chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, Loss of consciousness, Ventricular extrasystoles
Clinical narrative: Passed out at work; abnormal EKG; PVCs; This is a spontaneous report from a contactable other healthcare professional (patient).  A 52-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 12Jan2021 10:30 (Batch/Lot Number: UNKNOWN) as SINGLE DOSE for COVID-19 immunisation. Patient received first dose on unspecified date. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The  patient is not pregnant at the time of vaccination. Concomitant medications included losartan; nadolol; levothyroxine sodium, all were taken for an unspecified indication, start and stop date were not reported. On 27Jan2021 16:30, the patient passed out at work, has abnormal EKG, now PVCs. The event required Emergency Room visit. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Feeling abnormal, Haemolytic anaemia
Clinical narrative: Hemolytic anemia; He started feeling bad two days later; Fatigued / feeling tired; feeling sick; 102 Fever; sweating; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received a flu shot on the 26th (as reported). The patient's wife reported that her husband received the BNT162b2 vaccine on the 11th and he started feeling bad two days later and a little bit fatigued and then by Wednesday, he was feeling very sick and sweating. He had to come home from work. It was also reported that since Saturday, the patient started feeling tired. He could not stop sweating and then he was just feeling extremely fatigued and then yesterday (20Mar2021), he had a 102 fever, fatigued and he went to the urgent care and they made him go to the hospital and now all of his blood is out of whack. He is having hemolytic anemia where his body is attacking his red blood cells (as reported) and they do not really know what is causing it. They are perplexed. The patient's wife told the infectious disease doctor and blood doctor that her husband had the vaccine. The patient tested negative for COVID-19 four times. The clinical outcome of the started feeling bad, a fatigued/feeling tired, feeling very sick, sweating, 102 fever and hemolytic anemia was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: Hemolytic anemia; He started feeling bad two days later; Fatigued / feeling tired; feeling sick; 102 Fever; sweating; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received a flu shot on the 26th (as reported). The patient's wife reported that her husband received the BNT162b2 vaccine on the 11th and he started feeling bad two days later and a little bit fatigued and then by Wednesday, he was feeling very sick and sweating. He had to come home from work. It was also reported that since Saturday, the patient started feeling tired. He could not stop sweating and then he was just feeling extremely fatigued and then yesterday (20Mar2021), he had a 102 fever, fatigued and he went to the urgent care and they made him go to the hospital and now all of his blood is out of whack. He is having hemolytic anemia where his body is attacking his red blood cells (as reported) and they do not really know what is causing it. They are perplexed. The patient's wife told the infectious disease doctor and blood doctor that her husband had the vaccine. The patient tested negative for COVID-19 four times. The clinical outcome of the started feeling bad, a fatigued/feeling tired, feeling very sick, sweating, 102 fever and hemolytic anemia was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Investigation, Pericardial effusion
Clinical narrative: Chest pain; difficulty breathing/having challenges breathing; have fluid around his heart; This is a spontaneous report from a non-contactable physician via Pfizer sales representative. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced chest pain and difficulty breathing/having challenges breathing in Mar2021. He was hospitalized on an unspecified date. The doctor attributed the events to the vaccine and he was advised not to get a second shot. Patient was released from the hospital and upon-follow up with a cardiologist, he was found to have fluid around his heart on an unspecified date. The patient is currently getting more testing. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information provided, the reported events are likely intercurrent medical conditions and unrelated to BNT162B2. Of note, medical history, patient's age and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the events. Case will be reassess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots; This is a spontaneous report from a non-contactable consumer through a Pfizer sales representative. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had blood clots. The patient was hospitalized on an unspecified date due to the reported event. The outcome of the event, blood clot, was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ruptured cerebral aneurysm
