chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Loss of consciousness, Pyrexia
Clinical narrative: passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contactable consumer reporting for self. A 53-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:00 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient received the first dose, administered in Arm Left on 08Mar2021 09:45 (Batch/Lot Number: EN6205). The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported. The patient experienced passed out, chills, shakes, fever, headache, tiredness 30Mar2021 08:30. Outcome of events was recovering.   Follow-up attempts are needed. Information on lot/Batch number was obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contactable consumer reporting for self. A 53-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:00 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient received the first dose, administered in Arm Left on 08Mar2021 09:45 (Batch/Lot Number: EN6205). The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported. The patient experienced passed out, chills, shakes, fever, headache, tiredness 30Mar2021 08:30. Outcome of events was recovering.   Follow-up attempts are needed. Information on lot/Batch number was obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got the 2 doses of Pfizer vaccine 6 weeks ago and now has covid; now has covid; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation. Medical history included cancer. The patient's concomitant medications were not reported. On an unspecified date, the patient got covid after she received the 2 doses of pfizer vaccine 6 weeks ago. The outcome of event was unknown.   Information on the lot/batch number has been requested. Follow up attempts are needed.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: redness on the skin; This is a spontaneous report received from a Pfizer- sponsored program. A contactable consumer (patient) reported for herself that she received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on 02Mar2021 as single dose for covid-19 immunisation, second dose on 23Mar2021 for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient had her 1st dose on 02Mar2021 and experienced mild reactions like redness on the skin. She received the 2nd dose on 23Mar2021 and she thinks that she did not receive the full dose because she felt the vaccine shot drip down on her skin and she mentioned after the 2nd dose, she experienced no adverse events at all. She wants to know if it's okay. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he got COVID; he got COVID; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that he got Covid on an unspecified date in 2021 with unknown outcome. He was asking if he was supposed to get his 2nd dose.  Information on the lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscularly, administered in the left arm on 23Feb2021 at 11:32 (Batch/Lot Number: EN5318) at 86-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  Medical history included hypertension from 1981 and ongoing, ongoing High cholesterol from an unspecified date (" not sure 40 yrs. ago"). There were no concomitant medications. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 02Feb2021 (first dose, right arm, intramuscularly, Lot Number: EN5318 11:30).On an unspecified date in 2021 (also reported as 08Feb2021), the patient experienced fatigue (non-serious); with no treatment received. The clinical course was reported as follows: The adverse events occurred six days after the first vaccination, which kept the patient in bed for half a day. At which time her appetite returned, and the dizziness and nausea stopped. It really did not seem significant now, because after the second dose, the patient had no reaction at all; not even a sore arm, except feeling tired (as reported). There were no relevant tests. The clinical outcome of the event was recovered on an unspecified date. The patient considered that the bnt162b2 had a causal effect to the adverse event.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: patient experienced numbness on left side of face along with left arm from neck down entire arm; This is a spontaneous report from a Pfizer via male consumer (patient) of unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot no. unknown, Expiration date: unknown), via an unspecified route of administration on 28MAR2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. It was reported that after first dose patient experienced numbness on left side of face along with left arm from neck down entire arm on an unspecified date in 2021. The outcome of the events was unknown.  No Follow-up attempts made. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia
Clinical narrative: diagnosed with COVID with a 101F fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient received the first dose of Pfizer's COVID vaccine on 15Mar2021 with no problems. On 24Mar2021, she was diagnosed with COVID with a 101 Fahrenheit fever. She had an appointment on 06Apr2021 for the second dose, but would have to quarantine until 08Apr2021. She was asking when she could have the second dose. The patient stated her daughter was 19 years old and had allergic reactions to Zithromax, Augmentin, and amoxicillin and was asking if it was safe for her to receive Pfizer's COVID vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dysphagia, Illness, Vomiting
