chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Stomach pain; Kidney pain; Vomiting; Vascular stomach issue; Chills; Mild body aches; This is a spontaneous report received from a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EP7533) via an unspecified route of administration in Left Arm on 30Apr2021 12:00 as 2nd dose, single for COVID-19 immunization. Medical history included cerebellar ataxia and breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was having no allergies. Prior to vaccination the patient was not diagnosed with COVID-19. The reporter also reported that the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration in Left Arm on 02Apr2021 01:00 as 1st dose, single for COVID-19 immunization. On 06May2021 the patient experienced stomach pain, kidney pain and vomiting. On an unspecified date Patient also experienced chills, vascular stomach issue and mild body aches in 2021. The seriousness of the stomach pain, kidney pain was reported as serious, which leads to hospitalization for 3 days. The clinical outcome of the events was not recovered.  Follow-up pending was reassigned. further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dysphonia
Clinical narrative: lost her voice and had hoarseness; lost her voice and had hoarseness; This is spontaneous report from a contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 15Apr2021 as 1st dose single and received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified routed of administration on 06May2021 as 2nd dose single for COVID-19 immunization. Patient was 63-years-old at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient experienced body aches and had a body temperature of 99.9F after the second dose. She wants to know how long usually side effects last. On 30Apr2021 she lost her voice and had hoarseness - Rapid test. Patient received the 1st dose on 15Apr2021. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness bilateral, Pain
Clinical narrative: slowly lose her hearing in right ear/ mild hearing loss/ she could not hear out of her right ear/ started in her left ear that she sometimes could not hear out of; It started as a pain in her right ear going down through her jaw and neck; This is the spontaneous report received from a contactable consumer (patient). A 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ER8736) via an unspecified route of administration, administered in Arm Left on 01May2021 at single dose for COVID-19 immunisation at the age of 28-year-old. Medical history included mild allergy to bananas, stroke on mother's side of the family, hearing loss on Father's side of the family. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (Lot number: EW0158) on the left arm on 10Apr2021 at the age of 28-year old for Covid-19 immunization. The patient had started to slowly lose her hearing in right ear. It started as a pain in her right ear going down through her jaw and neck with mild hearing loss the first night of her second dose (01May2021) but had continued. She went through waves of times when she could not hear out of her right ear. Wednesday 05May2021 it how now started in her left ear that she sometimes could not hear out of. No treatment received for the events. The outcome of the event was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: tested positive after first dose/ I tested positive for Covid; She was still kind of under the weather a little bit; This is a spontaneous report received from a contactable consumer (patient) via medical information team and Pfizer sponsored program.  The 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: ER8731 and Expiration date: Jul2021), dose 1 via an unspecified route of administration, administered in arm right on 21Apr2021 at 12:50 (at the age of 47-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and family medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Apr2021, the patient was tested COVID positive after first dose and she did quarantine to the previous weekend. She was not showing any severe symptoms like fever or anything like that. She was still kind of under the weather a little bit. The patient wanted to know if she could proceed with second dose which was scheduled for 12May2021 or need to wait any longer to get her second dose. The patient was mostly recovered, but she was still feeling a little under the weather but had no more fever. On 28Apr2021, the patient underwent lab tests and procedures which included COVID-19 Rapid Test: positive. The outcome of the event tested positive after first dose/ I tested positive for COVID was recovering and she was still kind of under the weather a little bit was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: They were tested positive with Covid-19 10 days after taking the 1st dose; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for her wife. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 17Apr2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller also called on behalf of his wife, they took the 1st dose last 17Apr2021. The 2nd dose will be tomorrow (09May2021) which was more than 21 days. As per the caller, they were tested positive with Covid-19 10 days after taking the 1st dose. He is asking if they need to take the 2nd dose or not. Provided the PMI number. Call transfer to unit and created manual AE form. Medical Information, were any unaddressed medical questions referred or forwarded to Medical Information was yes, Customer and/or medical inquiry forwarded or referred to MI. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller received the first dose of the Pfizer-BioNtech covid-19 vaccine (she doesn't remember when) and one or two weeks later she got Covid-19.; Caller received the first dose of the Pfizer-BioNtech covid-19 vaccine (she doesn't remember when) and one or two weeks later she got Covid-19.; This is a spontaneous report from a Contactable consumer. A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient after received the first dose of the PFIZER-BIONTECH COVID-19 vaccine (she doesn't remember when) and one or two weeks later she got COVID-19 on an unspecified date. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had a stroke; This is a spontaneous case from a contactable consumer (Relative). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown, Expiry Date: unknown) via unspecified route of administration as Unknown dose, single for COVID-19 immunization. The patient's Medical history and concomitant medications were not reported. It was reported that the patient had no history of stroke prior to the vaccine. After receiving the Pfizer vaccine, the patient experienced a stroke and continued to have some afterwards. He was Hospitalized overnight. The outcome for the event was Unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got my vaccine and then I actually contracted COVID; Got my vaccine and then I actually contracted COVID; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer stated that, I just have a question. So, I got my vaccine and then I actually contracted COVID (PC Filed conservatively) but I haven't received my second dose. Do you think it would be okay if I did went to receive my second dose, I've been in quarantine for 8 days. The outcome of the events was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling drunk, Hyperhidrosis, Pyrexia
Clinical narrative: fever; I felt like (was drunk); unbalanced to dizzy; unbalanced to dizzy; sweating profusely; This is a spontaneous report from a contactable consumer (Patient) reporting for himself.  A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EW0170) via an unspecified route of administration on 08May2021 as 2nd dose single for COVID-19 immunization. Medical history included depression, type 2 diabetes mellitus and migraine. Concomitant medications included citalopram hydrobromide taken for depression, metformin hcl taken for type 2 diabetes mellitus, gabapentin taken for restless legs syndrome, muscle spasms, nortriptyline hydrochloride taken for headache, migraine, metoprolol tartrate taken for an unspecified indication. It was reported that, the patient had the vaccination the 2nd one on 8May2021 Saturday. On 08May2021 the patient experienced fever, I felt like (was drunk), unbalanced to dizzy, sweating profusely, and dizziness. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Fatigue, Lymphadenopathy
Clinical narrative: Swollen lymph node, neck and underarm, in varying sizes; Painful lymph nodes, under arm and neck, lymphadenopathy; Ridiculously tired, exhausted; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number: ER8737, expiration date: unknown), dose 1 via an unspecified route of administration in Arm Left on 31Mar2021 at 13:30 as 1ST DOSE, SINGLE; dose 2 via an unspecified route of administration in Arm Right on 28Apr2021 at 13:30 (Lot Number: EW0171) as 2ND DOSE, SINGLE (at the age of 37-years-old) for COVID-19 immunization. Medical history included ongoing smoker (patient stated probably started smoking 10 years ago and describes himself as a mild smoker, clarified as less than a half of pack or so, a day). The patient's concomitant medications were not reported. Patient had no prior vaccination and had no AE following prior vaccinations. Patient had no family history. On 23Apr2021 at 17:00, 2.5 to 3 weeks later, after first dose the patient experienced swollen lymph node, neck and underarm, in varying sizes; painful lymph nodes, under arm and neck, lymphadenopathy and patient was Ridiculously tired, exhausted. Patient reported that he had a lymph node on his neck that was the size of an egg and a cluster, more prominent and was getting larger; lymph node in his armpit was about an inch by an inch, he had a node off to the side of a larger node, that was the size of a nickel, and appeared similar to a marble under his skin. Patient stated that in first week he slept a lot, but then the tiredness may be lessened and still exhausted and takes a random nap. Painful nodes have worsened until 26Apr2021. Caller stated that he had seen multiple doctors, including an Urgent Care, and his sister is a doctor. He went to an ear, nose and throat doctor last week and the doctor was scheduling him for a biopsy of the lymph node, and it was assumed that this was a side effect of the vaccine. Patient went to the emergency room on 28Apr2021 for swollen and painful lymph nodes. Events continued after his second vaccine, on 28Apr2021. The patient underwent lab tests and procedures which included computerised tomogram on 29Apr2021: The largest lymph node, measuring 2.3cm by 3.1 cm. Patient also had blood work. Therapeutic measures were taken as a result of painful lymph nodes, under arm and neck, lymphadenopathy with Advil and Tylenol have been effective, but he can tell when the medication is wearing off, and it was time for the next dose. The outcome of Fatigue was unknown and other events were not recovered.  Follow up needed, further information has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Fatigue, Lymphadenopathy
