chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Lipoma, Lymphadenopathy, Pain in extremity
Clinical narrative: Arm was slightly sore but not unbearable; Collarbone was aching; When she felt her collar bone there was a squishy, moveable, tender lump sitting directly on the bone/lipoma; Positive it was a lymphnode. It has now shrunk and was less tender but still present; This is a spontaneous report from a contactable other health professional (the patient). A 23-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 25Mar2021 18:45 (at the age of 23-years-old) as DOSE 1, SINGLE for COVID-19 immunisation at hospital. The patient had no medical history. The patient was not allergic to medications, food and other products. Concomitant medication included desogestrel, ethinylestradiol (EMOQUETTE) taken for birth control from 2010 to an unspecified stop date (reported as taken for 11 years). The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient was not tested for COVID. On 31Mar2021 15:00, the patient experienced arm was slightly sore but not unbearable, collarbone was aching, when felt my collar bone there was a squishy, moveable, tender lump sitting directly on the bone/lipoma, positive it was a lymphnode. it has now shrunk and was less tender but still present. The patient reported that directly my vaccine, the arm was slightly sore but not unbearable. She always check herself for breast lumps during monthly checks as well as other lymph node locations collarbone and underarms. She have never had breast lumps or swollen lymph nodes prior to her vaccine. On 31Mar2021, she noticed her collarbone was aching. When she felt her collar bone there was a squishy, moveable, tender lump sitting directly on the bone. At first, she was terrified and immediately linked it to the shot. She also heard about women having swollen lymph nodes after the shot, so she assumed the same might have happened for her. She scheduled with the doctor for the next day. At the appointment, she palpated the area and said that it was a lipoma. She did not think this was accurate as she feel that area all the time and have never ever felt anything. Almost a month later, she was positive it was a lymph node. It has now shrunk and was less tender but still present. She said she would follow up with my doctor again to confirm. The patient did not received treatment for adverse events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Hypersensitivity
Clinical narrative: Heart beating fast when lying down. 30 minutes later I experienced difficulty breathing. I took my asthma puff but that only provided some relief.; Heart beating fast when lying down. 30 minutes later I experienced difficulty breathing. I took my asthma puff but that only provided some relief.; Heart beating fast when lying down. 30 minutes later I experienced difficulty breathing. I took my asthma puff but that only provided some relief.; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 34-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8729 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 at 11:00 as DOSE 2 (age at vaccination: 34-years-old), SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 at 11:00 (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included bupropion (BUPROPION), lamotrigine (LAMICTAL). 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. The patient experienced heart beating fast when lying down. 30 minutes later I experienced difficulty breathing. I took my asthma puff but that only provided some relief on 15Apr2021 at 17:00. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. Outcome of the events was not recovered.  No follow-up attempts are possible: information about lot/batch number/expiry date cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Blood pressure abnormal, Blood pressure measurement, Erythema, Headache
Clinical narrative: muscle soreness in the medial head of the shoulder blade; slight loss of taste; I experienced redness and skin itching on my neck and hip; I experienced redness and skin itching on my neck and hip; My BP was 141/111; I experienced a watering sensation in my mouth similarly to when you vomit.; mild headache; redness at the injection site area; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 15Apr2021 11:00 (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation. Medical history was none. The patient allergies were none. Concomitant medications included ibuprofen, received medication in two weeks, taken for an unspecified indication, start and stop date were not reported. Th patient was not received other vaccine in four weeks. The patient was not received covid prior vaccination. On 15Apr2021 at 11:30, the patient experienced redness and skin itching on my neck and hip, his BP was 141/111. The patient experienced a watering sensation in his mouth similarly to when you vomit. The patient had mild headache from the front area of his skull. Moreover, he got redness at the injection site area. Five hours later, the patient still had skin redness and itching. At the time of reporting on 16Apr2021, the patient had muscle soreness in the medial head of the shoulder blade. Lastly, he had noticed a slight loss of taste. No treatment was received for the reporting events. The patient underwent lab tests and procedures which included Nasal Swab Covid test on 01Feb2021 and result was Negative. The outcome of the events was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, SARS-CoV-2 antibody test, Saliva altered, Vaccination site erythema