Clinical narrative: Vomiting; diarrhea; chills; became very I'll; Could not even sip water; This is a spontaneous report received from Pfizer. A contactable consumer (Patient) reported that a 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the she became very I'll after her first shot. Vomiting, diarrhea and chills. Could not even sip water. She was a sixty year old female. Very afraid of second dose. Outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature fluctuation, Depressed mood, Fatigue, Feeling abnormal
Clinical narrative: irritability; tinnitus; body temperature fluctuations with no fever; suicidal ideation; Extreme fatigue; depressed mood; brain fog; This is a spontaneous report from a contactable other hcp (patient). A 30-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced suicidal ideation, extreme fatigue, depressed mood, brain fog, irritability, tinnitus, body temperature fluctuations with no fever on 28Mar2021. The patient underwent lab tests and procedures which included body temperature: fluctuations with no fever on 28Mar2021. No treatment was received for the events. The reporter considered the events as non-serious. The event outcome was recovering. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Considering close temporal association, a possible contributory role of bnt162b2 to the reported events cannot be completely excluded. However the clinical course, relevant medical history and concomitant medications are pending for a medically meaningful assessment.   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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Suicidal ideation, Tinnitus
Clinical narrative: irritability; tinnitus; body temperature fluctuations with no fever; suicidal ideation; Extreme fatigue; depressed mood; brain fog; This is a spontaneous report from a contactable other hcp (patient). A 30-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced suicidal ideation, extreme fatigue, depressed mood, brain fog, irritability, tinnitus, body temperature fluctuations with no fever on 28Mar2021. The patient underwent lab tests and procedures which included body temperature: fluctuations with no fever on 28Mar2021. No treatment was received for the events. The reporter considered the events as non-serious. The event outcome was recovering. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Considering close temporal association, a possible contributory role of bnt162b2 to the reported events cannot be completely excluded. However the clinical course, relevant medical history and concomitant medications are pending for a medically meaningful assessment.   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.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: fatigue; fever; pain at the injection site; lumbar pain; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:30 (Batch/Lot Number: EP6955) as single dose for Covid-19 immunisation. Medical history included allergies to Voltaren. Not pregnant at the time of vaccination. Historical Vaccine included first dose of BNT162B2 on 09Mar2021 Administration time: 09:30 AM, Lot number: EL3247, Vaccine location: Left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fatigue, fever, pain at the injection site and lumbar pain on 30Mar2021. Since the vaccination, the patient had not been tested for COVID-19. The event outcome was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, COVID-19
Clinical narrative: appendicitis; This is a spontaneous report from a contactable consumer (patient).   A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 66-year-old via an unspecified route of administration, administered in Arm Right on 10Mar2021 15:15 (Lot Number: EN6199) as single dose for covid-19 immunisation.  Medical history included High blood pressure, asthma. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. No known allergies. Concomitant medication included lisinopril received within 2 weeks of vaccination. The patient previous received first dose of BNT162B2 (Lot Number: EL9267) in Right arm on 17Feb2021 15:15 as single dose for covid-19 immunisation. The patient experienced appendicitis on 13Mar2021, resulted in Emergency room/department or urgent care.  The patient was hospitalized for appendicitis for 2 days. The patient had an appendectomy. The patient underwent lab tests and procedures which included covid-19 (Nasal Swab): negative on 16Mar2021.  The outcome was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: upset stomach; This is a spontaneous report received from a Pfizer sponsored program. A contactable female consumer reported for her mother (patient) age 86 years that she received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for Injection) via an unspecified route of administration as a SINGLE DOSE on unspecified date in 2021 (reported as a week ago) for COVID-19 immunization. Medical history included the first dose of BNT162B2 for COVID-19 immunization. The patient concomitant medications were not reported. Approximately on an unknown date in 2021, the patient, was having an upset stomach and wanted to know if this was caused by the vaccine. The outcome of the event upset stomach was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Photophobia
