chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Pharyngeal swelling, Swelling face, Urticaria
Clinical narrative: hives; Swelling of eyes, face; Swelling of eyes, face; Mouth swelling; pressure on her throat with little interruption in her breathing; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, one week after the vaccination, the patient experienced hives. patient also had eye and mouth swelling, and pressure on her throat. She stated the patient had little interruption in her breathing with the pressure on her throat. Patient received 2 Advil as a treatment for events and was just managing her symptoms. Caller asked, should the patient get the second COVID-19 Vaccine shot based on the side effects the patient experienced after the first COVID-19 Vaccine dose. She said the patient's side effects just seemed like hives, and the patient had no difficulty breathing. She said she had read not to get the second COVID-19 Vaccine if there were severe side effects within 4 hours of receiving the first COVID-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance with her question. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up: (29Jul2021): This follow-up is being submitted to notify that the new information is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Fatigue, Joint swelling
Clinical narrative: Toe area only on the feet hurt- no swelling; right hand- all her knuckles are hurting and swollen; Muscles in her arms and legs are hurting- feels like she has been working out with weights; has no strength in her right hand; right hand- all her knuckles are hurting and swollen; an increase of a flair up of arthritis; swelling in her feet; sleepy; feeling tired; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration on 02May2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unknown date as dose 1, single for covid-19 immunization. On an unknown date in May2021, she was complaining of an increase of a flair up of arthritis and swelling in her feet, feeling tired and sleepy the second day after the vaccine. She began having the following symptoms around the 09May2021, toe area only on the feet hurt- no swelling; right hand- all her knuckles are hurting and swollen; Muscles in her arms and legs are hurting- feels like she has been working out with weights; ripping boxes open at work is difficult, almost like she has no strength in her right hand. On 09May2021, she started feeling joint pains and her muscles hurt like she had been exercising, but she was not exercising. In the past she had arthritis in her left hand and now she has that arthritis pain in all joints and in both hands and feet. It was like her arthritis is flaring up. The first week the arthritis pains would come and go, but since last Monday it has been ongoing non-stop. The arthritis has flared up in other locations other than her left hand, again mentions she only had it in her left hand. Now she has it the right hand and in both in feet and they are swelling. Outcome of events increase of a flair up of arthritis, toe area only on the feet hurt- no swelling and right hand- all her knuckles are hurting and swollen was not resolved while the outcome of other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: Toe area only on the feet hurt- no swelling; right hand- all her knuckles are hurting and swollen; Muscles in her arms and legs are hurting- feels like she has been working out with weights; has no strength in her right hand; right hand- all her knuckles are hurting and swollen; an increase of a flair up of arthritis; swelling in her feet; sleepy; feeling tired; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration on 02May2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unknown date as dose 1, single for covid-19 immunization. On an unknown date in May2021, she was complaining of an increase of a flair up of arthritis and swelling in her feet, feeling tired and sleepy the second day after the vaccine. She began having the following symptoms around the 09May2021, toe area only on the feet hurt- no swelling; right hand- all her knuckles are hurting and swollen; Muscles in her arms and legs are hurting- feels like she has been working out with weights; ripping boxes open at work is difficult, almost like she has no strength in her right hand. On 09May2021, she started feeling joint pains and her muscles hurt like she had been exercising, but she was not exercising. In the past she had arthritis in her left hand and now she has that arthritis pain in all joints and in both hands and feet. It was like her arthritis is flaring up. The first week the arthritis pains would come and go, but since last Monday it has been ongoing non-stop. The arthritis has flared up in other locations other than her left hand, again mentions she only had it in her left hand. Now she has it the right hand and in both in feet and they are swelling. Outcome of events increase of a flair up of arthritis, toe area only on the feet hurt- no swelling and right hand- all her knuckles are hurting and swollen was not resolved while the outcome of other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer of an unspecified age reported for herself that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an 22May2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23May2021 patient experienced too much pain. Patient asked if she could go to the hospital or take Advil. The outcome of the event pain was unknown.  Information about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Erythema, Feeling abnormal, Feeling of body temperature change, Headache