Clinical narrative: muscle soreness in the medial head of the shoulder blade; slight loss of taste; I experienced redness and skin itching on my neck and hip; I experienced redness and skin itching on my neck and hip; My BP was 141/111; I experienced a watering sensation in my mouth similarly to when you vomit.; mild headache; redness at the injection site area; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 15Apr2021 11:00 (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation. Medical history was none. The patient allergies were none. Concomitant medications included ibuprofen, received medication in two weeks, taken for an unspecified indication, start and stop date were not reported. Th patient was not received other vaccine in four weeks. The patient was not received covid prior vaccination. On 15Apr2021 at 11:30, the patient experienced redness and skin itching on my neck and hip, his BP was 141/111. The patient experienced a watering sensation in his mouth similarly to when you vomit. The patient had mild headache from the front area of his skull. Moreover, he got redness at the injection site area. Five hours later, the patient still had skin redness and itching. At the time of reporting on 16Apr2021, the patient had muscle soreness in the medial head of the shoulder blade. Lastly, he had noticed a slight loss of taste. No treatment was received for the reporting events. The patient underwent lab tests and procedures which included Nasal Swab Covid test on 01Feb2021 and result was Negative. The outcome of the events was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Melanocytic naevus, Vaccination site discolouration, Vaccination site swelling
Clinical narrative: incredible lethargic; The mole appeared about a half week after my second vaccine; site of injection on my arm was now raised and slightly discolored; site of injection on my arm was now raised and slightly discolored; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in 2021 as dose 2, single (at the age of 23-years-old) for COVID-19 immunisation. Medical history included Loeys Dietz syndrome, heart surgery 4 years ago, blind in one eye. Concomitant medications included mirtazapine, guanfacine, losartan and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), all medications received in two weeks, taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6199), via an unspecified route of administered in left arm on 10Mar2021 at 11:30 am (at the age of 23-years-old) as dose 1, single (at the age of 23-years-old) for COVID-19 immunisation and the patient had Incredibly nauseous, Throwing up and had a terrible migraine. The patient was not pregnant at time of vaccination. Th patient was not received other vaccine in four weeks. The patient was not received covid prior vaccination. The patient has not been tested covid post vaccination. It was reported that the day after her second vaccine in 2021, she was incredible lethargic. The site of injection on her arm was now raised and slightly discolored, it looks like a mole. The mole appeared about a half week after my second vaccine. No treatment was received for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Discomfort, Dyspepsia, Fatigue
Clinical narrative: mild headache; Immediate elevation  in blood pressure, heart rate; Immediate elevation  in blood pressure, heart rate; Very cold with uncontrollable shaking with chills,; Very cold with uncontrollable shaking with chills; Very cold with uncontrollable shaking with chills; Tiredness; extremely sleepy; burning in stomach; extreme heaviness; slight nausea; This is a spontaneous report from a contactable consumer (Patient reporting herself).   A 72-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered at Left Arm on 15Apr2021 as DOSE 2, SINGLE and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered at Left Arm on 23Mar2021 12:00 as DOSE 1, SINGLE for COVID-19 immunisation in hospital. Medical history of the patient included high blood pressure, asthma and high cholesterol. The concomitant medications included 80mg valsartan, 6.25mg carvedilol and 10mg atorvastatin (Other medications in two weeks). The patient past medical history included known allergies to Dilaudid and Alleve. The patient not had covid prior vaccination and patient was not tested covid post vaccination. On 15Apr2021 at 8:30, patient had immediate elevation in blood pressure, heart rate, very cold with uncontrollable shaking with chills, extreme heaviness, tiredness and extremely sleepy, burning in stomach, slight nausea and mild headache. The adverse events resulted in visit of emergency room. Patient received IV treatment (unspecified medications). At time of this report event outcome was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. Information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Heart rate increased, Nausea, Somnolence
Clinical narrative: mild headache; Immediate elevation  in blood pressure, heart rate; Immediate elevation  in blood pressure, heart rate; Very cold with uncontrollable shaking with chills,; Very cold with uncontrollable shaking with chills; Very cold with uncontrollable shaking with chills; Tiredness; extremely sleepy; burning in stomach; extreme heaviness; slight nausea; This is a spontaneous report from a contactable consumer (Patient reporting herself).   A 72-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered at Left Arm on 15Apr2021 as DOSE 2, SINGLE and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered at Left Arm on 23Mar2021 12:00 as DOSE 1, SINGLE for COVID-19 immunisation in hospital. Medical history of the patient included high blood pressure, asthma and high cholesterol. The concomitant medications included 80mg valsartan, 6.25mg carvedilol and 10mg atorvastatin (Other medications in two weeks). The patient past medical history included known allergies to Dilaudid and Alleve. The patient not had covid prior vaccination and patient was not tested covid post vaccination. On 15Apr2021 at 8:30, patient had immediate elevation in blood pressure, heart rate, very cold with uncontrollable shaking with chills, extreme heaviness, tiredness and extremely sleepy, burning in stomach, slight nausea and mild headache. The adverse events resulted in visit of emergency room. Patient received IV treatment (unspecified medications). At time of this report event outcome was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. Information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: mild headache; Immediate elevation  in blood pressure, heart rate; Immediate elevation  in blood pressure, heart rate; Very cold with uncontrollable shaking with chills,; Very cold with uncontrollable shaking with chills; Very cold with uncontrollable shaking with chills; Tiredness; extremely sleepy; burning in stomach; extreme heaviness; slight nausea; This is a spontaneous report from a contactable consumer (Patient reporting herself).   