chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: dementia; there a lot of mucus whenever he's coughing up and when he defecates, there's more mucus than feces; there a lot of mucus whenever he's coughing up and when he defecates, there's more mucus than feces; experienced some "goofy things"; dropped 30lbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 13May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Deaf" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: DEMENTIA (medically significant), outcome "unknown", described as "dementia"; PRODUCTIVE COUGH (non-serious), MUCOUS STOOLS (non-serious), outcome "unknown" and all described as "there a lot of mucus whenever he's coughing up and when he defecates, there's more mucus than feces"; WEIGHT DECREASED (non-serious) with onset May2021, outcome "unknown", described as "dropped 30lbs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "experienced some "goofy things"". The patient underwent the following laboratory tests and procedures: weight: (May2021) 30 lbs, notes: dropped 30lbs. Clinical course: The patient got second shot of the Pfizer-BioNTech Covid19 vaccine on 13May2021, and after the second shot started having problems it affected his body in a way, patient dropped 30 lbs since May2021 and experienced some "goofy things", there a lot of mucus whenever patient was coughing up and when defecates, there was more mucus than faeces. Per caller, the doctor's think that patient was having dementia and does not believe the patient and the hospital said to call Pfizer for information on how to counter whatever patient was experiencing.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gait inability, Hypoaesthesia, Investigation, Paraesthesia
Clinical narrative: unable to walk; numbness in legs and knees; tingling sensation / Pins and needles; tightness in the stomach; vomitting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (hospitalization) with onset 22Dec2021, outcome "unknown", described as "unable to walk"; HYPOAESTHESIA (hospitalization) with onset 22Dec2021, outcome "unknown", described as "numbness in legs and knees"; PARAESTHESIA (hospitalization) with onset 22Dec2021, outcome "unknown", described as "tingling sensation / Pins and needles"; ABDOMINAL PAIN UPPER (hospitalization) with onset 22Dec2021, outcome "unknown", described as "tightness in the stomach"; VOMITING (hospitalization) with onset 22Dec2021, outcome "unknown", described as "vomitting". The patient was hospitalized for gait inability, hypoaesthesia, paraesthesia, abdominal pain upper, vomiting (hospitalization duration: 9 day(s)). The patient underwent the following laboratory tests and procedures: investigation: inconclusive, notes: thought patient had Guillain-Barre and acute transverse myelitis. The results have become inconclusive. Therapeutic measures were taken as a result of gait inability, hypoaesthesia, paraesthesia, abdominal pain upper, vomiting.  Clinical course: Patient received the booster shot of the Pfizer Covid 19 vaccine on 20Dec2021. Two days later patient was unable to walk and experienced numbness in legs and knees, tingling sensation which was described as 'pins and needles', tightness in the stomach, and vomiting episodes of about 2 times. Patient was hospitalized for nine days and transferred to an acute rehab facility. Patient took a number of tests because they thought he had Guillain-Barre and acute transverse myelitis. The results have become inconclusive but they have treated him with medication as if he did have those illnesses.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: unable to walk; numbness in legs and knees; tingling sensation / Pins and needles; tightness in the stomach; vomitting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (hospitalization) with onset 22Dec2021, outcome "unknown", described as "unable to walk"; HYPOAESTHESIA (hospitalization) with onset 22Dec2021, outcome "unknown", described as "numbness in legs and knees"; PARAESTHESIA (hospitalization) with onset 22Dec2021, outcome "unknown", described as "tingling sensation / Pins and needles"; ABDOMINAL PAIN UPPER (hospitalization) with onset 22Dec2021, outcome "unknown", described as "tightness in the stomach"; VOMITING (hospitalization) with onset 22Dec2021, outcome "unknown", described as "vomitting". The patient was hospitalized for gait inability, hypoaesthesia, paraesthesia, abdominal pain upper, vomiting (hospitalization duration: 9 day(s)). The patient underwent the following laboratory tests and procedures: investigation: inconclusive, notes: thought patient had Guillain-Barre and acute transverse myelitis. The results have become inconclusive. Therapeutic measures were taken as a result of gait inability, hypoaesthesia, paraesthesia, abdominal pain upper, vomiting.  Clinical course: Patient received the booster shot of the Pfizer Covid 19 vaccine on 20Dec2021. Two days later patient was unable to walk and experienced numbness in legs and knees, tingling sensation which was described as 'pins and needles', tightness in the stomach, and vomiting episodes of about 2 times. Patient was hospitalized for nine days and transferred to an acute rehab facility. Patient took a number of tests because they thought he had Guillain-Barre and acute transverse myelitis. The results have become inconclusive but they have treated him with medication as if he did have those illnesses.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension, Loss of consciousness, Syncope
