chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio decreased, Pain in extremity
Clinical narrative: his INR measured 2.1 which has been lower than it has been in 5 years; his arm hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date: 31May2021), via an unspecified route of administration (at the age of 74-years-old) on 30Jan2021 09:30 at a single dose in right upper arm for COVID-19 immunization. Medical history included Mechanical heart valve from Feb2000 and ongoing, Parkinson's disease, heart rate abnormal, blood pressure abnormal, penicillin and sulfonamide allergy, cholesterol, and rashes. Concomitant medication included warfarin from 2000 and ongoing for Mechanical heart valve and blood thinner for mechanical heart valve, carbidopa, levodopa (CARBIDOPA/LEVODOPA) for Parkinson's disease, carvedilol for Heart rate, hydrochlorothiazide for blood pressure (unknown, thinks it is blood pressure), simvastatin for Blood pressure or cholesterol, not sure which, lisinopril for Blood pressure, pramipexole for Parkinson's disease, macrogol 3350 (MIRALAX) as Laxative, docusate sodium (COLACE) as Stool softener. The patient previously took BACTRIM and experienced allergies. The patient experienced his arm hurt a little bit on Jan2021 with outcome of unknown and his INR measured 2.1 which has been lower than it has been in 5 years on 01Feb2021 with outcome of unknown. The patient and his wife received the 1st dose of the vaccine this past Saturday, 30Jan2021 and is scheduled to take the 2nd dose on 20Feb2021. He mentioned that his arm hurt a little bit, but other than that he was fine. He has been taking warfarin for 20 years and has been Home Monitoring his INR for 5 years. This morning his INR measured 2.1 which has been lower than it has been in 5 years. His usual range is 2.5 - 3.0 and he is worried that the lower INR might risk him for clotting diseases and a stroke. He is asking if there is an interaction with warfarin and the vaccine and will it be safe for him to take the 2nd dose. He has a mechanical heart valve placed year 2000 that he takes Warfarin sodium daily for as a blood thinner. He reported that today: 01Feb2021 at 09:05 his INR level is lower than he has ever recorded in last 5 years: 2.1. He asked if the Pfizer COVID-19 Vaccine can affect the Warfarin sodium or affect blood thinning. Adverse events did not require a visit to Emergency Room or Physician Office. No hospitalization. No prior Vaccinations (within 4 weeks). No adverse event following prior vaccinations. Years ago, he recovered completely from all medication reactions. Further described as he thinks all the reactions were rashes. Medications he had reactions to include Penicillin, Bactrim and Sulfa drugs.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Heart rate, Heart rate abnormal, X-ray
Clinical narrative: she experienced rapid heartbeat/ her heart rate kept fluctuating from her natural 50-60bpm to 135 and 110 bpm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number and expiry date unknown), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced rapid heartbeat and went to the ER as directed by the Fact Sheet for Recipients. She said that she had these tests: EKG, X-ray, and some blood test on an unspecified date with unknown results. She mentioned that her heart rate kept fluctuating from her natural 50-60bpm to 135 and 110 bpm. She wanted to know if she should take the second dose considering this adverse event. The outcome of the event was unknown  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had symptoms of COVID/COVID infection; This is a spontaneous report from a contactable pharmacist (patient). A 42-year-old female patient received her first dose of bnt162b2 (BNT162B2) at unknown vaccination age via an unspecified route of administration on 11Jan2021 at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient inquired if she can get the second dose if she got COVID19 after first dose. The pharmacist reported that she received the first dose of the Pfizer COVID 19 on 11Jan2021 and had symptoms of COVID on 18Jan2021. It has resolved and she has no symptoms in over a week. Today was day 15 (01Feb2021) since COVID infection so she was out of the isolation period. She added that her second dose is scheduled for tomorrow (02Feb2021). She declined safety report noting she feels the vaccine may have reduced her symptoms. She wanted to speak with a Medical Director for further discussion of clinical trial data. HCP requested information on published data on the phase 3 trial of those 39 patients in the clinical trials that received the first dose of the Pfizer Covid vaccine and were tested positive for covid. She is requesting the safety profile, their antibodies level and how did they tolerated the second dose. The outcome of the event was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: sore arm and bruising at injection site; sore arm and bruising at injection site; This is a spontaneous report from a contactable consumer.  A 54-year-old female patient received first dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on 30Jan2021 12:00 as SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 30Jan2021, the patient experienced sore arm and bruising at injection site. The patient is not pregnant at the time of vaccination. The outcome of the events was recovered. No treatment was given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Anxiety, Chest pain, Lip swelling, Nervousness
