chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: The lymph nodes in left armpit and surrounding areas became swollen, achy, and tender to the touch; The lymph nodes in left armpit and surrounding areas became swollen, achy, and tender to the touch; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0173) via an unspecified route of administration in the left arm on 05May2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity (body mass index (BMI) was 35). 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. The concomitant medication included spironolactone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 23:45, roughly 36 hours after the second dose of vaccination (roughly midnight on Thursday, 06May2021), the patient's lymph nodes in her left armpit and surrounding areas became swollen, achy and tender to the touch. The swollen area included the entire armpit and upper portion of the bicep. It was reported that the swelling did not began to decrease for over 48 hours after it began (until Sunday, 09May2021). It was reported that even once swelling reduced, the area was tender to the touch for several more days. The adverse events did not result in doctor or other healthcare professional office/clinic visit and 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 reported events. The clinical outcome of the events the lymph nodes in left armpit and surrounding areas became swollen, achy, and tender to the touch was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Developed shingles; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730; EP7533) via an unspecified route of administration in the left arm on 20Mar2021 at 13:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease. The patient was allergic to gluten. 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: Unknown) via an unspecified route of administration in the left arm on an unknown date 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 10May2021 at 14:30, the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 01Apr2021, the patient underwent rapid PCR test (nasal swab) for COVID-19 and the result was negative. Therapeutic measures were taken as a result of shingles and included treatment with unspecified medication. The clinical outcome of the event developed shingles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pruritus, Urticaria
Clinical narrative: Cold like symptoms; Small welts show up; Very itching; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration in the right arm on 16Apr2021 at 10:30 (at the age of 43-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 07May2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, the next day, after the first shot, the patient had cold like symptoms showed up, lasted 2 days and after that on an unknown date in 2021, small welts showed up and felt very itching. The same thing happened after the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 reported events. The clinical outcome of the events cold like symptoms, small welts show up and very itching were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Iritis, Ocular hyperaemia, Vision blurred
Clinical narrative: Iritis right eye; right eye very red; Irititus - right eye very red, swollen; Blurred vision; Irititus - right eye very red, swollen, blurred vision, painful; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 09May2021 at 14:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 16Apr2021 at 10:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 10May2021 at 07:30, the patient experienced iritis - right eye very red, swollen, blurred vision, painful. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with medications (Names unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events iritis - right eye very red, swollen, blurred vision, painful was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin exfoliation
Clinical narrative: Skin peeling; Rash all on chest, back and face; This is a spontaneous report from a contactable consumer, the patient. A 20-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 on an unknown date in 2021  as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 27Apr2021 at 14:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication received within 2 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 2021 the patient had rash all on chest, back and face, following with skin peeling. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and skin peeling. The clinical outcome of the events rash all on chest, back and face and skin peeling were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Mild fever; Body aches; Lethargic; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration in the right arm on 01May2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient previously had walnuts and experienced allergy to nuts and also grapes and experienced fruit allergy. The patient previously had penicillin for unknown indication on unknown date and experienced penicillin allergy. The patient previously took codeine (MANUFACTURER UNKNOWN) on unknown date for unknown indication and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included atenolol (MANUFACTURER UNKNOWN), famotidine (PEPCID), loratadine (CLARITIN) and iron (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ewo151) via an unspecified route of administration in the right arm on 10Apr2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. 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 01May2021 at 18:30, the patient experienced mild fever, body aches, lethargic. 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 mild fever, body aches, lethargic was resolved on an unknown date in May2021.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mood swings, Nausea, Pain
Clinical narrative: Nausea; Vomiting; Headache; Body ache; Exhaustion; Mood swing; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 at 20:00 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic sinus infection. The patient had unspecified known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. On 27Apr2021 at 00:00, the patient experienced nausea, vomiting, headache, body ache, exhaustion and mood swing that just keep going two weeks later (at the time of report). The event resulted in doctor or other healthcare professional office/clinic visit. 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 nausea, vomiting, headache, body ache, exhaustion and mood swing was resolving 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: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; Headache; Body ache; Exhaustion; Mood swing; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 at 20:00 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic sinus infection. The patient had unspecified known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. On 27Apr2021 at 00:00, the patient experienced nausea, vomiting, headache, body ache, exhaustion and mood swing that just keep going two weeks later (at the time of report). The event resulted in doctor or other healthcare professional office/clinic visit. 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 nausea, vomiting, headache, body ache, exhaustion and mood swing was resolving 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Nausea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Nausea-Medium
