chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Off label use, Pain, Pyrexia
Clinical narrative: chest tightness no SOB; left extremity numbness; hR 54; headache; could not lay in one position for long due to the pain; fever 100.7; chills; myalgias; 9-14 received booster at 9am; 9-14 received booster at 9am; heartburn; nausea; This is a spontaneous report from a contactable pharmacist (patient).  A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 14Sep2021 at 09:00 as dose 3 (booster), single for COVID-19 immunization. Medical history included PCOS, menopausal symptoms (Currently taking estradiol patch and progesterone 1 po qd for menopausal symptoms) and PCN allergy. Concomitant medication(s) included ongoing estradiol (ESTRADIOL TRANSDERMAL) and progesterone (PROGESTERONE) taken for menopausal symptoms. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 14Feb2021 as dose 2, single for COVID-19 immunization patient experienced similar but not quite as severe reaction after dose 2. On 14Sep2021 at 09:00, patient experienced fever 100.7, chills, myalgias and 9-14 received booster at 9am, on 15Sep2021 headache, could not lay in one position for long due to the pain, on Sep2021 nausea and heartburn, on 17Sep2021 at 01:00, chest tightness no sob, left extremity numbness, hr 54. On 14Sep2021, patient underwent lab tests and procedures which included body temperature resulted 100.7, on 17Sep2021, heart rate resulted 54. Patient took ibuprofen 800mg for headache. The outcome of event headache, nausea and heartburn was not recovered, myalgias was recovered on 16Sep2021, left extremity numbness recovered on 17Sep2021, 9-14 received booster at 9am and hR 54 was unknown, rest all events was recovered on Sep2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Migraine, Nausea, Pain, Vomiting
Clinical narrative: The day after I vomited more than 8 times; The pain got to the point where I had to make 2 different ER visits; I had vision loss and the pain was extreme; Nausea and migraine onset 4 hours after receiving vaccine.; migraine headache; This is a spontaneous report from a contactable consumer (patient himself). A 19-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in Arm Left, at age 19 years, on 02Sep2021 12:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes COVID-19 prior to vaccination. Patient had no known allergies. The patient had family history of migraine, had no personal history of headaches of any kind before the vaccine, but do have family history of migraines. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. On 02Sep2021 at 16:00, patient had nausea and migraine onset 4 hours after receiving vaccine. The day after, on 03Sep2021, patient vomited more than 8 times and nausea and vomiting continued for 3 days after receiving the vaccine. The migraine headache that occurred lasted for 17 days. The pain got to the point where patient had to make 2 different ER visits as patient had vision loss and the pain was extreme. Patient was seen by medical professionals for the headache and was put on medication that helped for a short amount of time, but the headaches have persisted nearly every day for the past 6 weeks, getting to a point that the pain is the worst pain he ever felt. Treatment for the other events was unknown. He had no personal history of headaches of any kind before the vaccine, but do have family history of migraines. Adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Patient recovered with lasting effects. COVID-19 was not tested post vaccination. The outcome of the event nausea and vomiting was recovered/resolved with sequel on 05Sep2021; while for the other events, it was recovered/resolved with sequel on an unspecified date in 2021.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Malaise, Parosmia, Pyrexia, Taste disorder
Clinical narrative: got sick after first dose; Fever; sense of smell, taste and touch became very exasperated/She could feel the threads in the sheets; sense of smell, taste and touch became very exasperated/could not stand the smell of anything; sense of smell, taste and touch became very exasperated; This is a spontaneous report from a sponsored program  support.   