chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure systolic, Hypertension
Clinical narrative: elevation in blood pressure/hypertension has persisted; This is a spontaneous report from a contactable Physician (patient himself). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266, expiry date: not reported) via unspecified route of administration in left deltoid, on 17Feb2021 13:00 (age at vaccination: 86-year-old) as DOSE 2, SINGLE for Covid-19 immunisation. Patient took first dose of vaccination (Lot: EN5318 or it could be ENS318, expiration date: not reported), via unspecified route of administration in left shoulder in the deltoid on 27Jan2021 13: 00 (age at vaccination: 86) as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history t and concomitant medication were not reported. He was taking a very modest dose of Lisinopril 2.5mg daily, now taking 10mg lisinopril daily. Information was reported regarding Lisinopril 5mg, expiration was filled 25Nov2019 says discard 24Nov2020. It was reported that his blood pressure has gone up after receiving the second dose Pfizer Covid 19 Vaccine, he doesn't know if his blood pressuring going up is a coincidence or if this is being seen by other people. Blood pressure has gone up: states 29Apr2021 was when the caller first noticed the hypertension, the blood pressure going up is ongoing and it is the same, states he has increased his anti hypertensive medication so in a sense. Before 29Apr2021 the caller's blood pressure systolic was below 120, and now the caller is getting ratings like 135, was taking a very modest dose of Lisinopril 2.5mg daily and is now taking 10mg Lisinopril daily. It was also reported that because this spike in protein reacts with the ACE2, the molecule on the surface of the cell spikes protein reactions, which has to do with blood pressure. Patient stated that on 29Apr2021 he noticed an elevation in blood pressure and this hypertension has persisted. He would like to know if this event is a coincidence or if this is a side effect that has been reported with the Pfizer COVID-19 vaccine. Patient was inquiring about the length of time the spike protein remains in the body and circulates after receiving the Pfizer COVID-19 vaccine. He escalated to secondline for further research. He asked if Pfizer would be interested in obtaining a blood sample from him to see if he still has spike proteins circulating in his system from the Pfizer COVID-19 vaccine after his second dose in Feb. Treatment was given for the adverse events includes Lisinopril 2.5mg daily and is now taking 10mg Lisinopril daily. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651524 same reporter/SD, different patient/AE
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Disturbed menstrual cycle, after first vaccine/her daughter had a few drops of blood; This is a spontaneous report received from a contactable consumer (mother of patient). A 21-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: EW0202) via an unspecified route of administration in Arm Left on 05Jun2021 16:30 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07Jun2021 reporter stated her daughter took the Pfizer vaccination yesterday and it disturbed her menstrual cycle in the evening and later she reclarified the vaccine for COVID. She stated as on 07Jun2021, her daughter had a few drops of blood and that was the same on 08Jun2021 and 09Jun2021 and her daughter still had no blood flow. It was reported as her daughter had a normal menstrual cycle before the vaccine and she is not taking any medications. Reporter stated as still people are taking the vaccination and having the same issue. Treatment received was reported as no. Outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for her sister. This is the one of two reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number and Expiration Date were not reported), via an unspecified route of administration on 29May2021 as dose number unknown, single for COVID-19 immunization. The patient medical history included COVID-19 from Sep2020 to an unknown date. Concomitant medications were not reported. The reporter states that, on unknown date in May2021, her sister having complaints of cough, her sister was 60 years old (Not confirmed hence not captured in tab). She had COVID last September (Sep2020). She and her sister got the covid vaccine on 29May2021 and both her and her sister were coughing, and still coughing like the cough occurred 5 days after getting the vaccine and they still have the complaints of the cough right now. The outcome of the event was not resolved.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021702539 same report/drug/AE, different patient
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the arm where the vaccine was administered; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0187), at the age of 40 years old, in left arm on 23May2021 at 12:00 at single dose for COVID-19 immunisation. The patient's medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines in four weeks of vaccination and any other medications in two weeks of vaccination. The patient experienced pain in the arm where the vaccine was administered on 23May2021 at 18:00. The patient had not been tested for COVID-19 since the vaccination. No treatment received. The outcome of event was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Cough, SARS-CoV-2 test
