chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Experienced some pain in my left side; I passed a urinary clot like a blood clot; It could be a urinary tract infection; I just passed the blood clot; felt really bad like he had no energy and slept on and off for 10 hours; felt really bad like he had no energy and slept on and off for 10 hours; felt really bad like he had no energy and slept on and off for 10 hours; I passed a urinary clot like a blood clot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Right shoulder on 15Apr2021 (at the age of 62 years) (Batch/Lot Number: EU00162) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included High Blood Pressure from 2010 to an unknown date. The Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on 20Mar2021 (at the age of 62 years) for covid-19 immunisation. Patient received the second dose of the Pfizer BioNTech Covid-19 vaccine on 15Apr2021, on 22Apr2021 he experienced pain in his left side and had no energy. This morning he passed a blood clot in his urine. He did not have any symptoms before, he was not sure if this is something that you have previously observed or heard maybe there is something in the past. He knew there are some issues with the vaccines like people were getting blood clots (further clarification unknown). Also, he was not sure if it was urinary clot, I was not sure if I was late, but it was just coincidental that it was after a week he got my shot. Patient stated, he guesses like he was in bed all day yesterday and today (not specified), he felt better but he just passed the blood clot, so he would say it was persisting. Stated, I was treating it now as a UTI infection until I find out otherwise, no such medications that he was taking. Stated yesterday, 22Apr2021, he experienced pain on his left side; felt really bad like he had no energy and slept on and off for 10 hours. He was reaching out to Pfizer to see if this has occurred with other people. The patient received the treatment for the event I passed a urinary clot like a blood clot. The clinical outcome of the event was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Lymphadenopathy, Malaise
Clinical narrative: Felt trash after getting the vaccine; Fever; Fatigue; Brain fog; Leg pain; Muscle pain; Swollen glands; Joint paint; This is a spontaneous report from a contactable consumer or other non-HCP (patient father). A 16-years-old male patient received 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 2, single and received 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. The patient felt trash after getting the vaccine, he experienced almost all side effects listed on the fact sheet for almost 3 weeks and side effects experienced are fever, fatigue that inhibits him to train for his sport, brain fog that caused missed school days, leg pain fir 20 days, muscle pain, swollen glands for 14 days, joint paint for 16 days, as reporter would be driving his son now to the doctor appointment. Reporter questioned about if we have any data as to any disproportionate adverse events experienced by younger recipient's vs that of the older ones. (In short, if AEs where way worst for younger than older recipients), is that if side effects are more severe if recipients had contracted COVID and had been asymptomatic and not know while vaccine was administered, if there is any way to distinguish if recipient's developed immunity was a result of natural immune's response in fighting off COVID19 infection or if this was attributed by the vaccine, could the side effects be possibly be brought about by receiving another dose of another COVID19 vaccine by mistake (another manufacturer, that given the side effects experienced, should he receive possible additional doses (booster shot) of the PFIZER-BIONTECH COVID-19 VACCINE in the future, is that could the side effects be possibly be brought about by mishandling of the vaccine outside of its recommended storage conditions. The outcome of all events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Felt trash after getting the vaccine; Fever; Fatigue; Brain fog; Leg pain; Muscle pain; Swollen glands; Joint paint; This is a spontaneous report from a contactable consumer or other non-HCP (patient father). A 16-years-old male patient received 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 2, single and received 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. The patient felt trash after getting the vaccine, he experienced almost all side effects listed on the fact sheet for almost 3 weeks and side effects experienced are fever, fatigue that inhibits him to train for his sport, brain fog that caused missed school days, leg pain fir 20 days, muscle pain, swollen glands for 14 days, joint paint for 16 days, as reporter would be driving his son now to the doctor appointment. Reporter questioned about if we have any data as to any disproportionate adverse events experienced by younger recipient's vs that of the older ones. (In short, if AEs where way worst for younger than older recipients), is that if side effects are more severe if recipients had contracted COVID and had been asymptomatic and not know while vaccine was administered, if there is any way to distinguish if recipient's developed immunity was a result of natural immune's response in fighting off COVID19 infection or if this was attributed by the vaccine, could the side effects be possibly be brought