Clinical narrative: Was in bed for two days post-vaccination (starting the day after vaccination).; Patient reported flu-like symptoms; Felt feverish, hot and then cold/feels sometimes feverish; Felt feverish, hot and then cold.; Foggy thinking.; Headache; muscle aches; nausea.; Arm hurts at site of injection and is swollen; Arm hurts at site of injection and is swollen; Arm still hurts/swollen/red,; Arm still hurts/swollen/red,; Arm still hurts/swollen/red; This is a spontaneous report from a contactable consumer. This consumer reported for a 54-year-old non-pregnant female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via intramuscular route of administration on 20May2021 (at 54-year-old), as dose 1, single for COVID-19 immunization. Patient had previously had COVID-19 but had reached outside the 3-month window to where they could receive the vaccine without worrying about antibody interference. The patient was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccinations, but reporter was unsure of medications. On 21May2021 at 06: 30 pm the patient was in bed for two days post-vaccination (starting the day after vaccination). Patient reported flu-like symptoms, felt feverish, hot and then cold, had foggy thinking, headache, muscle aches, fever, nausea. Her arm hurted at site of injection and was swollen. Her arm still hurts/swollen/red. No therapeutic measures were received. On 23May2021 the patient recovered.   No follow-up attempts were needed; information about lot/batch number could not be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Was in bed for two days post-vaccination (starting the day after vaccination).; Patient reported flu-like symptoms; Felt feverish, hot and then cold/feels sometimes feverish; Felt feverish, hot and then cold.; Foggy thinking.; Headache; muscle aches; nausea.; Arm hurts at site of injection and is swollen; Arm hurts at site of injection and is swollen; Arm still hurts/swollen/red,; Arm still hurts/swollen/red,; Arm still hurts/swollen/red; This is a spontaneous report from a contactable consumer. This consumer reported for a 54-year-old non-pregnant female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via intramuscular route of administration on 20May2021 (at 54-year-old), as dose 1, single for COVID-19 immunization. Patient had previously had COVID-19 but had reached outside the 3-month window to where they could receive the vaccine without worrying about antibody interference. The patient was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccinations, but reporter was unsure of medications. On 21May2021 at 06: 30 pm the patient was in bed for two days post-vaccination (starting the day after vaccination). Patient reported flu-like symptoms, felt feverish, hot and then cold, had foggy thinking, headache, muscle aches, fever, nausea. Her arm hurted at site of injection and was swollen. Her arm still hurts/swollen/red. No therapeutic measures were received. On 23May2021 the patient recovered.   No follow-up attempts were needed; information about lot/batch number could not be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Was in bed for two days post-vaccination (starting the day after vaccination).; Patient reported flu-like symptoms; Felt feverish, hot and then cold/feels sometimes feverish; Felt feverish, hot and then cold.; Foggy thinking.; Headache; muscle aches; nausea.; Arm hurts at site of injection and is swollen; Arm hurts at site of injection and is swollen; Arm still hurts/swollen/red,; Arm still hurts/swollen/red,; Arm still hurts/swollen/red; This is a spontaneous report from a contactable consumer. This consumer reported for a 54-year-old non-pregnant female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via intramuscular route of administration on 20May2021 (at 54-year-old), as dose 1, single for COVID-19 immunization. Patient had previously had COVID-19 but had reached outside the 3-month window to where they could receive the vaccine without worrying about antibody interference. The patient was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccinations, but reporter was unsure of medications. On 21May2021 at 06: 30 pm the patient was in bed for two days post-vaccination (starting the day after vaccination). Patient reported flu-like symptoms, felt feverish, hot and then cold, had foggy thinking, headache, muscle aches, fever, nausea. Her arm hurted at site of injection and was swollen. Her arm still hurts/swollen/red. No therapeutic measures were received. On 23May2021 the patient recovered.   No follow-up attempts were needed; information about lot/batch number could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported for a 15-year-old male patient (Reporter's Grandson) that: A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 17May2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. The reporter stated that patient took his first dose of the vaccine last Monday, 17May2021 and was "now" coughing. "PRIVACY" called to ask if coughing was one of the side effects of the vaccine though she mentioned that "PRIVACY" has also an underlying condition, asthma. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash macular