Clinical narrative: Had a severe cough; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age 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 2nd dose, single for covid-19 immunisation. Medical history included immunocompromised (she was immunocompromised) and severe arthritis. Concomitant medication included etanercept (ENBREL INJECTION). 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 for COVID-19 immunisation and experienced no reaction for 1st dose. The patient stated that she was immunocompromised because she had severe arthritis and was aware that the vaccine can be less effective to her. She was taking Enbrel injection and wanted to know information on the timing of the vaccine vs the timing of injectables. The patient added that her doctor had px taking multiple drugs that compromised her immune system. On an unspecified, patient had a severe cough and tested negative for COVID. They tested her antibodies with both doses of the Pfizer COVID-19 vaccine and got a result of zero antibodies. The patient underwent lab tests and procedures which included antibody test: zero antibodies and sars- cov-2 test: negative on an unspecified date. The outcome of the event was unknown.    Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Headache, Taste disorder
Clinical narrative: Can't stand up; Can't taste anything; Tremendous headaches; This is a spontaneous report from a Non contactable consumer (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via unspecified route of administration, on 18Jun2021, as 1st dose, single for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unknown date in Jun2021, the patient experienced tremendous headaches, can't stand up, and can't taste anything. The reporter reported events as non serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: got Mild side effects, had an allergic reaction consisting of hives on body including hands and legs, like 10 places; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0150, Expiration date: did not have any as such), via an unspecified route of administration, administered in Arm Left on 09Apr2021, as dose 1, single (age at vaccination: 29 years), for covid-19 immunization. Medical history included appendicectomy on an unknown date in Mar2021 (had a surgery a month before first shot vaccination). The patient was not taking any concomitant medication. The patient stated that, within 3-4 hours after taking first shot, he got mild side effects, had an allergic reaction consisting of hives on his body including his hands and legs, stating there were about 10 hives (like 10 places) and they resolved in 2 days and he was fine. After that he was referred to CVC during that time during Apr2021 time, it was mention in CVC that he should not take any second shot even if he had some minimal allergic reaction (hives), so he did not get his second dose of the vaccine because of his allergic reaction. Reportedly, there was no prior vaccination and there was no family medical history related to adverse event. As a treatment for the event, he just went to Emergency and took Benadryl, for which he did not remember the dose. The outcome of the event was recovered on an unknown date in Apr2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nausea, Palpitations
Clinical narrative: hot; nauseous; heart was racing; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: EW0186), via an unspecified route of administration on 25May2021 at 12:00 (at the age of 46-years) as single dose in the left arm for covid-19 immunisation. The patient's medical history included hypothyroid and had food allergies. The patient's concomitant medications included levothyroxine sodium (SYNTHYROID), Cetrizine from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25May2021 at 12:00 within 10 minutes of receiving vaccine the patient experienced hot, nauseous, and heart was racing. Patient stated that pharmacist gave me two doses of Benadryl and one of Tylenol. After a bit the symptoms abated. Patient scheduled an appointment with my PCP to discuss this reaction. She advised to continue and get the second dose. She had the second dose and the onset was faster and more severe. She had the shot and with 3 minutes she was dry heaving, very congested, throat felt tight. She could still breathe. This all happened even though she took Benadryl and a Tylenol 45 minutes prior to her injection. Again, the pharmacist gave a dose of Benadryl to help with the effects of the vaccine. She would like to know what is in the vaccine. Patient stated that she had food allergies and this reaction is frightening. Ae resulted in clinic visit and ER visit. The outcome of the events was resolved.  Information on Lot/Batch number was available. Additional information has been requested
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Hypoaesthesia, Joint swelling, Pain in extremity
