chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Heart rate, Heart rate increased, Heart rate irregular
Clinical narrative: irregular heart rate; my heart rate was 127/rapid heart beat; felt burning in my stomach/left side, under my breast.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 62-years-old, administered in Arm Left on 15Mar2021 (Lot Number: ENG204) as single dose for COVID-19 immunization. Medical history included artificial aortic and mitral valves and rapid heartbeat. Concomitant medication included metoprolol taken for heart rate increased, start and stop date were not reported (as needed). The patient stated that she got the shot on Monday, 15Mar2021. She was calling about having a burning in her stomach, underneath her left breast and having a rapid heart beat on Monday and last night. She got the shot in the morning and that evening (15Mar2021) was when the burning and rapid heart beat started. She did have artificial valves, aorta valve and mitral valve. She was wondering why she has the burning on the left side. It was mainly when she laid down at night. When she gets that [burning] she gets the rapid heart beat, her heart rate goes up to 120 or something. Patient reported, "laid down that night, felt burning in my stomach/left side, under my breast. Guess it was acid. My heart rate was 127- stayed for an hour or so, then I relaxed. Two (2) hours later, it all subsided." It skipped Tuesday but it did happen again last night. It was also like an irregular heart beat. Her heart beat went up to like 111. She states that she didn't notice the irregular heart beat until the fourth day [Wednesday], 17Mar2021. It is like beat skip beat skip. The irregular heart rate ended this morning 18Mar2021 and she confirmed she does not have that now. Treatment: states that she took metoprolol and Tylenol but not at the same time. Clarifies that she only takes Metoprolol if she is having a rapid heartbeat, takes only when needed. It is 25mg. BHC/SW, states this was also listed on the Covid Vaccine card. Patient asked if this is related to the vaccine and if it'll happen after getting the 2nd dose. The patient underwent lab tests and procedures which included heart rate: 127 on 15Mar2021 (my heart rate was 127- stayed for an hour or so), heart rate: 120 on 15Mar2021 (her heart rate goes up to 120 or something), heart rate: 111 on 17Mar2021 (Her heart beat went up to like 111). Therapeutic measures were taken as a result of events which included Tylenol and metoprolol. The outcome of the event irregular heart rate was recovered on 18Mar2021 while for the other events was recovering.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the first dose of the Pfizer covid vaccine and before he was suppose to get his second dose on 25Feb2021, he tested positive for covid.; received the first dose of the Pfizer covid vaccine and before he was suppose to get his second dose on 25Feb2021, he tested positive for covid.; This is a spontaneous report from a contactable nurse. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Patient received the first dose of the Pfizer covid vaccine and before he was suppose to get his second dose on 25Feb2021, he tested positive for covid. He received the monoclonal antibodies and caller wanted to know if  monoclonal antibodies could attenuate the first dose of the Pfizer covid vaccine. The outcome of the events was unknown.  Information about lot and batch number was requested.; Sender's Comments: A causal relationship between  BNT162B2  and the reported events cannot be excluded based on temporal association.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, SARS-CoV-2 test
Clinical narrative: mild flare up of ulerative colitis; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration administered in left arm on 17Feb2021 14:15 (at the age of 69-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a hospital. No other vaccine in four weeks. Medical history included ulcerative colitis (which has been in remission until the vaccine). The patient had no known allergies. Concomitant medications included olmesartan medoxomil (BENICAR); atorvastatin (LIPITOR) and metformin. It was reported that the first dose resulted in mild flare up of ulerative colitis that has been in remission for 10 years on 17Feb2021 at 16:00. The event resulted in doctor or other healthcare professional office/clinic visit. The treatment included increased dose of mesalazine (LIALDA), colonoscopy, endoscopy. The patient did not have Covid prior vaccination and was Covid tested (other) post vaccination on 04Mar2021 with result of negative. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After 1st dose he tested positive for COVID; After 1st dose he tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's wife) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ENG190; Expiration date was not reported) on 26Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, after the first dose of vaccination, the patient had tested positive for COVID-19. The outcome of the event was unknown. The patient was scheduled to get the second dose of vaccination on 19Mar2021, and was asking if he could have it.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Feb2021 (lot number: EL9263) as single dose at the age of 23 years old, for COVID-19 immunisation. Medical history included common variable immunodeficiency and covid-19 (prior to vaccination). The patient's concomitant medications were not reported. The patient previously took bactrim and clindamycin and experienced allergies. The patient did not receive any other vaccines 4 weeks prior to COVID vaccination. The patient was not pregnant at the time of vaccination. The patient experienced positive covid-19 test with symptoms on 17Mar2021. The patient underwent COVID-19 PCR test with result of positive on 17Mar2021. The patient has not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Body temperature, Chills, Lymphoedema, Peripheral swelling
