chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposed to somebody who is positive with COVID-19 in school; This is a spontaneous report from a contactable consumer (reporting for his son) via Pfizer Sponsored Program. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient been exposed to somebody who is positive with COVID-19 in school. The patient was advised to do home quarantine and has not tested yet. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Jaw disorder, Myalgia
Clinical narrative: locked jaw; Musculoskeletal-Myalgia; arthralgia; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age 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 an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced locked jaw, musculoskeletal-myalgia and arthralgia. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: have been diagnosed with Covid19 illness; have been diagnosed with Covid19 illness; This is a spontaneous report from a contactable consumer. This consumer reported for an 85-year-old male patient (Reporter's father) that the patient has received his first dose of BNT162B2 (Formulation: Solution for injection, Lot number: EK4175) on an unspecified date and second dose on 15Feb2020 (Lot number: EM9810) through an unspecified route, both doses received as single doses (Age at vaccination: unknown) for covid 19 immunization. patient's medical history and concomitant medication was not reported. It was reported that the patient has been diagnosed with Covid19 illness and patient is in hospital now, fighting for his life and not on a ventilator yet, but patient was close. Reporter also mentioned his father is on 10L of oxygen, heparin, and other bad drugs.The caller is trying to figure out how this happened as his parents were fully vaccinated, and very safe (following mask wearing guidelines, etc.). He concerned as his entire family has been vaccinated with the Pfizer product.Have there been reports of bad batches. The reporter also enquired that if Pfizer is evaluating booster doses, Is the product effective against variants of the Sars-CoV-2 virus. The outcome of the event vaccination failure and COVID-19 was unknown
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle disorder, Pain, Pain in extremity, Sinus headache, Vaccination site pain
Clinical narrative: pain radiating from neck down to left arm, felt like muscles were being shredded; couldn't raise arm above head or put on a coat without; her arm still hurts where the injection was placed; felt like muscles were being shredded; Sinus headache; This is a spontaneous report from a contactable consumer (reported for herself). A 63-year-old non pregnant female received the first dose of BNT162B2 (Pfizer Covid 19 vaccine, Lot number EP6955 expiry date unknown) via intramuscular route at left arm as a single dose on 26 March 11:30am, for Covid-19 immunization. She did not have any medical history and concomitant medication and stated that she was healthy, also she did not have cold or flu this year. She got the shingles shot a couple of years ago. A few hours after first pfizer vaccine dose, she had a sinus pressure headache which eventually went away. On 27Mar2021, within 24 hours of first dose, she had soreness in left arm at injection site plus pain lifting and moving arm. This pain was intermittent. It was stated that she could not put a coat on without pain or sleep on that side with pain. The pharmacist told her to take Aleve twice daily and use ice packs. The pain was the same and was the same consistency till this report. She stated that if she slept on that side she would have pain radiating down her neck. It had been 2 and a half weeks and she still had this. On the 27 Mar 2021, she was taking a walk and felt pain radiating from her neck down her arm and it felt like muscles were being shredded, her arm was aching like crazy, but it wasn't a heart attack evidently because that was two and a half weeks ago. It was stated that while in bed she could not use her left arm to put the covers over herself because she could not lift that arm and did not have that motion available. When she woke up in the morning she had to use her other arm to lift her left arm due to the pain. Her arm still hurts where the injection was placed. She did not feel it when she first got the shot but she did start to feel it the next day. She did not visit emergency room or physician office. She was due to have second shot on Friday next to this report, and the pharmacist said she should have it done. She had taken COVID tests. She did not have any other vaccinations within four weeks prior to the first. She recovered from the event of sinus headache on 24Mar2021, the outcome of the events of could not raise arm above head or put on a coat without, pain radiating from neck down to left arm, felt like muscles were being shredded, and Injection site pain was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Myalgia, Pain in extremity, Sinus headache, Vaccination site pain