A 72-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered at Left Arm on 15Apr2021 as DOSE 2, SINGLE and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered at Left Arm on 23Mar2021 12:00 as DOSE 1, SINGLE for COVID-19 immunisation in hospital. Medical history of the patient included high blood pressure, asthma and high cholesterol. The concomitant medications included 80mg valsartan, 6.25mg carvedilol and 10mg atorvastatin (Other medications in two weeks). The patient past medical history included known allergies to Dilaudid and Alleve. The patient not had covid prior vaccination and patient was not tested covid post vaccination. On 15Apr2021 at 8:30, patient had immediate elevation in blood pressure, heart rate, very cold with uncontrollable shaking with chills, extreme heaviness, tiredness and extremely sleepy, burning in stomach, slight nausea and mild headache. The adverse events resulted in visit of emergency room. Patient received IV treatment (unspecified medications). At time of this report event outcome was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Flushing, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Self-Reporting. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 05Apr2021 at 13:45 (Batch/Lot Number: ER8733) (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. The vaccine facility type was public health clinic/veteran's administration facility. The patient is not pregnant at time of vaccination. Medical history included endometriosis. The patient's known allergies included: Nickel skin contact, oral fruit allergy, any fruit you can eat the skin of swollen, itchy tongue, throat; environmental allergies itchy face, nose, eyes; allergic to all trees, grass, weeds except cocklebur. Concomitant medications included VITAMIN D taken in two weeks for an unspecified indication, start and stop date were not reported. The patient previously took BACTRIM and experienced allergy severe fever, sore throat, full body rash. The patient reported that she began feeling itchy on her back, sides, chest, outer upper arms, face, nose, ears. The attending nurse noticed that her eyes were swelling, she was very flush over her entire body, and her ears had hives on them. This began 15-20 minutes after receiving the vaccine. The event start date was on 05Apr2021 at 02:15 PM. They did not tell her vitals but remarked after treatment that they were coming back into normal range. They administered a shot of Benadryl and a shot of steroids and the reaction cleared. They seemed a bit alarmed and strongly advised that she should not receive the second dose. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment which included Benadryl and steroid shots. The patient had no COVID prior to vaccination. The patient was not tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster
Clinical narrative: I have Shingles.; My left arm has a lot of blisters.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 09Apr2021 at 14:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to crustacean.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 07:00, the patient experienced Shingles and left arm had a lot of blisters. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with valacyclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events shingles and blisters were not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: Swelling of lymph nodes; Pain; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Mar2021 at 10:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from unknown date for an unknown indication and unknow if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 the patient experienced swelling of lymph nodes and pain. The patient did not receive any treatment for the event. On an unknown date, the patient underwent Nasal swab and the result was unknown. Since the vaccination, the patient had tested for COVID-19. The clinical outcome of the event swelling of lymph nodes and pain was recovered on unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Vision blurred
Clinical narrative: Tingling sensation on hands and feet; Palpitations; Temporary blurry vision; This is a spontaneous report from a contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 16Apr2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN) and unspecified multivitamin; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 26Mar2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 16:30, the patient experienced tingling sensation on hands and feet, palpitations and temporary blurry vision (lasted a few seconds). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling sensation on hands and feet and palpitations were resolved on an unknown date in Apr2021 and the event temporary blurry vision was resolved on 17Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Nausea