Clinical narrative: Ridiculously tired, exhausted; Swollen lymph node, neck and underarm, in varying sizes; Painful lymph nodes, under arm and neck, lymphadenopathy; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 mRNA vaccine, formulation: solution for injection; Lot Number: ER8737, expiration date: unknown), dose 1 via an unspecified route of administration in arm left on 31Mar2021 at 13:30 as 1st dose, single; dose 2 via an unspecified route of administration in arm right on 28Apr2021 at 13:30 (Lot Number: EW0171) as 2nd dose, single (at the age of 37-years-old) for COVID-19 immunization. Medical history included ongoing smoker (patient stated probably started smoking 10 years ago and describes himself as a mild smoker, clarified as less than a half of pack or so, a day). The patient's concomitant medications were not reported. Patient had no prior vaccination and had no AE following prior vaccinations. Patient had no family history. On 23Apr2021 at 17:00, 2.5 to 3 weeks later, after first dose the patient experienced swollen lymph node, neck and underarm, in varying sizes; painful lymph nodes, under arm and neck, lymphadenopathy and patient was Ridiculously tired, exhausted. Patient reported that he had a lymph node on his neck that was the size of an egg and a cluster, more prominent and was getting larger; lymph node in his armpit was about an inch by an inch, he had a node off to the side of a larger node, that was the size of a nickel, and appeared similar to a marble under his skin. Patient stated that in first week he slept a lot, but then the tiredness may be lessened and still exhausted and takes a random nap. Painful nodes have worsened until 26Apr2021. Caller stated that he had seen multiple doctors, including an Urgent Care, and his sister is a doctor. He went to an ear, nose and throat doctor last week and the doctor was scheduling him for a biopsy of the lymph node, and it was assumed that this was a side effect of the vaccine. Patient went to the emergency room on 28Apr2021 for swollen and painful lymph nodes. Events continued after his second vaccine, on 28Apr2021. The patient underwent lab tests and procedures which included computerised tomogram on 29Apr2021: The largest lymph node, measuring 2.3cm by 3.1 cm. Patient also had blood work. Therapeutic measures were taken as a result of painful lymph nodes, under arm and neck, lymphadenopathy with Advil and Tylenol have been effective, but he can tell when the medication is wearing off, and it was time for the next dose. The outcome of Fatigue was unknown and other events were not recovered.  Follow up needed, further information has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Malaise, Pain
Clinical narrative: severe swelling lymph nodes; fever; chills; bodyaches; Blurred vision; feeling sick; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 10May2021 (at the age of 24-years-old) at 2ND DOSE, single for COVID-19 immunization. Ongoing medical history included patient had glasses. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at 1ST DOSE single for COVID-19 immunization. On 11May2021 09:00, the patient started to feel really bad described as severe swelling in lymph nodes, fever, chills and body aches; and blurred vision during the day of 11May2021. The patient had glasses and had them on. Her vision would go in and out of focus during the day. She was feeling sick and fatigue in May2021 after the second dose. The doctor's nurse only said she did research for about 10 to 15 minutes and said it was recommended that the patient go to the emergency room.  With blurred vision and at night, the patient could not drive herself.  The patient did not call 911 because she knew the other ones were expected.  The patient waited it out to see how it was. She further reported that her vision was better on 12May2021 in the morning, but her lymph nodes were still swollen and tender and still feeling sick, having body aches and fatigue. The outcome of the event blurred vision was recovering, outcome of the swelling lymph nodes, feeling sick, body aches and fatigue was not recovered; outcome of the events chills and pyrexia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: severe swelling lymph nodes; fever; chills; bodyaches; Blurred vision; feeling sick; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 10May2021 (at the age of 24-years-old) at 2ND DOSE, single for COVID-19 immunization. Ongoing medical history included patient had glasses. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at 1ST DOSE single for COVID-19 immunization. On 11May2021 09:00, the patient started to feel really bad described as severe swelling in lymph nodes, fever, chills and body aches; and blurred vision during the day of 11May2021. The patient had glasses and had them on. Her vision would go in and out of focus during the day. She was feeling sick and fatigue in May2021 after the second dose. The doctor's nurse only said she did research for about 10 to 15 minutes and said it was recommended that the patient go to the emergency room.  