chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: broke out in rash/hives all over; broke out in rash/hives all over; mild tongue swelling; sob throat felt sore and swollen; sob throat felt sore and swollen; swelling at injection site; redness at injection site; itching at injection site; feverish; This is a spontaneous report from a contactable other healthcare professional (patient).  A 33-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number=Ej1685, via an unspecified route of administration on left arm from 07Jan2021 11:00 to 07Jan2021 11:00 at SINGLE DOSE (dose 2) for COVID-19 immunisation. The patient as no known allergies, no other medical history, and no allergies to medications, food, or other products. Historical vaccine includes first dose of BNT162B2 on 18Dec2020, time=12:45 PM, vaccine location=Left arm, lot number=Eh9899.  The patient's concomitant medications were not reported. On 08Jan2021 05:00 AM, the patient experienced post vaccine swelling, redness, itching at injection site and feverish. On 13Jan2021, the patient broke out in rash/hives all over with mild tongue swelling and sob throat felt sore and swollen for a short time. The patient went to physician and received steroid injection and Benadryl.  The outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, SARS-CoV-2 test positive
Clinical narrative: COVID test/ tested positive; COVID test/ tested positive; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (Lot Number: EL1284), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID test/ tested positive on 29Dec2020, chills, body aches on 25Dec2020. She was supposed to get the second dose of the COVID Vaccine at the time of this report. She got the first dose on 23Dec2020 and after 2 days got chills and body aches. She took a COVID test swab on 29Dec2020. Then she tested positive on 31Dec2020. She was asymptomatic besides chills and body aches. She was in Isolation for 14 days and is done. She was wondering if she could take the second dose. Caller was a nursing assistant. The patient underwent lab tests and procedures which included COVID test swab: positive on 29Dec2020. The outcome of events was unknown.; Sender's Comments: The association between the event lack of effect (COVID test swab positive) with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Chills, Diarrhoea, Feeling abnormal
Clinical narrative: diarrhea; nausea; she was sick with a high fever; chills; felt deathly sick; couldn't get out of bed all day; headache; a little bit of a sore throat; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # and expiration not available) intramuscular in left arm at single dose on 11Jan2021 09:30 for Covid-19 immunisation, for precaution because she worked in hospital, administered ad hospital. There was no prescriber. Medical history included asthma diagnosed 30 years before when she was in her 20's around 1990, hypothyroidism. Family medical history was none. Concomitant medication included only levothyroxine sodium (SYNTHROID) taking for 30 years for hypothyroidism. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # and expiration not available) intramuscularly in left arm on 21Dec2020 09:30 (within 4 weeks prior to the 2nd dose of BNT162B2 suspect) Covid-19 immunisation and she was fine. No adverse events occurred following prior vaccinations. No additional vaccines administered on same date of BNT162B2 suspect.  On 12Jan2021, she was felt deathly sick at 15:00. On 11Jan2021 she experienced headache at 17:00. On 12Jan2021, at 17:00 she experienced high fever and chills and couldn't get out of bed all day. On 13Jan2021, she was fine during the day. On 13Jan2021 night, she had a fever that went past 100 degree F, she experienced diarrhea and nausea 02:00. The fever came and went. In Jan2021 she had a little bit of a sore throat. The patient underwent lab tests and procedures which included body temperature: a fever on 12Jan2021; wsa fien on 13-JAN-2021, fever went past 100 degree F, on 13Jan2021at night. No other relevant test performed. She has been out of work since 12Jan2021. On 14Jan2021 she still has diarrhea and nausea with a little bit of a sore throat as well. No ER or physician's office was required. The outcome of felt deathly sick and chills was recovering, of headache, high fever, diarrhea and nausea was not recovered, of couldn't get out of bed all day and a little bit of a sore throat was unknown. She was not sure if her new symptoms meant she should get COVID testing and would like to find out.   Information on lot number/batch number was requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: diarrhea; nausea; she was sick with a high fever; chills; felt deathly sick; couldn't get out of bed all day; headache; a little bit of a sore throat; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # and expiration not available) intramuscular in left arm at single dose on 11Jan2021 09:30 for Covid-19 immunisation, for precaution because she worked in hospital, administered ad hospital. There was no prescriber. Medical history included asthma diagnosed 30 years before when she was in her 20's around 1990, hypothyroidism. Family medical history was none. Concomitant medication included only levothyroxine sodium (SYNTHROID) taking for 30 years for hypothyroidism. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # and expiration not available) intramuscularly in left arm on 21Dec2020 09:30 (within 4 weeks prior to the 2nd dose of BNT162B2 suspect) Covid-19 immunisation and she was fine. No adverse events occurred following prior vaccinations. No additional vaccines administered on same date of BNT162B2 suspect.  