chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pharyngeal swelling, Walking disability, Weight
Clinical narrative: tiredness; patient was so tired; Muscle pain; swelling throat and lymph nodes.; Diarrhea/ having diarrhea for three years but it was now worse; Joint pain; she can't do any of the domestic housekeeping chores she usually did; swelling throat and lymph nodes; has lost 20 pounds since getting the shot; Patient can't do anything, can't even walk; These side effects all were started three weeks after the vaccination (Mar2021); they have been lingering a long time and getting worse; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200) via an unspecified route of administration, in the left arm, on 24Feb2021 (at the age of 77-year-old) (in the morning), as single dose, for COVID-19 immunization. The patient's medical history diarrhea, crohn's disease, kidney cancer with removal of her kidney two years ago and colonoscopy.  Patient's concomitant medications were not reported. The Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9299, expiry date: Unknown) via an unspecified route of administration, in the left arm, on 03Feb2021 (in the morning), as single dose, for COVID-19 immunization. Patient had the vaccination in Feb2021 (both doses). Patient had a lot joint pain, muscle pain, some trouble swallowing. Patient had some dental work done and they thought maybe that was it because her jaw has been sore but the dentist said no, her jaw checked out good, adds this dentist was like oral facial pain. Patient was still experiencing tiredness; patient was so tired she can't do any of the domestic housekeeping chores she usually did, swelling in her throat and lymph nodes. These side effects all were started three weeks after the vaccination (Mar2021); they have been lingering a long time and getting worse. Patient can't do anything, can't even walk, can't do nothing. Patient has also been having diarrhea. Patient has been having diarrhea for three years but it was now worse. Mentioned patient has lost 20 pounds since getting the shot. Mentioned that the doctor who did the colonoscopy, was treating her for diarrhea with a prescription of Kreon and Citron, but she still has diarrhea, but not like she had it before. Patient is having blood work tomorrow (unspecified date) because her doctor thinks this might be serious. No Emergency Room visit. Patient visited physician office, gone to the regular doctor for diarrhea. They have been treating her for diarrhea before the vaccine but now it was worse. The patient underwent lab tests and procedure which included the body weight and result was lost 20 pounds on an unknown date in Mar2021.  The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: tiredness; patient was so tired; Muscle pain; swelling throat and lymph nodes.; Diarrhea/ having diarrhea for three years but it was now worse; Joint pain; she can't do any of the domestic housekeeping chores she usually did; swelling throat and lymph nodes; has lost 20 pounds since getting the shot; Patient can't do anything, can't even walk; These side effects all were started three weeks after the vaccination (Mar2021); they have been lingering a long time and getting worse; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200) via an unspecified route of administration, in the left arm, on 24Feb2021 (at the age of 77-year-old) (in the morning), as single dose, for COVID-19 immunization. The patient's medical history diarrhea, crohn's disease, kidney cancer with removal of her kidney two years ago and colonoscopy.  Patient's concomitant medications were not reported. The Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9299, expiry date: Unknown) via an unspecified route of administration, in the left arm, on 03Feb2021 (in the morning), as single dose, for COVID-19 immunization. Patient had the vaccination in Feb2021 (both doses). Patient had a lot joint pain, muscle pain, some trouble swallowing. Patient had some dental work done and they thought maybe that was it because her jaw has been sore but the dentist said no, her jaw checked out good, adds this dentist was like oral facial pain. Patient was still experiencing tiredness; patient was so tired she can't do any of the domestic housekeeping chores she usually did, swelling in her throat and lymph nodes. These side effects all were started three weeks after the vaccination (Mar2021); they have been lingering a long time and getting worse. Patient can't do anything, can't even walk, can't do nothing. Patient has also been having diarrhea. Patient has been having diarrhea for three years but it was now worse. Mentioned patient has lost 20 pounds since getting the shot. Mentioned that the doctor who did the colonoscopy, was treating her for diarrhea with a prescription of Kreon and Citron, but she still has diarrhea, but not like she had it before. Patient is having blood work tomorrow (unspecified date) because her doctor thinks this might be serious. No Emergency Room visit. Patient visited physician office, gone to the regular doctor for diarrhea. They have been treating her for diarrhea before the vaccine but now it was worse. The patient underwent lab tests and procedure which included the body weight and result was lost 20 pounds on an unknown date in Mar2021.  