Clinical narrative: chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her arms; she had an abnormal feeling in her throat/abnormal feeling in her throat comes and goes, off and on; maybe she is nervous and anxious; maybe she is nervous and anxious; This is a spontaneous report received from a contactable consumer (patient).  A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left deltoid, on 19Dec2020, at single dose, for prevention/COVID-19 immunization, at the hospital. Medical history included allergies and allergies to propylene glycol 3350, polysorbate 20, polysulfate 20. It was reported that the patient had a "quick test" and confirmed she has allergies to propylene glycol and polysulfate 20. Her allergist gave her a list of things to stay away from and said to avoid those ingredients. She stated that COVID-19 vaccine has propylene glycol 3350. She clarified and said her allergist told her to stay away from propylene glycol products. Her allergist told her not to use the COVAX. On 19Dec2021, the patient got her first vaccine shot. Within 3 minutes of getting the vaccine, she had rash on her arms. 3 hours later, she had an abnormal feeling in her throat. She was told to go the emergency room and she was given a quick medicine (unspecified). The patient was unable to clarify what medication she received at the emergency room. On 20Dec2021 (the next day), her lips were swollen, on and off. The patient stated she uses dark shampoo and conditioners and maybe it has PEG in it or maybe she is touching something at the hospital. On 20Dec2020, the patient experienced palpitations. She asked the doctors and nurses about her palpitations and they said maybe she was nervous and anxious since she had a COVID patient in the unit. The patient reported that she thinks palpitation started when she went to pick up over the counter medications on 20Dec2020. On 02Jan2021, the patient experienced chest pain. The outcome of rash and palpitations were recovering; oropharyngeal discomfort, lip swelling, and chest pain were not recovered; and nervousness and anxiety were unknown.  Information on the Lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Palpitations, Rash
Clinical narrative: chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her arms; she had an abnormal feeling in her throat/abnormal feeling in her throat comes and goes, off and on; maybe she is nervous and anxious; maybe she is nervous and anxious; This is a spontaneous report received from a contactable consumer (patient).  A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left deltoid, on 19Dec2020, at single dose, for prevention/COVID-19 immunization, at the hospital. Medical history included allergies and allergies to propylene glycol 3350, polysorbate 20, polysulfate 20. It was reported that the patient had a "quick test" and confirmed she has allergies to propylene glycol and polysulfate 20. Her allergist gave her a list of things to stay away from and said to avoid those ingredients. She stated that COVID-19 vaccine has propylene glycol 3350. She clarified and said her allergist told her to stay away from propylene glycol products. Her allergist told her not to use the COVAX. On 19Dec2021, the patient got her first vaccine shot. Within 3 minutes of getting the vaccine, she had rash on her arms. 3 hours later, she had an abnormal feeling in her throat. She was told to go the emergency room and she was given a quick medicine (unspecified). The patient was unable to clarify what medication she received at the emergency room. On 20Dec2021 (the next day), her lips were swollen, on and off. The patient stated she uses dark shampoo and conditioners and maybe it has PEG in it or maybe she is touching something at the hospital. On 20Dec2020, the patient experienced palpitations. She asked the doctors and nurses about her palpitations and they said maybe she was nervous and anxious since she had a COVID patient in the unit. The patient reported that she thinks palpitation started when she went to pick up over the counter medications on 20Dec2020. On 02Jan2021, the patient experienced chest pain. The outcome of rash and palpitations were recovering; oropharyngeal discomfort, lip swelling, and chest pain were not recovered; and nervousness and anxiety were unknown.  Information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: His arm was a little sore, but not bad; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 01Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included ongoing acetylsalicylic acid (ASPIRIN) as blood thinner and unspecified medications. The patient got his first shot of COVID vaccine on an unspecified date and is going to get the second shot 18Feb2021. He took acetylsalicylic acid 4 hours before the first shot. He was wondering if he should acetylsalicylic acid before or after the shot. He had no reaction from taking acetylsalicylic acid. He was on 81 mg, one a day of acetylsalicylic acid as a blood thinner. He didn't think it was a problem. He has read the things about paracetamol (TYLENOL), but he doesn't take that. The patient was just curious because he has been reading up on the COVID vaccine. It said to wait to take paracetamol. He was glad he got the vaccine from Pfizer. His arm was a little sore on an unspecified date, but not bad. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Ultrasound scan