On 12Jan2021, she was felt deathly sick at 15:00. On 11Jan2021 she experienced headache at 17:00. On 12Jan2021, at 17:00 she experienced high fever and chills and couldn't get out of bed all day. On 13Jan2021, she was fine during the day. On 13Jan2021 night, she had a fever that went past 100 degree F, she experienced diarrhea and nausea 02:00. The fever came and went. In Jan2021 she had a little bit of a sore throat. The patient underwent lab tests and procedures which included body temperature: a fever on 12Jan2021; wsa fien on 13-JAN-2021, fever went past 100 degree F, on 13Jan2021at night. No other relevant test performed. She has been out of work since 12Jan2021. On 14Jan2021 she still has diarrhea and nausea with a little bit of a sore throat as well. No ER or physician's office was required. The outcome of felt deathly sick and chills was recovering, of headache, high fever, diarrhea and nausea was not recovered, of couldn't get out of bed all day and a little bit of a sore throat was unknown. She was not sure if her new symptoms meant she should get COVID testing and would like to find out.   Information on lot number/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: up most of the night; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and methylprednisolone (MEDROL), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient took a Medrol dosepak and she was up most of the night with 4 pillows. The action taken in response to the event for methylprednisolone and event outcome were unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild soreness in arm; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced mild soreness in arm on an unspecified date. The patient outcome of the event was unknown.  The information on the batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a non-contactable consumer. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever on 13Jan2021 with outcome of recovered.  No treatment received for the adverse event. The patient did not diagnosed with COVID-19 prior to vaccination, and did not tested for COVID-19 since the vaccination.  The case is non serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: Swollen lymph node; This is a spontaneous report from a contactable physician (patient).  A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose on 21Dec2020 and the second dose on 11Jan2021 both via an unspecified route of administration at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen lymph node on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included mammo screen: swollen lymph node on unknown date and ultrasound scan on 11Jan2021 with unknown results as follow-up. A new follow-up was scheduled in 6 weeks. Radiologist suspected side effect from BNT162b2 shots received 21Dec2020 and 11Jan2021.   Information on the Lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: Shortness of breath; Headache; Tinnitus; This is a spontaneous report from a contactable Physician.  A 55-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation.  Medical history included type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease and asthma, all from an unknown date and unknown if ongoing. Known allergies reported: drug intolerances with nausea/vomiting to Opiates, TRULICITY, sulfa antibiotics. The patient's concomitant medications were not reported.  The vaccine was administered at Hospital Facility.  It was unknown If other vaccine were administered in four weeks. The patient did not experience COVID prior vaccination. The patient was tested for COVID post vaccination on 01Jan2021 and was negative. On 31Dec2020 within minutes of vaccination the patient experienced shortness of breath, headache and tinnitus. The events required visit to Physician Office and Emergency Room. The patient was admitted to hospital for 7 days. Therapeutic measures taken as a result of the events included epinephrine without benefit, prednisone course but tinnitus remained about 12 days since vaccination, corticosteroids, and H1 and H2 antagonists.  The patient underwent lab tests and procedures which included COVID test post vaccination (Nasal Swab) on 01Jan2021 with negative result. The outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea, headache and tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HA; slight fever; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 2nd of two reports. A male patient (reporter's Grandson) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknow date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. On an unspecified date the patient Headache (HA) and slight fever. The outcome of events was unknown.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021024982 Same reporter/drug/event, different patient.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Hyperhidrosis, Vomiting
Clinical narrative: emesis; upset stomach; Sweating; headache; This is a spontaneous report from a contactable other healthcare professional. A 54-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine, brand: Pfizer) lot no: EK5730, intramuscular in left arm on 20Dec2020 09:30 at a single dose for Covid-19 immunization in a hospital. Medical history included allergies pineapple and coconut. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medication included warfarin sodium (JANTOVEN), sertraline, and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefaclor (CECLOR) and zithromax (Z-PACK) and experienced allergies to both. On 20Dec2020, after the first shot, the patient experienced emesis within 40 minutes. Then on unspecified dates, the patient experienced upset stomach for 3 hours approximately, sweating and headache lasting about 4 hours. Treatment was not given for the events. The patient recovered from the events.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: Fever; In morning my temperature was 100.4; Headache; Felt tired from weak; Felt tired from weak; Feels bad; Chills/shivering; This is a spontaneous report from a contactable nurse (patient).  