chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My uncle tested positive for COVID-19 five days after being exposed to his COVID positive daughter (she was not positive at the time of exposure), who was also fully vaccinated with the Pfizer vaccine; My uncle tested positive for COVID-19 five days after being exposed to his COVID positive daughter (she was not positive at the time of exposure), who was also fully vaccinated with the Pfizer vaccine; This is a spontaneous report from a contactable consumer or other non hcp.   A 63-years-old male patient (reporter's uncle) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unknown date in Mar2021 (Batch/Lot number was not reported) as dose 1, single dose and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unknown date in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization (at the age of 63-years-old). The patient medical history and concomitant medications were not reported. Facility type vaccine was unknown. It was unknown if patient had any known allergies. Patient had no covid prior vaccination. The reporter stated that on 06Aug2021,  the patient tested positive for Covid-19 five days after being exposed to his Covid positive daughter (she was not positive at the time of exposure), who was also fully vaccinated with the Pfizer vaccine. The patient underwent lab tests and procedures which included Covid nasal swab rapid test which result was positive on 06Aug2021. The outcome of the events were unknown.   Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: felt weak; fatigue; This is a spontaneous report from a contactable nurse. A 21-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included hydrochlorothiazide and escitalopram oxalate (LEXAPRO). Unsure when the patient received the first dose of COVID vaccine. The patient only stated she felt weak and fatigue afterwards on unspecified date. No problems with vaccines in past and no other vaccines given the same day as COVID vaccines. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I received the covid-19 vaccine and tested positive for Covid-19 by PCR test; I received the covid-19 vaccine and tested positive for Covid-19 by PCR test; This is a spontaneous report from a contactable consumer (patient). A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular on 09Feb2021 (Batch/Lot Number: EL3247) (at the age of 36-years-old) as dose 2, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL3247) (at the age of 36-years-old) as dose 1, single both for COVID-19 immunization. Medical history included acid reflux and seasonal allergies. Concomitant medications included dexlansoprazole (DEXILANT); cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she received the covid-19 vaccine and tested positive for covid-19 by pcr test on 03Aug2021. The patient visited doctor or other healthcare professional office/clinic visit due to events. No treatment was received for the events. The patient underwent lab tests and procedures which included covid-19 by pcr test: positive on 03Aug2021. The outcome of event was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: tremendous itching at "vaccination site"; diarrhea; sweating; light headedness/woozy; gagging that lasted about 10 minutes.; felt nauseated; weary; feeling like she was gonna go out, like this was gonna be bad/ She says she never had a feeling in her arm; This is a spontaneous report from a contactable consumer (patient).   A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19Jul2021 15:00 (Batch/Lot Number: ER8729) age at vaccination of 69-years-old, as single dose, for covid-19 immunisation.  The patient medical history was not reported.     There were no concomitant medications.   At 2:00 AM on 20Jul2021, the patient experienced tremendous itching at vaccination site, she felt like she needed to go to the bathroom, she emptied her bowels totally/had diarrhea, sweating/ pouring watery sweat over her whole body but mainly her face, she emptied her bowels totally, light headedness, gagging that lasted about 10 minutes (a couple times like she was gonna throw up, but she didn't). The patient didn't have any problem at 3PM in the afternoon. Her arms were itching, she felt nauseated and gagged twice. She has light headedness and sweating that lasted for 10-15 minutes. She mentioned that she unloaded real quick, and  had to get down on the floor and call (#) but called hotline instead, that was at 7:00PM in the evening. Then her symptoms suddenly went away after that.  She says her reaction lasted 10 minutes, and she had no labored breathing, when she called the hotline they asked how is she breathing and is her tongue swollen, and what she had was sweating, gagging, diarrhea the one time, very light headed, and woozy, then everything started to subside then. AE Treatment: the patient said she fell asleep and did no treatment. She says for 3-4 days she was weary, and she no pain at site. She e had itching, sweating, gagging, diarrhea, feeling like she was gonna go out, like this was gonna be bad, and then in ten minutes it was going to be over. She says she had no pain at the injection site, she just felt tired for 4 days, she didn't feel like doing too much, at 7:00PM for 4 days she felt really tired. She says it was an intense 10 minutes. She says she went to the doctor who checked her heart and lungs with a stethoscope, and did labs for liver, heart, and kidneys, all that. She will see her doctor this week, which is also her week to get second injection, so she sees her on the 12th to talk about results of that. She says this was more than a hurting arm so she would like to talk to someone about her questions about her reaction. Final outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Retching, Vaccination site pruritus
