chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart racing; This is a spontaneous report received from a contactable male consumer. This 53- year- old male consumer reported for himself that: A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0171 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 21Apr2021 14:20 (age at vaccination was 53-year-old) as DOSE 1, single dose for covid-19 immunisation. Medical history included ongoing diabetic, ongoing breathing problems, heart stent from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no adverse events following prior vaccinations. The patient had no additional administered vaccines and no vaccines administered on same date with the Pfizer vaccine considered as suspect. He had his first Covid 19 vaccine yesterday, on 21Apr2021 21:00 patient experienced heart racing. He did not know that the Covid 19 vaccine could cause that. He reports his heart started to race right away after receiving the Covid 19 vaccine. He did not check his heartrate, he just knows that it was fast. It's also irritating to him because he has a history of heart issues. He didn't know he would get this particular side effect. He thought, he has to go to the emergency department, but his heart rate slowed down around 9:00PM last night, 21Apr2021. The patient had no relevant tests. The patient did not visit emergency room and physician office. The outcome of the event was recovered on 21Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Depressed mood, Discomfort, Feeling hot
Clinical narrative: Felt feverish/little fever; Headache; Nausea; He is very hot; severe cough; Presented weakness; Felt sleepy; Felt 'down'; Severe flu; Very congested; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). An 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Apr2021 (at the age of 18-year-old) at dose 1, single for covid-19 immunisation. Medical history included covid-19 from 13Jan2021 to an unknown date. Concomitant medications were not reported. On an unspecified date the patient experienced presented felt feverish/little fever, headache, nausea, he is very hot, severe cough, on an unspecified date in Apr2021 severe flu, very congested, on 13Apr2021 presented weakness, felt sleepy, felt down. Reporter stated that his 18-year-old son had his last Covid-19 positive test on 13Jan2021 and on 13Apr2021 he had the first dose of the Pfizer Covid-19 vaccine. On the same day he presented weakness, felt sleepy, felt 'down' and three days after he had a severe flu, he was very congested, felt feverish, presented severe cough and headache. As if he had Covid-19 again. Stated that she gave him cough syrup, something for the headache and flu and two days later he felt better. Reporter would like to know if after presenting these events he should take the second dose of the vaccine on 02May2021. She is calling for her son. He is 18 years old. He had first dose and then developed symptoms which she said were: little fever, headache, nausea. He thinks he has COVID, and she said it is the reaction from the vaccine and not that. He is very hot. She would like to know if Pfizer recommends 2nd dose or not. It is scheduled for 04May2021. The patient underwent lab tests and procedures which included COVID-19 Test: positive on 13Jan2021. Patient received treatment with cough syrup, something for the headache and flu and two days later he felt better. Outcome of the event presented weakness, felt sleepy, felt down, felt feverish/little fever, nausea, he is very hot, very congested was unknown and severe flu, headache, severe cough was resolving. There is a Product Complaint. Description of Product Complaint: Received call from consumer regarding the Pfizer COVID vaccine. She is calling for her son. He is 18 years old. He had first dose and then developed symptoms which she said were: little fever, headache, nausea. He thinks he has COVID, and she said it is the reaction from the vaccine and not that. He is very hot. Product strength and count size dispensed: not provided. Additional lot numbers: none. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact: not provided.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Felt feverish/little fever; Headache; Nausea; He is very hot; severe cough; Presented weakness; Felt sleepy; Felt 'down'; Severe flu; Very congested; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). An 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Apr2021 (at the age of 18-year-old) at dose 1, single for covid-19 immunisation. Medical history included covid-19 from 13Jan2021 to an unknown date. Concomitant medications were not reported. On an unspecified date the patient experienced presented felt feverish/little fever, headache, nausea, he is very hot, severe cough, on an unspecified date in Apr2021 severe flu, very congested, on 13Apr2021 presented weakness, felt sleepy, felt down. Reporter stated that his 18-year-old son had his last Covid-19 positive test on 13Jan2021 and on 13Apr2021 he had the first dose of the Pfizer Covid-19 vaccine. On the same day he presented weakness, felt sleepy, felt 'down' and three days after he had a severe flu, he was very congested, felt feverish, presented severe cough and headache. As if he had Covid-19 again. Stated that she gave