Clinical narrative: She is worried about the red dots. She is seriously frightened. She is scared of all that; She is worried about the red dots. She is seriously frightened. She is scared of all that; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. This consumer reported for a female patient (reporter's wife). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she is worried about the red dots. she is seriously frightened. she is scared of all that. Reporter stated, "I am here to report a side effect. My wife's name is (Not clarified further) it is about her (Not clarified further). She has got two small dots on it. I am reporting a side effect. She has got the Pfizer shot, the second one on Thursday last week. She got the second shot last week on Thursday. She noticed two small dots the size of diamond on her foot. She is worried about the red dots. She is seriously frightened. She is scared of all that. She has got two dots one down by the pinkie toe one of them is the size of a diamond one up at the regular foot, the size of a diamond. It is faint, it is very faint. But they are red dots." When probed for permission to probe, Reporter stated, "She just wants to know she should worry about it or not?". The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood pressure decreased, Blood pressure measurement, Body temperature
Clinical narrative: Felt like I had COVID again, the trembles the shaking and the tiredness and the weakness; Still very weak, I was laying down all yesterday; Extremely tired; Felt like I had COVID again, the trembles the shaking and the tiredness and the weakness; Still very weak, I was laying down all yesterday; Extremely tired; BP is still get down; Soreness in all of my joints and muscles; Soreness in all of my joints and muscles; 101 fever; Shivering; Arm got very sore; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection,Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22May2021 10:00 am as DOSE 1, SINGLE for covid-19 immunisation (at the age of 59-Years). Medical history included asthma, blood cholesterol increased, have a hole in her heart, COVID before in Jan (unspecified) and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for hypersensitivity, cetirizine hydrochloride (ZYRTEC ALLERGY, atorvastatin calcium (LIPITOR) taken for blood cholesterol increased, carvedilol (COREG) taken for cardiac disorder, all from unknown start and stop date were not reported. Patient had her first Pfizer dose (Unspecified vaccine) on 22May2021 Saturday morning and her arm got very sore immediately and around like 9 in the evening she started feeling very soreness in all of her joints and muscles, at about on 23May2021 1:30 in the morning she woke up with 101 fever and she was shivering, and she had COVID before in January, it felt like she had COVID again, the trembles the shaking and the tiredness and the weakness. And she thought this wasn't supposed to happen until they get the seconds shot. So she was a little nervous about getting the second shot and she want to know if what she had experienced with the first shot was normal, was the normal side effect for the first shot, she mean she was still very weak, she was like laying down all yesterday. She iced her arm where the shot was given and taken Tylenol, the fever went away yesterday morning, not yesterday morning like yesterday afternoon. So, she just want to make sure that she was safe for the second round or will the first shot be enough since she had COVID before. She stated that she just wanted to make sure because she don't know if she should go for the second shot or not and if this was normal because everybody was tell her what the side effects were now (not clear). The outcome of the events fatigue n and blood pressure decreased was not recovered, event pyrexia was recovered, and outcome of other events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Felt like I had COVID again, the trembles the shaking and the tiredness and the weakness; Still very weak, I was laying down all yesterday; Extremely tired; Felt like I had COVID again, the trembles the shaking and the tiredness and the weakness; Still very weak, I was laying down all yesterday; Extremely tired; BP is still get down; Soreness in all of my joints and muscles; Soreness in all of my joints and muscles; 101 fever; Shivering; Arm got very sore; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection,Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22May2021 10:00 am as DOSE 1, SINGLE for covid-19 immunisation (at the age of 59-Years). Medical history included asthma, blood cholesterol increased, have a hole in her heart, COVID before in Jan (unspecified) and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for hypersensitivity, cetirizine hydrochloride (ZYRTEC ALLERGY, atorvastatin calcium (LIPITOR) taken for blood cholesterol increased, carvedilol (COREG) taken for cardiac disorder, all from unknown start and stop date were not reported. Patient had her first Pfizer dose (Unspecified vaccine) on 22May2021 Saturday morning and her arm got very sore immediately and around like 9 in the evening she started feeling very soreness in all of her joints and muscles, at about on 23May2021 1:30 in the morning she woke up with 101 fever and she was shivering, and she had COVID before in January, it felt like she had COVID again, the trembles the shaking and the tiredness and the weakness. And she thought this wasn't supposed to happen until they get the seconds shot. So she was a little