chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in his foot; This is a spontaneous report from the sponsored program. A contactable consumer (patient himself) reported that a male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 21Mar2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. The patient experienced pain in his foot and asked if he can take naproxen. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: taking medicine (Fluticasone nasal spray) for sinus congestion in between doses; This is a spontaneous report received from a sponsored program. This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 03Mar2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she received her 1st dose on 03Mar2021 and 2nd dose is tomorrow 24Mar2021,she is taking medicine (Fluticasone nasal spray) for sinus congestion in between doses. Therapeutic measures were taken as a result of sinus congestion. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19, TTOX
Symptoms: Accident
Clinical narrative: she got an accident; This is a spontaneous report received from sponsor 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 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; tetanus vaccine (TETANUS VACCINE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Reporter was calling on behalf of his wife his wife got the 1st dose last 19Feb2021 unfortunately she got an accident before the 2nd dose last 12Mar2021 her husband mentioned that she got tetanus shot so she needs to wait 1 week for her to get the 2nd dose of the vaccine. (She missed the 2nd dose). They want to know what procedure they would do for his wife to get the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. A 66-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: GN620, Expiration date: unknown) via an unspecified route of administration on 13Feb2021 16:30 at right arm at single dose for COVID-19 Immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch no: EL9261) on 22Jan2021 15:00, anatomical location was right arm and experienced sore arm on 23Jan2021 08:00. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient's Concomitant medications included Simvastatin 20mg once a day (for High cholesterol), Zyrtec 1tablet a day (For allergies), Centrum vitamin, Vitamin D (1tablet/day) and Caltrate (2tablet/day). On 14Feb2021 08:00, patient experienced sore arm. Reporter assessed the event as non-serious. The outcome of the event was unknown.  Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Chills, Headache, Pyrexia
Clinical narrative: Headache; Severe chills; fever; Lack of energy; hair loss; This is a spontaneous report from a contactable consumer. This contactable consumer reported for her husband. A male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6205) intramuscular on 01Mar2021 at 10:50 am at single dose on right arm for covid-19 immunisation. Patient's medical history included ongoing sinus issues with onset date as adult, all my life, no smoking-mild COPD from 2015; pertinent details; N/A (chronic obstructive pulmonary disease), covid-19 from an unknown date in Nov2020. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EM9810) intramuscular on 08Feb2021 at 11:00 am at single dose on right arm for covid-19 immunisation. Relevant test was reported as none. Patient's concomitant medications were reported as none. Patient experienced headache, severe chills, lack of energy and hair loss on an unknown date. Patient's wife reported that the severe side effects with 1st shot side effects were similar with 2nd shot but not as severe. 'My husband got the same 2 shots (Pfizer)- just an FYI- No side effects 1st shot but slight headache. His second shot he had severe effects. Headache, severe chills, fever, lack of energy. After 2nd shot, he did take an Advil but no Benadryl. After both shots, my husband noticed hair loss- more than usual. It is 16Mar2021 and it is slowing up. The outcome of events was unknown and for alopecia was recovering.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, COVID-19, Drug specific antibody, Peripheral swelling, Pyrexia
Clinical narrative: site on arm hot and swelling too large to reach at hand stretched out; site on arm hot and swelling too large to reach at hand stretched out; fevers everyday; This is a spontaneous report from a contactable consumer. A 78-years-old patient of an unspecified gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Mar2021 11:15 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes, cancer, from an unknown date and unknown if ongoing and Covid-19 from 14Nov2020 to 26Nov2020 from an unknown date and unknown if ongoing. Concomitant medication(s) included amoxicillin, clavulanate potassium (AUGUMENTIN ES) taken for diverticulitis from 16Jan2021 to 25Jan2021. The patient previously took first dose bnt162b2 on 08Feb2021 11:15am, Site and Route of injection: Anatomical Site of injection: Upper left arm, Batch/Lot number: EL9662. The patient experienced site on arm hot and swelling too large to reach at hand stretched out and fever began about 4hrs after injection 04Mar2021. The patient underwent lab tests and procedures which included covid-19: positive on 18Nov2020, drug specific antibody: 28Jan2020 on 18Nov2020 High, pyrexia: 102.8 on 05Mar2021 following day. Slowly went down 4th day. The report consider as a non serious. The patient did not received any events for the events. The outcome of the event was reported as site on arm hot and swelling