Clinical narrative: Fainting; Unconsciousness; Low blood pressure; 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 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "she had 12 screws put in her spine and neck" (unspecified if ongoing), notes: 12 screws in spine, neck, previous issues with pain, numbness; "had previous issues with pain and numbness" (unspecified if ongoing); "had previous issues with pain and numbness" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "Fainting"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Unconsciousness"; HYPOTENSION (non-serious), outcome "unknown", described as "Low blood pressure". The events "fainting", "unconsciousness" and "low blood pressure" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: low. Therapeutic measures were taken as a result of syncope, loss of consciousness.  Clinical information: she got the vaccine at 10:30 and then was discharged from the emergency room at 18:00. Her blood pressure was low, and she felt unconscious for 7 hours. She was given intravenous fluid, unspecified but states she eventually woke up and felt better. She waited for her booster shot because she had to have a surgery. It has been 4 months since her surgery, and over 6 months from her second vaccine. She had 12 screws put in her spine and neck, and she has had previous issues with pain and numbness, this was her third surgery for this issue. She had this issue prior to her vaccines. She had two surgeries before her vaccines and then the third one was scheduled after the vaccine. Reporter stated that she experienced adverse events following her second dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap). she was unconscious for a few hours and had low blood pressure.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202200100512 similar report from same reporter
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2), administration date 08Jan2022 (Lot number: FK5618) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 13Jan2022, outcome "unknown", described as "tested positive for Covid 19". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller clarifies that it is his 5 year old daughter, stated she tested positive for Covid 13Jan2021, caller states she had symptoms during the day that she got the vaccine, states at the time it was just some sniffles so they went ahead with the vaccination. States it was followed up by a rapid test, states yesterday that test came back negative. States she got the paediatric dose. Investigation Assessment: No.; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported event covid 19, and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200101731 similar report from same reporter
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Swelling face, Swollen tongue
Clinical narrative: Swelling/ tingling on left side face and base of Tongue; Swelling/ tingling on left side face and base of Tongue; Swelling/ tingling on left side face and base of Tongue; Swelling/ tingling on left side face and base of Tongue; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 09:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Allergic to lobster" (unspecified if ongoing), notes: Known allergies: Compazine, Champagne and lobster together; "Allergic to Champagne" (unspecified if ongoing), notes: Known allergies: Compazine, Champagne and lobster together. Concomitant medication(s) included: MOTRIN [IBUPROFEN]. Past drug history included: Compazine, reaction(s): "Known allergies: compazine, Champagne and lobster together", notes: Known allergies: Compazine, Champagne and lobster together. The following information was reported: PARAESTHESIA (non-serious), SWELLING FACE (non-serious), PARAESTHESIA ORAL (non-serious), SWOLLEN TONGUE (non-serious) all with onset 11Jan2022 11:00, outcome "recovering" and all described as "Swelling/ tingling on left side face and base of Tongue". Therapeutic measures were taken as a result of paraesthesia, swelling face, paraesthesia oral, swollen tongue. Additional information: Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks which included Motrin. Patient experienced swelling/tingling on left side face and base of Tongue on 11Jan2022 at 11:00. Patient received treatment for the adverse events which included Benadryl. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Neurological symptom, Paralysis
Clinical narrative: One of them is paralyzed; sickness; neurological symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE number unknown; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: PARALYSIS (medically significant) with onset 2021, outcome "unknown", described as "One of them is paralyzed"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sickness"; NEUROLOGICAL SYMPTOM (non-serious) with onset 2021, outcome "unknown", described as "neurological symptoms".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Vaginal haemorrhage