Clinical narrative: Under arm knot  as big as a baseball
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Pt states that he started with his numbing sensation on his left side of his mouth on Feb. 24 2021, for the next 3 days he had the same symptoms. By the  third day he had the same sensation and now has traveled to his left side of his ear. Mouth started to droop on left side.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pruritus, Throat tightness, Urticaria
Clinical narrative: Hives, throat got sore and felt itchy and tight
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in middle of back then neck, shoulders, legs and forehead. Went to the ER, and was some medicine, Zyrtec and EpiPen.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: loose stools since vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: severe dizziness; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown), via an unspecified route of administration on 29Jan2021 at 10:30 at a single dose on the left arm for COVID-19 immunization.  Medical history included ongoing diabetes from an unspecified date for about 3 years and ongoing Hashimoto's thyroiditis from an unspecified date for about 15 years. There were no concomitant medications. The patient did not other vaccinations within 4 weeks prior to the COVID vaccine. The patient reported that in the morning of 01Feb2021, 2 hours before calling, she started having severe dizziness to the point she was laying down, because she has to lay still. She can't go out of the room. She called her doctor and her doctor called in meclizine 25mg for her which she has not started yet. The patient was asking if this was safe to take and if it is counterintuitive to the shot. She has not picked it up yet. Her doctor didn't know anything about the vaccine other than she knows that the patient took the vaccine. The outcome of the event was not recovered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Body temperature increased, Chills
Clinical narrative: temperature 101.2-101.8; chills; increased blood pressure (144/75) HR 95
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt felt dizzy lightheaded and diaphoretic 15 min post vaccination Reports similar symptoms with other vaccinations/shots placed on the stretcher, 1 can of orange juice provided patient felt better after resting and orange juice
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: s/p vaccine complained of shortness of breath. No interventions. Resolved spontaneously
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Patient did "not feel well" while sitting in observation area after receiving shot.  No complaints of dizziness or lightheadedness.  Patient didn't eat breakfast.  Taking pravastatin, losartan and metformin.  Didn't take medications today - will do so after eating a full meal at lunch.  History of hypertension.  Vitals taken x2 - stable.  Offered powerade and granola bar, which patient drank and ate.  Patient felt much better after eating and drinking.  Conversing and laughing with clinic staff.  Left clinic area after 30 minutes.  Observed steady gait when leaving site.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Injection site pruritus, Throat tightness, Urticaria
Clinical narrative: After 15 minutes of my first vaccine, I experienced hives in my right arm and left arm. The  hives also radiated to my back, face and chest. I felt my chest and throat closing up on me. Every once in awhile I get an itchy spot where the first dose vaccine was injected. I did not get my 2nd dose vaccine due to my first dose symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Vaccine administration at 2pm. Patient complaint of nausea at213pm. Vital signs within normal. Patient felt water after drinking water. Discharged home at 1423.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Right arm pain, BP 135/78, pulse 100, 100% O2 sat.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer reporting for herself. An 84-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021, at single dose, for COVID-19 immunisation. Medical history included sinus disorder. Concomitant medications were not reported. The patient experienced dizziness in Feb2021, 3-4 days after vaccination. on an unspecified date with outcome of recovering. The patient did not know if the dizziness was due to the COVID-19 vaccine or her sinus disorder.  The information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itchiness, and sensitivity around injection site, roughly 2 inches in diameter. Developed around 20 hours after injection.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nodule, Pruritus, Pyrexia