The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: Hot, sore, turgid area (about 6 cu inches) at site of shot extending seemingly to the bone; Painful when using arm to pull up out of a chair; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (well controlled) and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN) for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jul2021 at 18:00 the patient experienced hot, sore, turgid area (about 6 cu inches) at site of shot extending seemingly to the bone and was painful when she used the arm to pull herself up out of a chair. Patient thought it was cellulitis. On 27Jul2021 patient saw the doctor and the doctor confirmed that it was not cellulitis. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with amoxicillin (MANUFACTURER UNKNOWN) 1000 mg thrice daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hot, sore, turgid area (about 6 cu inches) at site of shot extending seemingly to the bone and painful when she used the arm to pull herself up out of a chair were not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Muscle contracture, Muscle spasms, Muscle twitching, Paraesthesia
Clinical narrative: It was a pretty strong spasm and was completely uncontrollable/it was my right arm that started doing spasms; Muscles in my arm started twitching; episodes of muscle twitches; It was feeling like fire inside my arm; My fingers started tingling; Contraction of the muscle; This is a spontaneous report from a contactable consumer reported for herself. A 50-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jul2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 22Jul2021, the patient experienced muscles in her arm started twitching almost immediately, well not quite immediately, while later it started having these episodes of muscle twitches and during the evening last night, the muscles were spasming and then it was spasming and it was feeling like fire inside her arm and that lasted till about 12 o'clock then the spasming stopped and it was a pretty strong spasm and was completely uncontrollable and then it stopped, then her fingers started tingling and then didn't had any spasms for a little while and now it's just back to being little twitches again. The muscle spasming, it is not a spasm that causes pain. It's a contraction of the muscle. Consumer stated, "I would also like to know if the 2nd shot is advisable." Due date of 2nd shot: Consumer stated, "I am not sure the exact date but its 15Aug I think." The patient did not receive any treatment and just tried to apply pressure or massage it out and just try to do physically something to help it. The patient underwent lab tests and procedures which included weight: around 180 lbs. Outcome of the event muscle spasm was recovered; while others events was unknown. Information about batch/lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: It was a pretty strong spasm and was completely uncontrollable/it was my right arm that started doing spasms; Muscles in my arm started twitching; episodes of muscle twitches; It was feeling like fire inside my arm; My fingers started tingling; Contraction of the muscle; This is a spontaneous report from a contactable consumer reported for herself. A 50-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jul2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 22Jul2021, the patient experienced muscles in her arm started twitching almost immediately, well not quite immediately, while later it started having these episodes of muscle twitches and during the evening last night, the muscles were spasming and then it was spasming and it was feeling like fire inside her arm and that lasted till about 12 o'clock then the spasming stopped and it was a pretty strong spasm and was completely uncontrollable and then it stopped, then her fingers started tingling and then didn't had any spasms for a little while and now it's just back to being little twitches again. The muscle spasming, it is not a spasm that causes pain. It's a contraction of the muscle. Consumer stated, "I would also like to know if the 2nd shot is advisable." Due date of 2nd shot: Consumer stated, "I am not sure the exact date but its 15Aug I think." The patient did not receive any treatment and just tried to apply pressure or massage it out and just try to do physically something to help it. The patient underwent lab tests and procedures which included weight: around 180 lbs. Outcome of the event muscle spasm was recovered; while others events was unknown. Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Her father got both doses of the vaccine back in January; tested positivefor Covid-19 yesterday; This is a spontaneous report from a contactable consumer patient via sponsored program. A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported), as a single, second dose via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported) as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient experienced both doses of the vaccine back in January, tested positive for covid-19 yesterday. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 26Jul2021 tested positive for Covid-19 yesterday. The outcome of the event was reported as unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Body that itches really bad; Breaking out in a rash on her arms; This is a spontaneous report from a contactable consumer (patient) via the Regulatory Authority. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FA6780; expiration date: 01Sep2021), via an unspecified route of administration, administered in the left arm on 23Jul2021 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. Medical history included lupus and thyroid disorder. Concomitant medications included gabapentin, prednisone taken for lupus, and SYNTHROID taken for thyroid disorder. The patient reported that she received her first dose of BNT162B2 vaccine on 23Jul2021. The following day on 24Jul2021, the patient experienced a breaking out in a rash on her arms and body that itches really bad. The patient was taking Benadryl at night, so that she doesn't wake up itching. The patient was also using poison ivy medicine to try and relieve the rash and itching because she doesn't know what else to do. The patient wanted to know how long does the side effects last and if she should get the second dose scheduled for 23Aug2021. The patient was also wanted to know if she does get the second dose, will the side effects be even worse. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood urine present, Fatigue, Head discomfort, Nasal congestion
Clinical narrative: Body that itches really bad; Breaking out in a rash on her arms; This is a spontaneous report from a contactable consumer (patient) via the Regulatory Authority. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FA6780; expiration date: 01Sep2021), via an unspecified route of administration, administered in the left arm on 23Jul2021 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. Medical history included lupus and thyroid disorder. Concomitant medications included gabapentin, prednisone taken for lupus, and SYNTHROID taken for thyroid disorder. The patient reported that she received her first dose of BNT162B2 vaccine on 23Jul2021. The following day on 24Jul2021, the patient experienced a breaking out in a rash on her arms and body that itches really bad. The patient was taking Benadryl at night, so that she doesn't wake up itching. The patient was also using poison ivy medicine to try and relieve the rash and itching because she doesn't know what else to do. The patient wanted to know how long does the side effects last and if she should get the second dose scheduled for 23Aug2021. The patient was also wanted to know if she does get the second dose, will the side effects be even worse. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Rash vesicular, Urine analysis, Urogram
Clinical narrative: Body that itches really bad; Breaking out in a rash on her arms; This is a spontaneous report from a contactable consumer (patient) via the Regulatory Authority. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FA6780; expiration date: 01Sep2021), via an unspecified route of administration, administered in the left arm on 23Jul2021 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. Medical history included lupus and thyroid disorder. Concomitant medications included gabapentin, prednisone taken for lupus, and SYNTHROID taken for thyroid disorder. The patient reported that she received her first dose of BNT162B2 vaccine on 23Jul2021. The following day on 24Jul2021, the patient experienced a breaking out in a rash on her arms and body that itches really bad. The patient was taking Benadryl at night, so that she doesn't wake up itching. The patient was also using poison ivy medicine to try and relieve the rash and itching because she doesn't know what else to do. The patient wanted to know how long does the side effects last and if she should get the second dose scheduled for 23Aug2021. The patient was also wanted to know if she does get the second dose, will the side effects be even worse. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Malaise, Tremor
Clinical narrative: Feeling unwell; Feels like tremors inside, like shaking; if she moves around too much she feels it more; When she moves around she feels more like chills and tremors kind of like anxiety; When she moves around she feels more like chills and tremors kind of like anxiety; This is a spontaneous report from a contactable consumer. This consumer (husband) reported for a female patient (wife). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 23Jul2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient felt like tremors inside, like shaking; if she moves around too much, she feels it more. When she moves around, she feels more like chills and tremors kind of like anxiety. Reporter stated that She did the 2nd dose of Pfizer vaccine (Unspecified Vaccine) on Friday and within a last couple of days, she's feeling unwell more than the first couple of days in particularly (incomplete sentence). I will explain it exactly, she felt like tremors inside, like shaking, if she moves around too much, she feels it more, if she rest, she feels better and then if again when she moves around she feels more like chills and tremors kind of like anxiety, so we wanted to make sure that it's not one of the serious side effects that we need to pursue somebody. I did have a way to check her vitals here, I had the thermometer, I had an oximeter and I have a blood pressure gauge so I can do that right now and let you know how it reads. Reporter also stated that this stuff was not going to help right now, I need to know if I need to take my wife to the emergency room or not and asked was there something you can help him. Outcome of the events was unknown.   Information about Lot/Batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature fluctuation, Decreased appetite, Nasopharyngitis
Clinical narrative: his temperature fluctuates; feels like he has a cold; body aches; he is weak all through the day; lost all his appetite; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number FA6280), dose 1 via an unspecified route of administration on 24Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced his temperature fluctuates, feels like he has a cold, body aches, he is weak all through the day, lost all his appetite. The patient underwent lab tests and procedures which included body temperature: 99.7 his temp goes to 100.9. He said that his temperature fluctuates and this morning his temperature was 100.9. He said that he is driving to work and right now has a temperature of 99.7. He feels like he has a cold, he has body aches, he is weak all through the day, and said that when he goes home his temp goes to 100.9. He also stated that he lost all his appetite and has no appetite. He said that maybe the air conditioner has something to do with it. There is bad handwriting on his vaccination card and he had trouble reading the Lot number. The caller said that he is kind of wondering if these are usual side effects, he said that from people that he works with, he said that they usually say that their symptoms are gone after 2 days and he still has symptoms, and it has been 4 days now. No further details provided. Caller did not have time to complete a safety report at this time as he was at work. The outcome for all events was unknown.  Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: his temperature fluctuates; feels like he has a cold; body aches; he is weak all through the day; lost all his appetite; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number FA6280), dose 1 via an unspecified route of administration on 24Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced his temperature fluctuates, feels like he has a cold, body aches, he is weak all through the day, lost all his appetite. The patient underwent lab tests and procedures which included body temperature: 99.7 his temp goes to 100.9. He said that his temperature fluctuates and this morning his temperature was 100.9. He said that he is driving to work and right now has a temperature of 99.7. He feels like he has a cold, he has body aches, he is weak all through the day, and said that when he goes home his temp goes to 100.9. He also stated that he lost all his appetite and has no appetite. He said that maybe the air conditioner has something to do with it. There is bad handwriting on his vaccination card and he had trouble reading the Lot number. The caller said that he is kind of wondering if these are usual side effects, he said that from people that he works with, he said that they usually say that their symptoms are gone after 2 days and he still has symptoms, and it has been 4 days now. No further details provided. Caller did not have time to complete a safety report at this time as he was at work. The outcome for all events was unknown.  Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Condition aggravated, HLA-B*27 assay, Muscle strain
Clinical narrative: The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; Though pulled back; The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; Night stiffness; Pain in feet; Pain in feet, back and in soft tissues around bone joints; Pain in feet, back and in soft tissues around bone joints; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date in 2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included HBP (high blood pressure), high cholesterol but under control with meds and COVID-19 in Jan2021. Concomitant medications included atorvastatin and lisinopril. Historical vaccine included BNT162B2 (Lot number: Ek8737), dose 1 on an unspecified route in the arm left on 05Apr2021 at 02:00 PM (at the age of 52-years-old) for COVID-19 immunization in which the vaccine activated an autoimmune condition spondyloarthritis. The patient had no relevant past drug history. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient diagnosed with COVID-19 prior to vaccination. It was reported that the vaccine (1st shot) activated an autoimmune condition - spondyloarthritis. The second shot made so much worse. He did not realize what was happening. Though pulled back, cracked rib, etc. got worse and worse. Night stiffness. He was almost crippled, he had pain in feet, back and in soft tissues around bone joints. Finally, he got into a doctor and got on ENBREL and CELEBREX.  Which made him feel 99% back to normal. The patient mentioned that the shot crippled him and activated an autoimmune. He was tested positive for hla-b27, as he found out. And he also had covid early in Jan2021. So he had antibodies most likely already. He added that no one believed the shot caused it; but there was no doubt it did based on timeline and symptoms. The patient had not been tested for COVID-19 since the vaccination. The events' onset date was on 09May2021 with unknown outcome. No hospitalization/prolonged. Therapeutic measures were taken as a result of the events. The events resulted to doctor or other healthcare professional office/clinic visit    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Rib fracture, SARS-CoV-2 test, Spondylitis
Clinical narrative: The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; Though pulled back; The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; Night stiffness; Pain in feet; Pain in feet, back and in soft tissues around bone joints; Pain in feet, back and in soft tissues around bone joints; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date in 2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included HBP (high blood pressure), high cholesterol but under control with meds and COVID-19 in Jan2021. Concomitant medications included atorvastatin and lisinopril. Historical vaccine included BNT162B2 (Lot number: Ek8737), dose 1 on an unspecified route in the arm left on 05Apr2021 at 02:00 PM (at the age of 52-years-old) for COVID-19 immunization in which the vaccine activated an autoimmune condition spondyloarthritis. The patient had no relevant past drug history. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient diagnosed with COVID-19 prior to vaccination. It was reported that the vaccine (1st shot) activated an autoimmune condition - spondyloarthritis. The second shot made so much worse. He did not realize what was happening. Though pulled back, cracked rib, etc. got worse and worse. Night stiffness. He was almost crippled, he had pain in feet, back and in soft tissues around bone joints. Finally, he got into a doctor and got on ENBREL and CELEBREX.  Which made him feel 99% back to normal. The patient mentioned that the shot crippled him and activated an autoimmune. He was tested positive for hla-b27, as he found out. And he also had covid early in Jan2021. So he had antibodies most likely already. He added that no one believed the shot caused it; but there was no doubt it did based on timeline and symptoms. The patient had not been tested for COVID-19 since the vaccination. The events' onset date was on 09May2021 with unknown outcome. No hospitalization/prolonged. Therapeutic measures were taken as a result of the events. The events resulted to doctor or other healthcare professional office/clinic visit    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: My cycle has become irregular; This is a spontaneous report from a contactable consumer (patient). A female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: Unknown, expiry date: unknown), via an unknown route of administration on an unknown date as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced 'my cycle has become irregular'. It happened right after taking the 2nd vaccine. When paraphrased, consumer stated, "Irregular, it is no longer the same. It is irregular." The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle spasms
Clinical narrative: I am experiencing brain fog and muscle cramps on a regular basis.; I am experiencing brain fog and muscle cramps on a regular basis.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, cardiac arrhythmia (reported as quadrant of heart with different rhythm than others), crohn's (reported as chrohn's). The patient had no known allergies to medications, food, or other products. The patient had received other medications (unspecified) within two weeks of vaccination. Prior to the 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 vaccination. From 07Apr2021, the patient has been experiencing brain fog and muscle cramps on a regular basis. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events experiencing brain fog and muscle cramps on a regular basis was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Blood pressure abnormal, Blood pressure measurement, Deafness bilateral, Ear discomfort