A contactable consumer (patient) reported that a 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Lot Number: EW0169) as single dose (at the age of 61-years-old) for COVID-19 immunization. There were no medical history or concomitant medications. The patient got sick after first dose on 24Apr2021, then fever, sense of smell, taste and touch became very exasperated/she could feel the threads in the sheets on an unspecified date in 2021. The patient received first dose of COVID19 vaccine on 19Apr2021. She got sick after the first dose. She was sick for at least 4 weeks. She had a fever for 3 or 4 weeks. Her sense of smell, taste and touch became very exasperated. She could feel the threads in the sheets and could not stand the smell of anything and water even tasted funny. She did go to the hospital and saw primary. Clarified she went to ER and was not admitted. Took a little longer for her sense of smell and taste to get better but fever and sensitive to touch took 4 weeks to recover. She had three fusions in her cervical spine (PENDING CLARIFICATION) on 21Jul2021. She saw the surgeon for follow up and got her second dose on the way home after following up with the surgeon. The events required Emergency Room Visit and Physician Office Visit. The outcome of the event got sick after first dose was recovered on May2021 while for the rest of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pneumonitis, Pulmonary mass
Clinical narrative: nodule in the lung; large chicken pox like blisters; inflammation in the lungs; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient developed large chicken pox like blisters on an unspecified date. She also developed inflammation in the lungs and a nodule in the lung on an unspecified date. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events lung nodule,blisters, Pneumonitis and the suspect drug "BNT162B2" cannot be completely excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested for COVID-19 via PCR on 20Oct2021 and results Positive 21Oct2021.; tested for COVID-19 via PCR on 20Oct2021 and results Positive 21Oct2021.; This is a spontaneous report from a contactable other hcp. A 38-year-old female patient (Age at vaccination 38-years) received BNT162B2 (BNT162B2), dose 3 intramuscular on 31Aug2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE and first dose intramuscular, administered in Arm Left on 23Feb2021 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE and second dose intramuscular, administered in Arm Right on 16Mar2021 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested for covid-19 via pcr on 20Oct2021 and results positive 21Oct2021. Treatment for the events was reported as Unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Oct2021 (Nasal Swab). The outcome of the events was recovering.   The lot number for the vaccine (booster dose) [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory  role of  BNT162B2 to the reported events cannot  be totally excluded.  Case will be reassessed if additional information is received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: bilateral deep veins thrombosis of both legs; had multiple pulmonary emboli; This is a spontaneous report from a contactable physician (patient's spouse). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Right on 01Sep2021 10:00 (at the age of 72 years) (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. Medical history included arthritis and is taking a biological agent called Xeljanz but is not taking it this time, hernia repair in mid-Aug2021. The patient's concomitant medications were not reported. Patient previously took Xeljanz for arthritis. The patient previously received the first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2021. On 01Sep2021, the patient had her third booster shot of Pfizer vaccine and six weeks later, in Oct2021, she had a clotting event. She had an ultrasound that showed bilateral deep veins thrombosis of both legs and had multiple pulmonary emboli as result of that. The patient was hospitalized and she is on anticoagulants. The patient underwent lab tests and procedures which included ultrasound scan: normal in Aug2021 and ultrasound scan: shows bilateral deep veins thrombosis of both legs and had multiple pulmonary emboli as result of that in Oct2021. Therapeutic measures were taken as a result of the events. Outcome of the events was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association and profile of the product the contributory role of the suspect product to reported events is possible.
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Haematochezia, Haemorrhoidal haemorrhage, SARS-CoV-2 antibody test
Clinical narrative: had a lot of blood in her stool; busted hemorrhoid; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information Team and via Pfizer-sponsored program  support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included stroke in 2015, transient ischaemic attacks (TIAs) in 2015, and breast cancer. She reported she had breast cancer in her right breast and they still gave the shot on her right side, after she told them not to. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient reported she had a lot of blood in her stool on an unspecified date and had a colonoscopy a few days before reporting (Oct2021), it was a busted hemorrhoid, she knew it wasn't the vaccine. The patient reported she recently had an antibody test to measure the antibodies that are created against COVID-19 and no antibodies were present. She asked what should she do about booster shot if the first 2 did not give her antibodies. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Choking, Fatigue, Glossodynia