Clinical narrative: Nausea; Muscle aches all through body; Had a temperature of 1 100.1/ My Temperature was 98.8 normal.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0150) via an unspecified route of administration in the right arm on 17Apr2021 at 09:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications in two weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6204) via an unspecified route of administration in the right arm on 25Mar2021 at 13:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 00:00, the patient experienced body temperature of 100.1 (unspecified units), nausea and muscle aches all through his body. On 19Apr2021, the patient body temperature was 98.8 (unspecified units) which was normal. On 18Apr2021, the patient underwent lab test which included body temperature and result was 100.1 (unspecified units). On 19Apr2021, the patient again underwent lab test which included body temperature and result was 98.8 (unspecified units). And all his symptoms were now gone for the most part at the time of this report. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body temperature was recovered on 19Apr2021, while that of the events nausea and muscle aches all through body was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node on my left collar/ Others on left side around armpit and neck swollen.; Swollen lymph node on my left collar bone that was painful; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9263) via an unspecified route of administration in the left arm on 22Mar2021 at 09:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol high and seasonal allergy (going through allergy shots for seasonal allergies). Concomitant medications included allergy shots from unknown date. The patient previously took morphine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccination. On 01Apr2021, the patient experienced swollen lymph node on the left collar bone that was painful. Others on left side around armpit and neck swollen which was still swollen but no longer painful. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful lymph nodes was resolved on an unknown date in Apr2021; while that of swollen lymph node on my left collar bone and others on left side around armpit was and neck swollen were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Widespread hives on neck, torso; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 01Apr2021 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on 11Mar2021 at 15:00 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced widespread hives on neck, torso. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event widespread hives on neck, torso was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 06Apr2021 at 11:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 14Mar2021 at 17:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 12:00, the patient experienced dizziness. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8734) via an unspecified route of administration on 30Mar2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199) via an unspecified route of administration on 08Mar2021(at the age of 36-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced shingles. Therapeutic measures were taken as a result of the reported event which was not specified. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event shingles was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Vaccination site pain
Clinical narrative: Fatigue; Headache; Injection-site tenderness; Slight joint pain; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 17Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, asthma and pollen allergy. Concomitant medications included paracetamol (MANUFACTURER UNKNOWN), diphenhydramine (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and caffeine (MANUFACTURER UNKNOWN); all for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 27Mar2021 at 14:30 (at the age of 35-years-old) as a single dose, for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 04:00, the patient experienced fatigue, headache, injection site tenderness and slight joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, injection site tenderness and slight joint pain was resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 15Apr2021 at 16:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included low potassium and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received concomitant medication within two weeks of vaccination. The patient previously received ampicillin (AMPICILLIN), levofloxacin (LEVAQUIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER872) via an unspecified route of administration in the right arm on 23Mar2021 at 10:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Apr2021, at 12:30 after the second dose, in morning the patient got out of the shower and found two bruises. One on right thigh over three inches in length. A second bruise on left thigh that was smaller the patient husband check and found none. He took photos of those bruises. A few minutes later, actually watched a third bruise appear. We went to the ER. The patient can share photos and blood work had other symptoms, such as fever and aches, but am reporting this due to the bruising. The bruises are still present today. The patient underwent lab tests and procedures, which included blood test on 16Apr2021 and resulted platelets were within normal range. The events resulted in emergency room/department visit or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the event found two bruises, fever and aches was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Headache, Nasal congestion