too large to reach at hand stretched out recovered and fevers everyday recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: swelling, discomfort and pain in the left arm; incorrect dosing schedule; swelling, discomfort and pain in the left arm; pain in the left arm; This is a spontaneous report from a contactable consumer (Patient) reported for herself via. A female patient of an unspecified age received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and Expiration date were Unknown), via an unspecified route of administration on 21Feb2021 as a SINGLE DOSE and dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. The Caller was wondering about the possible side effects of the Pfizer Covid-19 vaccine. She already finished the series of 2 doses of the vaccine a month ago. And is confused if the swelling, discomfort and pain in the left arm that she is experiencing in the past weeks are normal side effects of the vaccine. Also she had an incorrect dosing schedule when she took the vaccine. The 1st dose was given on January 21, 2021 her 2nd dose has been delayed into February 21, 2021 which was supposed to be taken on February 11, 2021. The outcome for the event is unknown.  Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: could not sleep after the shot; This is an initial spontaneous report received from sponsored program . A contactable consumer (patient's sister) reported for a male patient of an unspecified age received BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiry Date: unknown), 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 experienced could not sleep after the shot. The consumer stated she has not received any dose of the vaccine at all. She received a flu shot in 2013 which resulted in a three month long bed rest. She would like to contact the provider of the Covid-19 vaccine in order to ask if any component of the flu shot is present in the Covid-19 vaccine. She mentioned that her brothers received the vaccine and could not sleep after the shot. She is also allergic to several antibiotics which makes her anxious about receiving the vaccine which is scheduled tomorrow, 24Apr2021. The outcome of event was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021337286 Same drug, same event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Had bad toothache that morning before 2nd dose and after 1st dose; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 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 reported, she had Pfizer 2nd dose last week 18Mar2021. She had bad toothache that morning before 2nd dose and after 1st dose. She took Tylenol before receiving her 2nd dose. After administering 2nd dose nurse told her she should not have take Tylenol prior to vaccine. The outcome of the event was unknown.   Information for batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Wheelchair user
Clinical narrative: Caller has appointment for second vaccination.but needs a wheelchair; This is a spontaneous report from Pfizer-sponsored program. A Non-contactable female consumer reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 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 reported, she has appointment for second vaccination. But needs a wheelchair, didn't know how to contact site for information. The patient didn't need a wheelchair for the first appointment. The outcome of event was unknown.   No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Toothache
Clinical narrative: He is wondering if the amoxicillin will have any effects on the Vaccine; Sore tooth; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A male patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date: Unknown) via an unspecified route of administration on 24Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of Covid vaccine (BNT162B2) on 03Mar2021.   On 22Mar2021 The patient had a dentist appointment for a sore tooth. He took one dose of amoxicillin. He is wondering if the amoxicillin will have any effects on the Vaccine. Medical Information: Yes, there Were unaddressed medical questions referred or forwarded to Medical Information.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died 12-15hrs after vaccination.; This is a spontaneous report from a contactable Consumer. A 40-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021 12:45 (Batch/Lot Number: ER8727) at the age of 40-year-old as single dose for covid-19 immunisation. Medical history reported as none. Concomitant medication included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient patient died 12-15 hours after vaccination. The patient died on 26Mar2021. An autopsy was not performed. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.; Reported Cause(s) of Death: Patient died 12-15hrs after vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Head cold (congestion and tired); Head cold (congestion and tired); Head cold (congestion and tired); Feeling flu like; Complete loss of taste within 24 hours; Leg muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date were not reported), via an unspecified route of administration, in Left arm on 27Mar2021 at 11:00 AM (at the age of 44-years-old) at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included aripiprazole(ABILIFY), fluoxetine hydrochloride (PROZAC), Valsartan and methylphenidate hydrochloride (RITALIN). The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced head cold (congestion, tired), feeling flu like, complete loss of taste within 24 hours, leg muscle pain and joint pain from 27Mar2021 at 14:00. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: Head cold (congestion and tired); Head cold (congestion and tired); Head cold (congestion and tired); Feeling flu like; Complete loss of taste within 24 hours; Leg muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date were not reported), via an unspecified route of administration, in Left arm on 27Mar2021 at 11:00 AM (at the age of 44-years-old) at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included aripiprazole(ABILIFY), fluoxetine hydrochloride (PROZAC), Valsartan and methylphenidate hydrochloride (RITALIN). The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced head cold (congestion, tired), feeling flu like, complete loss of taste within 24 hours, leg muscle pain and joint pain from 27Mar2021 at 14:00. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight pain in their arm; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (wife) reported that a male patient of an unknow age received BNT162B2 (Solution for injection) via an unknown route on 18Mar2021, at an unknown dose and single for COVID-19 immunization. The patient's medical history was not reported. The concomitant medication were not reported. The consumer reported that she, her mother, and her husband got the first dose last Thursday. The consumer would like to know the timeframe of getting the second dose. The caller said she wishes to get her second dose later (22 days or 25 days) so that she can take care of her 90-year-old mother in case she gets any side effects. The consumer mentioned that they have experienced slight pain in their arm after the first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight pain in their arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for her mother who is 90-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the caller, said that she, her mother, and her husband got the first dose last Thursday. The caller would like to know the timeframe of getting the second dose. The caller said she wishes to get her second dose later (22 days or 25 days) so that she can take care of her 90-year-old mother in case she gets any side effects. The caller mentioned that they have experienced slight pain in their arm after the first dose. Outcome of the event was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021344253 same drug/AE, different patient;US-PFIZER INC-2021344241 same drug/AE, different patient
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain, tenderness, soreness at the injection site; This is a spontaneous report received from a contactable consumer. This consumer reported adverse events with similar suspect for 2 patients. This report is 2nd of two patients. A 49-year-old patient of unspecified gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 23 mar 2021 at a single dose for COVID-19 immunisation. The patient's medical history and Concomitant medications were not reported. the patient experienced Pain, tenderness, soreness at the injection site on 24 Mar 2021. The events were resolving on 25 mar 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021344329 same drug, different event and patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, SARS-CoV-2 test
Clinical narrative: Onset of Severe stomach pain on 20Mar2021.; This is a spontaneous report from a contactable consumer reporting for herself. A 37-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 18Mar2021 13:45 (vaccinated at the age of 37 years old) as single dose for covid-19 immunisation. Medical history included High blood pressure and obesity. The patient's concomitant medications were not reported. The patient experienced severe stomach pain. Onset of Severe stomach pain on 20Mar2021 13:00 and resulting in an Appendectomy on 22Mar2021. Patient visited Emergency room/department or urgent care due to event. Patient had Nasal Swab on 21Mar2021 with negative result. Outcome of event was recovering.  Follow up needed, further information was requested.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient himself) reported that an unspecified aged male patient received second dose of BNT162B2 COVID vaccine (formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2 for COVID-19 immunization. Patient developed Tinnitus after 2nd Covid 19 vaccine on unknown date. After researching it online, I found that many others have experienced the same issue. It might be something you look into. It's a horrible condition. The outcome of the event was recovered in 2021.  Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Productive cough, Sputum discoloured
Clinical narrative: thick yellow mucous/she coughed and produced thick yellow mucous; coughed and produced thick yellow mucous; allergic reaction; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 25Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient may have experienced an allergic reaction. The allergic reaction was clarified as the patient coughed and produced thick yellow mucous. The outcomes of allergic reaction and coughed and produced thick yellow mucous was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he tested positive with Covid-19; This is a spontaneous report from a Pfizer sponsored program  via contactable consumer or other non hcp. A 36-year-old male patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 09Mar2021 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, the patient experienced he tested positive with covid-19. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  No follow-up information needed. Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Inappropriate schedule of product administration, Off label use, Thrombosis