Clinical narrative: choking and spitting up liquid, it was a clear liquid; he drinks a lot of water and thinks that is what he was spitting up.; pain on right side of tongue; from the stomach up there was pain at his stomach on the right side and if he took too big of a breath it would be all across his whole stomach; Muscle pain; Joint pain; Headache; Nausea; Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient).  A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 via an unspecified route of administration, administered in Arm Right on 19Oct2021 13:00 (Batch/Lot Number: FH8020; Expiration Date: 30Apr2022) age at vaccination of 69-years-old, as single dose (booster dose),for covid-19 immunisation.  Medical history was none. The patient received BNT162B2, dose 1 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: I or E followed by N6205) age at vaccination of 68-years-old, as single dose, for covid-19 immunisation and no adverse event occurred (he was completely fine). The patient received  BNT162B2, dose 2 via an unspecified route of administration, administered in Arm Right on 28Mar2021 (Lot Number: ER8727) age at vaccination of 68-years-old, as single dose, for covid-19 immunisation and no adverse event occurred (he was completely fine). The patient received flu shot vaccine, never had a reaction to a vaccine in the past, he gets the flu shot every year. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the booster when driving home he started having muscle pain in his shoulder on 19Oct2021; when he got home he had joint pain, headache, nausea, fever, and fatigue, all on 19Oct2021. The patient felt like he had every side effect a person could have. The patient wasn't throwing up but was choking and spitting up liquid, it was a clear liquid, not bile or phlegm (he drank a lot of water and thought that is what he was spitting up) on an unspecified date. The patient took medication daily but has had no changes (as reported). It was also noted he had pain on right side of tongue on an unspecified date, from the stomach up there was pain at his stomach on the right side and if he took too big of a breath it would be all across his whole stomach. No emergency room nor physician office visit required. was confirmed all events have resolved on 22Oct2021 except the fatigue that was resolving (as of this morning it is a little bit better).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: choking and spitting up liquid, it was a clear liquid; he drinks a lot of water and thinks that is what he was spitting up.; pain on right side of tongue; from the stomach up there was pain at his stomach on the right side and if he took too big of a breath it would be all across his whole stomach; Muscle pain; Joint pain; Headache; Nausea; Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient).  A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 via an unspecified route of administration, administered in Arm Right on 19Oct2021 13:00 (Batch/Lot Number: FH8020; Expiration Date: 30Apr2022) age at vaccination of 69-years-old, as single dose (booster dose),for covid-19 immunisation.  Medical history was none. The patient received BNT162B2, dose 1 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: I or E followed by N6205) age at vaccination of 68-years-old, as single dose, for covid-19 immunisation and no adverse event occurred (he was completely fine). The patient received  BNT162B2, dose 2 via an unspecified route of administration, administered in Arm Right on 28Mar2021 (Lot Number: ER8727) age at vaccination of 68-years-old, as single dose, for covid-19 immunisation and no adverse event occurred (he was completely fine). The patient received flu shot vaccine, never had a reaction to a vaccine in the past, he gets the flu shot every year. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the booster when driving home he started having muscle pain in his shoulder on 19Oct2021; when he got home he had joint pain, headache, nausea, fever, and fatigue, all on 19Oct2021. The patient felt like he had every side effect a person could have. The patient wasn't throwing up but was choking and spitting up liquid, it was a clear liquid, not bile or phlegm (he drank a lot of water and thought that is what he was spitting up) on an unspecified date. The patient took medication daily but has had no changes (as reported). It was also noted he had pain on right side of tongue on an unspecified date, from the stomach up there was pain at his stomach on the right side and if he took too big of a breath it would be all across his whole stomach. No emergency room nor physician office visit required. was confirmed all events have resolved on 22Oct2021 except the fatigue that was resolving (as of this morning it is a little bit better).
