chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Ear disorder, Vertigo
Clinical narrative: Hearing loss; Vertigo; Dizziness; Aural fullness; This is a literature report.  A 55 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Meniere's" (unspecified if ongoing), notes: 5+ years - stable. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; EAR DISORDER (non-serious), outcome "unknown", described as "Aural fullness". The events "hearing loss", "vertigo", "dizziness" and "aural fullness" were evaluated at the physician office visit.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  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: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Hearing loss; This is a literature report.  A 86 year-old male patient received bnt162b2 (COMIRNATY) (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), for COVID-19 immunisation. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". The event "hearing loss" was evaluated at the physician office visit.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events 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
Symptoms: Deafness
Clinical narrative: Hearing loss; This is a literature report.  A 78 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (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), for COVID-19 immunisation.  The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". The event "hearing loss" was evaluated at the physician office visit.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Nausea, Vertigo
Clinical narrative: Hearing loss; Vertigo; Dizziness; nausea; This is a literature report.  A 61 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (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: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; NAUSEA (non-serious), outcome "unknown", described as "nausea". The events "hearing loss", "vertigo", "dizziness" and "nausea" were evaluated at the physician office visit.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and 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: Deafness, Ear disorder, Tinnitus
Clinical narrative: Hearing loss; Tinnitus; Aural fullness; This is a literature report.  A 58 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (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: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; TINNITUS (non-serious), outcome "unknown", described as "Tinnitus"; EAR DISORDER (non-serious), outcome "unknown", described as "Aural fullness". The events "hearing loss", "tinnitus" and "aural fullness" were evaluated at the physician office visit.  No follow-up attempts are required. No further information is expected; Sender's Comments: As there is limited information in the case provided, the causal association between the event Deafness and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information is available. 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: Deafness, Ear disorder
Clinical narrative: Hearing loss; Aural fullness; This is a literature report.  A 66 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (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), for COVID-19 immunisation. The following information was reported: DEAFNESS (non-serious), outcome "unknown", described as "Hearing loss"; EAR DISORDER (non-serious), outcome "unknown", described as "Aural fullness". The events "hearing loss" and "aural fullness" were evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and 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.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monoplegia, Myelitis transverse
Clinical narrative: I lost complete use of my legs; Transverse myelitis; diagnosed with transverse myelitis from a direct reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2022 (Batch/Lot number: unknown) at the age of 30 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: MONOPLEGIA (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "I lost complete use of my legs"; MYELITIS TRANSVERSE (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "Transverse myelitis; diagnosed with transverse myelitis from a direct reaction". The patient was hospitalized for monoplegia, myelitis transverse (start date: 27Feb2022, discharge date: 07Mar2022, hospitalization duration: 8 day(s)). No other medication. No Prior vaccination (within 2 weeks). Consumer stated, I just would like to report a side effect of the Pfizer booster (Clarified as Pfizer COVID-19 Vaccine BNT162b2). Consumer stated, I received my COVID booster, my Pfizer COVID booster last week Monday, no 2 weeks ago 2 Monday's ago, 21Feb and within a week I lost complete use of my legs, I was diagnosed with Transverse myelitis from my Pfizer COVID booster and I am learning how to walk again right now. I was diagnosed with transverse myelitis from a direct reaction from my COVID Pfizer booster. Date of Hospitalization: Consumer stated, Last week Sunday, 27Feb I was admitted to the hospital, I have been in the hospital till today, today is Monday till 07Mar. This case was Serious case with Seriousness criteria-Caused hospitalization.The events "i lost complete use of my legs" and "transverse myelitis; diagnosed with transverse myelitis from a direct reaction" were evaluated at the physician office visit. Therapeutic measures were taken as a result of monoplegia, myelitis transverse.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Magnetic resonance imaging spinal, Muscular weakness, Myelitis transverse