Clinical narrative: I have experienced what seems like an excellerated cataract deterioration; I am also experiencing a high sensitivity to light.; This is a spontaneous report from a contactable nurse (patient). A 70-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm at age of 70-year-old on 27Feb2021 10:00 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. There were no concomitant medications. The patient previously took first dose of bnt162b2 at age of 70-year-old on 06Feb2021 10:30 in left arm for Covid-19 immunization. Patient had experienced what seems like an excellerated cataract deterioration on 01Mar2021. Patient was also experiencing a high sensitivity to light on 01Mar2021. Seriousness Criteria was disability. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported events and bnt162b2 cannot be fully excluded. Case will be reassessed when additional information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Fatigue
Clinical narrative: deep vein thrombosis on Sunday; Extreme fatigue on Friday; This is a spontaneous report received from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via unspecified route on left arm single dose for COVID-19 immunization on 17Mar2021, 10:45 AM, at 72-year-old. Medical history was not reported. The patient had not had COVID prior vaccination. Concomitant medications in two weeks included: fluoxetine 20 mg; atorvastatin 10 mg. The patient had not had other vaccine in four weeks. The patient previously took morniflumate (FLOMAX) and had allergy to it. The patient was extreme fatigue on Friday 19Mar2021 and deep vein thrombosis on Sunday 21Mar2021 06:00 PM. I was hospitalized for two days including a veinogram to remove the blood clots from my left leg. I'm now taking rivaroxaban (XARELTO) 15 mg twice a day and were wearing a compression sock for my left leg. Treatment also received as IV heparin. Emergency room/department or urgent care involved and reported as serious due to hospitalization for 2 days. The patient had not had COVID tested post vaccination. Outcome of the events was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: she felt a tingling sensation on her elbow down to her hand; she experienced numbing of the pinky and ring finger on her left; This is a spontaneous report from a contactable consumer or other non hcp (Patient) via Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via an unspecified route of administration on 28Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient experienced numbing of the pinky and ring finger on her left arm where she was injected; in addition, she felt a tingling sensation on her elbow down to her hand. The second dose is scheduled on April 18. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: She did not get her period she may be PG (she has not tested yet); This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, received first covax on 24Mar. She did not get her period she may be PG (she has not tested yet) and is asking if there is any information on pregnancy . The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, SARS-CoV-2 test negative, Troponin, Troponin increased
Clinical narrative: Chest Pain as a Result of Elevated Troponin Levels Caused by Myocarditis; Chest Pain as a Result of Elevated Troponin Levels Caused by Myocarditis; Chest Pain as a Result of Elevated Troponin Levels Caused by Myocarditis; This is a spontaneous report from Pfizer Sponsored Patient Support Program. A contactable consumer (patient) reported for himself that a 43-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), via an unspecified route of administration at the age of 43-year-old at arm left on 09Mar2021 14:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. The patient wasn't allergies to medications, food, or other products. Concomitant medications included metoprolol tartrate and vitamin D NOS. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202) at left arm on 15Feb2021 6:00 PM for COVID-19 immunisation. The patient experienced chest pain as a result of elevated troponin levels caused by myocarditis on 27Mar2021 14:00. The events were serious for being hospitalized (duration 3 days). The adverse events result in Emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests included nasal swab: negative on 29Mar2021. The patient was received treatment (Heparin, Nitroglycerin and Cardiac Catheterization) for events. The outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Pain in extremity
Clinical narrative: sore lump on her right arm and it hurts when it is touched; sore lump on her right arm and it hurts when it is touched; This is a spontaneous report from a contactable consumer. An 83-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration in right arm on 16Mar2021 at single dose for COVID-19 immunization. The patient medical history included hip problem, back burn injury and hypertensive (a patch for high blood pressure). Concomitant medications included certain medications. She gets epidural shots for three months now. The patient experienced sore lump on her right arm and it hurts when it is touched on an unspecified date in 2021. The outcome of the event was unknown. She is scheduled to get her second dose on 06Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Full blown shingles outbreak 5 days after second shot; This is a spontaneous report received from a contactable consumer (patient himself). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Lot Number: EN6205) (at age of 73-year-old) as single dose for COVID-19 immunization. Medical history included Heart stint. There was no allergies to medications, food, or other products.  The patient previously took the first dose of BNT162B2 on unknown date (lot number: unknown) for COVID-19 immunization. The patient concomitant drug was not reported. The patient experienced full blown shingles outbreak 5 days after second shot on 12Mar2021 10:00.  The event was reported as serious with seriousness criteria disability. The event resulted in Doctor or other healthcare professional office/clinic visit.  Therapeutic measures were taken as a result of 'full blown shingles outbreak 5 days after second shot' includes acyclovir, cababpentin, advil, creams.  Prior to vaccination, the patient  was not diagnosed with COVID-19. Since the vaccination, the patient has not  been tested for COVID-19. The event outcome was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling cold
