chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: face also became swollen; skin is breaking out; skin is peeling around her jaw line; skin became itchy; skin around her mouth is hot to the touch; It is dry and patchy; This is a spontaneous report received from a contactable consumer or other non hcp. A 29-years-old female patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: FC3180), via an unspecified route of administration, administered in Arm Right on 18Aug2021 10:30,at the age of 29 years old, as Dose 1,single for covid-19 immunization. Medical history included none.Concomitant medications included drospirenone, ethinylestradiol taken for an unspecified indication, start and stop date were not reported.The patient experienced face also became swollen, skin is breaking out, skin is peeling around her jaw line, skin became itchy, skin around her mouth is hot to the touch, it is dry and patchy on 30Aug2021.Therapeutic measures were taken as a result of skin is peeling around her jaw line.The outcome of the event was not recovered.When the patient had received her 1st dose, she also took a birth control pills and patient thinks the symptoms were related to the birth control pills.Upon follow up on 31st aug2021,patient stated to medical information team that She got her first dose on 18Aug2021 and She is scheduled for her second one 08Sep2021.She had taken her birth control tablets that week.The itching and breaking out started yesterday on 30Aug2021.The skin around her mouth is hot to the touch. It is dry and patchy even with moisturizer. It is flaking up and itching. She doesn't know if it is an interaction between the vaccine and birth control.  Follow-up(31Aug2021):This is a follow up spontaneous report from a Pfizer sponsored program.The patient had not received any vaccines within 4 weeks prior to covid vaccination.Patient was concerned whether to receive 2nd dose of covid vaccination or not.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Fatigue, Headache
Clinical narrative: Loss consciousness; Tiredness; Nausea; Headache; Feeling weak; BP dropped; Extremities were weak; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 25Aug2021 at 10:15 AM (at the age of 47 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included allergies to sulfa. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a doctor's office or urgent care facility. On 27Aug2021 at 11:00 PM (2 days post-vaccination), the patient was feeling mild side effects such as tiredness, nausea, and headache and later that day, she had a sudden onset of feeling weak and loss consciousness for a few seconds. The patient's blood pressure (BP) dropped and her extremities were weak, and she became very tired afterwards (27Aug2021 at 11:00 PM). No treatment was administered for the events. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the events in Aug2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscular weakness, Nausea
Clinical narrative: Loss consciousness; Tiredness; Nausea; Headache; Feeling weak; BP dropped; Extremities were weak; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 25Aug2021 at 10:15 AM (at the age of 47 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included allergies to sulfa. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a doctor's office or urgent care facility. On 27Aug2021 at 11:00 PM (2 days post-vaccination), the patient was feeling mild side effects such as tiredness, nausea, and headache and later that day, she had a sudden onset of feeling weak and loss consciousness for a few seconds. The patient's blood pressure (BP) dropped and her extremities were weak, and she became very tired afterwards (27Aug2021 at 11:00 PM). No treatment was administered for the events. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the events in Aug2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: had shingles after the first covid vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced had shingles after the first covid vaccine on an unspecified date. On her second shot she had taken an unspecified antiviral medication as a prophylaxis and then she took her second shot and didn't have any reaction. She is scheduled for the third and she is wondering if it will interact with Repatha. She is wondering if it is safe to take with her third dose. They told her when she took the first, she went to the ER. They don't think it was related, they said it was because of the smallpox vaccine. She doesn't know if it was a coincidence it happened the same day. She went to the dermatologist and they told her to take the antiviral before the second covid shot and 7 days after. Patient stated that the COVAX US Support agent said the hives was one of the side effects. That is the only reason she brought up if shingles is one the side effects. Event resulted to visit emergency room. The outcome of the event was reported as unknown.   Follow-up attempts are completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heavy menstrual bleeding, Lymph node pain, Lymphadenopathy