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3248), via an unspecified route of administration in the left arm on 09Jan2021 as single dose for COVID-19 immunization.  Medical history included covid-19 in Oct2020.  The patient's concomitant medications were not reported.  The patient experienced fever; in morning my temperature was 100.4 on 10Jan2021 with outcome of unknown; headache on 10Jan2021 with outcome of unknown; felt tired from weak in Jan2021 with outcome of unknown; chills/shivering in Jan2021 with outcome of recovered in Jan2021, feels bad in Jan2021 with outcome of unknown.  The patient underwent lab tests and procedures which included fever at 100.4 in Jan2021. Details were as follows: patient  received the first dose of the Covid-19 vaccination and woke up with a fever and a bad headache in the morning.  As it related to casualty, the reporting nurse indicated yes and commented that  she was fine the day prior and then when she woke up this morning,  she had fever and a bad headache.  She indicated that she felt like a little; she got it in the morning around the 11 O'clock. And then by the evening she felt tired. She  thought that she was just tired from the week. And when she woke up  on this morning, or in middle of the nigh, she was shivering a little bit. She fell asleep and woke up the next morning, with a temperature of 100.4.  She said that she did not feel really that bad; she had a headache; she did not have shivering or chills then. Therapeutic measures were taken as a result of fever; in morning my temperature was 100.4, headache, felt tired from weak, shivering, feels bad, chills and felt tired from weak ; she took ibuprofen. The chills/shivering recovered in Jan2021; the outcome of the other events was not reported
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; In morning my temperature was 100.4; Headache; Felt tired from weak; Felt tired from weak; Feels bad; Chills/shivering; This is a spontaneous report from a contactable nurse (patient).  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3248), via an unspecified route of administration in the left arm on 09Jan2021 as single dose for COVID-19 immunization.  Medical history included covid-19 in Oct2020.  The patient's concomitant medications were not reported.  The patient experienced fever; in morning my temperature was 100.4 on 10Jan2021 with outcome of unknown; headache on 10Jan2021 with outcome of unknown; felt tired from weak in Jan2021 with outcome of unknown; chills/shivering in Jan2021 with outcome of recovered in Jan2021, feels bad in Jan2021 with outcome of unknown.  The patient underwent lab tests and procedures which included fever at 100.4 in Jan2021. Details were as follows: patient  received the first dose of the Covid-19 vaccination and woke up with a fever and a bad headache in the morning.  As it related to casualty, the reporting nurse indicated yes and commented that  she was fine the day prior and then when she woke up this morning,  she had fever and a bad headache.  She indicated that she felt like a little; she got it in the morning around the 11 O'clock. And then by the evening she felt tired. She  thought that she was just tired from the week. And when she woke up  on this morning, or in middle of the nigh, she was shivering a little bit. She fell asleep and woke up the next morning, with a temperature of 100.4.  She said that she did not feel really that bad; she had a headache; she did not have shivering or chills then. Therapeutic measures were taken as a result of fever; in morning my temperature was 100.4, headache, felt tired from weak, shivering, feels bad, chills and felt tired from weak ; she took ibuprofen. The chills/shivering recovered in Jan2021; the outcome of the other events was not reported
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 1st of 8 patient.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.   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.,Linked Report(s) : US-PFIZER INC-2021034597 same  drug, reporter and event but different patient;US-PFIZER INC-2021034598 same  drug, reporter and event but different patient;US-PFIZER INC-2021034599 same  drug, reporter and event but different patient;US-PFIZER INC-2021034600 same  drug, reporter and event but different patient;US-PFIZER INC-2021034601 same  drug, reporter and event but different patient;US-PFIZER INC-2021034603 same  drug, reporter and event but different patient;US-PFIZER INC-2021034596 same drug, reporter and event but different patient.; Reported Cause(s) of Death: expired before receiving the second dose
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 2nd of 8 patients.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: expired before receiving the second dose
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 3rd of 8 patients.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/Batch number is requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported death and the administration of COVID 19 vaccine, bnt162b2.  However, more information on the patient's underlying medical condition, concomitant medications, patient's age group, clinical course and relevant lab tests would be helpful for the Company to make a more meaningful causality 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 RA, IEC, as appropriate.; Reported Cause(s) of Death: expired before receiving the second dose
