chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Illness, Tachycardia
Clinical narrative: sick; Heart was beating really fast/heart rate went up; shortness of breath; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 28Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant was not reported. Patient stated she received the first dose of the Pfizer Covid 19 vaccine last Wednesday (28Apr2021) and since Friday (30Apr2021) she felt sick, her heart rate went up, her heart was beating fast, and she had shortness of breath. She still had these symptoms today. It was queried that if her symptoms go away. She had a patient on the other line who got the COVID 19 vaccine and stated that she has had an elevated heart rate and that is all she told the USMI agent. She normally is brady and her heartrate was normally in the 50s and now it is in the 80s. Sometimes it will go to the 70s too. Her question was how she should continue with the second vaccine whether she get it or should she not get it. She was afraid and asked if it is mandatory to get the second one. If she does not get the second one will something change or happen. She was scared and if wondering if she would be in trouble with her health if she did not receive the second dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: blood pressure and found that it has decreased; high fever; body ache; some swelling at the inection site; This is a spontaneous report from a contactable consumer, the parent. A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 24Apr2021 as dose 2, single for covid-19 immunization. The medical history and concomitant medications were not reported. On 27Apr2021, the patient experienced a high fever that he had struggled to bring down, along with body aches and swelling at the injection site. On an unknown date, the patient checked his blood pressure and found that it had decreased substantially. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Ejection fraction, Magnetic resonance imaging thoracic abnormal, Myalgia, Myocarditis
Clinical narrative: blood pressure and found that it has decreased; high fever; body ache; some swelling at the inection site; This is a spontaneous report from a contactable consumer, the parent. A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 24Apr2021 as dose 2, single for covid-19 immunization. The medical history and concomitant medications were not reported. On 27Apr2021, the patient experienced a high fever that he had struggled to bring down, along with body aches and swelling at the injection site. On an unknown date, the patient checked his blood pressure and found that it had decreased substantially. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Troponin I increased
Clinical narrative: blood pressure and found that it has decreased; high fever; body ache; some swelling at the inection site; This is a spontaneous report from a contactable consumer, the parent. A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 24Apr2021 as dose 2, single for covid-19 immunization. The medical history and concomitant medications were not reported. On 27Apr2021, the patient experienced a high fever that he had struggled to bring down, along with body aches and swelling at the injection site. On an unknown date, the patient checked his blood pressure and found that it had decreased substantially. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dysgeusia, Fatigue, Feeling abnormal
Clinical narrative: I had  severe irregular heartbeats; Anxiety; Headache; Feeling of severe unwellness; Dizzy; Fatigue; Felt like was spaced out; Had a taste of metal or something in my mouth; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8737), dose 1 via an unspecified route of administration, administered in Left Arm on 02Apr2021 (at 03:30 PM) single dose for covid-19 immunization (at the age of 56-years-old). Medical history included Mitral valve prolapse, anxiety. The patient's concomitant medications were not reported. The patient previously took Aspartame, MSG, caffeine, Augmentin, Biaxin. artificial ingredients and experienced drug hypersensitivity. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination the patient has not been tested for COVID-19. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had to stay in bed. She went to (withheld) 6 days after the vaccine. She received a echocardiogram that revealed patient have a mitral valve prolapse. Patient was slowing feeling better a month later. On 02Apr2021 (at 03:30 PM), the patient experienced severe irregular heartbeats, anxiety ring, headache, feeling of severe unwellness, dizzy, felt like was spaced out, had a taste of metal or something in my mouth, sore arm.  She experienced this 5 hours after receiving the vaccine and lasted over a month. The outcome of all the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate irregular, Malaise, Pain in extremity
Clinical narrative: I had  severe irregular heartbeats; Anxiety; Headache; Feeling of severe unwellness; Dizzy; Fatigue; Felt like was spaced out; Had a taste of metal or something in my mouth; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8737), dose 1 via an unspecified route of administration, administered in Left Arm on 02Apr2021 (at 03:30 PM) single dose for covid-19 immunization (at the age of 56-years-old). Medical history included Mitral valve prolapse, anxiety. The patient's concomitant medications were not reported. The patient previously took Aspartame, MSG, caffeine, Augmentin, Biaxin. artificial ingredients and experienced drug hypersensitivity. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination the patient has not been tested for COVID-19. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had to stay in bed. She went to (withheld) 6 days after the vaccine. She received a echocardiogram that revealed patient have a mitral valve prolapse. Patient was slowing feeling better a month later. On 02Apr2021 (at 03:30 PM), the patient experienced severe irregular heartbeats, anxiety ring, headache, feeling of severe unwellness, dizzy, felt like was spaced out, had a taste of metal or something in my mouth, sore arm.  She experienced this 5 hours after receiving the vaccine and lasted over a month. The outcome of all the events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer or other non hcp. An adult male patient of unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation patient received other vaccines within 4 weeks prior to vaccination was unknown. The patient medical history and concomitant medications were not reported. The patient experienced fatigue on an unspecified date, patient diagnosed with COVID-19 prior to vaccination was unknown patient was tested for COVID-19 to post vaccination. No treatment received for the events. The outcome of the event fatigue was recovered.  No follow-up attempts are needed; information about the lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unchecked for reporter. Initial Supplier to Safety corrected as measurable supplier in general tab and keywords corrected as Received from Pfizer colleague in additional information tab as initial report is for a Pfizer colleague. Patient's initials updated to UNKNOWN, and patient's country was added. Vaccination Facility Country was added. Treatment Received checked as No.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: blood pressure has been going high; 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, Batch/Lot Number: ER8736, Expiry Date: Unknown), dose 2 via an unspecified route of administration on 21Apr2021 as a dose 2, single for covid-19 immunisation. The patient's medical history included ongoing chemotherapy and concomitant medications were not reported. The patient previously received first dose of 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 a dose 1, single for covid-19 immunisation. The patient experienced blood pressure has been going high on 21Apr2021. Patient did went to the emergency room. Patient stated, on 21Apr2021, the patient had second vaccine Pfizer, Pfizer Vaccine from that day the patient had been having blood pressure. The patient did not know, patient was not sure it was because of the vaccine, blood pressure has been going high everyday ever since afternoon, Saturday patient did went to the emergency room so patient was just asking to find out you know to see because at the moment patient was on chemo and patient was receiving Chemotherapy every 3 weeks so but patient blood pressure ever since patient got second vaccine has been going high so patient did not know there was something to do with the vaccine if you received any complained in terms of the blood pressure in relation to the vaccine? patient was on the bed rest and blood pressure at the moment was too high. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 16Apr2021 at 11:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient previously had nuts and experienced allergy to nuts and patient had sesame and experienced food allergy. The patient previously had sulfa and experienced sulfonamide allergy. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) for unknown indication on unknown date and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included cefalexin (CEPHALEXIN) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, the patient experienced swollen lymphnodes / pain in underarm on side of injection. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events swollen lymphnodes / pain in underarm on side of injection was resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heavy menstrual bleeding, Menstruation irregular, Nausea
Clinical narrative: heavier period (4 days early, started the day after the vaccine); Early, heavier period (4 days early, started the day after the vaccine); Body aches; Dizziness; Tingling in left hand and left foot; Nausea; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on an unknown date (at the age of 39-years-old) as dose 1, single for COVID-19 immunisation. This is first of two reports. The patient had no medical history and past medications. The concomitant medications of the patient were not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced early, heavier period (4 days early, started the day after the vaccine), tingling in left hand and left foot, body aches, dizziness, nausea, fatigue. No treatment was received by the patient. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: heavier period (4 days early, started the day after the vaccine); Early, heavier period (4 days early, started the day after the vaccine); Body aches; Dizziness; Tingling in left hand and left foot; Nausea; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on an unknown date (at the age of 39-years-old) as dose 1, single for COVID-19 immunisation. This is first of two reports. The patient had no medical history and past medications. The concomitant medications of the patient were not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced early, heavier period (4 days early, started the day after the vaccine), tingling in left hand and left foot, body aches, dizziness, nausea, fatigue. No treatment was received by the patient. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in right leg knee; Pain in hip; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 12:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported but unspecified. The patient had no allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included carbidopa, levodopa (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 9264) via an unspecified route of administration in the left arm on 08Feb2021 at 12:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine.  