Clinical narrative: Pain in Right and left shoulder/Pain in my joints and right knee; Wrist and fingers swollen and numb; Wrist and fingers swollen and numb; Pain in right arm and hand; Wrist and fingers swollen and numb; Over all general weakness; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7533, 69-years-old at the time of vaccination) via an unspecified route of administration, administered in arm right on 07Apr2021 at 09:00 as single for covid-19 immunisation. Medical history included enlarged prostate. Concomitant medications included finasteride at 5 mg and doxazosin at 2 mg. No known allergies present. 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. Since the vaccination, the patient has not been tested for COVID-19. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206, 69-years-old at the time of vaccination) via an unspecified route of administration, administered in arm right on 17Mar2021 at 06:00 as single for covid-19 immunisation. On 23Apr2021 at 12: 00 am, patient experienced pain in right and left shoulder, pain in right arm and hand, right hand, wrist and fingers swollen, and numb, left hand wrist and fingers were beginning to swell, pain in his joints and right knee and over all general weakness. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability, or permanent damage. Patient did not receive any treatment for the events. Outcome was not resolved for all the events.  Was requested for additional information.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Pain in Right and left shoulder/Pain in my joints and right knee; Wrist and fingers swollen and numb; Wrist and fingers swollen and numb; Pain in right arm and hand; Wrist and fingers swollen and numb; Over all general weakness; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7533, 69-years-old at the time of vaccination) via an unspecified route of administration, administered in arm right on 07Apr2021 at 09:00 as single for covid-19 immunisation. Medical history included enlarged prostate. Concomitant medications included finasteride at 5 mg and doxazosin at 2 mg. No known allergies present. 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. Since the vaccination, the patient has not been tested for COVID-19. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206, 69-years-old at the time of vaccination) via an unspecified route of administration, administered in arm right on 17Mar2021 at 06:00 as single for covid-19 immunisation. On 23Apr2021 at 12: 00 am, patient experienced pain in right and left shoulder, pain in right arm and hand, right hand, wrist and fingers swollen, and numb, left hand wrist and fingers were beginning to swell, pain in his joints and right knee and over all general weakness. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability, or permanent damage. Patient did not receive any treatment for the events. Outcome was not resolved for all the events.  Was requested for additional information.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Get out of breath easily; Feeling light headed the next day after vaccine; Sharp stabbing pain in chest twice; Palpitations; Hear racing, pounding, hot and cold flashes; hear racing, pounding, hot and cold flashes; Heart felt like it was being squeezed,heaviness in chest; Heart felt like it was being squeezed, heaviness in chest; High BP and heart rate; High BP and heart rate; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8733), via an unspecified route of administration on 21May2021 (at the age of 37-years) as single dose in the left arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, the patient experienced started feeling light headed the next day after vaccine, then sharp stabbing pain in chest twice, palpitations, hear racing, pounding, hot and cold flashes a few times. Heart felt like it was being squeezed, heaviness in chest and get out of breath easily. Still ongoing and had to be taken to the ER for this with high BP and heart rate. Patient stated that not normal for her, never had BP issues, or any health issues like this or ever been on any meds for anything. The patient did not received treatment for events. The patient had visited to emergency room and physician office. The outcome of the events was not recovered.  Information on the lot/ batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Heart rate increased, Hot flush, Hypertension
Clinical narrative: Get out of breath easily; Feeling light headed the next day after vaccine; Sharp stabbing pain in chest twice; Palpitations; Hear racing, pounding, hot and cold flashes; hear racing, pounding, hot and cold flashes; Heart felt like it was being squeezed,heaviness in chest; Heart felt like it was being squeezed, heaviness in chest; High BP and heart rate; High BP and heart rate; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8733), via an unspecified route of administration on 21May2021 (at the age of 37-years) as single dose in the left arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, the patient experienced started feeling light headed the next day after vaccine, then sharp stabbing pain in chest twice, palpitations, hear racing, pounding, hot and cold flashes a few times. Heart felt like it was being squeezed, heaviness in chest and get out of breath easily. Still ongoing and had to be taken to the ER for this with high BP and heart rate. Patient stated that not normal for her, never had BP issues, or any health issues like this or ever been on any meds for anything. The patient did not received treatment for events. The patient had visited to emergency room and physician office. The outcome of the events was not recovered.  