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 4th of 8 patient. A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/Batch number has been requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.   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.,Linked Report(s) : US-PFIZER INC-2021034595 same  drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 7 residents expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 6th of 8 patients.  A patient of unspecified age and gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The event death is assessed as related to BNT162b2 vaccine and documented as such in the  global safety database until sufficient information is available to allow an unrelated causality 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same  drug, reporter and event but different patient; Reported Cause(s) of Death: 7 residents expired before receiving the second dose
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 7th of 8 patient.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.   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.,Linked Report(s) : US-PFIZER INC-2021034595 same  drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: After getting the second dose, three days later every time she takes progesterone she experiences shortness of breath; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and progesterone, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient had her first covid vaccine (BNT162B2) last 18Dec2020 and had no reaction to the first dose. After getting the second dose, three days later every time she takes progesterone she experiences shortness of breath from an unspecified date. The patient was asking what she can do about it and also asked if the vaccine can wear off even though the immunity from the covid vaccine won't take effect as she needs to take her progesterone (as reported). The action taken in response to the event for progesterone was unknown. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Computerised tomogram normal, Dyspnoea, Echocardiogram, Fibrin D dimer increased
Clinical narrative: After getting the second dose, three days later every time she takes progesterone she experiences shortness of breath; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and progesterone, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient had her first covid vaccine (BNT162B2) last 18Dec2020 and had no reaction to the first dose. After getting the second dose, three days later every time she takes progesterone she experiences shortness of breath from an unspecified date. The patient was asking what she can do about it and also asked if the vaccine can wear off even though the immunity from the covid vaccine won't take effect as she needs to take her progesterone (as reported). The action taken in response to the event for progesterone was unknown. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary function test
Clinical narrative: After getting the second dose, three days later every time she takes progesterone she experiences shortness of breath; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and progesterone, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient had her first covid vaccine (BNT162B2) last 18Dec2020 and had no reaction to the first dose. After getting the second dose, three days later every time she takes progesterone she experiences shortness of breath from an unspecified date. The patient was asking what she can do about it and also asked if the vaccine can wear off even though the immunity from the covid vaccine won't take effect as she needs to take her progesterone (as reported). The action taken in response to the event for progesterone was unknown. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Epistaxis
Clinical narrative: Nose bleed; Dizziness; it left me little weak; This is a spontaneous report from a contactable consumer. This 75-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) at single dose for COVID-19 immunization on 09Jan2021. Relevant history included High blood pressure. Relevant concomitant drugs included Losartan for Blood pressure high, and hydrochlorothiazide. The patient had the first Covid 19 Vaccine on 09Jan2021 and she knew little bit dizziness was normal but she had a nose bleed in the next morning that she could hardly stop, she finally got it stopped it, it left she little weak so she just wanted to report that, she did not know if anyone had ever had that before (Hence, MI was made). Outcome of event Nose bleed was recovered, the outcome of other event was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Brain injury, Brain operation, Cerebral haemorrhage, Confusional state
Clinical narrative: Internal brain bleeding 10 days after 1st dose covid vaccine; Brain damage; confused; suffering memory loss; This is a spontaneous report from a contactable Physician (patient). This 39-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 18Dec2020 14:30 at single dose (lot number: EJ1685) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced internal brain bleeding and brain damage on 30Dec2020 07:30 after 1st dose covid vaccine. Brain surgery received on 29Dec2020. Events were still recovering. Patient was confused and suffering memory loss on 30Dec2020 07:30. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage. Days for hospitalization was 16. The patient received treatment for events as brain surgery due to internal brain bleeding. The patient was not pregnant. The patient had no COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was recovering.; Sender's Comments: The reported internal brain bleeding and brain damage with confused and memory loss more likely represented intercurrent disease, and less likely causally related to 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain operation, Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram head abnormal, Confusional state
