chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cough, Diarrhoea, Fatigue, Rhinorrhoea
Clinical narrative: Cough; running nose; tiredness; upset stomach; diarrhea lasted for another 7 days; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 28Jul2021 19:30 (age at the time of vaccination 79-years-old), as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 28Jul2021 19:30 (age at the time of vaccination 79-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. Patient had no known allergies. On 28Jul2021 19:30, the patient experienced Cough, running nose, tiredness, upset stomach, and diarrhea lasted for another 7 days. Patient received cough syrup / aspirin / steam vaporizer as a treatment for adverse events. Patient visited to physician office. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovered on an unspecified date Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain, Swelling, Thrombosis
Clinical narrative: swelling started July 19; pain started July 7; 4 blood clots in left leg; This is a spontaneous report from a contactable consumer (the patient). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26May2021 13:00 at age of 60-year-old at single dose for COVID-19 immunisation, the patient also received the second dose of other unspecified Pfizer vaccine on 26May2021 in Arm Left. Medical history was none. Perfect health. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination. There was no concomitant medication (the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient did not receive other medications within 2 weeks of vaccination). The patient experienced 4 blood clots in left leg on 07Jul2021, pain started 07Jul2021, swelling started 19Jul2021, spread then went to ER on August 8. They were shocked that there were FOUR. He have ZERO risk factors for blood clots. Perfect health, active, perfect blood work. Said blood clots don't occur with people with no risk factors, and definitely not four. The events resulted in Emergency room/department or urgent care, Life threatening illness(immediate risk of death from the event). Treatment was received for "4 blood clots in left leg", the patient was still on clot dissolving medication. 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: Subconjunctival hemorrhage; This is a spontaneous report from a contactable hcp.   A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Jun2021 (Batch/Lot number was not reported) as a single dose, for covid-19 immunisation  .  Medical history included , ongoing hypertension , ongoing diabetes mellitus (AODM , ongoing hypercholesterolaemia. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; valsartan (VALSARTAN) taken for hypertension from an unspecified start date and ongoing; rosuvastatin (ROSUVASTATIN) taken for hypercholesterolaemia from an unspecified start date and ongoing; metformin (METFORMIN) taken for diabetes mellitus from an unspecified start date and ongoing; glimepiride (GLIMEPIRIDE) taken for diabetes mellitus, start and stop date were not reported. On 21Jun2021, the patient experienced subconjunctival hemorrhage.  The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in 2021 (age at vaccination: 88 years) as dose number unknown, single for COVID-19 immunization. The patient medical history included Myelodysplasia and immunocompromised from an unknown date. The patient Concomitant medications included PROCRIT taken for Myelodysplasia from an unknown date. On 09Aug2021, the patient tested positive for covid-19. On an unspecified date in 2021, the patient experienced fever of 100-101, congestion, fatigue. It was reported that Received vaccine Jan/Feb2021. Male Patient has myelodysplasia and is on Procrit twice/month. The Myelodysplasia, immunocompromised, injection bi-monthly to boost red blood cell count. The lab tests included Body temperature: 100-101 on an unknown date in 2021. SARS-CoV-2 test positive on 09Aug2021. The outcome of events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, Headache
Clinical narrative: weak; tired; cough; headache; This is a spontaneous report from a contactable consumer or other non hcp (patients grandmother) via medical information team. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 14 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced weak, tired, had a cough, headache that went away. Reporter stated she read the side effects for the vaccine but did not see cough and headache. Reporter wanted to know if these are side effects to the vaccine. The outcome of the events was recovered on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Vertigo
Clinical narrative: This is a spontaneous report from a contactable other hcp (patient). A 33-year-old non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Dec2020 (Lot Number: EL1284) (at the age of 33-years-old) as dose 1, single and administered in left arm on 17Jan2021 (Lot Number: EL3246) (at the age of 33-years-old) as dose 2, single for covid-19 immunisation. Medical history included sinusitis and hashimoto's thyroiditis. The patient had no relevant past drug history. The patient did not receive any other concomitant medications within 2 weeks of vaccination. 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 was tested for COVID-19 since the vaccination. The patient developed vertigo on 19Jan2021, multiple episodes increasing in frequency through early Mar2021. The symptoms returned 2-3 months later, less frequent than previously, but mildly intermittent for several weeks. On 29Jul2021, the patient had polymerase chain reaction (PCR) test (nasal swab) and the result was positive. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was not hospitalized. The patient received evaluation by vertigo specialist as treatment for vertigo. The outcome of vertigo was recovered with sequelae on an unspecified date in 2021 and outcome all the other events was unknown. The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure, COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Exposure to SARS-CoV-2, Fatigue, Nasal congestion, Rhinorrhoea