Clinical narrative: pain radiating from neck down to left arm, felt like muscles were being shredded; couldn't raise arm above head or put on a coat without; her arm still hurts where the injection was placed; felt like muscles were being shredded; Sinus headache; This is a spontaneous report from a contactable consumer (reported for herself). A 63-year-old non pregnant female received the first dose of BNT162B2 (Pfizer Covid 19 vaccine, Lot number EP6955 expiry date unknown) via intramuscular route at left arm as a single dose on 26 March 11:30am, for Covid-19 immunization. She did not have any medical history and concomitant medication and stated that she was healthy, also she did not have cold or flu this year. She got the shingles shot a couple of years ago. A few hours after first pfizer vaccine dose, she had a sinus pressure headache which eventually went away. On 27Mar2021, within 24 hours of first dose, she had soreness in left arm at injection site plus pain lifting and moving arm. This pain was intermittent. It was stated that she could not put a coat on without pain or sleep on that side with pain. The pharmacist told her to take Aleve twice daily and use ice packs. The pain was the same and was the same consistency till this report. She stated that if she slept on that side she would have pain radiating down her neck. It had been 2 and a half weeks and she still had this. On the 27 Mar 2021, she was taking a walk and felt pain radiating from her neck down her arm and it felt like muscles were being shredded, her arm was aching like crazy, but it wasn't a heart attack evidently because that was two and a half weeks ago. It was stated that while in bed she could not use her left arm to put the covers over herself because she could not lift that arm and did not have that motion available. When she woke up in the morning she had to use her other arm to lift her left arm due to the pain. Her arm still hurts where the injection was placed. She did not feel it when she first got the shot but she did start to feel it the next day. She did not visit emergency room or physician office. She was due to have second shot on Friday next to this report, and the pharmacist said she should have it done. She had taken COVID tests. She did not have any other vaccinations within four weeks prior to the first. She recovered from the event of sinus headache on 24Mar2021, the outcome of the events of could not raise arm above head or put on a coat without, pain radiating from neck down to left arm, felt like muscles were being shredded, and Injection site pain was not recovered.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: his wife was hospitalized due to kidney infection; This is a spontaneous report via a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. It was stated that they missed their 2nd shot of vaccine on 30Mar2021 along with his wife. However, his wife was hospitalized due to kidney infection (Mar2021) from March 24th to 26Mar2021 and they were in the hospital the whole week. The reporter mentioned that his wife was already out of the hospital and he is trying to figure out where to get their 2nd shot of covid vaccine since they've missed it. The outcome of the event was unknown.   Information about lot and batch number was requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness in left shoulder after first dose; This is a spontaneous report received from a contactable consumer (patient, self -reported). This 62-years-old male patient received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8727 and expiry date: Jul2021) via Intramuscular route, into left upper arm in the muscle, on 22Mar2021, at 13: 15 (at the age of 62-year-old), as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 23Mar2021 at 02:00, the patient experienced tenderness in left shoulder after first dose. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid 19; This is a spontaneous report from Pfizer-sponsored program COVAX US Support. A contactable female consumer reported that she received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection), via an unspecified route of administration on 11Mar2021. The patient's medical history and concomitant medications were not reported. It was reported that, on 13Mar2021, the patient tested positive for COVID-19. The patient was quarantined after that and dont know the exact date for her 2nd dose and was told her to postpone the 2nd dose. The outcome for the event was reported as unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX support.   A 90-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (at the age of 90-year-old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced shortness of breath on an unspecified date. The event was considered serious as medically significant. The outcome of unknown.  He decided to skip second dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: then my son came down with the covid on the 15th of March and then I came down withit 6 days later; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program Pfizer Rx Pathways. A 69-years-old patient (gender unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 11Mar2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the first Pfizer shot on 11Mar2021 but then his son came down with the covid on 15Mar2021 and then patient came down with it on an unspecified date in Mar2021 (6 days later). Patient had a covid test on the 25Mar2021 and the Doctor told he could get the second shot after the 14 days. So, patient was hoping he can get the second shot today. The reporter was not the prescribing HCP. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Tinnitus