Clinical narrative: Soreness at the injection site; Fatigue; Chills; Achiness; Supraclavicular lymph node by my left collar bone became tender and swollen/Lymph node in my left armpit became tender and swollen; Supraclavicular lymph node by my left collar bone became tender and swollen/Lymph node in my left armpit became tender and swollen; Runny nose; Scratchy throat; Nausea; Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar; Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar; This is a spontaneous report from a non-contactable consumer (patient). This 43-year-old non-pregnant female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Apr2021 at 09:45 AM (lot number: ER8729), in left arm. as the first single dose, for COVID-19 immunisation. Medical history included allergies to triamcinolone acetonide (KENALOG), minocycline, doxycycline, sarecycline. The patient did not have COVID prior vaccination. Concomitant medications were none (no other vaccine in 4 weeks, no other medication in 2 weeks).  The patient experienced soreness at the injection site and fatigue on 08Apr2021, starting a few hours after the shot and lasting for over a week. On day 4 (Apr2021) she experienced chills for a day, achiness for a week, supraclavicular lymph node by her left collar bone became tender and swollen, lasting over three weeks, runny nose and scratchy throat. This was the same side as the shot. The healthcare worker injected the shot very high on the corner of my shoulder, almost on top of her shoulder. She also experienced. On day 5 (Apr2021) she had nausea lasting for two days. On day 7 (Apr2021) she experienced lymph node in her left armpit became tender and swollen. She couldn't close her arm without causing pain to the lymph node in my left armpit. On day 9 (Apr2021) she had chills again for a day. On day 10 (Apr2021) she had another lymph node by her left collar bond which became tender and swollen, lasting over three weeks. The other swollen lymph nodes grew in size. Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar. The patient had recovered from the reported events without any treatment. COVID was not tested after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Nausea, Pain, Rhinorrhoea, Throat irritation
Clinical narrative: Soreness at the injection site; Fatigue; Chills; Achiness; Supraclavicular lymph node by my left collar bone became tender and swollen/Lymph node in my left armpit became tender and swollen; Supraclavicular lymph node by my left collar bone became tender and swollen/Lymph node in my left armpit became tender and swollen; Runny nose; Scratchy throat; Nausea; Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar; Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar; This is a spontaneous report from a non-contactable consumer (patient). This 43-year-old non-pregnant female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Apr2021 at 09:45 AM (lot number: ER8729), in left arm. as the first single dose, for COVID-19 immunisation. Medical history included allergies to triamcinolone acetonide (KENALOG), minocycline, doxycycline, sarecycline. The patient did not have COVID prior vaccination. Concomitant medications were none (no other vaccine in 4 weeks, no other medication in 2 weeks).  The patient experienced soreness at the injection site and fatigue on 08Apr2021, starting a few hours after the shot and lasting for over a week. On day 4 (Apr2021) she experienced chills for a day, achiness for a week, supraclavicular lymph node by her left collar bone became tender and swollen, lasting over three weeks, runny nose and scratchy throat. This was the same side as the shot. The healthcare worker injected the shot very high on the corner of my shoulder, almost on top of her shoulder. She also experienced. On day 5 (Apr2021) she had nausea lasting for two days. On day 7 (Apr2021) she experienced lymph node in her left armpit became tender and swollen. She couldn't close her arm without causing pain to the lymph node in my left armpit. On day 9 (Apr2021) she had chills again for a day. On day 10 (Apr2021) she had another lymph node by her left collar bond which became tender and swollen, lasting over three weeks. The other swollen lymph nodes grew in size. Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar. The patient had recovered from the reported events without any treatment. COVID was not tested after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; Fatigue; Chills; Achiness; Supraclavicular lymph node by my left collar bone became tender and swollen/Lymph node in my left armpit became tender and swollen; Supraclavicular lymph node by my left collar bone became tender and swollen/Lymph node in my left armpit became tender and swollen; Runny nose; Scratchy throat; Nausea; Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar; Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar; This is a spontaneous report from a non-contactable consumer (patient). This 43-year-old non-pregnant female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Apr2021 at 09:45 AM (lot number: ER8729), in left arm. as the first single dose, for COVID-19 immunisation. Medical history included allergies to triamcinolone acetonide (KENALOG), minocycline, doxycycline, sarecycline. The patient did not have COVID prior vaccination. Concomitant medications were none (no other vaccine in 4 weeks, no other medication in 2 weeks).  