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: I received the first Pfizer shot in April of 2020 and got Covid about 4 to 5 days later.; This is a spontaneous report from a contactable consumer (patient); this report regards event under bnt162b2.  A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on Apr2020 (also reported as Mar or Apr) as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient received the first shot in Apr2020 and got Covid about 4 to 5 days later (unknown date in 2020). While ill she received an infusion of Monoclonal antibodies over the course of several hours. The final outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Aplastic anaemia, Bone marrow disorder, Pancytopenia, SARS-CoV-2 test
Clinical narrative: severe pancytopenia; bone marrow consistent with aplastic anemia; bone marrow consistent with aplastic anemia; This is a spontaneous report from a contactable physician. A 13-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration in Aug2021, 4 weeks after the first vaccine dose, at 13 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (Batch/Lot number was not reported), administered in early Aug2021, at 13 years of age, as single dose for COVID-19 immunization, after which she had heavy menses and developed fatigue. The patient didn't receive any other vaccine in the previous 4 weeks. Within 2 weeks after the second vaccine dose, the patient noted to have severe pancytopenia, bone marrow consistent with aplastic anemia. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized for 7 days and she received blood transfusion. The patient had not recovered yet from the reported events at the time of the report. In Aug2021 the patient underwent SARS-CoV-2 test via Nasal swab, which resulted negative.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101427272 same patient/drug, different vaccine dose/event
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Alopecia, Autoimmune disorder, Blood iron, Blood iron decreased
Clinical narrative: Idiopathic Pulm fibrosis; Gi distention/loss of ability to eat; loss of ability to eat; Hbg from 11 to 8.9; dramatic drop in iron/ferritin; dramatic drop in iron/ferritin; auto-immune inflammatory response; auto-immune inflammatory response; hair loss; pale/pallor appearance; short of breath; This is a spontaneous report from a contactable nurse (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 23Feb2021 17:00 (Lot Number: EN8203), at the age of 73-years-old, as dose 2, single for covid-19 immunisation. 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 and since the vaccination, the patient had not been tested for COVID-19. Medical history included Idiopathic thrombocytopenic purpura from 2003, lupus from 2004, hypertension from 2020. Concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported, and Multivits. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 28Jan2021 17:00 (Lot Number: EN6203), at the age of 73-years-old, as dose 1, single for covid-19 immunisation. The patient has known allergies to penicillin and  tetracycline. The patient reported having lupus and 3-4 months after last dose, in Jun2021 had an auto-immune inflammatory response, hair loss, pale/pallor appearance, short of breath. Later labs and tests showed in Aug2021 drop in hemoglobin (Hbg) from 11 to 8.9./ dramatic drop in iron/ferritin, gastrointestinal (GI) distention/loss of ability to eat, and computerized tomography (CT) scan showed new development of Idiopathic Pulmonary fibrosis. The events were reported as non serious. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. Treatment was received for the events. And new consults with primary, Hematology, GI (gastrointestinal), Rheumatology was required. The patient was recovering from the events.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported events 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Feeding disorder, Haemoglobin, Haemoglobin decreased
Clinical narrative: Idiopathic Pulm fibrosis; Gi distention/loss of ability to eat; loss of ability to eat; Hbg from 11 to 8.9; dramatic drop in iron/ferritin; dramatic drop in iron/ferritin; auto-immune inflammatory response; auto-immune inflammatory response; hair loss; pale/pallor appearance; short of breath; This is a spontaneous report from a contactable nurse (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 23Feb2021 17:00 (Lot Number: EN8203), at the age of 73-years-old, as dose 2, single for covid-19 immunisation. 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 and since the vaccination, the patient had not been tested for COVID-19. Medical history included Idiopathic thrombocytopenic purpura from 2003, lupus from 2004, hypertension from 2020. Concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported, and Multivits. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 28Jan2021 17:00 (Lot Number: EN6203), at the age of 73-years-old, as dose 1, single for covid-19 immunisation. The patient has known allergies to penicillin and  tetracycline. The patient reported having lupus and 3-4 months after last dose, in Jun2021 had an auto-immune inflammatory response, hair loss, pale/pallor appearance, short of breath. Later labs and tests showed in Aug2021 drop in hemoglobin (Hbg) from 11 to 8.9./ dramatic drop in iron/ferritin, gastrointestinal (GI) distention/loss of ability to eat, and computerized tomography (CT) scan showed new development of Idiopathic Pulmonary fibrosis. The events were reported as non serious. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. Treatment was received for the events. And new consults with primary, Hematology, GI (gastrointestinal), Rheumatology was required. The patient was recovering from the events.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported events 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Idiopathic pulmonary fibrosis, Inflammation, Pallor, Serum ferritin, Serum ferritin decreased