Clinical narrative: Brain aneurysm (ruptured); This is a spontaneous report from a contactable consumer (patient's sister) via the Pfizer-sponsored program. A female patient of an unspecified age, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 20Mar2021, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The sister reported that the patient received her first administration of the Pfizer Covid vaccine on the morning of 20Mar2021. In the early hours of 21Mar2021, the patient had a brain aneurysm (ruptured). The outcome of the event was unknown. Causality was reported as temporally related or possibly causal.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Haematochezia
Clinical narrative: blood in stool; cramping in lower abdominal area; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 13Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She experienced blood in stool and cramping in lower abdominal area on an unspecified date. Lasted 2 days. She wanted to report her experience. Outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, IPV, PPV, RV5
Symptoms: Extra dose administered
Clinical narrative: Patient received a dose of IPOL vaccine twice in one day with no ae; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00511293) and transmitted to Sanofi on 09-Mar-2021.  This case involves a six months old male patient who received a dose 0.5 mL dose of suspect IPV (VERO) [IPOL] (lot R1B252M and expiration date: 13-Mar-2021) via intramuscular route in left thigh for prophylactic vaccination twice in one day (extra dose administered) on 09-Mar-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), HIB VACCINE CONJ (TET TOX) (ACTHIB) (dose: other), PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Immunisation.  It was actual medication error due to extra dose administered (on same day).  The reporter would like to know the potential side effect.  At the time of report, the patients experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Gait disturbance, Musculoskeletal discomfort, SARS-CoV-2 test positive
Clinical narrative: they said he had Covid; he couldn't walk on the 17th; He is like bed ridden; his hips was bothering; a pain from both sides of his hip; This is a spontaneous report from a contactable Consumer (wife) via call center. A 72-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EN6199) as single dose for covid-19 immunisation.  Medical history included blood cholesterol from an unknown date and unknown if ongoing and he takes a pill for cholesterol.  The patient's concomitant medications were not reported. The patient's wife reported that "he had the shot on the 5th of this month and he couldn't walk on the 17th and she had to get the ambulance to take him to hospital where he was tested and they said he had Covid." The reporter also mentioned that they took X-ray because he was complaining about his hip, he had a pain from both sides of his hip. They also gave him Tylenol. The patient was discharged from the hospital on 17Mar2021. The reporter stated that the patient has been home upstairs in bed and that "he is scheduled for another shot on the 26th of this month" and inquired as to what to do with second dose appointment. Hospitalization date was 17Mar2021. Seriousness criteria for vents Covid-19 was hospitalization and medically significant, for gait disturbance and musculoskeletal discomfort was hospitalization. Events arthralgia (pain in hip) was reported as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test positive for covid on 17Mar2021 , x-ray: no result provided on unknown date .  The events outcome was unknown. Therapeutic measures were taken as a result of event musculoskeletal discomfort.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: they said he had Covid; he couldn't walk on the 17th; He is like bed ridden; his hips was bothering; a pain from both sides of his hip; This is a spontaneous report from a contactable Consumer (wife) via call center. A 72-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EN6199) as single dose for covid-19 immunisation.  Medical history included blood cholesterol from an unknown date and unknown if ongoing and he takes a pill for cholesterol.  The patient's concomitant medications were not reported. The patient's wife reported that "he had the shot on the 5th of this month and he couldn't walk on the 17th and she had to get the ambulance to take him to hospital where he was tested and they said he had Covid." The reporter also mentioned that they took X-ray because he was complaining about his hip, he had a pain from both sides of his hip. They also gave him Tylenol. The patient was discharged from the hospital on 17Mar2021. The reporter stated that the patient has been home upstairs in bed and that "he is scheduled for another shot on the 26th of this month" and inquired as to what to do with second dose appointment. Hospitalization date was 17Mar2021. Seriousness criteria for vents Covid-19 was hospitalization and medically significant, for gait disturbance and musculoskeletal discomfort was hospitalization. Events arthralgia (pain in hip) was reported as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test positive for covid on 17Mar2021 , x-ray: no result provided on unknown date .  The events outcome was unknown. Therapeutic measures were taken as a result of event musculoskeletal discomfort.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperaesthesia, Pain, Skin sensitisation