Clinical narrative: exposed to covid and symptomatic; Congestion; cough; runny nose; fatigue; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, 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 immunization. Medical history included glaucoma, OAB (hypertonic bladder), osteoarthritis all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced exposed to covid and symptomatic, congestion, cough, runny nose and fatigue. The patient underwent lab tests and procedures which included Covid rapid test (sars-cov-2 test): negative on 03Aug2021. Reportedly, event took place after use of product. Outcome of the events were unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: exposed to covid and symptomatic; Congestion; cough; runny nose; fatigue; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, 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 immunization. Medical history included glaucoma, OAB (hypertonic bladder), osteoarthritis all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced exposed to covid and symptomatic, congestion, cough, runny nose and fatigue. The patient underwent lab tests and procedures which included Covid rapid test (sars-cov-2 test): negative on 03Aug2021. Reportedly, event took place after use of product. Outcome of the events were unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Mar2021 as DOSE 2, SINGLE and received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was tested positive on 11Aug2021. Full vaccination (2 doses) completed in Mar2021. It was symptomatic, not hospitalized. Event took place after use of product. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on 11Aug2021. Positive rapid antigen Covid test following full vaccination. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Blood test, Burning sensation
Clinical narrative: Diarrhea; I had very dark black stool; Feeling of being unsafe like mentally mind just got blank and I became very emotional; I am still not right and tired; haven't got my previous stamina back yet; Injection site burning and my arm was burning; arm started to hurt; arm was burning; Dizziness; Weakness; Shortness of breath; Neck stiff; Headache; Chills; Joint pain; Fever; Stomach pain; Muscle pain in arm; arm started to hurt; Nauseous; Feeling of being unsafe like mentally mind just got blank and I became very emotional; Feeling of being unsafe like mentally mind just got blank and I became very emotional; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 61-years-old via an unspecified route of administration, administered in Arm Right on 25Jul2021 (Batch/Lot Number: FA7428) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included addison's disease from Dec1999. Concomitant medication included hydrocortisone (CORTEF) taken for addison's disease, start and stop date were not reported. The patient reported that on 25Jul2021, she was still not right, she was still tired. She had not gotten her previous stamina back yet. She experienced burning at the injection site and her arm was burning. She had dizziness, weakness and Shortness of breath. She had a very stiff neck, severe headache when she got home she was experiencing tiredness, chills, joint pain, Fever and Shortness of breath continued. She was getting stomach pain, stiff neck continued and then her arm started to hurt. She had muscle pain two days in the arm. She got nauseous then she got severe diarrhea for two days. When diarrhea stopped she had very dark black stool. She also have a feeling of being unsafe like mentally her mind just got blank and she became very emotional and she have been advised not to take the second vaccine. The events occurred on 25Jul2021. The patient underwent lab tests and procedures which included blood test: tested Covid negative before she got the vaccine but before she did the both she did the rapid. The other blood test that takes longer, she had done both test prior to the vaccine and sars-cov-2 test negative: negative on unspecified dates. The patient recovered from diarrhea on an unspecified date but did not recover from the other events.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Dyspnoea, Emotional disorder
Clinical narrative: Diarrhea; I had very dark black stool; Feeling of being unsafe like mentally mind just got blank and I became very emotional; I am still not right and tired; haven't got my previous stamina back yet; Injection site burning and my arm was burning; arm started to hurt; arm was burning; Dizziness; Weakness; Shortness of breath; Neck stiff; Headache; Chills; Joint pain; Fever; Stomach pain; Muscle pain in arm; arm started to hurt; Nauseous; Feeling of being unsafe like mentally mind just got blank and I became very emotional; Feeling of being unsafe like mentally mind just got blank and I became very emotional; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 61-years-old via an unspecified route of administration, administered in Arm Right on 25Jul2021 (Batch/Lot Number: FA7428) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included addison's disease from Dec1999. Concomitant medication included hydrocortisone (CORTEF) taken for addison's disease, start and stop date were not reported. The patient reported that on 25Jul2021, she was still not right, she was still tired. She had not gotten her previous stamina back yet. She experienced burning at the injection site and her arm was burning. She had