Clinical narrative: Rash left side of my body. Itching. Nodule under the clavicle (collarbone). Fever. Joint pain. Headache.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash left side of my body. Itching. Nodule under the clavicle (collarbone). Fever. Joint pain. Headache.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Breath sounds abnormal, Dizziness, Dyskinesia, Eyelid function disorder, Fall
Clinical narrative: Administered Moderna vaccination at 1746 and patient stated that he has experienced vagal responses to injections in the past.  Patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft].  After being the observation chair patient stood up and took 4-5 steps toward the wall and sat down on the floor.  The patient stated he felt dizzy and then became limp & slumped to the right side, eyes remained open with dilation of pupil fixed at 2mm with no blinking noted.  Patient's breathing pattern became shallow & snoring sounds noted.  Patient did not respond when spoken to nor did he respond to soft shaking of shoulders.  Patient began to demonstrate large jerky body movements similar to seizure activity.  The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions.  BP 120/72, HR 64, O2 sats 99%, RR 20.  Patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs.  EMS arrived to find the patient regaining stability.  Patient reported to EMS that his is familiar with this type of response and declined to be taken to
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypopnoea, Hypotonia, Muscle twitching, Pallor
Clinical narrative: Administered Moderna vaccination at 1746 and patient stated that he has experienced vagal responses to injections in the past.  Patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft].  After being the observation chair patient stood up and took 4-5 steps toward the wall and sat down on the floor.  The patient stated he felt dizzy and then became limp & slumped to the right side, eyes remained open with dilation of pupil fixed at 2mm with no blinking noted.  Patient's breathing pattern became shallow & snoring sounds noted.  Patient did not respond when spoken to nor did he respond to soft shaking of shoulders.  Patient began to demonstrate large jerky body movements similar to seizure activity.  The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions.  BP 120/72, HR 64, O2 sats 99%, RR 20.  Patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs.  EMS arrived to find the patient regaining stability.  Patient reported to EMS that his is familiar with this type of response and declined to be taken to
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Restless legs syndrome, Seizure like phenomena, Tremor
Clinical narrative: Administered Moderna vaccination at 1746 and patient stated that he has experienced vagal responses to injections in the past.  Patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft].  After being the observation chair patient stood up and took 4-5 steps toward the wall and sat down on the floor.  The patient stated he felt dizzy and then became limp & slumped to the right side, eyes remained open with dilation of pupil fixed at 2mm with no blinking noted.  Patient's breathing pattern became shallow & snoring sounds noted.  Patient did not respond when spoken to nor did he respond to soft shaking of shoulders.  Patient began to demonstrate large jerky body movements similar to seizure activity.  The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions.  BP 120/72, HR 64, O2 sats 99%, RR 20.  Patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs.  EMS arrived to find the patient regaining stability.  Patient reported to EMS that his is familiar with this type of response and declined to be taken to
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Eye swelling, Fatigue, Nasal congestion
Clinical narrative: I started feeling sick 7 hrs after the vaccine I developed chills, fevers, fatigue. My fever went up to 102.9, my eyes started to swell, I felt congestion. I went to the ER on 1/11/201 at around 11pm they gave me medications. The next day I also had diarrhea. The fevers resolved by the following day the body aches & the chills lasted for 1 week & the diarrhea lasted for 1 day.  Fatigue is still going on & off it has not completely resolved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I started feeling sick 7 hrs after the vaccine I developed chills, fevers, fatigue. My fever went up to 102.9, my eyes started to swell, I felt congestion. I went to the ER on 1/11/201 at around 11pm they gave me medications. The next day I also had diarrhea. The fevers resolved by the following day the body aches & the chills lasted for 1 week & the diarrhea lasted for 1 day.  Fatigue is still going on & off it has not completely resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen redness at the site of vaccination.  Hard and warm to touch and itchy.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy  Very swollen, sore and red lymph nodes on the left side of the neck