Clinical narrative: She had a stroke on 3/28/2021 due to a blood clot in her brain; She had a stroke on 3/28/2021 due to a blood clot in her brain; Administration_date=08/03/2021 number=1/administration_date=22/03/2021 number=2; Administration_date=08/03/2021 number=1/administration_date=22/03/2021 number=2; This is a spontaneous report from a contactable consumer reporting for herself. A 66-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 22Mar2021 17:45 (vaccinated at the age of 66 years old) as single dose for covid-19 immunisation. Patient received the first dose on 08Mar2021. Medical history included diabetes; obesity; high blood pressure, iodine allergy. The patient's concomitant medications were not reported. The patient experienced she had a stroke due to a blood clot in her brain on 28Mar2021 18:30, The patient was hospitalized for she had a stroke due to a blood clot in her brain (cerebrovascular accident) for 2 days. Patient visited Emergency room/department or urgent care for events a stroke due to a blood clot in her brain and received treatment. Outcome of event a stroke due to a blood clot in her brain was not recovered.   Information about lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She tested positive of Covid 19 last March 15; This is a spontaneous report from Pfizer Sponsored Patient Support Program. A contactable a female consumer (Patient herself) of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's  medical history and concomitant medications were not reported.The patient took first dose last march 06 and  and second dose is on March 27. she tested positive of covid 19 last march 15. The patient enquiring if she needs to wait before taking the second dose of the vaccine or if she should start again from the first dose. The patient underwent lab tests and procedures which included Covid 19 test: positive on 15Mar2021.The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Mar2021 09:30 am (Batch/Lot Number: En6204) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications within 2 weeks of vaccination were not unspecified. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received cefaclor (CECLOR) and experience allergies, and also received first dose of BNT162B2 (Lot number= En6200) on 25Feb2021 09:30 AM at single dose at left arm for COVID-19 immunization. The patient experienced nausea, fever, chills, headache, tired and diarrhea which led to loss of fluids and low blood pressure in Mar2021 08:00 PM with outcome of recovering. The adverse events resulted in hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage, emergency room/department or urgent care. Patient received treatments for the events included fluids, medicine, partial colon removal. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19: negative in Mar2021. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Mar2021 09:30 am (Batch/Lot Number: En6204) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications within 2 weeks of vaccination were not unspecified. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received cefaclor (CECLOR) and experience allergies, and also received first dose of BNT162B2 (Lot number= En6200) on 25Feb2021 09:30 AM at single dose at left arm for COVID-19 immunization. The patient experienced nausea, fever, chills, headache, tired and diarrhea which led to loss of fluids and low blood pressure in Mar2021 08:00 PM with outcome of recovering. The adverse events resulted in hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage, emergency room/department or urgent care. Patient received treatments for the events included fluids, medicine, partial colon removal. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19: negative in Mar2021. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood loss anaemia, Colectomy, Colitis ischaemic, Colon operation
Clinical narrative: Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Mar2021 09:30 am (Batch/Lot Number: En6204) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications within 2 weeks of vaccination were not unspecified. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received cefaclor (CECLOR) and experience allergies, and also received first dose of BNT162B2 (Lot number= En6200) on 25Feb2021 09:30 AM at single dose at left arm for COVID-19 immunization. The patient experienced nausea, fever, chills, headache, tired and diarrhea which led to loss of fluids and low blood pressure in Mar2021 08:00 PM with outcome of recovering. The adverse events resulted in hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage, emergency room/department or urgent care. Patient received treatments for the events included fluids, medicine, partial colon removal. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19: negative in Mar2021. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Gastrointestinal haemorrhage, Gastrointestinal procedural complication, Hepatorenal syndrome, Hypovolaemic shock
