chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: Red rashes over swollen area of injection site; Red rashes over swollen area of injection site; Itching over swollen arm; itching over other parts of body; itching over other parts of body, warm to touch; Swelling at the injection site; Warm on the injection site; knot at injection site; Slight arm pain; Elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, strength: 0.3 mL, Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 12Mar2021 at 09:30 (at the age of 55-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Medical history included Type II Diabetes; High Blood pressure (usually maintained by medication); low iron anemia, migranes; lichen planus; detached retina; prior to vaccination, patient was diagnosed with COVID-19. Other concomitant medications were received within 2 weeks of vaccination. The patient's known allergies included ciprofloxacin (CIPRO) (Highly allergic), moxifloxacin hydrochloride (VIGAMOX) and moxifloxacin hydrochloride (AVELOX), all experienced allergies. Slight arm pain evening of vaccination date on 12Mar2021 at 21:15. Small knot at injection site and arm pain following two days from 13Mar2021, larger knot at injection site and arm pain third day and arm pain, with warm to area to touch by late evening on 14Mar2021. By morning of fourth day (15Mar2021) area of injection site swelling three to five times more than evening before (14Mar2021), red, slight rash over swollen area, arm pain. By afternoon on 15Mar2021 itching where arm was swollen and continues to swell, and itching over other parts of body, warm to touch. NO fever during any of this time. Elevated blood pressure on 12Mar2021 at 21:15. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not tested for COVID-19. No treatment was received for events. The outcome of the events was not recovered. The report was reported as non-serious.  No follow-up attempts are needed. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Red rashes over swollen area of injection site; Red rashes over swollen area of injection site; Itching over swollen arm; itching over other parts of body; itching over other parts of body, warm to touch; Swelling at the injection site; Warm on the injection site; knot at injection site; Slight arm pain; Elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, strength: 0.3 mL, Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 12Mar2021 at 09:30 (at the age of 55-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Medical history included Type II Diabetes; High Blood pressure (usually maintained by medication); low iron anemia, migranes; lichen planus; detached retina; prior to vaccination, patient was diagnosed with COVID-19. Other concomitant medications were received within 2 weeks of vaccination. The patient's known allergies included ciprofloxacin (CIPRO) (Highly allergic), moxifloxacin hydrochloride (VIGAMOX) and moxifloxacin hydrochloride (AVELOX), all experienced allergies. Slight arm pain evening of vaccination date on 12Mar2021 at 21:15. Small knot at injection site and arm pain following two days from 13Mar2021, larger knot at injection site and arm pain third day and arm pain, with warm to area to touch by late evening on 14Mar2021. By morning of fourth day (15Mar2021) area of injection site swelling three to five times more than evening before (14Mar2021), red, slight rash over swollen area, arm pain. By afternoon on 15Mar2021 itching where arm was swollen and continues to swell, and itching over other parts of body, warm to touch. NO fever during any of this time. Elevated blood pressure on 12Mar2021 at 21:15. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not tested for COVID-19. No treatment was received for events. The outcome of the events was not recovered. The report was reported as non-serious.  No follow-up attempts are needed. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Red rashes over swollen area of injection site; Red rashes over swollen area of injection site; Itching over swollen arm; itching over other parts of body; itching over other parts of body, warm to touch; Swelling at the injection site; Warm on the injection site; knot at injection site; Slight arm pain; Elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, strength: 0.3 mL, Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 12Mar2021 at 09:30 (at the age of 55-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Medical history included Type II Diabetes; High Blood pressure (usually maintained by medication); low iron anemia, migranes; lichen planus; detached retina; prior to vaccination, patient was diagnosed with COVID-19. Other concomitant medications were received within 2 weeks of vaccination. The patient's known allergies included ciprofloxacin (CIPRO) (Highly allergic), moxifloxacin hydrochloride (VIGAMOX) and moxifloxacin hydrochloride (AVELOX), all experienced allergies. Slight arm pain evening of vaccination date on 12Mar2021 at 21:15. Small knot at injection site and arm pain following two days from 13Mar2021, larger knot at injection site and arm pain third day and arm pain, with warm to area to touch by late evening on 14Mar2021. By morning of fourth day (15Mar2021) area of injection site swelling three to five times more than evening before (14Mar2021), red, slight rash over swollen area, arm pain. By afternoon on 15Mar2021 itching where arm was swollen and continues to swell, and itching over other parts of body, warm to touch. NO fever during any of this time. Elevated blood pressure on 12Mar2021 at 21:15. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not tested for COVID-19. No treatment was received for events. The outcome of the events was not recovered. The report was reported as non-serious.  No follow-up attempts are needed. No further information is expected