Clinical narrative: Internal brain bleeding 10 days after 1st dose covid vaccine; Brain damage; confused; suffering memory loss; This is a spontaneous report from a contactable Physician (patient). This 39-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 18Dec2020 14:30 at single dose (lot number: EJ1685) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced internal brain bleeding and brain damage on 30Dec2020 07:30 after 1st dose covid vaccine. Brain surgery received on 29Dec2020. Events were still recovering. Patient was confused and suffering memory loss on 30Dec2020 07:30. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage. Days for hospitalization was 16. The patient received treatment for events as brain surgery due to internal brain bleeding. The patient was not pregnant. The patient had no COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was recovering.; Sender's Comments: The reported internal brain bleeding and brain damage with confused and memory loss more likely represented intercurrent disease, and less likely causally related to 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Platelet transfusion, Tensilon test, Thrombocytopenia, Thrombosis
Clinical narrative: Internal brain bleeding 10 days after 1st dose covid vaccine; Brain damage; confused; suffering memory loss; This is a spontaneous report from a contactable Physician (patient). This 39-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 18Dec2020 14:30 at single dose (lot number: EJ1685) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced internal brain bleeding and brain damage on 30Dec2020 07:30 after 1st dose covid vaccine. Brain surgery received on 29Dec2020. Events were still recovering. Patient was confused and suffering memory loss on 30Dec2020 07:30. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage. Days for hospitalization was 16. The patient received treatment for events as brain surgery due to internal brain bleeding. The patient was not pregnant. The patient had no COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was recovering.; Sender's Comments: The reported internal brain bleeding and brain damage with confused and memory loss more likely represented intercurrent disease, and less likely causally related to 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transfusion
Clinical narrative: Internal brain bleeding 10 days after 1st dose covid vaccine; Brain damage; confused; suffering memory loss; This is a spontaneous report from a contactable Physician (patient). This 39-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 18Dec2020 14:30 at single dose (lot number: EJ1685) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced internal brain bleeding and brain damage on 30Dec2020 07:30 after 1st dose covid vaccine. Brain surgery received on 29Dec2020. Events were still recovering. Patient was confused and suffering memory loss on 30Dec2020 07:30. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage. Days for hospitalization was 16. The patient received treatment for events as brain surgery due to internal brain bleeding. The patient was not pregnant. The patient had no COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was recovering.; Sender's Comments: The reported internal brain bleeding and brain damage with confused and memory loss more likely represented intercurrent disease, and less likely causally related to 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Haemolytic anaemia
Clinical narrative: The patient had Hemolytic Anemia with symptoms starting within the first 24 hours of vaccine administration.; The first dose received on 18Dec2020 and the second dose received on 06Jan2021; The first dose received on 18Dec2020 and the second dose received on 06Jan2021; This is a spontaneous report from a contactable consumer. This consumer reported for a 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 06Jan2021. Relevant history and concomitant drugs were unknown. The patient previously received the first dose of  BNT162B2 on 18Dec2020 for  COVID-19 immunization. The patient did not receive other vaccine in four weeks of vaccination. No known allergies. The patient had Hemolytic Anemia with symptoms starting within the first 24 hours of vaccine administration on 06Jan2021. The patient had emergency room visit and physician office visit. No treatment was received (as reported).  Outcome of event was unknown. The event was assessed as serious with serious criteria: Life-threatening, disability.    Information about Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cardiac arrest, Malaise, Nausea, SARS-CoV-2 test negative
Clinical narrative: Patient suffered cardiac arrest, though most likely result of illicit substance use; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; Patient suffered cardiac arrest, though most likely result of illicit substance use; This is a spontaneous report from a contactable physician. A 33-years-old male patient received bnt162b2 (BNT162B2, lot unknown), intramuscular on 14Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient suffered cardiac arrest 17Jan2021 11:15, though most likely result of illicit substance use since Jan2021, though patient had been feeling unwell with nausea and GI discomfort on 15Jan2021 23:15 after receiving the vaccine 36 hours prior to his arrest. The events were serious due to Life threatening illness (immediate risk of death from the event) and Disability or permanent damage. The patient had no COVID prior vaccination. COVID test type post vaccination=Nasal Swab on16Jan2021, test result was Negative. COVID test name post vaccination=Roche Cobas. The event outcome was not recovered. No treatment was received to events.  No follow-up attempts are possible; information on lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events cardiac arrest, substance abuse, abdominal discomfort, malaise and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.