nervous about getting the second shot and she want to know if what she had experienced with the first shot was normal, was the normal side effect for the first shot, she mean she was still very weak, she was like laying down all yesterday. She iced her arm where the shot was given and taken Tylenol, the fever went away yesterday morning, not yesterday morning like yesterday afternoon. So, she just want to make sure that she was safe for the second round or will the first shot be enough since she had COVID before. She stated that she just wanted to make sure because she don't know if she should go for the second shot or not and if this was normal because everybody was tell her what the side effects were now (not clear). The outcome of the events fatigue n and blood pressure decreased was not recovered, event pyrexia was recovered, and outcome of other events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: Felt like I had COVID again, the trembles the shaking and the tiredness and the weakness; Still very weak, I was laying down all yesterday; Extremely tired; Felt like I had COVID again, the trembles the shaking and the tiredness and the weakness; Still very weak, I was laying down all yesterday; Extremely tired; BP is still get down; Soreness in all of my joints and muscles; Soreness in all of my joints and muscles; 101 fever; Shivering; Arm got very sore; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection,Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22May2021 10:00 am as DOSE 1, SINGLE for covid-19 immunisation (at the age of 59-Years). Medical history included asthma, blood cholesterol increased, have a hole in her heart, COVID before in Jan (unspecified) and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for hypersensitivity, cetirizine hydrochloride (ZYRTEC ALLERGY, atorvastatin calcium (LIPITOR) taken for blood cholesterol increased, carvedilol (COREG) taken for cardiac disorder, all from unknown start and stop date were not reported. Patient had her first Pfizer dose (Unspecified vaccine) on 22May2021 Saturday morning and her arm got very sore immediately and around like 9 in the evening she started feeling very soreness in all of her joints and muscles, at about on 23May2021 1:30 in the morning she woke up with 101 fever and she was shivering, and she had COVID before in January, it felt like she had COVID again, the trembles the shaking and the tiredness and the weakness. And she thought this wasn't supposed to happen until they get the seconds shot. So she was a little nervous about getting the second shot and she want to know if what she had experienced with the first shot was normal, was the normal side effect for the first shot, she mean she was still very weak, she was like laying down all yesterday. She iced her arm where the shot was given and taken Tylenol, the fever went away yesterday morning, not yesterday morning like yesterday afternoon. So, she just want to make sure that she was safe for the second round or will the first shot be enough since she had COVID before. She stated that she just wanted to make sure because she don't know if she should go for the second shot or not and if this was normal because everybody was tell her what the side effects were now (not clear). The outcome of the events fatigue n and blood pressure decreased was not recovered, event pyrexia was recovered, and outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: Nausea; Headache; Painful bump on the left side of her neck.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date in May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she had a dose of the vaccine last Wednesday, and the first two days she did not feel anything, abnormal. Reported that on Friday, Saturday, Sunday and today, she was feeling nauseas and has a headache, not sure if it is from the vaccine. On an unspecified date in May2021, the patient experienced nausea, headache, painful bump on the left side of her neck. The outcomes of events were unknown.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Lymphadenopathy, Pharyngeal swelling, Swelling
Clinical narrative: Throat was swollen; Lymph nodes were swollen; Swelling on her neck; Lymph nodes were swollen; Swelling on her neck; This is a spontaneous report from a non-contactable consumer or other non-health care professional (parent reported for her daughter). A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 20-years), on 17May2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medication included menstrual cycle pills (not clarified further hence not coded in tab). On May2021, the patient experienced throat was swollen, lymph nodes were swollen; swelling on her neck. The treatment was received for the adverse event. Reporter stated, that I am trying to report an adverse reaction for my daughter and I need to ask some questions also. My daughter took the Pfizer shot and immediate symptoms did not show up but within 3 days she had to go emergency room twice and her throat was swollen, lymph nodes were swollen and they had to give her steroids shot and antibiotic another shot (treatment) to try to bring it down. So, the question I have is, the reaction would that be concerning for her second shot? Reporter stated that, I think she was 5 feet 3 or maybe 125 pounds. I believe she is 5 feet 2 or 3inches, 5 feet 2 and she was not sure. Reporter stated, for the vaccination date for first shot that I believe