him cough syrup, something for the headache and flu and two days later he felt better. Reporter would like to know if after presenting these events he should take the second dose of the vaccine on 02May2021. She is calling for her son. He is 18 years old. He had first dose and then developed symptoms which she said were: little fever, headache, nausea. He thinks he has COVID, and she said it is the reaction from the vaccine and not that. He is very hot. She would like to know if Pfizer recommends 2nd dose or not. It is scheduled for 04May2021. The patient underwent lab tests and procedures which included COVID-19 Test: positive on 13Jan2021. Patient received treatment with cough syrup, something for the headache and flu and two days later he felt better. Outcome of the event presented weakness, felt sleepy, felt down, felt feverish/little fever, nausea, he is very hot, very congested was unknown and severe flu, headache, severe cough was resolving. There is a Product Complaint. Description of Product Complaint: Received call from consumer regarding the Pfizer COVID vaccine. She is calling for her son. He is 18 years old. He had first dose and then developed symptoms which she said were: little fever, headache, nausea. He thinks he has COVID, and she said it is the reaction from the vaccine and not that. He is very hot. Product strength and count size dispensed: not provided. Additional lot numbers: none. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact: not provided.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Felt feverish/little fever; Headache; Nausea; He is very hot; severe cough; Presented weakness; Felt sleepy; Felt 'down'; Severe flu; Very congested; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). An 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Apr2021 (at the age of 18-year-old) at dose 1, single for covid-19 immunisation. Medical history included covid-19 from 13Jan2021 to an unknown date. Concomitant medications were not reported. On an unspecified date the patient experienced presented felt feverish/little fever, headache, nausea, he is very hot, severe cough, on an unspecified date in Apr2021 severe flu, very congested, on 13Apr2021 presented weakness, felt sleepy, felt down. Reporter stated that his 18-year-old son had his last Covid-19 positive test on 13Jan2021 and on 13Apr2021 he had the first dose of the Pfizer Covid-19 vaccine. On the same day he presented weakness, felt sleepy, felt 'down' and three days after he had a severe flu, he was very congested, felt feverish, presented severe cough and headache. As if he had Covid-19 again. Stated that she gave him cough syrup, something for the headache and flu and two days later he felt better. Reporter would like to know if after presenting these events he should take the second dose of the vaccine on 02May2021. She is calling for her son. He is 18 years old. He had first dose and then developed symptoms which she said were: little fever, headache, nausea. He thinks he has COVID, and she said it is the reaction from the vaccine and not that. He is very hot. She would like to know if Pfizer recommends 2nd dose or not. It is scheduled for 04May2021. The patient underwent lab tests and procedures which included COVID-19 Test: positive on 13Jan2021. Patient received treatment with cough syrup, something for the headache and flu and two days later he felt better. Outcome of the event presented weakness, felt sleepy, felt down, felt feverish/little fever, nausea, he is very hot, very congested was unknown and severe flu, headache, severe cough was resolving. There is a Product Complaint. Description of Product Complaint: Received call from consumer regarding the Pfizer COVID vaccine. She is calling for her son. He is 18 years old. He had first dose and then developed symptoms which she said were: little fever, headache, nausea. He thinks he has COVID, and she said it is the reaction from the vaccine and not that. He is very hot. Product strength and count size dispensed: not provided. Additional lot numbers: none. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact: not provided.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Underdose, Wrong technique in product usage process
Clinical narrative: Thinks the person who administered it pulled the vaccine out too fast; She thinks that not all of the dose went in her arm because she felt some fluid going down her elbow/she thinks that she did not receive all of her dose; Pain; Fatigue; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0179, Expiry date not reported) via an unspecified route of administration in left upper arm on an unspecified date as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant therapy included thyroid medication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. Patient reported that she received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine. However, she thinks that not all of the dose went in her arm because she felt some fluid going down her elbow. She thinks the person who administered it pulled the vaccine out too fast. She enquired what would happen if she received less than the recommended dose. Patient was referred to her HCP for more guidance. Upon follow up (29Apr2021), patient stated, she said something about sometimes it just does not go in that she never had a vaccination due that before and she was concerned if she had the full benefit of the second dose, if there was an issue if she did not get the full dose. She did not have much reaction other fatigue next day and some pain on 28Apr2021. Patient stated, she talked to her personal doctor about it but she do not have any treatment she just got the Covid shot. The outcome of the events fatigue, pain was recovered.    he outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.  Follow up (29Apr2021): This is a follow up spontaneous report from a contactable consumer (patient). New information included patient anatomical location for second dose, concomitant therapy, new events fatigue, pain outcome, onset date.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Herpes zoster
Clinical narrative: Shingles; Starting to dry up; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 51-year-old male patient (reporter's son) that who received first dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Medical history included the patient had covid-19 in early Jan2021 to an unknown date. The patient's concomitant medications were not reported. Two weeks later in 2021, the patient had shingles and now starting to dry up. Responded that you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Referred to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider knows your health situation and has access to information that can better help inform this decision. Caller was wondering if her son should get the second dose of the vaccine. Caller waned to know if he should skip his second dose or what he should do. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Abnormal heartbeat the day following vaccination.The highest bpm was 130+; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on an unknown date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the day following vaccination, the patient experienced abnormal heartbeat. The highest bpm was 130+ and for no reason(was not excising, only sitting on a chair listening to zoom lecture), calmed down after laying down but had a few more consecutive abnormal heartbeat occurrences. No longer experience such side effect now. On an unknown date ,patient underwent heartrate measurement and the result was 130+ bpm. The clinical outcome of the event abnormal heartbeat the day following vaccination was recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Update the event verbatim to "Abnormal heartbeat the day following vaccination. The highest bpm was 130+ "and recoded it to heart rate increased. Treatment received ticked No. Remove the wording "Unit: {DF}" from lab data results field.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate increased
Clinical narrative: Fast irregular heart rate; irregular chest tightness; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0151; Expiration Date: Jul2021) via an unspecified route in right arm on 12Apr2021 at 15:00 (33-years-old at vaccination) as dose 1, single for COVID-19 immunization. The patient had no medical history, family medical history relevant at AE(s) and concomitant medications reported. The patient was not administered with vaccine at facility. The patient was neither administered with any other vaccine 4 weeks prior to COVID-19 vaccine nor on the same date of Covid vaccine. On 12Apr2021 (3 hours later she began), the patient experienced a fast heart rate/ her heart rate started getting fast with a heart rate of 140 bmp, that lasted for 1 week. She stated her heart made her feel like she was running, even if she was sitting. She stated that the day it was really fast, was on Wednesday 14Apr2021, she had to go to the ER that day. She had irregular chest tightness that lasted for a week, for 8 days. The patient stated the chest tightness was still ongoing. The outcome of the chest tightness was that she felt it sometimes but not all the time. She described the irregular heart rate as something that felt like skipping heartbeat or something weird in her heart. The patient reported that she went to the ER and was told that she was ok and that it was probably a side effect of the vaccine and was discharged from the ER. The patient spoke with her HCP and was reportedly advised to get the second dose. The patient was scheduled to get her second vaccine dose at time of reporting. She wanted to know if this was normal and if she should get the second dose, reporting that she was nervous and wasn't sure what to do. The patient underwent lab tests and procedures which included heart rate: 140 bpm on 12Apr2021. No investigation assessment was reported. These adverse events resulted the patient to visit emergency room and physician office (talked to doctor via video call). The outcome of the event was fast irregular heart rate recovered on 20Ap2021 and the outcome of the event irregular chest tightness was not recovered.  No Follow-up attempts are needed. No further information was expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fear, Heart rate increased, Hyperventilation, Nausea
