chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Thrombosis
Clinical narrative: My last period lasted for three weeks with a lot of blood clots; My last period lasted for three weeks with a lot of blood clots/Period is also very runny and watery. Bleeding through many pads per hour.; Periods after covid are irregular; This is a spontaneous report from a contactable consumer (Patient herself). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 04Apr2021 12:00 (at the age of 29-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she did not receive any other medications within 2 weeks of vaccination. Prior and since to the vaccination the patient did not diagnosed with COVID-19. On an unspecified date the patient reported that her periods after COVID are irregular. Her last period lasted for three weeks with a lot of blood clots. Some blood clots were the about the size of a golf ball. Period is also very runny and watery. Bleeding through many pads per hour. Prolonged hospitalization reported as No. The treatment received reported as no. Outcome of events was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dry mouth, Eye disorder, Facial pain, Facial paralysis
Clinical narrative: Bell's Palsy, L. side (peripheral)-face began to feel different; facial paralysis; ttp of L. face; L. side tongue taste is overall poor; endorses dry mouth; L face soreness; inability to fully close L. eye; This is a spontaneous report from a contactable physician and consumer. A 25-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on May2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included vitamin d deficiency and Pet dander allergy (possible pet dander allergy. no official allergies on record). The patient concomitant medications were not reported. Prior to vaccination, the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19 reported as unknown. The patient experienced bell's palsy, l. side (peripheral)-face began to feel different, facial paralysis, l. side tongue taste is overall poor, endorses dry mouth, ttp of L. face, l face soreness and inability to fully close L. eye on May2021. The patient visits the emergency room and physician office for the adverse events. The ED gave patient prednisone 60mg QD 7 days of steroids and valacyclovir to which she was completed both medications and has experienced little to no improvement denies improvement with facial paralysis, just a slight improvement with taste and ability to drink and denies recent sick contacts and reports that she almost entirely works from home. The patient underwent lab tests and procedures which included physical examination: mouth droop is present along L. side, inability to smile along L. side, inability to furrow brow along L. side, slight drop of L. eyelid, diminished sensation of L. side of face on an unspecified date in 2021. The outcome of the event facial paralysis was not recovered, taste abnormality was recovering while unknown for another events.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events, Bell's palsy, Facial Paralysis, and Thrombotic Thrombocytopenic Purpura and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Physical examination, Taste disorder, Thrombotic thrombocytopenic purpura
Clinical narrative: Bell's Palsy, L. side (peripheral)-face began to feel different; facial paralysis; ttp of L. face; L. side tongue taste is overall poor; endorses dry mouth; L face soreness; inability to fully close L. eye; This is a spontaneous report from a contactable physician and consumer. A 25-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on May2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included vitamin d deficiency and Pet dander allergy (possible pet dander allergy. no official allergies on record). The patient concomitant medications were not reported. Prior to vaccination, the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19 reported as unknown. The patient experienced bell's palsy, l. side (peripheral)-face began to feel different, facial paralysis, l. side tongue taste is overall poor, endorses dry mouth, ttp of L. face, l face soreness and inability to fully close L. eye on May2021. The patient visits the emergency room and physician office for the adverse events. The ED gave patient prednisone 60mg QD 7 days of steroids and valacyclovir to which she was completed both medications and has experienced little to no improvement denies improvement with facial paralysis, just a slight improvement with taste and ability to drink and denies recent sick contacts and reports that she almost entirely works from home. The patient underwent lab tests and procedures which included physical examination: mouth droop is present along L. side, inability to smile along L. side, inability to furrow brow along L. side, slight drop of L. eyelid, diminished sensation of L. side of face on an unspecified date in 2021. The outcome of the event facial paralysis was not recovered, taste abnormality was recovering while unknown for another events.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events, Bell's palsy, Facial Paralysis, and Thrombotic Thrombocytopenic Purpura and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: U
Vaccine: COVID19
Symptoms: Mixed connective tissue disease, Multiple sclerosis, Raynaud's phenomenon, Rheumatoid arthritis, Sjogren's syndrome