Clinical narrative: Headache, body aches, skin sensitivity around 8:30pm. Chills and worse headache around 4:00am on 4/2/21.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Paraesthesia oral
Clinical narrative: Tingling around lips that started about 45 minutes after the vaccine. Lasted about 1/2 hour. Soreness around injection site the next 2 days.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Vaccination site pain
Clinical narrative: Tingling around lips that started about 45 minutes after the vaccine. Lasted about 1/2 hour. Soreness around injection site the next 2 days.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: First vaccine was Moderna 2 Feb 21  at other location, now deployed to another state and unable to get 2nd moderna.   As per protocol, Jannsen vaccine given as above.  Tolerated without issues.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Sudden onset of frequent palpitations occurring over days
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Cough, Ear pain, Fatigue
Clinical narrative: Thursday 4/1/21:  Tiredness, all over joint pain, shoulders and shoulder blades sore, neck pain especially on left side, ear ache on right side, congested, head ache, fever up to 102.3, fever for approximately  20 hours, nauseous. Friday 4/2/21: awoke with chest (not heart) pain, congested, runny nose, cough (I sometimes have a little congestion and cough in the mornings but not like this)
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Thursday 4/1/21:  Tiredness, all over joint pain, shoulders and shoulder blades sore, neck pain especially on left side, ear ache on right side, congested, head ache, fever up to 102.3, fever for approximately  20 hours, nauseous. Friday 4/2/21: awoke with chest (not heart) pain, congested, runny nose, cough (I sometimes have a little congestion and cough in the mornings but not like this)
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Thursday 4/1/21:  Tiredness, all over joint pain, shoulders and shoulder blades sore, neck pain especially on left side, ear ache on right side, congested, head ache, fever up to 102.3, fever for approximately  20 hours, nauseous. Friday 4/2/21: awoke with chest (not heart) pain, congested, runny nose, cough (I sometimes have a little congestion and cough in the mornings but not like this)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Injection site pain, Syncope
Clinical narrative: Left arm started to hurt minutes after the injection, radiating down toward elbow and my arm started to go numb, especially the pinkie and ring finger.  Difficult to hold my phone while waiting, I dropped it, then started to get dizzy.  Called a volunteer over, who summoned another lady.  They told me they were going to move me to another area, and attempted to help me there, but I fainted about 3 steps out.  When they were lying me down on the floor, I came to and was oriented at that point.  BP was somewhat low initially, but increased as I lay there,  and oxygen levels increased from 94 to 99 before I left facility.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Dark red rash started on upper arm on wrist and bicep on left arm and along left side day one faded away somewhat during the day. Day two rash still present light red with slight itch both arms, legs and most of body concentrated mid section of stomach, back and along arms.  No other symptoms.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Patient reported limb swelling (left arm-fingers) two days after vaccination 1st dose.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever 101.2 for 12 hours commencing 24 hours after shot Tiredness
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gaze palsy, Head injury, Headache, Hyperhidrosis
Clinical narrative: Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to needles".  Received vaccine to LUE and was waiting in Obs area with son (who reported only being seated for approx 5 mins.).  A loud noise was heard and participant was observed laying out prone on the floor.    Clinicians assisted him to roll over where his eyes were red, wide-open gaze, and diaphoretic but was not responding to commands.  After turning him to his Rgt side he began to sit up and became slightly combative and was able to be calmed down.    Moved to Tent 6 to cot via wheelchair where is RUE BP was 180/100 at 11:09, and Lft radial pulse taken by MD was "60 and weak", Resp 16 and unlabored so no oxygen in use but nearby.  Upon further assessment, participant repeatedly stated that, "he just did not feel well" and when probed, c/o frontal headache, nauseated (but did not vomit), and weak.  Offered water to sip and by now lip no longer bleeding.  When asked, "what did you feel prior to falling out of your seat?", he stated, "I just remember that you all were around me asking me questions...hence could not recall moments leading up to being found on the floor and no type of aura was identified as well.  Reported a h/o HTN but did not take his medication today...other history is unremarkable.    Ambulance arrival approx 11:13, VS taken, assessed and transported to nearest facility.  Family returned and later reported that he sustained only a large "goose-egg" on the forehead and fat lip but otherwise was treated and released.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lip injury, Malaise, Nausea, Ocular hyperaemia, Syncope
