chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Myalgia, Nasal congestion
Clinical narrative: Test: Home Ag/Positive; Test: Home Ag/Positive; cough; congestion; ST; myalgia; HA; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL3247), on 25Feb2021 as dose 2, single (Lot number: EL3247) and on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "exposed to someone 31Mar  who later tested positive" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 or not. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset 01Apr2022, outcome "unknown", described as "HA"; OROPHARYNGEAL PAIN (non-serious) with onset 01Apr2022, outcome "unknown", described as "ST"; NASAL CONGESTION (non-serious) with onset 01Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 01Apr2022, outcome "unknown"; MYALGIA (non-serious) with onset 01Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Apr2022, outcome "unknown" and all described as "Test: Home Ag/Positive". The patient had + covid test on 06Apr2022 but had classic COVID symptoms starting 01Apr2022 cough, HA ,myalgia ,congestion and ST. He was exposed to someone on 31Mar2022 who later tested positive and he found out about it 06Apr2022 so tested. He did not feel that he has had covid for a week. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Apr2022) Positive, notes: COVID test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, cough, nasal congestion, oropharyngeal pain, myalgia, headache.   No follow-up attempts are possible. No further information is expected.   ; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and vaccination failure.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test: Home Ag/Positive; Test: Home Ag/Positive; cough; congestion; ST; myalgia; HA; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL3247), on 25Feb2021 as dose 2, single (Lot number: EL3247) and on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "exposed to someone 31Mar  who later tested positive" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 or not. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset 01Apr2022, outcome "unknown", described as "HA"; OROPHARYNGEAL PAIN (non-serious) with onset 01Apr2022, outcome "unknown", described as "ST"; NASAL CONGESTION (non-serious) with onset 01Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 01Apr2022, outcome "unknown"; MYALGIA (non-serious) with onset 01Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Apr2022, outcome "unknown" and all described as "Test: Home Ag/Positive". The patient had + covid test on 06Apr2022 but had classic COVID symptoms starting 01Apr2022 cough, HA ,myalgia ,congestion and ST. He was exposed to someone on 31Mar2022 who later tested positive and he found out about it 06Apr2022 so tested. He did not feel that he has had covid for a week. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Apr2022) Positive, notes: COVID test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, cough, nasal congestion, oropharyngeal pain, myalgia, headache.   No follow-up attempts are possible. No further information is expected.   ; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and vaccination failure.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Culture, SARS-CoV-2 test, Vaccination site erythema, Vaccination site reaction
Clinical narrative: injection site reaction:  as of today:  5.5 cm red area around injection site.; injection site reaction:  as of today:  5.5 cm red area around injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 15:30 as dose 4 (booster), single (Lot number: FK9729) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREMARIN; DIPHENHYDRAMINE; CETIRIZINE. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 06Apr2022, outcome "not recovered", VACCINATION SITE REACTION (non-serious) with onset 06Apr2022, outcome "not recovered" and all described as "injection site reaction: as of today: 5.5 cm red area around injection site.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site reaction.  Additional information: If other vaccine in four weeks reported as No. If covid prior vaccination reported as No. If covid tested post vaccination reported as Yes.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid at the end January; covid at the end January; This is a spontaneous report received from a contactable reporter(s) (Physician) (epidemiologist) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "covid at the end Jan2022". The patient had done well, had had the 2 Pfizer shots and the booster, and subsequently had COVID at the end Jan2022, and she developed a pulmonary embolism.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. The case will be reevaluated should additional information become available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: covid at the end January; covid at the end January; This is a spontaneous report received from a contactable reporter(s) (Physician) (epidemiologist) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "covid at the end Jan2022". The patient had done well, had had the 2 Pfizer shots and the booster, and subsequently had COVID at the end Jan2022, and she developed a pulmonary embolism.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. The case will be reevaluated should additional information become available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An adult female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XARELTO. Vaccination history included: Bnt162b2 (Dose Number: 01), for Covid-19 Immunization, reaction(s): "covid at the end january", "covid at the end january"; Bnt162b2 (Dose Number: 02), for Covid-19 Immunization, reaction(s): "covid at the end january", "covid at the end january". The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown".  