chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (173415). A 36-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 36, single dose,  for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunisation. The patient experienced vaccination site discomfort (arm soreness after Pfizer COVID-19 vaccine), with outcome of unknown. Additional information: Other medications (including over-the-counter medications, nutritional and herbal supplements, etc.), past medical history, family history, social history (including occupational history, use of alcohol, tobacco, or recreational drugs) and other relevant information: Unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Motion sickness, Vomiting
Clinical narrative: threw up 10 times within a 12 hour period; motion sickness has gotten worse post the vaccine; motion sickness has gotten worse post the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2022 (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: VOMITING (non-serious), outcome "recovered", described as "threw up 10 times within a 12 hour period"; MOTION SICKNESS (non-serious), outcome "recovered", CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "motion sickness has gotten worse post the vaccine". Therapeutic measures were taken as a result of vomiting, motion sickness, condition aggravated.  Additional information: My 6-year-old was vaccinated with Pfizer Covid19 vaccine in Jan2022. She had an adverse reaction to the vaccine (threw up 10 times within a 12-hour period). We sought medical advice from her pediatrician who prescribed zofran and my daughter was fine after the first dose. I would like to know if there was a follow up study she can be enrolled in to gauge the side effects for younger children post vaccination. I have noticed her motion sickness has gotten worse post the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: I had continued headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 10:30 (Lot number: EN0158) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: avocado, melon/cantelope" (unspecified if ongoing), notes: Allergy: avocado, melon/cantelope; "Allergy: raw spinach, eggplant, zucchini" (unspecified if ongoing), notes: Allergy: raw spinach, eggplant, zucchini; "Allergy: dill" (unspecified if ongoing), notes: Allergy: dill. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8721, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 19Mar2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "I had continued headaches". The event "i had continued headaches" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of headache.  Additional information: Facility the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Trigger finger
Clinical narrative: Trigger finger in middle finger after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EW0182) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; SINGULAIR. Vaccination history included: Bnt162b2 (Covid vaccine details: product: COVID 19, brand: Pfizer, lot number: EW0161, lot unknown: False, administration date: 28Apr2021, administration time: 11:00 AM, dose number: 1, vaccine location: Left arm), administration date: 2021, for Covid-19 immunization, reaction(s): "Tingling in finger tips after first vaccine.". The following information was reported: TRIGGER FINGER (non-serious) with onset 2021, outcome "unknown", described as "Trigger finger in middle finger after second vaccine". Additional Information: Reporter stated that, Other vaccine (Dose 2) date reported as, 28Apr2021. Facility type vaccine mentioned as, Pharmacy or Drug Store. No other vaccine in four weeks. Other medications taken in two weeks: Vitamins, Syntroid, Singular. Adverse event for dose 1 reported as, Tingling in finger tips after first vaccine on 29Apr2021 which was Recovered with lasting effects. No treatment ae. No covid prior vaccination. No covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Red dot at the injection site; 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 female patient received bnt162b2 (BNT162B2) (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: Unknown, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "recovered", described as "Red dot at the injection site".  Additional information: Patient who was seeking information on a adverse reaction her 12-year-old son experienced with the Pfizer Covid 19 vaccine booster dose.The mother and son both received the booster dose injection on 26Jan2022. The mother only experienced a red dot at injection site that eventually went away. Her son she states had a red dot at the injection site that was only a small red dot for 5 weeks after injection. She states that at week 5.5 or 6 the dot grew seemingly overnight. She describes the area as bright red bulbous blood blister wart type area. She states that it didn't hurt but grew. The area was nicked and began to bleed. She reports that it bled for over 2 hour straight. He was taken to the ER and has also seen his pediatrician twice since then for this issue. The pediatrician does not know what the area is. She states that everyone at the doctors over was concerned with the area and stated that they had never seen something like this. Patient had not taken any prior vaccination within 4 weeks. The patient had not taken any medication for treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood fibrinogen, Blood triglycerides, Body temperature, Haemophagocytic lymphohistiocytosis, IL-2 receptor assay