Clinical narrative: After the second vaccine the ringing was louder; This is a spontaneous report from a contactable consumer (patient) and from a contactable Other Health Professional.   A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ER8727) via an unspecified route of administration, administered in right  arm on 23Mar2021 09:15 (at 71 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for fibromyalgia; metoprolol taken for blood pressure measurement; atorvastatin calcium (LIPITOR ORIFARM) taken for blood cholesterol; vitamin D3 taken for vitamin d deficiency; colecalciferol, ubidecarenone (COQ10 + D3) taken for hypovitaminosis; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication; calcium carbonate, colecalciferol, copper sulfate, magnesium carbonate, magnesium oxide, manganese sulfate, zinc oxide (CALTRATE + D PLUS) taken for an unspecified indication.  Previously the patient received the first dose of BNT162B2 (Lot: EN6205) on 02Mar2021 for COVID-19 immunisation and experienced tinnitus/ringing in the ear, like tinnitus; hearing loss/completely deaf in right ear.  The patient experienced after the second vaccine the ringing was louder on 24Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included magnetic resonance imaging: abnormal on unknown date (Test results: Had MRI to make sure, there are 2 things in the brain that could cause loss of hearing.  1 is a tumor and one is something else. Don't have either). Therapeutic measures were taken as a result of the event included steroid.  Clinical course was described as follows: Patient stated right before second Pfizer COVID vaccine she lost her hearing and she has a severe case of tinnitus. She went to the doctor, ENT specialist, when she lost her hearing. The doctor still wanted her to get second vaccine, which she did. He needed to give her steroids for hearing loss. The type of hearing loss she has is called SSHL, sensory sudden hearing loss. He didn't want to give her oral steroids because he thought maybe it wouldn't be good to take with the vaccine. She received 3 injections of steroid (unknown name) into her ear. Patient stated she is two weeks post vaccination, and she is wondering at this point if she can take the steroids orally without interfering with vaccine as opposed to getting it injected in the ear? Patient stated she had hearing loss after the first vaccine and right before the second vaccine. After the second vaccine the ringing was louder. Patient stated that she still does not know if the ringing, tinnitus is from the vaccine or not. She stated that the ringing was still occurring on 23Mar2021 when she got the second dose of the vaccine. Patient stated that on 24Mar2021, the ringing had increased in volume, and it is now pretty loud and hasn't stopped.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Fatigue and body ache; Fatigue and body ache; Injection site soreness - mild; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 09Apr2021 (at the age of 47-years-old) at a single dose for covid-19 immunisation. Medical history included seasonal allergies ongoing. Concomitant medication included cetirizine hydrochloride at 10 mg tablet OTC for seasonal allergies. The patient experienced injection site soreness - mild on 09Apr2021, fatigue and body ache on 10Apr2021. The outcome of the event Injection site soreness  mild was not recovered and the event Fatigue and body ache recovered on 11Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar skyrocketed to 480 something; This is a spontaneous report from a contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient medical history included ongoing diabetes. The patient's concomitant medication included unspecified insulin for diabetes. The patient experienced blood sugar skyrocketed to 480 something on an unspecified date, and he takes insulin. The outcome of the event was unknown.   No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: nausea (bad); exhaustion/fatigue (bad); pain in arm; headache; Diarrhea; body aches; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 05Apr2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's and Celiac disease, known allergies: Gluten, dairy and eggs, all from an unknown date and unknown if ongoing. Concomitant medications included citalopram and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop dates were not reported. The patient experienced nausea (bad), exhaustion/fatigue (bad), pain in arm, headache, diarrhea and body aches on 05Apr2021 at 19:30. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: nausea (bad); exhaustion/fatigue (bad); pain in arm; headache; Diarrhea; body aches; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 05Apr2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's and Celiac disease, known allergies: Gluten, dairy and eggs, all from an unknown date and unknown if ongoing. Concomitant medications included citalopram and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop dates were not reported. The patient experienced nausea (bad), exhaustion/fatigue (bad), pain in arm, headache, diarrhea and body aches on 05Apr2021 at 19:30. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial test, Body temperature, Epstein-Barr virus test, Feeling abnormal, Full blood count