Clinical narrative: described it as a light bleed, similar to a menstruation. She mentioned she has not had a period in years; bleeding from her vagina; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200102251 (Pfizer).  A 53 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Jan2022 (Lot number: FJ1611) at the age of 53 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: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "described it as a light bleed, similar to a menstruation. She mentioned she has not had a period in years"; VAGINAL HAEMORRHAGE (non-serious) with onset 18Jan2022, outcome "recovering", described as "bleeding from her vagina". Clinical Course: The patient received first dose of the COMIRNATY vaccine on 17Jan2022 and stated 2 days after the shot she was bleeding from her vagina. The patient doesn't see this on the paper of side effects. She never bled down there before so she was calling to see if this could be a side effect. It was light bleeding, similar to a menstruation but doesn't know if its from the shot because she wasn't bleeding before. At first it started spirting but now its not coming out really heavy but like a period or menstruation. The caller hasn't had a period in years. The caller has been in the hospital but this was way before she received the vaccine.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male 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: PERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Pericarditis". Therapeutic measures were taken as a result of pericarditis. Clinical information: Reporter is a consumer. She called on behalf of her 23 years old daughter. She stated her daughter received the booster dose of the COMIRNATY vaccine in earlier Jan2022. Reporter stated her daughter felt so sick and has nausea and fatigue even 3 weeks after receiving the booster dose. Reporter mentioned her daughter also experience these type of side effects after receiving the Flu vaccine. Reporter asked if there was any information regarding nausea and fatigue as side effects 3 weeks after receiving the booster dose. She stated her daughter also presented a bruise on her arm were she received the dose, for about a week.  cine.Reporter stated her husband had a previous history of pericarditis and was hospitalized due to this. He was prescribed ibuprofen. Reporter stated her husband "could tell he had pericarditis after receiving the vaccine" but did not reported it.  She asked for further information about Myocarditis and Pericarditis after receiving the Pfizer Biontech COVID 19 vaccine. Consumer calling about the Pfizer COVID-19 vaccine who is making an inquiry about side effects, and says there is also a person she knows who is reporting side effects. Reporter declines to report for the person who experienced possible side effects, and says she is the parent of a young adult who reports connections with vaccine and she works full time and doesn't always share all the information. She says her daughter is 23 and very independent, so she is seeking piece of mind though she trusts the vaccine, her daughter is having side effects. Reporter says the dose her daughter is having side effects with is the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Bronchitis viral, Eye swelling, Feeling abnormal, Hypersensitivity
Clinical narrative: viral infection bronchitis; wheezing; severe allergic reaction; swollen eyes; hives; felt weird; itchy; 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 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 16:15 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BRONCHITIS VIRAL (non-serious) with onset 19Jan2022, outcome "not recovered", described as "viral infection bronchitis"; WHEEZING (non-serious) with onset 16Dec2021, outcome "unknown", described as "wheezing"; HYPERSENSITIVITY (non-serious) with onset 16Dec2021, outcome "unknown", described as "severe allergic reaction"; EYE SWELLING (non-serious) with onset 16Dec2021, outcome "unknown", described as "swollen eyes"; URTICARIA (non-serious) with onset 16Dec2021, outcome "unknown", described as "hives"; FEELING ABNORMAL (non-serious) with onset 16Dec2021, outcome "unknown", described as "felt weird"; PRURITUS (non-serious) with onset 16Dec2021, outcome "unknown", described as "itchy". The events "viral infection bronchitis", "wheezing", "severe allergic reaction", "swollen eyes", "hives", "felt weird" and "itchy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient mentioned the reaction started kind of late. It was the next morning. Her eye got swollen, wheezing, felt weird, itchy, and breaking out in hives. AE(s) did not require a visit to emergency Room. Today she went to the doctor and has viral bronchitis. Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Family Medical History Relevant to AE(s) both of her parents got Johnson and Johnson vaccine and both of them got pretty sick. Outcome of Event reported was it has made it into bronchitis.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Wheezing