Clinical narrative: sojrnes; Multiple Sclerosis; Lupus; Mixed Connective Tissue Disease; Rhumatoid Arthritis; Raynauds; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single via an unspecified route of administration on an unspecified as dose 1, single for covid-19 immunization. Medical history included immunodeficiency. The patients concomitant medications were not reported. On an unspecified date, the patient experienced Sojrnes, multiple sclerosis, lupus, mixed connective tissue disease, Raynauds and rheumatoid arthritis. Because the patient on so many immunosuppressive medicines patient's rheumatologist wants patient to do a third Vax. Patient understand Pfizer going through clinical trials and patient would like to be part of it. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: sojrnes; Multiple Sclerosis; Lupus; Mixed Connective Tissue Disease; Rhumatoid Arthritis; Raynauds; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single via an unspecified route of administration on an unspecified as dose 1, single for covid-19 immunization. Medical history included immunodeficiency. The patients concomitant medications were not reported. On an unspecified date, the patient experienced Sojrnes, multiple sclerosis, lupus, mixed connective tissue disease, Raynauds and rheumatoid arthritis. Because the patient on so many immunosuppressive medicines patient's rheumatologist wants patient to do a third Vax. Patient understand Pfizer going through clinical trials and patient would like to be part of it. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Pain in the injection site; Fever of 37.7 °C; Malaise; This is a spontaneous report from a contactable consumer. This is one of the two reports.  A 14-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Jul2021 (reported as yesterday noon) (age at vaccination: 14 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history and concomitant medications were not reported. On 08Jul2021 at night, the patient had malaise. On 09Jul2021, the patient experienced pain in the injection site, and fever of 37.7 degree c. The patient underwent body temperature test which was 37.7 degree C. The patient was given paracetamol as treatment for the events. The outcome of the events was unknown.   Information on lot /batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021868661 same reporter/ drug, different AE/patient
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Circadian rhythm sleep disorder, Dizziness, Gait disturbance
Clinical narrative: She felt nauseated; Her heart was beating very fast; She didn't look good, she was pale, her lips were very white; She had hard time to wake up; Her blood pressure was 160 and then it went to down to 126; She tried to come back and start to talk and was able to start to walk; Lethargic; Dizzy; Allergic reaction; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0198, Expiration date: Unknown), dose 1 via an unspecified route of administration on 10Jul2021 15:00 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated, she had a, she do not know this part yet, she had a allergic reaction (Jul2021), she had a Pfizer shot yesterday at 3 o'clock in the afternoon. At 4 o'clock in the morning she felt nauseated and her heart was beating very fast (11Jul2021 04:00). She wanted to wake me up, she do not know what she said, in the morning she looked at her again she did not look good, she was pale (11Jul2021). she woke her up, she was lethargic (11Jul2021), she was like you know, she did not look good and she asked her to wake up and she had hard time to wake up (11Jul2021) but she was not, she was extremely dizzy and her lips were very white (11Jul2021). So, she took her to the bathroom, she needed help. Reporter stated, she called the paramedics and the paramedics came and her blood pressure was 160 and then it went to down to 126 (11Jul2021). She tried to come back and start to talk and was able to start to walk again (11Jul2021). Reporter again stated, it was the shot the number 1 shot the 1st shot she took for yesterday. Yes, it was a Pfizer COVID vaccine shot. Reporter stated, it's not good to get like that. she do not know if it was safe for her to have the second shot. she do not think so. Reporter stated, "EW0198 and the date that it was given was yesterday, 10Jul2021. Reporter stated her heart was beating really fast that morning and she did not feel good and she got nausea she was she was worried about her heart you know going so fast. The patient underwent lab tests and procedures which included blood pressure: 160 and then it went to down to 126 on 11Jul2021, Heart was beating: very fast on 11Jul2021. The outcome of event she tried to come back and start to talk and was able to start to walk was recovered on 11Jul2021 and for other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypersensitivity, Lethargy, Nausea