Clinical narrative: Hemophagocytic lymphohistiocytosis; This is a literature report for the following literature source(s):   A 52 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Viral syndrome" (unspecified if ongoing), notes: for 4 months; "Malaise" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (death, medically significant), outcome "fatal", described as "Hemophagocytic lymphohistiocytosis". Symptom onset after vaccination was 1 day after 1st vaccination. HLH-2004 diagnostic criteria included: fever (greater than or equals to 38.3 Centigrade); splenomegaly; ferritin greater than or equals to 500 ug/L; hypertriglyceridemia and/or hypofibrinogenemia (fasting triglycerides greater than or equals to 265 mg/dL, fibrinogen less than 1.5 g/L); hemophagocytosis in bone marrow or spleen or lymph nodes; soluble CD25 (soluble IL-2 receptor) greater than or equals to 2400 U/mL. The patient underwent the following laboratory tests and procedures: blood fibrinogen: less than 1.5 g/L; blood triglycerides: greater than or equals to 265 mg/dL; body temperature: greater than or equals to 38.3 centigrade; il-2 receptor assay: greater than or equals to 2400 IU/mL; serum ferritin: greater than or equals to 500 ug/L; H-score: 239. Therapeutic measures were taken as a result of haemophagocytic lymphohistiocytosis which included Dexamethasone, etoposide. The patient date of death was unknown. The reported cause of death was febrile neutropenia, bacteroides bacteraemia, haemophagocytic lymphohistiocytosis. It was not reported if an autopsy was performed.; Sender's Comments: Based on the information currently available and currently known drug safety profile, the reported event more likely represent intercurrent illness, but not related to BNT162B2.; Reported Cause(s) of Death: Neutropenic fever; Bacteroides bacteremia; Hemophagocytic lymphohistiocytosis
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Serum ferritin
Clinical narrative: Hemophagocytic lymphohistiocytosis; This is a literature report for the following literature source(s):   A 52 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Viral syndrome" (unspecified if ongoing), notes: for 4 months; "Malaise" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (death, medically significant), outcome "fatal", described as "Hemophagocytic lymphohistiocytosis". Symptom onset after vaccination was 1 day after 1st vaccination. HLH-2004 diagnostic criteria included: fever (greater than or equals to 38.3 Centigrade); splenomegaly; ferritin greater than or equals to 500 ug/L; hypertriglyceridemia and/or hypofibrinogenemia (fasting triglycerides greater than or equals to 265 mg/dL, fibrinogen less than 1.5 g/L); hemophagocytosis in bone marrow or spleen or lymph nodes; soluble CD25 (soluble IL-2 receptor) greater than or equals to 2400 U/mL. The patient underwent the following laboratory tests and procedures: blood fibrinogen: less than 1.5 g/L; blood triglycerides: greater than or equals to 265 mg/dL; body temperature: greater than or equals to 38.3 centigrade; il-2 receptor assay: greater than or equals to 2400 IU/mL; serum ferritin: greater than or equals to 500 ug/L; H-score: 239. Therapeutic measures were taken as a result of haemophagocytic lymphohistiocytosis which included Dexamethasone, etoposide. The patient date of death was unknown. The reported cause of death was febrile neutropenia, bacteroides bacteraemia, haemophagocytic lymphohistiocytosis. It was not reported if an autopsy was performed.; Sender's Comments: Based on the information currently available and currently known drug safety profile, the reported event more likely represent intercurrent illness, but not related to BNT162B2.; Reported Cause(s) of Death: Neutropenic fever; Bacteroides bacteremia; Hemophagocytic lymphohistiocytosis
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Haemoglobin, Haemophagocytic lymphohistiocytosis, Neutrophil count, Platelet count
Clinical narrative: This is a literature report for the following literature source(s): "Hyperinflammatory syndromes after SARS-CoV-2 mRNA vaccination in individuals with underlying immune dysregulation", Clinical Infect Dis, 2021; DOI:10.1093/cid/ciab1024. A 55 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "MAC" (unspecified if ongoing); "Pulmonary aspergillosis" (unspecified if ongoing); "MDS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (medically significant), outcome "recovered", described as "Hemophagocytic lymphohistiocytosis". Symptom onset after vaccination was 3 days after 1st vaccination. HLH-2004 diagnostic criteria included: fever (greater than or equals to 38.3 centigrade); splenomegaly; cytopenias in greater than or equals to 2 lines (HB less than 9 g/dL, plt less than 100/nL, neutrophils less than 1.0/nL); ferritin greater than or equals to 500 ug/L. The patient underwent the following laboratory tests and procedures: body temperature: greater than or equals to 38.3 centigrade; haemoglobin: less than 9 g/dL; neutrophil count: less than 1.0, notes: Unit:(/nL); platelet count: less than 100, notes: Unit:(/nL); serum ferritin: greater than or equals to 500 ug/L. Therapeutic measures were taken as a result of haemophagocytic lymphohistiocytosis included Anakinra. The event was slowly recovered. Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin
Clinical narrative: This is a literature report for the following literature source(s): "Hyperinflammatory syndromes after SARS-CoV-2 mRNA vaccination in individuals with underlying immune dysregulation", Clinical Infect Dis, 2021; DOI:10.1093/cid/ciab1024. A 55 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "MAC" (unspecified if ongoing); "Pulmonary aspergillosis" (unspecified if ongoing); "MDS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (medically significant), outcome "recovered", described as "Hemophagocytic lymphohistiocytosis". Symptom onset after vaccination was 3 days after 1st vaccination. HLH-2004 diagnostic criteria included: fever (greater than or equals to 38.3 centigrade); splenomegaly; cytopenias in greater than or equals to 2 lines (HB less than 9 g/dL, plt less than 100/nL, neutrophils less than 1.0/nL); ferritin greater than or equals to 500 ug/L. The patient underwent the following laboratory tests and procedures: body temperature: greater than or equals to 38.3 centigrade; haemoglobin: less than 9 g/dL; neutrophil count: less than 1.0, notes: Unit:(/nL); platelet count: less than 100, notes: Unit:(/nL); serum ferritin: greater than or equals to 500 ug/L. Therapeutic measures were taken as a result of haemophagocytic lymphohistiocytosis included Anakinra. The event was slowly recovered. Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: ended up in the hospital with pneumonia; ended up in the hospital with pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (174934).  A 70 year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), PNEUMONIA (hospitalization, medically significant), outcome "unknown" and all described as "ended up in the hospital with pneumonia". The lot number for pneumococcal 20-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Ocular discomfort, Vision blurred