Clinical narrative: headache; body aches; feeling bad; sick; he thought he was going to pass out at work; fever of 105.2F; This is a spontaneous report from a contactable consumer (mother). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 31Mar2021 12:00 (at 16-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The caller is calling about her 16 year old son. She just left the doctor with her son who received his first Covid 19 vaccine. She would like to report an adverse event. Her son has had a fever of 105.2F (07Apr2021). The doctor just did blood tests, a rapid test for Covid that was negative, they tested him for strep throat that was negative and he doesn't have an ear infection. He's been running a fever over 105F for the past 2 days (07Apr2021). The caller wanted to rule out that nothing else is going on. They have called the Medical Director of (name)  and he didn't know what was going on with her son. If this fever continues she'll be calling Pfizer back. She is waiting on the results of his blood tests like his mononucleosis test pending and other viral and bacterial tests (unknown result). Her son started feeling bad about 4-5 days (unspecified date) after he received the Covid 19 vaccine. The last 2 days he's had a very high fever. He has a headache and body aches (unspecified date). He had a Covid 19 test not long before he received the Covid 19 vaccine and it was negative. She thought her son might have the Covid 19 virus but he had the rapid Covid 19 rapid test (09Apr2021) and it was negative. The caller does not know what is going on with her son. She took her son to a clinic because he was sick and because his fevers are too high. She also called the state but they told her that fevers are normal with the Covid 19 vaccine but if it persists after today, 09Apr2021, she needs to seek medical attention. It was further reported that earlier in the week her son told her he thought he was going to pass out at work (unspecified date). He told her he thought he had a fever but she checked it with a forehead thermometer and it didn't show a fever. Then on Wednesday, 07Apr2021, her son woke up around 4:30AM and had a fever of 105.2F with an oral thermometer. He woke Thursday, 08Apr2021 and this morning, Friday 09Apr2021 with a fever. His mother can control the fever during the day with Ibuprofen but he's spiking these fevers in the middle of the night. She knows fevers spike at night but she can't come with any other reason why this is happening. The patient lab tests and procedures also included CBC: pending, mononucleosis: pending, and rapid strep test: Negative; all from 09Apr2021. The outcome of events fever of 105.2f, headache, and body aches was not recovered; while for other events was unknown.    Information on the lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Investigation, Malaise, Pain, Presyncope
Clinical narrative: headache; body aches; feeling bad; sick; he thought he was going to pass out at work; fever of 105.2F; This is a spontaneous report from a contactable consumer (mother). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 31Mar2021 12:00 (at 16-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The caller is calling about her 16 year old son. She just left the doctor with her son who received his first Covid 19 vaccine. She would like to report an adverse event. Her son has had a fever of 105.2F (07Apr2021). The doctor just did blood tests, a rapid test for Covid that was negative, they tested him for strep throat that was negative and he doesn't have an ear infection. He's been running a fever over 105F for the past 2 days (07Apr2021). The caller wanted to rule out that nothing else is going on. They have called the Medical Director of (name)  and he didn't know what was going on with her son. If this fever continues she'll be calling Pfizer back. She is waiting on the results of his blood tests like his mononucleosis test pending and other viral and bacterial tests (unknown result). Her son started feeling bad about 4-5 days (unspecified date) after he received the Covid 19 vaccine. The last 2 days he's had a very high fever. He has a headache and body aches (unspecified date). He had a Covid 19 test not long before he received the Covid 19 vaccine and it was negative. She thought her son might have the Covid 19 virus but he had the rapid Covid 19 rapid test (09Apr2021) and it was negative. The caller does not know what is going on with her son. She took her son to a clinic because he was sick and because his fevers are too high. She also called the state but they told her that fevers are normal with the Covid 19 vaccine but if it persists after today, 09Apr2021, she needs to seek medical attention. It was further reported that earlier in the week her son told her he thought he was going to pass out at work (unspecified date). He told her he thought he had a fever but she checked it with a forehead thermometer and it didn't show a fever. Then on Wednesday, 07Apr2021, her son woke up around 4:30AM and had a fever of 105.2F with an oral thermometer. He woke Thursday, 08Apr2021 and this morning, Friday 09Apr2021 with a fever. His mother can control the fever during the day with Ibuprofen but he's spiking these fevers in the middle of the night. She knows fevers spike at night but she can't come with any other reason why this is happening. The patient lab tests and procedures also included CBC: pending, mononucleosis: pending, and rapid strep test: Negative; all from 09Apr2021. The outcome of events fever of 105.2f, headache, and body aches was not recovered; while for other events was unknown.    Information on the lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Viral test
