chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got exposed to unvaccinated child 14Jan2022 then sx 17Jan2022 HA and cough mild illness - + test 19Jan2022 AG now recovered; Got exposed to unvaccinated child 14Jan2022 then sx 17Jan2022 HA and cough mild illness - + test 19Jan2022 AG now recovered; Got exposed to unvaccinated child 14Jan2022 then sx 17Jan2022 HA and cough mild illness - + test 19Jan2022 AG now recovered; Cough mild illness; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (Lot number: EL3247) at the age of 33 years as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), EXPOSURE TO SARS-COV-2 (non-serious) all with onset 17Jan2022, outcome "recovered" (Jan2022) and all described as "Got exposed to unvaccinated child 14Jan2022 then sx 17Jan2022 HA and cough mild illness - + test 19Jan2022 AG now recovered"; ILLNESS (non-serious) with onset 17Jan2022, outcome "recovered" (Jan2022), described as "Cough mild illness". The events "got exposed to unvaccinated child 14jan2022 then sx 17jan2022 ha and cough mild illness - + test 19jan2022 ag now recovered", "got exposed to unvaccinated child 14jan2022 then sx 17jan2022 ha and cough mild illness - + test 19jan2022 ag now recovered", "got exposed to unvaccinated child 14jan2022 then sx 17jan2022 ha and cough mild illness - + test 19jan2022 ag now recovered" and "cough mild illness" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, exposure to sars-cov-2, illness. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was not hospitalized for the events. The device date was reported as 28Jan2022. The case was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and VACCINATION FAILURE , COVID-19, EXPOSURE TO SARS-COV-2,  ILLNESS  cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nausea, Pain
Clinical narrative: COVID-19; COVID-19; experienced body aches; sick to stomach; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. A 50-year-old adult female received a dose (unknown dose number) of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date for COVID-19 immunisation. Relevant medical history included Vitiligo. Concomitant medications included zinc; lisinopril; ascorbic acid (VITAMIN C); retinol acetate (VITAMIN A); colecalciferol (VITAMIN D3); amlodipine besylate; tocopherol (VITAMIN E); metoprolol succinate. The patient previously received treatment for an unspecified indication with hydrochlorothiazide and experienced allergies. The patient reported that in Oct2021 she experienced body aches and was sick to her stomach from COVID-19. There was no laboratory testing reported. The outcome of the events body aches and was sick to her stomach was recovering. The outcome of the remaining events was not recovered.    The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19, suspected LOE and other events.  There is limited information provided in this report.  This case will be reassessed once additional 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, UNK
Symptoms: Condition aggravated, Pain assessment, Pyrexia, Upper respiratory tract infection
Clinical narrative: low grade fever; Disease aggravation/having a "flare with pain at 7 out of 10". normally pain is at "4 out of 10"; Upper respiratory infection; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (054550).  A 47 year-old female patient received tofacitinib citrate (XELJANZ XR), first regimen oral from 2020 (Batch/Lot number: unknown) to Jan2022 at 11 mg daily and second regimen oral (ongoing) (Batch/Lot number: unknown) at 11 mg daily; bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer unknown), for covid-19 immunisation. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset Jan2022, outcome "not recovered", described as "Disease aggravation/having a "flare with pain at 7 out of 10". normally pain is at "4 out of 10""; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset Jan2022, outcome "not recovered", described as "Upper respiratory infection"; PYREXIA (non-serious) with onset 28Jan2022, outcome "unknown", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for tofacitinib citrate was dosage not changed. Therapeutic measures were taken as a result of upper respiratory tract infection.  Additional information included that the patient  reports holding xeljanz xr for 2 weeks "early Jan2022" to receive covid booster. She have resumed Xeljanz XR but currently having a "flare with pain at 7 out of 10". Normally pain is at "4 out of 10". She reported upper respiratory infection recently, "finished z-pak last week". Again she has low grade fever today. Dose delayed. Md/do not aware.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain
Clinical narrative: Stabbing sensation in her heart, chest area; Stabbing sensation in her heart, chest area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 29Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN,dose number unknown), for COVID-19 Immunization. The following information was reported: ANGINA PECTORIS (medically significant), CHEST PAIN (medically significant) all with onset 29Jan2022, outcome "unknown" and all described as "Stabbing sensation in her heart, chest area". Additional Context:  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Loss of consciousness, Lymphadenopathy, Malaise
