chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Lymphadenopathy
Clinical narrative: Chills; Slight fever; swelling is from a lymph node.; Headache; very tired; felt crappy; her neck was swollen; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 44 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 (Batch/Lot Number: EW0153; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (Batch/Lot Number: EP7533; Expiration Date: 31Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline (SERTRALINE) taken for anxiety, start and stop date were not reported. The patient experienced chills on 15Apr2021 with outcome of recovered, slight fever on 15Apr2021 with outcome of unknown, swelling is from a lymph node. causing lymphadenopathy on 15Apr2021 with outcome of recovering, headache on 15Apr2021 with outcome of unknown, very tired causing fatigue on 15Apr2021 with outcome of unknown, felt crappy on Apr2021 with outcome of unknown and her neck was swollen on Apr2021 with outcome of unknown.    The caller is calling about the covid vaccine. The caller had her vaccine last Wednesday at 11:30am. The caller didn't have any side effects the first day. The next morning the caller had chills, slight fever and later in the day she noticed on her right arm, 4-5 inches from where the vaccine was administered, it was swollen quite a bit to the size of a good size tennis ball, it was fluid like, it would bounce and it felt like a pillow on her neck. The caller called her primary care provider and the nurse said to watch it and mark it and if it gets bigger to come see them. The caller wants us to be aware of it. The caller is assuming the swelling is from a lymph node. The caller has nodules on her neck that she gets scanned every year.   After the second dose of the vaccine the caller had a headache and was very tired. As soon as the caller had a headache she took some Ibuprofen but the headache lasted for about 2 days, unknown lot and expiration date, the caller finished the bottle and threw it out. The caller had a fever and felt really crappy. That afternoon the next day the caller noticed by her neck was swollen. It took another day or day and a half for it do disintegrate. This bubble was on the same side that she received the vaccine and was 5-4 inches from where she received the vaccine.   Caller reporting on the COVID Vaccine. While reporting on the COVID Vaccine caller provided details about a treatment medication due to event that occurred, headache. As soon as the caller had a headache she took some Ibuprofen but the headache lasted for about 2 days, unknown lot and expiration date, the caller finished the bottle and threw it out.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Chills; Slight fever; swelling is from a lymph node.; Headache; very tired; felt crappy; her neck was swollen; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 44 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 (Batch/Lot Number: EW0153; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (Batch/Lot Number: EP7533; Expiration Date: 31Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline (SERTRALINE) taken for anxiety, start and stop date were not reported. The patient experienced chills on 15Apr2021 with outcome of recovered, slight fever on 15Apr2021 with outcome of unknown, swelling is from a lymph node. causing lymphadenopathy on 15Apr2021 with outcome of recovering, headache on 15Apr2021 with outcome of unknown, very tired causing fatigue on 15Apr2021 with outcome of unknown, felt crappy on Apr2021 with outcome of unknown and her neck was swollen on Apr2021 with outcome of unknown.    The caller is calling about the covid vaccine. The caller had her vaccine last Wednesday at 11:30am. The caller didn't have any side effects the first day. The next morning the caller had chills, slight fever and later in the day she noticed on her right arm, 4-5 inches from where the vaccine was administered, it was swollen quite a bit to the size of a good size tennis ball, it was fluid like, it would bounce and it felt like a pillow on her neck. The caller called her primary care provider and the nurse said to watch it and mark it and if it gets bigger to come see them. The caller wants us to be aware of it. The caller is assuming the swelling is from a lymph node. The caller has nodules on her neck that she gets scanned every year.   After the second dose of the vaccine the caller had a headache and was very tired. As soon as the caller had a headache she took some Ibuprofen but the headache lasted for about 2 days, unknown lot and expiration date, the caller finished the bottle and threw it out. The caller had a fever and felt really crappy. That afternoon the next day the caller noticed by her neck was swollen. It took another day or day and a half for it do disintegrate. This bubble was on the same side that she received the vaccine and was 5-4 inches from where she received the vaccine.   Caller reporting on the COVID Vaccine. While reporting on the COVID Vaccine caller provided details about a treatment medication due to event that occurred, headache. As soon as the caller had a headache she took some Ibuprofen but the headache lasted for about 2 days, unknown lot and expiration date, the caller finished the bottle and threw it out.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Dizziness, Hypersensitivity, Movement disorder