Information on the lot/ batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Get out of breath easily; Feeling light headed the next day after vaccine; Sharp stabbing pain in chest twice; Palpitations; Hear racing, pounding, hot and cold flashes; hear racing, pounding, hot and cold flashes; Heart felt like it was being squeezed,heaviness in chest; Heart felt like it was being squeezed, heaviness in chest; High BP and heart rate; High BP and heart rate; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8733), via an unspecified route of administration on 21May2021 (at the age of 37-years) as single dose in the left arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, the patient experienced started feeling light headed the next day after vaccine, then sharp stabbing pain in chest twice, palpitations, hear racing, pounding, hot and cold flashes a few times. Heart felt like it was being squeezed, heaviness in chest and get out of breath easily. Still ongoing and had to be taken to the ER for this with high BP and heart rate. Patient stated that not normal for her, never had BP issues, or any health issues like this or ever been on any meds for anything. The patient did not received treatment for events. The patient had visited to emergency room and physician office. The outcome of the events was not recovered.  Information on the lot/ batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dysarthria, Eye disorder, Pain, Pain in extremity
Clinical narrative: Sharp pain in left hand/Feet swollen and in pain; Slurred speech eyes dilated; Body heavy and in pain; Body heavy and in pain; Throat feels like it's closing up; I can feel my heart beating and like their are ants in my veins.; Felt like arms swollen/Feet swollen and in pain; My vision is now blurred and reduced significantly; My vision is now blurred and reduced significantly; Severe panic attacks; Slurred speech eyes dilated; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; 43-year and non pregnant at the time of vaccination), first dose via an unspecified route of administration, in arm left on 20Mar2021 11:00 (Batch/Lot Number: EN6204; Expiration Date: Jun2021) at unknown dose single for covid-19 immunisation. Medical history included Hashimoto's Thyroiditis; Metronidazole Allergy. Concomitant medication included levothyroxine at 25 ug. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination was Levothyroxine 25 ug. On 20Mar2021 11:30, patient had "I have chronic disease, Hashimoto's thyroiditis. Severe reaction, sharp pain in left hand, 20 mins later slurred speech eyes dilated, body heavy and in pain, throat feels like it's closing up. I can feel my heart beating and like theirare ants in my veins. Felt like arms swollen. Feet swollen and in pain. Took antihistamine Benadryl. Doctors at Urgent care said I'm not having anaphylaxis but having severe panic attacks. Given steroid injection. Swelling reduced, pain reduced. I was able to see again although my vision is now blurred and reduced significantly ". Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, covid test post vaccination: covid test type post vaccination=Other, covid test date=08Jun2021, covid test result=Negative. The outcome of the events was resolved with sequel.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Panic attack, Peripheral swelling, SARS-CoV-2 test, Throat tightness
Clinical narrative: Sharp pain in left hand/Feet swollen and in pain; Slurred speech eyes dilated; Body heavy and in pain; Body heavy and in pain; Throat feels like it's closing up; I can feel my heart beating and like their are ants in my veins.; Felt like arms swollen/Feet swollen and in pain; My vision is now blurred and reduced significantly; My vision is now blurred and reduced significantly; Severe panic attacks; Slurred speech eyes dilated; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; 43-year and non pregnant at the time of vaccination), first dose via an unspecified route of administration, in arm left on 20Mar2021 11:00 (Batch/Lot Number: EN6204; Expiration Date: Jun2021) at unknown dose single for covid-19 immunisation. Medical history included Hashimoto's Thyroiditis; Metronidazole Allergy. Concomitant medication included levothyroxine at 25 ug. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination was Levothyroxine 25 ug. On 20Mar2021 11:30, patient had "I have chronic disease, Hashimoto's thyroiditis. Severe reaction, sharp pain in left hand, 20 mins later slurred speech eyes dilated, body heavy and in pain, throat feels like it's closing up. I can feel my heart beating and like theirare ants in my veins. Felt like arms swollen. Feet swollen and in pain. Took antihistamine Benadryl. Doctors at Urgent care said I'm not having anaphylaxis but having severe panic attacks. Given steroid injection. Swelling reduced, pain reduced. I was able to see again although my vision is now blurred and reduced significantly ". Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, covid test post vaccination: covid test type post vaccination=Other, covid test date=08Jun2021, covid test result=Negative. The outcome of the events was resolved with sequel.