Clinical narrative: tremendous itching at "vaccination site"; diarrhea; sweating; light headedness/woozy; gagging that lasted about 10 minutes.; felt nauseated; weary; feeling like she was gonna go out, like this was gonna be bad/ She says she never had a feeling in her arm; This is a spontaneous report from a contactable consumer (patient).   A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19Jul2021 15:00 (Batch/Lot Number: ER8729) age at vaccination of 69-years-old, as single dose, for covid-19 immunisation.  The patient medical history was not reported.     There were no concomitant medications.   At 2:00 AM on 20Jul2021, the patient experienced tremendous itching at vaccination site, she felt like she needed to go to the bathroom, she emptied her bowels totally/had diarrhea, sweating/ pouring watery sweat over her whole body but mainly her face, she emptied her bowels totally, light headedness, gagging that lasted about 10 minutes (a couple times like she was gonna throw up, but she didn't). The patient didn't have any problem at 3PM in the afternoon. Her arms were itching, she felt nauseated and gagged twice. She has light headedness and sweating that lasted for 10-15 minutes. She mentioned that she unloaded real quick, and  had to get down on the floor and call (#) but called hotline instead, that was at 7:00PM in the evening. Then her symptoms suddenly went away after that.  She says her reaction lasted 10 minutes, and she had no labored breathing, when she called the hotline they asked how is she breathing and is her tongue swollen, and what she had was sweating, gagging, diarrhea the one time, very light headed, and woozy, then everything started to subside then. AE Treatment: the patient said she fell asleep and did no treatment. She says for 3-4 days she was weary, and she no pain at site. She e had itching, sweating, gagging, diarrhea, feeling like she was gonna go out, like this was gonna be bad, and then in ten minutes it was going to be over. She says she had no pain at the injection site, she just felt tired for 4 days, she didn't feel like doing too much, at 7:00PM for 4 days she felt really tired. She says it was an intense 10 minutes. She says she went to the doctor who checked her heart and lungs with a stethoscope, and did labs for liver, heart, and kidneys, all that. She will see her doctor this week, which is also her week to get second injection, so she sees her on the 12th to talk about results of that. She says this was more than a hurting arm so she would like to talk to someone about her questions about her reaction. Final outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster, Hypoaesthesia, Insomnia, Neuralgia
Clinical narrative: neuropathy; Her ankle and both feet, hands, calves, and from the thighs the pain was severe enough; shingles pain; numbness and tingling in feet; trouble sleeping/could not sleep; Nerve pain; Her ankle and both feet, hands, calves, and from the thighs the pain was severe enough; tingling in multiple places in the body; severe ringing of the ears; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient has already reported about the vaccine to her family doctor and will be calling the (Public agency name). She had the first dose of the Pfizer Covid vaccine on Tuesday (unspecified date) and immediately afterwards in the afternoon, about 3 hours later, had severe ringing of the ears and that went in through Wednesday. Then Wednesday she started having tingling and numbness in her feet. That continued to increase to the point by Friday afternoon she was not able to get any sleep because of having nerve pain and tingling in multiple places in the body. It was almost like with someone who has neuropathy or shingles pain, that the nerve pain you would get. Her ankle and both feet, hands, calves, and from the thighs the pain was severe enough that she could not sleep because of it. She has never had or felt anything like that in her life. Knows that it is not the stereotypical symptoms talked about, but she mentioned this to her primary care provider and to the pharmacist. Normally people get the flu like symptoms, but she did not get it, this vaccine did not manifest in her system like that. It was added that she felt she needed to let the company know and everybody know that she is seeing more reports of this and her doctor said that she has a lady that has had this for a while and it is still ongoing. There have been reports of people saying they've had these symptoms 3-4 weeks after getting the vaccine and this is alarming she is not going to lie, but it is doing something to the immune system. Declined to complete report on lady her doctor informed her about stating her doctor had mentioned that this was rare, it's a 1% chance of happening, but she is still having it. No further details provided.  The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity, Paraesthesia, Tinnitus
