covid-19 vaccine booster.* *On an unspecified date, the patient developed arthritis and had lost muscle.* At the time of this report, therapy with isavuconazole (CRESEMBA) was ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Musculoskeletal stiffness
Clinical narrative: my thumb kept getting stuck (as if in a trigger position); when I woke up the injection arm was feeling tight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 2, single 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: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Feb2021, outcome "unknown", described as "my thumb kept getting stuck (as if in a trigger position)"; MUSCLE TIGHTNESS (non-serious) with onset 13Feb2021, outcome "unknown", described as "when I woke up the injection arm was feeling tight".  Additional information: Call transferred. Caller reported that on the next morning, she experienced events. Caller wanted to know if these are normal side effects of the vaccine and had these been reported"? Offered to transfer Caller accepted. Checked with line and had "20 calls ahead" in queue. Informed caller and mentioned she is willing to wait. Cold transferred Caller and e-transmitting possible AE. It is unknown that reporter is Healthcare Professional (HCP): Unknown. Verbatim and event description: Swap from (removed). Caller is having side effects from the Covid vaccine and she wanted to know who she could speak to and find out if they are normal or not. Provided Number and was going to transfer to for AE, but there are 17 calls holding. Transferred to (Name) with and he took call. Fax to (removed) for AE, since caller is reporting side effects from the Covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Nausea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: nausea; upper back ache; pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 03:40 (Lot number: EN6202) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension (ongoing); AMLODIPINE BESYLATE taken for hypertension (ongoing). The following information was reported: NAUSEA (non-serious) with onset 04Mar2021, outcome "recovered" (04Mar2021), described as "nausea"; VACCINATION SITE PAIN (non-serious) with onset 21Feb2021, outcome "recovered" (22Feb2021), described as "pain at the injection site"; BACK PAIN (non-serious) with onset 02Mar2021, outcome "recovered with sequelae" (04Mar2021), described as "upper back ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of back pain.  Additional information: Patient didn't reported any Prior Vaccinations (within 4 weeks). AE(s) following prior vaccinations was not reported. Patient's did not have any Medical History and Family Medical History Relevant to AE. Metoprolol: Has been taking for about 5 years. Amlodipine Besylate: Caller has been taking for 5 years. Patient still had a little pain. Patient started taking Tylenol pain killer for her back ache. Patient had a flu shot back in Aug. Supplemental Vaccination Form. History of all previous immunization with the Pfizer vaccine considered as suspect was none Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Family Medical History Relevant to AE no  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "received the Pfizer vaccine and has been experiencing pain. She applied a Lidocaine Roll-on at the injection site."; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "it started to burn."; VACCINATION SITE RASH (non-serious), outcome "unknown", described as "She says she noticed a breakout at the injection site as well.". Therapeutic measures were taken as a result of vaccination site pain, vaccination site warmth, vaccination site rash. Additional information: Patient applied a Lidocaine Roll-on at the injection site. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Diarrhea; Stomachache; This is a spontaneous report received from the contactable reporter(s) (Physician) from the medical information team. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Mar2021 13:00 (Lot number: EN6200) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 01Mar2021, outcome "unknown", described as "Diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 01Mar2021, outcome "unknown", described as "Stomachache". Therapeutic measures were not taken as a result of diarrhoea. Additional information: The first dose of the Pfizer-BioNTech Covid-19 vaccine, 20 minutes later she experienced diarrhea. She would like to know if this could be a non-typical allergic reaction that prevents her from getting the second dose of the vaccine. The clinical course was she had explosive diarrhea 20 minutes after getting her first dose, and a bad stomachache that lasted maybe 40 minutes to an hour and she just wanted to find out since it was so explosive if for the second dose would it be possible to have this reaction to it if this first is an allergic reaction, though not a typical reaction, and if it would prevent getting the second dose.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP) from Regulatory Authority sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as single dose for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feeling tired". No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenitis, Lymphadenopathy
Clinical narrative: lymph node inflammation; swollen lymph nodes on injection side; 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 29 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 09Feb2021 10:00 (Lot number: EC3246) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "overweight" (ongoing), notes: a little overweight. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16Feb2021, outcome "recovering", described as "swollen lymph nodes on injection side"; LYMPHADENITIS (non-serious) with onset 16Feb2021 12:00, outcome "recovering", described as "lymph node inflammation".  Additional information: The patient received vaccine at Hospital. The patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine or on administration date of the suspect vaccine. states on 09Feb2021, he received his first dose of pfizer covid vaccine and developed swollen lymph nodes on injection side  one week after vaccine and is still ongoing. He is supposed to have his 2nd dose on 02Mar2021 however it was rescheduled to 07Mar2021. The event lymph nodes inflamed started at Around 12:00. It was mentioned that the patient is a radiology technician who was administered his first dose of Pfizer-BioNTech COVID-19 Vaccine 09Feb2021. He was then scheduled for second dose on 02Mar2021, but second dose was temporarily discontinued due to his wife having been diagnosed with COVID and he himself being quarantined while taking care of her. He was then advised to get the second dose of the vaccine on 07Mar2021 after his quarantine period was complete; but due to his lymph nodes inflamed onset on 16Feb2021. He called to ask for dosing recommendations relative to these events. The lymph node inflammation was slightly decreased, improved. He assumed the Lot is EC3246, but the handwriting was not very clear, but believed it to be EC3246.  No follow-up attempts are possible. No further information is expected.