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site scar
Clinical narrative: Got a keloid (scar) in the injection spot; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced got a keloid (scar) in the injection spot on 2021. The outcome of event was unknown.    Information about lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Dizziness
Clinical narrative: FEELING FAIINT APPROX 20 MINUTES AFTER VACCINATION.  B/P FLUCTUATING, AMBULANCE CALLED
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: 2/2/2021 vaccination  2/3/2021 24 hours later, I was getting really fatigue at work. Got to the point where hard time keeping eyes open, muscle stiffness, HA, chills, temp 100.5 was the highest. 3 days i felt run down, terrible body aches, HA.  *other symptoms have subsided EXCEPT the HA. I wake up daily with HA. I try to alternate between Excedrin, Tylenol and hot compress.  **1st vaccine; 'Covid arm'
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: 2/2/2021 vaccination  2/3/2021 24 hours later, I was getting really fatigue at work. Got to the point where hard time keeping eyes open, muscle stiffness, HA, chills, temp 100.5 was the highest. 3 days i felt run down, terrible body aches, HA.  *other symptoms have subsided EXCEPT the HA. I wake up daily with HA. I try to alternate between Excedrin, Tylenol and hot compress.  **1st vaccine; 'Covid arm'
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: All over body rash the afternoon after getting the vaccine.  Extremely itchy legs.  Symptoms dissipated by mid-morning the next day.  Went to urgent care.   Only had a little bit of rash at that time.  Doctor suggested Benadryl and Zyrtec.  Had a bad flare-up of redness on the back and under the arms on the way home from the appointment.  Took Benadryl when I got home.  That helped a lot.   Took Zyrtec in the morning and Benadryl in the PM for the next 2 days.  No more rash,  just a little bit of itchiness.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 7 days post-vaccination, patient states that the injection site  had redness, itching and swelling.  Patient notified her primary care provider and was informed that this is a common side effect.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Eye pain, Grip strength decreased, Hyperhidrosis
Clinical narrative: Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities.  Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Injection site streaking, Loss of consciousness
Clinical narrative: Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities.  Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Nausea, Pain in extremity, Paraesthesia, Vision blurred
Clinical narrative: Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities.  Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities.  Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Angiogram, Coagulation test normal, Computerised tomogram head normal, Dysarthria, Full blood count normal
Clinical narrative: presents to the hospital due to acute R sided weakness and numbness which developed a few minutes after receiving her 1st Covid-19 vaccine.  Got 1st shot at POD.  Patient not sure if it was the Pfizer or Moderna vaccine.  Patient developed RUE weakness, R face and arm numbness and dysarthria shortly after receiving her vaccination.  Mild hives were also observed along chest in the ED. Patient received Diphenhydramine and tenecteplase
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Hemiparesis, Human chorionic gonadotropin normal, Hypoaesthesia, Urticaria
Clinical narrative: presents to the hospital due to acute R sided weakness and numbness which developed a few minutes after receiving her 1st Covid-19 vaccine.  Got 1st shot at POD.  Patient not sure if it was the Pfizer or Moderna vaccine.  Patient developed RUE weakness, R face and arm numbness and dysarthria shortly after receiving her vaccination.  Mild hives were also observed along chest in the ED. Patient received Diphenhydramine and tenecteplase
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: within 15 minutes of immunization, patient experienced a feeling of fainting, lightheadedness, and ringing of the ears. Patient laid on the floor for an additional 30 minutes and was then released after feeling better.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Got the vaccine, she went home around 3:30, and was very tired.  She woke up after 6:00 PM.  This morning she had swelling in her arms, real bumpy about 2 1/2" in diameter, looks like rocks, red/pink area 1 1/2".  It is very painful throbbing area on her arms,  getting worse.   She has been taking Tylenol.  She felt a little relief of the pain with the Tylenol.  She rested all day yesterday.  She left at 10:00 for her bridge club and that's where she noticed the reaction and has gotten home around 3:00 and not feeling well.  They told her to call us as they did not have any side effects from the vaccine.   She does have an appointment on 3/11/21 with her PCP.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Influenza like illness, Pain, Pain in extremity
