chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 10:30 (Lot number: EN6201) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "allergy"; Naproxen, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EI9265, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 01Feb2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "I experienced severe body aches"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no covid prior vaccination and was not tested for covid post vaccination. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: receiving Pfizer COVID 19 vaccine booster shot; developed injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old female patient received 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: Bnt162b2 (1st dose, Batch/Lot number: unknown), for COVID-19 Immunization; Bnt162b2 (2nd dose, Batch/Lot number: unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "receiving Pfizer COVID 19 vaccine booster shot"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "developed injection site soreness". Additional information: patient developed injection site soreness that started 12 hrs after injection and lasting 24 hrs. No other symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: hands and feet had turned red, swollen slightly with severe itching; hands and feet had turned red, swollen slightly with severe itching; hands and feet had turned red, swollen slightly with severe itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 15:00 (Lot number: fk5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU. The following information was reported: ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious) all with onset 09Nov2021, outcome "not recovered" and all described as "hands and feet had turned red, swollen slightly with severe itching". The event "hands and feet had turned red, swollen slightly with severe itching", "hands and feet had turned red, swollen slightly with severe itching" and "hands and feet had turned red, swollen slightly with severe itching" was evaluated at the physician office visit. Therapeutic measures were taken as a result of erythema, peripheral swelling, pruritus.  Additional Information: Within 24 hours hands and feet had turned red, swollen slightly with severe itching. Some itchy red skin elsewhere on body. Treatment received with antihistamines, topical cream. No Other medications in two weeks. No Covid prior vaccination and No Covid tested post vaccination and No Known allergies.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, SARS-CoV-2 test negative, Vestibular migraine
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 10:30 (Batch/Lot number: EW0187) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "short episode of Vertigo", start date: 2019, stop date: 2019. Concomitant medication(s) included: ALLOPURINOL; HYDROCHLOROTHIAZIDE;LOSARTAN POTASSIUM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 29Apr2021, when the patient was 42 years old, for Covid-19 immunization, reaction(s): "lightheaded"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 29Apr2021, when the patient was 42 years old, for COVID-19 Immunization, reaction(s): "headache".The following information was reported: DIZZINESS (non-serious) with onset 20May2021, outcome "not recovered", described as "lightheaded"; HEADACHE (non-serious) with onset 20May2021, outcome "not recovered", described as "headache"; VESTIBULAR MIGRAINE (non-serious) with onset Aug2021, outcome "not recovered", described as "Vestibular Migraines". The events "lightheaded", "headache" and "vestibular migraines" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, headache, vestibular migraine.Additional information: Other concomitant medication included vitamin. The facility type vaccine was pharmacy or drug store. With both shots the patient was almost immediately lightheaded and got a headache. Both times the lightheaded symptoms lasted maybe 15 mins or so, but the headaches for a couple of days. As the months past he had a couple of occasions when he would get light headed but again it didn't last to long. In Aug2021 he got what he thought was signs of vertigo but had turned out to be vestibular migraines. He had never had migraines in his life, but he did have a short episode of vertigo in 2019. He was not sure if this is a direct affect of the vaccine but he would like to find out if there is a link and a solution to this. The adverse event start date was also reported as 24Apr2021 10:30 AM. There was no COVID prior vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Pulmonary oedema, SARS-CoV-2 test
Clinical narrative: positive for COVID; positive for COVID; fluid in lungs; severe shortness of breath; This is a spontaneous report received from contactable reporter (Other HCP) via Pfizer Sales Representative. The reporter is the patient.  A 26-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) (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 "positive for COVID"; PULMONARY OEDEMA (medically significant), outcome "unknown", described as "fluid in lungs"; DYSPNOEA (non-serious), outcome "unknown", described as "severe shortness of breath". Clinical course: Patient had direct exposure to relative with COVID and subsequently tested positive for COVID two weeks after their first bnt162b2. Patient had severe COVID symptoms (described as worse than flu) including severe shortness of breath and fluid in lungs. Event took place after use of product. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  Covid-19,drug ineffective,pulmonary oedema. 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, COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: Contracted COVID four weeks after having our booster injection; Contracted COVID four weeks after having our booster injection; Contracted COVID four weeks after having our booster injection; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program.  A female patient (reporter's wife) received bnt162b2 (PFIZER COVID-19 VACCINE) (Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID four weeks after having our booster injection". Clinical course: Patient contracted COVID four weeks after having our booster injection. Reporter thought the vaccine was effective, since patient only had moderate symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101590456 same reporter and drug, different patient and event