Clinical narrative: Full body ache; Chills/ Shivers; Cold sweats; Headache; Mild nausea; Nasal congestion; Temperature over 103.5; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 14Apr2021 at 12:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and obesity (Obese: 282lbs, 6ft). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took cefalexin (CEPHALEXIN) and experienced drug allergy. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and tocopherol (VITAMIN E). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7534) via an unspecified route of administration in the left arm on 24Mar2021 at 12:15 as a single dose for COVID-19 immunisation. On 14Apr2021 at 20:00, the patient experienced full body ache, chills/ shivers, cold sweats, headache, mild nausea, nasal congestion and temperature over 103.5. The patient stated that he experienced shivers around 8 PM on the day of vaccination. He stated that he took some Ibuprofen, but he continued to have symptoms for over 40 hours. Therapeutic measures were taken as a result of full body ache, chills/ shivers, cold sweats, headache, mild nausea, nasal congestion and temperature over 103.5 and included treatment with Ibuprofen from an unspecified date in Apr2021 and unknown if ongoing. On 14Apr2021, the patient underwent body temperature and the result was 103.5 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the events full body ache, chills/ shivers, cold sweats, headache, mild nausea, nasal congestion and temperature over 103.5 were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Full body ache; Chills/ Shivers; Cold sweats; Headache; Mild nausea; Nasal congestion; Temperature over 103.5; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 14Apr2021 at 12:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and obesity (Obese: 282lbs, 6ft). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took cefalexin (CEPHALEXIN) and experienced drug allergy. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and tocopherol (VITAMIN E). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7534) via an unspecified route of administration in the left arm on 24Mar2021 at 12:15 as a single dose for COVID-19 immunisation. On 14Apr2021 at 20:00, the patient experienced full body ache, chills/ shivers, cold sweats, headache, mild nausea, nasal congestion and temperature over 103.5. The patient stated that he experienced shivers around 8 PM on the day of vaccination. He stated that he took some Ibuprofen, but he continued to have symptoms for over 40 hours. Therapeutic measures were taken as a result of full body ache, chills/ shivers, cold sweats, headache, mild nausea, nasal congestion and temperature over 103.5 and included treatment with Ibuprofen from an unspecified date in Apr2021 and unknown if ongoing. On 14Apr2021, the patient underwent body temperature and the result was 103.5 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the events full body ache, chills/ shivers, cold sweats, headache, mild nausea, nasal congestion and temperature over 103.5 were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Gait disturbance, Migraine, Myalgia
Clinical narrative: I developed multiple migraine headaches days and weeks after the vaccine after not having any migraine episodes for years prior.; I have also been continuing to experience long lasting muscle and joint pain/weakness, to the point where my knees feel unsteady or unstable while walking.; I have also been continuing to experience long lasting muscle and joint pain/weakness, to the point where my knees feel unsteady or unstable while walking.; I have also been continuing to experience long lasting muscle and joint pain/weakness, to the point where my knees feel unsteady or unstable while walking.; I have also been continuing to experience long lasting muscle and joint pain/weakness, to the point where my knees feel unsteady or unstable while walking.; This is a spontaneous report from a non-contactable consumer, the patient. A 32-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 04Mar2021 at 10:30 (at the age of 32-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient developed multiple migraine headaches days and weeks after the vaccine after not having any migraine episodes for years prior. From an unknown date in Mar2021, the patient also has been continuing to experience long lasting muscle and joint pain/weakness, to the point where his knees feel unsteady or unstable while walking. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events developed multiple migraine headaches days and weeks after the vaccine after not having any migraine episodes for years prior; continuing to experience long lasting muscle and joint pain/weakness, to the point where his knees feel unsteady or unstable while walking was not  resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lethargy
Clinical narrative: Lethargic; Headache; Light headed; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 16Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included heart PVCs (premature ventricular contractions). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 11:00, the patient experienced headache and was light headed. The patient was also lethargic. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lethargic, headache and light headed were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypokinesia, Injection site erythema, Nausea
Clinical narrative: Friday morning I work up with a terrible headache, that worsened tremendously when I opened my eyes; Could hardly move; Everything hurt; Nauseated; Injection site was swollen; The injection site was red; Injection site was hot; Chills; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 10:15 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), fibromyalgia, osteoarthritis and COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient take concomitant medications quite a few, but no room to put them was reported by the patient. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 06:30 (she had the shot Thursday morning), on friday morning she woke up with a terrible headache, that worsened tremendously when she opened her eyes. she could hardly move. Everything hurt. she was nauseated. The injection site was swollen and was red and hot. She had chills, no fever. But she think she would have to die to feel better. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19 The clinical outcome of the event terrible headache, could hardly move, everything hurt, nauseated, vaccination site was swollen, vaccination site was red, vaccination site was hot and chills were recovering at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.