Clinical narrative: felt like i had the flu; arm got sore; threw up" in middle of night; achy weakness; achy weakness; low grade temp; chills; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162b2 ((Pfizer-BIONTECH Covid-19 Vaccine) , via an unspecified route of administration on 31Jan2021, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient received 1st dose of vaccine on 31Jan2021 and was "fine for 2 days" then felt the effects in Feb2021: "threw up" in middle of night, achy weakness, chills, low grade temp. He stated, "soreness in arm, Achy and weak this morning when I got up. I am feeling better now." The patient reported that , "'my arm got sore and I felt like I had the flu for about 24 hrs.-took Tylenol" and was asking if he should be concerned the symptoms started more than 36 hours after getting the 1st dose. The outcome of the events was not reported.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: felt like i had the flu; arm got sore; threw up" in middle of night; achy weakness; achy weakness; low grade temp; chills; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162b2 ((Pfizer-BIONTECH Covid-19 Vaccine) , via an unspecified route of administration on 31Jan2021, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient received 1st dose of vaccine on 31Jan2021 and was "fine for 2 days" then felt the effects in Feb2021: "threw up" in middle of night, achy weakness, chills, low grade temp. He stated, "soreness in arm, Achy and weak this morning when I got up. I am feeling better now." The patient reported that , "'my arm got sore and I felt like I had the flu for about 24 hrs.-took Tylenol" and was asking if he should be concerned the symptoms started more than 36 hours after getting the 1st dose. The outcome of the events was not reported.  Information on lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing
Clinical narrative: About 40 minutes after receiving the vaccine, I experienced shortness of breath for about 2 minutes, followed by flushing at which time the breathing returned to normal and has not reoccurred. No other symptoms have been experienced at this time.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Muscle fatigue, Nausea
Clinical narrative: First day after - muscle fatigue, dizziness, general fatigue (not localized), lower back pain  Five days after - vertigo, nausea
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: First day after - muscle fatigue, dizziness, general fatigue (not localized), lower back pain  Five days after - vertigo, nausea
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: headache, dizziness
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient started feeling lightheaded while walking from vaccination station to post observation area.  Patient then started feeling nauseated while sitting in post observation area.  Patient ate breakfast this morning.  Not on any medication.  Conversing with clinic staff and wondering if feeling lightheaded is normal after receiving the shot.  Vital signs taken x2 - stable.  Offered water but declined.  Offered yoga mat to lay down but declined.  Feeling better.  Looking at phone.  Conversing with clinic staff.  Nausea resolved but still feeling "a little lightheaded."  Steady gait after leaving clinic at 10:15 am.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Computerised tomogram head, Dizziness, Eye haematoma, Fall
Clinical narrative: 02/20/2021 at 6:30am  when getting up, dizziness, nausea, vomiting, fainted, fell and hurt back.  9:00am when getting up a second time, again - dizziness, nausea, fainting , falling and hitting head in bathroom.   During day , hematoma over left eye, swelling, no Headache, no blurred vision, back pain increased.  Treated with heat.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Magnetic resonance imaging, Nausea, Skull X-ray, Spinal X-ray
Clinical narrative: 02/20/2021 at 6:30am  when getting up, dizziness, nausea, vomiting, fainted, fell and hurt back.  9:00am when getting up a second time, again - dizziness, nausea, fainting , falling and hitting head in bathroom.   During day , hematoma over left eye, swelling, no Headache, no blurred vision, back pain increased.  Treated with heat.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal compression fracture, Swelling, Syncope, Vertebroplasty, Vomiting
Clinical narrative: 02/20/2021 at 6:30am  when getting up, dizziness, nausea, vomiting, fainted, fell and hurt back.  9:00am when getting up a second time, again - dizziness, nausea, fainting , falling and hitting head in bathroom.   During day , hematoma over left eye, swelling, no Headache, no blurred vision, back pain increased.  Treated with heat.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; This is spontaneous report from a contactable patient.  A 30-years-old male patient received the first dose on bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/lot number: EL3247), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation, when 30 years old. Medical history was none. The patient's concomitant medications were not reported. The patient experienced got the first dose and then on 24Jan2021 tested positive for covid with outcome of unknown. The patient wanted to know when he could receive the second dose. The patient was treated with Tylenol.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: High fever, chills, body aches, headache, sore arm, swollen arm, red rash on arm,  lasted almost 48 hours. Worse than when I actually had covid in early January 2021.  Arm still swollen and painful.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: High fever, chills, body aches, headache, sore arm, swollen arm, red rash on arm,  lasted almost 48 hours. Worse than when I actually had covid in early January 2021.  Arm still swollen and painful.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Flank pain, Injection site pain, Pain