dizziness, weakness and Shortness of breath. She had a very stiff neck, severe headache when she got home she was experiencing tiredness, chills, joint pain, Fever and Shortness of breath continued. She was getting stomach pain, stiff neck continued and then her arm started to hurt. She had muscle pain two days in the arm. She got nauseous then she got severe diarrhea for two days. When diarrhea stopped she had very dark black stool. She also have a feeling of being unsafe like mentally her mind just got blank and she became very emotional and she have been advised not to take the second vaccine. The events occurred on 25Jul2021. The patient underwent lab tests and procedures which included blood test: tested Covid negative before she got the vaccine but before she did the both she did the rapid. The other blood test that takes longer, she had done both test prior to the vaccine and sars-cov-2 test negative: negative on unspecified dates. The patient recovered from diarrhea on an unspecified date but did not recover from the other events.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured, Fatigue, Feeling abnormal, Headache, Mental impairment
Clinical narrative: Diarrhea; I had very dark black stool; Feeling of being unsafe like mentally mind just got blank and I became very emotional; I am still not right and tired; haven't got my previous stamina back yet; Injection site burning and my arm was burning; arm started to hurt; arm was burning; Dizziness; Weakness; Shortness of breath; Neck stiff; Headache; Chills; Joint pain; Fever; Stomach pain; Muscle pain in arm; arm started to hurt; Nauseous; Feeling of being unsafe like mentally mind just got blank and I became very emotional; Feeling of being unsafe like mentally mind just got blank and I became very emotional; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 61-years-old via an unspecified route of administration, administered in Arm Right on 25Jul2021 (Batch/Lot Number: FA7428) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included addison's disease from Dec1999. Concomitant medication included hydrocortisone (CORTEF) taken for addison's disease, start and stop date were not reported. The patient reported that on 25Jul2021, she was still not right, she was still tired. She had not gotten her previous stamina back yet. She experienced burning at the injection site and her arm was burning. She had dizziness, weakness and Shortness of breath. She had a very stiff neck, severe headache when she got home she was experiencing tiredness, chills, joint pain, Fever and Shortness of breath continued. She was getting stomach pain, stiff neck continued and then her arm started to hurt. She had muscle pain two days in the arm. She got nauseous then she got severe diarrhea for two days. When diarrhea stopped she had very dark black stool. She also have a feeling of being unsafe like mentally her mind just got blank and she became very emotional and she have been advised not to take the second vaccine. The events occurred on 25Jul2021. The patient underwent lab tests and procedures which included blood test: tested Covid negative before she got the vaccine but before she did the both she did the rapid. The other blood test that takes longer, she had done both test prior to the vaccine and sars-cov-2 test negative: negative on unspecified dates. The patient recovered from diarrhea on an unspecified date but did not recover from the other events.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Diarrhea; I had very dark black stool; Feeling of being unsafe like mentally mind just got blank and I became very emotional; I am still not right and tired; haven't got my previous stamina back yet; Injection site burning and my arm was burning; arm started to hurt; arm was burning; Dizziness; Weakness; Shortness of breath; Neck stiff; Headache; Chills; Joint pain; Fever; Stomach pain; Muscle pain in arm; arm started to hurt; Nauseous; Feeling of being unsafe like mentally mind just got blank and I became very emotional; Feeling of being unsafe like mentally mind just got blank and I became very emotional; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 61-years-old via an unspecified route of administration, administered in Arm Right on 25Jul2021 (Batch/Lot Number: FA7428) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included addison's disease from Dec1999. Concomitant medication included hydrocortisone (CORTEF) taken for addison's disease, start and stop date were not reported. The patient reported that on 25Jul2021, she was still not right, she was still tired. She had not gotten her previous stamina back yet. She experienced burning at the injection site and her arm was burning. She had dizziness, weakness and Shortness of breath. She had a very stiff neck, severe headache when she got home she was experiencing tiredness, chills, joint pain, Fever and Shortness of breath continued. She was getting stomach pain, stiff neck continued and then her arm started to hurt. She had muscle pain two days in the arm. She got nauseous then she got severe diarrhea for two days. When diarrhea stopped she had very dark black stool. She also have a feeling of being unsafe like mentally her mind just got blank and she became very emotional and she have been advised not to take the second vaccine. The events occurred on 25Jul2021. The patient underwent lab tests and procedures which included blood test: tested Covid negative before she got the vaccine but before she did the both she did the rapid. The other blood test that takes longer, she had done both test prior to the vaccine and sars-cov-2 test negative: negative on unspecified dates. The patient recovered from diarrhea on an unspecified date but did not recover from the other events.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vaccination site pain