On 01Mar2021 at 23:00 the patient experienced pain in right leg knee and pain in hip. Therapeutic measures were taken as a result of pain in right leg knee and pain in hip and included treatment with physical therapy and MRI.  Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in right leg knee and pain in hip were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm at injection arm over 1 month after receiving the second vaccine.; Muscle soreness in injection arm.; Hurts to lift arms over head.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 06Apr2021 at 13:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 13:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 14:00, the patient experienced sore arm at injection arm over 1 month after receiving the second vaccine, it hurt to lift arms over head and the patient also experienced muscle soreness in injection arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm at injection arm, it hurt to lift arms over head and muscle soreness in injection arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Bedridden, Chills, Decreased appetite, Diarrhoea
Clinical narrative: unable to eat; unable to stand; muscles are in pain; unable to smell; no appetite; diarrhea; cold chills; cold chills; fever; she has in bed since Thursday; tenderness on the site/soreness to her arm on the site; This is a spontaneous report from a contactable consumer (patient's daughter). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown) via unknown route of administration on 27Apr2021, dose 1, single (age at vaccination: 71 years) for Covid-19 immunisation. Relevant medical history was none. The concomitant medications were not reported. Consumer reported that her mother took the vaccine last Tuesday on 27Apr2021 and afterwards experienced soreness to her arm and tenderness on the site but she has in bed since Thursday on 29Apr2021. She has been sick with all the symptoms that they list. Adds she unable to eat, unable to stand, all of her muscles are in pain, she unable to smell; she has no appetite; she has diarrhea; cold chills and fevers. Consumer states she is trying to take care of her. Adds her mother was sore and tender at first but then on Thursday all the other symptoms started and they are getting worse. Adds Thursday her mother could not move and she is not getting better. Her mother was healthy before getting the shot. She is on no medications and has no health concerns. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Feeding disorder, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: unable to eat; unable to stand; muscles are in pain; unable to smell; no appetite; diarrhea; cold chills; cold chills; fever; she has in bed since Thursday; tenderness on the site/soreness to her arm on the site; This is a spontaneous report from a contactable consumer (patient's daughter). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown) via unknown route of administration on 27Apr2021, dose 1, single (age at vaccination: 71 years) for Covid-19 immunisation. Relevant medical history was none. The concomitant medications were not reported. Consumer reported that her mother took the vaccine last Tuesday on 27Apr2021 and afterwards experienced soreness to her arm and tenderness on the site but she has in bed since Thursday on 29Apr2021. She has been sick with all the symptoms that they list. Adds she unable to eat, unable to stand, all of her muscles are in pain, she unable to smell; she has no appetite; she has diarrhea; cold chills and fevers. Consumer states she is trying to take care of her. Adds her mother was sore and tender at first but then on Thursday all the other symptoms started and they are getting worse. Adds Thursday her mother could not move and she is not getting better. Her mother was healthy before getting the shot. She is on no medications and has no health concerns. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: unable to eat; unable to stand; muscles are in pain; unable to smell; no appetite; diarrhea; cold chills; cold chills; fever; she has in bed since Thursday; tenderness on the site/soreness to her arm on the site; This is a spontaneous report from a contactable consumer (patient's daughter). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown) via unknown route of administration on 27Apr2021, dose 1, single (age at vaccination: 71 years) for Covid-19 immunisation. Relevant medical history was none. The concomitant medications were not reported. Consumer reported that her mother took the vaccine last Tuesday on 27Apr2021 and afterwards experienced soreness to her arm and tenderness on the site but she has in bed since Thursday on 29Apr2021. She has been sick with all the symptoms that they list. Adds she unable to eat, unable to stand, all of her muscles are in pain, she unable to smell; she has no appetite; she has diarrhea; cold chills and fevers. Consumer states she is trying to take care of her. Adds her mother was sore and tender at first but then on Thursday all the other symptoms started and they are getting worse. Adds Thursday her mother could not move and she is not getting better. Her mother was healthy before getting the shot. She is on no medications and has no health concerns. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: her tongue was going numb/mouth was going numb; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included hypersensitivity. Concomitant medication included diphenhydramine hcl (DIPHENHYDRAMINE HCL) taken for an unspecified indication, start and stop date were not reported. It was reported that a few minutes after taking the vaccine her tongue was going numb. Today it's still the same but also her mouth was going numb. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: After she got the first shot, she had numbness in her legs and it is still there now, it has not completely resolved; This is a spontaneous report from a contactable consumer. A contactable consumer reported for a female patient that a female patient of an unspecified age received first 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 single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was just calling because reporter have a patient here that has come back for her second Pfizer COVID vaccine and she just told reporter today that about three days after she got the first shot, she had numbness in her legs and it was still there now, it has not completely resolved. Reporter didn't know about this previously, but reporter just wanted to call and see if there was any other reports of that and if it was okay to go ahead and give her the second one. Reporter haven't heard of any reports of that, so reporter just wanted to check directly before giving her another shot. Reporter was going to report to VAERS this evening but reporter just wanted to see if they are having any reports of that, as reporter don't know about it and the patient was still waiting for the second dose? Also, it his recommended for her to take the vaccine. The outcome of event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Headache, Hyperhidrosis
Clinical narrative: Fever; Body ache, really severe body ache; Headache; Swelling on the injection site; Vomiting; There was too much sweating overnight, way too much that he has to shower his face; He was shivering like cold; Blood pressure gone down, it was like over 108/62; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. On Apr2021, the patient experienced Fever, Body ache, really severe body ache, Headache, Swelling on the injection site, Vomiting, There was too much sweating overnight, way too much that he has to shower his face, He was shivering like cold, Blood pressure gone down, it was like over 108/62. Reporter stated, "My son he is 23-year-old, he got his second vaccination for Covid the last Saturday at around 10:00 am and then the same day around 6:00 pm or 7:00 pm, he was kind of feeling like fever and body ache, really severe body ache and headache, so I gave him a Tylenol (treatment). Also, he has got swelling on the injection site and vomiting. So, this is Saturday night and I keep giving him Tylenol (treatment), I gave Tylenol at night time around 4:00 am. There was too much sweating overnight, way too much that he has to shower his face and also, he was shivering like cold. So, I called my consultant and as due to this Covid, he is not in the clinic. So, I still want to know as he has little bit fever but it controlled by Tylenol again. Also, this morning, his blood pressure gone down, it was like over 108/62. My son, he has no underlying condition, he is healthy, he is an athletic. So, I was wondering, is there any kind of side effect to the Pfizer dose like I described to you now." The 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: Pain, Pyrexia, Vaccination site swelling, Vomiting
Clinical narrative: Fever; Body ache, really severe body ache; Headache; Swelling on the injection site; Vomiting; There was too much sweating overnight, way too much that he has to shower his face; He was shivering like cold; Blood pressure gone down, it was like over 108/62; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. On Apr2021, the patient experienced Fever, Body ache, really severe body ache, Headache, Swelling on the injection site, Vomiting, There was too much sweating overnight, way too much that he has to shower his face, He was shivering like cold, Blood pressure gone down, it was like over 108/62. Reporter stated, "My son he is 23-year-old, he got his second vaccination for Covid the last Saturday at around 10:00 am and then the same day around 6:00 pm or 7:00 pm, he was kind of feeling like fever and body ache, really severe body ache and headache, so I gave him a Tylenol (treatment). Also, he has got swelling on the injection site and vomiting. So, this is Saturday night and I keep giving him Tylenol (treatment), I gave Tylenol at night time around 4:00 am. There was too much sweating overnight, way too much that he has to shower his face and also, he was shivering like cold. So, I called my consultant and as due to this Covid, he is not in the clinic. So, I still want to know as he has little bit fever but it controlled by Tylenol again. Also, this morning, his blood pressure gone down, it was like over 108/62. My son, he has no underlying condition, he is healthy, he is an athletic. So, I was wondering, is there any kind of side effect to the Pfizer dose like I described to you now." The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Influenza like illness, Malaise, Pyrexia
Clinical narrative: It is like I am ill, I have like a flu feeling and all that; It is like I am ill, I have like a flu feeling and all that; I have a rash, it is like itching over my whole body; Slight fever; My blood pressure went up; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution of injection, Lot number was not reported) dose 2 via an unspecified route of administration on Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Historical vaccine included BNT162B2 dose 1 on an unspecified date for COVID-19 immunisation. On Mar2021 the patient experienced slight fever, my blood pressure went up. On Apr2021 it is like I am ill, I have like a flu feeling and all that, I have a rash it is like itching over my whole body with an unknown outcome. The patient underwent lab tests and procedures which included blood pressure measurement went up on Mar2021, blood pressure measurement brought it back down on Mar2021. The adverse events slight fever, my blood pressure went up resulted in an emergency visit. The clinical outcome of the events slight fever, my blood pressure went up, it is like I am ill, I have like a flu feeling and all that was