chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Inflammation, Malaise
Clinical narrative: fatigue; slept 9 hours which in unnormal; felt like an irritation in my lungs or inflammation in my chest; felt like an irritation in my lungs or inflammation in my chest; general malaise; irritation in his chest and cough; irritation in his chest and cough; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot Number: EM9810) via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunisation. Medical history included ongoing asthma. Concomitant medication(s) included dupilumab (DUPIXENT) taken for asthma from an unspecified start date and ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Another operator transferred call in. Stated reporter did not provide his age but says he was born in#. he got his first vaccine at the hospital yesterday about 2pm. Within 3 hours he had general malaise and slept 9 hours which in unnormal. He noticed some irritation in his chest that started yesterday. He didn't notice it today when he woke up, but it is back now after taking a walk. It was causing an odd cough yesterday and felt like an irritation in his lungs or inflammation in his chest. He woke up this morning feeling better, feeling refreshed. Reporter stated he got the Pfizer Covid vaccine yesterday and the guy told him he should experience limited or no side effects. Reporter stated that he did experience very serious fatigue after the injection. States he slept for 9 hours and because he was an older man, so he typically gets 5, 6, or 7 hours of sleep. Reporter stated he had just a general feeling of malaise but what concerned him the most is that he felt this irritation, inflammation in his chest and an odd cough, states it's not deep or heavy just an odd cough. Stated this all set in within 3 hours of the vaccination, felt like it may have improved this morning, he went on a walk in the sunshine and then he started feeling it again. Reporter stated the symptoms he was experiencing are not listed on the sheet, wants to know if they could be due to the vaccine. Outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract irritation, Somnolence
Clinical narrative: fatigue; slept 9 hours which in unnormal; felt like an irritation in my lungs or inflammation in my chest; felt like an irritation in my lungs or inflammation in my chest; general malaise; irritation in his chest and cough; irritation in his chest and cough; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot Number: EM9810) via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunisation. Medical history included ongoing asthma. Concomitant medication(s) included dupilumab (DUPIXENT) taken for asthma from an unspecified start date and ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Another operator transferred call in. Stated reporter did not provide his age but says he was born in#. he got his first vaccine at the hospital yesterday about 2pm. Within 3 hours he had general malaise and slept 9 hours which in unnormal. He noticed some irritation in his chest that started yesterday. He didn't notice it today when he woke up, but it is back now after taking a walk. It was causing an odd cough yesterday and felt like an irritation in his lungs or inflammation in his chest. He woke up this morning feeling better, feeling refreshed. Reporter stated he got the Pfizer Covid vaccine yesterday and the guy told him he should experience limited or no side effects. Reporter stated that he did experience very serious fatigue after the injection. States he slept for 9 hours and because he was an older man, so he typically gets 5, 6, or 7 hours of sleep. Reporter stated he had just a general feeling of malaise but what concerned him the most is that he felt this irritation, inflammation in his chest and an odd cough, states it's not deep or heavy just an odd cough. Stated this all set in within 3 hours of the vaccination, felt like it may have improved this morning, he went on a walk in the sunshine and then he started feeling it again. Reporter stated the symptoms he was experiencing are not listed on the sheet, wants to know if they could be due to the vaccine. Outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Severe joint pain, in thumb joint, both thumbs, after first vaccine, and hurts more after the second vaccine; experienced pain after the first dose; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration 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, the patient experienced severe joint pain, in thumb joint, both thumbs, after first vaccine and experienced pain after the first dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain
Clinical narrative: extreme anxiety; chest tightness and pain; chest tightness and pain; This is a spontaneous report from a contactable consumer. A 24-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an un-specified route of administration, administered in Arm Left on 06May2021 as dose 2, single for covid-19 immunisation (at the age of 24 years). The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Reporter reporting on behalf of her son. He received his second dose of the Pfizer Covid vaccine on 06May2021 and has since experienced extreme anxiety, chest tightness and pain. Caller wants to know if this has bene reported before. His MD diagnosed him with anxiety. Reporter stated that her son received his second dose last Thursday, and he has tightness in his chest and a little bit of pain in his chest every so often, and he is anxious for over a week, and it is still going on. Caller states he has been checked by a physician and she thinks it is anxiety. Caller states she is calling to see if anyone has reported this or if it is common. Caller states it is very concerning. Reporter stated that her son received his second dose of the Covid 19 vaccine last Thursday, 06May2021 and he's experienced tightness in his chest, a little bit of pain, and anxiety over it. He went to the doctor and the doctor thought he was having anxiety and that was what's causing it. He's 24 years old. She's filed a safety report already. Report number 4M8CBO0J. She just wants to speak to someone about her son's symptoms. The outcome of the event anxiety was not recovered, outcome of the events chest tightness and pain was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dark circles under eyes, Eye swelling, Rash, Skin discolouration
Clinical narrative: felt some tightness in her chest, "like a weak compression" that lasted about 20 minutes; rash around her eyes; swollen eyes all week long; the skin around her eyes is very wrinkly, like an elephant, and burgundy colored; dark circles around the whole eye; the skin around her eyes is very wrinkly, like an elephant, and burgundy colored; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route administered on 27Apr2021 (age at vaccination 53-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Apr2021 the patient experienced felt some tightness in her chest, like a weak compression that lasted about 20 minutes. The patient reported that she received her first dose of the Pfizer-Biontech Covid19 vaccine on 27Apr2021.She reported that when leaving the vaccination site, she felt some tightness in her chest, like a weak compression that lasted about 20 minutes, and was resolved within 30 minutes after vaccination. She thought about going back to the vaccination site, but was too far away, and the symptoms resolved. In 2021 the patient experienced rash around her eyes with, swollen eyes all week-long, the skin around her eyes is very wrinkly, like an elephant, and burgundy coloured and dark circles around the whole eye. She was most concerned about the rash around her eyes that has developed, this week. Her friend told her to call and let this know, Is it the symptom of the vaccine of the first shot. The patient spoke to her doctor and the doctor prescribed the Claritin, loratadine (lot and NDC were Unknown, expiration date 13May2022) 1 tablet a day. The swelling around the eyes was gone down a little bit but she was still had the effect. She was asking if the rash/eye swelling could be caused by the vaccine (Is this from the vaccine or a food allergy), and if she should get her second dose? She had spoken with her HCP prior to calling, and they think the reaction may be a food allergy. She was scheduled for her second dose of Pfizer Covid vaccine 18May2021.Therapeutic measures were taken as a result of events Skin wrinkling, swollen eyes, rash around her eyes, skin discoloration. The clinical outcome of the event tightness in her chest was recovered on 27Apr2021 and recovering for swollen eyes and unknown for other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Skin wrinkling
Clinical narrative: felt some tightness in her chest, "like a weak compression" that lasted about 20 minutes; rash around her eyes; swollen eyes all week long; the skin around her eyes is very wrinkly, like an elephant, and burgundy colored; dark circles around the whole eye; the skin around her eyes is very wrinkly, like an elephant, and burgundy colored; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route administered on 27Apr2021 (age at vaccination 53-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Apr2021 the patient experienced felt some tightness in her chest, like a weak compression that lasted about 20 minutes. The patient reported that she received her first dose of the Pfizer-Biontech Covid19 vaccine on 27Apr2021.She reported that when leaving the vaccination site, she felt some tightness in her chest, like a weak compression that lasted about 20 minutes, and was resolved within 30 minutes after vaccination. She thought about going back to the vaccination site, but was too far away, and the symptoms resolved. In 2021 the patient experienced rash around her eyes with, swollen eyes all week-long, the skin around her eyes is very wrinkly, like an elephant, and burgundy coloured and dark circles around the whole eye. She was most concerned about the rash around her eyes that has developed, this week. Her friend told her to call and let this know, Is it the symptom of the vaccine of the first shot. The patient spoke to her doctor and the doctor prescribed the Claritin, loratadine (lot and NDC were Unknown, expiration date 13May2022) 1 tablet a day. The swelling around the eyes was gone down a little bit but she was still had the effect. She was asking if the rash/eye