Clinical narrative: deep breaths; anxiety attacks; fear; heart was beating fast; nausea for a little bit longer than yesterday; sore arm; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via an unspecified route of administration in arm left on 01May2021 (at the age of 86-year-old) as a dose 1, single for COVID-19 immunisation. The patient medical history included arthritis, diagnosed some years ago. Its in both of her knees. The patient's concomitant medications were not reported. Enquired that, the caller was called about the Pfizer COVID vaccine. This was the caller first dose of the vaccine. She went to her grandson union, where they were giving shots. The caller was not going to get the vaccine but her grandson tricked her into getting it, she was so scared. She did not really want it, her grandson did it because he did not want her to get the virus. The caller had the first dose of the vaccine yesterday or two days ago and she thinks she had some side effects. On 02May2021, the patient experienced nausea, it was not too long, the nausea lasted about 10 minutes, it was a couple times, then it kind of went away, she had it twice. Stated that, she had so much fear that she could not even think on an unspecified date. Stated that, then the caller heart was beating really fast on 02May2021 and after a while it stopped. Then today, the caller had the nausea and then it went away, she drank some ginger ale and kind of helped it. The nausea and heartbeat could have been an anxiety attack because she got really scared. Yesterday she just took deep breaths, because she had anxiety attacks, so thought to do that and it helps. This morning, the caller feels a little better now but she still has a lot of fear. The caller had a sore arm yesterday, it was really sore but its kind of going away, today she could move it and it does not hurt, just very little. She had asked, how many days more or less do side effects from the vaccine last. The caller declined to wait and stated that, her PCP was (name withheld), but she has not seen him for a year. The caller declined further information. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: deep breaths; anxiety attacks; fear; heart was beating fast; nausea for a little bit longer than yesterday; sore arm; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via an unspecified route of administration in arm left on 01May2021 (at the age of 86-year-old) as a dose 1, single for COVID-19 immunisation. The patient medical history included arthritis, diagnosed some years ago. Its in both of her knees. The patient's concomitant medications were not reported. Enquired that, the caller was called about the Pfizer COVID vaccine. This was the caller first dose of the vaccine. She went to her grandson union, where they were giving shots. The caller was not going to get the vaccine but her grandson tricked her into getting it, she was so scared. She did not really want it, her grandson did it because he did not want her to get the virus. The caller had the first dose of the vaccine yesterday or two days ago and she thinks she had some side effects. On 02May2021, the patient experienced nausea, it was not too long, the nausea lasted about 10 minutes, it was a couple times, then it kind of went away, she had it twice. Stated that, she had so much fear that she could not even think on an unspecified date. Stated that, then the caller heart was beating really fast on 02May2021 and after a while it stopped. Then today, the caller had the nausea and then it went away, she drank some ginger ale and kind of helped it. The nausea and heartbeat could have been an anxiety attack because she got really scared. Yesterday she just took deep breaths, because she had anxiety attacks, so thought to do that and it helps. This morning, the caller feels a little better now but she still has a lot of fear. The caller had a sore arm yesterday, it was really sore but its kind of going away, today she could move it and it does not hurt, just very little. She had asked, how many days more or less do side effects from the vaccine last. The caller declined to wait and stated that, her PCP was (name withheld), but she has not seen him for a year. The caller declined further information. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Neck pain, Pain in extremity
Clinical narrative: Legs have been hurting; Neck hurting; Feeling 'off' after the vaccine; This is a spontaneous report received from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included valaciclovir hydrochloride (VALTREX). On 01Apr2021, the patients legs had been hurting, neck hurting and feeling 'off' after the vaccine. Patient reported that she had the first dose of Pfizer's COVID vaccine on 01Apr2021 and she hadn't been feeling right since 01Apr2021. She knew it was not a common side effect. Her legs had been hurting and neck hurting. Her neck started hurting immediately following the shot. She had to do physical therapy for it, but it was getting better. It was almost instant from the time they put the needle into her and the pain shot up her neck. She was wondering if there had been reports of feeling 'off' after the vaccine and caller was concerned on how the second shot might feel. She stated she did speak with the doctor and they said to give it some more time before receiving my second shot. They said to give it a couple more weeks to let her body respond and then go get the second dose. Patient