Clinical narrative: Idiopathic Pulm fibrosis; Gi distention/loss of ability to eat; loss of ability to eat; Hbg from 11 to 8.9; dramatic drop in iron/ferritin; dramatic drop in iron/ferritin; auto-immune inflammatory response; auto-immune inflammatory response; hair loss; pale/pallor appearance; short of breath; This is a spontaneous report from a contactable nurse (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 23Feb2021 17:00 (Lot Number: EN8203), at the age of 73-years-old, as dose 2, single for covid-19 immunisation. 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 and since the vaccination, the patient had not been tested for COVID-19. Medical history included Idiopathic thrombocytopenic purpura from 2003, lupus from 2004, hypertension from 2020. Concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported, and Multivits. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 28Jan2021 17:00 (Lot Number: EN6203), at the age of 73-years-old, as dose 1, single for covid-19 immunisation. The patient has known allergies to penicillin and  tetracycline. The patient reported having lupus and 3-4 months after last dose, in Jun2021 had an auto-immune inflammatory response, hair loss, pale/pallor appearance, short of breath. Later labs and tests showed in Aug2021 drop in hemoglobin (Hbg) from 11 to 8.9./ dramatic drop in iron/ferritin, gastrointestinal (GI) distention/loss of ability to eat, and computerized tomography (CT) scan showed new development of Idiopathic Pulmonary fibrosis. The events were reported as non serious. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. Treatment was received for the events. And new consults with primary, Hematology, GI (gastrointestinal), Rheumatology was required. The patient was recovering from the events.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported events 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Hypoaesthesia
Clinical narrative: she was not able to speak afterward and then the left side of her face was numb; she was not able to speak afterward and then the left side of her face was numb; This is a spontaneous report from a contactable pharmacist. A 32-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 15Sep2021 (Batch/Lot Number: FF2588; Expiration Date: Dec2021) as DOSE 1, 0.3 ML SINGLE (at the age of 32 years) for covid-19 vaccination. The patient has no medical and family history. There were no concomitant medications. Later on 15Sep2021 (in the evening), the patient was not able to speak afterward and then the left side of her face was numb. The patient went to bed and when she got up everything had turned to normal. The outcome of the events was recovered on 16Sep2021.   Follow-up attempts are completed. No further information is expected. Information about batch/lot number already obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events  Hypoesthesia, Aphasia  and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Speech disorder
Clinical narrative: she was not able to speak afterward and then the left side of her face was numb; she was not able to speak afterward and then the left side of her face was numb; This is a spontaneous report from a contactable pharmacist. A 32-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 15Sep2021 (Batch/Lot Number: FF2588; Expiration Date: Dec2021) as DOSE 1, 0.3 ML SINGLE (at the age of 32 years) for covid-19 vaccination. The patient has no medical and family history. There were no concomitant medications. Later on 15Sep2021 (in the evening), the patient was not able to speak afterward and then the left side of her face was numb. The patient went to bed and when she got up everything had turned to normal. The outcome of the events was recovered on 16Sep2021.   Follow-up attempts are completed. No further information is expected. Information about batch/lot number already obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events  Hypoesthesia, Aphasia  and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Neoplasm malignant, Scan
Clinical narrative: he has 7 spots/he might have Stage 4 cancer; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in arm left on 30Sep2021 (Batch/Lot Number: EW0185) (at age 82-years-old) as dose 3 (booster), single for covid-19 immunisation. The patient received the first dose on 30Jan2021 (lot number: EL9262) and the 2nd dose on 10Feb2021 (lot number: EL9266); both at age 81-years-old. The patient medical history was not reported. Concomitant medication(s) included nitric oxide (NITRIC OXIDE) taken for an unspecified indication, start and stop date were not reported.  On Oct2021 (reported as either 10Oct2021 or 11Oct2021), patient developed a bump on his back the left side, everything was on his left side. He saw one on his neck as well as his left knee measuring "16 inches by something". There was something on his upper arm which developed about 3 days ago. They just got back from the hospital where a full body scan done and they said he has 7 spots, but reporter does not know where they all were and they are telling them that he might have Stage 4 cancer. Patient was getting biopsy back on Monday or Tuesday (unspecified date). Reporter was wondering if this could be from the vaccine. Patient did not remember what side he received the vaccine on but he stated usually gets things like that on his left side because he uses his right arm to write so this way if his arm was sore it won't bother him as much. Patient has not had any new bumps developed