Clinical narrative: viral infection bronchitis; wheezing; severe allergic reaction; swollen eyes; hives; felt weird; itchy; 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 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 16:15 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BRONCHITIS VIRAL (non-serious) with onset 19Jan2022, outcome "not recovered", described as "viral infection bronchitis"; WHEEZING (non-serious) with onset 16Dec2021, outcome "unknown", described as "wheezing"; HYPERSENSITIVITY (non-serious) with onset 16Dec2021, outcome "unknown", described as "severe allergic reaction"; EYE SWELLING (non-serious) with onset 16Dec2021, outcome "unknown", described as "swollen eyes"; URTICARIA (non-serious) with onset 16Dec2021, outcome "unknown", described as "hives"; FEELING ABNORMAL (non-serious) with onset 16Dec2021, outcome "unknown", described as "felt weird"; PRURITUS (non-serious) with onset 16Dec2021, outcome "unknown", described as "itchy". The events "viral infection bronchitis", "wheezing", "severe allergic reaction", "swollen eyes", "hives", "felt weird" and "itchy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient mentioned the reaction started kind of late. It was the next morning. Her eye got swollen, wheezing, felt weird, itchy, and breaking out in hives. AE(s) did not require a visit to emergency Room. Today she went to the doctor and has viral bronchitis. Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Family Medical History Relevant to AE(s) both of her parents got Johnson and Johnson vaccine and both of them got pretty sick. Outcome of Event reported was it has made it into bronchitis.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis
Clinical narrative: I currently have Hashimoto disease; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Immunocompromised" (unspecified if ongoing), notes: an immunocompromised person; "Childhood asthma" (unspecified if ongoing); "Autoimmune condition" (unspecified if ongoing), notes: more than one autoimmune condition, my mother also has an autoimmune disease. The patient's concomitant medications were not reported. The following information was reported: AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "I currently have Hashimoto disease". clinical information: Caller was an immunocompromised person caller have had childhood asthma and more than one autoimmune condition, caller currently have Hashimoto disease". Caller did not specify whether this diagnosis was prior to her vaccination with the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap). Caller's age was not requested. Patient's demographic information: Female, age unknown.Caller provided information on additional potential AE's. Caller stated: "My husband that has asthma, my children also have autoimmune diseases and my mother also has an autoimmune disease. Wil they qualify to receive a third primary series vaccination and a booster dose?" Caller did not specify whether these diagnosis were prior vaccination with the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap). Responded as per attached. Informed caller: "COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine are also authorized under EUA to provide a 2-dose primary series to individuals 5 years of age and older; a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise; a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA); and a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cellulitis, Investigation
Clinical narrative: have cellulitis in the face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male 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: CELLULITIS (medically significant), outcome "unknown", described as "have cellulitis in the face". The patient underwent the following laboratory tests and procedures: blood test: unknown results; investigation: unknown results; negative test results.  Clinical course: Find damages photos. Apparently the patient now had cellulitis in the face which obviously had been totally neglected for a while. He insisted on getting all his blood work. Clinic with tests for pulmonary embolism dvt scrotum rash etc. He needed a correct diagnosis now as this had been nightmare. He sent a letter of intent to sue and to follow will be court summons and claims. He needed to get correct medical attention and damages due to direct intent to injure and connected injuries. He had negative test results but needed to correctly diagnose the skin damage done by the experiment vaccine. Totally and abject unfair and bodily harm.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gastrointestinal inflammation, Systemic lupus erythematosus, Vaccination site pain
Clinical narrative: Lupus sores in mouth; Sore at injection site; Acute and chronic inflammation in intestinal lining and gut; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (MARKETING PROGRAME NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4231447-00.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous since 20Aug2019 (Batch/Lot number: unknown) at weekly (unk, weekly) and second regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at weekly for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "recovered", described as "Lupus sores in mouth"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Sore at injection site"; GASTROINTESTINAL INFLAMMATION (non-serious), outcome "not recovered", described as "Acute and chronic inflammation in intestinal lining and gut". The action taken for adalimumab was dosage increased. The physician switched patient to weekly dosage due to acute and chronic inflammation in the intestinal lining. She was diagnosed with acute and chronic inflammation in her gut. She had also lupus sores in mouth. She thought that this had to do with her lupus. Her rheumatologist had suggested to bump up her dosing to weekly to help. She recently went to see her gastroenterologists as of 11Jan2022.  