Clinical narrative: headache; body aches; feeling bad; sick; he thought he was going to pass out at work; fever of 105.2F; This is a spontaneous report from a contactable consumer (mother). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 31Mar2021 12:00 (at 16-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The caller is calling about her 16 year old son. She just left the doctor with her son who received his first Covid 19 vaccine. She would like to report an adverse event. Her son has had a fever of 105.2F (07Apr2021). The doctor just did blood tests, a rapid test for Covid that was negative, they tested him for strep throat that was negative and he doesn't have an ear infection. He's been running a fever over 105F for the past 2 days (07Apr2021). The caller wanted to rule out that nothing else is going on. They have called the Medical Director of (name)  and he didn't know what was going on with her son. If this fever continues she'll be calling Pfizer back. She is waiting on the results of his blood tests like his mononucleosis test pending and other viral and bacterial tests (unknown result). Her son started feeling bad about 4-5 days (unspecified date) after he received the Covid 19 vaccine. The last 2 days he's had a very high fever. He has a headache and body aches (unspecified date). He had a Covid 19 test not long before he received the Covid 19 vaccine and it was negative. She thought her son might have the Covid 19 virus but he had the rapid Covid 19 rapid test (09Apr2021) and it was negative. The caller does not know what is going on with her son. She took her son to a clinic because he was sick and because his fevers are too high. She also called the state but they told her that fevers are normal with the Covid 19 vaccine but if it persists after today, 09Apr2021, she needs to seek medical attention. It was further reported that earlier in the week her son told her he thought he was going to pass out at work (unspecified date). He told her he thought he had a fever but she checked it with a forehead thermometer and it didn't show a fever. Then on Wednesday, 07Apr2021, her son woke up around 4:30AM and had a fever of 105.2F with an oral thermometer. He woke Thursday, 08Apr2021 and this morning, Friday 09Apr2021 with a fever. His mother can control the fever during the day with Ibuprofen but he's spiking these fevers in the middle of the night. She knows fevers spike at night but she can't come with any other reason why this is happening. The patient lab tests and procedures also included CBC: pending, mononucleosis: pending, and rapid strep test: Negative; all from 09Apr2021. The outcome of events fever of 105.2f, headache, and body aches was not recovered; while for other events was unknown.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Insomnia, Panic reaction, Paralysis
Clinical narrative: entire left area where the patient received the vaccine had fallen asleep and paralyzed/it moved to the right area; throat problems such as throbbing; shoulder pain became unbearable; panicked; feel it in the throat and I could not breathe; the patient took an Advil to be able to sleep; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), dose 2 via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the BNT162B2 for COVID-19 immunization. The patient received the Pfizer vaccine in the morning of 08Apr2021 and she had no reaction and it was perfect at 2 in the afternoon however at 4 the patient began to have throat problems such as throbbing and the shoulder pain became unbearable, the patient could not move it. During that night, the patient took an Advil to be able to sleep because the pain in the shoulder was unbearable, the patient put an ice pack and tried to sleep but got up at 12 and the entire left area where the patient received the vaccine had fallen asleep and paralyzed. The patient then panicked because it moved to the right area and the patient began to feel it in the throat and could not breathe. The patient was treated in the ER. It was also reported that the patient was confident that the effects will be normal and at most have a fever or any of the 7 side effects that were listed on the sheet that was given during vaccination but the patient did not think that he/she was going to be put in these circumstances because the patient could not breathe, or speak, or move for a period of time that also mixed with his/her nerves because the patient was not prepared and did not know what to do and they had to see the patient in the ER to be certain that he/she was fine and happily, the patient was stable. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal disorder
Clinical narrative: entire left area where the patient received the vaccine had fallen asleep and paralyzed/it moved to the right area; throat problems such as throbbing; shoulder pain became unbearable; panicked; feel it in the throat and I could not breathe; the patient took an Advil to be able to sleep; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), dose 2 via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the BNT162B2 for COVID-19 immunization. The patient received the Pfizer vaccine in the morning of 08Apr2021 and she had no reaction and it was perfect at 2 in the afternoon however at 4 the patient began to have throat problems such as throbbing and the shoulder pain became unbearable, the patient could not move it. During that night, the patient took an Advil to be able to sleep because the pain in the shoulder was unbearable, the patient put an ice pack and tried to sleep but got up at 12 and the entire left area where the patient received the vaccine had fallen asleep and paralyzed. The patient then panicked because it moved to the right area and the patient began to feel it in the throat and could not breathe. The patient was treated in the ER. It was also reported that the patient was confident that the effects will be normal and at most have a fever or any of the 7 side effects that were listed on the sheet that was given during vaccination but the patient did not think that he/she was going to be put in these circumstances because the patient could not breathe, or speak, or move for a period of time that also mixed with his/her nerves because the patient was not prepared and did not know what to do and they had to see the patient in the ER to be certain that he/she was fine and happily, the patient was stable. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Chest discomfort, Dysphagia, Laryngitis, Rash macular