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Headache, Patient isolation
Clinical narrative: I am immune compromised and contracted delta. I have been off work at home isolated. Fever, cough, headache, diarrhea, vomiting
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Vomiting
Clinical narrative: I am immune compromised and contracted delta. I have been off work at home isolated. Fever, cough, headache, diarrhea, vomiting
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Confusional state, Dysphagia, Dyspnoea, Hyperventilation
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Confusion-Medium, Systemic: Hyperventilation-Medium
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Confusion-Medium, Systemic: Hyperventilation-Medium
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: pt has had arm soreness that started at injection site, but has now travelled to elbow area for four weeks following first dose. Describes it as "bone pain"
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site reaction, Mobility decreased, Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Pt reported her upper arm was numb and unable to move it. She was able to move her fingers. She reported numbness as well as pins and needle feelings around the injection site / upper arm area.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Throat irritation, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: throat became red. redness dissipated after epi pen given
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Severe
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash in the entire arm where the injection was given; Itching/Also had itching on legs; This is a spontaneous report from a non-contactable consumer, the patient. A 17-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 in the left arm on 24Apr2021 at 13:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient previously took ibuprofen(MOTRIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced itching and rash in the entire arm where the injection was given. This lasted 5 days, very itchy, itching on legs but no rash there. 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, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event rash was recovered on an unknown date in 2021 and the clinical outcome of the event itching was resolving 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: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Visual impairment
Clinical narrative: Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient fainted at observation area
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient stated she was having numbness (pins and needles sensation) through arm and fingers during the 15 minute observation period. No other symptoms or presentation of allergy. No shortness of breath or anaphylactic like reaction.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Injection site urticaria, Neck pain
Clinical narrative: Beginning 27 hours after vaccination, Chills and fever of 101* even while taking acetaminophen . Headache and sore neck. Golf ball sized welt at vaccination site
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Beginning 27 hours after vaccination, Chills and fever of 101* even while taking acetaminophen . Headache and sore neck. Golf ball sized welt at vaccination site
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Cold sweat, Dizziness, Dyspnoea
Clinical narrative: like  sizure and a heart attack with numbnes and tingling as the first symptom then sick for following  2 days. 3rd day barely walk short of breath dizziness pain in back of neck lathargic ,major sweats followed by cold.5th daythrough7th major back pain lathergic realy weak still short of breath not as bad. 8th day weak cold sweats still dripping
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Gait disturbance, Hyperhidrosis, Hypoaesthesia, Lethargy
Clinical narrative: like  sizure and a heart attack with numbnes and tingling as the first symptom then sick for following  2 days. 3rd day barely walk short of breath dizziness pain in back of neck lathargic ,major sweats followed by cold.5th daythrough7th major back pain lathergic realy weak still short of breath not as bad. 8th day weak cold sweats still dripping
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Myocardial infarction, Neck pain, Paraesthesia, Seizure like phenomena
Clinical narrative: like  sizure and a heart attack with numbnes and tingling as the first symptom then sick for following  2 days. 3rd day barely walk short of breath dizziness pain in back of neck lathargic ,major sweats followed by cold.5th daythrough7th major back pain lathergic realy weak still short of breath not as bad. 8th day weak cold sweats still dripping
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Head injury, Paraesthesia, Seizure, Skin laceration
Clinical narrative: Systemic: Seizure-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: HE SEIZED WHILE WAITING. HE FELL DOWN THE CHAIR AND HIT HIS HEAD. THERE WAS A LACERATION ABOVE HIS RIGHT EYEBROW. HE SAT DOWN ON A CHAIR ABOUT 15 MIN AFTER SEIZING AND PROCEEDED TO VOMIT IN A BAG. CONCERNED, HIS PARENTS DECIDED TO TAKE HIM TO ER.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Seizure-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: HE SEIZED WHILE WAITING. HE FELL DOWN THE CHAIR AND HIT HIS HEAD. THERE WAS A LACERATION ABOVE HIS RIGHT EYEBROW. HE SAT DOWN ON A CHAIR ABOUT 15 MIN AFTER SEIZING AND PROCEEDED TO VOMIT IN A BAG. CONCERNED, HIS PARENTS DECIDED TO TAKE HIM TO ER.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Hypoaesthesia, Muscle spasms