about by receiving another dose of another COVID19 vaccine by mistake (another manufacturer, that given the side effects experienced, should he receive possible additional doses (booster shot) of the PFIZER-BIONTECH COVID-19 VACCINE in the future, is that could the side effects be possibly be brought about by mishandling of the vaccine outside of its recommended storage conditions. The outcome of all events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergy was activated more severe and began to spread to the upper lip; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 28-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW01620), via an unspecified route of administration, administered in Arm Left on 22Apr2021 11:00 (Age at vaccination: 28-years-old) as Single dose for covid-19 immunization. (Vaccination facility: Other). Medical history was reported as no.  Concomitant medication included lisinopril dihydrate (LISINOPRIL [LISINOPRIL DIHYDRATE]) taken for an unspecified indication, start and stop date were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 Prior to vaccination. It was reported that patient already had an allergy in her hands which had already been controlled by a soothing eczema cream but a few hours after the application of the Pfizer vaccine, on 23Apr2021 14:45 the allergy was activated more severe and began to spread to the upper lip. Patient received treatment for the event with Fexofenadine. The outcome for the events was reported as not resolved at the time of this report.   Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Rash, Vaccination site pain, Vaccination site warmth
Clinical narrative: presented some side effects that are listed, such as aches; Chills; a rash like patches here and there; the injection site is warm; the injection site is warm and sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose number unknown at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID-19 vaccine and presented with some side effects that are listed, such as aches, chills and a rash like patches here and there and the injection site is warm and sore. She would like to know if there is anything she could take before the second vaccine such as Benadryl to prevent side effects from happening. The clinical outcome of events was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: shortness of breath; sore throat; cough; This is a spontaneous report from a non contactable consumer(patient) reported for herself. A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 20Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of COVID-19 VACCINE as dose 1, single for COVID-19 immunization. Patient received the 2nd dose of Pfizer vaccine on Tuesday the 20th, started getting sore throat day of vaccine, next day started with shortness of breath and cough. Patient wanted to know how long these were going to last? at what point should patient be concerned? Patient asked at what point should patient get medical attention, patient was having trouble breathing. What are the risks, Side effects after second shot may be more intense than the ones experienced after first shot. These side effects were normal signs that body was building protection and should go away within a few days. It was mentioned that, doctor/health care provider in the best position to assess and advise as doctor/health care provider was most familiar with your medical condition, clinical history, how treatment has been conducted and any relevant information to your specific case. Patient went to ER yesterday, they told me to stay hydrated. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling hot, Paraesthesia
Clinical narrative: After receiving the first dose experienced a burning tingling sensation in her chest and tingling sensation in her arm; After receiving the first dose experienced a burning tingling sensation in her chest and tingling sensation in her arm; Sometimes like in between when I was getting those shots, I had this hotness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EN6208) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included estradiol taken for an unspecified indication, start and stop date were not reported. Patient stated, "Sometimes I feel a little bit of that tingling in my arm and when I got the vaccine, I got one in left arm and one in the right arm. I was just doing some experiment in different way just to see (sentence incomplete). Also, sometimes like in between when I was getting those shots, I had this hotness, '' it was like I need help with someone'' (not clear). I did have lab work done when I went to the hospital on March 31st, but they said everything was normal with the lab work and also with the EKG and the chest x-ray that was performed." (Not clarified further). She did receive the second dose and stated that she had these mild symptoms off and on since getting the second dose. She did also make the statement that she knows people who received the COVID vaccine and did not state if it was the Pfizer product, who became sick or tested positive for COVID after getting the first dose and decided not to get the second dose but again she did not confirm if those were Pfizer products or not (further clarification unknown)." Patient further stated, "I just had a question if it was anything to do with vaccine or not as it just happened within the time of getting the vaccine, that was why I was calling and if other people had reported the same symptoms or not." The events resulted in visit to emergency room. The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460628 same reporter/drug, different event/patient