Clinical narrative: She felt nauseated; Her heart was beating very fast; She didn't look good, she was pale, her lips were very white; She had hard time to wake up; Her blood pressure was 160 and then it went to down to 126; She tried to come back and start to talk and was able to start to walk; Lethargic; Dizzy; Allergic reaction; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0198, Expiration date: Unknown), dose 1 via an unspecified route of administration on 10Jul2021 15:00 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated, she had a, she do not know this part yet, she had a allergic reaction (Jul2021), she had a Pfizer shot yesterday at 3 o'clock in the afternoon. At 4 o'clock in the morning she felt nauseated and her heart was beating very fast (11Jul2021 04:00). She wanted to wake me up, she do not know what she said, in the morning she looked at her again she did not look good, she was pale (11Jul2021). she woke her up, she was lethargic (11Jul2021), she was like you know, she did not look good and she asked her to wake up and she had hard time to wake up (11Jul2021) but she was not, she was extremely dizzy and her lips were very white (11Jul2021). So, she took her to the bathroom, she needed help. Reporter stated, she called the paramedics and the paramedics came and her blood pressure was 160 and then it went to down to 126 (11Jul2021). She tried to come back and start to talk and was able to start to walk again (11Jul2021). Reporter again stated, it was the shot the number 1 shot the 1st shot she took for yesterday. Yes, it was a Pfizer COVID vaccine shot. Reporter stated, it's not good to get like that. she do not know if it was safe for her to have the second shot. she do not think so. Reporter stated, "EW0198 and the date that it was given was yesterday, 10Jul2021. Reporter stated her heart was beating really fast that morning and she did not feel good and she got nausea she was she was worried about her heart you know going so fast. The patient underwent lab tests and procedures which included blood pressure: 160 and then it went to down to 126 on 11Jul2021, Heart was beating: very fast on 11Jul2021. The outcome of event she tried to come back and start to talk and was able to start to walk was recovered on 11Jul2021 and for other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: She felt nauseated; Her heart was beating very fast; She didn't look good, she was pale, her lips were very white; She had hard time to wake up; Her blood pressure was 160 and then it went to down to 126; She tried to come back and start to talk and was able to start to walk; Lethargic; Dizzy; Allergic reaction; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0198, Expiration date: Unknown), dose 1 via an unspecified route of administration on 10Jul2021 15:00 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated, she had a, she do not know this part yet, she had a allergic reaction (Jul2021), she had a Pfizer shot yesterday at 3 o'clock in the afternoon. At 4 o'clock in the morning she felt nauseated and her heart was beating very fast (11Jul2021 04:00). She wanted to wake me up, she do not know what she said, in the morning she looked at her again she did not look good, she was pale (11Jul2021). she woke her up, she was lethargic (11Jul2021), she was like you know, she did not look good and she asked her to wake up and she had hard time to wake up (11Jul2021) but she was not, she was extremely dizzy and her lips were very white (11Jul2021). So, she took her to the bathroom, she needed help. Reporter stated, she called the paramedics and the paramedics came and her blood pressure was 160 and then it went to down to 126 (11Jul2021). She tried to come back and start to talk and was able to start to walk again (11Jul2021). Reporter again stated, it was the shot the number 1 shot the 1st shot she took for yesterday. Yes, it was a Pfizer COVID vaccine shot. Reporter stated, it's not good to get like that. she do not know if it was safe for her to have the second shot. she do not think so. Reporter stated, "EW0198 and the date that it was given was yesterday, 10Jul2021. Reporter stated her heart was beating really fast that morning and she did not feel good and she got nausea she was she was worried about her heart you know going so fast. The patient underwent lab tests and procedures which included blood pressure: 160 and then it went to down to 126 on 11Jul2021, Heart was beating: very fast on 11Jul2021. The outcome of event she tried to come back and start to talk and was able to start to walk was recovered on 11Jul2021 and for other events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Epistaxis, Headache, Malaise, Pyrexia
Clinical narrative: increasingly off balance; 99 degree temp all week; feeling ill; Long narrow 3-4" red blood clot came out; Nose started bleeding profusely; Odd headache off & on 1st 2 days, then slowing increasing in frequency & duration & intensity. On day 5 around 10:30 pm I'd been sitting on couch a while talking on phone. Nose started bleeding profus; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0187), via an unspecified route of administration in left arm on 01Jul2021 at 14:00 (at the age of 51 years old) as single for covid-19 immunisation. Medical history included autoimmune disorder (numerous including autoimmune). The patient had known allergies to numerous; history of anaphylaxis to different non-vaccine shot and many medications, food, etc. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 01Jul2021 at 18:00, patient experienced odd headache off and on 1st 2 days, then slowing increasing in frequency, duration and intensity. On day 5 around 10:30 pm (06Jul2021 22:00), she had been sitting on couch a while talking on phone. Nose started bleeding profusely. Ran to bathroom and blood squirting out right nostril w/her pulse. Long narrow 3-4" red blood clot came out. Blood everywhere, running down throat and spraying over sink/wall. Packed nose w/kleenex tightly and applied pressure. Left Kleenex in placed around 20 min, removed slowly but no blood on Kleenex which to implies bleeding was up higher or in sinuses. It was not a normal bloody nose. Day 6 (07Jul2021), headache continued, increasingly off balance, 99 degree temp all week and feeling ill. Advised to go to ER to rule out low platelets and stroke/brain bleed. The patient underwent lab tests and procedures which included pyrexia: 99 degree on 01Jul2021, sars-cov-2 test (Nasal swab): negative on 08Jul2021. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit. Therapeutic measures were taken as a result of events with ER evaluation, CT scan. The outcome of events was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: increasingly off balance; 99 degree temp all week; feeling ill; Long narrow 3-4" red blood clot came out; Nose started bleeding profusely; Odd headache off & on 1st 2 days, then slowing increasing in frequency & duration & intensity. On day 5 around 10:30 pm I'd been sitting on couch a while talking on phone. Nose started bleeding profus; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0187), via an unspecified route of administration in left arm on 01Jul2021 at 14:00 (at the age of 51 years old) as single for covid-19 immunisation. Medical history included autoimmune disorder (numerous including autoimmune). The patient had known allergies to numerous; history of anaphylaxis to different non-vaccine shot and many medications, food, etc. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 01Jul2021 at 18:00, patient experienced odd headache off and on 1st 2 days, then slowing increasing in frequency, duration and intensity. On day 5 around 10:30 pm (06Jul2021 22:00), she had been sitting on couch a while talking on phone. Nose started bleeding profusely. Ran to bathroom and blood squirting out right nostril w/her pulse. Long narrow 3-4" red blood clot came out. Blood everywhere, running down throat and spraying over sink/wall. Packed nose w/kleenex tightly and applied pressure. Left Kleenex in placed around 20 min, removed slowly but no blood on Kleenex which to implies bleeding was up higher or in sinuses. It was not a normal bloody nose. Day 6 (07Jul2021), headache continued, increasingly off balance, 99 degree temp all week and feeling ill. Advised to go to ER to rule out low platelets and stroke/brain bleed. The patient underwent lab tests and procedures which included pyrexia: 99 degree on 01Jul2021, sars-cov-2 test (Nasal swab): negative on 08Jul2021. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit. Therapeutic measures were taken as a result of events with ER evaluation, CT scan. The outcome of events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: After receiving his COVID vaccine on 21Mar he has been unable to breathe without oxygen 24/7 at 8 LPM.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient's wife) reported for a male patient (Reporter's husband) an unspecified age who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on 21Mar2021 as unknown single dose for COVID-19 immunization. Medical history included pulmonary fibrosis from 2018 to an unknown date. The patient's concomitant medications were not reported. It was reported that, after receiving his COVID vaccine on 21Mar2021 he has been unable to breathe without oxygen 24/7 at 8 LPM on an unspecified date in Mar2021. Therapeutic measures were taken as a result of after receiving his COVID vaccine on 21mar he has been unable to breathe without oxygen 24/7 at 8 LPM. Reporter enquired as, this was side effect of vaccine or not. The outcome of event was unknown.  Information on lot /batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 17Apr2021 as a dose 1, single for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 08May2021 as a dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm after his covax which he received on 17Apr2021 and 08May2021. He had heard on the news about the booster and asked when it would be available, he was informed that it has not been approved by the FDA yet and was provided with PMI phone number to see if they have further information on the booster. Medical questions were addressed by the program and forwarded/referred to medical information. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Cough, Drug ineffective, Dyspnoea