Clinical Information: The patient had the 2 Pfizer shots and the booster, and subsequently had covid at the end January, and she developed a pulmonary embolism. Currently she is on Xarelto until the 20Apr, but will be on baby ASA by the time they give the second booster shot. Do you know of any information that shows if there would be a problem if  she takes the vaccine while on baby aspirin. Caller states she is Actemra, and was on it when she was vaccinated with the Pfizer Covid vaccine in Feb2022. "When I was initially vaccinated back in February, I started calling Pfizer and Agency, in the early part of the month, they had no advisement, no one told what you just told me which was, people with immunosuppressant to be off them 60 days prior" If somebody would have told me that, so I made my own decision, because nobody told me what you just told me. She is Actemra, and was on it when she was vaccinated with the Pfizer Covid vaccine in Feb2022. "When I was initially vaccinated back in February, I started calling Pfizer and Agency, in the early part of the month, they had no advisement, no one told what you just told me which was, people with immunosuppressant to be off them 60 days prior If somebody would have told me that, so I made my own decision, because nobody told me what you just told me.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely 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, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An adult female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XARELTO. Vaccination history included: Bnt162b2 (Dose Number: 01), for Covid-19 Immunization, reaction(s): "covid at the end january", "covid at the end january"; Bnt162b2 (Dose Number: 02), for Covid-19 Immunization, reaction(s): "covid at the end january", "covid at the end january". The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown".  Clinical Information: The patient had the 2 Pfizer shots and the booster, and subsequently had covid at the end January, and she developed a pulmonary embolism. Currently she is on Xarelto until the 20Apr, but will be on baby ASA by the time they give the second booster shot. Do you know of any information that shows if there would be a problem if  she takes the vaccine while on baby aspirin. Caller states she is Actemra, and was on it when she was vaccinated with the Pfizer Covid vaccine in Feb2022. "When I was initially vaccinated back in February, I started calling Pfizer and Agency, in the early part of the month, they had no advisement, no one told what you just told me which was, people with immunosuppressant to be off them 60 days prior" If somebody would have told me that, so I made my own decision, because nobody told me what you just told me. She is Actemra, and was on it when she was vaccinated with the Pfizer Covid vaccine in Feb2022. "When I was initially vaccinated back in February, I started calling Pfizer and Agency, in the early part of the month, they had no advisement, no one told what you just told me which was, people with immunosuppressant to be off them 60 days prior If somebody would have told me that, so I made my own decision, because nobody told me what you just told me.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Testing positive for COVID; Testing positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EN6201), on 06Mar2021 as dose 2, single (Lot number: EN6200) and on 24Oct2021 as dose 3 (booster), single (Lot number: EN FE3592) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Bone density" (unspecified if ongoing), notes: Bone density. Concomitant medication(s) included: ALENDRONATE oral taken for bone density abnormal. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Oct2021, outcome "unknown" and all described as "Testing positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She tested positive for COVID.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Parosmia, Vaccination site swelling
Clinical narrative: Exhaustion; brain fog; nausea associated with certain smells; nausea associated with certain smells; swelling at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "Exhaustion"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "brain fog"; NAUSEA (non-serious), PAROSMIA (non-serious), outcome "recovering" and all described as "nausea associated with certain smells"; VACCINATION SITE SWELLING (non-serious), outcome "recovering", described as "swelling at injection site".  Additional information: Exhaustion, brain fog, nausea associated with certain smells, swelling at injection site. Things have normalized since then. She premeditated with Tylenol and Claritin with doctor recommendation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR; Positive; Nasal Swab; PCR; Positive; Nasal Swab; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL3247), on 01Mar2021 as dose 2, single (Lot number: EL3247) and on 04Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 02Apr2022, outcome "unknown" and all described as "PCR; Positive; Nasal Swab". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Apr2022) Positive, notes: COVID test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course: 02Apr sick cough HA stuffy nose and chill d fever and then + PCR test 04Apr2022. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 at 11:15 as dose 4, (booster), single (Lot number: FL3197) at the age of 58 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN. Past drug history included: Known allergies: bactrim, reaction(s): "Known allergies: Bactrim". Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF2589, Location of injection: Arm Right, Vaccine Administration Time: 11:30 AM, Route of Administration: Intramuscular), administration date: 01Oct2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 18Feb2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 03:45 PM, Route of Administration: Intramuscular), administration date: 28Jan2021, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: VERTIGO (non-serious) with onset 07Apr2022 at 03:30, outcome "recovered" (07Apr2022 at 03:40), described as "Vertigo symptoms". Therapeutic measures were not taken as a result of vertigo.  Additional information: If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Benign breast neoplasm, Vaccination site pain