resolved on an unspecified date of 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: It is like I am ill, I have like a flu feeling and all that; It is like I am ill, I have like a flu feeling and all that; I have a rash, it is like itching over my whole body; Slight fever; My blood pressure went up; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution of injection, Lot number was not reported) dose 2 via an unspecified route of administration on Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Historical vaccine included BNT162B2 dose 1 on an unspecified date for COVID-19 immunisation. On Mar2021 the patient experienced slight fever, my blood pressure went up. On Apr2021 it is like I am ill, I have like a flu feeling and all that, I have a rash it is like itching over my whole body with an unknown outcome. The patient underwent lab tests and procedures which included blood pressure measurement went up on Mar2021, blood pressure measurement brought it back down on Mar2021. The adverse events slight fever, my blood pressure went up resulted in an emergency visit. The clinical outcome of the events slight fever, my blood pressure went up, it is like I am ill, I have like a flu feeling and all that was resolved on an unspecified date of 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: 2 days after that or 2-3 days after that she experienced low grade fever, body ache diarrhea and vomiting; 2 days after that or 2-3 days after that she experienced low grade fever, body ache diarrhea and vomiting; 2 days after that or 2-3 days after that she experienced low grade fever, body ache diarrhea and vomiting; 2 days after that or 2-3 days after that she experienced low grade fever, body ache diarrhea and vomiting; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) reported for herself that. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, on 26Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 2 days after that or 2-3 days after that she experienced low grade fever, body ache diarrhoea and vomiting on Apr2021. She wanted to report that and she would like to know as well that would be normal for her to experience was it normal these kind of adverse events after 2-3 days of getting the first dose of the vaccine. Patient stated, I just want someone to simply tell me that was it normal to have side effect 2 days after the vaccine and diarrhoea was one of them. That's all I need to know. The outcome of the events was reported as unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer or other non hcp submitted by Call Center. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: ER8731) via unknown route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unknown date the patient experienced fever. The outcome of the event was unknown.     No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Vaccination site pain
Clinical narrative: tongue numbness/ Mouth numbness; pain at injection site; she was feeling bad; This is a spontaneous report from a contactable consumer (patient's daughter in law). A female patient in her forties received bnt162b2 (BNT162B2) via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient was taking an allergy medication prior to getting the vaccine. She stopped taking it after the second day. The patient experienced tongue numbness/ mouth numbness, pain at injection site, she was feeling bad (non-serious) on 02May2021. The outcome of the events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Pain in extremity, Pyrexia, X-ray
Clinical narrative: fever; Pain from Covid arm; chills; Covid arm; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9621), via an unspecified route of administration, administered in arm right on 29Jan2021 as single dose for COVID-19 immunization. Medical history included back pain ongoing since 2009 and had back surgery, pneumonia and heart surgery. Concomitant medication included hydrocodone from 2012 and ongoing and morphine from 2015 to ongoing; both for back pain. As per ADR description, Caller reported that the first dose of the Covid-19 vaccine was fine. Caller reported that everything went the way it was supposed to. Caller reported that she had the Covid arm and a little bit of fever and stuff.  Covid arm - first dose: Caller reported that the Covid arm began about 6 hours after she received the injection on 29Jan2021. Caller reported that the pain lasted for about 3 days. Caller reported that her arm hurt and she couldn't sleep on that side. Little bit of chills - first dose: Caller reported that she experienced a little bit of chills on 29Jan2021 and just went to bed early. Caller reported that the next day, 30Jan2021, she felt fine except for her arm. Caller reported that she received her Covid-19 vaccine early in the morning and the chills began around 5 in the evening on 29Jan2021. Caller reported that she was fine the next day on 30Jan2021 like nothing had happened except for her arm.  First dose: Administration date: 29Jan2021; Lot Number: EL9261; Anatomical Location: Right arm Caller reported that her right arm was so sore that she couldn't sleep on it following the first dose of the Covid-19 vaccine. she's had pneumonia in her past life and she has had heart surgery, so she doesn't want to get Covid-19. Caller reported that she totally believes in the Covid-19 vaccine, but she never thought that she would be the one calling Pfizer after the fact. Caller reported that she was informed that before the Covid-19 vaccine, don't take any pain medicine. Caller reported that she followed all of the rules and didn't take any before receiving the Covid-19 vaccine. Caller reported that she didn't take any aspirin following the Covid-19 vaccine because she didn't want it to interfere with her immune system. Caller reported that she didn't take any pain medication for 4 days after the Covid- 19 vaccine