Clinical narrative: Losing voice, like Laryngitis; Chest was heavy; Red spots on arm; Losing voice, like Laryngitis; Hard to swallow; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left, 2 inches below shoulder on 31Mar2021 14:45 at the age of 67-years-old (Lot Number: EP7533) as single dose for covid-19 immunisation. The patient medical history included Covid in January in an unspecified year and underlying health issues. Concomitant medication included diphenhydramine hydrochloride (BENADRYL).  The patient had adverse reactions to some medications, she did not know the names of the medications. On 31Mar2021, the patient experienced hard to swallow after she had the shot about 15 minutes at 3 p.m.; losing voice 20 minutes after the shot, chest was heavy and red spots on arm about 20 minutes after the shot. The patient stated she went to the emergency room where the doctor gave her 50mg of diphenhydramine hydrochloride and she tought some type of stomach pill. The patient stated she fell asleep for an hour and when she woke up, her chest was not heavy and she could swallow better, reclarifies that, her voice, felt like she had some laryngitis. The patient stated she had an appointment on 28Apr2021. The patient stated that she talked to the provider about taking the second vaccine, and her doctor told her to take the diphenhydramine hydrochloride before the she got the vaccine. She would have had the second vaccine by the time of her next appointment. The events outcome was recovered on 31Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site discolouration
Clinical narrative: Mark at injection site; Mark on the back left shoulder blade; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6203, expiry date unknown) on an unspecified route of administration on Arm Left on 14Mar2021 (at the age of 61-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Solution for injection; Lot Number: EL9269, expiry date unknown), on an unspecified route of administration on 21Feb2021 as single dose for COVID-19 immunisation. Two days after the second dose on 16Mar2021, the patient got mark on the injection site on the left upper arm and in the back of the left shoulder blade. The patient reported that both marks were black in colour and the mark on the arm was bad. She went to the doctor and he couldn't say anything, said it was just a reaction from the injection. She clarified that both marks are black in color, and both on the left arm, she clarifies that one mark is Not on the forearm but what she meant to say was the injection site on the upper arm and the second mark is on the back left shoulder blade. She has taken pictures and is willing to provide it to the safety department. The Marks have no texture to them, but they are getting better, the darkness is fading away, its not as dark. The outcome of the events was reported as recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Delirium, Headache
Clinical narrative: mildly delirious; a thumping headache; shivers; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient also received first dose of BNT162B2 on unspecified date (unknown lot number and expiration) for COVID-19 immunization.  The patient experienced a thumping headache, shivers, and mildly delirious after his second shot on unspecified date. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Sick; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Jan2021 (Batch/Lot Number: 1283) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was sick. She was at the ENT and they thought she had a respiratory infection, but she did not have one, and she did not get second shot. The outcome of the event was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling in injection site.; Redness and swelling in injection site.; This is a spontaneous report received from a contactable consumer (Pfizer colleague). A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 45-year-old) as a single dose for COVID-19 immunization. Medical history included covid-19 (Prior to vaccination the patient diagnosed) and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if any other medications the patient received within 2 weeks of vaccination. On 08Apr2021, the patient experienced redness and swelling in injection site. The patient did not receive any treatment for the events. The outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Loss of consciousness, Lymphadenopathy