Clinical narrative: Diarrhea; I had very dark black stool; Feeling of being unsafe like mentally mind just got blank and I became very emotional; I am still not right and tired; haven't got my previous stamina back yet; Injection site burning and my arm was burning; arm started to hurt; arm was burning; Dizziness; Weakness; Shortness of breath; Neck stiff; Headache; Chills; Joint pain; Fever; Stomach pain; Muscle pain in arm; arm started to hurt; Nauseous; Feeling of being unsafe like mentally mind just got blank and I became very emotional; Feeling of being unsafe like mentally mind just got blank and I became very emotional; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 61-years-old via an unspecified route of administration, administered in Arm Right on 25Jul2021 (Batch/Lot Number: FA7428) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included addison's disease from Dec1999. Concomitant medication included hydrocortisone (CORTEF) taken for addison's disease, start and stop date were not reported. The patient reported that on 25Jul2021, she was still not right, she was still tired. She had not gotten her previous stamina back yet. She experienced burning at the injection site and her arm was burning. She had dizziness, weakness and Shortness of breath. She had a very stiff neck, severe headache when she got home she was experiencing tiredness, chills, joint pain, Fever and Shortness of breath continued. She was getting stomach pain, stiff neck continued and then her arm started to hurt. She had muscle pain two days in the arm. She got nauseous then she got severe diarrhea for two days. When diarrhea stopped she had very dark black stool. She also have a feeling of being unsafe like mentally her mind just got blank and she became very emotional and she have been advised not to take the second vaccine. The events occurred on 25Jul2021. The patient underwent lab tests and procedures which included blood test: tested Covid negative before she got the vaccine but before she did the both she did the rapid. The other blood test that takes longer, she had done both test prior to the vaccine and sars-cov-2 test negative: negative on unspecified dates. The patient recovered from diarrhea on an unspecified date but did not recover from the other events.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Rash macular, Rash pruritic
Clinical narrative: red blotches on both of my forearms; my skin looked blotchy and inflamed; had random itchy spots on my body including my scalp, legs, palms, nose and chest; This is a spontaneous report from a non-contactable consumer reporting for herself. A 33-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Aug2021 18:15 (lot number: FC3180) at the age of 33 years old on the left arm as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. Medical history included congenital spinal fusion in C1 and C2, Ovary and breast cysts, wasp/hornet allergy. Concomitant medication included norethisterone acetate (NORETHINDRONE). The patient stated "About 15 minutes after receiving the vaccine (10Aug2021 18:30), I started noticing red blotches on both of my forearms. There were no hives but my skin looked blotchy and inflamed. I also had random itchy spots on my body including my scalp, legs, palms, nose and chest." Treatment received for the events included Benadryl. The outcome of the events were resolved in Aug2021.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Being quarantine by my employer; Have symptoms of COVID; I have COVID; Being quarantine by my employer; Have symptoms of COVID; I have COVID; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EK9231) via an unspecified route of administration on an unspecified date in Jan2021 as DOSE 2, SINGLE and received dose 1 (Lot number: EJ1685) via an unspecified route of administration on an unspecified date in Dec2020 as DOSE 1, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, being quarantined by my employer, had symptoms of COVID, I had COVID on an unspecified date in 2021.  Well, I was calling because I wanted some information about the I guess the booster vaccine for people that are immune compromised. I would like information about the third injection for the pfizer COVID vaccine for the people that are immune compromised. The reason I was asking is because I had my first shot in december and my second in january and I was now being quarantined by my employer because I had symptoms of COVID. The outcome of the events was unknown at the time of this report.  Further probing could not be done as the consumer was unwilling to share any further information, hence limited information available over the call.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from contactable consumer. A 29-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6199) intramuscularly, administered in Arm Right on 04Mar2021 12:00 as single dose and dose 2 intramuscularly, administered in Arm Left on 26Mar2021 12:00 (Batch/Lot Number: EP7533) as single dose (at the age of 29-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 11Aug2021, patient experienced breakthrough Infection, patient tested positive for COVID 19. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on 09Aug2021 Nasal swab. The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 18Dec2020 (Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 07May2021 (Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from 25Sep2020 to 25Sep2020, rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced got vaccine 18Dec2020. got covid infection 30Dec2020, received second vaccine 07May2021. 