Clinical narrative: Dizziness/ light-headed; Confusion; Numbness in hands; Muscle spasms in right leg calf/ almost cramping muscle pain in arms, shoulders, neck and legs; Very scary; Chills; Continued muscle pain full body through night; Red injection site; Sore injection site; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171) via an unspecified route of administration in the left arm on 11May2021 at 16:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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 medications within two weeks prior to the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 11May2021 at 16:15, about 25 minutes after the injection (as reported), the patient experienced dizziness, lightheaded, confusion, numbness in hands, muscle spasms in right leg calf, almost cramping muscle pain in arms, shoulders, neck and legs. The patient reported that it was very scary and she had chills and continued muscle pain in full body through the night. She also experienced a red sore injection site. The patient was not sure if she should receive second dose. 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 dizziness, light-headed, confusion, numbness in hands, muscle spasms in right leg calf, almost cramping muscle pain in arms, shoulders, neck and legs, very scary, chills, muscle pain in full body and red sore injection site were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nervousness, Vaccination site erythema, Vaccination site pain
Clinical narrative: Dizziness/ light-headed; Confusion; Numbness in hands; Muscle spasms in right leg calf/ almost cramping muscle pain in arms, shoulders, neck and legs; Very scary; Chills; Continued muscle pain full body through night; Red injection site; Sore injection site; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171) via an unspecified route of administration in the left arm on 11May2021 at 16:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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 medications within two weeks prior to the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 11May2021 at 16:15, about 25 minutes after the injection (as reported), the patient experienced dizziness, lightheaded, confusion, numbness in hands, muscle spasms in right leg calf, almost cramping muscle pain in arms, shoulders, neck and legs. The patient reported that it was very scary and she had chills and continued muscle pain in full body through the night. She also experienced a red sore injection site. The patient was not sure if she should receive second dose. 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 dizziness, light-headed, confusion, numbness in hands, muscle spasms in right leg calf, almost cramping muscle pain in arms, shoulders, neck and legs, very scary, chills, muscle pain in full body and red sore injection site were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Woke up around 12:30 am feeling body aches, couldn?t go back to sleep, started rigoring, took temp of 100.2 . Took Tylenol before I went to sleep around 9:00 pm and then again at 3:00 am - started sweating and got a couple more hours of sleep. Woke up freezing again with a headache
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sleep disorder
Clinical narrative: Woke up around 12:30 am feeling body aches, couldn?t go back to sleep, started rigoring, took temp of 100.2 . Took Tylenol before I went to sleep around 9:00 pm and then again at 3:00 am - started sweating and got a couple more hours of sleep. Woke up freezing again with a headache
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Dizziness, Panic attack
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: she was very anxious and got dizzy after the vaccine. she said it almost felt like a panic attack. had her sit on the floor, she had water and granola bar and started feeling better pretty quickly. after about 30 minutes she was a lot better and felt fine and then left with her friend.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: she was very anxious and got dizzy after the vaccine. she said it almost felt like a panic attack. had her sit on the floor, she had water and granola bar and started feeling better pretty quickly. after about 30 minutes she was a lot better and felt fine and then left with her friend.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Nausea, Presyncope, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Called paramedics Patient taken to hospital--was told it was vagal response to vaccination
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Called paramedics Patient taken to hospital--was told it was vagal response to vaccination
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Acupuncture, Inflammation, Tinnitus
Clinical narrative: Ringing in both ears.Supplements-Acupuncture-Chiropractor-have ringing in both ears now for 5 months after 2nd shot which was 4/14/21-Audiologist
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache
Clinical narrative: He developed severe headache and fatigue on day 1 then by day 2 he was reporting stabling chest pain but no SOB.  I have been treating him with ibuprofen 800mg q 4-6 hours, vitamins and fluids.  At the time of this report I have not taken him in for any tests.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Myalgia
Clinical narrative: Began experiencing chills; Began experiencing fever; Muscle pain in back; Joint pain in back; Very weak; Tired; This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on an unknown date in May2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications which were unknown within two weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on an unknown date in Apr2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10May2021, roughly 12 hours after the second dose, the patient experienced chills, fever, muscle joint pain in the back and felt very weak and tired. The patient took a hot bath and ibuprofen (ADVIL) and fell asleep. The patient reported that the symptoms resolved within four hours of onset. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with hot bath and ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events fever, chills, muscle pain in back, joint pain in back, very weak and tired were resolved on an unspecified date in May2021.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Began experiencing chills; Began experiencing fever; Muscle pain in back; Joint pain in back; Very weak; Tired; This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on an unknown date in May2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications which were unknown within two weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on an unknown date in Apr2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10May2021, roughly 12 hours after the second dose, the patient experienced chills, fever, muscle joint pain in the back and felt very weak and tired. The patient took a hot bath and ibuprofen (ADVIL) and fell asleep. The patient reported that the symptoms resolved within four hours of onset. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with hot bath and ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events fever, chills, muscle pain in back, joint pain in back, very weak and tired were resolved on an unspecified date in May2021.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Tinnitus