Clinical narrative: Blurry vision in right eye; Pressure behind and around the eye; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 14:00 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Lot No: Er8736, administered in Arm Left on 21Apr2021 at 11:00 AM), administration date: 21Apr2021, when the patient was 43 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, single, Lot No: Fw0182, administered in Arm Left on 12May2021 at 01:00 PM), administration date: 12May2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: VISION BLURRED (hospitalization, disability) with onset 23Jan2022 13:00, outcome "not recovered", described as "Blurry vision in right eye"; OCULAR DISCOMFORT (hospitalization, disability) with onset 23Jan2022 13:00, outcome "not recovered", described as "Pressure behind and around the eye"; HEADACHE (hospitalization, disability) with onset 23Jan2022 13:00, outcome "not recovered", described as "headaches". The patient was hospitalized for vision blurred, ocular discomfort, headache (start date: 2022, discharge date: 2022, hospitalization duration: 3 day(s)). The events "blurry vision in right eye", "pressure behind and around the eye" and "headaches" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vision blurred, ocular discomfort, headache which included steroids. The patient experienced blurry vision in right eye pressure behind and around the eye leads to headaches. It has been 2 months and have no improvement. This has been horrible. 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 has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Visual impairment
Clinical narrative: Vision changed drastically after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 24Feb2022 12:00 (Lot number: FK9895) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "PVD in right eye" (unspecified if ongoing); "Vitrectomy" (unspecified if ongoing), notes: in the left eye but it receovered very well. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 03Mar2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Blurred and distorted vision", "Blurred and distorted vision"; BNT162B2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 24Mar2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Blurred and distorted vision", "Blurred and distorted vision". The following information was reported: VISUAL IMPAIRMENT (disability) with onset 2022, outcome "not recovered", described as "Vision changed drastically after the booster dose". The event "vision changed drastically after the booster dose" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Dec2021) negative, notes: COVID test type: Nasal Swab. Therapeutic measures were not taken as a result of visual impairment. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has seen several ophthalmologists, retina specialists, cornea specialist and they cannot figure out what was wrong. The patient's vision continued deteriorating since last year after the previous COVID-19 vaccinations. The patient dose not relate her vision problem to the vaccines because she was dealing with PVD in right eye. The patient also had a vitrectomy in the left eye, and it recovered very well. She had no issues until right after the COVID-19 vaccines in 2021. She has also been in the emergency room, and they could not figure it out. This year, 2022, her vision changed drastically after the booster dose, that was when she realized that it was related to the vaccine. She did not know where to go to find answers or help. She spoke with the retina specialist, but he seemed not to believe her.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pain
Clinical narrative: myocarditis; some pains; This is a spontaneous report received from non-contactable healthcare professional.  A male patient received 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: MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "myocarditis"; PAIN (hospitalization), outcome "recovered", described as "some pains". The patient was having some pains. He ended up in the hospital. Reported causality was related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Rash
Clinical narrative: This is a spontaneous report received from a contactable pharmacist. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jun 10, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown), for immunisation. The patient developed a rash (skin eruption), blister (blistering under armpits) and fatigue, onset 2021, with outcome of unknown. Skin eruption and blistering under armpits evaluated at a physician office visit. Additional information: The patient had a severe reaction after receiving the second shot of Pfizer COVID vaccine on Jun 10, 2021. Patient broke-out in skin eruption. Blistering under armpits. 80% of reaction was on the left-side (where she got the shot). Patient also had fatigue; both fatigue and blistering lasted 5-7 months. Patient saw an allergist but the allergist did not know anything about allergic reactions to COVID-19 vaccines. The  patient would like to know which specialist would be able to evaluate what caused her reaction to the vaccine, and also what Pfizer recommends in regards to booster shots. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse
Clinical narrative: MS exacerbation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4558645.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant), outcome "unknown", described as "MS exacerbation". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: 2 weeks later had gotten pneumonia; 2 weeks later had gotten pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (174934). The reporter is the patient.  A 71 year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, 20 mg single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "2 weeks later had gotten pneumonia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sudden death