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Hot sensation in left side of chest; This is a spontaneous report from a non-contactable other healthcare professional. A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: EN6205), via an unspecified route of administration on 15Mar2021 (at the age of 35-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Mar2021 after 15 minutes wait period post vaccination, the patient experienced hot sensation in left side of chest. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures were not taken for event hot sensation in left side of chest. The follow up response to treatment was excellent. Patient was stable to go home and follow up with PCP. The outcome of the event hot sensation in left side of chest was resolved. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Age/Units (captured as 35 years per event's onset 15Mar2021), for event: "Treatment Received?" captured as "No" per verbatim "Treatment included: no therapy", "None" removed from concomitant therapy field since not reported if had any con-meds and amended narrative.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm for about 48hrs/Pain was moderate; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; Unknown) via an unspecified route of administration on the right arm on 14Mar2021 at 16:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included GERD and asthma. The patient was allergic to Penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Omeprazole since an unknown date for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccine. The patient took penicillin on an unknown date for an unknown indication and experienced allergy. On 14Mar2021, the patient experienced pain in arm for about 48hrs.The patient also reported that the pain was moderate. No treatment received for the event. Therapeutic measure taken for the adverse event was unknown. The outcome of the event pain in arm was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained  Amendment: This follow-up report is being submitted to amend previously reported information: Patient first name added. Patient's Age/Units captured as 40 years per event's onset 14Mar2021. Vaccination Facility added. "Unknown" removed from Lot# field. For both events: "Treatment Received?" captured as "No" per source "if treatment ae: No". Final sentence "Information about lot/batch number cannot be obtained. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." Patient's Ethnic Group captured "Unknown" removed from Lot# field "OMEPRAZOLE". Event stop date captured as 16Mar2021 per verbatim "Pain in arm for about 48hrs". Yes removed from Concomitant Therapy since already coded out.  In narrative, "This is a spontaneous report from a non-contactable consumer, the patient".  In narrative, "Therapeutic measure taken for the adverse event was unknown" should be "no" per source "if treatment ae: No". Initial information need be updated in consolidated narrative: adverse event: Pain in arm for about 48hrs. Nothing more. Pain was moderate. if treatment ae: No
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Throat tightness
Clinical narrative: throat felt very tight; although I could swallow, it felt difficult to do so; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH, Solution for injection) (Lot no: 5318) via unspecified route of administration at right arm on 29Jan2021 at 16:30 as single dose for COVID-19 Immunization. Medical history included high blood pressure and high cholesterol. Concomitant medications included Lisinopril, Amlodipine, Pravastatin, ergocalciferol (Vit. D). On 29Jan2021 after 15 minutes of receiving first dose the patient felt that her throat was very tight and although she can swallow, it was difficult to do so. This lasted between 10 to 15 minutes and gradually subsided and did not return afterward. Since the vaccination, the patient had not been tested positive for Covid-19. No other therapeutic measures were taken. Patient did not receive any other vaccine 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for COVID-19 since vaccination. The clinical outcome for the events throat felt very tight, difficult to swallow was recovered on 29Jan2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's First Name added; Postal Code added; Patient's Ethnic Group captured. Patient's Age/Units captured as 80 years per event's onset=29Jan2021. For Relevant Med History: Verbatim "Blood pressure high" updated as "high blood pressure" per source reported. For suspect vaccine: Indication "COVID-19 immunization" captured twice, removed one. All Con-Meds were re-coded to remove from "Obtain Drug Country/Drug Authorization Country" since both fields should be Blank for con-med per SOP.  6. For all events: "Treatment Received?" captured as "No" per verbatim "if treatment ae: No"; Onset updated from "29Jan2021 00:00" to "29Jan2021 16:45" per source reported. Event term "difficult to swallow" updated as "although I could swallow, it felt difficult to do so" per source reported. "None" removed from Concomitant Therapy field since con-meds already coded in Product tab. Initial missed information "administration date=29Jan2021, administration time=04:30 PM", "adverse event start date: 29Jan2021, adverse event start time: 04:45 PM", "known allergies: No"