swelling could be caused by the vaccine (Is this from the vaccine or a food allergy), and if she should get her second dose? She had spoken with her HCP prior to calling, and they think the reaction may be a food allergy. She was scheduled for her second dose of Pfizer Covid vaccine 18May2021.Therapeutic measures were taken as a result of events Skin wrinkling, swollen eyes, rash around her eyes, skin discoloration. The clinical outcome of the event tightness in her chest was recovered on 27Apr2021 and recovering for swollen eyes and unknown for other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Malaise, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: He has a cold with a cough and a sore throat.; He has a cold with a cough and a sore throat.; He has a cold with a cough and a sore throat.; not feeling well; This is a spontaneous report from a contactable consumer reported. A 39-year-old male patient received PFIZER-BIONTECH COVID-19 VACCINE (Formulation: Solution for injection, Batch/Lot Number was unknown, Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration on 25Apr2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.On an unknown date patient stated as of two days ago, he started presenting cold symptoms consisting of a cough and sore throat. The patient reported that for his throat hurting and a cold  started a couple of days ago but today he was feeling much better although he still has the throat condition. The patient stated that he was possibly missing the second dose of the COVID vaccine on Sunday, 16May2021, since he was not feeling well as of two days ago. The outcome of all the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Skin disorder
Clinical narrative: Some little bumps under in his arm; Fever; Chills; This is a spontaneous report from a contactable consumer. A 41-years-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 11May2021 (at the age of 41-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date as dose 1, single for COVID-19 immunisation. Reporter stated, I would like to know because my husband he got the second COVID-19 Vaccine already the day before yesterday and now 13May2021 he has some little bumps under in his arm. Reporter added, Yesterday night on 12May2021 he has fever and chills and now he had the bump under his arm. Patient did not receive any treatment for the event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: armpit is swollen and tender/lymph nodes in the arm pit and that could be the swelling and tenderness; armpit is swollen and tender/lymph nodes in the arm pit and that could be the swelling and tenderness; This is a spontaneous report from a contactable consumer (patient). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route, administered in the right deltoid on 11May2021 at 13:50 (at the age of 23 years old) (Batch/Lot Number: EW0179) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient did not receive any prior vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 13May2021, around 17:00, the patient experienced his armpit was swollen and tender/ lymph nodes in the arm pit and that could be the swelling and tenderness. He got his shot-on Tuesday afternoon in his right shoulder and then he started to notice on Friday, 3 days after shot the arm he got the shot in, his arm pit was swollen and tender. The patient stated there are lymph nodes in the arm pit and that could be the swelling and tenderness. He was wanting to know if this is normal or a side effect. He took Advil a day before this report and he had not taken any on the day of this report. The patient was treated with Advil. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Illness, Pain, Pyrexia
Clinical narrative: Felt sick; Had a fever; Body ached; Headache; Feeling weak; This is a spontaneous report from a contactable consumer (patient) reported that:  A 55-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), (At the age of 55 years) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient was scheduled for her second Covid 19 vaccine on 17May2021. The patient medical history was not reported. The patient's concomitant medications were not reported. About 2 weeks after receiving her Covid 19 vaccine. On an unspecified date, the patient had experienced feeling really sick, Fever, body aches, headaches and feeling kind of weak. At the time of reporting, the outcome of the events were unknown.   No follow-up attempts are needed; No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Experienced rash in both arms; This is a spontaneous report from a non-contactable consumer (patient) reporting for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number and Expiry date are not provided), via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Investigation assessment was not provided. On an unspecified date, the patient experienced rash in both arms. The clinical course was reported as follows: The reporter stated that she received her first Pfizer covid vaccine and experienced rash in both arms. Started in the injection arm below the site. The rash was on the arm the shot was in, but not where they put it, it was right below it. Now, it's moved to the other arm. She wanted to know about it. She was wondering if it was normal to have a rash after the first Pfizer Covid vaccine. The paperwork given where she got the shot didn't say anything about a rash. The case was reported as non-serious. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Insomnia, Lethargy