Clinical narrative: Almost passed out; not feeling good; eyes start getting blurry and glassy; tingling sensation, in my chest; I was real slow; weak; hurting in my neck; could not move my neck, like my lymph nodes swell up in my neck; ribs hurt like when I cough; body hurt; my body felt like somebody beat the hell out of me and I was in so much pain; back is hurting; hurting in my neck; could not move my neck, like my lymph nodes swell up in my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): -PFIZER INC-202200175283 (Pfizer).  A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Jan2022 (Lot number: FJ6369, Expiration Date: 31May2022) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Almost passed out"; MALAISE (non-serious), outcome "unknown", described as "not feeling good"; VISION BLURRED (non-serious), outcome "unknown", described as "eyes start getting blurry and glassy"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation, in my chest"; ASTHENIA (non-serious), outcome "unknown", described as "I was real slow; weak"; LYMPHADENOPATHY (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "hurting in my neck; could not move my neck, like my lymph nodes swell up in my neck"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "ribs hurt like when I cough"; PAIN (non-serious), outcome "unknown", described as "body hurt; my body felt like somebody beat the hell out of me and I was in so much pain"; BACK PAIN (non-serious), outcome "unknown", described as "back is hurting".
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Neck pain, Pain, Paraesthesia, Vision blurred
Clinical narrative: Almost passed out; not feeling good; eyes start getting blurry and glassy; tingling sensation, in my chest; I was real slow; weak; hurting in my neck; could not move my neck, like my lymph nodes swell up in my neck; ribs hurt like when I cough; body hurt; my body felt like somebody beat the hell out of me and I was in so much pain; back is hurting; hurting in my neck; could not move my neck, like my lymph nodes swell up in my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): -PFIZER INC-202200175283 (Pfizer).  A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Jan2022 (Lot number: FJ6369, Expiration Date: 31May2022) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Almost passed out"; MALAISE (non-serious), outcome "unknown", described as "not feeling good"; VISION BLURRED (non-serious), outcome "unknown", described as "eyes start getting blurry and glassy"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation, in my chest"; ASTHENIA (non-serious), outcome "unknown", described as "I was real slow; weak"; LYMPHADENOPATHY (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "hurting in my neck; could not move my neck, like my lymph nodes swell up in my neck"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "ribs hurt like when I cough"; PAIN (non-serious), outcome "unknown", described as "body hurt; my body felt like somebody beat the hell out of me and I was in so much pain"; BACK PAIN (non-serious), outcome "unknown", described as "back is hurting".
Sex: M
Vaccine: COVID19
Symptoms: Hemiplegia, Loss of consciousness
Clinical narrative: passed out; paralyzed on his left side ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) as dose number unknown ,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEMIPLEGIA (medically significant) with onset Feb2021, outcome "unknown", described as "paralyzed on his left side ever since"; LOSS OF CONSCIOUSNESS (medically significant) with onset 02Feb2021 00:15, outcome "unknown", described as "passed out".  Clinical Course: Reporter had who had a Pfizer Covid vaccine on 02Feb2021. He passed out 15 minutes after receiving shot. He has been paralyzed on his left side ever since. Reporter asked if there was any way to get physical or mental health and financial thru Pfizer.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had a major allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (hospitalization, medically significant), outcome "unknown", described as "had a major allergic reaction". The event "had a major allergic reaction" was evaluated at the physician office visit. Clinical course: Doctor from the patient's pharmacy called on behalf of the patient to confirm if the patient would need a booster shot for the Janssen COVID 19 Vaccine due to have taking the Pfizer-BioNTech COVID-19 Vaccine and not being able to complete the series of shots due to having an adverse reaction. During the call reporter stated: She received a dose of the Pfizer Biotech vaccine she had a major allergic reaction which put her in the hospital therefore her doctor advised her to switch to Janssen which she received back in October so now she's back for a booster dose of Janssen but reporter just wanted to confirm that would she not need another dose since technically she started with Pfizer even though she was not able to complete the series because of an allergic reaction.  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 known safety profile of the vaccine BNT162B2, a causal relation between the event Hypersensitivity and the administration of the vaccine 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: I had a very extreme flare up of my psoriasis condition on my feet; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 at 15:00 (Lot number: FJ1611) at the age of 64 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing) and "Psoriasis" (ongoing). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0153; Anatomical Location: Left arm; Administration time: 15:00), administration date: 09Apr2021, when the patient was 64 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0179; Anatomical Location: Left arm; Administration time: 15:00), administration date: 30Apr2021, when the patient was 64 years old, for COVID-19 immunisation.  The following information was reported: PSORIASIS (non-serious) with onset 06Dec2021, outcome "recovered with sequelae", described as "I had a very extreme flare up of my psoriasis condition on my feet". The event "I had a very extreme flare up of my psoriasis condition on my feet" was evaluated at the physician office visit. Therapeutic measures were taken as a result of psoriasis.  Additional Information: The patient had no known allergies which he was aware of. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Treatment included unspecified topical ointment for psoriasis. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Guillain-Barre syndrome