With blurred vision and at night, the patient could not drive herself.  The patient did not call 911 because she knew the other ones were expected.  The patient waited it out to see how it was. She further reported that her vision was better on 12May2021 in the morning, but her lymph nodes were still swollen and tender and still feeling sick, having body aches and fatigue. The outcome of the event blurred vision was recovering, outcome of the swelling lymph nodes, feeling sick, body aches and fatigue was not recovered; outcome of the events chills and pyrexia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Lymphadenopathy, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: severe swelling lymph nodes; fever; chills; bodyaches; Blurred vision; feeling sick; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 10May2021 (at the age of 24-years-old) at 2ND DOSE, single for COVID-19 immunization. Ongoing medical history included patient had glasses. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at 1ST DOSE single for COVID-19 immunization. On 11May2021 09:00, the patient started to feel really bad described as severe swelling in lymph nodes, fever, chills and body aches; and blurred vision during the day of 11May2021. The patient had glasses and had them on. Her vision would go in and out of focus during the day. She was feeling sick and fatigue in May2021 after the second dose. The doctor's nurse only said she did research for about 10 to 15 minutes and said it was recommended that the patient go to the emergency room.  With blurred vision and at night, the patient could not drive herself.  The patient did not call 911 because she knew the other ones were expected.  The patient waited it out to see how it was. She further reported that her vision was better on 12May2021 in the morning, but her lymph nodes were still swollen and tender and still feeling sick, having body aches and fatigue. The outcome of the event blurred vision was recovering, outcome of the swelling lymph nodes, feeling sick, body aches and fatigue was not recovered; outcome of the events chills and pyrexia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: severe swelling lymph nodes; fever; chills; bodyaches; Blurred vision; feeling sick; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 10May2021 (at the age of 24-years-old) at 2ND DOSE, single for COVID-19 immunization. Ongoing medical history included patient had glasses. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at 1ST DOSE single for COVID-19 immunization. On 11May2021 09:00, the patient started to feel really bad described as severe swelling in lymph nodes, fever, chills and body aches; and blurred vision during the day of 11May2021. The patient had glasses and had them on. Her vision would go in and out of focus during the day. She was feeling sick and fatigue in May2021 after the second dose. The doctor's nurse only said she did research for about 10 to 15 minutes and said it was recommended that the patient go to the emergency room.  With blurred vision and at night, the patient could not drive herself.  The patient did not call 911 because she knew the other ones were expected.  The patient waited it out to see how it was. She further reported that her vision was better on 12May2021 in the morning, but her lymph nodes were still swollen and tender and still feeling sick, having body aches and fatigue. The outcome of the event blurred vision was recovering, outcome of the swelling lymph nodes, feeling sick, body aches and fatigue was not recovered; outcome of the events chills and pyrexia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary embolus; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170) via an unspecified route of administration at left arm on 06May2021 (42-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination), asthma, allergies to sulfa, and allergies to PCN. Concomitant medications in two weeks included escitalopram oxalate (LEXAPRO), fexofenadine hydrochloride (ALLEGRA), and multivitamin (unspecified). The patient previously received naproxen sodium (NAPROXEN SOD) and experienced allergies; ipratropium bromide (ATROVENT) and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810) via an unspecified route of administration at right arm on 15Apr2021 (42-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. The patient experienced pulmonary embolus on 07May2021. Adverse event resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient did not test for COVID-19 post vaccination. Therapeutic measures were taken as a result of the event and included blood thinner. The outcome of the event was recovering.