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 antibody test
Clinical narrative: loss of taste; This is a spontaneous report from a contactable HCP. This HCP reported for unknown (patient). A male patient with an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) via unknown route of administration on 09Mar2021 as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) via unknown route of administration on 27Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The experienced loss of taste after the first dose of the vaccine. The lab data included covid test with negative result on 07Apr2021. At the time of this report outcome of the event was unknown.  No follow-up attempts were needed, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Inflammation, Pyrexia
Clinical narrative: Inflammation  lines lesions that come and go; Inflammation  lines lesions that come and go; chills; fever; immediate synthetic headache; Experienced brain fog; This is a spontaneous report from a contactable consumer (patient) for herself. This 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number were not reported), via an unspecified route of administration on 02Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. On an unspecified date in Apr2021 after the vaccination, the patient experienced inflammation lines lesions that come and go, chills, fever, immediate synthetic headache and experienced brain fog. It was reported that, the patient reluctantly received first dose 02Apr2021, 7-10 days following first dose the patient reported inflammation, lines lesions that come and go. Not historical and blood clots. They occur again, resolve and experienced brain fog, an immediate synthetic headache, chills and fever. The patient did not take any medication and declined complete demographics. The HCP indicated to receive second dose and asked if adverse events was worse Potential Duplicate AE. Spoke from attached and Full EUA Prescribing Information Table 1: Study 2 - Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days after each dose - Participants 18-55 Years of Age-Reactogenicity Subset of the Safety Population. Refer to HCP numerous time. The patient asked about efficacy of vaccine and how long the patient be protected. When was the patient knowns that he was protected and if he get Sars-COV-2, it be less symptomatic and the patient safely went out. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: Inflammation  lines lesions that come and go; Inflammation  lines lesions that come and go; chills; fever; immediate synthetic headache; Experienced brain fog; This is a spontaneous report from a contactable consumer (patient) for herself. This 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number were not reported), via an unspecified route of administration on 02Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. On an unspecified date in Apr2021 after the vaccination, the patient experienced inflammation lines lesions that come and go, chills, fever, immediate synthetic headache and experienced brain fog. It was reported that, the patient reluctantly received first dose 02Apr2021, 7-10 days following first dose the patient reported inflammation, lines lesions that come and go. Not historical and blood clots. They occur again, resolve and experienced brain fog, an immediate synthetic headache, chills and fever. The patient did not take any medication and declined complete demographics. The HCP indicated to receive second dose and asked if adverse events was worse Potential Duplicate AE. Spoke from attached and Full EUA Prescribing Information Table 1: Study 2 - Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days after each dose - Participants 18-55 Years of Age-Reactogenicity Subset of the Safety Population. Refer to HCP numerous time. The patient asked about efficacy of vaccine and how long the patient be protected. When was the patient knowns that he was protected and if he get Sars-COV-2, it be less symptomatic and the patient safely went out. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Insomnia, Vision blurred
Clinical narrative: her vision got blurry, unfocused for a 1-2 seconds then went away; felt dizzy/dizziness/felt light headed; couldn't sleep until 3:00 AM; felt pressure in her chest; had a hard time breathing; This is a spontaneous report from a contactable consumer(patient) other non-healthcare professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown),via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing a strange allergic reaction to Cetafhil face wash, immediately had tightness in her chest, difficulty breathing, her throat felt raw. Concomitant medications included xylometazoline hydrochloride (NASAL SPRAY II), triamcinolone acetonide (NASACORT ALLERGO) were taken for an unspecified indication, start and stop date were not reported. After first vaccination (past Wednesday at 10:30 am) after 10 min Patient's vision got blurry, unfocused for a 1-2 seconds then went away. Patient felt dizzy about an hour later which lasted all throughout the night and couldn't sleep until 3:00 AM. It lasted into Thursday. Patient went to lay down about 3-4 hours later, felt pressure in her chest, had a hard time breathing and