Clinical narrative: Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to needles".  Received vaccine to LUE and was waiting in Obs area with son (who reported only being seated for approx 5 mins.).  A loud noise was heard and participant was observed laying out prone on the floor.    Clinicians assisted him to roll over where his eyes were red, wide-open gaze, and diaphoretic but was not responding to commands.  After turning him to his Rgt side he began to sit up and became slightly combative and was able to be calmed down.    Moved to Tent 6 to cot via wheelchair where is RUE BP was 180/100 at 11:09, and Lft radial pulse taken by MD was "60 and weak", Resp 16 and unlabored so no oxygen in use but nearby.  Upon further assessment, participant repeatedly stated that, "he just did not feel well" and when probed, c/o frontal headache, nauseated (but did not vomit), and weak.  Offered water to sip and by now lip no longer bleeding.  When asked, "what did you feel prior to falling out of your seat?", he stated, "I just remember that you all were around me asking me questions...hence could not recall moments leading up to being found on the floor and no type of aura was identified as well.  Reported a h/o HTN but did not take his medication today...other history is unremarkable.    Ambulance arrival approx 11:13, VS taken, assessed and transported to nearest facility.  Family returned and later reported that he sustained only a large "goose-egg" on the forehead and fat lip but otherwise was treated and released.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Insomnia, Myalgia
Clinical narrative: Severe muscle ache, chills, sweating, severe headache, loss of sleep, low-grade fever
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe muscle ache, chills, sweating, severe headache, loss of sleep, low-grade fever
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Malaise, Nausea, Pyrexia
Clinical narrative: Patient reported fever 101.5 for a couple days, rash all over his chest, general malaise- lethargic, pain in the injection side and nausea.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient reported fever 101.5 for a couple days, rash all over his chest, general malaise- lethargic, pain in the injection side and nausea.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in left ear
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous, Skin warm
Clinical narrative: EDD 5/21/21 Red hot rash on left arm where vaccine was given
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: fatigue, headache, muscle pain, joint pain, shills, fever, diarrhea,  stomach pain, fast heartbeat
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: fatigue, headache, muscle pain, joint pain, shills, fever, diarrhea,  stomach pain, fast heartbeat
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Headache, Photophobia, Pyrexia
Clinical narrative: Tired slight h/a 3 hrs post. Took nap, better. About 8 pm went to bed. Now, h/a severe, photophobia, wants to go to hospital, afraid. Fever of 100.8. Can?t lay down, get comfortable
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Tired slight h/a 3 hrs post. Took nap, better. About 8 pm went to bed. Now, h/a severe, photophobia, wants to go to hospital, afraid. Fever of 100.8. Can?t lay down, get comfortable
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Pain at injection site only lasted an hour. Nausea started about 20 minutes after injection and increasing got worse through the day accompanied by a severe headache. Day 2 Nausea was still present but not as severe although headache remained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported a skin reaction on the injection side, pain, redness, swelling
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Injection site pain
Clinical narrative: Started with a headache at 8:30pm, body aches started at 9:30pm. Had hot flashes & cold chills all night. Entire body feels like it got hit by a truck at 5am. Soreness at the injection site.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, headache, body ache, chills, congestion
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: severe shaking; low grade fever, pain in left arm
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site reaction