Clinical narrative: I lost complete use of my legs; Transverse myelitis; diagnosed with transverse myelitis from a direct reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2022 (Batch/Lot number: unknown) at the age of 30 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: MONOPLEGIA (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "I lost complete use of my legs"; MYELITIS TRANSVERSE (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "Transverse myelitis; diagnosed with transverse myelitis from a direct reaction". The patient was hospitalized for monoplegia, myelitis transverse (start date: 27Feb2022, discharge date: 07Mar2022, hospitalization duration: 8 day(s)). No other medication. No Prior vaccination (within 2 weeks). Consumer stated, I just would like to report a side effect of the Pfizer booster (Clarified as Pfizer COVID-19 Vaccine BNT162b2). Consumer stated, I received my COVID booster, my Pfizer COVID booster last week Monday, no 2 weeks ago 2 Monday's ago, 21Feb and within a week I lost complete use of my legs, I was diagnosed with Transverse myelitis from my Pfizer COVID booster and I am learning how to walk again right now. I was diagnosed with transverse myelitis from a direct reaction from my COVID Pfizer booster. Date of Hospitalization: Consumer stated, Last week Sunday, 27Feb I was admitted to the hospital, I have been in the hospital till today, today is Monday till 07Mar. This case was Serious case with Seriousness criteria-Caused hospitalization.The events "i lost complete use of my legs" and "transverse myelitis; diagnosed with transverse myelitis from a direct reaction" were evaluated at the physician office visit. Therapeutic measures were taken as a result of monoplegia, myelitis transverse.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Discomfort, Nervousness, Syncope, Tinnitus
Clinical narrative: pressure is up like almost felt like he is going to faint; He experience tinnitus so bad ringing in his ears; He gets lot of anxiety and gets nervous; He gets lot of anxiety and gets nervous; pressure is up like almost felt like he is going to faint; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202200383082 (Pfizer).  A male patient received bnt162b2 (BNT162B2) (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: SYNCOPE (medically significant), DISCOMFORT (non-serious), outcome "unknown" and all described as "pressure is up like almost felt like he is going to faint"; TINNITUS (non-serious), outcome "unknown", described as "He experience tinnitus so bad ringing in his ears"; ANXIETY (non-serious), NERVOUSNESS (non-serious), outcome "unknown" and all described as "He gets lot of anxiety and gets nervous". Reporter stated, "Well I am calling in regards to my son he got both vaccines but he got them he experience tinnitus so bad ringing in his ears and he gets well it seems like when the tinnitus is going on he gets lot of anxiety and gets nervous you know what an anxiety and he is 'believes like' pressure is up like almost felt like he is going to faint. I don't know that's one of the side effects from that."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test date: 25Dec2021, Covid test result: Positive; Covid test date: 25Dec2021, Covid test result: Positive; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: FC3184) at the age of 66 years as dose 3 (booster), single, administration date 10Mar2021 (Lot number: EL9269) as dose 2, single and administration date 17Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The vaccine was administered in Pharmacy or Drug Store. Relevant medical history included: "known allergy: environmental" (unspecified if ongoing); "known allergy: pet danger" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "coccydynia" (unspecified if ongoing). The patient took concomitant medications in two weeks. It was unknown if other vaccine was received in four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "not recovered" and all described as "Covid test date: 25Dec2021, Covid test result: Positive". The event "covid test date: 25dec2021, covid test result: positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) positive, notes: Nasal swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Bursitis, SARS-CoV-2 test, Vaccination site discomfort, Vaccination site erythema
Clinical narrative: Covid test date: 25Dec2021, Covid test result: Positive; Covid test date: 25Dec2021, Covid test result: Positive; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: FC3184) at the age of 66 years as dose 3 (booster), single, administration date 10Mar2021 (Lot number: EL9269) as dose 2, single and administration date 17Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The vaccine was administered in Pharmacy or Drug Store. Relevant medical history included: "known allergy: environmental" (unspecified if ongoing); "known allergy: pet danger" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "coccydynia" (unspecified if ongoing). The patient took concomitant medications in two weeks. It was unknown if other vaccine was received in four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "not recovered" and all described as "Covid test date: 25Dec2021, Covid test result: Positive". The event "covid test date: 25dec2021, covid test result: positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) positive, notes: Nasal swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site inflammation, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Covid test date: 25Dec2021, Covid test result: Positive; Covid test date: 25Dec2021, Covid test result: Positive; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: FC3184) at the age of 66 years as dose 3 (booster), single, administration date 10Mar2021 (Lot number: EL9269) as dose 2, single and administration date 17Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The vaccine was administered in Pharmacy or Drug Store. Relevant medical history included: "known allergy: environmental" (unspecified if ongoing); "known allergy: pet danger" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "coccydynia" (unspecified if ongoing). The patient took concomitant medications