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4261477-00 (RA). A 45-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 14May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1139577) at unknown (citrate free) and second regimen (Lot number: 1157581), all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BENIGN BREAST NEOPLASM (medically significant) with onset Jan2022, outcome "unknown", described as "two benign lumps in the right breast"; VACCINATION SITE PAIN (non-serious), outcome "unknown". The action taken for adalimumab was unknown. Clinical course: In Jan2022. Patient had two benign lumps in right breast. On 04Feb2022, Surgery was performed to remove lump which were benign. She had sore arm after Covid vaccine. It was the unknown if the patient was enrolled in a Covid-19 vaccine trial. Regulatory Authority opinion is that the events of two benign lumps in right breast is not assessable. Regulatory Authority opinion is that there is no reasonable possibility that the event of sore arm after vaccines is related Humira (Adalimumab). The reporter's assessment of the causal relationship of "two benign lumps in the right breast" and "vaccination site pain" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for Humira(Adalimumab): The reporter's causality for the event(s) of two benign lumps in right breast and sore arm after vaccines was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the available information in the case, the causal association between the events benign breast neoplasm, vaccination site pain and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: M
Vaccine: COVID19
Symptoms: Decreased appetite, Gastrointestinal pain
Clinical narrative: Loss of appetite; Severe GI pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, manufacture: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, single, manufacture: Unknown), for COVID-19 Immunization. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "Loss of appetite"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "Severe GI pain". The events "loss of appetite" and "severe gi pain" required emergency room visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Limb injury, Movement disorder, Musculoskeletal stiffness, Pain
Clinical narrative: she has a lot of pain in the body; Tenderness; Stiffness; Dizzy; she can't lay her arms/can't raise it over her head; she can't lay her arms/can't raise it over her head; she has the soreness; she has 'shaken right her arm, head; she has 'shaken right her arm, head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: PAIN (non-serious), outcome "not recovered", described as "she has a lot of pain in the body"; TENDERNESS (non-serious), outcome "unknown"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; MOVEMENT DISORDER (non-serious), LIMB INJURY (non-serious), outcome "unknown" and all described as "she can't lay her arms/can't raise it over her head"; PAIN (non-serious), outcome "unknown", described as "she has the soreness"; TREMOR (non-serious), TREMOR (non-serious), outcome "unknown" and all described as "she has 'shaken right her arm, head".  Additional Information: Transferring agent stated, "I have a caller on the other line and the concern of the caller is, she reported this after of the booster shot. She has a lot of pain in the body after 6 months of receiving booster dose of the COVID. Until now she has the soreness and she has 'shaken right her arm, head (Not clear)' and tenderness and the stiffness and being dizzy so a lot of adverse events. she can't lay her arms/can't raise it over her head. The adverse event after taking the injection and it's been 6 months but she hasn't gotten any better 'still the same she can't lay her arms can't raise it over her head.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab. Call got disconnected during the warm transfer. Call back was done however not successful. Hence limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Tremor
Clinical narrative: she has a lot of pain in the body; Tenderness; Stiffness; Dizzy; she can't lay her arms/can't raise it over her head; she can't lay her arms/can't raise it over her head; she has the soreness; she has 'shaken right her arm, head; she has 'shaken right her arm, head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: PAIN (non-serious), outcome "not recovered", described as "she has a lot of pain in the body"; TENDERNESS (non-serious), outcome "unknown"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; MOVEMENT DISORDER (non-serious), LIMB INJURY (non-serious), outcome "unknown" and all described as "she can't lay her arms/can't raise it over her head"; PAIN (non-serious), outcome "unknown", described as "she has the soreness"; TREMOR (non-serious), TREMOR (non-serious), outcome "unknown" and all described as "she has 'shaken right her arm, head".  Additional Information: Transferring agent stated, "I have a caller on the other line and the concern of the caller is, she reported this after of the booster shot. She has a lot of pain in the body after 6 months of receiving booster dose of the COVID. Until now she has the soreness and she has 'shaken right her arm, head (Not clear)' and tenderness and the stiffness and being dizzy so a lot of adverse events. she can't lay her arms/can't raise it over her head. The adverse event after taking the injection and it's been 6 months but she hasn't gotten any better 'still the same she can't lay her arms can't raise it over her head.