The patient experienced soreness at the injection site and fatigue on 08Apr2021, starting a few hours after the shot and lasting for over a week. On day 4 (Apr2021) she experienced chills for a day, achiness for a week, supraclavicular lymph node by her left collar bone became tender and swollen, lasting over three weeks, runny nose and scratchy throat. This was the same side as the shot. The healthcare worker injected the shot very high on the corner of my shoulder, almost on top of her shoulder. She also experienced. On day 5 (Apr2021) she had nausea lasting for two days. On day 7 (Apr2021) she experienced lymph node in her left armpit became tender and swollen. She couldn't close her arm without causing pain to the lymph node in my left armpit. On day 9 (Apr2021) she had chills again for a day. On day 10 (Apr2021) she had another lymph node by her left collar bond which became tender and swollen, lasting over three weeks. The other swollen lymph nodes grew in size. Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar. The patient had recovered from the reported events without any treatment. COVID was not tested after vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness at injection site; Itchy at injection site; redness wide; feels like hives; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (COMIRNATY,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 experienced redness at injection site, itchy at injection site, redness wide and feels like hives on an unspecified date.Caller notified that Pfizer is unable to provide medical advice, and Caller encouraged to contact her healthcare provider for her concern.The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Bad fever/ fever 102, 103; body ache for 24 hours/ my body was hurting me; Shivering like for hours like less, less than 24 hours; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX Support. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: FC3180, Expiration date: Unknown) via an unspecified route of administration on 09Aug2021 as Dose 1, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The report was related to a study or programme. On 10Aug2021, she experience bad fever and body ache for 24 hours. Her concern was she had fever like a couple hour after she had a Pfizer vaccine. She had fever 102, 103, she was shivering like for hours like less, less than 24 hours, she said for less than 10 hours she had a fever. She had fever, she was shivering, her body was hurting her/body ache for 24 hours and then like up to like 24 hours she get better." Now she was scheduled for the second dose today which was the exactly the 21st day. She was asking if, it was okay to take it after she had experienced a bad fever, body ache for 24 hours. She stated that lot number as "FC3180 (Not clarified). This was the number of vaccine: FC3180." Expiry Date of Covid 19 vaccine: Unknown. She was informed about the Pfizer Medical Information. Limited information available over the call. The patient underwent lab tests and procedures which included body temperature: 102, 103 (units unspecified) on 09Aug2021 102, 103. The outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Chest pain, Condition aggravated, Feeling abnormal
Clinical narrative: had some odd / weird feelings (painful - on and off) in my chest / heart; had some odd / weird feelings (painful - on and off) in my chest / heart; get aches and pains in my joints (feet, ankles, knees)/Left elbow was sore / painful; get aches and pains in my joints (feet, ankles, knees); neck is still stiff; got worse after I got the second shot; not feeling so great since he got the shots/feel like I'm 80 years old; This is a spontaneous report from a contactable consumer (patient).  A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 (Batch/Lot Number: EW0158) age at vaccination of 57-years-old, as single dose, for covid-19 immunisation.  Medical history was none. No known allergies. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (Batch/Lot Number: ER2613), as single dose, for covid-19 immunisation and experienced stiff neck, pain in elbow, feeling unwell. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced stiff neck on left side (the side he got shots on) after getting the first shot, it started to go away after 2 weeks, and then it got worse after he got the second shot. It's not as bad as before, but neck was still stiff. Left elbow was sore/painful ever since he got the shots. Also, he had some odd / weird feelings (painful - on and off) in chest/heart area for a few weeks after the second shot, but they went away eventually. It's been a few months of generally not feeling so great since he got the shots. Example, he get aches and pains in joints (feet, ankles, knees) and he felt like he is 80 years old - especially in the morning. He had never had that before. It was unknown if patient had COVID prior vaccination or if was tested for COVID post vaccination. No treatments were given for the events. The patient was not recovered from the events.