Clinical narrative: My father felt like he had a cold, gave him the test; Somewhere between 13th to 15th they go the covid virus; Somewhere between 13th to 15th they go the covid virus; This is a spontaneous report from a contactable consumer received via medical information team. A 71-year-old male patient received first dose of bnt162b2 (Formulation: Solution for injection), via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced somewhere between 13th to 15th they go the covid virus. On an unspecified date the patient experienced my father felt like he had a cold, gave him the test. Calling on behalf of his parents who received the first dose of the Pfizer covid vaccine on 01Feb2021. Somewhere between 13th to 15th they go the covid virus. My father felt like he had a cold, gave him the test. The patient did not receive any treatment for the events. The outcomes of events the events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Epistaxis, Pharyngeal haemorrhage
Clinical narrative: Blood was coming out both nostrils and down throat and could not be stopped without intervention; went to emergency room with gushing bloody nose that would stop. Blood was coming out both nostrils and down throat and could not be stopped without intervention; Bruising also noticed on arm and leg; This is a spontaneous report from a contactable HCP (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:00 (Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included Allergic to penicillin (body rash). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) for Allergy pills and multi-vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took bnt162b2 dose 1 in arm left on 04Mar2021 (lot number: EN6198) for covid-19 immunization. The patient experienced blood was coming out both nostrils and down throat and could not be stopped without intervention, went to emergency room with gushing bloody nose that would stop, bruising also noticed on arm and leg on 30Mar2021 16:00. Reported as: On Tuesday 30Mar2021 went to emergency room with gushing bloody nose that would stop. Blood was coming out both nostrils and down throat and could not be stopped without intervention. Bruising also noticed on arm and leg.  Bleeding resumed after returning home from ER, used Afrin to stop (Afrin up both nostrils).  Now stabilize. The adverse event result in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected; Sender's Comments: The events "blood was coming out both nostrils and down throat" most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when additional information becomes 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Shaking chills; vomiting; fever; extreme achiness; This is a spontaneous report received from a contactable consumer reporting for herself. A 69year old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 26Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient did not have underlying conditions and rarely get ill. The patient's concomitant medications were not reported. On Mar2021 (10 hours after vaccination), the patient experienced shaking chills for about 3 hours, vomiting, fever, extreme achiness etc. which lasted about 22 hours. The outcome of the events was unknown.               No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: 1st shot, she experienced nausea and pain; 1st shot, she experienced nausea and pain; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. An 85-year-old female patient received first dose of bnt162b2, Solution for injection (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced nausea and pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Rhinorrhoea
Clinical narrative: random pain in the lymph nodes in neck.; Very Runny Nose for a week.; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer.     A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) single dose for covid-19 immunization. Medical history included Sjogren's from an unknown date and inadequate mucus from an unknown date. The patient's concomitant medications were not reported. The patient experienced random pain in the lymph nodes in neck and very runny nose for a week on an unspecified date. The outcome of random pain in the lymph nodes in neck and very runny nose for a week was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: a-fib/ heart condition; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 04Mar2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she got her first shot on 04Mar2021 and is supposed to get her second shot. Since her first shot, she ended up in the ICU for 2 days and now has a-fib (in Mar2021) and they don't know what caused it. She was put on blood thinners, two different ones, and was put on a heart monitor. She had to be hospitalized due to heart condition. Clarified heart condition was not preexisting. She asked if she can get the second dose of the vaccine with the heart monitor. She asked if she can get the vaccine if she is on a blood thinner. Therapeutic measures were taken as a result of the event and included blood thinners and heart monitor. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood count, Dizziness, Lymph node pain, Pain