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Sharp pain in left hand/Feet swollen and in pain; Slurred speech eyes dilated; Body heavy and in pain; Body heavy and in pain; Throat feels like it's closing up; I can feel my heart beating and like their are ants in my veins.; Felt like arms swollen/Feet swollen and in pain; My vision is now blurred and reduced significantly; My vision is now blurred and reduced significantly; Severe panic attacks; Slurred speech eyes dilated; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; 43-year and non pregnant at the time of vaccination), first dose via an unspecified route of administration, in arm left on 20Mar2021 11:00 (Batch/Lot Number: EN6204; Expiration Date: Jun2021) at unknown dose single for covid-19 immunisation. Medical history included Hashimoto's Thyroiditis; Metronidazole Allergy. Concomitant medication included levothyroxine at 25 ug. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination was Levothyroxine 25 ug. On 20Mar2021 11:30, patient had "I have chronic disease, Hashimoto's thyroiditis. Severe reaction, sharp pain in left hand, 20 mins later slurred speech eyes dilated, body heavy and in pain, throat feels like it's closing up. I can feel my heart beating and like theirare ants in my veins. Felt like arms swollen. Feet swollen and in pain. Took antihistamine Benadryl. Doctors at Urgent care said I'm not having anaphylaxis but having severe panic attacks. Given steroid injection. Swelling reduced, pain reduced. I was able to see again although my vision is now blurred and reduced significantly ". Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, covid test post vaccination: covid test type post vaccination=Other, covid test date=08Jun2021, covid test result=Negative. The outcome of the events was resolved with sequel.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Electrocardiogram, Herpes zoster, Investigation, Musculoskeletal pain
Clinical narrative: Shingles; Feeling a strong pain on my left buttock; Pain moved to left part of abdomen and became unbearable; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in right arm on 29Apr2021 04:00 (Batch/Lot number: EWO173, Expiration Date: was not reported, Age at Vaccination: 53-year-old) as DOSE 2, single for covid-19 immunisation. The patient's medical history included High blood pressure, acid reflux, ADD, obesity. The concomitant medication included Vyvanse, Benazepril, Omeprazole, Loratadine. On 29Apr2021 04:45, patient experienced a strong pain on left buttock about 30 minutes after getting the second vaccine. It came and went for the next 4 weeks. On 29May2021, she went to urgent care when pain moved to left part of abdomen and became unbearable. Urgent care doctor sent her to ER. ER did ekg and other tests but couldn't figure out what was causing pain. Patient reported they gave me a small dose of morphine, then sent me home. Told me to take 1000 mil of Tylenol for pain. On 31May2021, I awakened with rash all over left abdomen, went to urgent care, was diagnosed with shingles. Patient took Valacyclovir HCL 1 gram as treatment for events. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, he was not tested for COVID-19. Patient had no allergies. The outcome of all events was recovered with Sequel on an unspecified date in 2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Menstruation irregular, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Irregular menstrual cycle/ First cycle after the first dose was a 40 day cycle; extreme fatigue; arm soreness; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 16:00 (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had 23-MAR-2021 19:00, Irregular menstrual cycle. First cycle after the first dose was a 40 day cycle. My cycle is typically 26-28 days and VERY heavy lasting about 5 days. Unknown when it will end. she usually very regular. After getting the vaccine I have no idea when her period is coming. Also, immediately after the first vaccine she experienced extreme fatigue and arm soreness the night of the 1st dose on 23-MAR-2021. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Mar2021 Nasal Swab. The outcome of the events was Resolved with Sequel.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Dyspnoea, Fatigue
Clinical narrative: This morning 19Jun at about 6:35 am I woke up with chest pains that feel like burning; accelerated heartbeat; shortness of breath; on Thursday morning 17Jun I woke up with a 101degree fever at 5:20; body aches; chills; extreme fatigue; nausea; headache; This is a spontaneous report from a contactable consumer. A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, batch/lot number: unknown), via an unspecified route of administration on 16Jun2021 3:15 PM as unknown dose single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient had no known allergies. Historical vaccine included first dose of BNT162b2 on 22May2021 at 02:30 AM on left arm for covid-19 immunization. Patient did not have covid prior to vaccination. Patient was not tested for covid post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient provided privacy policy consent. On Thursday morning 17Jun patient woke up with a 101degree fever at 5:20 along with body aches, chills, extreme fatigue, shortness of breath, nausea, and headache. On 18Jun she woke up with a continuing headache, slight fever of 99.6, fatigue, and shortness of breath. On 19Jun at about 6:35 am she woke up with chest pains that feel like burning, along with shortness of breath, accelerated heartbeat, and fatigue. Patient reported that this was awful. The outcome of events was recovering.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Nausea, Pain, Pyrexia