it was last Friday, I do not have the exact date or probably that was Thursday and her daughter was supposed to take the next one on 04Jun so back it of 3 weeks, it was I believe the 14th. I cannot believe they do not have a date on this document, the date she went to the emergency room it was on 19 and she took the shot 2 days before, so I believe 17, she was not sure of the date. Reporter stated for other medication or other medical conditions that no, I believe she was taking some menstrual cycle pills. I do not know what they are, I just know they are menstrual cycle pills, she is 20 years old. Reporter stated, for the treatment that when she went to the emergency room, she had to take steroids and an antibiotic, the doctor gave her that and Amoxycillin or whatever it is and then the steroid to help bring down the swelling on her neck and lymph node and stuff. Reporter stated about lab test that she went to the emergency room twice because we are assuming that this is the effect of the vaccine because she has never been sick before, she is not a very sick person. Other than the Covid and the strep throat and stuff like that. The patient underwent lab tests and procedures which included body height: she is 5 feet 3/i believe she is 5 feet 2 or 3inch on unspecified date she is 5 feet 3/I believe she is 5 feet 2 or 3inches, 5 feet 2 I think. The adverse events resulted in emergency room visit. The clinical outcome of the events was reported as unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Pain in extremity, Peripheral swelling
Clinical narrative: first dose: left arm swollen; first dose: left breast swollen; pain under her left arm; This is a spontaneous report from a contactable 62-year-old female consumer (patient).  A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 17Mar2021 (at the age of 62-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 07Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported On an unspecified date, after the vaccination, the patient experienced her left arm and breast were swollen Stated that she is still having pain under her left arm. The outcome of the events peripheral swelling and breast swelling was unknown and pain in extremity was not recovered.  No follow-up attempts possible. No further information expected.  Follow-up: (29Jul2021): This follow-up is being submitted to notify that the new information is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye disorder, Headache, Nasopharyngitis, Pain
Clinical narrative: ache all over; chills; can't keep eyes open; they are cold, then they have a headache; can't keep eyes open; This is a spontaneous report from a contactable consumer. The consumer reported for a patient (1st cousin) that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Caller reported she has a first cousin and her sister they had their shots pretty close the same time she did. There was a tough spell 4 days after the shot, then she was fine, then the same thing happened again for a couple of days at a time where they can't keep their eyes open because they ache all over, have chills, and then it goes away and then comes back. Caller added her other cousin had the same shots and she did the same thing she had. Caller added she does not want to complete her report or complete a report on her cousins. Caller added that it has been the same for them as hers, their last shot was a few days before her second one. They had the exact same thing happen. She does not know if maybe it is in the DNA or something. They still get this annoying thing that will pop up and they just lay down and sleep, then they are cold, then they have a headache. It does not last long, a day or a day and a half. The outcome of the events ache all over, chills, can't keep eyes open was not recovered and they are cold, then they have a headache was recovered on unspecified date.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain, Breast swelling, Breast tenderness, Mammogram
Clinical narrative: Nipple pain/nipple which is on a flat chested body was so sore he couldn't touch it; His breast is still very tender; There is some discomfort in the left breast.; Pain; Extraordinary pain in nipple area, breast,; In my left arm, my left breast/nipple was swollen and was hurting; In my left arm, my left breast/nipple was swollen and was hurting; In my left arm, my left breast/nipple was swollen and was hurting; In my left arm, my left breast/nipple was swollen and was hurting; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiration date:), via an unspecified route of administration, administered in arm left on 07May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 08May2021, the patient experienced nipple pain/nipple which is on a flat chested body was so sore he couldn't touch it, his breast was still very tender, there was some discomfort in the left breast, pain, extraordinary pain in nipple area, breast, in her left arm, her left breast/nipple was swollen and was hurting. Patient stated he received his first dose of the Pfizer COVID-19 vaccine on 07May2021. the next day got in left arm c/o having nipple pain on left side could hardly touch it. He did call his HCP and had a mammogram done which did not show cancer. The pain has gotten better but still with some pain in the left nipple. In regard to the first one he did it in the left arm. The next day, his nipple which is on a flat chested body was so sore he