Clinical narrative: Pain at injection site within hours same date Pain in armpit on same side of inject developing on first day but more severe day 2 (2/27)and resolving by end of day 3 (2/28) Body aches and fatigue day 2 (2/27) managed with 800mg ibuprofen resolved mostly by afternoon Virtigo from  early morning on day 4(3/1) -day 5(3/2) worse while laying down when turn head Woke with left sided flank pain this morning (3/3) but had a physically stressful day prior while moving so not sure if this is related to vaccine, moving or UTI will notify primary if persists.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Stress, Vertigo
Clinical narrative: Pain at injection site within hours same date Pain in armpit on same side of inject developing on first day but more severe day 2 (2/27)and resolving by end of day 3 (2/28) Body aches and fatigue day 2 (2/27) managed with 800mg ibuprofen resolved mostly by afternoon Virtigo from  early morning on day 4(3/1) -day 5(3/2) worse while laying down when turn head Woke with left sided flank pain this morning (3/3) but had a physically stressful day prior while moving so not sure if this is related to vaccine, moving or UTI will notify primary if persists.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Herpes zoster, Pain, Pyrexia
Clinical narrative: Following my vaccination on 2/23-I awoke at 5 am on 2/24/21 fever, body aches, chills, fatigue.  On Sunday 2/28 in the evening, I developed a rash on my right buttock which at first just looked like a simple rash.  As Monday 3/1 and Tuesday 3/2 progressed, the rash became, very painful, hot and it hurt to sit or even have clothing touch it.  I went to the doctor today, 3/3/21 at 3 pm and was diagnosed with Shingles.   I have been prescribed an anti-viral medication to treat the Shingles.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Sensitive skin
Clinical narrative: Following my vaccination on 2/23-I awoke at 5 am on 2/24/21 fever, body aches, chills, fatigue.  On Sunday 2/28 in the evening, I developed a rash on my right buttock which at first just looked like a simple rash.  As Monday 3/1 and Tuesday 3/2 progressed, the rash became, very painful, hot and it hurt to sit or even have clothing touch it.  I went to the doctor today, 3/3/21 at 3 pm and was diagnosed with Shingles.   I have been prescribed an anti-viral medication to treat the Shingles.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Herpes zoster, Impaired work ability, Malaise, Pain
Clinical narrative: Following my vaccination on 2/23-I awoke at 5 am on 2/24/21 fever, body aches, chills, fatigue.  On Sunday 2/28 in the evening, I developed a rash on my right buttock which at first just looked like a simple rash.  As Monday 3/1 and Tuesday 3/2 progressed, the rash became, very painful, hot and it hurt to sit or even have clothing touch it.  I went to the doctor today, 3/3/21 at 3 pm and was diagnosed with Shingles.   I have been prescribed an anti-viral medication to treat the Shingles.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dysphagia, Feeling hot, Lacrimation increased, Throat tightness
Clinical narrative: Burning sensation throughout body. Some tightness in throat difficult swallowing at times. Feel like my Blood is boiling. Watery eyes some. burning feeling not going away.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Syncope
Clinical narrative: The coroner called Dr. on 3.2.2021 to advise that he had a witnessed collapse and Mr. was taken to the ED where he was pronounced.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: flu-like symptoms; head ache; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced that after her first dose on Jan2021, about 4 weeks ago, she experienced flu-like symptoms and head ache for about 4 days. The outcome of the events was recovered on Jan2021.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: I experienced bad chills and body aches like having the flu and when I previously had Covid 19; headaches have been really bad.  Chills and body aches are better as of today, 03/03/2021 but the headaches remains.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cough
Clinical narrative: Patient felt like she needed to cough, dry throat. Iniital BP 151/83. Final BP 137/88 (pulse 71). Given water.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling right hand