3rd covid infection on 06Aug2021 on an unspecified date, got vaccine 18Dec2020. Received second vaccine 07May2021. The patient underwent lab tests and procedures which included covid-19: positive on 25Sep2020, covid-19 positive on 30Dec2020. Covid-19 positive on 06Aug2021. Therapeutic measures were taken as a result of experienced got vaccine 18Dec2020. Covid infection 30Dec2020, received second vaccine 07May2021. 3rd covid infection on 06Aug2021. Got COVID infection 30Dec2020 monoclonal therapy on 15Jan2021 out of work for over 100 days. I have RA but have been off my medication since Jan2021.  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: contracted COVID; contracted COVID; This is a spontaneous report from a contactable physician. This physician (patient's wife) reported for a male patient (reporter's husband).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA 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 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient contracted COVID-19 after having been vaccinated on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: contracted on an unspecified date. It was unknown if any treatment was received for the events. Outcome of the events was recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The possibility of COVID-19, Drug Ineffective cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Nephrolithiasis, Renal infarct, Renal pain
Clinical narrative: Renal Infarction; assumed it was kidney stones; pain in kidney; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received the first dose of Pfizer COVID vaccine on 05Jun2021. The patient started feeling pain in kidney a few days later on 22Jun2021. It eventually got to the point the patient had to go to the emergency room on 22Jun2021 (the patient assumed it was kidney stones). The patient was admitted with a renal infarction and they believe it was caused by the Pfizer vaccine. The patient would like to reach out and make sure that the company is aware of these. Outcome of the events was unknown.  The events were assessed as serious (hospitalization).  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart problems; This is a spontaneous report from a contactable consumer (not the patient) via telephonic activity. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-immunization. The patient experienced heart problems (seriousness criteria: death, medically significant) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart problems
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PCR: Covid-19 Positive and related symptoms; PCR: Covid-19 Positive and related symptoms; This is a spontaneous report from a contactable consumer. This consumer reported for a 40-Year-old male (patient) that, A 40-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: not reported) via an unspecified route of administration on Apr2021 (at the age of 40-years-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Aug2021 the patient experienced PCR: COVID-19 positive and related symptoms (drug ineffective) (medically significant). PCR: COVID-19 positive and related symptoms (COVID-19) (medically significant). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Aug2021 the patient underwent lab tests and procedures which included sars-cov-2 test as positive (Nasal Swab). No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. No prolonged hospitalization. Therapeutic measures were taken as a result of adverse events. Treatment received for the adverse event was Advil. The outcome of the events was unknown.  Follow-up(12Aug2021): This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. The response included that: Awareness date: 11Aug2021, EA: 11Aug2021 and Full vaccinated Best.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: breakthrough case of Covid; breakthrough case of Covid; This is a spontaneous report from a contactable physician received via a Pfizer representative.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received the Pfizer vaccine and had a breakthrough case of Covid. Patient is alive and stable. The patient underwent lab tests and procedures which included sars-cov-2 test: positive un an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Lymphadenopathy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient experienced a breakthrough covid infection; patient experienced a breakthrough covid infection; swollen lymph node in her arm pit; This is a spontaneous report from a contactable consumer. A consumer reported for 37-year-old female that: A Non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 intramuscular, administered in Arm Left on 05May2021 17:15 (Batch/Lot Number: EW0176) as DOSE 2, SINGLE for Covid-19 Immunization. The patient medical history included Historical vaccine BNT162B2 on 11Apr2021 12:45 for Covid-19-Immunization with Lot number ER2613 via intramuscular route on Left arm. Concomitant medication(s) included Escitalopram Oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient experienced a breakthrough Covid infection on Aug2021, Swollen lymph node in her arm pit on 05May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Aug2021 Nasal Swab, Sars-cov-2 test: negative on Aug2021 Unknown, Sars-cov-2 test: positive on Aug2021 Unknown. 