Clinical narrative: My mother in law received the vaccine 4-5 months ago. She caught Covid and died; My mother in law received the vaccine 4-5 months ago. She caught Covid and died; Just couldn't breathe; A little cough; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program. The caller is calling on behalf of her deceased Mother-in-law. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration Date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included COPD from an unknown date and unknown if ongoing, Bypass (She had bypass 19 years ago) from an unknown date and unknown if ongoing. The reporter stated that " I don't know what else was she taking." The patient's concomitant medications were not reported. Reporter wants to know if Pfizer was giving a placebo or the actual vaccine. She believes her mother-in-law had received a placebo vaccine. My mother-in-law received the vaccine 4-5 months ago. She caught Covid and died (2021). The doctor confirmed she did not have any antibodies. We all had been exposed to her. We are currently in quarantine. My father-in-law is 80 years old and was nervous. He was wondering why did he take the vaccine if it did not protect his wife or him. Reported doctor had basically tested her and they had found no antibodies. At the moment she was nervous because her father-in-law lived with them and they were both quarantined and he was 80 years old. Reporter stated they said she had no antibodies like she never got the vaccine. Reporter stated I do not know the name of antibody Test, but the hospital did it and they said she had no antibody at all. Date of Death: Reporter stated, I am not sure my father-in-law did knows exactly when they got vaccinated but it was 3 or 5 months ago. Reporter stated, "No, she went to the hospital on Thursday evening, and she had been on the ventilator like 3 hours later and she died on Saturday morning 2 O'clock. She had no fever, she had a little cough not major stuff, it was like flu the fever and usual cough she did not had any of that. She had no flu, she just couldn't breathe (2021). Anatomical Site of Administration: Reporter stated, I just know that she received it 4 months ago. The patient underwent lab tests and procedures which included antibody test: no antibody at all, Covid-19: positive on 2021 (She caught Covid and died). Therapeutic measures were taken as a result of my mother in law received the vaccine 4-5 months ago. she caught covid and died, just couldn't breathe. The patient died on 10Jul2021. An autopsy was not performed. The outcome of events just couldn't breathe  and cough was unknown, while other events was fatal.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: My mother in law received the vaccine 4-5 months ago. She caught Covid and died
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: My mother in law received the vaccine 4-5 months ago. She caught Covid and died; My mother in law received the vaccine 4-5 months ago. She caught Covid and died; Just couldn't breathe; A little cough; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program. The caller is calling on behalf of her deceased Mother-in-law. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration Date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included COPD from an unknown date and unknown if ongoing, Bypass (She had bypass 19 years ago) from an unknown date and unknown if ongoing. The reporter stated that " I don't know what else was she taking." The patient's concomitant medications were not reported. Reporter wants to know if Pfizer was giving a placebo or the actual vaccine. She believes her mother-in-law had received a placebo vaccine. My mother-in-law received the vaccine 4-5 months ago. She caught Covid and died (2021). The doctor confirmed she did not have any antibodies. We all had been exposed to her. We are currently in quarantine. My father-in-law is 80 years old and was nervous. He was wondering why did he take the vaccine if it did not protect his wife or him. Reported doctor had basically tested her and they had found no antibodies. At the moment she was nervous because her father-in-law lived with them and they were both quarantined and he was 80 years old. Reporter stated they said she had no antibodies like she never got the vaccine. Reporter stated I do not know the name of antibody Test, but the hospital did it and they said she had no antibody at all. Date of Death: Reporter stated, I am not sure my father-in-law did knows exactly when they got vaccinated but it was 3 or 5 months ago. Reporter stated, "No, she went to the hospital on Thursday evening, and she had been on the ventilator like 3 hours later and she died on Saturday morning 2 O'clock. She had no fever, she had a little cough not major stuff, it was like flu the fever and usual cough she did not had any of that. She had no flu, she just couldn't breathe (2021). Anatomical Site of Administration: Reporter stated, I just know that she received it 4 months ago. The patient underwent lab tests and procedures which included antibody test: no antibody at all, Covid-19: positive on 2021 (She caught Covid and died). Therapeutic measures were taken as a result of my mother in law received the vaccine 4-5 months ago. she caught covid and died, just couldn't breathe. The patient died on 10Jul2021. An autopsy was not performed. The outcome of events just couldn't breathe  and cough was unknown, while other events was fatal.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: My mother in law received the vaccine 4-5 months ago. She caught Covid and died
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dehydration, Dyspnoea, Heart rate