in the couple of days since then. The event results in hospitalization and emergency room and physician's office visit. Clinical course were reported as: Patient went to the emergency room three times and out after three days there, he was hospitalized from 19Oct-21Oct2021 and thought he had stage IV cancer and he was in pain and all this stuff and these things is the reason for the hospitalization. He went to the ER and it showed his neck and left leg about 9:30pm at night on 12Oct2021 and said his bloodwork was fine and he has fast growing cancer. They then told him to go to the HCP office and get a biopsy; the ER told him to go to the dermatologist on Monday and they went and the dermatologist did the biopsy which said there was malignancy there from the little bump on his shoulder and the one on his neck but did not biopsy the big one. A couple of days later got a bump on his arm and they went to again in the hospital to be admitted and for care and to not let this go on and he had been in the hospital for three days and came home last night. Outcome of the event was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia oral, Paraesthesia oral, Peripheral swelling, Urticaria
Clinical narrative: severe allergic reaction; hives; swollen fingers; numbing lips; tingling tongue; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System . A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 11Feb2021, at 14:00 (Batch/Lot Number: CL9264; at the age of 65 years old) as dose 2, single for COVID-19 immunisation. The patient has no relevant medical history and concomitant medications. He did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2, administered in the right arm on 22Jan2021, at 15:00 (Batch/Lot Number: CL3248; at the age of 65 years old) for COVID-19 immunisation. The patient reported that he has never had any allergic reaction before he had the vaccine. On an unspecified date in 2021, after the second shot, he had a fish (tilapia) taco and had a severe allergic reaction, hives, swollen fingers, numbing lips, and tingling tongue. The events were reported as non-serious by the consumer. The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. The patient took diphenhydramine hydrochloride (BENEDRYL) and went to an emergency clinic and was given a shot of diphenhydramine hydrochloride and steroid. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He tested positive for COVID in October, after being vaccinated in early 2020.; He tested positive for COVID in October, after being vaccinated in early 2020.; This is a spontaneous report from a contactable consumer. An adult male patient received the first and second doses of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration in early 2021 (Batch/Lot number was not reported for neither of the two doses) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID in Oct2021, after being vaccinated in early 2021. Th event resulted in Doctor or other healthcare professional office/clinic visit. The event outcome was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Immunisation
Clinical narrative: Severe chills; Fevers went up to 103 deg. F; Postural hypotension; faintness and lightheadedness; Headache; administered with dose 3 or booster shot; This is a spontaneous report from a contactable pharmacist (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: FF2590; Expiration date was not reported), via an unspecified route of administration in the left arm on 16Oct2021 03:00 PM (at the age of 55-years-old) as dose 3 (booster), single for COVID-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy or drug store. The patient has no relevant medical history. Concomitant medication included influenza vaccine (FLU) via unspecified route of administration in the left arm on 05Oct2021 as single dose for influenza immunization. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 21Jan2021 (at the age of 54-years-old; Lot number: El1283; Expiration date was not reported) as dose 2, single and on 31Dec2020 (at the age of 54-years-old; Lot number: Ej1685; Expiration date was not reported) as dose 1, single, both via an unspecified route of administration in the left arm and for COVID-19 immunisation. It was reported that the patient did not have any reaction to the first 2 Pfizer-BioNTech vaccines. The patient previously took Aspirin and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Oct2021 03:00 PM, the patient was administered with dose 3 or booster shot of BNT162B2. On 17Oct2021 03:00 AM, 12 hrs after the booster shot, the patient experienced severe chills, fevers went up to 103 degrees Fahrenheit, postural hypotension leading to faintness and lightheadedness lasting 48hrs and headache lasting 72 hrs. Fevers lasted 3 days despite acetaminophen and ibuprofen round the clock. Events were reported as non-serious by the reporter. Treatment with acetaminophen and ibuprofen round the clock was taken for event fevers went up to 103 degrees Fahrenheit and no treatment was taken for the other events. The outcome of event severe chills was recovered on an unspecified date in Oct2021, outcome of event fevers went up to 103 degrees Fahrenheit was recovered on 20Oct2021, outcome of events postural hypotension leading to faintness and lightheadedness was recovered on 19Oct2021 03:00 AM and outcome of event headache was recovered on 20Oct2021 03:00 AM.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Orthostatic hypotension, Pyrexia