Clinical narrative: This morning 19Jun at about 6:35 am I woke up with chest pains that feel like burning; accelerated heartbeat; shortness of breath; on Thursday morning 17Jun I woke up with a 101degree fever at 5:20; body aches; chills; extreme fatigue; nausea; headache; This is a spontaneous report from a contactable consumer. A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, batch/lot number: unknown), via an unspecified route of administration on 16Jun2021 3:15 PM as unknown dose single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient had no known allergies. Historical vaccine included first dose of BNT162b2 on 22May2021 at 02:30 AM on left arm for covid-19 immunization. Patient did not have covid prior to vaccination. Patient was not tested for covid post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient provided privacy policy consent. On Thursday morning 17Jun patient woke up with a 101degree fever at 5:20 along with body aches, chills, extreme fatigue, shortness of breath, nausea, and headache. On 18Jun she woke up with a continuing headache, slight fever of 99.6, fatigue, and shortness of breath. On 19Jun at about 6:35 am she woke up with chest pains that feel like burning, along with shortness of breath, accelerated heartbeat, and fatigue. Patient reported that this was awful. The outcome of events was recovering.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood pressure systolic decreased, Body temperature, Cardiac monitoring, Echocardiogram
Clinical narrative: full generalized tonic clonic seizure; fever; troponins checked and they were elevated; 70-80 systolic on 06Jun2021; heart rate 160s on; This is a spontaneous report from a non-contactable consumer (patient). A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 05Jun2021 12:00 as dose 2, single for covid-19 immunisation. Medical history included history of autism, controlled seizures. The patient's concomitant medications were not reported. patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 15May2021 as dose 1, single for covid-19 immunisation. The patient underwent lab tests and procedures which included blood pressure measurement: 70-80 systolic on 06Jun2021, cardiac monitoring: unknown results on 06Jun2021, echocardiogram: unknown results on 06Jun2021, heart rate: 160s on 06Jun2021, neuropathy peripheral: unknown results on 06Jun2021, body temperature: 103.6 on 06Jun2021, troponin: elevated on 06Jun2021. On 06Jun2021 08:00. After shot done at 12 PM, next morning at 8 AM patient had full generalized tonic clonic seizure lasting 20-25 minutes, fever of 103.6. EMS was called, went to ER, fever eventually went down and got IV fluids due to HR in 160s and BP 70-80 systolic. After 2 hours, troponins checked, and they were elevated. Transferred to hospital for overnight observation and monitoring of troponins (peaked at midnight, then trended down). Echo was okay. Will follow up with neurology and cardiology. The outcome of the events was resolved on unknow date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Heart rate, Heart rate increased, Neuropathy peripheral, Pyrexia
Clinical narrative: full generalized tonic clonic seizure; fever; troponins checked and they were elevated; 70-80 systolic on 06Jun2021; heart rate 160s on; This is a spontaneous report from a non-contactable consumer (patient). A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 05Jun2021 12:00 as dose 2, single for covid-19 immunisation. Medical history included history of autism, controlled seizures. The patient's concomitant medications were not reported. patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 15May2021 as dose 1, single for covid-19 immunisation. The patient underwent lab tests and procedures which included blood pressure measurement: 70-80 systolic on 06Jun2021, cardiac monitoring: unknown results on 06Jun2021, echocardiogram: unknown results on 06Jun2021, heart rate: 160s on 06Jun2021, neuropathy peripheral: unknown results on 06Jun2021, body temperature: 103.6 on 06Jun2021, troponin: elevated on 06Jun2021. On 06Jun2021 08:00. After shot done at 12 PM, next morning at 8 AM patient had full generalized tonic clonic seizure lasting 20-25 minutes, fever of 103.6. EMS was called, went to ER, fever eventually went down and got IV fluids due to HR in 160s and BP 70-80 systolic. After 2 hours, troponins checked, and they were elevated. Transferred to hospital for overnight observation and monitoring of troponins (peaked at midnight, then trended down). Echo was okay. Will follow up with neurology and cardiology. The outcome of the events was resolved on unknow date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin, Troponin increased