Clinical narrative: Vaccine shot on 22MAR2021 Chills, fatigue, gi upset, headache and very sore arm 24MAR2021 All symptoms then I thought went away. 30MAR2021 sore arm started again and noticed red splotch around injection site.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Vaccine shot on 22MAR2021 Chills, fatigue, gi upset, headache and very sore arm 24MAR2021 All symptoms then I thought went away. 30MAR2021 sore arm started again and noticed red splotch around injection site.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Patient experienced tongue swelling starting a few hours after receiving the vaccine. She presented to clinic where she was treated with benadryl, famotidine, and prednisone. Her symptoms resolved in clinic and she was discharged home a few hours later.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Patient reported headache, muscle pain, fever 38 (celsius), fatigue/tiredness
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea headache fever very tired and muscle aches
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Dizziness, Echocardiogram abnormal, Electrocardiogram T wave amplitude increased, Syncope
Clinical narrative: Pt. was sitting in waiting area and walked into the building and informed that she was feeling dizzy.  Pt. then fainted and was lowered to the ground by medic before actually falling.  Pt. was given sternum rub and capillary refills were done.  Pt. was taken to medic area where BP/BS/EKG was performed.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Fever, chills, headache, body ache, exhaustion, pain at injection site
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, body ache, exhaustion, pain at injection site
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fatigue, headache, body aches, low grade fever (99.5), nausea
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Status asthmaticus
Clinical narrative: Status asthmaticus with heart rate 130's, SpO2 in high 70's.  Treated with albuterol x2, nearly resolved, transported to hospital via EMS.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Chest X-ray, Condition aggravated, Electrocardiogram, Full blood count
Clinical narrative: Status asthmaticus with heart rate 130's, SpO2 in high 70's.  Treated with albuterol x2, nearly resolved, transported to hospital via EMS.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test
Clinical narrative: Status asthmaticus with heart rate 130's, SpO2 in high 70's.  Treated with albuterol x2, nearly resolved, transported to hospital via EMS.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Fluid retention, Oedema peripheral
Clinical narrative: Began to have edema around my ankles, feet and lower leg. Contacted my primary Doctor and he never heard of fluid retention as a side affect of the shot and prescribed furosemide. I continue to have fluid retention today, 2 months after first shot. My spouse- received shots on same day and also retained fluid in same areas. However, her skin broke open and drained fluid for 2 days. Her swelling has reduced now. She has had previous heart attack and I have renal failure.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, chills, headache for 8-10 hours
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Red rash on neck (like a deep sunburn), rash on back of both knees, skin blotches on arms and legs. No treatment and ongoing, as of today.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over my body
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Started with burning muscles throughout my body. Around 9 PM I started to get a headache. Then chills followed by intenses fever and sweating. All night and through to the next morning I had a high fever, though I didn?t take my temperature. I was achy all over, had an incredibly horrific headache which strong migraine over the counter pills did not help,  I would go back and forth from shivering to sweating (my body would be drenched in sweat) and just feeling miserable. I slept off and on until about noon. Then all symptoms slowly went away. By about 2:00 I was up and around though tired. By early evening I was perfectly fine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Somnolence
Clinical narrative: Started with burning muscles throughout my body. Around 9 PM I started to get a headache. Then chills followed by intenses fever and sweating. All night and through to the next morning I had a high fever, though I didn?t take my temperature. I was achy all over, had an incredibly horrific headache which strong migraine over the counter pills did not help,  I would go back and forth from shivering to sweating (my body would be drenched in sweat) and just feeling miserable. I slept off and on until about noon. Then all symptoms slowly went away. By about 2:00 I was up and around though tired. By early evening I was perfectly fine.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Patient reported " A few days after the vaccine, I developed a large red spot on my torso, a few days later I started to get pale splotches scattered on my torso. Each day I have more splotches, spread out even more, and they have gotten darker".