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. It was unknown if the patient received treatment for the events. The clinical outcome for all the events was Unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: Got Covid about 48 hours after getting the first shot; Headaches went away after receiving the vaccine; This is a spontaneous report from a contactable physician (patient's husband). A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included headache from an unknown date to 2021 (She had always gotten headaches). The patient's concomitant medications were not reported. She had always gotten headaches and she wasn't getting them anymore. It was statedthat it's very obvious that it's the Covid Vaccine that had gotten rid of headaches (Headaches went away after receiving the vaccine). She got Covid about 48 hours after getting the first shot (in 2021), so she was probably exposed to it before getting the vaccine. But she got better right away, so the Covid vaccine helped her. The patient underwent lab tests and procedures which included COVID test: positive in 2021. The outcome of the event COVID-19 was recovering, of the other event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Vaccine BNT162B2 requires atleast a period of 14 days to be effective since vaccination of the first dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Malaise, Nausea
Clinical narrative: not feeling good; nauseous; blood sugar is not very stable; This is a spontaneous report from a contactable consumer (parent).  A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA6780), via an unspecified route on 31Jul2021 as dose 2, single for covid-19 immunization. The patient medical history included Type-1 diabetic from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 2021 as dose 1, single for covid-19 immunization. On unspecified date, the patient experienced adverse reaction to medication for diabetics. Reporter stated, "patient father was calling about some questions regarding, and wanted to know any side effects of the Pfizer vaccine how long it last for? his kids all had their second dose on the same day, 3 of his kid. patients children 3 children had vaccination, second dose at the same time at same day. One kid had stomach ache and was really yucky for couple of days. Patients fathers other child had to continue to have headache since during the second shot migraine headaches since the second vaccine. patient father himself personally had his second shot. There was, last Saturday and he had headache so, like bad headache, may get headache all days. So, he took two Ibuprofen (Hence, captured as suspect) it's (headache) not going away so, he just wants to know. he wants to know, his son was Type-1 diabetic and it's not little managed and he had his first vaccination try to figure out to have his second and he didn't tried Ketone and BKA since he got his first vaccination, his first shot. He was not feeling good at all, he was been sick, he had no energy and he just feel yucky. So, how long last for how long before we are ok, just wanted to know about headache and stuff." Reporter stated, "He immediately, first of all like we sat there for 30 minutes after vaccination, because he had an adverse reaction to medication for diabetics (Further not clarified, hence Captured as unspecified Medication). So, we waited 30 minutes before they left there and got home, and it take 20 minutes of time. So, he has not feeling good nauseous didn't feel good, he lay down, he didn't take ketones because he is diabetic should have blood sugar his blood sugar is not very stable and he is not feeling good." The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Disorientation, Euphoric mood, Feeling abnormal
Clinical narrative: disoriented; ran a red light when driving; don't feel right; Anxiety; Euphoria; Nausea; pain around site; Muscle pain; chills; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 09Aug2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included diabetic and bone on bone. Concomitant medications included cortisone acetate (CORTISONE) taken for bone on bone and unspecified heart medications (as reported: and stuff). The patient experienced disoriented, ran a red light when driving, don't feel right, anxiety, euphoria, nausea, pain around site, muscle pain, and chills on 10Aug2021. The clinical course was reported as follows: She had to leave work on 10Aug2021 because of anxiety, euphoria, nausea, and pain around site. She had to finish most of her job. She was just trying to report the muscle pain and soreness at site. She wanted to go into work on 11Aug2021, but she was not one hundred percent. She works night shift. She went to have a cortisone injection put in the knee and that was the main reason she went in. While she was there, she got the BNT162B2 vaccine. That evening she had to stay home and iced it. She took ibuprofen (MANUFACTURER UNKNOWN) that night and iced her knee. She works shift work from 14:30 to 23:00. On 10Aug2021, she had to leave at 20:30 which was two and a half hours early because she was so disoriented in a way. She shouldn't have been driving. She made it to the house. She still didn't feel right. The patient clarified her symptoms started about 18:00. It started coming on and she pushed through and finished the job. She had to sit down because she was disoriented. It was so bad that she ran a red light when driving. Everyone was sitting at the red light. She wasn't just taking off and going through it. They were just sitting there and a person did a U-turn and she just went ahead and went. That was about nine something at night. She is not going to get on the road. She also iced her arm. The patient stated she knows that it was not the cortisone injection as she has had them before. She had one 8 months prior to this one in the right knee as both of her knees have bone on bone. Therapeutic measures were taken as a result of pain around site, muscle pain, and chills as aforementioned. The clinical outcome of disoriented, ran a red light when driving, don't feel right, anxiety, euphoria, nausea, pain around site, muscle pain, and chills was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.