Clinical narrative: "awaken" the Guillain-Barre syndrome (GBS) in his body; "awaken" the Guillain-Barre syndrome (GBS) in his body; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Guillain-Barre syndrome (GBS)" (ongoing), notes: he explained having GBS at the age of 16, which "damaged" his body and for which he was hospitalized. The patient's concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as ""awaken" the Guillain-Barre syndrome (GBS) in his body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive case of covid; Positive case of covid; MARKETING NAME NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4246404-00.  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single and intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "upper respiratory infections", start date: 2018, stop date: 2018, notes: In 2018, the patient experienced upper respiratory infections. In 2018, event resolved.; "sick", start date: May2021, stop date: May2021, notes: Event sick occurred in May2021 and resolved in May2021. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "recovered with sequelae" and all described as "Positive case of covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive, notes: Positive. On unknown dates, the patient experienced upper respiratory infections and non-fda approved indication for enteropathic arthritis. in 2018, the patient experienced upper respiratory infections. in 2018, the upper respiratory infections resolved. in May2021, the patient experienced sick. In May2021, the sick resolved. In Nov2021, the patient experienced positive case of covid. On unknown dates, positive case of covid resolved with sequelae and non-FDA approved indication for Enteropathic arthritis resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Moderna. In May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Moderna.    The reporter causality for the event positive case of covid was Not Reported with BNT162B2.  The reporter causality for the event positive case of covid was Not Reported with covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE)   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Burning sensation, Decreased appetite, Fatigue
Clinical narrative: high BP over 130; rapid heart beat; arms burning, sore and swollen; arms burning, sore and swollen; arms burning, sore and swollen; rashes from her back and legs; no appetite; fatigued; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "asthmatic" (unspecified if ongoing); "she's allergic to a lot of things" (unspecified if ongoing), notes: she's allergic to a lot of things. The patient's concomitant medications were not reported. Vaccination history included: Jansen vaccine (Dose 1, Jansen vaccine, she got allergy), for Covid-19 immunization, reaction(s): "she got allergy". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "high BP over 130"; HEART RATE INCREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "rapid heart beat"; BURNING SENSATION (non-serious), PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "arms burning, sore and swollen"; RASH (non-serious) with onset Jan2022, outcome "not recovered", described as "rashes from her back and legs"; DECREASED APPETITE (non-serious) with onset Jan2022, outcome "not recovered", described as "no appetite"; FATIGUE (non-serious) with onset Jan2022, outcome "not recovered", described as "fatigued". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: high BP over 130; rapid heart beat; arms burning, sore and swollen; arms burning, sore and swollen; arms burning, sore and swollen; rashes from her back and legs; no appetite; fatigued; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "asthmatic" (unspecified if ongoing); "she's allergic to a lot of things" (unspecified if ongoing), notes: she's allergic to a lot of things. The patient's concomitant medications were not reported. Vaccination history included: Jansen vaccine (Dose 1, Jansen vaccine, she got allergy), for Covid-19 immunization, reaction(s): "she got allergy". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "high BP over 130"; HEART RATE INCREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "rapid heart beat"; BURNING SENSATION (non-serious), PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "arms burning, sore and swollen"; RASH (non-serious) with onset Jan2022, outcome "not recovered", described as "rashes from her back and legs"; DECREASED APPETITE (non-serious) with onset Jan2022, outcome "not recovered", described as "no appetite"; FATIGUE (non-serious) with onset Jan2022, outcome "not recovered", described as "fatigued". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia bacterial
Clinical narrative: Pneumonia bacterial; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for psoriasis. There was no reported medical history. The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA BACTERIAL (medically significant), outcome "recovered", described as "Pneumonia bacterial". The action taken for adalimumab was unknown. It was reported that, the solicited report from the privacy by a consumer of an adult female patient with an event of non-serious bacterial pneumonia with humira (adalimumab). Pfizer biontech covid-19 vaccine (tozinameran) was also considered as suspect. It was unknown whether the patient was enrolled in a covid-19 vaccine trial. The primary reporter contact for lot number information was unsuccessful.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of bacterial pneumonia was not reported. The reporter's causality of PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) for the event of bacterial pneumonia was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on 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