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: had some odd / weird feelings (painful - on and off) in my chest / heart; had some odd / weird feelings (painful - on and off) in my chest / heart; get aches and pains in my joints (feet, ankles, knees)/Left elbow was sore / painful; get aches and pains in my joints (feet, ankles, knees); neck is still stiff; got worse after I got the second shot; not feeling so great since he got the shots/feel like I'm 80 years old; This is a spontaneous report from a contactable consumer (patient).  A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 (Batch/Lot Number: EW0158) age at vaccination of 57-years-old, as single dose, for covid-19 immunisation.  Medical history was none. No known allergies. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (Batch/Lot Number: ER2613), as single dose, for covid-19 immunisation and experienced stiff neck, pain in elbow, feeling unwell. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced stiff neck on left side (the side he got shots on) after getting the first shot, it started to go away after 2 weeks, and then it got worse after he got the second shot. It's not as bad as before, but neck was still stiff. Left elbow was sore/painful ever since he got the shots. Also, he had some odd / weird feelings (painful - on and off) in chest/heart area for a few weeks after the second shot, but they went away eventually. It's been a few months of generally not feeling so great since he got the shots. Example, he get aches and pains in joints (feet, ankles, knees) and he felt like he is 80 years old - especially in the morning. He had never had that before. It was unknown if patient had COVID prior vaccination or if was tested for COVID post vaccination. No treatments were given for the events. The patient was not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program. A female patient (reporter's girlfriend) of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), 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. Patient had a stroke on an unspecified date and it was reported that reporter knew several others that died from the COVID vaccine. Reporter wanted to know the side effects of the COVID vaccine. Reporter also wanter to know how it got approved and was advised to check out government website. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 12Aug2021 (Lot Number: FA7484) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks prior to the administration of the suspect vaccine. The patient experienced appendicitis (caused hospitalization, medically significant) on 25Aug2021 with outcome of recovering. The event required emergency room visit. The patient was hospitalized for appendicitis from 25Aug2021 to 28Aug2021. Therapeutic measures were taken as a result of the event and included appendectomy on 25Aug 2021.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Burning sensation, Dizziness, Infection, Productive cough
Clinical narrative: I had a little infection in my uterus; spitting up phlegm; she has been throwing up; dizzy; her appetite has changed; rash; too mild infections; had a itching, Burning sensation; sleepy; had a itching, Burning sensation; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 26Mar2021 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she was difficult to understand but from her, what she got, she had first dose of the COVID-19 vaccine and was supposed to go for her 2nd dose, and she did not give her any dates or notes but, she has been spitting up Phlegm, has seen her healthcare provider so, she going to go back and tested again (Unspecified test) but she has been throwing up, dizzy and has had a change in her appetite. She said that they checked her urine but have not found any infection. She said that she had a rash, too mild infections and she said that one doctor told her, might be from the vaccine. She did not have any questions. She just wants to report those side effects. Consumer stated, "See I'm starting to get the COVID Shot. I got the first one and anyhow, but I had a little infection in my uterus. I had an itching, burning sensation. Something else and doctor said, I have more rash in my arm". Consumer stated, "What was the last thing you said? I am a little sleepy". Consumer stated, "I do not know my email address. I am making a new email address for my friends, tomorrow so, she was trying to do tonight but I grow from a disability". Consumer stated, "I am on birth control right now so, where would you like to give my child, but I have general wards too something in my room and then trying. "Where it would be? 32612. Is that it or is it # 4606? The number is 4606 # or it be 82621. I am sorry. Two numbers, Which I never can decide 193". Consumer stated, "No, I just took one shot right now and I was on in and doctor told me to quit to one pill (Further clarification Unknown) today so, I am on a double check with the clinic. My family doctors. There is another one on 16Sep2021, that actually, When I was on my appointment". The patient received unknown treatment for all the events. The patient underwent lab tests and procedures which included urine analysis: have not found an infection on an unknown date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Somnolence, Urine analysis, Uterine infection