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rash all over body; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old, non-pregnant female patient received BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH) (Lot/batch no: unknown) via unspecified route of administration at unspecified site on an unknown date in Mar2021 as single dose for COVID-19 Immunisation. The patient was not allergic to any medication, food or other product. The patient was neither diagnosed with COVID-19 nor had any symptoms prior to vaccination. The patient was not tested positive for covid-19 since vaccination. After six days of vaccination, on 09Mar2021 the patient experienced red rash all over body that lasted for four days. Benadryl was taken for four nights as a therapeutic measurement for the event. The event of red rash all over body was resolved on 13Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in lips; Numbness in fingers; Numbness in toes; This is a spontaneous report from a contactable Consumer. A non-pregnant female patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) 2nd dose (lot/batch no: not available/provided to reporter at the time of report completion) for covid-19 immunization, administered in right arm on 11Mar2021 at 16:15pm. Medical history included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot/batch no: not available/provided to reporter at the time of report completion) for covid-19 immunization, administered on left arm on 18Feb2021 at 16:15 hours. Concomitant medication included Sertraline. The patient had taken sertraline within 2 weeks of covid-19 vaccination. The patient had no allergies of food, medications and other products. The patient experienced numbness in fingers, lips and toes on 16March2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient had not been tested COVID-19 since the vaccination. No therapeutic measures were taken. The patient was not pregnant at the time of vaccination. The patient had not recovered from the events at the time of reporting. No follow-up attempts are possible. information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: On 15Jan2021, I became infected with COVID and my test became positive; This is a spontaneous report from a contactable physician (patient, specialty: Internal Medicine). A 48-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 05Jan2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Physician reported that he received his first dose of the Pfizer-BioNTech COVID-19 Vaccine on 05Jan2021. On 15Jan2021, he became infected with COVID and his test became positive so he did not take the second dose yet. He was trying to determine timing of his second dose at this time. The patient underwent lab tests and procedures which included SARs-COV-2 test with result positive  on 15Jan2021 The outcome of the event was unknown.   Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Migraine, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number and Expiry date was unknown), via an unspecified route of administration, on an unknown date, as first dose, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient had a reaction occurred after the first dose of rather vaccine, experienced fever, nausea, headache, sore arm, and metallic taste in her mouth and lasted for 5 days. All symptoms subsided after 5 days except slight headache. Headache subsided after 7 days. She does suffer from Migraine headaches. Event took place after use of product. The outcome of the events fever, nausea, sore arm and metallic taste was recovered after 5 days and migraine headache/headache was recovered after 7 days.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number and Expiry date was unknown), via an unspecified route of administration, on an unknown date, as first dose, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient had a reaction occurred after the first dose of rather vaccine, experienced fever, nausea, headache, sore arm, and metallic taste in her mouth and lasted for 5 days. All symptoms subsided after 5 days except slight headache. Headache subsided after 7 days. She does suffer from Migraine headaches. Event took place after use of product. The outcome of the events fever, nausea, sore arm and metallic taste was recovered after 5 days and migraine headache/headache was recovered after 7 days.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Extreme nausea; vomiting; fatigue; fever 101 (unspecified units); This is a spontaneous report from a non-contactable consumer, the patient.  