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: arm soreness; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in right arm, administration date 19Feb2021 13:00 (Lot number: EL9266) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Batch/Lot Number: EN53185/21) intramuscular in right arm, at 12:00 PM), administration date: 29Jan2021, when the patient was 51 years old, for COVID-19 immunisation, reaction(s): "Arm soreness", "fatigue", "Throbbing headache/intermittent headache", "Rib & upper back pain", "Axilla pain and swelling", "Rapid pulse", "Temp". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm soreness"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigue"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache". Additional information: Event duration was reported as 32 hours. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypoaesthesia, Nasal congestion, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Numbness in fingers; Congestion; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4244455-00 (Abbvie).  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Aug2021 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single and intramuscular, administration date 23Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; HYPOAESTHESIA (non-serious), outcome "recovering", described as "Numbness in fingers"; NASAL CONGESTION (non-serious), outcome "recovering", described as "Congestion". Reported that the patient contracted covid two times. He was still healing and had some congestion as of 20Jan2022. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result, notes: The patient contracted covid two times; unknown result, notes: The patient contracted covid two times. The action taken for upadacitinib was unknown.  The reporter's causality for events (numbness in fingers, Covid-19 and congestion) with the RINVOQ was not reported. The reporter's causality for events (numbness in fingers, Covid-19 and congestion) with the BNT162B2 was possible.  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 and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abscess limb, Cellulitis
Clinical narrative: Cellulitis in left buttock; Abscess on buttock; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4247306-00.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for colitis ulcerative. Relevant medical history included: "Lump on left buttock" (unspecified if ongoing). The patient took concomitant medications with antibiotics. The following information was reported: CELLULITIS (medically significant), outcome "not recovered", described as "Cellulitis in left buttock"; ABSCESS LIMB (non-serious), outcome "not recovered", described as "Abscess on buttock". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Abscess and cellulitis in left buttock/patient on antibiotics unknown onset and Abscess and cellulitis in left buttock/patient on antibiotics unknown onset was not provided. Causality for Pfizer BioNTech Covid-19 vaccine: The reporter's causality for the event Abscess on buttock (Abscess limb) and cellulitis was reported as possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Cellulitis and Abscess limb. 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: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Frustration tolerance decreased, Head discomfort, Illness
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; Frustration; Sickness; Head discomfort; Vomiting; Migraine; Joint pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4248486-00.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster) single, intramuscular, administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 virus test positive"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "Frustration"; ILLNESS (non-serious), outcome "unknown", described as "Sickness"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "Head discomfort"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; MIGRAINE (non-serious), outcome "unknown", described as "Migraine"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown. On unknown dates, the patient was tested positive for covid-19, frustrated, sick, throwing up and could not lift head, migraine and joints were hurting. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of tested positive for covid-19, frustrated, sick, throwing up and could not lift head, migraine and joints were hurting was not provided. Causality for bnt162b2 (BNT162B2): The reporter's causality for the event(s) of could not lift head, throwing up and migraine was possible. The reporter's assessment of the causal relationship of the events tested positive for covid-19, frustrated, sick and joints were hurting with the suspect product 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.   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.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Migraine, SARS-CoV-2 test, Vaccination failure, Vomiting
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; Frustration; Sickness; Head discomfort; Vomiting; Migraine; Joint pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4248486-00.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster) single, intramuscular, administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 virus test positive"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "Frustration"; ILLNESS (non-serious), outcome "unknown", described as "Sickness"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "Head discomfort"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; MIGRAINE (non-serious), outcome "unknown", described as "Migraine"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown. On unknown dates, the patient was tested positive for covid-19, frustrated, sick, throwing up and could not lift head, migraine and joints were hurting. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of tested positive for covid-19, frustrated, sick, throwing up and could not lift head, migraine and joints were hurting was not provided. Causality for bnt162b2 (BNT162B2): The reporter's causality for the event(s) of could not lift head, throwing up and migraine was possible. The reporter's assessment of the causal relationship of the events tested positive for covid-19, frustrated, sick and joints were hurting with the suspect product 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.   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.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Hand dermatitis