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab. Call got disconnected during the warm transfer. Call back was done however not successful. Hence limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I'm trying to recover from my COVID booster with lots of sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US079420_NS (regulatory authority).  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "I'm trying to recover from my COVID booster with lots of sleep". Additional Information: Product: COVID Vaccine. Relationship to patient: Self Event: I'm trying to recover from my COVID booster with lots of sleep. DOB/Age: 38 Years. Gender: Female. (Docket No. #) dated Mar1992 (Part VI, I), require that: "Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant." Additionally, per 21 CFR 314.80, Post-marketing Reporting of Adverse Drug Experiences, updated 01Apr2016, the requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section, concerning the submission of post-marketing 15-day Alert reports, also apply to any person other than the applicant whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor (non-applicant). To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs (c)(1)(i) and (c)(1)(ii) of this section, obligations of a non-applicant may be met by submission of all reports of serious adverse drug experiences to the applicant. If a non-applicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the non-applicant must submit, by any appropriate means, each report to the applicant within 5 calendar days of initial receipt of the information by the non-applicant, and the applicant must then comply with the requirements of this section. We are, therefore, forwarding the information below relating to your product which was obtained by one of our employees during the normal course of business.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness, Pain in extremity
Clinical narrative: Upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain; Upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain; Upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain/I can hardly walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 06Apr2022 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 (Previous immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Booster, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 07Apr2022, outcome "unknown" and all described as "Upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain"; GAIT DISTURBANCE (non-serious) with onset 07Apr2022, outcome "unknown", described as "Upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain/I can hardly walk".  Additional Information: Consumer stated, "I had my second booster yesterday and I woke this morning and the upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain."  Comment: Reporter type could not be probed as the consumer was unwilling to share any further information, hence captured by default as consumer or other non-health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen axillary lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 18:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 39 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FHP020, Location of injection: Arm Left, Vaccine Administration Time: 17:00 PM), administration date: 29Oct2021, when the patient was 39-year-old, for covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FP4554, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 08Oct2021, when the patient was 39-year-old. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Apr2022 at 12:00, outcome "not recovered", described as "Swollen axillary lymph nodes". The event "swollen axillary lymph nodes" required physician office visit. It was unknown if therapeutic measures were taken as a result of lymphadenopathy.  Additional information:  The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19 vaccine.  Follow-Up (11Apr2022): Follow-up attempts are completed. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Type 1 diabetes mellitus
Clinical narrative: My son was diagnosed with Type 1 diabetes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 at 17:00 as dose 2, single (Lot number: FK5127) at the age of 7 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1,single, Lot Number: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 14:00), administration date: 07Nov2021, when the patient was 6-year-old, for Covid-19 Immunization. The following information was reported: TYPE 1 DIABETES MELLITUS (hospitalization, medically significant) with onset 10Mar2022, outcome "not recovered", described as "My son was diagnosed with Type 1 diabetes".   The patient was hospitalized for type 1 diabetes mellitus (hospitalization duration: 3 day(s)). The event "my son was diagnosed with type 1 diabetes" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Mar2022) Negative. Therapeutic measures were taken as a result of type 1 diabetes mellitus.Clinical course: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported no. List of any other medications the patient received within 2 weeks of vaccination was reported None. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as No. Since the vaccination, has the patient been tested for COVID-19 was reported yes. Known allergies was reported as no. Reported Event: My son was diagnosed with Type 1 diabetes on 10Mar2022. He received first Pfizer Covid vaccine on 07Nov and 2nd Pfizer vaccine 29Nov. Started noticing symptoms in Nov and discussed with his pediatrician 19Nov2021. What treatment received for the adverse event was Insulin.