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Graft complication, Headache, Nasopharyngitis, Pulpitis dental
Clinical narrative: lost a dental bone graft due to inflammation; Hand arthritis; Cold symptoms; Headache; Tooth inflammation; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4153883-00 (AbbVie).  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization. The following information was reported: GRAFT COMPLICATION (medically significant) with onset 2021, outcome "not recovered", described as "lost a dental bone graft due to inflammation"; ARTHRITIS (non-serious) with onset 2021, outcome "not recovered", described as "Hand arthritis"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Cold symptoms"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; PULPITIS DENTAL (non-serious) with onset 2021, outcome "unknown", described as "Tooth inflammation". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality as per reporter for events, lost a dental bone graft due to inflammation, hand arthritis and tooth inflammation was not reported and for the events cold symptoms and headache 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 the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, SARS-CoV-2 test, Urticarial vasculitis
Clinical narrative: Urticarial Vasculitis; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 13:00 (Lot number: EWO187) at the age of 61 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing), notes: Healthy with seasonal allergies treated with antihistamine as needed.; "known allergies: Corn" (unspecified if ongoing); "known allergies: Apples" (unspecified if ongoing); "known allergies: Pears" (unspecified if ongoing). The patient did not have COVID-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccine within four weeks. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9264, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM), administration date: 13Feb2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1283, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM), administration date: 23Jan2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 26Aug2021 03:00, outcome "unknown", described as "Booster"; URTICARIAL VASCULITIS (medically significant) with onset 27Aug2021 03:00, outcome "not recovered", described as "Urticarial Vasculitis". The event "urticarial vasculitis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jun2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of urticarial vasculitis and included 300 milligrams Prednisolone tablets.; Sender's Comments: Based on a compatible temporal association, a causality between event and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died after taking the Pfizer COVID-19 vaccine with "no other health issues"; This is a spontaneous report received from non-contactable reporters (Consumers or other non HCPs) from medical information team.  A 27 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died after taking the Pfizer COVID-19 vaccine with "no other health issues"". The patient's date of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: There is very limited information provided in this report to make a robust medical judgment regarding the causality of the event. This consumer report lacks confirmation from a healthcare professional. Confirmation from the patient's treating physician would be helpful. Information regarding the patient's significant medical history and use concomitant medications.  An autopsy report would be useful if this was done. This case will be reassessed upon receipt of follow-up information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: died after taking the Pfizer COVID-19 vaccine with "no other health issues"
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Immunisation
Clinical narrative: Booster; She got the booster dose and her hair started falling out again; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program via Regulatory Authority.. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 06Nov2021 (Lot number: 32030BD) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "A little anemic" (unspecified if ongoing); "Borderline diabetic" (unspecified if ongoing). There were no concomitant medications. No prior Vaccinations (within 4 weeks). Vaccination history included: bnt162b2 (Dose: 1, Lot number: EN6203), administration date: 26Feb2021, when the patient was 68 years old, for COVID-19 Immunization, reaction(s): "Hair failing about within a month of first dose"; bnt162b2 (Dose: 2, Lot number: EP6955), administration date: 19Mar2021, when the patient was 68 years old, for COVID-19 Immunization, reaction(s): "After her second dose, her hair started to fall out even more". The following information was reported: ALOPECIA (medically significant) with onset Nov2021, outcome "unknown", described as "She got the booster dose and her hair started falling out again". The event did not require emergency room visit or physician office visit.; Sender's Comments: Based on temporal relationship the causal association between the reported events and the vaccine BNT162B2 cannot be completely excluded. The 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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got Covid after 2 doses of vaccine; Got Covid after 2 doese of vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 1 intramuscular, administered in Arm Right on 23Feb2021 (Age at the time of vaccination 39-year-old) as DOSE 1, SINGLE, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203), dose 2 intramuscular, administered in Arm Right on 16Mar2021 (Age at the time of vaccination 39-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history includes drug allergy. Concomitant medication included levothyroxine sodium (LEVOXYL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had tested for COVID-19. Patient visits Doctor or other healthcare professional office/clinic for Adverse events. On 14Nov2021 the patient experienced got COVID after 2 doses of vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive, on 15Nov2021 Nasal Swab. No hospitalization and no treatment received.The outcome of event was recovering.  Follow-up (22Nov2021): Follow-up attempts completed. No further information expected