Clinical narrative: neuropathy; Her ankle and both feet, hands, calves, and from the thighs the pain was severe enough; shingles pain; numbness and tingling in feet; trouble sleeping/could not sleep; Nerve pain; Her ankle and both feet, hands, calves, and from the thighs the pain was severe enough; tingling in multiple places in the body; severe ringing of the ears; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient has already reported about the vaccine to her family doctor and will be calling the (Public agency name). She had the first dose of the Pfizer Covid vaccine on Tuesday (unspecified date) and immediately afterwards in the afternoon, about 3 hours later, had severe ringing of the ears and that went in through Wednesday. Then Wednesday she started having tingling and numbness in her feet. That continued to increase to the point by Friday afternoon she was not able to get any sleep because of having nerve pain and tingling in multiple places in the body. It was almost like with someone who has neuropathy or shingles pain, that the nerve pain you would get. Her ankle and both feet, hands, calves, and from the thighs the pain was severe enough that she could not sleep because of it. She has never had or felt anything like that in her life. Knows that it is not the stereotypical symptoms talked about, but she mentioned this to her primary care provider and to the pharmacist. Normally people get the flu like symptoms, but she did not get it, this vaccine did not manifest in her system like that. It was added that she felt she needed to let the company know and everybody know that she is seeing more reports of this and her doctor said that she has a lady that has had this for a while and it is still ongoing. There have been reports of people saying they've had these symptoms 3-4 weeks after getting the vaccine and this is alarming she is not going to lie, but it is doing something to the immune system. Declined to complete report on lady her doctor informed her about stating her doctor had mentioned that this was rare, it's a 1% chance of happening, but she is still having it. No further details provided.  The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive to COVID-19 on 03Aug2021.; Patient tested positive to COVID-19 on 03Aug2021.; This is a spontaneous report from a contactable Consumer. A Consumer reported for a 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via Intramuscularly, in Arm Right, on 01Apr2021 at 09:00 AM (age at vaccination: 16 years), as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via Intramuscularly, in Arm Right, on 22Apr2021 at 09:00 AM (age at vaccination: 16 years), as a single dose for COVID-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medication which included birth control within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient tested positive to COVID-19 on 03Aug2021. The patient did not receive any treatment for the events. The patient underwent lab test and producers which included SARS-CoV-2 test (Nasal Swab) on 03Aug2021: positive. Outcome of the events was recovered on an unspecified date in Aug2021.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Cough, Oropharyngeal pain
Clinical narrative: chills that were uncontrollable (sister said they were almost like seizures); Chills; fever; cough; sore throat; Chest Pain; joint pain; shook so hard; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 06Aug2021 11:00 (Batch/Lot Number: FC3180) (at age 77-years-old) as dose 2, single for covid-19 immunisation. The first dose was received on 14Jul2021 10:30 (lot number EW0185) (at age 77 years-old) on the right arm. Medical history included open heart surgery and cochlear implant. Concomitant medication(s) included thyroid (THYROID); atorvastatin calcium (LIPITOR); acetylsalicylic acid (BABY ASPIRIN); and trazodone; all taken for an unspecified indication, start and stop date were not reported. There were no other vaccine within 4 weeks. The patient previously took codeine and experienced allergy. The patient experienced chills that were uncontrollable (sister said they were almost like seizures), fever, cough, sore throat, chest pain, joint pain on 06Aug2021 23:00. It was also reported that going to bathroom challenge because patient shook so hard could hardly make it. Patient was 2 days sick. There were no treatment given for the events. Outcome of the events was recovering. Patient was not diagnosed with covid 19 prior to vaccination and has not been tested post-vaccination.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure like phenomena, Tremor