Clinical narrative: burning; throat kind of burnt after this shot; weak; dizzy; Can't move around; Feels like some kind of allergic reactions; This is a spontaneous report from a contactable consumer (patient). A 18-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0176; Expiration Date: Aug2021), via an unspecified route of administration on 26Apr2021 (at the age of 18-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Apr2021 (on the same day), the patient experienced burning, throat kind of burnt after this shot, weak, dizzy, can't move around, feels like some kind of allergic reactions. It was reported that patient didn't feels the events all day (unspecified). The outcomes of events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: burning; throat kind of burnt after this shot; weak; dizzy; Can't move around; Feels like some kind of allergic reactions; This is a spontaneous report from a contactable consumer (patient). A 18-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0176; Expiration Date: Aug2021), via an unspecified route of administration on 26Apr2021 (at the age of 18-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Apr2021 (on the same day), the patient experienced burning, throat kind of burnt after this shot, weak, dizzy, can't move around, feels like some kind of allergic reactions. It was reported that patient didn't feels the events all day (unspecified). The outcomes of events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Chest tightness, shortness of breath, chest pain for over 2 weeks
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nausea, Pain
Clinical narrative: Drowsiness; Fever; Restless sleep; Body aches; Chills; Nausea; He felt generally unwell; Woke up with a little headache; This is a spontaneous report from a contactable consumer . A 23-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation the patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on an unspecified date (at age of 23-years-old) as single dose for COVID-19 immunisation. It was reported that patient received the second dose of Pfizer COVID-19 vaccine around 10:30. No effects until about 19:30 when some drowsiness began. Around 21:00 fever started. During the night, he experienced restless sleep (including fever dreams, body aches, and chills) and a little nausea. In the morning the fever was gone but he felt generally unwell. That slowly got better throughout the day. On the second morning, he woke up with a little headache and feels pretty normal now (the afternoon of that day). Event took place after use of product. The Outcome of the all the events was Unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia, Somnolence
Clinical narrative: Drowsiness; Fever; Restless sleep; Body aches; Chills; Nausea; He felt generally unwell; Woke up with a little headache; This is a spontaneous report from a contactable consumer . A 23-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation the patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on an unspecified date (at age of 23-years-old) as single dose for COVID-19 immunisation. It was reported that patient received the second dose of Pfizer COVID-19 vaccine around 10:30. No effects until about 19:30 when some drowsiness began. Around 21:00 fever started. During the night, he experienced restless sleep (including fever dreams, body aches, and chills) and a little nausea. In the morning the fever was gone but he felt generally unwell. That slowly got better throughout the day. On the second morning, he woke up with a little headache and feels pretty normal now (the afternoon of that day). Event took place after use of product. The Outcome of the all the events was Unknown.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood bilirubin increased
Clinical narrative: Elevated bilirubin; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced elevated bilirubin. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470248 same reporter/drug/AE, different patients (1st of 3 patients)
Sex: U
Vaccine: COVID19
Symptoms: Blood bilirubin increased
Clinical narrative: Developed elevated bilirubin; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included breast cancer metastatic from an unknown date and unknown if ongoing, gilbert's syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced developed elevated bilirubin on an unspecified date.  The patient underwent lab tests and procedures which included blood bilirubin increased: increased   on unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470248  same reporter/drug/AE, different patients(2nd of 3 patients)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: I got the arm sore as little lump or whatever and inability to lift my arm; I got the arm sore as little lump or whatever and inability to lift my arm; it's like rash it's like not rash, all red like a good circle around the Infusion; like very itchy; chills; Headache; fatigue; fever 100.8; but the problem my now is the Injection site I did not feel then my am burn that could have been alcohol; This is a spontaneous report from a contactable consumer (patient) reported for herself.   A 55-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 21Apr2021 (lot number: EW0170) (age at vaccination 55-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included hypertension from 20 years back, auto immune disease, Covid in December and was very ill for about 8 weeks when she was available to get the vaccine. The patient concomitant medications included metoprolol, lisinopril for blood pressure high and Vitamins. The patient had, the problem in the injection site did not feel then my am burn that could have been alcohol, chills, headache, which is reminiscent of actual virus then, had fatigue and in the night had a fever 100.8 on 22Apr2021 and then got the arm sore as little lump or whatever and inability to lift my arm within next day or two which was told have Wednesday, Thursday night, the soreness has been gone like nothing going to be wrong whatever and now like it's one more thing, It's like how it's like rash it's like not rash, all red like a good circle around the Infusion, I do not know it's like very itchy now and it hurts and it's itchy. The patient took Tylenol as this was becoming unbearable like it was Itchy and hurts, do not want to scratch them. The patient lab tests included SarS-Cov-2 test was positive like in December 3 and body temperature was found to be 100.8 on 22Apr2021. The outcome of the events was reported as unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, SARS-CoV-2 test, Vaccination site discolouration