couldn't touch it and it hasn't gotten much better. He went to his primary care doctor. He went in to see her right away, he was so worried. He was a 69-year-old man, and he can get breast cancer. She said normally with cancer you usually don't get pain. So, she sent him to have a mammogram. The left breast was so sore, and she didn't think it was cancer, should not be cancer and wasn't cancer. Knock on wood. And it's less tender as gone a long, but it's still tender. She seemed to be under the impression that usually women have this reaction in the breast, but men can have reactions in their breast. His breast was still very tender. This happened the day after Pfizer shot and that's the one, he wanted. In fact, that's the one he wanted, and he wants to know if it's a side effect. It's still tender, not as tender. He can touch his breast, but there was some discomfort in the left breast. His first shot was in the left arm and the next day he started having pain. The patient underwent lab tests and procedures which included mammogram: which did not show cancer on an unspecified date. The outcome of the event his breast was still very tender not recovered and recovering for all other events.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nipple pain, Nipple swelling, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Nipple pain/nipple which is on a flat chested body was so sore he couldn't touch it; His breast is still very tender; There is some discomfort in the left breast.; Pain; Extraordinary pain in nipple area, breast,; In my left arm, my left breast/nipple was swollen and was hurting; In my left arm, my left breast/nipple was swollen and was hurting; In my left arm, my left breast/nipple was swollen and was hurting; In my left arm, my left breast/nipple was swollen and was hurting; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiration date:), via an unspecified route of administration, administered in arm left on 07May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 08May2021, the patient experienced nipple pain/nipple which is on a flat chested body was so sore he couldn't touch it, his breast was still very tender, there was some discomfort in the left breast, pain, extraordinary pain in nipple area, breast, in her left arm, her left breast/nipple was swollen and was hurting. Patient stated he received his first dose of the Pfizer COVID-19 vaccine on 07May2021. the next day got in left arm c/o having nipple pain on left side could hardly touch it. He did call his HCP and had a mammogram done which did not show cancer. The pain has gotten better but still with some pain in the left nipple. In regard to the first one he did it in the left arm. The next day, his nipple which is on a flat chested body was so sore he couldn't touch it and it hasn't gotten much better. He went to his primary care doctor. He went in to see her right away, he was so worried. He was a 69-year-old man, and he can get breast cancer. She said normally with cancer you usually don't get pain. So, she sent him to have a mammogram. The left breast was so sore, and she didn't think it was cancer, should not be cancer and wasn't cancer. Knock on wood. And it's less tender as gone a long, but it's still tender. She seemed to be under the impression that usually women have this reaction in the breast, but men can have reactions in their breast. His breast was still very tender. This happened the day after Pfizer shot and that's the one, he wanted. In fact, that's the one he wanted, and he wants to know if it's a side effect. It's still tender, not as tender. He can touch his breast, but there was some discomfort in the left breast. His first shot was in the left arm and the next day he started having pain. The patient underwent lab tests and procedures which included mammogram: which did not show cancer on an unspecified date. The outcome of the event his breast was still very tender not recovered and recovering for all other events.  Information about the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Burning sensation, Pain in extremity, Peripheral swelling
Clinical narrative: On the second shot my left hand point finger knuckle swelled, it hurts, it burns; On the second shot my left hand point finger knuckle swelled, it hurts, it burns; my left hand point finger knuckle swelled, it hurts, it burns; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0168, expiration date unspecified), via an unspecified route of administration on 21May2021 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. Medical history included hypertension and kidney transplant. Concomitant medications included tacrolimus (PROGRAF) taken for kidney transplant, from an unknown start date and amlodipine taken for hypertension, from an unknown start date. The patient previously received dose 1 of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0167, expiration date unspecified), via an unspecified route of administration on 30Apr2021 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization and experienced swelling in the side of the foot. On an unknown date, the patient reported that post 2nd dose his left hand point finger knuckle swelled, it hurts, its burns. On an unknown date, the patient had his blood creatinine checked and results were unknown. Therapeutic measures were taken as a result of the events and patient was taking Tylenol which did not made any difference. The outcome of the events was reported as unknown at the time of report.   Information on Lot/Batch number was available. Additional information has been requested