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Malaise, Musculoskeletal stiffness
Clinical narrative: Fever,  chills, fatigue, malaise, soreness, stiffness, flu-like:  4 days
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever,  chills, fatigue, malaise, soreness, stiffness, flu-like:  4 days
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Ct. c/o tingling in the left arm 10 minutes after receiving vaccine.  Client denies any other symptom and was seen by EMT.  Vital assessments are BP 188/115, HR 72, O2 99.  Ct. appears calm.  Client  verbalized that she was just given a  new prescription for HTN med but had not started and had been monitoring her BP for a week.  Ct. advised to notify MD of finding and cleared to go home by EMT.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache for 6+ hours until went to sleep
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Nausea
Clinical narrative: Chills Body aches Sore joints Fever 100.5F Nausea Fatigue Brain fog Lasted 48 hours
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Chills Body aches Sore joints Fever 100.5F Nausea Fatigue Brain fog Lasted 48 hours
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Chills, arm pain, slight headache but only lasted a few hours - less than 24 hours
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain
Clinical narrative: Soreness at injection site.  Fatigue Body aches Chills  Only took ibuprofen   Rested   Symptoms lasted about 18hrs
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, uninterrupted hissing on the right side
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort
Clinical narrative: Significant full facial/sinus pressure. No visible swelling. Sudafed and ibuprofen did not alleviate symptoms. Claritin helped. Symptoms resolved in 24 hours.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Very mild tinnitus worsened drastically a day or two after the 2nd dose. It occurred a day or so after 2nd vaccine. Don't know if there was any increase after 1st dose but if so, not significant.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Client states she became dizzy after receiving the vaccine. Fire Rescue at scene to evaluate patient.  Client cleared to leave @ 12:30pm.  Per Fire Rescue no further evaluation needed.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeding disorder, Headache, Pyrexia, Vomiting
Clinical narrative: On my first dose without 1 hour I experienced chills within three hours I experienced headaches and the high grade fever also unable to eat and when I did I vomited the following day midday I started to feel better and as of this report no side effects. However I?m concerned about taking the second dose
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Mild, Additional Details: Pt recovered. Fire dept called. Pt declined care of paramedics and returned home with boyfriend.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, Neck pain, Pain in extremity
Clinical narrative: Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermometer), throbbing pain in left arm traveling to neck.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermometer), throbbing pain in left arm traveling to neck.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nasopharyngitis, Nausea
Clinical narrative: Body Aches, Headache, Cold Symptoms, Chills, Loss of appetite , nausea
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body Aches, Headache, Cold Symptoms, Chills, Loss of appetite , nausea
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19 immunisation, Death
Clinical narrative: Unknown.  Decedent died several days after receiving COVID-19 vaccine (unknown manufacturer).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Hyperhidrosis, Nausea, Pain
Clinical narrative: Severe nausea and body aches. Fever with sweating and chills. Metallic taste in my mouth. Arm soreness. These side effects lasted for about 12 hours,
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe nausea and body aches. Fever with sweating and chills. Metallic taste in my mouth. Arm soreness. These side effects lasted for about 12 hours,
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Diarrhoea, Injection site swelling, Musculoskeletal stiffness, Neck pain
Clinical narrative: Diarrhea Swelling  at injection site Stiffness of upper arm and shoulder a little pain at lymph nodes under arm and left side of neck.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: High fever 103.7 Headache  Chills Sweating Body aches All lasted 24 hours  Fatigue -5 days
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Erythema, Fatigue, Headache