Clinical narrative: I had a little infection in my uterus; spitting up phlegm; she has been throwing up; dizzy; her appetite has changed; rash; too mild infections; had a itching, Burning sensation; sleepy; had a itching, Burning sensation; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 26Mar2021 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she was difficult to understand but from her, what she got, she had first dose of the COVID-19 vaccine and was supposed to go for her 2nd dose, and she did not give her any dates or notes but, she has been spitting up Phlegm, has seen her healthcare provider so, she going to go back and tested again (Unspecified test) but she has been throwing up, dizzy and has had a change in her appetite. She said that they checked her urine but have not found any infection. She said that she had a rash, too mild infections and she said that one doctor told her, might be from the vaccine. She did not have any questions. She just wants to report those side effects. Consumer stated, "See I'm starting to get the COVID Shot. I got the first one and anyhow, but I had a little infection in my uterus. I had an itching, burning sensation. Something else and doctor said, I have more rash in my arm". Consumer stated, "What was the last thing you said? I am a little sleepy". Consumer stated, "I do not know my email address. I am making a new email address for my friends, tomorrow so, she was trying to do tonight but I grow from a disability". Consumer stated, "I am on birth control right now so, where would you like to give my child, but I have general wards too something in my room and then trying. "Where it would be? 32612. Is that it or is it # 4606? The number is 4606 # or it be 82621. I am sorry. Two numbers, Which I never can decide 193". Consumer stated, "No, I just took one shot right now and I was on in and doctor told me to quit to one pill (Further clarification Unknown) today so, I am on a double check with the clinic. My family doctors. There is another one on 16Sep2021, that actually, When I was on my appointment". The patient received unknown treatment for all the events. The patient underwent lab tests and procedures which included urine analysis: have not found an infection on an unknown date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I had a little infection in my uterus; spitting up phlegm; she has been throwing up; dizzy; her appetite has changed; rash; too mild infections; had a itching, Burning sensation; sleepy; had a itching, Burning sensation; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 26Mar2021 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she was difficult to understand but from her, what she got, she had first dose of the COVID-19 vaccine and was supposed to go for her 2nd dose, and she did not give her any dates or notes but, she has been spitting up Phlegm, has seen her healthcare provider so, she going to go back and tested again (Unspecified test) but she has been throwing up, dizzy and has had a change in her appetite. She said that they checked her urine but have not found any infection. She said that she had a rash, too mild infections and she said that one doctor told her, might be from the vaccine. She did not have any questions. She just wants to report those side effects. Consumer stated, "See I'm starting to get the COVID Shot. I got the first one and anyhow, but I had a little infection in my uterus. I had an itching, burning sensation. Something else and doctor said, I have more rash in my arm". Consumer stated, "What was the last thing you said? I am a little sleepy". Consumer stated, "I do not know my email address. I am making a new email address for my friends, tomorrow so, she was trying to do tonight but I grow from a disability". Consumer stated, "I am on birth control right now so, where would you like to give my child, but I have general wards too something in my room and then trying. "Where it would be? 32612. Is that it or is it # 4606? The number is 4606 # or it be 82621. I am sorry. Two numbers, Which I never can decide 193". Consumer stated, "No, I just took one shot right now and I was on in and doctor told me to quit to one pill (Further clarification Unknown) today so, I am on a double check with the clinic. My family doctors. There is another one on 16Sep2021, that actually, When I was on my appointment". The patient received unknown treatment for all the events. The patient underwent lab tests and procedures which included urine analysis: have not found an infection on an unknown date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Feeling hot, Investigation, Magnetic resonance imaging, Myelitis transverse