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: I was very tired; very sore arm for 24 hours; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: EL9263) via an unspecified route of administration, administered in arm left on 06Feb2021 at 11:30 as dose 2, single (at the age of 77-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (Dose: 1 Batch/Lot number: EL1284) on 16Jan2021 (at the age of 77-years-old) for COVID-19 immunisation. History of all previous immunization with the Pfizer Vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations) were not available. On an unknown date in Feb2021, after the second shot, the patient was tired and had very sore arm for 24 hours and nothing since. The events were not resulted in emergency room and physician office visit. Relevant tests were reported as none. The clinical outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: Fatigue and tiredness, after the first vaccine; Chills, after the first vaccine; Joint pain, after first vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), dose 1 via an unspecified route of administration, administered in Deltoid Left on 19May2021 11:00 as dose 1, single for COVID-19 immunisation. Medical history included lung neoplasm malignant from an unknown date and unknown if ongoing Verbatim: Lung cancer, ongoing sickle cell anaemia Verbatim: Sickle cell anemia. There were no concomitant medications. On 20May2021, the patient experienced joint pain, after first vaccine, chills, after the first vaccine and fatigue and tiredness, after the first vaccine on 20May2021 08:00. The outcome of all the events was recovered.  Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Nausea
Clinical narrative: Chest pains shortness of breath nausea and anxiety; Chest pains shortness of breath nausea and anxiety; Chest pains shortness of breath nausea and anxiety; Chest pains shortness of breath nausea and anxiety; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 47-years-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Qw0168 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 (age at vaccination: 47) at 09:45 as dose 2 single for covid-19 immunisation. Medical history included Chronic migraines high blood pressure, fibromyalgia & mistrial valve prolapse. The patient had no known allergies. Concomitant medications were not reported. The patient previously received dose 1 of bnt162b2 on 24APR2021 at 09:45 AM for covid-19 immunisation (Lot number: Ew0171, Vaccine location: Left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Chest pains shortness of breath nausea and anxiety on 25May2021. The patient received treatment for the events (Sent home from work to recover). No seriousness criteria reported. Outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash, Tinea infection
Clinical narrative: eczema-like or ringworm-like rash on arms and face; Eczema-like or ringworm-like rash on arms and face; eczema-like or ringworm-like rash on arms and face; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in arm right on 23Feb2021 at 07:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroid and diabetes (diabetes type 2). Concomitant medications included Nature Throid, received within 2 weeks of vaccination. The COVID-19 vaccine was administered at doctor's  office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Mar2021 at 10:15, the patient experienced eczema-like or ringworm-like rash on arms and face. The patient reported that she was experiencing a eczema-like or ringworm-like rash on arms and face. It was started on right arm and then left. Seems to be getting worse, spreading to face. Using eczema cream on it seems to help. Slowing disappearing. The adverse event result in doctor or other healthcare professional office/clinic visit. The outcome of the event was resolving.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Both of my arms from my shoulder down to my wrists have broken out in an itchy red rash; I also have some minor rash on both lower legs.; This is a spontaneous report from a contactable consumer. A 68-years-old (age at vaccination) male consumer (patient) reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EW0179) via an unspecified route of administration on 18May2021 at 10:15 am in left arm as dose 2, single for covid-19 immunisation. Patient's medical history included Known allergies: Penicillin (dates unspecified). Historical vaccine included that patient previously took first dose of COVID-19 Vaccine (BNT162B2, Lot number: EW0172) via an unspecified route of administration on 29Apr2021 at 10:30 am in left arm for covid-19 immunisation. Patient did not receive other vaccine in four weeks. Concomitant medications (Other medications in two weeks) included Pravastatin sodium (PRAVASTATIN) at 40 mg for unknown indication and omega q plus 100 for unknown indication. Patient stated that 'On 19May2021 at 08:00 am experienced both of my arms from my shoulder down to my wrists have broken out in an itchy red rash. I also have some minor rash on both lower legs. No treatment for the AE was given. Patient did not have covid-19 prior vaccination. Patient was not tested for covid-19 post vaccination. The seriousness criteria was reported as non-serious. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.