got up, sat in a chair. It was not severe enough to pass out but fluctuated on and off for 2 hours. With the dizziness, patient also felt light headed on and off throughout. Patient to know whether their side effects to the covid vaccine are normal. A few months ago, patient had a strange allergic reaction to Cetafhil face wash, and it was the exact same thing that happened where patient immediately had tightness in her chest, difficulty breathing, her throat felt raw. Patient was told not to use it again. Cetafhil contains something called PEG. Patient asked is it the same PEG item that is in the covid vaccine and is that a reaction that would happen from it and patient wanted to know would she fall into the category of someone who should not get the second shot. The clinical outcome of the events was unknown.  Follow-up attempts are completed. information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: swelling of my feet and legs; Sat 4/17 I went to the beach for 2 hours. By Sunday 4/18 I had patches and streaks of red like sun burn and severe swelling of my feet and legs. This has continued with the swelling decreasing but sti; This is a spontaneous report from a contactable consumer (herself). A 43-years-old non pregnant female patient received second dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Apr2021 06:00 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 43 years). The patient medical history was not reported. The patient was unaware of allergies to medication, food, or other products. The patient's concomitant medications were not reported. Not pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. And no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced on 17Apr2021 that sat 4/17 i went to the beach for 2 hours. by sunday 4/18 she had patches and streaks of red like sun burn and severe swelling of her feet and legs. This has continued with the swelling decreasing but still present w the redness, swelling of my feet and legs. The patient underwent lab test Ultrasound of legs to review if a blood clot which resulted negative. The patient received treatment. The patient visited doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were recovering/ resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Left sided pain; Feel like its swollen; She felt dizzy on and off; Very tired; She also had a headache the first day and then the pain gradually disappeared; On the back of hand and top of her feet she can feel blood vessels and they are slightly painful; This is a spontaneous report received from a contactable consumer (patient).  A 55-years-old female patient received bnt162b2 (BNT162B2, Lot Number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient's medical history included seasonal allergies and high cholesterol. Concomitant medications were not reported. On an unknown date, the patient received the first dose of the Pfizer COVID vaccine two weeks ago. Consumer stated she has had left sided pain and feel like its swollen. Consumer stated for one week after the vaccine she felt dizzy on and off and very tired. Consumer stated she also had a headache the first day and then the pain gradually disappeared. Consumer stated on the back of hand and top of her feet she can feel blood vessels and they are slightly painful. Consumer would like to know if these symptoms are normal? Consumer stated she has high cholesterol and was worried about blood clots as well. Caller would also like to know if she can receive the second dose? Consumer stated her son who was 20 year male and special needs received the first dose of the Pfizer COVID vaccine and during vaccination after the needle was removed water and blood sprayed out. Caller states she was not sure he received the vaccine or if a blood vessel was hit during vaccination. Consumer stated she has seasonal allergies and would like to know if she can take allergy medications such as Benadryl and Allegra? Consumer would like to know if her son should receive the second dose if during the first dose administration water and blood sprayed out once the needle was removed from his arm? Consumer would like to know how people have reported blood clots after receiving the Pfizer COVID vaccine? Consumer would like to know what are the symptoms of blood clots and the age range for people who get blood clots? No information regarding leakage of vaccine during first dose and recommendations regarding second dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Left sided pain; Feel like its swollen; She felt dizzy on and off; Very tired; She also had a headache the first day and then the pain gradually disappeared; On the back of hand and top of her feet she can feel blood vessels and they are slightly painful; This is a spontaneous report received from a contactable consumer (patient).  