Clinical narrative: angioedema; lymphedema; her left arm is not swollen at the injection site but lower on the arm right before the elbow; fleshy skin is all swollen.; 102 fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 for COVID-19 immunisation on an unspecified date. On an unspecified date, the patient experienced angioedema and lymphedema. The patient stated that she had the second vaccine on Tuesday, 16Mar2021 and had chills Tuesday night, 16Mar2021; and into Wednesday, 17Mar2021, she had 102 fever. Everything was fine now and she took a couple of Tylenol. She stated that starting today, 18Mar2021, her left arm was not swollen at the injection site but lower on the arm right before the elbow, like right where the elbow starts all the flesh was swollen. She stated the fleshy skin was all swollen. She said there was nothing else going on, her arms were perfect. She rested all day after the shot and did not lift anything. The patient asked if she needs to go to a hospital or a lymphedema specialist and if this will be a permanent distortion of her body, or a permanent lymphedema. After verbal response, the patient asked if she was saying this was angioedema and what kind of test does she need to get to see if this was angioedema versus lymphedema. She asked how the HCP will know what test to run if we do not know. Outcome of events chills, 102 fever was recovered on an unspecified date; and outcome of the rest of events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin swelling
Clinical narrative: angioedema; lymphedema; her left arm is not swollen at the injection site but lower on the arm right before the elbow; fleshy skin is all swollen.; 102 fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 for COVID-19 immunisation on an unspecified date. On an unspecified date, the patient experienced angioedema and lymphedema. The patient stated that she had the second vaccine on Tuesday, 16Mar2021 and had chills Tuesday night, 16Mar2021; and into Wednesday, 17Mar2021, she had 102 fever. Everything was fine now and she took a couple of Tylenol. She stated that starting today, 18Mar2021, her left arm was not swollen at the injection site but lower on the arm right before the elbow, like right where the elbow starts all the flesh was swollen. She stated the fleshy skin was all swollen. She said there was nothing else going on, her arms were perfect. She rested all day after the shot and did not lift anything. The patient asked if she needs to go to a hospital or a lymphedema specialist and if this will be a permanent distortion of her body, or a permanent lymphedema. After verbal response, the patient asked if she was saying this was angioedema and what kind of test does she need to get to see if this was angioedema versus lymphedema. She asked how the HCP will know what test to run if we do not know. Outcome of events chills, 102 fever was recovered on an unspecified date; and outcome of the rest of events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 16Mar2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the COVID-19 vaccine manufactured by Pfizer on Tuesday (16Mar2021), and on Tuesday night (16Mar2021) he started to have some reactions (unspecified) that he thought could be related to the vaccine. At the day of the report, 18Mar2021, he tested positive for COVID-19. He has an appointment for his second dose in 3 weeks. He wants to know if he can receive the second dose of the vaccine if he tested positive for the COVID-19 infection after the first dose. He also wants to know if the second shot might have milder side effects since he already had his first shot. Outcome of the event was unknown.   Information about lot and batch number was requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dysstasia, Heart rate, Heart rate increased
Clinical narrative: i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose  at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported.  The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Ill-defined disorder, Lip swelling, Nausea, Peripheral coldness
Clinical narrative: i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose  at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported.  The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Swelling face, Thirst, Tinnitus, Tremor
Clinical narrative: i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose  at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported.  The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Malaise
Clinical narrative: Caller stated the first day her husband's arm bothered him and he felt sick the next day; Caller stated the first day her husband's arm bothered him and he felt sick the next day; slight headache; This is a spontaneous report from a contactable consumer (patient's wife) via the medical information team. This consumer reported for 2 patients. This is the second (husband) of 2 reports.  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included COVID-19 from 2020. Caller stated that she and her husband had COVID-19 around thanksgiving last year. He spent 6 days in hospital. The patient's concomitant medications were not reported. On an unspecified date, the reporter stated that the first day her husband's arm bothered him and he felt sick the next day and he felt sick the next day. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299440 same drug, different patient and event.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 18Mar I had a POSITIVE PCR test for Covid 19; 18Mar I had a POSITIVE PCR test for Covid 19; This is a spontaneous report from a contactable consumer (patient), received Pfizer-sponsored program. A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in right arm on 24Feb2021 17:45 (Lot number and expiration date was not reported) at single dose, first dose via an unspecified route of administration, administered in Left arm on 03Feb2021 17:00 (Lot number and expiration date was not reported) at single dose for Covid-19 immunization. The patient's medical history included obese and high blood pressure. The patient's concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), and metoprolol. On 18Mar2021, the patient had a positive PCR test for Covid-19.  The patient did not received treatment for the events. There is a high likelihood it will be the (Country Name) Variant from (Name). The patient caught it from a (Country Name) whose roommates friends had just come back from that region. The patient underwent lab tests and procedures which includes PCR test for Covid 19: positive on 18Mar2021 . The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Oxygen saturation
Clinical narrative: 18Mar I had a POSITIVE PCR test for Covid 19; 18Mar I had a POSITIVE PCR test for Covid 19; This is a spontaneous report from a contactable consumer (patient), received Pfizer-sponsored program. A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in right arm on 24Feb2021 17:45 (Lot number and expiration date was not reported) at single dose, first dose via an unspecified route of administration, administered in Left arm on 03Feb2021 17:00 (Lot number and expiration date was not reported) at single dose for Covid-19 immunization. The patient's medical history included obese and high blood pressure. The patient's concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), and metoprolol. On 18Mar2021, the patient had a positive PCR test for Covid-19.  The patient did not received treatment for the events. There is a high likelihood it will be the (Country Name) Variant from (Name). The patient caught it from a (Country Name) whose roommates friends had just come back from that region. The patient underwent lab tests and procedures which includes PCR test for Covid 19: positive on 18Mar2021 . The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: he got a positive PCR test result for COVID-19; he got a positive PCR test result for COVID-19; felt short of breath; This is a spontaneous report from a contactable consumer.  A 72-year-old male patient received the first and the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administrations on an unspecified dates as a single dose for covid-19 immunization. The patient's medical history included Hashimoto, a thyroid autoimmune disease and has a comorbidity of obesity [being] 70 lbs overweight. The patient's concomitant medications were not reported.  On an unknown date, the patient completed the Pfizer-BioNTech COVID-19 vaccine over 24 days ago and last night he got a positive PCR test result for COVID-19.  Patient further stated he was from a states where a "young woman brought the COVID-19 strain from (Municipality name)". He works with a colleague, who tested positive and lives in a "home with person", yet he always wears a mask at work.The patient stated he has "no symptoms". He explained he thought he "felt short of breath" but he went to a test center where his oxygen level was at 95%, then at 96% when he removed his mask. He specified he will get an oximeter. The patient asked if he should get the antibody cocktail. He also asked if this treatment would interact with the COVID-19 vaccine. He then added he was with his week-old grand-son on Monday, and spent the whole night researching. The outcome of the events was unknown.   Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Oxygen saturation
Clinical narrative: he got a positive PCR test result for COVID-19; he got a positive PCR test result for COVID-19; felt short of breath; This is a spontaneous report from a contactable consumer.  A 72-year-old male patient received the first and the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administrations on an unspecified dates as a single dose for covid-19 immunization. The patient's medical history included Hashimoto, a thyroid autoimmune disease and has a comorbidity of obesity [being] 70 lbs overweight. The patient's concomitant medications were not reported.  On an unknown date, the patient completed the Pfizer-BioNTech COVID-19 vaccine over 24 days ago and last night he got a positive PCR test result for COVID-19.  Patient further stated he was from a states where a "young woman brought the COVID-19 strain from (Municipality name)". He works with a colleague, who tested positive and lives in a "home with person", yet he always wears a mask at work.The patient stated he has "no symptoms". He explained he thought he "felt short of breath" but he went to a test center where his oxygen level was at 95%, then at 96% when he removed his mask. He specified he will get an oximeter. The patient asked if he should get the antibody cocktail. He also asked if this treatment would interact with the COVID-19 vaccine. He then added he was with his week-old grand-son on Monday, and spent the whole night researching. The outcome of the events was unknown.   Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got Covid-19; got Covid-19; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history includes exposure to COVID-19 since she works in ER with COVID patients. Concomitant medications were not reported. On an unspecified date (reported as 9 days later), the patient got Covid-19. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 63-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ET1685) via intramuscular route of administration in the left arm on 21Dec2020 at 15:30 (at the age of 63-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. Relevant family medical history was reported as not applicable. Concomitant medications were not reported. On an unspecified date, the patient experienced left arm pain. The clinical outcome of left arm pain was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on 02Mar2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer Covid 19 on 02Mar2021, then experienced what she thought were side effects of the shot, but then she was tested positive for Covid. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction to the Pfizer vaccine; This is a spontaneous report from a contactable physician. A non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19 infection on Mar2020. The patient's concomitant medications were not reported. The patient with previous COVID-19 infection experienced severe allergic reaction to the Pfizer vaccine on an unspecified date. The patient and her husband had COVID-19 infections in Mar2020 and patient's reaction to the vaccine occurred much later. It was unknown if treatment was given in response to the event. The outcome of the event was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received first dose of Pfizer Covid vaccine on 4Jan2021. She tested positive for covid a few days later; received first dose of Pfizer Covid vaccine on 4Jan2021. She tested positive for covid a few days later; This is a spontaneous report from a contactable consumer (patient's daughter). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer COVID vaccine on 04Jan2021. She tested positive for COVID a few days later (2021) and was in rehab for a few months. Reporter calling to see if her mother can receive her second dose so late after the first one. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid after more than a month of 2nd vaccine (Rapid & PCR tests); Tested positive for Covid after more than a month of 2nd vaccine (Rapid & PCR tests); This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 12Feb2021 (Batch/Lot Number: EL9266) as SINGLE DOSE for COVID-19 immunization. Medical history included Penicillin allergy from an unknown date. The patient has no COVID history prior vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL9266), on 22Jan2021, on left arm, for COVID-19 immunization. The patient tested positive for COVID after more than a month of 2nd vaccine (Rapid & PCR tests) on 17Mar2021. The patient did not receive treatment for the event. The patient underwent lab tests and procedures which included Nasal Swab (Rapid and PCR): positive on 17Mar2021 and 18Mar2021, respectively. The patient was recovering from the event.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Body temperature, Breast pain, Chest discomfort
Clinical narrative: ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Ear discomfort, Fatigue, Glossodynia
Clinical narrative: ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Myalgia, Nausea, Pyrexia, Thinking abnormal
Clinical narrative: ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspepsia, Rash, Swelling face
Clinical narrative: anaphylactic reaction; Had heartburn; significant rash; facial swelling; This is a spontaneous report from a contactable physician. A 58-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer covid vaccine 2 days ago. Patient had heartburn then significant rash then facial swelling. Gave her Benadryl and ice and keeping an eye on it, did not give prednisone yet. They were asking for recommendation on how to manage anaphylactic reaction and the time course. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Considering the plausible drug-event temporal association and known safety profile, a contributory role of the suspect product bnt162b2 to the reported Anaphylactic reaction cannot be excluded. Case will be reassessed upon receipt of additional information.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypersensitivity, Pruritus, Rash
Clinical narrative: a rash all over his body well not all over his body but it was on his extremities, the upper and lower extremities and on his chest; Itching; Immune allergic reaction; This is a spontaneous report from a contactable Physician (her husband). A 75-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN6205) via an unspecified route of administration in Arm Right on 05Mar2021 11:34 as single dose for covid-19 immunisation. Medical history included joint injury, prostate infection and gastrooesophageal reflux disease. Concomitant medications were not reported. Patient lab data included blood tests the few days and everything was okay with that. On an unspecified date in mar2021, the patient developed Immune allergic reaction. On 12Mar2021, the patient developed rash and itching. Caller stated that his husband got his first dose of the Pfizer Covid 19 vaccine and developed a rash and itching. His HCP diagnosed this as immune allergic reaction and asked if it is safe for him to get the second dose of the vaccine. Additional Context included, Caller says she is a doctor in private practice in psychiatry. She wanted to see she was concerned and it may not be related to the COVID vaccine but something happened to her husband that she would like to ask if they have had any other reports of this. She confirms she is calling about the Pfizer COVID 19 vaccine. Her husband got the vaccine at the (facility name) on 05Mar2021 and on the 12Mar2021 he developed a rash all over his body well not all over his body but it was on his extremities, the upper and lower extremities and on his chest. He went to see his primary care doctor. She did not know if it was something related to the vaccination or not she doesn't know but he is still suffering from the rash. Patient was prescribed a corticosteroid cream, the itching responds well but the rash in itself is still there. The outcome of the event Immune allergic reaction, and itching was unknown and rash was not resolved.; Sender's Comments: Based on the known safety profile of the vaccine, a temporal relationship between the onset of events and the administration of vaccine cannot be excluded. However, the information mentioned in the report is limited. A complete medical assessment is not possible till information about concomitant medications of patient is provided.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autoimmune haemolytic anaemia, Biopsy skin abnormal, Candida infection, Chills, Decreased appetite
Clinical narrative: a rash all over his body well not all over his body but it was on his extremities, the upper and lower extremities and on his chest; Itching; Immune allergic reaction; This is a spontaneous report from a contactable Physician (her husband). A 75-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN6205) via an unspecified route of administration in Arm Right on 05Mar2021 11:34 as single dose for covid-19 immunisation. Medical history included joint injury, prostate infection and gastrooesophageal reflux disease. Concomitant medications were not reported. Patient lab data included blood tests the few days and everything was okay with that. On an unspecified date in mar2021, the patient developed Immune allergic reaction. On 12Mar2021, the patient developed rash and itching. Caller stated that his husband got his first dose of the Pfizer Covid 19 vaccine and developed a rash and itching. His HCP diagnosed this as immune allergic reaction and asked if it is safe for him to get the second dose of the vaccine. Additional Context included, Caller says she is a doctor in private practice in psychiatry. She wanted to see she was concerned and it may not be related to the COVID vaccine but something happened to her husband that she would like to ask if they have had any other reports of this. She confirms she is calling about the Pfizer COVID 19 vaccine. Her husband got the vaccine at the (facility name) on 05Mar2021 and on the 12Mar2021 he developed a rash all over his body well not all over his body but it was on his extremities, the upper and lower extremities and on his chest. He went to see his primary care doctor. She did not know if it was something related to the vaccination or not she doesn't know but he is still suffering from the rash. Patient was prescribed a corticosteroid cream, the itching responds well but the rash in itself is still there. The outcome of the event Immune allergic reaction, and itching was unknown and rash was not resolved.; Sender's Comments: Based on the known safety profile of the vaccine, a temporal relationship between the onset of events and the administration of vaccine cannot be excluded. However, the information mentioned in the report is limited. A complete medical assessment is not possible till information about concomitant medications of patient is provided.