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonitis, Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: blood clots in both lungs along with lung inflammation; blood clots in both lungs along with lung inflammation; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose (reported as dose 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613), via an unspecified route of administration, administered in the right arm on 16Apr2021 at 08:45 AM as single dose for COVID-19 immunisation. Medical history included cholestoral, blood pressure, indigestion. No known allergies. No covid prior vaccination. Concomitant medications included losartan, avoristatin, omezrapole. The patient previously took the first dose (reported as dose 2) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613), via an unspecified route of administration, administered in the left arm on 22Mar2021 at 08:45 AM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02May2021 at 16:00, patient experienced blood clots in both lungs along with lung inflammation. Events caused a call to the emergency responders and a 2-day hospital stay from 02May2021 to 04May2021. Events resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Lab data included covid test on 02May2021 was negative (Nasal swab). Lots treatment received for the events. The outcome of events was resolved with sequel on unspecified date.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Skin discolouration
Clinical narrative: 2 arms redness and purple dots; 2 arms redness and purple dots; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8737 and expiration date was not reported), via an unspecified route of administration in right arm, on 23Apr2021 at 14:00 (at the age of 46-years-old), as first dose, single for COVID-19 immunization. Medical history included depression. It was unknown if the patient had any allergies. Concomitant medications included buspirone hydrochloride (BUSPAR) and celecoxib (CELEXA). Prior to vaccination, the patient did not receive any other vaccine within 4 weeks prior and was not diagnosed with COVID-19. The patient experienced redness in the 2 arms and purple dots on 23Apr2021 at 20:00. The events were reported as non-serious and resulted in the doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received by the patient for these events. The outcome of these events was not recovered at the time of report.  No follow up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This is a spontaneous report form a contactable consumer (patient). A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) dose 1 via an unspecified route of administration, administered on 19Apr2021 (at the age of 37-year-old) as a single dose for covid-19 immunisation. Medical history and concomitant medications of the patient were not reported. On 19Apr2021, 12 hours after receiving the shot, patient experienced soreness throughout body and had little bit of chills. On an unspecified date in 2021, patient experienced cough, lethargic, had no fever until a couple of days later and he did not lose his sense of taste or smell. Caller was certainly not expecting to have COVID and the timing made perfect sense that the symptoms were from the shot. Patient started experiencing symptoms that were normal with getting the vaccine and then things started getting worsened on an unspecified date in 2021 and at that point he was tested positive for COVID, seven days after administration of vaccine on 26Apr2021.  Patient was scheduled to get the second shot on 10May2021, but he cancelled it and he had received differing education from an urgent care as far as whether or not to get second shot as scheduled or to wait in between. It was reported that chills stopped sometime around the change of the months, confirmed that it stopped around Apr2021 or May2021. The patients cough and being lethargic were the only symptoms he had left. The soreness throughout body, this also stopped around end of Apr2021 or beginning of May2021. Patient was calling now to ask if he should reschedule the appointment that he had cancelled for 10May2021. Patient asked if it was safe to get the shot now or should he wait. Reporter considered all events as non-serious. Outcome of the event unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Death, Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: died; tested positive for covid; tested positive for covid; This is a spontaneous report from a non-contactable consumer. This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukemia untreated since 2018 or 2019. Concomitant medications were not provided. It was reported that on unspecified date, patient got BNT162B2 and later tested positive for covid and died. It was not reported if an autopsy was performed. Lab data included covid test was positive on unspecified date. The outcome of the event died was fatal, while of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fear, Irritability, Loss of consciousness, Nervousness