A 55-years-old female patient received bnt162b2 (BNT162B2, Lot Number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient's medical history included seasonal allergies and high cholesterol. Concomitant medications were not reported. On an unknown date, the patient received the first dose of the Pfizer COVID vaccine two weeks ago. Consumer stated she has had left sided pain and feel like its swollen. Consumer stated for one week after the vaccine she felt dizzy on and off and very tired. Consumer stated she also had a headache the first day and then the pain gradually disappeared. Consumer stated on the back of hand and top of her feet she can feel blood vessels and they are slightly painful. Consumer would like to know if these symptoms are normal? Consumer stated she has high cholesterol and was worried about blood clots as well. Caller would also like to know if she can receive the second dose? Consumer stated her son who was 20 year male and special needs received the first dose of the Pfizer COVID vaccine and during vaccination after the needle was removed water and blood sprayed out. Caller states she was not sure he received the vaccine or if a blood vessel was hit during vaccination. Consumer stated she has seasonal allergies and would like to know if she can take allergy medications such as Benadryl and Allegra? Consumer would like to know if her son should receive the second dose if during the first dose administration water and blood sprayed out once the needle was removed from his arm? Consumer would like to know how people have reported blood clots after receiving the Pfizer COVID vaccine? Consumer would like to know what are the symptoms of blood clots and the age range for people who get blood clots? No information regarding leakage of vaccine during first dose and recommendations regarding second dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Taking a steroid because allergic to antihistamines and since he had 2nd covid vaccine he get the rashes after his steroid treatment; Brook out in big patches of hives; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Er8734 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 23Apr2021 at 11:00 as DOSE 2, SINGLE for covid-19 immunisation (age at vaccination: 47-years-old). Medical history included drug hypersensitivity (Antihistamines). The patient's concomitant medications were not reported. The patient previously received bnt162b2, on 02Apr2021 at 11:00 AM as dose 1 (Batch/Lot Number: Ep7534) for covid-19 immunisation (vaccine location: Right arm, age at vaccination: 47-years-old). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced brook out in big patches of hives on 23Apr2021 at 17:00, taking a steroid because allergic to antihistamines and since he had 2nd covid vaccine he get the rashes after his steroid treatment on an unspecified date. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of brook out in big patches of hives as Prednisone 20mg. Outcome of the events Brook out in big patches of hives was Recovering, Taking a steroid because allergic to antihistamines and since he had 2nd covid vaccine he get the rashes after his steroid treatment was unknown.  Follow-up(30Apr2021): This is a follow-up spontaneous report from a contactable consumer.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Under my arm and shoulder is sore; Under my arm and shoulder is sore; Pain; This is a spontaneous report received from contactable consumer (patient). A patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number/ NDC number/ UPC number and Expiry Date: unknown), via an unknown route of administration on 17Apr2021 (Saturday) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 18Apr2021, next day of vaccination, the patient experienced under my arm and shoulder was sore and pain. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain
Clinical narrative: had bone pain as well in her ankles and her knees and her back as well; had bone pain as well in her ankles and her knees and her back as well; had bone pain as well in her ankles and her knees and her back as well; This is a spontaneous report received from a contactable consumer (Patient). An unspecified age of female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Not Provided), via an unspecified route of administration on 14Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date Apr2021, the patient had bone pain as well in her ankles and her knees and her back as well. Her mother received their COVID vaccines on Wednesday 14APR2021 and was reporting AE/ MI on her mother after the COVID vaccine and the caller had mentioned during that report that She, the caller, has had bone pain as well in her ankles and her knees and her back as well. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea exertional
Clinical narrative: short of breath with very mild exertion; This is a spontaneous report from a contactable consumer or other non-healthcare professional via Pfizer Sponsored Program Rx Pathways. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 13Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 17Apr2021, the patient experienced short of breath with very mild exertion. It was reported that four days after receiving the second vaccine the patient started becoming short of breath with very mild exertion. The patient received the second does on 13Apr2021 It was now the 21st and patient still experiencing shortness of breath. The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Menstruation delayed, Pain