in two weeks. It was unknown if other vaccine was received in four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "not recovered" and all described as "Covid test date: 25Dec2021, Covid test result: Positive". The event "covid test date: 25dec2021, covid test result: positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) positive, notes: Nasal swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test positive; COVID test positive; 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 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 14:00 (Lot number: FL3997) at the age of 72 years as dose 3 (booster), single, administered in arm left, administration date 27Mar2021 14:00 (Lot number: ER8730) as dose 2, single and administered in arm left, administration date 27Feb2021 14:00 (Lot number: EL9266) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history, no known allergies. Concomitant medication(s) included: FINASTERIDE; ATORVASTATIN; METPROLOL; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. The patient did not receive other vaccine in 4 weeks. The patient had no covid-19 prior vaccination. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 01Feb2022, outcome "unknown" and all described as "COVID test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) positive, notes: Covid test type post vaccination. The events were reported as Non-serious, No Results in death, No Life threatening, No Caused/prolonged hospitalization, No Disabling/Incapacitating, No Congenital anomaly/birth defect.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dysphagia, Dyspnoea, Influenza like illness
Clinical narrative: shortness of breath; Chest pain/feels like sharp pains are stabbing her chest; a lot of dry coughing/dry cough; migraine headaches; flu- like symptoms; sneezing; the cough is bringing up a lot of phlegm; difficult to for to consume harder, more solid foods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2022 (Lot number: FK9894) at the age of 23 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Johnson and johnson covid-19 vaccine (Johnson and Johnson Covid-19 vaccine, Date received: 23May2021, Lot: 201A21A, NDC, EXP: unknown, Administered in Left arm; dose unknown), administration date: 23May2021, when the patient was 22 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 05Mar2022, outcome "not recovered", described as "shortness of breath"; CHEST PAIN (non-serious) with onset 05Mar2022, outcome "not recovered", described as "Chest pain/feels like sharp pains are stabbing her chest"; COUGH (non-serious) with onset 05Mar2022, outcome "not recovered", described as "a lot of dry coughing/dry cough"; MIGRAINE (non-serious) with onset 04Mar2022, outcome "recovering", described as "migraine headaches"; INFLUENZA LIKE ILLNESS (non-serious) with onset 04Mar2022, outcome "not recovered", described as "flu- like symptoms"; SNEEZING (non-serious) with onset Mar2022, outcome "not recovered", described as "sneezing"; PRODUCTIVE COUGH (non-serious) with onset Mar2022, outcome "not recovered", described as "the cough is bringing up a lot of phlegm"; DYSPHAGIA (non-serious) with onset Mar2022, outcome "not recovered", described as "difficult to for to consume harder, more solid foods". Therapeutic measures were taken as a result of dyspnoea, chest pain, cough, migraine, influenza like illness, sneezing, productive cough, dysphagia.  Additional information: Received the Covid-19 vaccine booster on Friday and is still experiencing side effects today. She reached out to report side effects to the vaccine. Shortness of breath: Started in the evening. Outcome: She explains it fluctuates. Sometimes feels like its getting better, but then it gets worse after she thinks its getting better. Chest pain: When she is not coughing, it feels okay, but when she is coughing it feels like sharp pains are stabbing her chest. She thinks the chest pain coincided with the dry cough which is also ongoing as well.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Productive cough, Sneezing
Clinical narrative: shortness of breath; Chest pain/feels like sharp pains are stabbing her chest; a lot of dry coughing/dry cough; migraine headaches; flu- like symptoms; sneezing; the cough is bringing up a lot of phlegm; difficult to for to consume harder, more solid foods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2022 (Lot number: FK9894) at the age of 23 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Johnson and johnson covid-19 vaccine (Johnson and Johnson Covid-19 vaccine, Date received: 23May2021, Lot: 201A21A, NDC, EXP: unknown, Administered in Left arm; dose unknown), administration date: 23May2021, when the patient was 22 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 05Mar2022, outcome "not recovered", described as "shortness of breath"; CHEST PAIN (non-serious) with onset 05Mar2022, outcome "not recovered", described as "Chest pain/feels like sharp pains are stabbing her chest"; COUGH (non-serious) with onset 05Mar2022, outcome "not recovered", described as "a lot of dry coughing/dry cough"; MIGRAINE (non-serious) with onset 04Mar2022, outcome "recovering", described as "migraine headaches"; INFLUENZA LIKE ILLNESS (non-serious) with onset 04Mar2022, outcome "not recovered", described as "flu- like symptoms"; SNEEZING (non-serious) with onset Mar2022, outcome "not recovered", described as "sneezing"; PRODUCTIVE COUGH (non-serious) with onset Mar2022, outcome "not recovered", described as "the cough is bringing up a lot of phlegm"; DYSPHAGIA (non-serious) with onset Mar2022, outcome "not recovered", described as "difficult to for to consume harder, more solid foods". Therapeutic measures were taken as a result of dyspnoea, chest pain, cough, migraine, influenza like illness, sneezing, productive cough, dysphagia.  Additional information: Received the Covid-19 vaccine booster on Friday and is still experiencing side effects today. She reached out to report side effects to the vaccine. Shortness of breath: Started in the evening. Outcome: She explains it fluctuates. Sometimes feels like its getting better, but then it gets worse after she thinks its getting better. Chest pain: When she is not coughing, it feels okay, but when she is coughing it feels like sharp pains are stabbing her chest. She thinks the chest pain coincided with the dry cough which is also ongoing as well.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Injection site oedema