Clinical narrative: Bilateral SN hearing loss; Ear fullness; Tinnitus; Dysautonomia; Vestibular neuritis; Heart rate increased; Blood pressure issues; Vision changes; Rash; Hyperthyroidism; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in left arm, on 11Jan2021 at 01:15 PM (13:15) (at the age of 48 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included asthma, seasonal allergies, and allergies to sulfa drugs. The patient's concomitant medications included cetirizine hydrochloride (ZYRTEC), Montelukast sodium (SINGULAIR), and fluticasone propionate/ salmeterol xinafoate (ADVAIR). The patient previously received the first dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 at 01:15 PM at the age of 48 years (intramuscular in left arm) for COVID-19 immunization and experienced no reaction on exposure to previous vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Feb2021, the patient experienced bilateral SN hearing loss, ear fullness, tinnitus, dysautonomia, vestibular neuritis, heart rate increased, blood pressure issues, vision changes, rash, and hyperthyroidism. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Treatment was received for the adverse events including steroids, oral and intratympanic medications, and beta blockers. The events were considered serious as disabling or incapacitating. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.; Sender's Comments: Based on plausible temporality  the causal role of the BNT162B2 vaccine cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperthyroidism, Rash, Tinnitus
Clinical narrative: Bilateral SN hearing loss; Ear fullness; Tinnitus; Dysautonomia; Vestibular neuritis; Heart rate increased; Blood pressure issues; Vision changes; Rash; Hyperthyroidism; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in left arm, on 11Jan2021 at 01:15 PM (13:15) (at the age of 48 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included asthma, seasonal allergies, and allergies to sulfa drugs. The patient's concomitant medications included cetirizine hydrochloride (ZYRTEC), Montelukast sodium (SINGULAIR), and fluticasone propionate/ salmeterol xinafoate (ADVAIR). The patient previously received the first dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 at 01:15 PM at the age of 48 years (intramuscular in left arm) for COVID-19 immunization and experienced no reaction on exposure to previous vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Feb2021, the patient experienced bilateral SN hearing loss, ear fullness, tinnitus, dysautonomia, vestibular neuritis, heart rate increased, blood pressure issues, vision changes, rash, and hyperthyroidism. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Treatment was received for the adverse events including steroids, oral and intratympanic medications, and beta blockers. The events were considered serious as disabling or incapacitating. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.; Sender's Comments: Based on plausible temporality  the causal role of the BNT162B2 vaccine cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vestibular neuronitis, Visual impairment
Clinical narrative: Bilateral SN hearing loss; Ear fullness; Tinnitus; Dysautonomia; Vestibular neuritis; Heart rate increased; Blood pressure issues; Vision changes; Rash; Hyperthyroidism; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in left arm, on 11Jan2021 at 01:15 PM (13:15) (at the age of 48 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included asthma, seasonal allergies, and allergies to sulfa drugs. The patient's concomitant medications included cetirizine hydrochloride (ZYRTEC), Montelukast sodium (SINGULAIR), and fluticasone propionate/ salmeterol xinafoate (ADVAIR). The patient previously received the first dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 at 01:15 PM at the age of 48 years (intramuscular in left arm) for COVID-19 immunization and experienced no reaction on exposure to previous vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Feb2021, the patient experienced bilateral SN hearing loss, ear fullness, tinnitus, dysautonomia, vestibular neuritis, heart rate increased, blood pressure issues, vision changes, rash, and hyperthyroidism. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Treatment was received for the adverse events including steroids, oral and intratympanic medications, and beta blockers. The events were considered serious as disabling or incapacitating. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.; Sender's Comments: Based on plausible temporality  the causal role of the BNT162B2 vaccine cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: pain the arm; feeling a little tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that, A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration on 26Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain the arm and feeling a little tired. It was reported that, caller got her 1st dose and had severe reactions to it like cramping, pain in the arm and she was tired. She mentioned even a possible blood clot. She stated she got the 2nd dose yesterday but has had only pain the arm and feeling a little tired. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional. This is a report received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history included immunodeficiency, I'm immunocompromised, gastrointestinal disorder from an unknown date and unknown if ongoing. Recently she had undergone several surgeries, radiology, and chemotherapy for a problem in my lower intestine. The patient concomitant medications were not reported. The patient previously took dilantin [phenytoin sodium] for seizure, levetiracetam for seizure. On an unspecified date patient had previous episodes of seizures. She would want to know if the Pfizer-BioNTech COVID-19 Vaccine would "trigger" seizures.  Outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable nurse (patient). This nurse reported in response to HCP letter sent via follow-up letter which included that a 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), via intramuscular, administered in deltoid right on 21May2021 at 15:00 (vaccinated at the age of 55 years) as DOSE 1, SINGLE for covid-19 immunisation. Vaccination facility type was other and not administered at facility. Medical history, prior vaccinations and concomitant drugs were none. Family medical history includes Heart disease and diabetes mellitus (DM). The patient experienced soreness at injection site on 21May2021. First vaccine adverse reaction except arm soreness at injection site. Relevant tests were none. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever; body ache; headache; tired; no appetite; This is a spontaneous report received from a contactable consumer (patient).  An unspecified gender 73-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 09Jun2021 09:00 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19May2021 09:00 for COVID-19 immunization. On 10Jun2021 patient was experienced with fever, body ache, headache, tired and no appetite. Outcome of events was recovered on 12Jun2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Lip disorder, Mouth cyst, Swelling, Toothache
Clinical narrative: swelling; lumps and bumps on her lips; lumps and bumps and grainy feeling in her lips is ongoing; toothache; cystic pimple at the injection site around her mouth; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on 19Mar2021 as dose 2, single (at 56-years-old) for covid-19 immunisation. Medical history included allergy to sulfa. Concomitant medication included hyaluronic acid (RESTYLANE) taken for an unspecified indication from 07Jul2021 to an unspecified stop date; hyaluronic acid, lidocaine (RESTYLANE L) taken for an unspecified indication from 07Jul2021 to an unspecified stop date; hyaluronic acid (JUVEDERM VOLUMA) taken for an unspecified indication from 07Jul2021 to an unspecified stop date. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on 19Feb2021 as dose 1, single (at 56-years-old) for covid-19 immunisation. Patient was injected with 1 syringe of Restylane Kysse in the lips and 1 syringe of Restylane Lyft in the cheeks, and 2 syringes of Voluma, injected around the mouth area, on 07Jul2021.Patient had immediately experienced swelling in the areas, the same date of injection, 07Jul2021. Patient swelling was subsided after a couple of days (exact date unknown) and in Jul2021, patient started to feel lumps and bum on her lips when she applied lipstick (exact date unknown). she palpated the area and could feel the lumps and bumps and it also felt grainy. Patient also reported that, within a couple days of the injection, she developed a cystic pimple at the injection site around her mouth (exact date unknown), on her nasolabial fold and it subsided after a few days (exact date unknown). Patient reported that, in Jul 2021, last week sometime (exact date unknown) she developed a toothache. The lumps and bumps and grainy feeling in her lips is ongoing, as well as the toothache. she notified the injecting HCP who told her to wait a full 2 weeks before coming back in to the office. she only took vitamins and supplements (unspecified) daily. Patient had not received fillers in the past. She denied any other vaccinations in the past 6-12 months, also denied that any illness leading up to injection date. she had a dental cleaning on 09Jun2021. Patient had not received treatment. The outcome of the event swelling and mouth cyst was recovered and for rest all it was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lymphadenopathy, Pain in extremity, Vaccination site reaction, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 44-year) on 26Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jul2021 the patient experienced diarrhea, soreness of arms, swelling of underarm (arm where she got injected) that has a knot and feels warm, swollen lymph nodes. It was reported that the patient reported diarrhea, soreness of the arm, swelling under the arm that was injected after receiving her first dose of the Pfizer COVID-19 vaccine. The caller clarified that there was a knot under the arm that feels warm and said that it was a swollen lymph node. The caller also reported that her son also experienced swollen lymph nodes after he received the vaccine same day as her and the patient asked if swollen lymph node was one of the side effects of Pfizer COVID-19 vaccine. The clinical outcome of the events was unknown.  Information about lot/batch number has been requested.