The reporter assessed the causality as no reasonable possibility between Adalimumab and Lupus erythematosus (Systemic lupus erythematosus), Vaccination site pain and Gastrointestinal inflammation. The reporter did not assessed the causality between bnt162b2 and Lupus erythematosus (Systemic lupus erythematosus), Vaccination site pain and Gastrointestinal inflammation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Pain in extremity, SARS-CoV-2 test, Upper limb fracture
Clinical narrative: aching and swelling for no; aching and swelling for no; elbow allograft fractured; shoulders were very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6208) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "L shoulder repair", start date: 1985 (unspecified if ongoing); "R shoulder repair", start date: 1998 (unspecified if ongoing); "tumor removed", start date: 1985 (unspecified if ongoing), notes: Background - In 1985 I had synovial, sarcoma soft tissue tumor removed, from right elbow followed by radiation.; "radiation", start date: 1985 (unspecified if ongoing), notes: Background - In 1985 I had synovial, sarcoma soft tissue tumor removed, from right elbow followed by radiation.; "synovial sarcoma soft tissue tumor" (unspecified if ongoing), notes: Background - In 1985 I had synovial, sarcoma soft tissue tumor removed, from right elbow followed by radiation.; "right medial epicondyle", start date: Mar2017 (unspecified if ongoing), notes: March 2017, I had a second tumor, removed from right medial epicondyle. Concomitant medication(s) included: AMLODIPINE BESYLATE; FAMOTIDINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left), administration date: 26Feb2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (disability) with onset Jul2021, outcome "not recovered", described as "shoulders were very sore"; UPPER LIMB FRACTURE (disability) with onset Jul2021, outcome "not recovered", described as "elbow allograft fractured"; PAIN IN EXTREMITY (disability), JOINT SWELLING (disability), outcome "not recovered" and all described as "aching and swelling for no". The events "shoulders were very sore", "elbow allograft fractured", "aching and swelling for no" and "aching and swelling for no" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Jan2022) negative, notes: Nasal swab. Therapeutic measures were taken as a result of arthralgia, upper limb fracture, pain in extremity, joint swelling.  Clinical course: Facility type Vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Drug ineffective, Headache, Suspected COVID-19
Clinical narrative: might have gotten Covid around time booster; might have gotten Covid around time booster; headaches; GI trouble; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 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: Covid-19 vaccine (Dose 1, single, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "might have gotten Covid around time booster"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "GI trouble".  Clinical course: Patient was eating out and stuff but did not think it was the vaccine. Caller stated that she did not have any further information to provide regarding her mother-in-law and her experience with the Covid vaccine. She stated that she thought she got the Pfizer but did not know.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lung neoplasm malignant
Clinical narrative: Shortly after I got my shot with Pfizer I was diagnosed with lung cancer/ They took everything out, part of my lung; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: LUNG NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Shortly after I got my shot with Pfizer I was diagnosed with lung cancer/ They took everything out, part of my lung". Therapeutic measures were taken as a result of lung neoplasm malignant. Patient reported that they took everything out, part of the lung. Patient reported that it is five months now since her first booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid 19; I tested positive for Covid 19; 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 Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "I tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. Clinical course: Patient took the 2 doses of the Pfizer vaccine in May2021 and followed it up with a booster in Nov2021. The booster made patient sick. Around 05Jan2022, patient tested positive for Covid 19, although Covid symptoms started on 31Dec2021. Patient's unvaccinated family who had been around the patient several days never contracted Covid. Patient thought there were two issues here: 1) The vaccine had not protected patient against Covid despite claims of Pfizer, the news media and government officials. 