A 26-year-old female patient received unknown dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VAACINE; Lot/batch no: Unknown) via unspecified route of administration and anatomical site on 17Mar2021 at 03:45 PM as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication included vaccine (Active substance and Manufacturer Unknown) within 4 weeks prior to the COVID vaccine for which indication and start date was not reported. The patient was not tested for COVID-19 after having vaccination. On 17Mar2021, the patient experienced extreme nausea, vomiting, fatigue and developed fever of 101(unspecified unit). The patient did not receive any treatment for the events. The clinical outcome for the events extreme nausea, vomiting, fatigue and fever 101 were resolving. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: a week after I got covid/tested positive for Covid; This is a spontaneous report from a Pfizer . A contactable consumer (patient) reported that a male patient of an unspecified age (age: 50, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got his first shot on 01Mar2021 and a week after, he got covid/ tested positive for Covid in Mar2021. He went out of quarantine this last Thursday (as reported) and he went today to get his second dose and they weren't sure what to do about his second dose and they rescheduled his second dose to 30 days from the day he got out of quarantine which was 17Apr2021 and they told him to contact you for further guidance.  He was wondering if that was the right thing to do and wondering if he will need to start over with the 1st dose when he was vaccinated. Outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: first dose of the vaccine on 10Mar2021, on 16Mar2021 he had a positive PCR and rapid test; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age (reported as 46 no units reported) received bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as 1ST DOSE,SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had his first dose of the vaccine on 10Mar2021, he started feeling symptoms on 15Mar2021 and had a covid test (both positive PCR and rapid test) on 16Mar2021 that came back positive. The patient stated that he is still having symptoms. He wants to know if he should proceed with his 2nd shot or should he delay it. The outcome of the event was not recovered.   Information about lot/batch number has been requested
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ear infection, SARS-CoV-2 test, Visual impairment
Clinical narrative: she thought she had an ear infection; patient looking at lot number, stated that her eyes are bad; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 52-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 high up in the muscle, at age 52 years, on 04Mar2021 18:00 (Batch/Lot Number: EN6205; Expiration Date: 30Jun2021) as 1ST DOSE, SINGLE for COVID-19 immunisation as she did not want to get COVID. Medical history included hypothyroidism and chemical allergies from unspecified dates so she was  nervous to get the COVID shot. There were no concomitant medications. There were no additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations within 4 weeks was none. Patient reported that she received the first dose of the Pfizer COVID-19 vaccine on 04Mar2021 at 18:00, she got the shot in her left arm, high up in the muscle. Then, stated that last Sunday (14Mar2021) she started feeling symptoms and then tested positive last Tuesday on 16Mar2021 for COVID. Symptoms started with stomach, diarrhea thing and it was like wow what is going on, the symptoms are mild as far as COVID goes. She had a fever for a day and a half from an unspecified date. Patient stated she used paracetamol (TYLENOL 500mg) the night she got the vaccine and the morning after (total of 1000 mg) by mouth. The AEs did not require emergency room or physician office visit. Patient stated she made it a year and got the vaccine and then got COVID. Patient stated thank goodness nothing really happened. Patient really didn't think the symptoms, like from watching commercials it lists you can have all this and think you would have everything and she thought she had an ear infection on an unspecified date. When patient was looking at the lot number, she stated her eyes are bad from an unspecified date. She also stated that she can't be the only person that has gone through this, she knows she isn't. Patient stated her friends got the MODERNA vaccine and they didn't say anything and just went and got their 2nd dose and she was just trying to do the right thing here and is not holding for much longer. She wanted to know if she should go back for her second dose scheduled on Thursday (25Mar2021). The outcome of the events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Heart rate increased, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: got covid symptoms one week after her first dose/positive Covid 19 viral test on 22Mar2021; heart rate was accelerated at Covid 19 testing site; body ache; a little soreness on her left arm where the injection site is but then soreness in both arms; her right arm is also sore/sore in both arms; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 13Mar2021 at 14:00 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she got COVID symptoms one week after her first dose of the Pfizer COVID 19 vaccine and wanted to know if you can get COVID from the vaccine. She wanted to know when does isolation start, from