Clinical narrative: He died suddenly in his sleep; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jun2021 10:00 (Lot number: EWD198) at the age of 17 years 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 Number: 1, Batch/Lot No: EW0211, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 05Jun2021, when the patient was 17 years old, for Covid-19 immunization. The following information was reported: SUDDEN DEATH (death) with onset 24Jan2022 09:00, outcome "fatal", described as "He died suddenly in his sleep". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of death. The patient date of death was 24Jan2022. The cause of death was unknown. The autopsy was performed, and results were not provided. 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.; Sender's Comments: "He died suddenly in his sleep" occurred almost 6 months after vaccination are unrelated to bnt162b2 (BNT162B2). The case will be reassessed once more information become 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.; Reported Cause(s) of Death: He died suddenly in his sleep
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: One of her friends died (67 years old) after getting the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 67 year-old 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: DEATH (death, medically significant), outcome "fatal", described as "One of her friends died (67 years old) after getting the vaccine". The patient date of death was unknown. The reported cause of death was "One of her friends died (67 years old) after getting the vaccine". 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.; Reported Cause(s) of Death: One of her friends died (67 years old) after getting the vaccine
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: dead in bed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774).  A 14 year-old female patient received bnt162b2 (BNT162B2) (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), administration date: Jun2021, for COVID-19 immunization . The following information was reported: DEATH (death) with onset 12Oct2021, outcome "fatal", described as "dead in bed". The patient date of death was 12Oct2021. The reported cause of death was "dead in bed". 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.; Reported Cause(s) of Death: dead in bed
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: You killed my mom, after she got the vaccine. I can't prove it, but you did; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (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: DEATH (death, medically significant), outcome "fatal", described as "You killed my mom, after she got the vaccine. I can't prove it, but you did". The patient date of death was unknown. The reported cause of death was "You killed my mom, after she got the vaccine. I can't prove it, but you did". It was not reported if an autopsy was performed.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: You killed my mom, after she got the vaccine. I can't prove it, but you did
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she also had Covid; she also had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "she also had Covid". Therapeutic measures were taken as a result of covid-19.  Clinical course: It was stated she had 3 doses of the Pfizer Covid 19 vaccine, she also had Covid back in August and received special treatment.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has tested positive for the Covid virus/she has had both Pfizer Covid 19 vaccines and the booster some months ago; she has tested positive for the Covid virus/she has had both Pfizer Covid 19 vaccines and the booster some months ago; 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 (172086). The reporter is the patient.  A 72 year-old 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. 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 "she has tested positive for the Covid virus/she has had both Pfizer Covid 19 vaccines and the booster some months ago". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical information: On an unknown date, the patient also received Paxlovid (considered as co suspect). She wanted to know if it was FDA-approved. Action Taken with Paxlovid was Unknown. She presently was not taking Paxlovid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous; Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 12:00 (Lot number: FFA587) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Major depressive disorders" (unspecified if ongoing), notes: Other medical history: Major depressive disorders; "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites; "Known allergies: cats" (unspecified if ongoing), notes: Known allergies: cats; "anxiety" (unspecified if ongoing), notes: Other medical history: anxiety; "add" (unspecified if ongoing), notes: Other medical history:add; "insomnia" (unspecified if ongoing), notes: Other medical history: insomnia; "PCOS" (unspecified if ongoing), notes: Other medical history: PCOS; "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites. Concomitant medication(s) included: BEYAZ; VYVANSE; BUPROPION; XANEXTRA; ZOLOFT; AMBIEN. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 19Dec2021, outcome "not recovered" and all described as "Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous". The event "unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous" and "unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous" was evaluated at the physician office visit.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: No, Since the vaccination, has the patient been tested for COVID-19: No, Device Date : 13Mar2022.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Heavy menstrual bleeding, Impaired work ability, Menstrual disorder