had been taking Valtrex and was wondering if that will be a problem with the vaccine. The outcome of legs hurting and feeling off was unknown and outcome of neck hurting was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: fast heart beat; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Apr2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing irregular heartbeat sometimes since 2005. Concomitant medications were not reported. On an unspecified date, the patient experienced fast heartbeat. Patient was due for the second dose at the time of reporting and asked if vaccine had anything to do with the heart. She does not know if the vaccine caused it or not, since she had it for off and on for 6-months. She was uncertain if she should take the second dose. Patient asked what the risks of the Pfizer-Biontech Covid-19 vaccine were and who should not get it. The outcome of event was unknown.  No Follow-up attempts are needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Visual impairment
Clinical narrative: Fast heartbeat; Dizziness; Trouble seeing; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated he was calling about the Pfizer COVID 19 vaccine, stated he had the first vaccine and immediately after had a fast heartbeat, dizziness, and trouble seeing which could be a sign of a severe allergic reaction which he saw on the FDA website, also stated he was scheduled for the second dose today and had read if one has experienced a severe allergic reaction it may not be best to get the second dose so he was wondering what Pfizer would recommend for him to do and stated he talked to his primary doctor and the doctor said it should be fine for him to get the second dose. The patient underwent lab tests and procedures which included heart rate which was fast on an unspecified date. The events were assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: Fast Heart Beat; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number/ NDC/ UPC number/ Expiry Date not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had some fast heartbeat. Patient reported that might have received this vaccine for 2 weeks and 2 days. Patient stated "I recorded for if you say I note you like give and pay attention but I start to measure the oxygen level and the heart beat, I am "90" but they "85" I don't know is this normal or not but I have around "80" score than to the "90" (not clarified numbers)." Patient was supposed to have second dose the 01Mar2021 and wanted to know if can go ahead and take the second dose. Patient wanted to know for how long this side effects can stay, the duration of side effect. The outcome of the adverse event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Mitral valve prolapse, Palpitations
Clinical narrative: very strong heart pounding which was constant/like it was trying to be out of my chest, heart is beating like this, sensation of really heart pounding; Echo found mitral valve prolapse; This is a spontaneous report from a Pfizer sponsored marketing program Pfizer RX Pathways. A contactable 39-year-old female consumer (patient herself) received first dose of bnt162b2 (BNT162B2, solution for injection, batch/lot number Lot:ER8737), via an unspecified route in left arm on 06Apr2021, dose 1, single (age at vaccination time 39-year-old) as single dose for COVID-19 immunization. Medical history included anxiety. Concomitant medications included (Xanax) ALPRAZOLAM (start date: she did not know over the past 10 years and she was taking for Anxiety).On an unspecified date in Apr2021 patient experienced a very strong heart pounding, which was constant. BP and HR were both normal. It got less severe after about 5 days. However, she had a dull constant heart pounding ever since. Echo found mitral valve prolapse (never been seen or heard before), and she read that some medications can cause valve issues. Still awaiting further test results. The patient eats healthy, exercises regularly. No prior health issues. The patient had the first shot and had the other usual normal problem there but then a day or two day after her heart started pounding like really hard like it was trying to be out of my chest but it wasn't like my heart beat wasn't elevated and her Blood Pressure wasn't elevate everything was normal. So just a sensation of really heart pounding and that lasted for, she wanted to say may be five days and then what else, since then she still have the heart pounding feeling but a lot less, so it's really mild but is still constantly there. Most of her test were fine but Echocardiogram showed a Mitral valve prolapse which she never had before and now she got some, she did not know if the causing factor if it just triggered it but now, she was still working with the cardiologist to figure out why her heart was so beating like this. The patient had a regular blood test like full CBC then I also had additional test for cardiologist, went for full blood test and that was all normal.The outcome for both events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: Movable 1/4" nodule on left shoulder blade at end of old, healed break in center of bone. Slightly tender; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 04May2021 at 10:00 (at the age of 60-year-old) at single dose for COVID-19 immunisation. Medical history included old, healed break in center of bone (shoulder blade, not ongoing), it also reported as lifetime typical for age, nothing chronic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medication included curcumin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration in left arm on 13Apr2021 at 16:00 (at the age of 60-year-old) at single dose for COVID-19 immunisation. On 06May2021 at 12:00, the patient experienced a movable 1/4" nodule on left shoulder blade at the end of old, healed break in center of bone. Slightly tender. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event painful nodule was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 'old, healed break in center of bone (shoulder blade)' added as medical history, patient received bnt162b2 in US.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Throat irritation, Throat tightness
Clinical narrative: Rash with itching on abdomen, bilateral arms, and little bit on back upon waking up on 5/6. Quickly spread to upper chest, neck/Initial rash areas increased in number and some in size; Rash with itching on abdomen, bilateral arms, and little bit on back upon waking up on 5/6. Quickly spread to upper chest, neck; Throat felt a little tight; Throat became very itchy; This is a spontaneous report from a non-contactable consumer. A 58-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in the right arm on 04May2021 15:30 (Batch/Lot Number: ER8735) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included High Blood Pressure and Anaemia, both from an unknown date and unknown if ongoing. Concomitant medications included fish oil taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took lisinopril and experienced allergies. The patient had rash with itching on abdomen, bilateral arms, and little bit on back upon waking up on 06May2021. It quickly spread to upper chest, neck, eventually throat felt a little tight, but throat became very itchy. Initial rash areas increased in number and some in size. Outcome of events was reported as recovering. Patient received steroid shot and Medrol Dose Pack as result of the events.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypertension, Pruritus
Clinical narrative: Patient complained of itching  at LAC site. She believed it may be from the blouse she is wearing.; Patient complained of redness at LAC site. She believed it may be from the blouse she is wearing.; Her blood pressure was slightly elevated. Heart rate, oxygen saturation, and temperature were normal. Patient reported improvement with clothing sensitivity. No medications given. Patient drank two8 fluid ounces of water.; This is a spontaneous report from a contactable healthcare professional, the pharmacist. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot Number: ER8733), via intramuscular route of administration in the left arm on 19April2021 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient was known allergic to tetanus antitoxin. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot Number: ER8727), via intramuscular route of administration in the left arm on 29Mar2021 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19April2021, the patient experienced itching and redness at LAC site and believed it may be from the blouse. Blood pressure was slightly elevated. Heart rate, oxygen saturation, and temperature were normal. The patient reported improvement with clothing sensitivity. Patient drank two 8 fluid ounces of water. No therapeutic measures were taken for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events itching and redness at LAC site and slightly elevated blood pressure was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Malaise, Nasopharyngitis, Palpitations
Clinical narrative: she had an episode of her heart racing for 10 minutes and she felt unwell and her heart is elevated still.; she had an episode of her heart racing for 10 minutes and she felt unwell.  She fell asleep right after to get away from the symptoms and this morning, she is still not well;; She fell asleep right after to get away from the symptoms and this morning, she is still not well; she feels clammy, cold and her heart is elevated still.; She fell asleep right after to get away from the symptoms and this morning, she is still not well; she feels clammy, cold and her heart is elevated still.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age reported for herself who received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 07May2021 12:00 Pm (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had an episode of her heart racing for 10 minutes and she felt unwell. She fell asleep right after to get away from the symptoms and this morning, she was still not well; she feels clammy, cold and her heart is elevated still. The patient was concern about is this a side effect can it happen this far out. The patient disconnected abruptly as she did not like the answers what they had. It was unable to get her age. The clinical outcome of heart racing and felt unwell was not recovered and outcome of all other events was unknown.  The patient had a question that she had a side effect after the first dose of the vaccine. Should she get the second dose.  Response: As noted in the Fact Sheet for Recipients, patient should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knows her health situation and had access to information that he can better help inform this decision.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Confusional state, Diarrhoea, Dizziness, Heart rate decreased