the day of symptoms or diagnosis, if she should get another COVID test done and how long does it take for symptoms to show up once you have been exposed. She got the Pfizer COVID 19 vaccine in the left arm and her right arm is also sore. She wanted to know if that was common. She had her first vaccine on the 13Mar2021 and ended up having Covid 19 virus symptoms on Saturday, 20Mar2021, a week after receiving her Covid 19 vaccine. She had a positive Covid 19 viral test on 22Mar2021. Was asking "Did this have anything to do with the vaccine?" She also had a little soreness on her left arm where the injection site is but then she was sore in both arms. When probing Covid 19 symptoms, she reported on Saturday, 20Mar2021, it was allergy like symptoms - a runny nose, sneezing, congestion, and chills. On Sunday, 21Mar2021, she woke up with more of a chill and a low-grade fever, congestion, body ache and headache. She took acetaminophen, dextromethorphan HBr, phenylephrine HCl (DAYQUIL) every 4 hours at 10:30AM/PM and 2:30AM/PM. She had no appetite, but she drank lots of fluids and ate chicken noodle soup all day. Her temperature at the pharmacy Covid testing site was 99.7F. Her heart rate was accelerated at the Covid 19 testing site, but they weren't concerned with it. Today (unspecified date) she's much better. Therapeutic measures were taken as a result of runny nose, sneezing and congestion. The outcome of the events 'got covid symptoms one week after her first dose/positive Covid 19 viral test on 22Mar2021', 'a little soreness on her left arm where the injection site is but then soreness in both arms', her right arm is also sore and heart rate was accelerated at Covid 19 testing site was unknown, while of the rest was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: got covid symptoms one week after her first dose/positive Covid 19 viral test on 22Mar2021; heart rate was accelerated at Covid 19 testing site; body ache; a little soreness on her left arm where the injection site is but then soreness in both arms; her right arm is also sore/sore in both arms; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 13Mar2021 at 14:00 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she got COVID symptoms one week after her first dose of the Pfizer COVID 19 vaccine and wanted to know if you can get COVID from the vaccine. She wanted to know when does isolation start, from the day of symptoms or diagnosis, if she should get another COVID test done and how long does it take for symptoms to show up once you have been exposed. She got the Pfizer COVID 19 vaccine in the left arm and her right arm is also sore. She wanted to know if that was common. She had her first vaccine on the 13Mar2021 and ended up having Covid 19 virus symptoms on Saturday, 20Mar2021, a week after receiving her Covid 19 vaccine. She had a positive Covid 19 viral test on 22Mar2021. Was asking "Did this have anything to do with the vaccine?" She also had a little soreness on her left arm where the injection site is but then she was sore in both arms. When probing Covid 19 symptoms, she reported on Saturday, 20Mar2021, it was allergy like symptoms - a runny nose, sneezing, congestion, and chills. On Sunday, 21Mar2021, she woke up with more of a chill and a low-grade fever, congestion, body ache and headache. She took acetaminophen, dextromethorphan HBr, phenylephrine HCl (DAYQUIL) every 4 hours at 10:30AM/PM and 2:30AM/PM. She had no appetite, but she drank lots of fluids and ate chicken noodle soup all day. Her temperature at the pharmacy Covid testing site was 99.7F. Her heart rate was accelerated at the Covid 19 testing site, but they weren't concerned with it. Today (unspecified date) she's much better. Therapeutic measures were taken as a result of runny nose, sneezing and congestion. The outcome of the events 'got covid symptoms one week after her first dose/positive Covid 19 viral test on 22Mar2021', 'a little soreness on her left arm where the injection site is but then soreness in both arms', her right arm is also sore and heart rate was accelerated at Covid 19 testing site was unknown, while of the rest was recovering.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program, . A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 14Mar2021 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient received the first dose of the Pfizer COVID vaccine on 14Mar2021. He tested positive for COVID-19 on 17Mar2021. The patient was scheduled to receive the second dose on 03Apr2021. The patient would like to know if it would be okay to receive the second dose after having a positive diagnosis of COVID-19 after dose one. He was scheduled for the second dose on 03Apr2021 and he just wanted to ask if he is able to receive the second dose on that date. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: felt fatigue; body aches; This is a spontaneous report from a contactable consumer (patient).   