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: 2 minutes after received 1st dose of Moderna COVID vaccine, patient stated unilateral headache, advised to drink water. 3 minutes after receiving vaccine, patient stated " I feel funny, I can't breathe" and lost consciousness x 5-10 seconds. Patient airway clear and breathing monitored. Patient regained consciousness, diaphoretic, oriented. Patient A&O x 4 after sternal rub. HR: 52, SPO2: 97% RA. Provided breath coaching, held patient in upright position, monitored breathing, had patient orally drink water. Manual B/P: 95/60, HR: 64. Patient became more coherent and stated prior to loss of consciousness he felt chest pain, denied any current chest pain, SOB, dizziness, headache, confusion, itching, rash, swelling.   Consulted with MD on site who advised EMS called and to monitor patient vitals. Patient declined EMS. Patient placed in wheelchair and taken to private room to lay supine and orally drink fluids. 15 minutes later supine vitals: B/P: 117/77 HR: 68, SPO2: 99% RA. Patient rested for additional 15 minutes, sat upright for 5 minutes. Vitals sitting: B/P 117/79, HR: 69, SPO2: 99% RA. Per MD, patient approved to return home but advised not to drive. Patient stated had not eaten or been drinking water and driven 2 hours prior to vaccination. Patient stated all symptoms resolved except feeling fatigued. Advised patient's wife to drive, to eat/drink prior to leaving, if develops chest pain, SOB, facial swelling, hives, loss of consciousness, lethargy, confusion to go to ER or call 911. Patient and wife verbalized understanding. Patient monitored for 1 hour after loss of consciousness.   Telephone call to patient 4 hours after vaccination. Patient stated "feeling much better," ate and drank water after leaving clinic, and resting. Patient denied SOB, chest pain, loss of consciousness, confusion, lethargy, HA, dizziness, lightheadedness. Patient advised to inform PCP of symptoms/reaction and discuss plan for when/if 2nd dose. Explained may have been vasovagal response. Patient stated several years ago having similar episode at ER when seeing blood, stated at vaccine clinic today, watched wife receive vaccine, then saw small drop of blood on his arm before loss of consciousness. Patient stated he will discuss with his PCP.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: 2 minutes after received 1st dose of Moderna COVID vaccine, patient stated unilateral headache, advised to drink water. 3 minutes after receiving vaccine, patient stated " I feel funny, I can't breathe" and lost consciousness x 5-10 seconds. Patient airway clear and breathing monitored. Patient regained consciousness, diaphoretic, oriented. Patient A&O x 4 after sternal rub. HR: 52, SPO2: 97% RA. Provided breath coaching, held patient in upright position, monitored breathing, had patient orally drink water. Manual B/P: 95/60, HR: 64. Patient became more coherent and stated prior to loss of consciousness he felt chest pain, denied any current chest pain, SOB, dizziness, headache, confusion, itching, rash, swelling.   Consulted with MD on site who advised EMS called and to monitor patient vitals. Patient declined EMS. Patient placed in wheelchair and taken to private room to lay supine and orally drink fluids. 15 minutes later supine vitals: B/P: 117/77 HR: 68, SPO2: 99% RA. Patient rested for additional 15 minutes, sat upright for 5 minutes. Vitals sitting: B/P 117/79, HR: 69, SPO2: 99% RA. Per MD, patient approved to return home but advised not to drive. Patient stated had not eaten or been drinking water and driven 2 hours prior to vaccination. Patient stated all symptoms resolved except feeling fatigued. Advised patient's wife to drive, to eat/drink prior to leaving, if develops chest pain, SOB, facial swelling, hives, loss of consciousness, lethargy, confusion to go to ER or call 911. Patient and wife verbalized understanding. Patient monitored for 1 hour after loss of consciousness.   Telephone call to patient 4 hours after vaccination. Patient stated "feeling much better," ate and drank water after leaving clinic, and resting. Patient denied SOB, chest pain, loss of consciousness, confusion, lethargy, HA, dizziness, lightheadedness. Patient advised to inform PCP of symptoms/reaction and discuss plan for when/if 2nd dose. Explained may have been vasovagal response. Patient stated several years ago having similar episode at ER when seeing blood, stated at vaccine clinic today, watched wife receive vaccine, then saw small drop of blood on his arm before loss of consciousness. Patient stated he will discuss with his PCP.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Lymphadenopathy, Rash vesicular, Skin burning sensation
Clinical narrative: Shingles. About 1.5 weeks after shot had burning on lower left side. About 2 weeks after shot blistering rash appeared on front lower left abdomen (side still burns but no rash there). Rash area burns and stings. Random pinching and burning throughout body in evening. 3 weeks after shot, rash still burns but not quite as inflamed/raised. Centers of blisters are now darkly colored. Extremely tired. Neck feels like swollen glands.