Clinical narrative: Couldn't sleep; Diarrhea; tired; Chills; I have temperature of 100.6; Extremely lethargic; Severe sore arm; This is a spontaneous report received from a contactable consumer (patient). A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 13May2021 (age at vaccination: 79 years), as dose 1, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had severe sore arm (arm hurt and hurt through the night) on 13May2021, and she couldn't sleep. However, the next day (today 14May2021) she was experiencing she was burning in fever chills (I have a temperature of a 100.6) and was feeling lethargic, tired and she also had diarrhea on an unspecified date. Everyone else she knows just had side effects after the second dose and asked was it normal to have side effects after the first dose. Now was this normal or she felt the people who had the first injection have no reaction with just with the second injection, so she was a little bit concerned. She could only take tylenol not any other medicines. The patient underwent lab test and procedure included Fever 100.6 on 14May2021. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Couldn't sleep; Diarrhea; tired; Chills; I have temperature of 100.6; Extremely lethargic; Severe sore arm; This is a spontaneous report received from a contactable consumer (patient). A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 13May2021 (age at vaccination: 79 years), as dose 1, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had severe sore arm (arm hurt and hurt through the night) on 13May2021, and she couldn't sleep. However, the next day (today 14May2021) she was experiencing she was burning in fever chills (I have a temperature of a 100.6) and was feeling lethargic, tired and she also had diarrhea on an unspecified date. Everyone else she knows just had side effects after the second dose and asked was it normal to have side effects after the first dose. Now was this normal or she felt the people who had the first injection have no reaction with just with the second injection, so she was a little bit concerned. She could only take tylenol not any other medicines. The patient underwent lab test and procedure included Fever 100.6 on 14May2021. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Cough, Dysgeusia
Clinical narrative: loss of taste; metallic taste; small cough; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on 04May2021 (Batch/Lot number was not reported, expiry date: unknown) as dose 2, single for COVID19 immunisation. The patient's medical and concomitant medications were not reported. The patient had previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on unspecified date (Batch/Lot number was not reported, expiry date: unknown) as dose 1, single for COVID19 immunisation. On 07May2021 the patient reported ''started get-ting very small cough and non other he got but also to had what's his taste, his taste almost like metal, he almost feel like metal taste and he told he know it was reaction that happens like three days after the shot and he was fine before but he took on the for since today's like 10 days later was that normal to last this long (loss of taste, metallic taste, and small cough). Patient was asking whether is it normal after 14 days to still have side effects and what he should do about it. Patient stated he would rather speak to doctor right now considering un-comfortable. The outcome of the events was recovered on unspecific date in May 2021  No follow-up attempts are needed; Information related to batch/Lot number could not be re-quested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: swelling of her legs, that was painful/ legs were like swollen and hurting a lot, and it did not go away; swelling of her legs, that was painful/ legs were like swollen and hurting a lot, and it did not go away; inflammation; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0173 and expiry date was not reported), via an unspecified route of administration in right arm, on 01May2021 (age at vaccination: 50 years), as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were none. On 05May2021, 3-4 days after the patient presented swelling of her legs, that was painful/ legs were like swollen and hurting a lot, and it did not go away and inflammation. The patient queried what she should take to reduce inflammation. The patient used cold water as treatment. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Swelling