Clinical narrative: I got the arm sore as little lump or whatever and inability to lift my arm; I got the arm sore as little lump or whatever and inability to lift my arm; it's like rash it's like not rash, all red like a good circle around the Infusion; like very itchy; chills; Headache; fatigue; fever 100.8; but the problem my now is the Injection site I did not feel then my am burn that could have been alcohol; This is a spontaneous report from a contactable consumer (patient) reported for herself.   A 55-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 21Apr2021 (lot number: EW0170) (age at vaccination 55-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included hypertension from 20 years back, auto immune disease, Covid in December and was very ill for about 8 weeks when she was available to get the vaccine. The patient concomitant medications included metoprolol, lisinopril for blood pressure high and Vitamins. The patient had, the problem in the injection site did not feel then my am burn that could have been alcohol, chills, headache, which is reminiscent of actual virus then, had fatigue and in the night had a fever 100.8 on 22Apr2021 and then got the arm sore as little lump or whatever and inability to lift my arm within next day or two which was told have Wednesday, Thursday night, the soreness has been gone like nothing going to be wrong whatever and now like it's one more thing, It's like how it's like rash it's like not rash, all red like a good circle around the Infusion, I do not know it's like very itchy now and it hurts and it's itchy. The patient took Tylenol as this was becoming unbearable like it was Itchy and hurts, do not want to scratch them. The patient lab tests included SarS-Cov-2 test was positive like in December 3 and body temperature was found to be 100.8 on 22Apr2021. The outcome of the events was reported as unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I got the arm sore as little lump or whatever and inability to lift my arm; I got the arm sore as little lump or whatever and inability to lift my arm; it's like rash it's like not rash, all red like a good circle around the Infusion; like very itchy; chills; Headache; fatigue; fever 100.8; but the problem my now is the Injection site I did not feel then my am burn that could have been alcohol; This is a spontaneous report from a contactable consumer (patient) reported for herself.   A 55-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 21Apr2021 (lot number: EW0170) (age at vaccination 55-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included hypertension from 20 years back, auto immune disease, Covid in December and was very ill for about 8 weeks when she was available to get the vaccine. The patient concomitant medications included metoprolol, lisinopril for blood pressure high and Vitamins. The patient had, the problem in the injection site did not feel then my am burn that could have been alcohol, chills, headache, which is reminiscent of actual virus then, had fatigue and in the night had a fever 100.8 on 22Apr2021 and then got the arm sore as little lump or whatever and inability to lift my arm within next day or two which was told have Wednesday, Thursday night, the soreness has been gone like nothing going to be wrong whatever and now like it's one more thing, It's like how it's like rash it's like not rash, all red like a good circle around the Infusion, I do not know it's like very itchy now and it hurts and it's itchy. The patient took Tylenol as this was becoming unbearable like it was Itchy and hurts, do not want to scratch them. The patient lab tests included SarS-Cov-2 test was positive like in December 3 and body temperature was found to be 100.8 on 22Apr2021. The outcome of the events was reported as unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Insomnia
Clinical narrative: severe enough to prevent me from sleeping or moving without vomiting; fever; chills; severe joint pain; sore throat; headache; dizziness; nausea; severe enough to prevent me from sleeping or moving without vomiting; This is a spontaneous report from a contactable consumer. A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0170, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 10:15 (age at vaccination 32 years) as dose 2, single for covid-19 immunisation. Medical history included covid-19 prior to vaccination. Concomitant medication(s) included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) occasional. The patient had no allergies. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:15 as dose 1, single for covid-19 immunisation. Facility type vaccine other was mass Vaccination Drive. Prior to vaccination, the patient was 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. On 27Apr2021 21:30 the patient experienced severe enough to prevent me from sleeping or moving without vomiting, fever, chills, severe joint pain, sore throat, headache, dizziness, nausea. Patient received treatment for reported events took Excedrine. The outcome of event was recovering.  No follow up attempts are needed. No further information is expected