Clinical narrative: Period 3 days late; body aches; Fever; chills; Head ache; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 27-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Unknown dose number single for covid-19 immunization. No medical history and no concomitant medications were not reported. patient was not diagnosed with COVID-19 Prior to vaccination. On 22Apr2021 patient experienced period 3 days late, Fever, chills, body aches, headache, fatigue. Since the vaccination patient was not tested for COVID-19. Patient did not receive any treatment for the events. The outcome for the event Period 3 days late was resolved on 25Apr2021and for remaining events outcome was reported as resolved on an unspecified date in May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Period 3 days late; body aches; Fever; chills; Head ache; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 27-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Unknown dose number single for covid-19 immunization. No medical history and no concomitant medications were not reported. patient was not diagnosed with COVID-19 Prior to vaccination. On 22Apr2021 patient experienced period 3 days late, Fever, chills, body aches, headache, fatigue. Since the vaccination patient was not tested for COVID-19. Patient did not receive any treatment for the events. The outcome for the event Period 3 days late was resolved on 25Apr2021and for remaining events outcome was reported as resolved on an unspecified date in May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: She is still experiencing the excruciating headache; fever; nausea; diarrhea; dizziness; confusion; This is a spontaneous report from a contactable consumer (Self) or other non-healthcare professional.  A 43-years-old female patient received the second dose of BNT162B2 (BNT162B2, PFIZER-BioNTech COVID-19 VACCINE, solution for injection, lot number: ER8729), via an unspecified route of administration on 10Apr2021 (Age at vaccination 43 years) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. She has previously received the first dose of BNT162B2 (BNT162B2, PFIZER-BioNTech COVID-19 VACCINE, solution for injection, lot number: ER8727) via an unspecified route of administration on 20Mar2021 as dose 1, single for COVID-19 immunisation, and had excruciating headaches. On an unspecified date, she was still experiencing excruciating headaches, fever, nausea, diarrhea, dizziness, and confusion. The clinical course was she had the second dose of the COVID-19 Vaccine on 10Apr2021. She had bad side effects. She was still experiencing the excruciating headache. States that her doctor gave her some medication for it, but it was only enough for 5 days. Reports her age as 43 years and 4 months. The caller stated she had the second dose of the Pfizer COVID-19 vaccine on 10Apr2021. The caller stated the first two days she had very bad side effects. The caller stated the worst was an excruciating headache plus fever, nausea, and diarrhea. The caller stated all the symptoms went away on day three. The caller stated the headache has not gone away on day 11. The caller stated it was not bad but still there. The caller stated she was also experiencing dizziness and confusion since the second dose. The caller stated she saw her doctor last Thursday and the neurology exam was normal. The caller stated the doctor gave her migraine medicine for short-term use and it helped some but now the medicine is gone. The case was classified as non-serious. On an unspecified date, the patient underwent lab tests and procedures which included neurological examination: normal. The outcome of the event headache was not resolved, events fever, nausea, and diarrhea was resolved on an unspecified date and the remaining events confusion and dizziness was unknown.  Follow-up (21Apr2021): This is a follow-up spontaneous report from a contactable consumer.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, Pyrexia
Clinical narrative: She is still experiencing the excruciating headache; fever; nausea; diarrhea; dizziness; confusion; This is a spontaneous report from a contactable consumer (Self) or other non-healthcare professional.  A 43-years-old female patient received the second dose of BNT162B2 (BNT162B2, PFIZER-BioNTech COVID-19 VACCINE, solution for injection, lot number: ER8729), via an unspecified route of administration on 10Apr2021 (Age at vaccination 43 years) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. She has previously received the first dose of BNT162B2 (BNT162B2, PFIZER-BioNTech COVID-19 VACCINE, solution for injection, lot number: ER8727) via an unspecified route of administration on 20Mar2021 as dose 1, single for COVID-19 immunisation, and had excruciating headaches. On an unspecified date, she was still experiencing excruciating headaches, fever, nausea, diarrhea, dizziness, and confusion. The clinical course was she had the second dose of the COVID-19 Vaccine on 10Apr2021. She had bad side effects. She was still experiencing the excruciating headache. States that her doctor gave her some medication for it, but it was only enough for 5 days. Reports her age as 43 years and 4 months. The caller stated she had the second dose of the Pfizer COVID-19 vaccine on 10Apr2021. The caller stated the first two days she had very bad side effects. The caller stated the worst was an excruciating headache plus fever, nausea, and diarrhea. The caller stated all the symptoms went away on day three. The caller stated the headache has not gone away on day 11. The caller stated it was not bad but still there. The caller stated she was also experiencing dizziness and confusion since the second dose. The caller stated she saw her doctor last Thursday and the neurology exam was normal. The caller stated the doctor gave her migraine medicine for short-term use and it helped some but now the medicine is gone. The case was classified as non-serious. On an unspecified date, the patient underwent lab tests and procedures which included neurological examination: normal. The outcome of the event headache was not resolved, events fever, nausea, and diarrhea was resolved on an unspecified date and the remaining events confusion and dizziness was unknown.  Follow-up (21Apr2021): This is a follow-up spontaneous report from a contactable consumer.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 test