Clinical narrative: chills that were uncontrollable (sister said they were almost like seizures); Chills; fever; cough; sore throat; Chest Pain; joint pain; shook so hard; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 06Aug2021 11:00 (Batch/Lot Number: FC3180) (at age 77-years-old) as dose 2, single for covid-19 immunisation. The first dose was received on 14Jul2021 10:30 (lot number EW0185) (at age 77 years-old) on the right arm. Medical history included open heart surgery and cochlear implant. Concomitant medication(s) included thyroid (THYROID); atorvastatin calcium (LIPITOR); acetylsalicylic acid (BABY ASPIRIN); and trazodone; all taken for an unspecified indication, start and stop date were not reported. There were no other vaccine within 4 weeks. The patient previously took codeine and experienced allergy. The patient experienced chills that were uncontrollable (sister said they were almost like seizures), fever, cough, sore throat, chest pain, joint pain on 06Aug2021 23:00. It was also reported that going to bathroom challenge because patient shook so hard could hardly make it. Patient was 2 days sick. There were no treatment given for the events. Outcome of the events was recovering. Patient was not diagnosed with covid 19 prior to vaccination and has not been tested post-vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: I had an increased heart rate, my heart rate after getting vaccine was 69 to 80 and then it's been staying between 100 and 115; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Aug2021 (Age of vaccination: Unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Aug2021 the patient had an increased heart rate, also heart rate after getting vaccine was 69 to 80 and then it's been staying between 100 and 115. The patient underwent lab tests and procedures which included heart rate: 69 to 80 on an unspecified date, heart rate: between 100 and 115 on an unspecified date, heart rate: increased on an unspecified date. The outcome of event was unknown. Information about Lot/Batch number is requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 49-years-old male patient received bnt162b2 (BNT162B2 Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: ewolf3), via an unspecified route of administration on 30Apr2021(at the age of 49-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On Jun2021, the patient experienced blood clot. The patient was hospitalized for blood clot (thrombosis) for 1 days. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid months after getting the second dose; Tested positive for Covid months after getting the second dose; This is a spontaneous report from Contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1 single and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2 single for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient stated that on an unspecified date her husband and she both tested positive for Covid months after getting the second dose of the Pfizer vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date The outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid months after getting the second dose; Tested positive for Covid months after getting the second dose; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history and concomitant medications was not reported. On an unspecified date, the patient had tested positive for Covid months after getting the second dose (medically significant).The patient underwent lab tests which included Sars-cov-2 test: positive.The outcome of the events was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Pain
Clinical narrative: Headache; Fever; Chills; Body Aches; Fatigue; Coughing; Tested positive for COVID; Tested positive for COVID; Runny nose; This is a spontaneous report from a non-contactable consumer or other non hcp. A 37-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: EL3247; Expiration Date: 31May2021) via an unspecified route of administration, administered on 18Mar2021 10:37 (at the age of 37-years-old) as dose 2,single for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: EL3247; Expiration Date: 31May2021) via an unspecified route of administration, administered on 25Feb2021 as a dose 1,single for covid-19 immunisation. The patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She has an a 11 month old baby, so she must have had a newborn. It was reported that on 02Aug2021 the patient experienced runny nose and on 04Aug2021 08:44 the patient tested positive for covid 19 who had both doses of the Pfizer COVID vaccine. Reporter further stated that on an unspecified date patient experienced headache, fever, chills, body aches, fatigue and reporter know patient was coughing because reporter heard patient was coughing. patient has no loss of taste or smell. On 04Aug2021 the patient underwent lab tests and procedures PCR SARS COVID 2 RNA which resulted positive and underwent QLNAAT, RT, PCR/TMA (COVID 19) which resulted positive. The patient was recovering from the events.  For Lack of Efficacy, request the following information: Description of complaint: Received call from HCP to report a patient at the site she works at tested positive for COVID 19 virus after receiving both doses of the Pfizer COVID 19 vaccine. She did not wish to provide patient name and only gave initials as she did not tell patient that she was reporting on her behalf.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Headache; Fever; Chills; Body Aches; Fatigue; Coughing; Tested positive for COVID; Tested positive for COVID; Runny nose; This is a spontaneous report from a non-contactable consumer or other non hcp. A 37-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: EL3247; Expiration Date: 31May2021) via an unspecified route of administration, administered on 18Mar2021 10:37 (at the age of 37-years-old) as dose 2,single for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: EL3247; Expiration Date: 31May2021) via an unspecified route of administration, administered on 25Feb2021 as a dose 1,single for covid-19 immunisation. The patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She has an a 11 month old baby, so she must have had a newborn. It was reported that on 02Aug2021 the patient experienced runny nose and on 04Aug2021 08:44 the patient tested positive for covid 19 who had both doses of the Pfizer COVID vaccine. Reporter further stated that on an unspecified date patient experienced headache, fever, chills, body aches, fatigue and reporter know patient was coughing because reporter heard patient was coughing. patient has no loss of taste or smell. On 04Aug2021 the patient underwent lab tests and procedures PCR SARS COVID 2 RNA which resulted positive and underwent QLNAAT, RT, PCR/TMA (COVID 19) which resulted positive. The patient was recovering from the events.  