Clinical narrative: Myelitis transverse; Paralyzed; her knees down to her feet into her toes stayed on fire now; This is a spontaneous report from contactable nurse (patient). A 75-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular administered in arm right on 06Feb2021 10:10 (Lot Number: EL9264) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included spinal operation from in Jan2020 (not ongoing). The patient's concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (Lot# 2L3302) on 05Jan2021 at 75 years for COVID-19 immunisation with no adverse effect. In Mar2021 or Apr2021 the patient became paralyzed. The event caused patient's hospitalization for 2 days and they did MRI and CT scan. Both tests came out normal. She was told her spinal cord was wide open and hardware looked good. The event also required emergency room visit and physician office visit (neurologist). On 27Jul2021 she saw the neurologist which diagnosed her with transverse myelitis with outcome of unknown. She could walk now, she was diagnosed transverse myelitis from the vaccine. Treatment included physical therapy. She reported that below her knees down to her feet into her toes stayed on fire in Aug2021 with outcome of not recovered, and she had testing done another MRI. She also had a test in Aug2021 on her muscles and nerves, she does not know the name of the test.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events Transverse myelitis, Paralysis and suspect drug BNT162B2 cannot be excluded.   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: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Myelitis transverse; Paralyzed; her knees down to her feet into her toes stayed on fire now; This is a spontaneous report from contactable nurse (patient). A 75-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular administered in arm right on 06Feb2021 10:10 (Lot Number: EL9264) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included spinal operation from in Jan2020 (not ongoing). The patient's concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (Lot# 2L3302) on 05Jan2021 at 75 years for COVID-19 immunisation with no adverse effect. In Mar2021 or Apr2021 the patient became paralyzed. The event caused patient's hospitalization for 2 days and they did MRI and CT scan. Both tests came out normal. She was told her spinal cord was wide open and hardware looked good. The event also required emergency room visit and physician office visit (neurologist). On 27Jul2021 she saw the neurologist which diagnosed her with transverse myelitis with outcome of unknown. She could walk now, she was diagnosed transverse myelitis from the vaccine. Treatment included physical therapy. She reported that below her knees down to her feet into her toes stayed on fire in Aug2021 with outcome of not recovered, and she had testing done another MRI. She also had a test in Aug2021 on her muscles and nerves, she does not know the name of the test.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events Transverse myelitis, Paralysis and suspect drug BNT162B2 cannot be excluded.   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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle twitching
Clinical narrative: eye will not stop twitching; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of ad-ministration on 13Aug2021 (age at vaccination 33years old) as for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing Patient History: No. There were no concomitant medications. The patient experienced eye will not stop twitching on 15Aug2021 16:00, tired on 14Aug2021. Clinical course was reported as she is calling to see where to report side effects. Two Fridays ago, about 2 and a half weeks ago. She was tired. Two days after the vaccine her eye will not stop twitching. It is 80% of the day. Only her left eye. The clinical outcome of the event tired was recovered on 15Aug2021 and another event was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID after getting the Pfizer COVID vaccine; tested positive for COVID after getting the Pfizer COVID vaccine; This is a spontaneous report from a program from a non-contactable consumer.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced tested positive for covid after getting the pfizer covid vaccine on an unspecified date with outcome of unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: Positive Covid test; Positive Covid test; This is a spontaneous report from a non-contactable consumer (patient).   A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced positive covid test via Nasal Swab, on 27Aug2021 with outcome of recovering. The patient did not receive any treatment for the event. No covid prior vaccination.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Fully vaccinated with CV19 positive via PCR test; Fully vaccinated with CV19 positive via PCR test; This is a spontaneous report from a contactable healthcare professional.  A 28-year-old (also the age at time of vaccination) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 27Mar2021 (Batch/Lot Number: EP6955) as DOSE 1, SINGLE then on 17Apr2021 (Batch/Lot Number: EP6955) as DOSE 2, SINGLE both given intramuscularly administered on arm left for COVID-19 immunization at workplace clinic. Medical history and concomitant medications were not reported. On 27Aug2021, the fully vaccinated patient with COVID-19 vaccine was noted to be positive via Nasal Swab (PCR test) on that same day of 27Aug2021.  The event requires doctor or other healthcare professional office/clinic visit. The patient was recovering from the events.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram coronary artery, Oedema, Peripheral swelling, Scan, Swelling