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: severe enough to prevent me from sleeping or moving without vomiting; fever; chills; severe joint pain; sore throat; headache; dizziness; nausea; severe enough to prevent me from sleeping or moving without vomiting; This is a spontaneous report from a contactable consumer. A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0170, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 10:15 (age at vaccination 32 years) as dose 2, single for covid-19 immunisation. Medical history included covid-19 prior to vaccination. Concomitant medication(s) included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) occasional. The patient had no allergies. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:15 as dose 1, single for covid-19 immunisation. Facility type vaccine other was mass Vaccination Drive. Prior to vaccination, the patient was 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. On 27Apr2021 21:30 the patient experienced severe enough to prevent me from sleeping or moving without vomiting, fever, chills, severe joint pain, sore throat, headache, dizziness, nausea. Patient received treatment for reported events took Excedrine. The outcome of event was recovering.  No follow up attempts are needed. No further information is expected
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Dysgeusia, Fatigue
Clinical narrative: chest pain and pressure; flu like symptoms and fatigue; metal taste in mouth; chest pain and pressure; flu like symptoms and fatigue; chills; nausea; taste disruption; This is a spontaneous report from a contactable consumer(patient). A 36-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (at the age of 36years) as dose 1, single for COVID-19 immunization. Medical history included allergies to penicillin and also penicillin related drugs, childhood asthma she had sort of severe childhood asthma. Concomitant medications were not reported. The patient experienced chest pain and pressure, flu like symptoms and fatigue, metal taste in mouth, chest pain and pressure, flu like symptoms and fatigue, chills, nausea, taste disruption. It was reported Caller states she was a little bit concerned because she was experiencing chest pain and chest pressure because she had sort of severe childhood asthma. Caller states another hot line she talked to today said that was not a usual side effect. Caller states she did experience a lot of the other symptoms she saw on the website like flu like symptoms, fatigue, chills, nausea, metal taste in mouth, taste disruption were common. Caller states she has an allergy to penicillin and penicillin related drugs and that is in the mix she guesses. Caller wants to know was she a good candidate for the second vaccine. Caller states she was a little bit she has to go pick up her son in a few minutes. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Taste disorder
Clinical narrative: chest pain and pressure; flu like symptoms and fatigue; metal taste in mouth; chest pain and pressure; flu like symptoms and fatigue; chills; nausea; taste disruption; This is a spontaneous report from a contactable consumer(patient). A 36-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (at the age of 36years) as dose 1, single for COVID-19 immunization. Medical history included allergies to penicillin and also penicillin related drugs, childhood asthma she had sort of severe childhood asthma. Concomitant medications were not reported. The patient experienced chest pain and pressure, flu like symptoms and fatigue, metal taste in mouth, chest pain and pressure, flu like symptoms and fatigue, chills, nausea, taste disruption. It was reported Caller states she was a little bit concerned because she was experiencing chest pain and chest pressure because she had sort of severe childhood asthma. Caller states another hot line she talked to today said that was not a usual side effect. Caller states she did experience a lot of the other symptoms she saw on the website like flu like symptoms, fatigue, chills, nausea, metal taste in mouth, taste disruption were common. Caller states she has an allergy to penicillin and penicillin related drugs and that is in the mix she guesses. Caller wants to know was she a good candidate for the second vaccine. Caller states she was a little bit she has to go pick up her son in a few minutes. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Dermatitis, Joint swelling, Limb discomfort, Peripheral swelling, Swelling
Clinical narrative: Body is swelling and its swollen, I am swell up; Forearms are tight; Swollen elbows; Swollen hands; Skin is really gonna burst; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0170, Expiry date: Unknown) via an unspecified route of administration on 20Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date in 2021, the patient experienced body is swelling and its swollen, i am swell up, forearms are tight, swollen elbows, swollen hands, skin is really gonna burst. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: My arm has been sore, hurting and now the other arm hurting.; I start itching I still do itch.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 02Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient arm has been sore, hurting and now the other arm hurting and started itching, the patient still does itching. The seriousness of the events was unspecified. The outcome of the event arm has been sore, hurting and now the other arm hurting was unknown while outcome of the event start itching, the patient still do itch was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Have some inflammation issues going on right now; This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting for itself. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunization. Patient medical history included rheumatoid arthritis and Ehlers-Danlos syndrome. Concomitant medications were not reported. It was stated that he was getting his second dose tomorrow and he just find that his first dose well not expecting anything unusual with his second dose. On an unspecified date patient reported that  he has some inflammation issues going on right now. His doctor would like to put him on steroids and they were wondering how long after he get his second dose tomorrow. Should they wait for starting the course of steroids. The outcome of then event was unknown.  No follow-up attempts are needed; No further is information expected