Clinical narrative: having swelling under armpit near the breast area; her arm pit like swollen like a lump; This is a spontaneous report from a contactable consumer or other non-health professional (patient). This 35-year-old female patient received bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0158) via an unspecified route of administration, in Left arm on Wednesday 12May2021, as DOSE 1, single for COVID-19 immunisation (age at vaccination:35-years-old). The patient medical history and concomitant medication was not reported. Patient informed that the scheduled date of second shot of COVID Vaccine was 04Jun2021.Patient reported that on the site on Wednesday where she got the shot under her arm and her arm pit was swollen like a lump. She added the swelling under armpit near the breast area. The patient wanted to know if this was normal and when it will go away, or when she should go to hospital. The patient treatment medication include Tylenol and it makes it feel better. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: severe" pain in both thumb joints since the second dose/pretty severe joint pain in only the thumb joint; it has gotten worse/ hurts more after the second vaccine; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), 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. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation and patient experienced severe joint pain, in thumb joint, both thumbs. She stated she was experiencing pretty severe joint pain in only the thumb joint. It was in both the thumb joints and they hurt pretty bad. She stated she had this event with her first vaccine, but it hurts more, after the second vaccine. She stated it has been about 3 weeks after the second vaccine. She asks if this was something that people have experienced, thumb joint pain? She stated she would like to know if anyone has specifically reported joint pain in the thumb joint. She experienced pain after the first dose of the Pfizer COVID-19 vaccine but it has gotten worse, "severe" pain in both thumb joints since the second dose. Severe joint pain, in thumb joint, both thumbs, after first vaccine, and hurts more after the second vaccine. How long should this last? The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; I had a rash/really big rash on my behind; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported, Expiry Date: Unknown) via an unspecified route of administration, administered in Left arm on 12May2021 (at the age of 57-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Patient stated he got his second dose yesterday and stated that "I started experiencing the itching after I got it and when I woke up this morning I had a rash, really big rash on my behind" on an unspecified date in 2021. Outcome of the events was unknown.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza, Nasal congestion, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cold like symptoms; Cough; Stuffy nose; Cold; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient that,   A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 25Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the received the first dose of vaccine on 25Apr2021 with her husband and on an unknown date she developed cold or cold like symptoms, cough and stuffy nose. She went to her doctor because she thought she had cold like symptoms, on an unspecified date. The doctor did a COVID test which came negative. She was asked to wait before getting the second dose. The outcome for the events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Hypersensitivity, Sneezing
Clinical narrative: Skin allergy; Lot of allergic reaction on both hands/across my body; Sneezing; is really discomfort able right now; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0164), via an unspecified route of administration on 10May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient stated was having allergy like skin allergy it had been like 3 to 4 days (May2021) after getting second shot of vaccine and early morning patient was having like sneezing (May2021) continually when patient got up and right then patient was having lot of allergic reaction on both hands, it was getting spread across the body. Patient further stated that patients condition was really discomfort (May2021) able right then. The clinical outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blister, Rash
Clinical narrative: I am having bad allergic reaction to this Pfizer Vaccine, I broken out, I am sitting here broken out in blisters and everything; I don't want to my skin being inside out, they test the rash that I am breaking out; This is a spontaneous report received from a contactable consumer (Patient reported for herself). A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Right on 05Apr2021 (at the age of 33-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma, migraine and seasonal allergy all from an unknown date and ongoing. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for asthma, start and stop date were not reported, sumatriptan succinate (IMITREX DF) taken for migraine, start and stop date were not reported, caffeine, paracetamol (EXCEDRIN ASPIRIN FREE) taken for migraine, start and stop date were not reported, diphenhydramine hydrochloride (BENADRYL) taken for seasonal allergy, start and stop date were not reported. The reporter reported as I am having bad allergic reaction to this Pfizer Vaccine, I broken out, I am sitting here broken out in blisters and everything, went to emergency room and I don't want to my skin being inside out, they test the rash that I am breaking out on an unknown date. Consumer stated, she had both shots of Pfizer vaccines. After both shots she experienced a breakout. This second break out she experience was way worsened first, her skin has evaluated into a blisters. She went to the emergency room both times and the first time it did breakout then. This time they had to do biopsy of my skin to test the skin. She have been prescribed medications for allergic reactions and they gave me some ointment to put on my skin because my skin was hurting. Patient got the first vaccine on 05Apr and on 08Apr I experienced my first breakout. It lasted from 08Apr until 13Apr. On the Second shot I have got 25Apr and my breakout started yesterday, today and my breakout started on 11May and it's still on off. The patient underwent lab tests and procedures which included skin biopsy with unknown result on an unknown date. The outcome of the events was reported as recovered on 13Apr2021.  No follow-up attempts are needed. No further information is expected.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: patient got her second COVID shot, her second dose yesterday and shot was around noon, she forgot and took a Tylenol at 5.00; Very little sore arm; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on 13May2021 at 12:00, as dose 2, single for COVID-19 immunization and the patient also received paracetamol (TYLENOL) via an unspecified route of administration, start and stop date, lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on unspecified date, as dose 1, single for COVID-19 immunization. Patient had very little sore arm on unspecified date in May2021. The patient stated that when patient got her second COVID shot, her second dose yesterday on 13May2021 and shot was around noon, she forgot and took a Tylenol at 5.00. The patient got one of the captions of not to take Tylenol before get the shot and that was what she did and she wondered if that was going to hurt anything. The patient reported that she had very little sore arm and that was (incomplete sentence).  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash pruritic
Clinical narrative: Itchy rash; Very small pockets of liquid after the first dose (maybe 4) that only spread toscratched area after the second dose.; This is a spontaneous report from a contactable consumer, the patient. This is second of two reports. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO161) via an unspecified route of administration in the left arm on 20Apr2021 at 16:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was reported as none. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 30Mar2021 at 16:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation and experienced very small pockets of liquid after the first dose maybe 4. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced very small pockets of liquid after the first dose maybe 4 that only spread to scratched area after the second dose. On 24Apr2021, the patient experienced Itchy rash within 2 days of getting the 2nd vaccine on both arms near the elbow joint similar to poison ivy. Patient stated that it eventually cleared up after a few weeks. Had not eaten anything new or been around any plants. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very small pockets of liquid, Itchy rash was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Rash erythematous, Skin burning sensation
Clinical narrative: I still have bad headaches; it burned my skin instantly; I had fever 103.2 for 4 days; terrible body aches for 3 weeks; I had a red rash on my arm; This is a spontaneous report from a contactable consumer (patient), received via Pfizer RXPathways. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date in 2021 as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. Patient reported that she had the second vaccine 3 weeks ago and she still had bad headaches (2021). Patient had a rash on her arm and it burned her skin instantly (2021). On an unspecified date in 2021, she had fever 103.2 for 4 days, terrible body aches for 3 weeks, she had a red rash on her arm. The clinical outcome for the events was unknown except not recovered for I still have bad headaches and recovered for I had fever 103.2 for 4 days and terrible body aches for 3 weeks on an unspecified date in 2021.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness
Clinical narrative: Extremely fatigued; Stiffness; This is a spontaneous report received from a contactable other healthcare professional. A 22-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration, on an unspecified date as dose number unknown, single for COVID-19 immunisation and patient also received co-suspect as tofacitinib citrate (XELJANZ) (Batch/Lot number: Unknown), via an unspecified route of administration from 13Mar2021 to an unspecified date, at 5 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced extremely fatigued on an unspecified date. Reported missing doses after receiving COVID 19 vaccine because she was extremely fatigued. on an unspecified date 2021, also had a flare up that caused stiffness throughout body that lasted the weekend and resolved on its own. The outcome of the event stiffness was reported as recovered on an unspecified date 2021 and fatigue was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Contusion, Dyspnoea, Neck pain
Clinical narrative: Chest pain; Bruises; Neck pain; Shortness of breath; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).   A 33-Year-old female (non-pregnant) patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no: not reported/ Lot number: Ewo183) via unspecified route of administration on 14May2021 09:00 AM (at the age of 33-years-old) in Arm Left as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 15May2021, patient experienced with chest pain, bruises, neck pain, shortness of breath. No Hospitalization required for the events caused. Seriousness reported as no. No treatment received for the events caused. Outcome of the events was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Rash, Weight
Clinical narrative: she said she had pain; developed rashes in the crease of her left arm which started out yesterday, and has increased today/Has a few dots on the same arm; muscle in the left arm, where received the second dose Pfizer Covid 19 Vaccine is in pain, just like a throb; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 60-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 11May2021, at 15:23 (Age at the vaccination 60 years), as DOSE 2, SINGLE for covid-19 immunization. Medical history included blood pressure and acid reflux from an unknown date and unknown if ongoing. Blood pressure medication and acid reflux medication was not specified. Patient did not receive prior vaccinations within 4 weeks. Concomitant medications were not reported. Patient previously received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EW0161, Expiration: unknown), via an unspecified route of administration, administered in Left shoulder on 20Apr2021 (Age at the vaccination 60 years), as DOSE 1, SINGLE for covid-19 immunization. The patient said she had pain at the muscle from where she received the vaccine. She also said she developed rashes in the crease of her left arm which started out yesterday, had a few dots on the same arm and muscle in the left arm, where received the second dose pfizer covid 19 vaccine was in pain, just like a throb on 16May2021. Timeframe between vaccination and starting of symptoms was 4 days 8 hrs 37 min. The patient underwent lab tests and procedures which included weight was 220lbs or 219lbs lbs on an unspecified date. The clinical outcome of the events she had pain and she developed rashes in the crease of her left arm which started out yesterday was unknow. Outcome of the events had a few dots on the same arm, muscle in the left arm, where received the second dose Pfizer Covid 19 Vaccine was in pain, just like a throb was not recovered at the time of reporting.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Condition aggravated, Erythema, Feeling abnormal
Clinical narrative: it seems like she has arthritis; sore arm,cannot move her thumbs; her right heel and right knee beginning to hurt,elbowpain; it is getting worse and starting to travel to her wrists; her neck started making a kind of cracking noise; her left elbow that she has two little pea sized bumps and when she presses them it hurts and they are red;; after the 5th of April, she has felt like a 90 year old person; massive body pains; she can't drive because she can't bend her thumbs; her left elbow that she has two little pea sized bumps and when she presses them it hurts and they are red;; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150, Expiry Date: Unknown) via an unspecified route of administration in left arm on 05Apr2021 at 12:16 (at the age of 48 years-old) as dose 2, single for COVID-19 immunization. Patient medical history included alpha tryptasemia (a hereditary condition called alpha tryptasemia where her tryptase 22 is triplication of the gene). The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number Batch/Lot Number EN6206) via an unspecified route of administration on 15Mar2021 as single for COVID-19 immunization. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. The patient experienced it seems like she has arthritis, sore arm, her right heel and right knee beginning to hurt, some pain left elbow, nodules (bumps) on left elbow, cannot move her thumbs, it is getting worse and starting to travel to her wrists,  her neck started making a kind of cracking noise (remained the same since it began and it has been probably 4 weeks since that started), her left elbow that she has two little pea sized bumps and when she presses them it hurts and they are red, after the 5th of April, she has felt like a 90 year old person , massive body pains , she can't drive because she can't bend her thumbs on an unspecified date, her left elbow that she has two little pea sized bumps and when she presses them it hurts and they are red on 19Apr2021. She experienced an adverse reaction and is unable to get medical care because she can't get an appointment and is just calling to see if there is something to do that Pfizer can advise her. she reported that she cannot drive because she can't bend her thumbs. The report is not related to as study or programme. No investigation assessment was done. The outcome of events were unknown.  Follow-up attempts are needed.further information is expected..