Clinical narrative: autoimmune disorder but never had a reaction in the past; had an edema response in her tear troughs; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): GL-021622-4085 (Agency).  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 03Oct2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunization; hyaluronic acid, lidocaine (RESTYLANE L) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: 03Jan2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, single), administration date: 24Jan2021, for COVID-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset Oct2021, outcome "unknown", described as "autoimmune disorder but never had a reaction in the past"; INJECTION SITE OEDEMA (non-serious) with onset 2021, outcome "unknown", described as "had an edema response in her tear troughs". The action taken for hyaluronic acid, lidocaine was unknown. Clinical course was reported as: Patient got injected with Restylane-L and had an edema response in her tear troughs. She got her booster the week prior and an autoimmune disorder but never had a reaction in the past.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and 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.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: arm pain started maybe a couple of days after the first dose; shoulder pain in the arm of injection which is his left arm for both doses/ shoulder still hurts; 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 81 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 09Feb2021 09:45 (Lot number: EL3247) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Myeloma" (ongoing), notes: He has Myeloma, blood cancer. He was diagnosed with both of those 10 years ago; "Melanoma" (ongoing), notes: He has Melanoma, skin cancer. He was diagnosed with both of those 10 years ago. There were no concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm pain started maybe a couple of days after the first dose"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "shoulder pain in the arm of injection which is his left arm for both doses/shoulder still hurts".  Additional information: Vaccine was not Administered at Facility. There was no History of all previous immunization with the Pfizer vaccine considered as suspect. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no prior Vaccinations (within 4 weeks). Patient has been having shoulder pain in the arm of injection which was his left arm for both doses. He was wondering if someone could tell him why his shoulder still hurted him where he got the injections. Like was there something to do for the pain? It wasn't painful, but it hurted. The arm pain started maybe a couple of days after the first dose. He does have two types of cancer. He has Myeloma, blood cancer, and Melanoma, skin cancer. He was diagnosed with both of those 10 years ago. AE(s) did not require a visit to Emergency Room and Physician Office.  No follow-up attempts are possible. No further information is expected.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Anaemia, Cardiac disorder, Fungaemia, Pneumonia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 100 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 100 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "gallbladder removed" (unspecified if ongoing), notes: had gallbladder removed; "colon cancer surgery" (unspecified if ongoing), notes: colon cancer surgery; "damage to her legs" (unspecified if ongoing), notes: recovered from an accident where a grave stone fell on her causing damage to her legs while visiting her husband in cemetery. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (got ill from Covid on Feb2022), administration date: Sep2021, when the patient was 100 years old, for Covid-19 immunisation, reaction(s): "Covid-19", "drug ineffective". The following information was reported: PNEUMONIA (death, medically significant) with onset Feb2022, outcome "fatal", described as "Pneumonia"; FUNGAEMIA (death, medically significant) with onset Feb2022, outcome "fatal", described as "Fungaemia"; ACUTE KIDNEY INJURY (death, medically significant) with onset Feb2022, outcome "fatal", described as "Acute Kidney injury"; ANAEMIA (death) with onset Feb2022, outcome "fatal", described as "Anemia"; RENAL FAILURE (medically significant) with onset Feb2022, outcome "unknown", described as "kidneys failed"; CARDIAC DISORDER (medically significant) with onset Feb2022, outcome "unknown", described as "heart became an issue". Therapeutic measures were taken as a result of renal failure, cardiac disorder. The patient date of death was 25Feb2022. The reported cause of death was pneumonia, fungaemia, acute kidney injury, anaemia. No autopsy was performed. The patient date of death was 25Feb2022. The reported cause of death was drug ineffective, Covid-19, pneumonia, fungaemia, acute kidney injury, anaemia. No autopsy was performed. My Patient became ill from COVID-19 in Feb2022. She got weak, had some cough, chest congestion. She was in the emergency room for 2 days before being transferred to Hospital when bed became available. Slowly, her kidneys failed, heart became an issue, dialysis used, tubes inserted, and she became critical and died on 25Feb2022 just one day from her 101st birthday. Pneumonia. Approximate interval Onset to Death: 45 days, Covid Approximate interval Onset to Death: 45 days. (Onset to death interval for clarification). Tobacco use did not contribute to death. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200389930 Pfizer; Reported Cause(s) of Death: Pneumonia; Fungaemia; Acute Kidney injury; Anemia.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 100 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 100 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "gallbladder removed" (unspecified if ongoing), notes: had gallbladder removed; "colon cancer surgery" (unspecified if ongoing), notes: colon cancer surgery; "damage to her legs" (unspecified if ongoing), notes: recovered from an accident where a grave stone fell on her causing damage to her legs while visiting her husband in cemetery. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (got ill from Covid on Feb2022), administration date: Sep2021, when the patient was 100 years old, for Covid-19 immunisation, reaction(s): "Covid-19", "drug ineffective". The following information was reported: PNEUMONIA (death, medically significant) with onset Feb2022, outcome "fatal", described as "Pneumonia"; FUNGAEMIA (death, medically significant) with onset Feb2022, outcome "fatal", described as "Fungaemia"; ACUTE KIDNEY INJURY (death, medically significant) with onset Feb2022, outcome "fatal", described as "Acute Kidney injury"; ANAEMIA (death) with onset Feb2022, outcome "fatal", described as "Anemia"; RENAL FAILURE (medically significant) with onset Feb2022, outcome "unknown", described as "kidneys failed"; CARDIAC DISORDER (medically significant) with onset Feb2022, outcome "unknown", described as "heart became an issue". Therapeutic measures were taken as a result of renal failure, cardiac disorder. The patient date of death was 25Feb2022. The reported cause of death was pneumonia, fungaemia, acute kidney injury, anaemia. No autopsy was performed. The patient date of death was 25Feb2022. The reported cause of death was drug ineffective, Covid-19, pneumonia, fungaemia, acute kidney injury, anaemia. No autopsy was performed. My Patient became ill from COVID-19 in Feb2022. She got weak, had some cough, chest congestion. She was in the emergency room for 2 days before being transferred to Hospital when bed became available. Slowly, her kidneys failed, heart became an issue, dialysis used, tubes inserted, and she became critical and died on 25Feb2022 just one day from her 101st birthday. Pneumonia. Approximate interval Onset to Death: 45 days, Covid Approximate interval Onset to Death: 45 days. (Onset to death interval for clarification). Tobacco use did not contribute to death. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200389930 Pfizer; Reported Cause(s) of Death: Pneumonia; Fungaemia; Acute Kidney injury; Anemia.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, COVID-19, Drug ineffective, Fluorescent in situ hybridisation
Clinical narrative: known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report.  Authors sampled 130 Nursing Home (NH) residents and 95 HCWs 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the buildings and medical center who all had access to the same vaccine at the same time as the residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 81-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  An 81 year-old male patient received bnt162b2 (BNT162B2) (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 "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report.  Authors sampled 130 Nursing Home (NH) residents and 95 HCWs 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the buildings and medical center who all had access to the same vaccine at the same time as the residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 81-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  An 81 year-old male patient received bnt162b2 (BNT162B2) (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 "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: On 30Dec2021 covid test done and it was positive; On 30Dec2021 covid test done and it was positive; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Sep2021 15:00 (Lot number: 30155BA) at the age of 39 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 19Jan2021 (Lot number: EL1283) as dose 2, single and intramuscular, administered in arm left, administration date 23Dec2020 (Lot number: EK5370) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "On 30Dec2021 covid test done and it was positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab. No family history of autoimmune disease, no personal history of autoimmune disease and blood work for another etiology all negative. No other vaccine in four weeks and no other medications in two weeks. Patient did not have COVID prior to vaccine. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Blood test, Imaging procedure, SARS-CoV-2 test
Clinical narrative: On 30Dec2021 covid test done and it was positive; On 30Dec2021 covid test done and it was positive; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Sep2021 15:00 (Lot number: 30155BA) at the age of 39 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 19Jan2021 (Lot number: EL1283) as dose 2, single and intramuscular, administered in arm left, administration date 23Dec2020 (Lot number: EK5370) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "On 30Dec2021 covid test done and it was positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab. No family history of autoimmune disease, no personal history of autoimmune disease and blood work for another etiology all negative. No other vaccine in four weeks and no other medications in two weeks. Patient did not have COVID prior to vaccine. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out