Clinical narrative: Severe chills; Fevers went up to 103 deg. F; Postural hypotension; faintness and lightheadedness; Headache; administered with dose 3 or booster shot; This is a spontaneous report from a contactable pharmacist (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: FF2590; Expiration date was not reported), via an unspecified route of administration in the left arm on 16Oct2021 03:00 PM (at the age of 55-years-old) as dose 3 (booster), single for COVID-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy or drug store. The patient has no relevant medical history. Concomitant medication included influenza vaccine (FLU) via unspecified route of administration in the left arm on 05Oct2021 as single dose for influenza immunization. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 21Jan2021 (at the age of 54-years-old; Lot number: El1283; Expiration date was not reported) as dose 2, single and on 31Dec2020 (at the age of 54-years-old; Lot number: Ej1685; Expiration date was not reported) as dose 1, single, both via an unspecified route of administration in the left arm and for COVID-19 immunisation. It was reported that the patient did not have any reaction to the first 2 Pfizer-BioNTech vaccines. The patient previously took Aspirin and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Oct2021 03:00 PM, the patient was administered with dose 3 or booster shot of BNT162B2. On 17Oct2021 03:00 AM, 12 hrs after the booster shot, the patient experienced severe chills, fevers went up to 103 degrees Fahrenheit, postural hypotension leading to faintness and lightheadedness lasting 48hrs and headache lasting 72 hrs. Fevers lasted 3 days despite acetaminophen and ibuprofen round the clock. Events were reported as non-serious by the reporter. Treatment with acetaminophen and ibuprofen round the clock was taken for event fevers went up to 103 degrees Fahrenheit and no treatment was taken for the other events. The outcome of event severe chills was recovered on an unspecified date in Oct2021, outcome of event fevers went up to 103 degrees Fahrenheit was recovered on 20Oct2021, outcome of events postural hypotension leading to faintness and lightheadedness was recovered on 19Oct2021 03:00 AM and outcome of event headache was recovered on 20Oct2021 03:00 AM.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Heavy menstrual bleeding, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Severe joint pain in fingers and toes; Unable to use hands at times due to severity of pain. Pain was more severe than the time I broke my finger; Unable to use hands at times due to severity of pain. Pain was more severe than the time I broke my finger; Menstrual bleeding that lasted three months; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 36-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Ew0196) via an unspecified route of administration, administered in arm left on 07Jul2021 at 18:00 (at the age of 36 years old) as dose 2, single for COVID-19 immunization. Medical history included chronic fatigue syndrome and post-traumatic stress disorder. Concomitant medications included baclofen and clobazam. No known allergies. The patient previously received BNT162B2 (Lot number: Ew0191) administered on arm left on 18Jun2021 (at the age of 36 years old) as dose 1, single for COVID-19 immunization. On 30Jul2021, the patient experienced severe joint pain in fingers and toes, unable to use hands at times due to severity of pain and that pain was more severe than the time patient broke her finger and menstrual bleeding that lasted three months. The patient underwent lab tests and procedures which included nasal swab: negative on an unspecified date. Patient had no other vaccine in four weeks. Patient had no COVID prior vaccination and was COVID test post vaccination. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered with no treatment received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: menstrual cycle  unusually heavy /bleeding has Not Stopped as of today's date; menstrual cycle... unusually heavy, severe cramps; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3181), via an unspecified route of administration in Arm Left on 03Sep2021 at 10:00 (at 49 years) as single dose for covid-19 immunisation.  Patient had known allergies to Penicillin and Codeine. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included semaglutide (RYBELSUS) taken for an unspecified indication, start and stop date were not reported. Previously 13Aug2021 at 10:00 am (at 49 years) the patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3180), via an unspecified route of administration in Arm Right for covid-19 immunisation.On 06Sep2021 (within 3 days of second shot, as reported) the patient started menstrual cycle, unusually heavy, severe cramps and bleeding has not stopped as of 22Oct2021. This was debilitating . There was no way she could hold a job with these effects. No treatment given and patient not recovered from the events.No follow-up attempts are needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Investigation, Neoplasm, Neoplasm malignant
Clinical narrative: He has been diagnosed with stage 4 cancer; lumps all over the left side of his body; some on his neck, back, arms, a very large one on his left leg that is wrapped around the muscle in his leg.; Her dad took the booster shot; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: Unknown) via unspecified route on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received Dose 1 and Dose 2 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on unspecified dates as single doses for COVID-19 immunization. It was reported that the patient took the booster shot and he has now developed lumps all over the left side of his body; some on his neck, back, arms, a very large one on his left leg that is wrapped around the muscle in his leg. He has been diagnosed with stage 4 cancer. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.