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Immunisation, Neck pain
Clinical narrative: This is a spontaneous report from a contactable Nurse. This Nurse reported for a 67-year-old female consumer that: A 67-year-old female non-pregnant patient received bnt162b2 (COMIRNATY), administered in unknown (Lot number: unknown at the age of 67 years as dose 3, Intramuscular, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications were not reported. The following information was reported: Patient received booster dose of Pfizer VXN, remained in observation for 20 minutes without symptoms. On drive home, she "didn't feel quite right", then developed neck and chest pain. Patient takes nitro-glycerine for underlying cardiac disorder, so took nitro and pain stopped onset on 10Nov2021 without come of recovered. Therapeutic measures were nitro-glycerine taken as a result of Recovered Vaccination history included: Comirnaty (product=COVID 19, lot number=EX. unknown, number=1, vaccine location=left arm), COVID 19, lot number=unknown, number=2, vaccine location=left arm) for Covid-19 immunisation. Additional information: The patient had not received any other vaccine within 4 weeks. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not hospitalized, case was assessed as non-serious, No treatment was taken. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Gait disturbance, Product administered to patient of inappropriate age, Vomiting
Clinical narrative: he was brought to the hospital because he experienced vomiting, sever stomach distention, and currently, has difficulties in walking.; he was brought to the hospital because he experienced vomiting, sever stomach distention, and currently, has difficulties in walking.; he was brought to the hospital because he experienced vomiting, sever stomach distention, and currently, has difficulties in walking.; Her grandson is 9 years old and received a Pfizer Covid19 vaccine pediatric dose last 11Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Batch/Lot number: unknown) at the age of 9 years 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: GAIT DISTURBANCE (hospitalization), VOMITING (hospitalization), ABDOMINAL DISTENSION (hospitalization) all with onset 11Nov2021, outcome "unknown" and all described as "he was brought to the hospital because he experienced vomiting, sever stomach distention, and currently, has difficulties in walking."; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Her grandson is 9 years old and received a Pfizer Covid19 vaccine pediatric dose last 11Nov2021".Her grandson is 9 years old and received a Pfizer Covid19 vaccine pediatric dose last 11Nov2021, one holiday. At the same night, he was brought to the hospital because he experienced vomiting, sever stomach distention, and currently, has difficulties in walking. She was asking if these have been reported and if there are any patients, ages 5-11 years old, who experienced the same side effects? She stated her grandson is still currently in the hospital. Caller states he had the vaccine one holiday and that night he started having symptoms.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: broke out in hives and itched; broke out in hives and itched; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: EP7533) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: 2016 (ongoing), notes: Verbatim: High blood pressure; "Chronic kidney disease", start date: 2014 (ongoing), notes: Verbatim: Chronic kidney disease. The patient's concomitant medications were not reported. The following information was reported: PRURITUS (medically significant), URTICARIA (medically significant) all with onset 2021, outcome "unknown" and all described as "broke out in hives and itched". The event "broke out in hives and itched" and "broke out in hives and itched" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pruritus, urticaria.  Additional information: Treatment medication: Benadryl. The patient did not receive any other vaccines within four weeks prior to the vaccination. No AE following prior vaccinations. No family medical history relevant to AE. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Inappropriate schedule of product administration, Knee arthroplasty, Rash
Clinical narrative: in April I had 'knee' replacement done; head to toe rash and I have been kind of dealing with ever since; Shortness of breath; In march I got the Pfizer vaccine and two weeks later I went and got the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: Bnt162b2 (dose 1, single), administration date: Mar2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "In march I got the Pfizer vaccine and two weeks later I went and got the second dose"; KNEE ARTHROPLASTY (medically significant) with onset Apr2021, outcome "unknown", described as "in April I had 'knee' replacement done"; RASH (non-serious) with onset Apr2021, outcome "unknown", described as "head to toe rash and I have been kind of dealing with ever since"; DYSPNOEA (non-serious) with onset Apr2021, outcome "unknown", described as "Shortness of breath". It was reported that patient had a question that In Mar got the Pfizer vaccine and two weeks later went and got the second dose and then in Apr had 'knee' replacement done about two weeks after that patient started with this really head to toe rash and had been kind of dealing with ever since and shortness of breath. Now they put patient on prednisone and was on prednisone for like two or three months to be honest with you. They couldn't figure out they can't figure out what's wrong with patient so anyway went in to withheld and got Pfizer booster shot last Monday well started breaking out head to toe with the rash again and I am just trying, I am asking do you think this is a side effect of Pfizer or this is something else. I just wanted to double check I am not sure." Patient stated, was looking at little dog and had to get him out to the bathroom before he has an accident. Therapeutic measures were taken as a result of knee arthroplasty, rash, dyspnoea. The patient received treatment of prednisone for like two or three months for adverse events.