For Lack of Efficacy, request the following information: Description of complaint: Received call from HCP to report a patient at the site she works at tested positive for COVID 19 virus after receiving both doses of the Pfizer COVID 19 vaccine. She did not wish to provide patient name and only gave initials as she did not tell patient that she was reporting on her behalf.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Dysuria, Fatigue
Clinical narrative: Fever; My temperature was about two Degrees above my normal; Sensation of nausea but I am not vomiting; it is not serious but uncomfortable; had unusual high number bowel movement; my weight was below normal; my pattern of my urination was less than half volume; Chills; Fatigue; elevated Heart rate; my heart rate is normally 60 and it was up around 90; This is a spontaneous report received from a contactable consumer (patient) reported for himself via a Pfizer regulatory authority. A 65-year-old male patient received bnt162b2 (Formulation: Solution for injection, Batch/Lot Number: EW0179), dose 1 via an unspecified route of administration on 20Jul2021 as single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient stated that his temperature was about two Degrees above my normal and would say it was lasted for about 30 hours. Now his normal temperature was about 97-97.5 Degrees. It was higher for a while up to 99.3, he had a sensation of nausea, not vomiting and it was not serious but uncomfortable. He didn't have diarrhea but had unusual high number bowel movements that day. He had a bowel movement for about 18 hours which it was very unusual, weight mention was below normal, the patient generally drinks a lot of water and  have pretty good familiarity with his pattern of his urination but it was less than half volume that he normally produce. Recovered back to normal after 30 hour time period. He did have a period of enough chills shivering put on jacket, He had pretty strong fatigue and it seems like my elevated Heart rate and his blood pressure was normal, his heart rate was normally 60 and it was up around 90. He also have a pulse auxometer, my normal reading were usually "96-98" (not clarified). Now the patient feel much better now, some minor Local reaction; delayed reaction; but in his suspicion that was most likely a systemic reaction". The patient reported that on Friday he began to experience local side effects. Seeking information on whether these could be from the vaccine or covid 19 infection, also seeking information if he can get the second dose of the Pfizer BioNtech covid 19 vaccine with a current covid 19 infection and also queried that can he get the second dose of the Pfizer BioNtech covid 19 vaccine if it has been longer than 21 days since his first dose. The patient also said that about 17 days from the first dose, he had symptoms. He wanted to know if this could be the delayed reaction. He said he "extremely" (not clarified) followed the protocol when it came to "isolation" (further not clarified). He was scheduled for the second dose tomorrow (10Aug2021)." Consumer stated, "I am not concerned about reaction, I am concerned about how long it will take, I have to take my second shot." Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Frequent bowel movements, Heart rate increased, Nausea, Oxygen saturation, Pyrexia
Clinical narrative: Fever; My temperature was about two Degrees above my normal; Sensation of nausea but I am not vomiting; it is not serious but uncomfortable; had unusual high number bowel movement; my weight was below normal; my pattern of my urination was less than half volume; Chills; Fatigue; elevated Heart rate; my heart rate is normally 60 and it was up around 90; This is a spontaneous report received from a contactable consumer (patient) reported for himself via a Pfizer regulatory authority. A 65-year-old male patient received bnt162b2 (Formulation: Solution for injection, Batch/Lot Number: EW0179), dose 1 via an unspecified route of administration on 20Jul2021 as single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient stated that his temperature was about two Degrees above my normal and would say it was lasted for about 30 hours. Now his normal temperature was about 97-97.5 Degrees. It was higher for a while up to 99.3, he had a sensation of nausea, not vomiting and it was not serious but uncomfortable. He didn't have diarrhea but had unusual high number bowel movements that day. He had a bowel movement for about 18 hours which it was very unusual, weight mention was below normal, the patient generally drinks a lot of water and  have pretty good familiarity with his pattern of his urination but it