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Lymph node pain, Swelling, Ultrasound scan
Clinical narrative: Diarrhea after first, really painful swollen lymph nodes in both armpits.; Diarrhea after first, really painful swollen lymph nodes in both armpits.; Diarrhea after first, really painful swollen lymph nodes in both armpits.; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received the second dose of bnt162b2 (Solution injection; Batch/Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left on 19Apr2021 (at the age of 39-years-old) at 10:30 as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EN9809), via an unspecified route of administration, administered in Arm Left on 29Mar2021 at 10:00 as single dose for covid-19 immunisation. Medical history included headache and depression. Concomitant medications included cimetidine, bupropion, paracetamol and clonazepam. The patient previously took benadryl and experienced drug hypersensitivity. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 25Apr2021, patient experienced diarrhea after first, really painful swollen lymph nodes in both armpits. The patient underwent lab tests and procedures which included ultrasound scan result of which was unknown. Therapeutic measures were taken as a result of the event and was treated with antibiotic. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: felt bad a week after her shot; had a fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 15Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (Lot number: EL9266) on 18Feb2021 for COVID-19 immunisation. On 29Mar2021 patient experienced had a fever, on an unspecified date felt bad a week after her shot. Caller states his wife and himself got their shots on 15Mar2021. This past Sunday his wife started getting a low-grade fever and they are wondering if that is a side effect even though its 2 weeks later. Caller mentions that his wife had a swollen arm for about 12 hours after the first vaccine. States they had the shot in the afternoon so it might have been the next day, but he cannot recall. States she completely recovered from the swollen arm after about 12 hours. Caller states that he read it takes 2-4 weeks for the vaccine to be effective. Wondering if that is a side effect even though it's 2 weeks later. The outcome of the event fever was not recovered, and outcome of the event felt bad was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Muscle spasms, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm on 23Apr2021 14:30 as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route, in left arm on 02Apr2021, 03:30 PM as dose 1, single for covid-19 immunisation. Patients medical history was not reported. She had no known allergies. Concomitant medication included ibuprofen taken for unspecified indication, start and stop date not reported, taken in two weeks. Patient did not take any other vaccines in four weeks. On 24Apr2021 12:00 PM patient experienced extremely weak, headaches, nausea, and muscle spasms/ fatigue. The AE resulted in doctor or other healthcare professional office/clinic visit. Patient felt the side effects are not going away as fast as expected. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient did not receive any treatment for the adverse events. The outcome of events was not recovered.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021501876 Same reporter/product/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Muscle spasms, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, left arm, on Apr 23, 2021, at 14:35, single dose, for COVID-19 immunisation. Medical history reported as none. Concomitant medications included ibuprofen. The patient received the first dose of BNT162B2 on Apr 2, 2021, at 14:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. It has been 5 days since patient's second dose. On Apr 24, 2021, at 12:00, patient still felt extremely weak, have headaches, nausea, and muscle spasms/fatigue. The side effects were not going away as fast as expected. It was unknown if patient received the treatment or not. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events: not resolved. No follow-up attempts possible: information about lot/batch number/expiry date cannot be obtained. No further information expected. Sender's comments: Linked report(s): PFIZER INC-2021501866 same reporter/product/event, different patient.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Injection site soreness; low-grade fever (100-101); headache; fatigue; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:30 (at the age of 62-years-old) at dose 2, single for covid-19 immunization. Medical history included known allergies to CT scan dye. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY); calcium citrate; ergocalciferol (VIT D); ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:45 (at the age of 62-years-old) at dose 1, single for covid-19 immunization. The most recent vaccine was administered at Workplace clinic. The patient experienced injection site soreness, low grade fever, headache and fatigue on 25Mar2021. No treatment was given for the events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021240148 Same patient and drug, different event separated in time, similar events
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Depressed mood, Fatigue, Pain, Sensitive skin