Clinical narrative: Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous; Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 12:00 (Lot number: FFA587) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Major depressive disorders" (unspecified if ongoing), notes: Other medical history: Major depressive disorders; "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites; "Known allergies: cats" (unspecified if ongoing), notes: Known allergies: cats; "anxiety" (unspecified if ongoing), notes: Other medical history: anxiety; "add" (unspecified if ongoing), notes: Other medical history:add; "insomnia" (unspecified if ongoing), notes: Other medical history: insomnia; "PCOS" (unspecified if ongoing), notes: Other medical history: PCOS; "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites. Concomitant medication(s) included: BEYAZ; VYVANSE; BUPROPION; XANEXTRA; ZOLOFT; AMBIEN. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 19Dec2021, outcome "not recovered" and all described as "Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous". The event "unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous" and "unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous" was evaluated at the physician office visit.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: No, Since the vaccination, has the patient been tested for COVID-19: No, Device Date : 13Mar2022.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound pelvis abnormal, Ureteral wall thickening, Uterine polyp
Clinical narrative: Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous; Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 12:00 (Lot number: FFA587) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Major depressive disorders" (unspecified if ongoing), notes: Other medical history: Major depressive disorders; "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites; "Known allergies: cats" (unspecified if ongoing), notes: Known allergies: cats; "anxiety" (unspecified if ongoing), notes: Other medical history: anxiety; "add" (unspecified if ongoing), notes: Other medical history:add; "insomnia" (unspecified if ongoing), notes: Other medical history: insomnia; "PCOS" (unspecified if ongoing), notes: Other medical history: PCOS; "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites. Concomitant medication(s) included: BEYAZ; VYVANSE; BUPROPION; XANEXTRA; ZOLOFT; AMBIEN. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 19Dec2021, outcome "not recovered" and all described as "Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous". The event "unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous" and "unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous" was evaluated at the physician office visit.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: No, Since the vaccination, has the patient been tested for COVID-19: No, Device Date : 13Mar2022.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Discomfort, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: mild symptoms of a low grade fever; mild general discomfort; Last night my daughter (10) tested positive for covid.; Last night my daughter (10) tested positive for covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2 (tris), single and administration date Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Mar2022, outcome "unknown" and all described as "Last night my daughter (10) tested positive for covid."; PYREXIA (non-serious), outcome "unknown", described as "mild symptoms of a low grade fever"; DISCOMFORT (non-serious), outcome "unknown", described as "mild general discomfort". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Mar2021) positive. Clinical Course was reported as, Last night on 10MAR2022 reporter daughter (10) tested positive for covid. She was vaccinated with both shots of Pfizer vaccine in Dec2021. She was experiencing mild symptoms of a low grade fever and mild general discomfort. It was believed that she was exposed at school where other kids also reported testing positive. Because of privacy policies at school, Reporter did not know which kids tested positive or if they were vaccinated. No one else in his home tested positive or has any symptoms. His wife, other daughter (7) and he were all also vaccinated with Pfizer vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: COVID19+: Yes-positive rapid test last month.; COVID19+: Yes-positive rapid test last month.; 29Jun2021  as dose 2/ 10May2021 as dose 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDCA22-00635.  A male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Jun2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 10May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "MS" (unspecified if ongoing), notes: Infusion every 6 months for MS. Concomitant medication(s) included: OCREVUS taken for multiple sclerosis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2022, outcome "recovered" and all described as "COVID19+: Yes-positive rapid test last month."; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Jun2021, outcome "unknown", described as "29Jun2021  as dose 2/ 10May2021 as dose 1". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Feb2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back injury, Buttock injury, COVID-19, Drug ineffective, Fall
Clinical narrative: COVID; COVID; fell/injured back down to buttocks; fell/injured back down to buttocks; fell/injured back down to buttocks; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4311759-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1156159) for rheumatoid arthritis. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "recovering" and all described as "COVID"; FALL (non-serious), BACK INJURY (non-serious), BUTTOCK INJURY (non-serious) all with onset Jan2022, outcome "recovering" and all described as "fell/injured back down to buttocks". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB)  The reporter's causality for the event(s) of COVID and Fell/Injured back down to buttocks onset in Jan2022 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Fell/Injured back down to buttocks onset in Jan2022 and Fell/Injured back down to buttocks onset in Jan2022 was not provided.  The reporter's assessment of the causal relationship of the (COVID, fell/injured back down to buttocks) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. Based on the current available limited information in the case provided, the causal association between the events fall, back injury and buttock injury and the use of suspect product BNT162B2 cannot be fully excluded.