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Hypertension, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: the vaccine has cured his insomnia starting after the first dose.his sleep is a lot deeper than it has been in 40 years, he wakes up with crust in his eyes.; he sleeps a short amount of time and wakes up in 3 hours totally refreshed; after getting his first Pfizer Covid 19 Vaccine Shot he started to get high blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EP8727) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: HYPERTENSION (non-serious) with onset Apr2021, outcome "unknown", described as "after getting his first Pfizer Covid 19 Vaccine Shot he started to get high blood pressure"; ENERGY INCREASED (non-serious) with onset Apr2021, outcome "unknown", described as "he sleeps a short amount of time and wakes up in 3 hours totally refreshed"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 04Apr2022, outcome "unknown", described as "the vaccine has cured his insomnia starting after the first dose.his sleep is a lot deeper than it has been in 40 years, he wakes up with crust in his eyes.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: 329. Therapeutic measures were taken as a result of hypertension.  Additional information: The reporter was calling to let Pfizer know that after getting his first Pfizer Covid 19 Vaccine Shot he started to get high blood pressure and he also experienced high blood pressure after his second and after his booster his blood pressure skyrocketed. Caller clarified that after his first Vaccine he did not bother checking his blood pressure, so he did not know whether or not his blood pressure was elevated. Caller stated the vaccine has cured his insomnia starting after the first dose. Caller stated Pfizer has discover so many things by accident.  He had found that his sleep was a lot deeper than it has been in 40 years, he woke up with crust in his eyes. Caller stated it was beyond what he has had in 40 years, he slept a short amount of time and woke up in 3 hours totally refreshed. Treatment included he stated he got put on a blood pressure medication for almost a year now.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Insomnia, Peripheral swelling
Clinical narrative: diabetes is acting; can't sleep; swelling up her feet and arms; swelling up her feet and arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes is acting"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; PERIPHERAL SWELLING (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "swelling up her feet and arms". Additional information: Reporter was not a Healthcare Professional (HCP). Reporter's contact information available to you or a sub-contracted party was reported as 'unknown''. It was unknown if the Reporter was the prescribing HCP. It was reported that one of their ladies in the church was swollen after receiving the booster shot last week. right now, she can't sleep, her diabetes is acting and swelling up her feet and arms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chillblains
Clinical narrative: diagnosed with chilblains with NO exposure to cold temperatures; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization.  The following information was reported: CHILLBLAINS (non-serious), outcome "unknown", described as "diagnosed with chilblains".  Additional information: Patient reported as diagnosed with chilblains with NO exposure to cold temperatures. In addition gave several friends who also were in the same situation following their vacation with Pfizer. Some of the research that patient read indicates a connection to Covid or the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Autoimmune disorder, Blood test, Emotional distress, Renal failure
Clinical narrative: progressive renal failure; autoimmune diseases; asthma; distress; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 Immunization; Bnt162b2 (dose 2, single), for COVID-19 Immunization.  The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "progressive renal failure"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune diseases"; ASTHMA (non-serious), outcome "unknown"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "distress". The patient underwent the following laboratory tests and procedures: Blood test: autoimmune diseases, notes: Based on routine bloodwork I was found to suffer from autoimmune diseases.".  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: Abdominal discomfort, Fatigue, Inflammation, Nausea, Pain in extremity
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4261290-00 (RA). A 63-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1155267) till 2021 at citrate free and second regimen since Oct2021 (Lot number: 1155267) at citrate free (increased to weekly dosage (1 in 1 wk.)), all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The reporter's assessment of the causal relationship of "polymyalgia rheumatica", "fatigue", "sore arm with all Pfizer Covid vaccines", "inflammation", "abdominal distress" and "nausea" with the co suspect product adalimumab (HUMIRA) was not provided at the time of this report and the reporter's assessment of the causal relationship of "fatigue", "sore arm with all Pfizer Covid vaccines and "abdominal distress" was possible with suspect product BNT162b2 and of the event Polymyalgia rheumatica and Inflammation  was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. 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 the events of  Inflammation, Pain in extremity, Abdominal discomfort, Fatigue, Nausea, Polymyalgia Rheumatica are assessed as possibly related to the suspect vaccine BNT162B2 based on causal association. 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.