Clinical narrative: lightheaded for 2-3 weeks; sore under armpits (lymph nodes); The pain at times is bad; This is a spontaneous report from a contactable consumer. This 66-year-old female consumer reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW6200) on 19Mar2021 at left arm for COVID-19 immunisation. Medical history included high cholesterol and allergies: Sulfar, penicillin. Historical vaccine included 1st dose of BNT162B2 (lot EL9262) on 26Feb2021 at left arm for COVID-19 immunisation with adverse event lightheaded and dizzy. Concomitant drugs included ibuprofen, simvistatin, paracetamol (TYLENOL) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient was lightheaded for 2-3 weeks, sore under armpits (lymph nodes) which was still effecting her 2 weeks after the second dose was administered. Event resulted in Doctor or other healthcare professional office/clinic visit and no treatment was received except paracetamol or Ibuprofen for pain. She was concerned about this because it was affecting her life and job. The pain at times was bad (She used heating pad to relieve pain). The patient reported lightheaded, dizzy and pain underneath the arm pits, she guessed in the lymph nodes. She was curious as to how long those lymph node pains were going to be around because sometimes it's so painful that she thought she was having a heart attack but people say - No, that's lymph node which is going into your breast. She was concerned about how long this was going to be happening to her or what she was supposed to be doing. Covid test with nasal swab on 17Mar2021 was negative. The patient had complete blood count, urine analysis, Lipid Panel for Cholesterol. The outcome of the events was not resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urine analysis
Clinical narrative: lightheaded for 2-3 weeks; sore under armpits (lymph nodes); The pain at times is bad; This is a spontaneous report from a contactable consumer. This 66-year-old female consumer reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW6200) on 19Mar2021 at left arm for COVID-19 immunisation. Medical history included high cholesterol and allergies: Sulfar, penicillin. Historical vaccine included 1st dose of BNT162B2 (lot EL9262) on 26Feb2021 at left arm for COVID-19 immunisation with adverse event lightheaded and dizzy. Concomitant drugs included ibuprofen, simvistatin, paracetamol (TYLENOL) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient was lightheaded for 2-3 weeks, sore under armpits (lymph nodes) which was still effecting her 2 weeks after the second dose was administered. Event resulted in Doctor or other healthcare professional office/clinic visit and no treatment was received except paracetamol or Ibuprofen for pain. She was concerned about this because it was affecting her life and job. The pain at times was bad (She used heating pad to relieve pain). The patient reported lightheaded, dizzy and pain underneath the arm pits, she guessed in the lymph nodes. She was curious as to how long those lymph node pains were going to be around because sometimes it's so painful that she thought she was having a heart attack but people say - No, that's lymph node which is going into your breast. She was concerned about how long this was going to be happening to her or what she was supposed to be doing. Covid test with nasal swab on 17Mar2021 was negative. The patient had complete blood count, urine analysis, Lipid Panel for Cholesterol. The outcome of the events was not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Salivary hypersecretion
Clinical narrative: With second shot, I had Lots of Saliva; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program . A patient of an unspecified age and gender received second dose of BNT162B2 (Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unspecified date at single dose for Covid-19 immunization. It was reported that, "had Sjogren's, an autoimmune disease. Body had inadequate mucus. After first COVID shot, the patient had random pain in the lymph nodes in neck. Also had a very runny nose for a week. With second shot, had lots of saliva. Understood mRNA was being used in clinical trials or to be used in clinical trials with multiple sclerosis and strongly suggested, Pfizer look into mRNA and Sjogren's". Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19 despite receiving two doses of vaccine; tested positive for covid-19 despite receiving two doses of vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 50-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE (50 years at the time of vaccination) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have COVID prior vaccination. On 31Mar2021, the patient was tested positive for covid-19 despite receiving two doses of vaccine. The patient did not receive any treatment for the events. The patient was recovering from the event of COVID-19 while the outcome of event drug ineffective was unknown.    No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Fall, Gastrointestinal injury, Headache