Clinical narrative: Heart racing; Thirst; The shot made her so dehydrated.; breathlessness with the increased heart rate; her blood pressure was 166/102 with a heart rate of 130; her blood pressure was 166/102 with a heart rate of 130/The highest her heart rate got was 166. Then, it would go to 130 or 120.; This is a spontaneous report received from a contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0175 and expiry dates was not provided, 24-years-old at the time of vaccination) via an unspecified route of administration on left arm on 10Jul2021 (11:40, Saturday), at unknown dose single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient was perfectly fine before the vaccine. Six hours later on 10Jul 2021, her heart started racing, she did not think about it at first. She road it out through the day. The next day, her heart was still racing. She went to Urgent care, and her blood pressure was 166/102 with a heart rate of 130 on an unspecified dated in Jul 2021. It was 100% from the shot. Her doctor downplayed it. He said he hopes it does not stop her from taking the second one, and she said what an idiot. Racing heart has been reported though. The patient did not have a history of high blood pressure or abnormal heart rates. It was sad because she did not get any other side effects. Other than this she feels 100 percent. Heart racing is not a good feeling. she just went to the walk-in pharmacy at the grocery store, she got the vaccine 48 hours ago on the 10Jul2021 at 11:40 am. Last night (on unspecified date), she went to the ER. She was told to drink a lot of water before the shot. Even her pharmacist told her that. The shot made her so dehydrated. She was drinking bottles of water down constantly. She went to the ER, and it looked like she did not drink any water. It depleted her. It made her so thirsty, and her heart was racing. It seemed like it would improve, but it kept spiking. The highest her heart rate got was 166. Then, it would go to 130 or 120. Her blood pressure last night was 105/71. The first and second day the thirst was worse. Today it has improved. She also experienced breathlessness with the increased heart rate. Her mother told her to go to the urgent care, she had an appointment tomorrow (on unspecified date) with her regular physician in the morning, she called drug safety over the weekend but could not understand the agent. The outcome of the event Heart racing, her blood pressure was 166/102 with a heart rate of 130 and Thrist was recovered on unspecified date in Jul2021, the outcome for event breathlessness with the increased heart rate and Dehydration was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations, Thirst
Clinical narrative: Heart racing; Thirst; The shot made her so dehydrated.; breathlessness with the increased heart rate; her blood pressure was 166/102 with a heart rate of 130; her blood pressure was 166/102 with a heart rate of 130/The highest her heart rate got was 166. Then, it would go to 130 or 120.; This is a spontaneous report received from a contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0175 and expiry dates was not provided, 24-years-old at the time of vaccination) via an unspecified route of administration on left arm on 10Jul2021 (11:40, Saturday), at unknown dose single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient was perfectly fine before the vaccine. Six hours later on 10Jul 2021, her heart started racing, she did not think about it at first. She road it out through the day. The next day, her heart was still racing. She went to Urgent care, and her blood pressure was 166/102 with a heart rate of 130 on an unspecified dated in Jul 2021. It was 100% from the shot. Her doctor downplayed it. He said he hopes it does not stop her from taking the second one, and she said what an idiot. Racing heart has been reported though. The patient did not have a history of high blood pressure or abnormal heart rates. It was sad because she did not get any other side effects. Other than this she feels 100 percent. Heart racing is not a good feeling. she just went to the walk-in pharmacy at the grocery store, she got the vaccine 48 hours ago on the 10Jul2021 at 11:40 am. Last night (on unspecified date), she went to the ER. She was told to drink a lot of water before the shot. Even her pharmacist told her that. The shot made her so dehydrated. She was drinking bottles of water down constantly. She went to the ER, and it looked like she did not drink any water. It depleted her. It made her so thirsty, and her heart was racing. It seemed like it would improve, but it kept spiking. The highest her heart rate got was 166. Then, it would go to 130 or 120. Her blood pressure last night was 105/71. The first and second day the thirst was worse. Today it has improved. She also experienced breathlessness with the increased heart rate. Her mother told her to go to the urgent care, she had an appointment tomorrow (on unspecified date) with her regular physician in the morning, she called drug safety over the weekend but could not understand the agent. The outcome of the event Heart racing, her blood pressure was 166/102 with a heart rate of 130 and Thrist was recovered on unspecified date in Jul2021, the outcome for event breathlessness with the increased heart rate and Dehydration was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Received the vaccine 4-5 months ago and was quarantined; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program . A 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as, dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller stated that the patient had received vaccine 3 or 5 months ago. On an unspecified date after receiving the