Clinical narrative: Development of eczema (on hands) two months following second vaccine; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 8-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Lot number: FK5127) at the age of 8 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications included: FLU VACCINE taken for Immunization, start date: 02Nov2021, stop date: 02Nov2021; CLARITIN and unspecified DAILY VITAMIN. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE; Lot Number: FK5127), administration date: 08Nov2021, when the patient was 8 years old, for COVID-19 immunisation.  The following information was reported: HAND DERMATITIS (non-serious) with onset 26Jan2022, outcome "recovering", described as "Development of eczema (on hands) two months following second vaccine". Therapeutic measures were taken as a result of hand dermatitis.  Additional information: Known allergies were reported as not applicable. The patient received other vaccine within four weeks prior to the COVID-19 vaccine. The patient had no prior history of eczema. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included over the counter (OTC) Hydrocortisone cream for hand dermatitis. Since the vaccination, the patient had not been tested for COVID-19.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Hand dermatitis
Clinical narrative: Development of hand eczema approximately 2 months following second vaccine.; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the parent.   A 6-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 29Nov2021 (Lot number: FK5127)at the age of 5 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? : Yes. Concomitant medications included: INFLUENZA taken for Immunisation, start date: 02Nov2021, stop date: 02Nov2021 and unspecified daily vitamin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FK5127; Anatomical site: Left arm; Route of administration: Unspecified.), administration date: 08Nov2021, when the patient was 5 years old, for COVID-19 immunisation.  The following information was reported: HAND DERMATITIS (non-serious) with onset 18Jan2022, outcome "recovering", described as "Development of hand eczema approximately 2 months following second vaccine". Therapeutic measures were taken as a result of hand dermatitis.  Additional Information: The patient had no known allergies. The patient received other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient had no prior history of eczema. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment included over the counter (OTC) hydrocortisone cream.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Heart palpitations and racing; Tingling finger on right hand; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date an unknown date in Jun2021 at 15:30 (Lot number: EW0178) at the age of 54 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: No; Known allergies: No. Concomitant medication included: IBUPROFEN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0178; Anatomical site: Left arm; Administration time: 15:45), administration date: an unknown date in May2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: PALPITATIONS (non-serious) with onset 01Aug2021, outcome "not recovered", described as "Heart palpitations and racing"; PARAESTHESIA (non-serious) with onset 01Aug2021, outcome "not recovered", described as "Tingling finger on right hand". Therapeutic measures were not taken as a result of palpitations and paraesthesia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: And now her and her husband have COVID; And now her and her husband have COVID; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (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) all with onset 08Jan2022, outcome "unknown" and all described as "And now her and her husband have COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: her and her husband have COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. The doctor prescribed paxlovid and patient did not get it till around 13th or 14th and took it for 5 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Blood pressure measurement, Eye haemorrhage, Eye pain, Investigation
Clinical narrative: And now her and her husband have COVID; And now her and her husband have COVID; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (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) all with onset 08Jan2022, outcome "unknown" and all described as "And now her and her husband have COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: her and her husband have COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. The doctor prescribed paxlovid and patient did not get it till around 13th or 14th and took it for 5 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: And now her and her husband have COVID; And now her and her husband have COVID; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (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) all with onset 08Jan2022, outcome "unknown" and all described as "And now her and her husband have COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: her and her husband have COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. The doctor prescribed paxlovid and patient did not get it till around 13th or 14th and took it for 5 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.