to make sure that her immune system would interact with the vaccine naturally. Caller reported that she did not take pain medication before and for 4 days after she received both doses of the Covid-19 vaccine. The clinical outcome of the events was resolved on 30Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Malaise, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# EW0164; expiry date not reported), at the age of 69, via an unspecified route of administration, right arm right, Apr 27, 2021, 13:45, single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease and paroxysmal supraventricular tachycardia (PSVT) from an unknown date and unknown if ongoing. Concomitant medication included metoprolol taken for PSVT, start and stop date not reported. On Apr 27, 2021, patient experienced onset of symptoms. During administration of the shot, patient's heart rate went from 96 and dropped to 70. Patient raised her hand and nurse came over. She said her pulse rate was 70 and saw a bit lower 68. Reportedly, patient had headache, nausea and felt unwell  about 10 min into the vaccine. Exactly 4 hours, patient had a rapid heart rate, which sent her into a tachycardia episode. It was suggested she not take ibuprofen, if possible, to try and endure, otherwise it would stop the effectiveness of the vaccine. So patient did not receive any treatment. Outcome of the events: unknown. No follow-up attempts needed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# EW0164; expiry date not reported), at the age of 69, via an unspecified route of administration, right arm right, Apr 27, 2021, 13:45, single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease and paroxysmal supraventricular tachycardia (PSVT) from an unknown date and unknown if ongoing. Concomitant medication included metoprolol taken for PSVT, start and stop date not reported. On Apr 27, 2021, patient experienced onset of symptoms. During administration of the shot, patient's heart rate went from 96 and dropped to 70. Patient raised her hand and nurse came over. She said her pulse rate was 70 and saw a bit lower 68. Reportedly, patient had headache, nausea and felt unwell  about 10 min into the vaccine. Exactly 4 hours, patient had a rapid heart rate, which sent her into a tachycardia episode. It was suggested she not take ibuprofen, if possible, to try and endure, otherwise it would stop the effectiveness of the vaccine. So patient did not receive any treatment. Outcome of the events: unknown. No follow-up attempts needed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I had a much more intense increase in pain in both arms that has been ongoing now and has so far persisted 2.5 days; injection site discomfort; injection site pain; headache; chills; low grade fever; This is a spontaneous report from a contactable consumer (patient, self-reported). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8736 and expiry date: 30Jun2021), via an unspecified route of administration, in Left leg, on 29Apr2021 at 14:45 PM (age at vaccination: 39 years), as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient was not pregnant at the time of vaccination. The patient's medical history included hypothyroid, suspected Covid-19 (Is suspected to be a post-Covid/long haul symptom that arose a few months following my clinically diagnosed Covid case in April2020 (I was infected before testing was allowed for my age and was therefore diagnosed based on symptoms and ruling out other respiratory viruses), and neurological condition with my arms (bilateral pain, weakness) (that began 7 months ago). The patient did not have any known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0158 and expiry date was not provided), via an unspecified route of administration, in Left leg, on 08Apr2021 at 02:45 PM (age at vaccination: 39 years), as a single dose for COVID-19 immunization at doctor's office/urgent care and had product administered at inappropriate site, Pain in extremity, vaccination site discomfort, and fatigue. Concomitant medications included Levothyroxine 88mcg and Gabapentin 300mg 3x/day. The patient did not receive any other vaccine in four weeks. It was unknown if the patient was diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that she had a neurological condition with her arms (bilateral pain, weakness) that began 7 months ago and was suspected to be a post-Covid/long haul symptom that arose a few months following her clinically diagnosed Covid case in Apr2020 (she was infected before testing was allowed for her age and was therefore diagnosed based on symptoms and ruling out other respiratory viruses). Following my first Covid vaccine 08Apr (into her left thigh to avoid her arms), she had a brief slight increase in the level of pain in both arms, but the pain level decreased in 48h when other "normal" side effects (injection site discomfort, fatigue) subsided. With her second shot (again, left thigh), on 30Apr2021 at 09:00 AM, she had a much more intense increase in pain in both arms that has been ongoing now and has so far persisted 2.5 days beyond when the "normal" side effects (injection site pain, headache, chills, low grade fever) subsided. The pain in her arms remains strong and persistent. The patient did not receive any treatment for the events. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 105f fiever for 24h; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 04Apr2021 11:45 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 11:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included COPD, Covid-19 from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took penicillin and had drug allergy. The patient experienced 105f fever for 24h. The patient underwent lab tests and procedures which included Body temperature: 105 fahrenheit on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.