Clinical narrative: Cold sore; Tinnitus-bilateral; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 02Apr2021 at 18:00 (at the age of 40-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 23Apr2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis and Premature Ventricular Contractions (PVCs). Concomitant medications included verapamil (MANUFACTURER UNKNOWN). The patient previously took atenolol (MANUFACTURER UNKNOWN) and experienced drug allergy. 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 Apr2021, after first dose of vaccination, the patient had bilateral tinnitus and cold sore broke out. On 28Apr2021 at 04:00, after second dose of vaccination, the patient had bilateral tinnitus and cold sore broke out. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of bilateral tinnitus and cold sore which included treatment with prednisone and a hearing test. The clinical outcome of the event bilateral tinnitus and cold sore was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise
Clinical narrative: Tiredness; Chills; Headache; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 08May2021 at 09:45 (at the age of 63-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 15:30, as a single dose for COVID-19 immunisation. On 08May2021 at 23:00, the patient experienced tiredness, chills, headache and felt unwell. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tiredness, chills, headache and felt unwell was recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on R side of back/side; This is a spontaneous report from a contactable consumer, the patient. A 44-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 30Apr2021 at 13:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The medical history included obesity. The patient's known allergies was reported as not applicable. 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. The patient did not receive any medication within two weeks of vaccination. 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 11Apr2021 at 15:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. On 09May2021, the patient experienced shingles on R side of back/side. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received antiviral medicine (unspecified) as treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles on R side of back/side was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperacusis, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headache; dizziness; elevated hearing; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11May2021 at 10:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 right arm on 20Apr2021 at 10:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11May2021 at 20:00, the patient experienced fever night of headache, dizziness, elevated hearing, and arm pain. The events did not result in a visit to doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, headache, dizziness, elevated hearing, and arm pain were not resolved at the time of this report.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 14:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included previous migraine headaches in past (no migraine for 4 years), penicillin allergy and garlic allergy. 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 vaccine. The patient received unspecified chinese herbs (MANUFACTURER UNKNOWN) prescribed by licensed acupuntu within two weeks of vaccination. On 29Apr2021 at 14:00, the patient experienced left arm pain around injection site for 13 days and continues, instantly felt tired after injection, fatigue increased and continued for 48 hours, headache for 7 days. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm pain around injection site for 13 days was resolving. The clinical outcome of the events instantly felt tired after injection/ fatigue increased and continued for 48 hours was resolved on an unknown date inMay2021 and the clinical outcome of the event headache for 7 days was resolved on 05May2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Fibromyalgia, Neuralgia
Clinical narrative: Generalized nerve pain; Relapse of  fibromyalgia; relapse of fibromyalgia; This is a spontaneous report from a contactable consumer, the patient. A 50-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 02Apr2021 at 19:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 07:30 the patient experienced generalized nerve pain and relapse of fibromyalgia. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events generalized nerve pain and relapse of fibromyalgia were not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in the arm pit.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-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 in the left arm on 09May2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, penicillin allergy and antihistamines allergy (drug allergy). Concomitant medications included over the counter medications vitamin d nos (VITAMIN D) and vitamin b complex (MANUFACTURER UNKNOWN); taken from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 18Apr2021 at 10:30 (at the age of 49-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 10May2021 at 07:00, the patient experienced swollen lymph nodes in the armpit. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in the armpit was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Strong headache; This is a spontaneous report from a contactable consumer, the patient. An adult male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not take any concomitant medications. 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 03May2021 at 14:00 the patient experienced strong headache since the third day after the first dose of vaccine. It had been 10 days almost and he had headache every day and this kind of strong headache never happened before.  The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were 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 strong headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.