Clinical narrative: Fainted within 30 seconds/Passed out completely after shot; Passed out completely after shot; Some intermittent light headedness and dizziness; Some intermittent light headedness and dizziness; Irritating; scary/ fearful; scary/ fearful; This is a spontaneous report from a contactable consumer (patient's mother).   An 18-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0169) at single dose, on 22Apr2021 at 17:30, for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were unknown. Patient's mother reported that her son fainted within 30 seconds of receiving the Pfizer vaccine 1st dose and since then he had experienced some intermittent light headedness and dizziness. He passed out completely after shot. Adverse events were described as following: "patient is due to get his second dose of the shot later this evening but is having periods of lightheadedness and dizziness. Patient's mother states that her son also feels like he is going to pass out. She states that this started 30 seconds after the first shot. Her son only passed out once, completely right after the shot, it was a bad experience. She's glad he actually wants the other one today, but he is concerned because he is still lightheaded and dizzy after 3 weeks. Patient's mother states that he has been trying to function, work, and live his life but its irritating to him and scary. The doctor suggested that he should get his second dose but her son is a little fearful". Physician Office Visit required. The patient did not recover from intermittent light headedness and dizziness, while clinical outcome of the other events was unknown.; Sender's Comments: Based on known drug safety profile and strong temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted within 30 seconds/Passed out completely after shot; Passed out completely after shot; Some intermittent light headedness and dizziness; Some intermittent light headedness and dizziness; Irritating; scary/ fearful; scary/ fearful; This is a spontaneous report from a contactable consumer (patient's mother).   An 18-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0169) at single dose, on 22Apr2021 at 17:30, for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were unknown. Patient's mother reported that her son fainted within 30 seconds of receiving the Pfizer vaccine 1st dose and since then he had experienced some intermittent light headedness and dizziness. He passed out completely after shot. Adverse events were described as following: "patient is due to get his second dose of the shot later this evening but is having periods of lightheadedness and dizziness. Patient's mother states that her son also feels like he is going to pass out. She states that this started 30 seconds after the first shot. Her son only passed out once, completely right after the shot, it was a bad experience. She's glad he actually wants the other one today, but he is concerned because he is still lightheaded and dizzy after 3 weeks. Patient's mother states that he has been trying to function, work, and live his life but its irritating to him and scary. The doctor suggested that he should get his second dose but her son is a little fearful". Physician Office Visit required. The patient did not recover from intermittent light headedness and dizziness, while clinical outcome of the other events was unknown.; Sender's Comments: Based on known drug safety profile and strong temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Chills, Pain, Renal failure, Septic shock
Clinical narrative: Body chills; Body aches; Blindness; Septic shock due to serratia infection (not sure how the infection came to be); Septic shock due to serratia infection (not sure how the infection came to be); Kidney failure; This is a spontaneous report from a non-contactable consumer.    A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 (Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included type 2 diabetes, stage 4 kidney disease, high blood pressure. Concomitant medications included unspecified drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. On 14Feb2021, the patient experienced body chills, body aches, blindness, septic shock due to serratia infection (not sure how the infection came to be), kidney failure. The events required a visit to the emergency room. No treatment required. The patient was hospitalized due to the events for 18 days and condition was life threatening. The final outcome was fatal. The patient died on 06Mar2021. An autopsy was not performed. Cause of death was septic shock.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Septic shock
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Serratia infection
Clinical narrative: Body chills; Body aches; Blindness; Septic shock due to serratia infection (not sure how the infection came to be); Septic shock due to serratia infection (not sure how the infection came to be); Kidney failure; This is a spontaneous report from a non-contactable consumer.    A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 (Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included type 2 diabetes, stage 4 kidney disease, high blood pressure. Concomitant medications included unspecified drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. On 14Feb2021, the patient experienced body chills, body aches, blindness, septic shock due to serratia infection (not sure how the infection came to be), kidney failure. The events required a visit to the emergency room. No treatment required. The patient was hospitalized due to the events for 18 days and condition was life threatening. The final outcome was fatal. The patient died on 06Mar2021. An autopsy was not performed. Cause of death was septic shock.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Septic shock