2) Patient's family did not contract Covid while patient was positive and exposed to them. One can conclude that the Covid vaccine either gave patient Covid or weakened patient's immune system as to make patient more susceptible to Covid. Patient thought a refund of the cost of the vaccine along with missing work, doctors visits, pain and suffering should be the least Pfizer provides. Inevitably, the larger population of this world was going to band together and bring a class action suit against Pfizer for false claims, and misrepresentation.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Became sick with COVID 19; Became sick with COVID 19; Became sick with COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date May2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single and administered in arm right, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered with sequelae" and all described as "Became sick with COVID 19"; ILLNESS (non-serious) with onset 08Jan2022 23:00, outcome "recovered with sequelae", described as "Became sick with COVID 19". The event "became sick with covid 19", "became sick with covid 19" and "became sick with covid 19" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of covid-19, illness.  Clinical course was reported as: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not any other medications the patient received within 2 weeks of vaccination. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient had received treatment for the adverse event with inhaler. Prior to vaccination, was the patient was diagnosed with COVID-19, Since the vaccination, has the patient been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata, SARS-CoV-2 test
Clinical narrative: Diagnose with Alopecia areata; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Apr2021 (Lot number: EW0162) at the age of 19 years as dose 1, single, administration date 21May2021 (Lot number: EW0186) as dose 2, single and administration date 04Jan2022 (Lot number: FL3209) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESTARYLLA. The following information was reported: ALOPECIA AREATA (non-serious) with onset 09May2021, outcome "not recovered", described as "Diagnose with Alopecia areata". The event "diagnose with alopecia areata" was 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 alopecia areata.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Estarylla. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no other history. No known allergies. Was diagnosed with alopecia aereta after first vaccine, we could through remission before getting it against after 2nd and 3rd dose. Treatment received for the adverse event was steroid cream that treats alopecia aereta. The adverse event resulted in doctor or other healthcare professional office/clinic visit Hospitalization prolonged was no. Since the vaccination, the patient had been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed thrombosis/blood clots (medically significant), with outcome of unknown. Clinical course: She said she had family members who got the first and second dose of the Pfizer COVID-19 vaccine. One of them had blood clots. The other one had myocarditis and he's 24 years old. The reporter wanted to know if they can proceed with the booster dose. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 24 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown," described as "myocarditis." The reporting family member wanted to know if the patient could proceed with the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Platelet count
Clinical narrative: heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.); heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.); my PLT count Keep dropping, from 200 to 156.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), administered in arm left, administration date 18Nov2021 (Lot number: FH8028) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 01:15 AM), administration date: 31Mar2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 64 years old, for COVID-19 Immunization; Influenza vaccine, administration date: 23Sep2021, for immunisation. The following information was reported: HEART RATE INCREASED (medically significant), BLOOD PRESSURE INCREASED (medically significant) all with onset 19Nov2021 07:00, outcome "not recovered" and all described as "heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.)"; PLATELET COUNT DECREASED (non-serious) with onset 19Nov2021 07:00, outcome "not recovered", described as "my PLT count Keep dropping, from 200 to 156.". The events "heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.)", "heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.)" and "my plt count keep dropping, from 200 to 156." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (19Nov2021) 150; heart rate: (19Nov2021) 140; platelet count: (18Apr2018) 210; (23Jan2019) 226; (20Feb2020) 206; (24May2021) 195; (19Nov2021) 200 to 156; (22Nov2021) 175; (16Dec2021) 156. Therapeutic measures were not taken as a result of heart rate increased, blood pressure increased, platelet count decreased. Clinical course: On 19Nov2021 at 07:00, second day from third dose, heart rate and blood pressure increased (140 heartbeats, 150 blood pressure). Patient checked blood test record by accident and found out that PLT count kept dropping from 200 to 156. Since the vaccination, the patient has not been tested for COVID-19. Case was reported as non-serious.