vaccine, the patient was exposed to the caller's mother-in-law who took vaccine 4-5 months ago, had COVID and died from it. The patient was wondering why he had taken the vaccine if it couldn't protect them. The patient was quarantined. The clinical outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots from COVID Vaccine/Can you please repeat the product name; Eliquis; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received unknown number dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced blood clots from covid vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: states her husband died 5 months ago with the second shot, after he had his second shot in 5 days; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 02Feb2021 as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The reporter stated that on 05Feb2021, her husband died 5 months ago with the second shot, after he had his second shot in 5 days and reporter confirmed that her husband had the Pfizer Covid-19 vaccine. She stated that her husband was in the hospice before that, he died a little bit over 5 months. Reporter stated she was a nursing student and said no to completing a report, by saying that her husband was gone, he died but because she looked at the medical statement that the Medicare paid for him the first time $35 and the second time $35 but she sees he took the second shot on 02Feb2021 and he died on 05Feb2021. He was in the emergency right after the shot, she thought, on the same day he had the shot on 02Feb2021 and he died in the hospital, but he was in the nursing home facility paid for seven months and hospice for seven months. She stated they wouldn't let her visit him and she was not able to visit him for a while before he died. The patient died on 05Feb2021. Cause of death was not provided. The outcome of event was fatal.  Information on Lot/Batch information has been requested.; Reported Cause(s) of Death: states her husband died 5 months ago with the second shot, after he had his second shot in 5 days
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I know of three people that had the original 2 Pfizer shots and within 90 days contracted the Delta variant.; I know of three people that had the original 2 Pfizer shots and within 90 days contracted the Delta variant.; This is a spontaneous report from a Pfizer sponsored program- General Company Information via contactable consumer. A contactable consumer reported for a patient (1 of 3 patients). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that the patient received original 2 Pfizer shots and within 90 days contracted the delta variant. The reporter understand that Pfizer was asking the FDA for 6 months booster for the covid 19 to cover the Delta variant, but reporter know of three people that had the original 2 Pfizer shots and within 90 days contracted the Delta variant and six months was too late. The outcome of all events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021885306 Same reporter/ drug/ event, different patients.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They both had COVID 28Jun and 3Jul; They both had COVID 28Jun and 3Jul; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 19-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported that after the vaccination on an unknown date in an unknown month, on 28Jun2021, the patient got tested positive for COVID-19. The patient had to visit the emergency room due to the event. The outcome of the event was reported as unknown at the time of report.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021885554 Same reporter/ drug/ event, different patients.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had COVID on 7/3; had COVID on 7/3; This is a spontaneous report received from a contactable consumer (patient's daughter/son) reported for the patient (reporter's mother) forwarded as an Adverse Event by the call center team. A 78-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jul2021, the patient had COVID. The patient underwent lab tests which included Sars-cov-2 test: positive on 03Jul2021. The patient had emergency room visit due to the event. It was reported that the reporter's mother had the Pfizer vaccine in Jan/Feb2021 and had COVID on 03Jul2021. The reporter stated that they needed a third vaccine. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021885466 Same reporter/ drug/ event, different patients.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I had an outbreak of shingles or herpes zoster on my right hand.; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot number and expiry date was not reported) dose 1 via an unspecified route of administration at Arm Right on 23Jun2021 11:00 (at the age of 57-years-old) as a single dose, for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder, depression from an unknown date and unknown if ongoing Verbatim: ADHD. Concomitant medication(s) included levocetirizine dihydrochloride (XYZAL), citalopram taken for an unspecified indication, start and stop date were not reported. patient had no Known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jul2021 04:00 the patient experienced outbreak of shingles or herpes zoster on her right hand. with outcome of recovering. No treatment was given for the event. Outcome of the event was recovering.