Clinical narrative: pass out; sharp pain on the left side of her chest that continually got worse; it seemed muscle or lymph node related; This is a spontaneous report from a contactable consumer (patient) reported that a 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ep6955), via an unspecified route of administration, administered in arm left on 23Mar2021 15:45 (at the age of 54-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient medical history included Hashimoto's from an unknown date. The patient had known allergies to shellfish. The patient had no covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin c [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); cyanocobalamin (B 12); magnesium; and cetirizine hydrochloride (ZYRTEC); all were taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 16:30 45-minutes after getting the shot the patient had a sharp pain on the left side of her chest that continually got worse. It seemed muscle or lymph node related - and eventually got to the point where she couldn't easily move without feeling like she was going to pass out from the pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included prescription pain reliever and muscle relaxant. The outcome of the events was recovered. The patient did not covid tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Migraine, Pain, Pain assessment
Clinical narrative: her migraines it went out of control; suffering from heart problems; last night because the pain flared up so bad that she was just in tears/excruciating pain; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A non-contactable consumer (patient) reported that a female patient of unspecified age 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 on an unspecified date at single dose for COVID-19 immunisation. Medical history included she is immunocompromised and is suffering from heart problems (both ongoing), had a hysterotomy 2 months before an unspecified date, ongoing auto-immune issues. Concomitant medications included had botulinum toxin type a (BOTOX) injections 2 weeks prior to her first injection; golimumab (SIMPONI) for auto-immune issues. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at single dose for COVID-19 immunization and experienced migraines. Patient reported that she suffered from migraines and when she got the Pfizer COVID vaccine, her migraines it went out of control on an unspecified date. Her chronic pain was so bad that if she would rate her pain from 1 to 10 it would be in her 30s. She was in excruciating pain. She suffered heart problems on an unspecified date and had a hysterotomy 2 months before and had some hydrocodone left over and took a couple of those last night (08Apr2021) because the pain flared up so bad that she was just in tears. She already had the injections of golimumab done. After receiving the first dose of Pfizer's COVID vaccine, it kicked her migraines to overdrive. Her migraine doctor started another medication and started another side medication on top of that. And she was still having migraines. She had 2nd injection and she was still having the same effect even 2 days after the 2nd one. Therapeutic measures were taken as a result of events 'migraines it went out of control' and 'pain flared up so bad'. The outcome of the event migraines was not recovered, outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pruritus, Rhinorrhoea
Clinical narrative: Chills; very itchy episode; Runny nose; This is a spontaneous report from a contactable consumer, the patient via PPDi. An 82-year-old male patient received first dose of BNT162B2 (BioNTech COVID 19 vaccine, solution for injection, lot number: caller could not locate the lot number, NDC number: Unknown, Expiry Date: Unknown) on 11Mar2021 at 13:00 as a single dose for COVID-19 immunization. Patient took the second dose on 01Apr2021 at 1pm (unknown NDC number, for lot number and expiry date: caller could not locate the information).  Caller stated both doses were received in the left arm. Patient had no family and medical history. Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. Patient did not receive any prior vaccination (within 4 weeks). relevant to AE(s). There were no AE(s) following prior vaccinations. For concomitant products caller stated "no" because he took his regular medication from his primary care doctor. Caller clarified that the antibody test was given at the church and he was given the number to find out results of the COVID-19 antibody test, which was 2 weeks before the first dose. Caller stated the antibody test was not Pfizer. He got a telephone number (Withheld) that he called which was who told him the results for not being exposed to the virus. Caller stated he was not exposed to the virus and decided to follow up to get the Pfizer vaccine and he received the first dose on 11Mar2021 and the second dose on 01Apr2021. Caller stated he was calling about the BioNTech COVID-19 vaccine. Caller stated he took the shot at Church. The runny nose started a day or two before the first shot, he clarified it was around 10Mar2021 this started, which was still ongoing. Caller stated he was experiencing a very itchy episode right after the first shot of the COVID 19 vaccine which was on 11Mar2021. Caller stated those are the two items he was complaining about. Caller stated chills started in between the two doses. Caller stated it is not going on now but sometimes early in the morning when he woke up and until he got the temperature up in his apartment, he experienced chills. Caller stated if the heat was on, he does not noticed chills but if the heat was not on, he does notice it. The temperature is in the high number and he had a little chill right now while speaking. Caller stated the outcome is the same. Patient took one except for Tylenol. He has taken a couple of Tylenols, he clarified he had just been taking tablets of Tylenol for chills. Outcome of the events very itchy episode was not recovered while that of chills and was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.