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever; chills; severe arm pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8736 and expiration date was not reported), via an unspecified route of administration in right arm, on 11May2021 at 19:15 (at the age of 17 years old) as second dose, single for COVID-19 immunization at a pharmacy or drug store. Medical history was reported as none. The patient had no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), loratadine (CLARITIN) and birth control (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170 and expiration date was not reported), via an unspecified route of administration in right arm, on 17Apr2021 at 13:00  (at the age of 17 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant and 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 and since the vaccination, the patient was never tested for COVID-19. The patient experienced fever, chills, severe arm pain and nausea on 12May2021 at 05:00. No treatment was given to the patient for these events. The outcome of these events was recovering at the time of report.   No follow up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Rash, Urticaria
Clinical narrative: Itching; Muscle pain; Rash and itching hives in face and in other parts of body; Rash and itching hives in face and in other parts of body; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date: unknown), via an unspecified route of administration on an unspecified date, 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itching, muscle pain, rash, and itching hives in face and in other parts of the body. The patient mentioned that these were some type of reactions from the first shot that the patient had of the COVID-19 vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Miliaria, Rash, Rash macular, Rash pruritic, Skin exfoliation
Clinical narrative: He believes that he has contracted a rash on his back from the Pfizer covid vaccine, less painful now; less painful now, but is itching more.; Then it actually started to peel, like a bad sunburn; It started out as a red spot; irritating his back; heat rash; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 17Mar2021 at 13:30 (Lot Number: EN6208; Expiration Date: 30Jun2021) as SINGLE DOSE for COVID-19 immunization. The patient did not have any medical history. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for cholesterol from an unspecified start date and ongoing; metformin (METFORMIN) taken for pre-diabetes, start and stop date were not reported. The patient previous received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left shoulder on 24Feb2021 at 14:30 (Lot Number: EN6200; Expiration Date: unknown) as SINGLE DOSE for COVID-19 immunization. No other vaccine was administered on the same day of Pfizer COVID vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date of 2021, about two weeks ago, the patient started noticing the rash on a hot day, because it was irritating his back. He was thinking that it might have been a heat rash. After a while, it started peeling like sunburn. The patient believed that he had contracted a rash on his back from the Pfizer COVID vaccine. It started out as a red spot and was closer to the middle of his back. Then it started to peel, like a bad sunburn. It was moving a little over to the right and reported that It was less painful but was itching more. The outcome was reported as not recovered for the reported events.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: He believes that he has contracted a rash on his back from the Pfizer covid vaccine, less painful now; less painful now, but is itching more.; Then it actually started to peel, like a bad sunburn; It started out as a red spot; irritating his back; heat rash; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 17Mar2021 at 13:30 (Lot Number: EN6208; Expiration Date: 30Jun2021) as SINGLE DOSE for COVID-19 immunization. The patient did not have any medical history. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for cholesterol from an unspecified start date and ongoing; metformin (METFORMIN) taken for pre-diabetes, start and stop date were not reported. The patient previous received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left shoulder on 24Feb2021 at 14:30 (Lot Number: EN6200; Expiration Date: unknown) as SINGLE DOSE for COVID-19 immunization. No other vaccine was administered on the same day of Pfizer COVID vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date of 2021, about two weeks ago, the patient started noticing the rash on a hot day, because it was irritating his back. He was thinking that it might have been a heat rash. After a while, it started peeling like sunburn. The patient believed that he had contracted a rash on his back from the Pfizer COVID vaccine. It started out as a red spot and was closer to the middle of his back. Then it started to peel, like a bad sunburn. It was moving a little over to the right and reported that It was less painful but was itching more. The outcome was reported as not recovered for the reported events.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Testicular disorder
Clinical narrative: His testicles grew the size of basketballs; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), on an unspecified date, via unspecified route of administration as a 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced his testicles grew the size of basketballs. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.