An adult patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date were not provided) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunization. The patient did not have medical allergies, no other medical conditions. On an unknown date, the patient felt fatigue and body aches for 24 hours after second dose of Covid vaccination. The outcome of the events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: was diagnosed with covid on Saturday 20Mar2021/ symptoms started on Thursday, 18Mar2021; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age (age reported as Age: 64; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in right shoulder (reported as "he assumes it was in the muscle") on 10Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma diagnosed 10 years ago (in 2011). He was never treated the Non-Hodgkin's Lymphoma and is on a watch and wait. There were no concomitant medications. The patient had first dose of the Pfizer vaccine on 10Mar2021 Wednesday, due to have the 2nd dose this coming Wednesday. The patient was diagnosed with COVID on Saturday 20Mar2021. His symptoms started on Thursday, 18Mar2021. The patient was pretty much through Covid at the time of report but was not 100% but feeling much better. The patient asked if there is any data on side effects after having COVID and getting the vaccine. The patient underwent lab tests and procedures which included COVID test: positive on 20Mar2021. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Swelling face
Clinical narrative: Milder facial numbness and swelling; Milder facial numbness and swelling; extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL0142, expiry date:not reported), dose 2 via an unspecified route of administration on 04Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EH9899, expiry date: not reported) via an unspecified route of administration on 14DEC2020 as SINGLE DOSE for covid-19 immunisation and experienced flushed swollen face, thick swallowing, mild facial numbness, gastrointestinal pain, nausea, extreme fatigue and mild joint pain. All resolved 2 days post 1st vaccine dose except mild facial numbness. The patient medical history was not reported. Concomitant medications included estrogens conjugated (PREMARIN) .625 mg daily for an unspecified indication for the past 18 years and ongoing, cetirizine hydrochloride (ZYRTEC) 5mg daily for an unspecified indication for more than 10 years and ongoing, levothyroxine sodium (SYNTHROID) 50mcg taken for an unspecified indication from Oct2020 and ongoing, multivitamins and calcium for the past 28 years. On an unspecified date, the patient experienced milder facial numbness and swelling, extreme fatigue. The outcome was events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Insomnia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: really sore and she could not sleep on it; she had COVID-19/tested positive for COVID; left arm was very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 11:30 (Lot Number: EN6206) as 1st dose, single for covid-19 immunisation, administered at the hospital. Medical history included high blood pressure, diagnosed many years ago; diabetes, diagnosed 4 1/2 years around age 65 and a half, she is not on Insulin shots, just on Metformin; obese and overweight, she has been heavy all of her life since age 16-17; and allergies to Novocain at the dentist office and allergies to Sulfa. When she had Shingles shot first one, she reacted to it. She took Tylenol and it took care of it. She never went to the ER or doctor. There were no concomitant medications. The patient stated that she had COVID-19. Her quarantine period was 15Mar2021 through 25Mar2021. She received only first dose of Pfizer-BioNTech COVID-19 Vaccine on 04Mar2021 but could not get the second dose since she was still in the quarantine period, getting over the COVID-19 infection. She stated: "I'm pretty much over my symptoms, still have a little bit of cough but nothing dangerous or anything" "They already re-scheduled me for second dose appointment 01Apr2021 and wanted to make sure it is safe, won't make me sick again". The patient was supposed to have second dose on 25Mar2021. She caught COVID in between. She caught COVID on 15Mar2021. She later stated she did not get tested until 20Mar2021 and got results on 22Mar2021. They wanted her to take last shot this Thursday. She wants to know if she will be sick again and is worried.  She would like some guidance about getting second dose since she tested positive for COVID after receiving the first dose. She said it took two days to get results because they do not have a fast test where she is. She had a terrible dry cough for 2 days that started on 15Mar2021, or 16Mar2021, noticed a terrible cough at 12:00. By 16Mar2021, she was coughing, but the drainage did not start until 17Mar2021. She still had the cough but a lot of drainage on 17Mar2021.  She still has a slight cough, but it is not bad and does not keep her up. Her left arm was very sore on 04Mar2021 at 15:00. It lasted for 2 days. It was really sore and she could not sleep on it. The patient tested positive for COVID on 20Mar2021 at 08:22. The patient's COVID symptoms started on 15Mar2021. No emergency room or physician's office visit required. Outcome of the event left arm was very sore was recovered on 06Mar2021, outcome of event really sore and she could not sleep on it was unknown, and outcome of other event was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Extreme fatigue; I had a fever of 102; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, at a single dose for covid-19 immunization. Medical history included COVID last April (Apr2020) but otherwise patient was very healthy. Concomitant medications were not reported. On an unspecified date, the patient had fever of 102 and extreme fatigue with the first COVID vaccine. Patient enquired to get the 2nd dose which was scheduled for tomorrow. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 29Mar2021 (lot number was not reported), as 1st dose, single dose, for COVID-19 immunisation. Medical history included being exposed to someone with COVID-19 on 29Mar2021. The patient's concomitant medications were not reported. It was reported that the patient received the first dose of the Pfizer COVID-19 vaccine on 29Mar2021 and was exposed to someone with COVID-19 on the same day. The patient got sick in the evening of 01Apr2021 and tested positive for COVID-19 on 02Apr2021. The 2nd dose was scheduled on 19Apr2021. The patient wanted to know if the vaccine is helping her out in fighting off the virus and if there is further protection since she had the first dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 06Mar2021 at 1st dose, single dose for COVID-19 immunization. Medical history included shingles from an unspecified date to Feb2021. The patient's concomitant medications were not reported. The reporter and the patient received their first doses of COVID-19 vaccine on 06Mar2021 and then the patient tested positive for COVID-19 on 17Mar2021, he felt symptoms and tiredness and then he was quarantined. After being quarantined, he got his second dose today, 01Apr2021. The patient just recovered from shingles a week before he had his first dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Back disorder, Toothache
Clinical narrative: back problems; My new teeth are hurting on the top; This is a spontaneous report from a contactable consumer (patient) . A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date in Jan2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient had back problems and new teeth were hurting on top. Patient reported that when it was time to get second dose patient was laid up. Patient figured by the time that they get around to making an appointment for 2nd shot the back would be fine. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Headache, Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting).    A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8732 and expiration dates were not reported), via an unspecified route of administration in arm left on 25Mar2021 as first dose, single for COVID-19 immunisation. The patient was also taking diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date for an unspecified indication and epinephrine (EPINEPHRINE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included Thyroid, High Blood Pressure and patient previously took benadryl for drug hypersensitivity and experienced drug hypersensitivity, epinephrine [epinephrine hydrochloride] for drug hypersensitivity and experienced drug hypersensitivity. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) 5 ug taken for an unspecified indication, from an unspecified date. The patient reported that she was calling to report an adverse reaction to first shot and she got the shot and about ten minutes after got the shot, she had a pain radiating down her arm and upper whole right side of the body and in her head and then it went numb and then about two minutes later, it tingled and she also had tingling on face and around her lips on 25Mar2021. The outcome of the event was recovering. Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Decreased appetite, Disturbance in attention, Feeling abnormal
Clinical narrative: no appetite; can't fall asleep; have a surge of adrenaline and it is very bizarre; bad headaches; cant concentrate well; sudden inexplicable panic attack; strong waves of panic and anxiety; palpitations; brain fog; forgetfulness; chills; sweating; poor apetite; elevated resting heart rate; dry heaving; higher than normal blood pressure; This is a spontaneous report from a contactable consumer or other non-HCP. A 30-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955) via an unspecified route of administration, administered in Left Arm on 16Mar2021 12:15 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and none other medications the patient received within 2 weeks of vaccination. On 04Apr2021 14:00 the patient experienced sudden inexplicable panic attack, strong waves of panic and anxiety, palpitations, brain fog, forgetfulness, chills, sweating, poor appetite, elevated resting heart rate, dry heaving and higher than normal blood pressure. On an unspecified date the patient experienced no appetite, can't fall asleep, have a surge of adrenaline and it is very bizarre, bad headaches, cant concentrate well. No treatment received for the event. The outcome of event sudden inexplicable panic attack, strong waves of panic and anxiety, palpitations, brain fog, forgetfulness, chills, sweating, poor appetite, elevated resting heart rate, dry heaving, higher than normal blood pressure was not recovered and the outcome of event no appetite, can't fall asleep, have a surge of adrenaline and it is very bizarre, bad headaches, cant concentrate well was unknown   No follow-up attempts are needed. No further information is expected