Clinical narrative: He had some swelling a lot of swelling after his second shot; swelling in his feet about a month after getting the second dose/his legs were swollen/swelling in the lower extremities; he is getting edema/pitting edema; This is a spontaneous report from a contactable Nurse. A 66-years-old male patient (reporter's husband) received 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 on an unspecified date 2021 (age at the time of vaccination 66-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Flu, he always has reactions, caller states her husband gets the flu, every year and has reactions to the shot; His family had covid earlier, a year ago and his symptoms are moving fast, so I'm wondering if this is the variant. The patient's concomitant medications were not reported. The patient previously 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, on an unspecified date Mar2021 (age at the time of vaccination 66-years-old), as a single dose for COVID-19 immunization and experienced soreness in bones, alot of inflammation, felt bad, and swollen feet. On an unspecified date 2021, the patient experienced He had some swelling a lot of swelling after his second shot, swelling in his feet about a month after getting the second dose/his legs were swollen/swelling in the lower extremities, and he is getting edema/pitting edema. On an unspecified date, the patient underwent lab tests and procedures which included heart scan, Computerised tomogram coronary artery: heart was swollen Endocarditis, it was look like his heart was swollen Endocarditis or if there was anything Myocarditis; and on an unspecified date 2021 heart scan, Computerised tomogram coronary artery: wonderful, everything was wonderful; and on an unspecified date 2021 scan of his feet: wonderful. Treatment was received. The outcome of the events was not recovered.  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: tested positive for COVID after getting the Pfizer COVID vaccine; tested positive for COVID after getting the Pfizer COVID vaccine; This is a spontaneous report from a Pfizer sponsored program from a non contactable consumer.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient tested positive for COVID after getting the Pfizer COVID vaccine with outcome of unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: miscarriage; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration, administered in right arm on 27Mar2021 at 15:00 (at the age of 42-years-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had a missed miscarriage on 20Apr2021 at 14:00. The mother reported she became pregnant while taking bnt162b2.  The mother was 10 weeks pregnant at the onset of the event.  The mother was due to deliver on 10Nov2021.  The pregnancy resulted in spontaneous abortion. The event resulted in Emergency room/department or urgent care and was treated with pain medication. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The event was resolved.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Dizziness, Electrocardiogram, Facial paralysis
Clinical narrative: Facial paralysis; Migraines; pressure in my head and behind my eyes; pressure in my head and behind my eyes; chest pain; facial twitching and body twitching; dizziness; feeling of suffocation; left head, face, arm, hand, leg and foot paralysis; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID-19) via an unspecified route of administration on the right arm on 08Apr2021 (Lot Number: ER8729) at the age of 45-year-old as single does for COVID-19 immunization. Medical history included COVID and thyroid. Known allergy was none. On 04May2021, the patient performed for COVID test (Nasal Swab) and result was negative. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 18Mar2021 (Lot Number: EN6208) at the age of 45-year-old as single does for COVID-19 immunization. On 04May2021 at 11:30 AM, the patient experienced facial paralysis, migraines, left head, face, arm, hand, leg and foot paralysis. The patient had since been back to withheld Hospital 2 times with facial paralysis, pressure in head and behind eyes, chest pain, facial twitching and body twitching. Waiting for next MRI and MRV, as patient have the feeling of suffocation and dizziness all the time and chest pain was completely fine before receiving the shot. The events resulted in hospitalization for 2 days. Treatment was received for events included CT Scan, MRI, EKG, IV Therapy. The outcome of events was not recovered.