Clinical narrative: I blacked out completely; Felt very dizzy; fallen on the dresser; hit myself on my stomach and leg; hit myself on my stomach and leg; Was completed disoriented; Headache; Sore arm; Body ache; wound on my stomach; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 30Mar2021 19:45 as single dose for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. Concomitant medications were unspecified received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine at 19:45, the patient drove back home and had minor symptoms when she went to bed (headache, sore arm, body ache) on 30Mar2021. She woke up around 3:45 am on 31Mar2021 to use the restroom and felt very dizzy. While walking back to bed, she blacked out completely, fallen on the dresser and hit herself on her stomach and leg. She was feeling extremely dizzy at this point, was completed disoriented and couldn't process what was happening around me. Her husband walked her back to bed and put her to sleep. Treatment was reported as First aid for the wound on her stomach. Since the vaccination, the patient had not been tested for COVID-19. The report was non-serious. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Loss of consciousness, Pain, Pain in extremity, Wound
Clinical narrative: I blacked out completely; Felt very dizzy; fallen on the dresser; hit myself on my stomach and leg; hit myself on my stomach and leg; Was completed disoriented; Headache; Sore arm; Body ache; wound on my stomach; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 30Mar2021 19:45 as single dose for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. Concomitant medications were unspecified received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine at 19:45, the patient drove back home and had minor symptoms when she went to bed (headache, sore arm, body ache) on 30Mar2021. She woke up around 3:45 am on 31Mar2021 to use the restroom and felt very dizzy. While walking back to bed, she blacked out completely, fallen on the dresser and hit herself on her stomach and leg. She was feeling extremely dizzy at this point, was completed disoriented and couldn't process what was happening around me. Her husband walked her back to bed and put her to sleep. Treatment was reported as First aid for the wound on her stomach. Since the vaccination, the patient had not been tested for COVID-19. The report was non-serious. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue
Clinical narrative: seems more confused and fatigued than usual afterward; seems more confused and fatigued than usual afterward; This is a spontaneous report received from a Pfizer-sponsored program. A non-contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 27Mar2021 at a single dose for covid-19 immunization. Patient had medical history of Alzheimer's which was prior to receiving first dose of vaccine. The patient's concomitant medications were not reported. On an unspecified date, after receiving the first dose, the patient seems more confused and fatigued than usual afterward. The outcome of events was unknown.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever- over 102; Body aches; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13247), via an unspecified route of administration in the right arm on 05Feb2021 03:30 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever- over 102, body aches, chills, nausea on 06Feb2021 at 02:00 PM. The patient was not pregnant at the time of vaccination. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had covid test post vaccination via nasal swab with negative result. Outcome of the events was recovered.   No Follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever- over 102; Body aches; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13247), via an unspecified route of administration in the right arm on 05Feb2021 03:30 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever- over 102, body aches, chills, nausea on 06Feb2021 at 02:00 PM. The patient was not pregnant at the time of vaccination. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had covid test post vaccination via nasal swab with negative result. Outcome of the events was recovered.   No Follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid 19 infection; tested positive for covid 19 infection; This is a spontaneous report from a contactable pharmacist via a 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 at single dose for COVID-19 immunisation at the age of 43-year-old. Lot number was EN6208. Medical history and concomitant medications were unknown. On 31Mar2021, the patient resulted positive to Covid-19 test. The outcome of the event was unknown.; Sender's Comments: The contributory role of the suspect product  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE to reported events cannot be excluded. This case will be reassessed if follow-up information is received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in mouth beginning approximately 10 days after vaccine and still persisting 10 days later; This is a spontaneous report from a contactable consumer.   A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12Mar2021 12:45 as single dose for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination, no covid tested post vaccination. No allergies. Concomitant medication(s) included Diltiazem ER 240mg, Rosuvastatin 10mg, Fortest 50. The patient experienced metallic taste in mouth beginning approximately 10 days after vaccine and still persisting 10 days later on 20Mar2021 with outcome of not recovered with no treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained