chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vasodilatation
Clinical narrative: thought she was having a heart attack; cramping in abdominal area; finger went blue; sweating; chest pain/pain in chest; pressure near breast; back cramping/severe cramping; left pupil dilated; arm went numb; turned pale; Veins popping out of skin; This is a spontaneous report from a Pfizer-sponsored program, Support. A contactable consumer (patient) reported that an adult female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as 1 st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 48 hours after first dose of bnt162b2 (unspecified date), the patient felt side effects of cramping in abdominal area, finger went blue, sweating, chest pain and pressure near breast (has been receiving episodes of this pressure and pain for a week after dose), back cramping and left pupil dilated. Stated that side effects were only for left side of body, none on the right. Also reported pain in chest, arm went numb, sweating, turned pale, thought she was having a heart attack and left pupil larger, severe cramping and veins popping out of skin. The patient was supposed to get 2 nd vaccine yesterday wanted to know what to do. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Menstrual Issues (Continued bleeding); This is a spontaneous report received from a contactable healthcare professional (patient). This 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 08Feb2021 (Batch/Lot Number: EL9264) as 2nd dose, single for COVID-19 immunization. Patient received the first dose on 13Jan2021 (Batch/lot number: EL1283). The patient's medical history and concomitant medications were not reported. Patient is not pregnant at time of vaccination. The patient previously took a cortisone shot at the end of Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has not been tested for COVID-19 since the vaccination. Patient experienced menstrual issues: continued bleeding on 08Feb2021 with outcome of not recovered. Treatment was received. Event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event "menstrual issues: continued bleeding" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Hemiplegia, Nerve injury, Nervous system disorder
Clinical narrative: she is having paralysis on her whole left side; And very bad slurred speech; She is having nerve issues and has nerve damage; She is having nerve issues and has nerve damage; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer reported for daughter. A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter stated the patient took your vaccine and now she was having paralysis on her whole left side (which she got the shot) and very bad slurred speech. She was having nerve issues and had nerve damage. Reporter also stated "I took your first shot but will not be taking the second one. But we need your help."  The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electromyogram, Guillain-Barre syndrome, Physical examination, SARS-CoV-2 test
Clinical narrative: Guillain-Barre suspected; Left arm hurt (at injection site) at the same time as weakness; This is a spontaneous report from a contactable other-health care professional reported for himself. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in left arm on 19Dec2020 (Lot Number: EL0140) as single dose for COVID-19 immunisation. Medical history included allergy to cashews. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced lost use of legs and left arm hurt (at injection site) at the same time as weakness on 31Dec2020. Called ambulance, the patient went to ER. Evaluated for Stroke-like symptoms (negative). Guillain-Barre was suspected and EMG (Electromyography) confirmed it. The patient was hospitalized for event guillain-barre for 54 days. Event guillain-barre was also assessed as life-threatening and disability. The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room visit. Treatment for events included IV-IG (Intravenous immunoglobulin); pneumothrombectomy (clots caused by IV-IG). The patient underwent nasal swab tests on 31Dec2020, 11Jan2021, 04Feb2021 and blood test on 24Mar2021, all were negative. The patient was not to have any more COVID vaccine per Neurology. The outcome of events was recovering.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of Guillain-Barre cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Guillain-Barre suspected; Left arm hurt (at injection site) at the same time as weakness; This is a spontaneous report from a contactable other-health care professional reported for himself. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in left arm on 19Dec2020 (Lot Number: EL0140) as single dose for COVID-19 immunisation. Medical history included allergy to cashews. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced lost use of legs and left arm hurt (at injection site) at the same time as weakness on 31Dec2020. Called ambulance, the patient went to ER. Evaluated for Stroke-like symptoms (negative). Guillain-Barre was suspected and EMG (Electromyography) confirmed it. The patient was hospitalized for event guillain-barre for 54 days. Event guillain-barre was also assessed as life-threatening and disability. The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room visit. Treatment for events included IV-IG (Intravenous immunoglobulin); pneumothrombectomy (clots caused by IV-IG). The patient underwent nasal swab tests on 31Dec2020, 11Jan2021, 04Feb2021 and blood test on 24Mar2021, all were negative. The patient was not to have any more COVID vaccine per Neurology. The outcome of events was recovering.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of Guillain-Barre cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bacterial infection, Colitis, SARS-CoV-2 test
Clinical narrative: got colitis; high infections; severe stomach pains; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 54-years-old via an unspecified route of administration, administered in arm left on 03Mar2021 11:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included dry eye and dry mouth from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient reported that they got colitis, and continue to have high infections, and severe stomach pains on 06Mar2021 12:00 for almost 2 months now since the time of the vaccine. The patient was hospitalized due to the events for 6 days. The patient's hospitalization was prolonged as a result of the events. The patient underwent lab tests and procedures which included Covid 19 testing PCR (Nasal Swab): negative on 23Mar2021. Therapeutic measures were taken as a result of the events which included treatment with IV and antibiotics. The patient did not recover from the events.  Information on lot number/batch number was requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533), via an unspecified route of administration in left arm, on 19Apr2021 at 03:30 PM (15:30), as second dose, single, for COVID-19 immunization. The patient's medical history herpes (for 31 years), possible exposure to HPV from 20 years ago (2001), and allergies to sulfa. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EP7534) on 29Mar2021 at 03:15 PM at the age of 58 years for COVID-19 immunization (left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01May2021 at 12:30 PM, the patient came down with Bell's palsy. The event resulted in doctor or other healthcare professional office or clinic visit. Treatment received for the adverse event included acyclovir and prednisone prescription. The patient considered the event as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Contusion, Drug ineffective, Heart rate increased, SARS-CoV-2 test positive
Clinical narrative: A week after the bruises appeared patient had syncope episode and a heart rate of 160s; A week after the bruises appeared patient had syncope episode and a heart rate of 160s; Patient was tested for COVID and came back positive; Patient was tested for COVID and came back positive coded as COVID-19; After patient received COVID vaccine bruises appeared all over patient's body; This is a spontaneous report from a contactable other health professional (HCP). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  After the patient received COVID vaccine, bruises appeared all over patient's body on an unspecified date. A week after, the bruises appeared. Patient also had syncope episode and a heart rate of 160s. Patient was tested for COVID and came back positive. A week after showing positive for COVID, patient started to show Covid symptoms. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the company assessed there was not a reasonable possibility that the reported events Syncope, Heart rate increased, Covid -19  were related to the suspect product BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: A week after the bruises appeared patient had syncope episode and a heart rate of 160s; A week after the bruises appeared patient had syncope episode and a heart rate of 160s; Patient was tested for COVID and came back positive; Patient was tested for COVID and came back positive coded as COVID-19; After patient received COVID vaccine bruises appeared all over patient's body; This is a spontaneous report from a contactable other health professional (HCP). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  After the patient received COVID vaccine, bruises appeared all over patient's body on an unspecified date. A week after, the bruises appeared. Patient also had syncope episode and a heart rate of 160s. Patient was tested for COVID and came back positive. A week after showing positive for COVID, patient started to show Covid symptoms. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the company assessed there was not a reasonable possibility that the reported events Syncope, Heart rate increased, Covid -19  were related to the suspect product BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Nasal congestion, Suspected COVID-19, Wheezing
Clinical narrative: I have to use inhaler because I can't breath; my cough is very just wheezy sounding; my cough is very just wheezy sounding; Little stuffy nose and everything; I have like all of the symptoms of like COVID and its like progressively getting worse; Little stuffy nose and everything; I have like all of the symptoms of like COVID and its like progressively getting worse; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. On 03May2021, the patient had a little stuffy nose and everything but she have like all of the symptoms of like COVID and its like progressively getting worse and patient reported that everybody was telling me that these symptoms were normal to get like this. She thought she was on her day 3 now or something, which it should probably be gone because she kept reading everywhere that they only have symptoms for like 1-3 days but it's been getting worse. On 04May2021, the patient had to use an inhaler because she can't breath and her cough was very just wheezy sounding. She was not sure if she should go get the COVID test or was that normal to have these symptoms. Treatment for the events included over the counter medicine like Advil and inhaler. Outcome of events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Limb discomfort, Magnetic resonance imaging head, Scan brain
Clinical narrative: some problem with her left leg and her left arm; stroke; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported) as the 1st dose, single for COVID-19 immunization. The patient got her vaccine at the hospital. Relevant medical history included arthritis and had half of thyroid (not clarified further); both from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication and tramadol taken for pain when she had arthritis; both start and stop date were not reported. The patient had her shots in Jan2021 and had been visiting her doctor's place since then. On 06Feb2021, the patient had a stroke. On an unspecified date, the patient had some problem with her left leg and her left arm, which she thought had improved. The patient underwent lab tests and procedures, which included brain scanning and magnetic resonance imaging (MRI's), both with unknown results on an unspecified date in 2021. Therapeutic measures were taken as a result of stroke, which included a clot buster medicine. The patient was recovering from the event "some problem with her left leg and her left arm," while the outcome of the event "stroke" was unknown.  Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Skin depigmentation, Thrombosis
Clinical narrative: blood clots in his nose; White Spots on the Palm of Hand; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was having allergic reaction he did have blood clots in his nose that did go after some days but now he did have white spots on the palms of his hands and he wanted to know if it was like common allergic reaction. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; Allergy like symptoms; This is a spontaneous report from a contactable nurse (patient's wife). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 01Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 30Apr2021, the patient had tested positive for COVID-19; and had allergy-like symptoms. The patient had received paracetamol (TYLENOL) as treatment for the event, 'tested positive for COVID-19'. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective with SARS-CoV-2 test positive and hypersensitivity cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Disorientation, Headache, Influenza, Pain
Clinical narrative: my left hand and my foot swell; my left hand and my foot swell; I had the temperature almost like I got the flu; my head is really hurting; Body hurting; I feel disoriented; it is not working; It started in the area where they shot me and then it became my entire arm and then my whole body just hurt though; I am cold but like I am hot really hot. I felt like I am burning up; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0160; Expiration Date: 31Aug2021) as second dose single for COVID-19 immunization. Historical Vaccine of BNT162B2 was received as a first dose on an unspecified date. Medical history included diabetes mellitus, infectious thyroiditis from an unknown date and unknown if ongoing. She stated, takes medicine for diabetes and thyroid medication. I have been taking the medication for the past, it's been some years now. Concomitant medications with paracetamol route of administration, start and stop date were not reported for an unspecified indication. The patient experienced my left hand and my foot swell (hand swelling and swelling of feet), had the temperature almost like she got the flu, my head is really hurting, body hurting, she felt disoriented, it is not working, it started in the area where they shot me and then it became my entire arm and then my whole body just hurt though, I am cold but like I am really hot. I felt like I am burning up on an unspecified date. Consumer stated, she took Tylenol, and she work for the government. A lot of medical workers do. A nurse said you take Tylenol. So, that's what I have been taking but it is not working. She stated, there was no need to have any treatment. I got the vaccine. I came home. I lay on the bed yesterday when I left there so, it was just started hurting. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: my left hand and my foot swell; my left hand and my foot swell; I had the temperature almost like I got the flu; my head is really hurting; Body hurting; I feel disoriented; it is not working; It started in the area where they shot me and then it became my entire arm and then my whole body just hurt though; I am cold but like I am hot really hot. I felt like I am burning up; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0160; Expiration Date: 31Aug2021) as second dose single for COVID-19 immunization. Historical Vaccine of BNT162B2 was received as a first dose on an unspecified date. Medical history included diabetes mellitus, infectious thyroiditis from an unknown date and unknown if ongoing. She stated, takes medicine for diabetes and thyroid medication. I have been taking the medication for the past, it's been some years now. Concomitant medications with paracetamol route of administration, start and stop date were not reported for an unspecified indication. The patient experienced my left hand and my foot swell (hand swelling and swelling of feet), had the temperature almost like she got the flu, my head is really hurting, body hurting, she felt disoriented, it is not working, it started in the area where they shot me and then it became my entire arm and then my whole body just hurt though, I am cold but like I am really hot. I felt like I am burning up on an unspecified date. Consumer stated, she took Tylenol, and she work for the government. A lot of medical workers do. A nurse said you take Tylenol. So, that's what I have been taking but it is not working. She stated, there was no need to have any treatment. I got the vaccine. I came home. I lay on the bed yesterday when I left there so, it was just started hurting. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid after first dose; got covid after first dose; This is a spontaneous report from rugulatory authority, program Adverse Event Report, via a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported she/he got COVID after first dose on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Angina pectoris, Headache, Insomnia, Pyrexia
Clinical narrative: Heart pain; Fever; Headache; Stomach ache; Difficulty to sleep; This is a spontaneous report received from a contactable consumer (patient).  A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 28-years-old), administered in Arm Left on 03May2021 10:00 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 28-years-old), administered in Arm Left on Apr2021 10:00 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient experienced the normal symptoms like fever but it was just a mild fever, headache, stomach ache, and difficulty to sleep but the reason he is calling is because he was experiencing heart pain. He received the vaccine for protection on 03May2021 and for all the symptoms he had all started the same day he got the vaccine which all the symptoms started that night. The heart pain was only 10 minutes to 15 minutes that the pain lasted and it was painful but he relaxed himself and the pain went away by itself and he was not scared. He just laid down until the pain relieved and he took no medication. The outcome of the event heart pain was recovered on 03May2021, while for the rest of the events was recovered on 04May2021. The events were considered as non-serious by reporter. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional administered vaccines. No prior vaccinations (within 4 weeks).  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Feeling hot, Headache, Pain, Peripheral swelling
Clinical narrative: my left hand and my foot swell; my left hand and my foot swell; my entire body hurts; I had the temperature almost like I got the flu; my head is really hurting; I feel disoriented; I am cold but like I am hot really hot. I felt like I am burning up; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0160; Expiration Date: 31Aug2021) as 2nd, single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus, ongoing thyroid disorder. The patient's concomitant medications were not reported. The patient stated "I take medicine for diabetes. I take thyroid medication. I have been taking the medication for the past, it's been some years now." The patient previously took BNT162B2, dose 1, on an unspecified date. On 07May2021 the patient experienced my left hand and my foot swell, my entire body hurts, i had the temperature almost like i got the flu, my head is really hurting, i feel disoriented, i am cold but like i am hot really hot. i felt like i am burning up. The patient stated that "I take Tylenol, I work for the government. A lot of medical workers do. A nurse said you take Tylenol . So, that's what I have been taking but it is not working."  The outcome of the events were unknown.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: my left hand and my foot swell; my left hand and my foot swell; my entire body hurts; I had the temperature almost like I got the flu; my head is really hurting; I feel disoriented; I am cold but like I am hot really hot. I felt like I am burning up; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0160; Expiration Date: 31Aug2021) as 2nd, single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus, ongoing thyroid disorder. The patient's concomitant medications were not reported. The patient stated "I take medicine for diabetes. I take thyroid medication. I have been taking the medication for the past, it's been some years now." The patient previously took BNT162B2, dose 1, on an unspecified date. On 07May2021 the patient experienced my left hand and my foot swell, my entire body hurts, i had the temperature almost like i got the flu, my head is really hurting, i feel disoriented, i am cold but like i am hot really hot. i felt like i am burning up. The patient stated that "I take Tylenol, I work for the government. A lot of medical workers do. A nurse said you take Tylenol . So, that's what I have been taking but it is not working."  The outcome of the events were unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the 1st dose on 15Apr2021 and 2nd dose supposed to be today (06May2021). The patient was not able to get the 2nd dose because he got a back surgery and had a back pain. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Polymenorrhoea
Clinical narrative: I've been in chemo induced menopause for almost 5 years. Following the second vaccine, my menstrual cycles began again, were very heavy and less than two weeks apart.; I've been in chemo induced menopause for almost 5 years. Following the second vaccine, my menstrual cycles began again, were very heavy and less than two weeks apart.; I've been in chemo induced menopause for almost 5 years. Following the second vaccine, my menstrual cycles began again, were very heavy and less than two weeks apart.; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 19Mar2021 (Batch/Lot Number: en6199) at the age of 39-year-old as single dose for covid-19 immunization. The patient was not pregnant. Medical history included breast cancer, chemotherapy induced menopause for almost 5 years. The patient had no known allergies. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (Lot number: EN6198) on 25Feb2021 at the age of 39-year-old, at right arm, as single dose for Covid-19 Immunization. There was no other vaccine in four weeks. The patient had been in chemo induced menopause for almost 5 years. Following the second vaccine, her menstrual cycles began again, were very heavy and less than two weeks apart. No treatment received for the events. The outcome of the events was unknown. No Covid prior vaccination. No Covid tested post vaccination.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Dysphagia, Feeling abnormal, Feeling hot, Flushing
Clinical narrative: Similar to covid infection; Similar to covid infection; Shock sensation on different locations of the body; Could not eat or drink; Feeling weird; Heart beat went up; Tensed; Pink warm face; Flushing of the skin for about 20 mins; Pink warm face/feeling warm; Drank water and then it went away somewhat like after drinking alcohol; Butterflies sensations in the throat; This is a spontaneous report from a contactable consumer. A 29-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. It was reported that the patient (male, 29 years old) had COVID and then took vaccine and experienced similar side effects like next morning could not eat or drink, feeling weird, heartbeat went up, tensed, pink warm face, flushing of the skin for about 20 mins, feeling warm, drank water and then it went away somewhat like after drinking alcohol. The patient again felt different sensation, butterflies sensations in the throat, heart rate went up, shock sensation on different locations of the body and taking deep breathing. It lasted for about 3-4 days. The outcome of events was recovered/resolved.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Oropharyngeal discomfort, Shock symptom, Skin discolouration
Clinical narrative: Similar to covid infection; Similar to covid infection; Shock sensation on different locations of the body; Could not eat or drink; Feeling weird; Heart beat went up; Tensed; Pink warm face; Flushing of the skin for about 20 mins; Pink warm face/feeling warm; Drank water and then it went away somewhat like after drinking alcohol; Butterflies sensations in the throat; This is a spontaneous report from a contactable consumer. A 29-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. It was reported that the patient (male, 29 years old) had COVID and then took vaccine and experienced similar side effects like next morning could not eat or drink, feeling weird, heartbeat went up, tensed, pink warm face, flushing of the skin for about 20 mins, feeling warm, drank water and then it went away somewhat like after drinking alcohol. The patient again felt different sensation, butterflies sensations in the throat, heart rate went up, shock sensation on different locations of the body and taking deep breathing. It lasted for about 3-4 days. The outcome of events was recovered/resolved.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Tension, Vomiting
Clinical narrative: Similar to covid infection; Similar to covid infection; Shock sensation on different locations of the body; Could not eat or drink; Feeling weird; Heart beat went up; Tensed; Pink warm face; Flushing of the skin for about 20 mins; Pink warm face/feeling warm; Drank water and then it went away somewhat like after drinking alcohol; Butterflies sensations in the throat; This is a spontaneous report from a contactable consumer. A 29-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. It was reported that the patient (male, 29 years old) had COVID and then took vaccine and experienced similar side effects like next morning could not eat or drink, feeling weird, heartbeat went up, tensed, pink warm face, flushing of the skin for about 20 mins, feeling warm, drank water and then it went away somewhat like after drinking alcohol. The patient again felt different sensation, butterflies sensations in the throat, heart rate went up, shock sensation on different locations of the body and taking deep breathing. It lasted for about 3-4 days. The outcome of events was recovered/resolved.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, COVID-19, Drug ineffective, Nausea, Oral herpes
Clinical narrative: diagnosed with COVID; diagnosed with COVID; Nausea; large cold sore on lip and a canker sore on the roof of the mouth; large cold sore on lip and a canker sore on the roof of the mouth; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 16:30 (Batch/Lot Number: ER8731) at 47-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  Medical history included COVID-19 from an unknown date and unknown if ongoing (also reported as none and if COVID prior vaccination: No). The patient had no known allergies. There were no concomitant medications. On 13Apr2021 at 20:30, the patient experienced: large cold sore on lip and a canker sore on the roof of the mouth (non-serious). On 18Apr2021 at 09:00, the patient experienced: nausea (non-serious). On 05May2021, the patient was diagnosed with COVID (medically significant). The events, large cold sore on lip and a canker sore on the roof of the mouth and nausea, required a physician office visit; however, no therapeutic measures were received. The clinical course was reported as follows: Four hours after the injection, the patient developed a large cold sore on her lip and a canker sore on the roof of her mouth. On 18Apr2021 at 09:00 (also reported as five days later), the patient began experiencing nausea that she was still experiencing 18 days later. The patient was then diagnosed with COVID on 05May2021. The patient underwent lab tests and procedures which included Qualitative PCR (Nasal Swab): positive   on 05May2021. The clinical outcome of the events: large cold sore on lip and a canker sore on the roof of the mouth and nausea, was not recovered. The clinical outcome of the event, diagnosed with COVID, was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: diagnosed with COVID; diagnosed with COVID; Nausea; large cold sore on lip and a canker sore on the roof of the mouth; large cold sore on lip and a canker sore on the roof of the mouth; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 16:30 (Batch/Lot Number: ER8731) at 47-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  Medical history included COVID-19 from an unknown date and unknown if ongoing (also reported as none and if COVID prior vaccination: No). The patient had no known allergies. There were no concomitant medications. On 13Apr2021 at 20:30, the patient experienced: large cold sore on lip and a canker sore on the roof of the mouth (non-serious). On 18Apr2021 at 09:00, the patient experienced: nausea (non-serious). On 05May2021, the patient was diagnosed with COVID (medically significant). The events, large cold sore on lip and a canker sore on the roof of the mouth and nausea, required a physician office visit; however, no therapeutic measures were received. The clinical course was reported as follows: Four hours after the injection, the patient developed a large cold sore on her lip and a canker sore on the roof of her mouth. On 18Apr2021 at 09:00 (also reported as five days later), the patient began experiencing nausea that she was still experiencing 18 days later. The patient was then diagnosed with COVID on 05May2021. The patient underwent lab tests and procedures which included Qualitative PCR (Nasal Swab): positive   on 05May2021. The clinical outcome of the events: large cold sore on lip and a canker sore on the roof of the mouth and nausea, was not recovered. The clinical outcome of the event, diagnosed with COVID, was unknown.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Brain oedema, Ear swelling, Fall, Limb injury, Peripheral swelling
Clinical narrative: Brain swelling; Swelling of fingers; Ear swelling; Leg injury; Fall; This is a solicited report based on the information received by Pfizer  Control No.:21K-163-3887651-00. A contactable consumer (patient) and a physician reported that a 61 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscularly on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 Vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose and frequency (Citrate Free) for psoriatic arthritis.  The patient's medical history and concomitant medications was not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient experienced swelling in ears, head and fingers; fall/was on crutches due to hurt leg after fall, all on an unknown date. The patient was treated with BENADRYL. The outcome of fall was recovering. The outcome of other events was unknown. Causality for HUMIRA(ADALIMUMAB) was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information about Lot/Batch number cannot be obtained. Additional information has been requested.; Sender's Comments: Based on the information currently available,vaccine BNT162B2 or comirnarity is unrelated to the event brain edema.. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Chronic lymphocytic leukaemia
Clinical narrative: chronic lymphocytic leukaemia (CLL); This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he did not have a response/did not generate any antibodies on an unspecified date after taking the Pfizer-BioNTech COVID-19 vaccine. He stated it was due to having chronic lymphocytic leukaemia (CLL). The outcome of the adverse event was unknown.  Information about the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Pain, Renal pain, Vascular injury
Clinical narrative: Stomach pain; Kidney pain; Vomiting; Vascular stomach issue; Chills; Mild body aches; This is a spontaneous report received from a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EP7533) via an unspecified route of administration in Left Arm on 30Apr2021 12:00 as 2nd dose, single for COVID-19 immunization. Medical history included cerebellar ataxia and breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was having no allergies. Prior to vaccination the patient was not diagnosed with COVID-19. The reporter also reported that the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration in Left Arm on 02Apr2021 01:00 as 1st dose, single for COVID-19 immunization. On 06May2021 the patient experienced stomach pain, kidney pain and vomiting. On an unspecified date Patient also experienced chills, vascular stomach issue and mild body aches in 2021. The seriousness of the stomach pain, kidney pain was reported as serious, which leads to hospitalization for 3 days. The clinical outcome of the events was not recovered.  Follow-up pending was reassigned. further information has been requested.