Clinical narrative: I had a huge almost quarter-sized allergic reaction on the middle of my chest.; This is a spontaneous report from a contactable consumer (Patient). A 20-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0161, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 16Apr2021 (age at vaccination: 20years-old) as dose 1, single for COVID-19 immunisation. Medical history included polycystic ovaries, asthma and food allergy to Peanuts and nuts. Concomitant medications included sertraline; spironolactone; drospirenone, ethinylestradiol (LORYNA) and alprazolam. Patient was not pregnant at the time of vaccination. The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination. On 16Apr2021, the patient experienced "I had a huge almost quarter-sized allergic reaction on the middle of my chest." It was reported that after receiving the shot, less than an hour later, she had a huge almost quarter-sized allergic reaction on the middle of her chest. It went away later in the day, but it was irritated and took almost the entire day to disappear. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Apr2021, 19Apr2021, 21Apr2021 and 24Apr2021 Other. No treatment received for the event. This case was reported as non-serious. The outcome of the event was recovered on 17Apr2021.  No follow-up attempts are needed. No further information is expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test
Clinical narrative: Itching since the second day; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number: Ew0162) via an unspecified route of administration, administered in arm left on 12Apr2021 12:00 PM (age at vaccination was 54 years) as dose 1, single for COVID-19 immunization at Doctor's office/urgent care. Medical history included back issues and blood clot issue. Concomitant medications included blood thinners he did not have the name at the time of reporting. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There were no any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, she was not diagnosed with COVID-19. The patient experienced itching since the second day on 14Apr2021. The patient had received Benadryl as treatment. The patient underwent lab test and procedure included nasal swab: negative on 17Mar2021. Since the vaccination, he has been tested for COVID-19. The outcome of event was not recovered.  No follow-up attempts were needed. No further information was expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Vaccination site bruising
Clinical narrative: Bruise/the arm where he received the second dose of the Covid-19 vaccine was bruised/; he would be sick following the second dose of the Covid-19 vaccine; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: AW0153; Expiration Date: Jul2021, NDC Number: 59267-1000-1), via intramuscular route of administration, administered in arm right on 14Apr2021 at 09:30 (at the age of 61-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no family medical history relevant to adverse events. The patient did not receive any other vaccine prior vaccinations within 4 weeks. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number EN6199, Expiration Date: Jun2021, NDC Number: 59267-1000-1), via intramuscular route of administration, administered in arm left on 23Mar2021 as dose 1, single for COVID-19 immunization. On an unspecified date in Apr2021, the patient experienced he would be sick following the second dose of the Covid-19 vaccine. On 14Apr2021, the patient experienced Bruise/the arm where he received the second dose of the Covid-19 vaccine was bruised. Adverse events did not require to visit emergency Room or physician Office. Second dose of Covid-19 vaccine administered at 22 days. Covax agent reported that the patient received his second dose of the Covid-19 vaccine on 14Apr2021. Covax agent reported that the patient had a little bit of a bruise following the second dose of the Covid-19 vaccine, but that other than that the patient was ok. Covax agent reported that the patient is wondering if the Pfizer Covid-19 vaccine is working on him because the caller is not feeling any other side effects other than the bruise. Patient reported that the arm where he received the second dose of the Covid-19 vaccine was bruised for the first 2 days after receiving the vaccine on 14Apr2021, but after that, he had no reaction whatsoever. Bruise: patient reported that the bruise appeared a couple of hours after he received the second dose of the Covid-19 vaccine on 14Apr2021 and was gone the next day on 15Apr2021. Patient reported that he has no headache, upset stomach, fever, or nothing. Patient reported that he thought that he would be sick following the second dose of the Covid-19 vaccine, so he bought all kinds of medication. Therapeutic measures were taken as a result of sick. Outcome of the events sick was unknown and vaccination site bruising was recovered on 15Apr2021.  No follow-up attempts are needed. No further information is expected.