Clinical narrative: she had an episode of her heart racing for 10 minutes and she felt unwell and her heart is elevated still.; she had an episode of her heart racing for 10 minutes and she felt unwell.  She fell asleep right after to get away from the symptoms and this morning, she is still not well;; She fell asleep right after to get away from the symptoms and this morning, she is still not well; she feels clammy, cold and her heart is elevated still.; She fell asleep right after to get away from the symptoms and this morning, she is still not well; she feels clammy, cold and her heart is elevated still.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age reported for herself who received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 07May2021 12:00 Pm (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had an episode of her heart racing for 10 minutes and she felt unwell. She fell asleep right after to get away from the symptoms and this morning, she was still not well; she feels clammy, cold and her heart is elevated still. The patient was concern about is this a side effect can it happen this far out. The patient disconnected abruptly as she did not like the answers what they had. It was unable to get her age. The clinical outcome of heart racing and felt unwell was not recovered and outcome of all other events was unknown.  The patient had a question that she had a side effect after the first dose of the vaccine. Should she get the second dose.  Response: As noted in the Fact Sheet for Recipients, patient should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knows her health situation and had access to information that he can better help inform this decision.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Malaise, Palpitations, Panic attack
Clinical narrative: she had an episode of her heart racing for 10 minutes and she felt unwell and her heart is elevated still.; she had an episode of her heart racing for 10 minutes and she felt unwell.  She fell asleep right after to get away from the symptoms and this morning, she is still not well;; She fell asleep right after to get away from the symptoms and this morning, she is still not well; she feels clammy, cold and her heart is elevated still.; She fell asleep right after to get away from the symptoms and this morning, she is still not well; she feels clammy, cold and her heart is elevated still.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age reported for herself who received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 07May2021 12:00 Pm (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had an episode of her heart racing for 10 minutes and she felt unwell. She fell asleep right after to get away from the symptoms and this morning, she was still not well; she feels clammy, cold and her heart is elevated still. The patient was concern about is this a side effect can it happen this far out. The patient disconnected abruptly as she did not like the answers what they had. It was unable to get her age. The clinical outcome of heart racing and felt unwell was not recovered and outcome of all other events was unknown.  The patient had a question that she had a side effect after the first dose of the vaccine. Should she get the second dose.  Response: As noted in the Fact Sheet for Recipients, patient should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knows her health situation and had access to information that he can better help inform this decision.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (wife of patient). A male 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 dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced terrible reaction with the first dose, he was down the first day. The reporter stated that he didn't want to take it, was a skeptic, but reported said to take it. It was stated that the patient would get the second dose. Outcome of the event was unknown. No follow-up attempts were needed; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Hypertension
Clinical narrative: rapid heartbeat; mild hypertension; Difficulty breathing; Swelling of your face and throat; Swelling of your face and throat; A bad rash all over your body; Dizziness and weakness; Dizziness and weakness; This is a spontaneous report from a contactable consumer (Patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Apr2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, she received the first dose of the Pfizer Covid vaccine on 29 Apr 2021. 4 days after taking the vaccine she began to experience a rapid heartbeat that continues until now. Caller states that she does have mild hypertension, and that she does have an appointment setup with her HCP. On an unspecified date, the patient experienced rapid heartbeat, mild hypertension, difficulty breathing, swelling of your face and throat, a bad rash all over your body, dizziness and weakness. Outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.