Clinical narrative: had body aches; sensitive skin; very tired; felt depressed for the day; wasn't hungry; This is a spontaneous report from a non-contactable consumer (patient). A 32-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 30Apr2021 10:45 as DOSE 2, SINGLE for covid-19 immunization. The medical history included ADHD and depression. Concomitant medication(s) included amfetamine aspar-tate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and lamotrigine (LAMICTAL). The patient previously took first dose of BNT162B2 (lot number: ER8737) in Left Arm, on 31Mar2021 for Covid-19 Immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On May1, 2021, the patient reported that I had body aches, sensitive skin and was very tired. I also felt depressed for the day and wasn't hungry. All of this happened the day after the injection. Patient did not receive any treatment for the event. The outcome of event depression recovered on 01May2021 and other event recovered on an unspecified May2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother). A male patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced psoriasis on an unspecified date. Reporter stated she and her son take Stelara every 3 months for psoriasis. The outcome of event: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): PFIZER INC-2021525511 same reporter/drug/AE, different patient.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypersomnia, Lethargy, SARS-CoV-2 test negative, Vaccination site pain
Clinical narrative: slept most of the next day; Soreness at the injection site; chills and uncontrollable shivering severe afternoon; very lethargic; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left deltoid on 19Feb2021 11:00 (Lot Number: EL9267) (at the age of 73-years-old) as dose 2, single for covid-19 immunisation. Medical history included chemotherapy from Apr2020 to Jun2020 for diffuse large B-cell Lymphoma, pneumonia from Apr2020 to Aug2020, hospitalized 3 nights for pneumonia (not covid-19 tested negative eight times in 2020). Concomitant medications included meloxicam taken for an unspecified indication from 3 years ago and ongoing; latanoprost taken for an unspecified indication from 1 years ago and ongoing; paracetamol (TYLENOL) taken for an unspecified indication from many years ago and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left deltoid on 22Jan2021 11:00 (Lot Number: EL9263) (at the age of 73-years-old) as dose 2, single for covid-19 immunisation and experienced lethargic, no appetite, no bowel movements, soreness at the injection site, chills and uncontrollable shivering, kept awake and slept most of the next day and fever. The patient was very lethargic, chills and uncontrollable shivering severe afternoon on 19Feb2021, day of and day after injection. On 20Feb2021 day after injection, patient had soreness at the injection site and slept most of the next day. The patient did not receive any treatment for the events. Patient was not admitted to hospital due to event. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood test, Diarrhoea, Ophthalmological examination
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer or other non hcp.    A 74-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN9581), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 as 1st dose, single for covid-19 immunisation. Medical history included ongoing blindness legally blind, ongoing hypersensitivity neuropathy peripheral. The patient's concomitant medications were not reported. The patient previously took klonopin and experienced coma, flu. It was reported that, the patient experienced diarrhoea on an unspecified date with outcome of recovered. The patient underwent lab tests and procedures which included acoustic stimulation tests: no results on blood test: no results on ophthalmological examination: no results. Therapeutic measures were taken as a result of diarrhoea (diarrhoea).  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature increased, Chills, Diarrhoea, Fatigue
Clinical narrative: fever 102; chills; vomiting; diarrhea; abdominal pain; fatigue; nausea; This is a spontaneous report received from a contactable other hcp. A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EI9265) via an intramuscular route of administration in Arm Left on 23Feb2021 08:30 (age at vaccination 62years old) as single dose for covid-19 immunisation. the patient has not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine. Medical history included hypersensitivity from an unknown date and unknown if ongoing Medication: Sulpha, allergy to arthropod bite from an unknown date and unknown if ongoing, thrombocytopenia from an unknown date and unknown if ongoing. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9261) via an intramuscular route of administration in Arm right on 05Feb2021 15.30 PM (age at vaccination 62years old) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced fever 102, chills, vomiting, diarrhoea, abdominal pain, nausea on 24Feb2021, and fatigue on 25Feb2021. The patient underwent lab tests and procedures which included body temperature increased: 102 on unspecified date. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: fever 102; chills; vomiting; diarrhea; abdominal pain; fatigue; nausea; This is a spontaneous report received from a contactable other hcp. A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EI9265) via an intramuscular route of administration in Arm Left on 23Feb2021 08:30 (age at vaccination 62years old) as single dose for covid-19 immunisation. the patient has not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine. Medical history included hypersensitivity from an unknown date and unknown if ongoing Medication: Sulpha, allergy to arthropod bite from an unknown date and unknown if ongoing, thrombocytopenia from an unknown date and unknown if ongoing. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9261) via an intramuscular route of administration in Arm right on 05Feb2021 15.30 PM (age at vaccination 62years old) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced fever 102, chills, vomiting, diarrhoea, abdominal pain, nausea on 24Feb2021, and fatigue on 25Feb2021. The patient underwent lab tests and procedures which included body temperature increased: 102 on unspecified date. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.