Clinical narrative: Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Mar2021 09:30 am (Batch/Lot Number: En6204) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications within 2 weeks of vaccination were not unspecified. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received cefaclor (CECLOR) and experience allergies, and also received first dose of BNT162B2 (Lot number= En6200) on 25Feb2021 09:30 AM at single dose at left arm for COVID-19 immunization. The patient experienced nausea, fever, chills, headache, tired and diarrhea which led to loss of fluids and low blood pressure in Mar2021 08:00 PM with outcome of recovering. The adverse events resulted in hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage, emergency room/department or urgent care. Patient received treatments for the events included fluids, medicine, partial colon removal. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19: negative in Mar2021. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ileostomy, Metabolic acidosis, Wound secretion
Clinical narrative: Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Mar2021 09:30 am (Batch/Lot Number: En6204) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications within 2 weeks of vaccination were not unspecified. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received cefaclor (CECLOR) and experience allergies, and also received first dose of BNT162B2 (Lot number= En6200) on 25Feb2021 09:30 AM at single dose at left arm for COVID-19 immunization. The patient experienced nausea, fever, chills, headache, tired and diarrhea which led to loss of fluids and low blood pressure in Mar2021 08:00 PM with outcome of recovering. The adverse events resulted in hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage, emergency room/department or urgent care. Patient received treatments for the events included fluids, medicine, partial colon removal. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19: negative in Mar2021. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial flutter, SARS-CoV-2 test
Clinical narrative: heart was shocked back into rhythm; a-flutter; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 17Feb2021 (Lot Number: EN6200) as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL9264 on 28Jan2021 12:00 in left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other unspecified medications in two weeks. Medical history included diabetic, heart disease. The patient experienced heart was shocked back into rhythm, a-flutter on 10Mar2021 13:00 with outcome of recovering.  The patient was hospitalized for the events from 12Mar2021 to 16Mar2021, the events were also reported as life-threatening. Events resulted in Emergency room/department or urgent care. The patient did not have COVID tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Mar2021.  Events treatment was reported as yes, Heart shocked back into rhythm.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal
Clinical narrative: stroke; feel "foggy"; This is a spontaneous report received from a contactable consumer (Patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204), via an unspecified route of administration in left arm on an unspecified date in Mar2021 at 11:00 AM as single dose for COVID-19 immunization. Medical history included none. Allergies to medications, food, or other products: No. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Other. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced feel "foggy" on Mar2021 with outcome of recovering, stroke on 14Mar2021 20:30 with outcome of recovering. Clinical course: About an hour after receiving the shot the patient began to feel "foggy", the feeling continued over to the next day. The patient didn't remember how long after that it continued. The patient then had a stroke 5 days after receiving the vaccine. The patient had no health risks prior to the vaccine and the hospital was unable to find a cause or leading indicator of what could have triggered the stroke, leaving the vaccine as the elephant in the room. Treatment received for the adverse events: Everything. The evens resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for feel "foggy" and stroke for 2 days. Seriousness criteria-Results in death/Disabling/Incapacitating/Congenital anomaly/birth defect: No.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) 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 was not reported. The patient's concomitant medications were not reported. The reporter stated that patient received first dose wants to know if she can take Tylenol for injection site pain on an unspecified date. The outcome of the event was reported as unknown.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Sensory loss
Clinical narrative: Bad muscle pain left leg below hip for 36 hours.After that 48 hours of shoulder up neck bad muscle pain; Lose of feeling in that area when it does not hurt.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:30 (Batch/Lot Number: ER2613) at the age of 66-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Bad muscle pain left leg below hip for 36 hours. After that 48 hours of shoulder up neck bad muscle pain. This is still occurring but not real bad. Lose of feeling in that area when it did not hurt. Adverse event (AE) started on 25Mar2021 15:30. AE 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, Congenital anomaly or birth defect. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested positive with the Covid-19 virus; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient had her first dose of the vaccine on 19Mar2021 and she tested positive with the Covid-19 virus today 25Mar2021. Her husband was waiting for his result for today but had been exposed and currently had a sore throat and cough. Her husband was scheduled to get his 2nd dose on 01Apr2021. The patient asked if her husband, would be tested positive with the Covid-19 virus, can he still get the 2nd dose on the scheduled date or does he need to reschedule it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This is a spontaneous report from a contactable other health care professional (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EN6206), via an unspecified route of administration on 11Mar2021 (at the age of 43-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EN6200), via an unspecified route of administration on 18Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced dizziness and nausea on 11Mar2021 and lasted for two weeks after the second dose of the vaccine. The events were reported as non-serious. No treatment was given for the events. The outcome of the events was recovered in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: couldn't breath; This is spontaneous report from a contactable consumer reported for himself. A 59-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Leg Left on 28Mar2021 04:00 (Batch/Lot Number: tr8734) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced couldn't breath (life threatening) on 28Mar2021 08:00. Outcome of event was unknown.   Follow-up requested for more information.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, Pericarditis, SARS-CoV-2 test
Clinical narrative: Pericarditis leading to pericardial effusion; Pericarditis leading to pericardial effusion; This is a spontaneous report from a contactable other hcp (Patient). A 57-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in arm right on 01Mar2021 (Lot Number: EN6201) as single dose for COVID-19 immunisation. Age at vaccination was 57-year-old. Medical history included chronic pancreatitis, gastritis from an unknown date. No Known allergies. No covid prior vaccination. Concomitant medications in two weeks included amlodipine; losartan; trazodone; ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nicotinic acid, pantothenic acid, phosphorus, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, zinc (CENTRUM MEN 50+), all taken for an unspecified indication, start and stop date were not reported. The patient experienced pericarditis leading to pericardial effusion on 05Mar2021 20:30. AE treatment included Pericardiocentesis. AE 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). The serious criteria for the event was hospitalization, medically significant, life threatening. The patient was hospitalized for 4 days. The patient received bnt162b2, dose 2 Intramuscularly, administered in arm right on 23Mar2021 07:00 AM (Lot Number: EP6955) as single dose for COVID-19 immunisation. Covid tested post vaccination included Nasal Swab Covid19 PCR on 07Mar2021: Negative. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Pfizer vaccination killed patient; This is a spontaneous report from a Pfizer-sponsored program, Corporate (Pfizer) Social Media Platforms. A contactable consumer reported for mother (patient) that a female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), 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 reporter reported that Pfizer vaccination killed reporter's mom (patient) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Pfizer vaccination killed patient
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort
Clinical narrative: mild GI upset; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse and consumer reported that a 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021(Batch/Lot number was not reported) at the age of 67-years-old as single dose for covid-19 immunisation; bosutinib (BOSULIF), via an unspecified route of administration from 26Mar2021 (Batch/Lot number was not reported, expiration date: 31Dec2023) at 400 mg, once daily for chronic myeloid leukaemia. Medical history included acute sinusitis, allergic rhinitis, anemia, chronic myeloid leukemia, cough, depression, elevated white blood cell count, gastro-esophageal reflux disease, anxiety, osteoarthrosis, fatigue, pleural effusion, postanasal drip, allergies: sulfa, doxycycline, morphine, stadolol, vytorin. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; furosemide taken for an unspecified indication, start and stop date were not reported; montelukast taken for an unspecified indication, start and stop date were not reported; escitalopram taken for an unspecified indication, start and stop date were not reported, dasatinib monohydrate (SPRYCEL) taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant. Patient recieved covid vaccination yesterday on 25Mar2021 and the patient experienced mild GI upset this morning on 26Mar2021. The action taken in response to the event for bosutinib was unknown. The outcome of the event GI upset was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received her 1st dose of our COVID-19 vaccine last 03/08 but dated 03/11 she tested COVID-19 positive; This is a spontaneous report received from Pfizer sponsored program  via contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 08Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 11Mar2021, the patient experienced received her 1st dose of our covid-19 vaccine last 03/08 but dated 03/11 she tested covid-19 positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Mar2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.