was less than half volume that he normally produce. Recovered back to normal after 30 hour time period. He did have a period of enough chills shivering put on jacket, He had pretty strong fatigue and it seems like my elevated Heart rate and his blood pressure was normal, his heart rate was normally 60 and it was up around 90. He also have a pulse auxometer, my normal reading were usually "96-98" (not clarified). Now the patient feel much better now, some minor Local reaction; delayed reaction; but in his suspicion that was most likely a systemic reaction". The patient reported that on Friday he began to experience local side effects. Seeking information on whether these could be from the vaccine or covid 19 infection, also seeking information if he can get the second dose of the Pfizer BioNtech covid 19 vaccine with a current covid 19 infection and also queried that can he get the second dose of the Pfizer BioNtech covid 19 vaccine if it has been longer than 21 days since his first dose. The patient also said that about 17 days from the first dose, he had symptoms. He wanted to know if this could be the delayed reaction. He said he "extremely" (not clarified) followed the protocol when it came to "isolation" (further not clarified). He was scheduled for the second dose tomorrow (10Aug2021)." Consumer stated, "I am not concerned about reaction, I am concerned about how long it will take, I have to take my second shot." Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Fever; My temperature was about two Degrees above my normal; Sensation of nausea but I am not vomiting; it is not serious but uncomfortable; had unusual high number bowel movement; my weight was below normal; my pattern of my urination was less than half volume; Chills; Fatigue; elevated Heart rate; my heart rate is normally 60 and it was up around 90; This is a spontaneous report received from a contactable consumer (patient) reported for himself via a Pfizer regulatory authority. A 65-year-old male patient received bnt162b2 (Formulation: Solution for injection, Batch/Lot Number: EW0179), dose 1 via an unspecified route of administration on 20Jul2021 as single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient stated that his temperature was about two Degrees above my normal and would say it was lasted for about 30 hours. Now his normal temperature was about 97-97.5 Degrees. It was higher for a while up to 99.3, he had a sensation of nausea, not vomiting and it was not serious but uncomfortable. He didn't have diarrhea but had unusual high number bowel movements that day. He had a bowel movement for about 18 hours which it was very unusual, weight mention was below normal, the patient generally drinks a lot of water and  have pretty good familiarity with his pattern of his urination but it was less than half volume that he normally produce. Recovered back to normal after 30 hour time period. He did have a period of enough chills shivering put on jacket, He had pretty strong fatigue and it seems like my elevated Heart rate and his blood pressure was normal, his heart rate was normally 60 and it was up around 90. He also have a pulse auxometer, my normal reading were usually "96-98" (not clarified). Now the patient feel much better now, some minor Local reaction; delayed reaction; but in his suspicion that was most likely a systemic reaction". The patient reported that on Friday he began to experience local side effects. Seeking information on whether these could be from the vaccine or covid 19 infection, also seeking information if he can get the second dose of the Pfizer BioNtech covid 19 vaccine with a current covid 19 infection and also queried that can he get the second dose of the Pfizer BioNtech covid 19 vaccine if it has been longer than 21 days since his first dose. The patient also said that about 17 days from the first dose, he had symptoms. He wanted to know if this could be the delayed reaction. He said he "extremely" (not clarified) followed the protocol when it came to "isolation" (further not clarified). He was scheduled for the second dose tomorrow (10Aug2021)." Consumer stated, "I am not concerned about reaction, I am concerned about how long it will take, I have to take my second shot." Outcome of the events was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram, Hypoaesthesia, Pain, SARS-CoV-2 test
Clinical narrative: Pain; Numbness in the hand, feet, legs, and back; This is a spontaneous report received from a contactable male consumer (patient).  A 58-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 23Apr2021, at the age of 58 years old, as 2nd single dose, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included verapamil. Historical vaccine included 1st dose of BNT162b, via an unspecified route of administration, administered in the left arm, on 02Apr2021 at 10:00 AM (Lot Number: EN6200), at the age of 58 years old. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had never been diagnosed with COVID-19. The patient stated having been experiencing numbness in the hand, feet, legs, and back since 03May2021 at 03:30 PM. Due to the events, the patient had to schedule an appointment with a neurologist on 13May2021 and a follow-up meeting on 14Jun2021 with EMG performed on 14Jun2021 (unknown results). He was told that BNT162b2 was possibly a contributor to his condition at the time of the reporting. The patient added that at the time of the reporting he was walking with a cane since the second week of Jun2021, and was in pain. On 05Aug2021, a nasal swab was done which resulted negative. No treatment was needed for the event. The patient had not recovered from the events at the time of the reporting. According to the patient, the events were disabling.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Heart rate irregular