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Lip swelling, Pyrexia
Clinical narrative: Lip swollen; I was experiencing high temperature/always there like 100.5 and 100 something/fever; I am lying down always on bed; 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. Other Case identifier(s): US-PFIZER INC-202101638041 (Pfizer).  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Migraine" (unspecified if ongoing), notes: Verbatim: Migraine; "COVID-19", start date: Mar2020 (unspecified if ongoing), notes: I got Covid back in March 2020. Concomitant medication(s) included: AIMOVIG taken for migraine. The following information was reported: LIP SWELLING (medically significant) with onset 19Nov2021, outcome "unknown", described as "Lip swollen"; PYREXIA (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was experiencing high temperature/always there like 100.5 and 100 something/fever"; BEDRIDDEN (non-serious) with onset Nov2021, outcome "unknown", described as "I am lying down always on bed". The event "lip swollen" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (19Nov2021) 100.5, notes: 100.5 and 100 something; (19Nov2021) 100, notes: 100.5 and 100 something. Therapeutic measures were taken as a result of lip swelling. The patient's lips swollen. So, patient read all side effects and went to the hospital and they treat with some steroid and they told that had to report this as it was probably side effects from the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A 63 year-old female patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Lot number: ER2613, Expiration Date: Dec2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "Minor bleeding". No follow-up attempts possible. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Gallbladder disorder, Respiratory symptom
Clinical narrative: gallbladder is failing; respiratory issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 77 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 76 years as dose 1, single and administration date 13Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: GALLBLADDER DISORDER (hospitalization) with onset Apr2021, outcome "not recovered", described as "gallbladder is failing"; RESPIRATORY SYMPTOM (hospitalization) with onset 2021, outcome "unknown", described as "respiratory issues". Therapeutic measures were not taken as a result of gallbladder disorder, respiratory symptom.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable consumer. A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 19Nov2021 (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: first dose and second dose of Bnt162b2 (Lot number: not reported), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Third dose of COVID-19 Vaccine administered"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "unknown", described as "Swollen lymph nodes". The event "swollen lymph nodes" was evaluated at the physician office visit. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; 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 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: ER8733) at the age of 41 years as dose 2, single and administration date 16Mar2021 (Lot number: EP7534) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Events considered as non-serious as per the reporter. Patient did not receive other vaccine in four weeks. Patient diagnosed with covid-19 prior vaccination and patient tested for Covid-19 post vaccination. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Nov2021, COVID-19 (medically significant) with onset 21Nov2021, outcome "not recovered" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) positive, notes: Nasal Swab. Patient did not receive any treatment for adverse event. Therapeutic measures were not taken as a result of covid-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Inappropriate schedule of product administration, Pharyngeal swelling, Rash, Sleep disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 10:00 (Lot number: FF8839) at the age of 36 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: Migraine and anxiety; "anxiety" (unspecified if ongoing), notes: Other medical history: Migraine and anxiety; "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19:Yes. Concomitant medication(s) included: IMITREX. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0217, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 17Aug2021, when the patient was 36 years old, for COVID-19 immunization, reaction(s): "severe headache". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Sep2021 10:00, outcome "unknown", described as "administration date= 17Aug2021, previous dose administration date= 29Sep2021"; RASH (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Bad skin rash"; DYSPNOEA (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Have trouble breathing at night"; THROAT TIGHTNESS (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Throat closes up"; PHARYNGEAL SWELLING (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Throat swelling"; SLEEP DISORDER (non-serious) with onset 2021, outcome "recovered with sequelae", described as "I am now awaiting a sleep study". The events "bad skin rash", "have trouble breathing at night", "throat closes up", "throat swelling" and "I am now awaiting a sleep study" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, dyspnoea, throat tightness, pharyngeal swelling, sleep disorder. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Hospitalization Prolonged reported as No. Treatment received for the adverse event with Prescription pain relief and steroids, sleep study. Since the vaccination, patient had not been tested for COVID-19. Known allergies reported as No. Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 10:00 (Lot number: FF8839) at the age of 36 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: Migraine and anxiety; "anxiety" (unspecified if ongoing), notes: Other medical history: Migraine and anxiety; "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19:Yes. Concomitant medication(s) included: IMITREX. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0217, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 17Aug2021, when the patient was 36 years old, for COVID-19 immunization, reaction(s): "severe headache". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Sep2021 10:00, outcome "unknown", described as "administration date= 17Aug2021, previous dose administration date= 29Sep2021"; RASH (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Bad skin rash"; DYSPNOEA (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Have trouble breathing at night"; THROAT TIGHTNESS (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Throat closes up"; PHARYNGEAL SWELLING (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Throat swelling"; SLEEP DISORDER (non-serious) with onset 2021, outcome "recovered with sequelae", described as "I am now awaiting a sleep study". The events "bad skin rash", "have trouble breathing at night", "throat closes up", "throat swelling" and "I am now awaiting a sleep study" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, dyspnoea, throat tightness, pharyngeal swelling, sleep disorder. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Hospitalization Prolonged reported as No. Treatment received for the adverse event with Prescription pain relief and steroids, sleep study. Since the vaccination, patient had not been tested for COVID-19. Known allergies reported as No. Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Drug interaction
Clinical narrative: Humira not effective; Drug interaction Humira with Vaccine Bnt162b2; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4161040-00.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single and intramuscular, administration date 11Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Humira not effective"; DRUG INTERACTION, outcome "unknown", described as "Drug interaction Humira with Vaccine Bnt162b2". The action taken for adalimumab was unknown.  Additional information: Causality: Causality for the event not effective was not reported by the reporter with respect to HUMIRA. Causality for the event for the event not effective was assessed as possible by the reporter with respect to bnt162b2.  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 reported information, Suspect product Humira no effective after the administration of the company suspect product BNT162b2, a causal association can be derived due to its interaction with Humira.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Diarrhoea, Immunisation, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 30Oct2021 10:15 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunization; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 30Oct2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Blood pressure meds" (unspecified if ongoing); "cholesterol meds" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. I am the patient, Location of injection: Arm Left), administration date: 21Feb2020, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. I am the patient, Location of injection: Arm Left), administration date: 28Jan2021, when the patient was 66 years old, for COVID-19 Immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Other medications in two weeks were Diuretic, vitamins. Patient had not been tested for COVID-19 since the vaccination. The following information was reported: blood pressure abnormal (non-serious) with onset 04nov2021, outcome "not recovered", described as "erratic blood pressure"; nausea (non-serious) with onset 04nov2021, outcome "not recovered", described as "nausea"; diarrhea (non-serious) with onset 04nov2021, outcome "not recovered", described as "diarrhea"; immunization (non-serious) with onset 30oct2021, outcome "unknown", described as "since the booster shot". The events "erratic blood pressure", "nausea" and "diarrhea" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood pressure abnormal, nausea, diarrhea. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Groin pain, Immunisation, Pain in jaw
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030) via an unspecified route of administration in the left arm on 21Nov2021 at 17:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine/pseudoephedrine hydrochloride (ALLEGRA-D) 24hours, zinc (MANUFACTURER UNKNOWN) and vitamin D NOS (MANUFACTURER UNKNOWN); all for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 15May2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient previously received neomycin sulfate (MANUFACTURER UNKNOWN) for an unknown indications on an unknown date and experienced drug allergy. On 22Nov2021 at 05:00, the patient experienced major swelling in the left armpit, pain in jaw and ears, joint pain and pain in the groin area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events major swelling in the left armpit, pain in jaw and ears, joint pain and pain in the groin area was resolving at the time of this report.