Clinical narrative: full generalized tonic clonic seizure; fever; troponins checked and they were elevated; 70-80 systolic on 06Jun2021; heart rate 160s on; This is a spontaneous report from a non-contactable consumer (patient). A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 05Jun2021 12:00 as dose 2, single for covid-19 immunisation. Medical history included history of autism, controlled seizures. The patient's concomitant medications were not reported. patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 15May2021 as dose 1, single for covid-19 immunisation. The patient underwent lab tests and procedures which included blood pressure measurement: 70-80 systolic on 06Jun2021, cardiac monitoring: unknown results on 06Jun2021, echocardiogram: unknown results on 06Jun2021, heart rate: 160s on 06Jun2021, neuropathy peripheral: unknown results on 06Jun2021, body temperature: 103.6 on 06Jun2021, troponin: elevated on 06Jun2021. On 06Jun2021 08:00. After shot done at 12 PM, next morning at 8 AM patient had full generalized tonic clonic seizure lasting 20-25 minutes, fever of 103.6. EMS was called, went to ER, fever eventually went down and got IV fluids due to HR in 160s and BP 70-80 systolic. After 2 hours, troponins checked, and they were elevated. Transferred to hospital for overnight observation and monitoring of troponins (peaked at midnight, then trended down). Echo was okay. Will follow up with neurology and cardiology. The outcome of the events was resolved on unknow date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Paraesthesia, Peripheral swelling, Pharyngeal swelling, Swelling face
Clinical narrative: My body started to swell up including my face and my legs my arm and my throat; My body started to swell up including my face and my legs my arm and my throat; My body started to swell up including my face and my legs my arm and my throat; My legs were tingly; Felt like it was closing it didn't close but it was swelling up; My whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance; "via subcutaneous route"; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via subcutaneous route, administered in arm left in shoulder area on 06Jun2021 at 16:30 (age at vaccination was 53-years-old) (Batch/Lot Number: EW0196) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing hay fever (I take allergy medication for hay fever you know for regular allergy). Concomitant medication included gliclazide (CLARITIN) taken for hay fever, start and stop date were not reported. Prior vaccination (within 4 weeks) was reported as no. The patient stated I just wanted to report my reaction to the vaccine for record purpose. I got the 1st shot, within few hours my body started to swell up, including my face and my legs my arm and my throat. I felt like it was closing it did not close but it was swelling up and my whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance and they put me on oxygen I could breath but I think they were just worried so they put me on oxygen, and then I spent 5 days in hospital in recovering from it, I just want you guys to know when you collect your data that this was one of the side effects. Patient also stated that her legs were tingly. The event my whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance resulted in hospitalization. Period of hospitalization was reported as 06Jun2021 to 10Jun2021 (duration 5 days). When asked patient if still experiencing events, the patient stated no, I am fine now, in the hospital they pumped with a lot of fluid and including lot of electrolyte, I had follow-up visit with my doctor and I am very healthy now I am fine, I think they just needed to flush it out of my system. The outcome of the events was recovered on an unspecified date in Jun2021.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tremor
Clinical narrative: My body started to swell up including my face and my legs my arm and my throat; My body started to swell up including my face and my legs my arm and my throat; My body started to swell up including my face and my legs my arm and my throat; My legs were tingly; Felt like it was closing it didn't close but it was swelling up; My whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance; "via subcutaneous route"; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via subcutaneous route, administered in arm left in shoulder area on 06Jun2021 at 16:30 (age at vaccination was 53-years-old) (Batch/Lot Number: EW0196) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing hay fever (I take allergy medication for hay fever you know for regular allergy). Concomitant medication included gliclazide (CLARITIN) taken for hay fever, start and stop date were not reported. Prior vaccination (within 4 weeks) was reported as no. The patient stated I just wanted to report my reaction to the vaccine for record purpose. I got the 1st shot, within few hours my body started to swell up, including my face and my legs my arm and my throat. I felt like it was closing it did not close but it was swelling up and my whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance and they put me on oxygen I could breath but I think they were just worried so they put me on oxygen, and then I spent 5 days in hospital in recovering from it, I just want you guys to know when you collect your data that this was one of the side effects. Patient also stated that her legs were tingly. The event my whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance resulted in hospitalization. Period of hospitalization was reported as 06Jun2021 to 10Jun2021 (duration 5 days). When asked patient if still experiencing events, the patient stated no, I am fine now, in the hospital they pumped with a lot of fluid and including lot of electrolyte, I had follow-up visit with my doctor and I am very healthy now I am fine, I think they just needed to flush it out of my system. The outcome of the events was recovered on an unspecified date in Jun2021.  Information on the lot/batch number has been requested.