Clinical narrative: intense heart rate increase; blood pressure was elevated, 140/84, 132/86; increased heart rate and it spiked and then decreased; This is a spontaneous report from a Pfizer sponsored program  from a contactable consumer (patient)   A 57 year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 26Jul2021  at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included allergies during seasonal changes and sometimes she had e a runny nose and difficulty breathing. Concomitant medications were not reported. On 26Jul2021 patient noticed an intense heart rate increase and feels different like something has changed and not like before (as reported). A few days after she was seeing her cardiologist and her blood pressure was elevated which she states is not normal for her and has not happened before. She states that it was 140/84 and 132/86. She recalled that after the dose of the vaccine she had an increased heart rate and it spiked and then decreased.  At the time of the reporting the patient had not yet recovered from the events.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 following full vaccination completion.; Tested positive for COVID-19 following full vaccination completion.; This is a spontaneous report from a non-contactable other health professional.   A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318, Expiration date was not reported) dose 1 via an unspecified route of administration on 29Jan2021 (at the age of 53 years old) as dose 1 single, and patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318, Expiration date was not reported) dose 1 via an unspecified route of administration on 19Feb2021 as dose 2 single, both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 following full vaccination completion on 05Aug2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Aug2021. Outcome of the event COVID-19 was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Contracted the Delta variant two weeks ago; we were fully vaccinated with your vaccine 6 months ago/Contracted the Delta variant two weeks ago; Very sick; This is a spontaneous report from a contactable consumer. A 7-decade-old female consumer (patient) reported for herself that she received second 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 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 patient and her husband were in their 60s and they were fully vaccinated with the vaccine 6 months ago. On unspecified dates in 2021, the patient contracted the delta variant (two weeks ago) and was very sick. The patient wanted Covid boosters to be developed and distributed as soon as possible. Also, she wanted that Pfizer should provide booster soon to help out county. The patient underwent lab tests and procedures which included sars-cov-2 test: contracted the delta variant on an unspecified date in 2021. The outcome of all events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac disorder, Chest pain, Head discomfort, Headache
Clinical narrative: heart hurting; allergic reaction; head felt weird; Arm ached a little bit; chest pain/chest hurting; heart felt uncomfortable/Heart did not feel comfortable; didn't feel good; head hurts; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as a Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The reporter stated that the patient had received his first dose of the Pfizer Covid-19 vaccine and had "an allergic reaction". The reporter stated that his head felt weird, head hurts, didn't feel good and he had other minor side effect, like his arm ached a little bit, stated it was no big deal. He said that what was concerning to him was he had chest pain/chest hurting and his heart did not feel comfortable/ heart felt uncomfortable. The reporter wanted to know if chest/heart hurting was a serious side effect. The pharmacist told the patient that the first shot normally doesn't do anything and since the patient had a reaction already to the first shot; the pharmacist didn't know if the patient should get the second shot. His doctor told him that he should receive the second dose. Reporter asked whether the second shot be as bad or worse than the first. The patient stated that his doctor said he should take it to be protected. Full details not obtained. The patient thought about not taking the second dose. The patient was advised to refer his HCP for further guidance. As noted in the Fact Sheet for Recipients, the patient should not get the Pfizer-BioNTech COVID-19 Vaccine if the patient had a severe allergic reaction after a previous dose of the vaccine or if the patient had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Pfizer refer the patient to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The patient's healthcare provider knew his health situation and had access to information that can better help inform this decision. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.