Clinical narrative: Hot, swollen very sore arm with an angry red silver dollar sized uproar within 24 hours, mostly dissipated after 3-4 days except for a 2 1/2 inch circular bruise which exists to this day. Couldn't even sleep on that arm. About 2 weeks later, joints are sore, muscles are sore, having intermittent shooting pain headaches (I never get headaches), feel run down and tired. I will NOT be getting the second dose. I was already scheduled for back surgery to occur one week after the second shot. Don't need the grief of side effects (possible even stronger, OMG) while trying to recover from surgery.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Hot, swollen very sore arm with an angry red silver dollar sized uproar within 24 hours, mostly dissipated after 3-4 days except for a 2 1/2 inch circular bruise which exists to this day. Couldn't even sleep on that arm. About 2 weeks later, joints are sore, muscles are sore, having intermittent shooting pain headaches (I never get headaches), feel run down and tired. I will NOT be getting the second dose. I was already scheduled for back surgery to occur one week after the second shot. Don't need the grief of side effects (possible even stronger, OMG) while trying to recover from surgery.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: four hours after taking shot - temperature, chills, extreme skin sensitivity, nausea, headache, overall flu like symptoms. Lasted 14 hours, and then recurring bouts of general malaise off and on for over a week.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Skin temperature
Clinical narrative: four hours after taking shot - temperature, chills, extreme skin sensitivity, nausea, headache, overall flu like symptoms. Lasted 14 hours, and then recurring bouts of general malaise off and on for over a week.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Additional Details: vagal response - fainted
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Left arm soreness, body ache
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: Red itchy irritation at injection site, no treatment needed.  It went away after two days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Fever-Medium
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: Fever, chills, body aches, headache, tiredness, lack of appetite, two patches of hives on back and chest.  Onset approximately 14 hours post-2nd dose, lasting approximately 24 hours.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever, chills, body aches, headache, tiredness, lack of appetite, two patches of hives on back and chest.  Onset approximately 14 hours post-2nd dose, lasting approximately 24 hours.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Nausea  Chills Fatigue I slept for 16 hours and woke feeling fine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included hypertension, type 2 diabetes mellitus, kidney disease, and known allergies to Penicillin and Sulfa drugs. Concomitant medications included amlodipine besylate (AMLODIPINE BESYLATE) and dulaglutide (TRULICITY); both taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 (13:00 Friday), the patient experience left side of face became numb and droopy with droopy eye lid and numb lips. The patient sought medical care; stroke was ruled out. The diagnosis was Bell's Palsy. Valacyclovir hcl 1-gram tab was prescribed. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. The event was considered serious (seriousness criteria: important medical event).  Information about lot and batch number was requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site rash, Injection site reaction
Clinical narrative: Rash, red bumps around injection site
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Systemic: Scratchy Throat-Mild
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Sleep disorder
Clinical narrative: Nightly Lucid Dreams, disrupted sleep.  1-2 dreams per night, and usually awaken by the end of the dream.  No other reaction whatsoever to the vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: headache   sore arm   stiff neck    tired
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension (BP 88/73, HR 91), Amnesia? Did not remember what occured.-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Pt was layed on floor and feet elevated. BP during incident was 88/73, HR was 91. Pt recovered briefly after, but did not remember what happened.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: pt waited 15 minutes after vaccination and 30 minutes after receiving vaccine pt passed out driving home
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: large body rash, extreme itching affecting back, hands, thighs, ears, scalp, legs etc.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Fever (101) started at 1:22 AM 3/31/2021 and did not break until about mid morning.  Also had severe headache until approximately 9 PM 3/31/2021.  Pain in joints (especially in both hips) until approximately 6 PM 3/31/2021.  Nausea and light headed until 4/1/2021 morning.  Very tired (slept all day on 3/31/2021).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (101) started at 1:22 AM 3/31/2021 and did not break until about mid morning.  Also had severe headache until approximately 9 PM 3/31/2021.  Pain in joints (especially in both hips) until approximately 6 PM 3/31/2021.  Nausea and light headed until 4/1/2021 morning.  Very tired (slept all day on 3/31/2021).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Hypertension, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Hypertension-Severe
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Throat tightness
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Hypertension-Severe
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Acute vertigo lasting for three days with some lessening after 3 days but but normal activity has not resumed. It is not accompanied by tinnitus or hearing loss.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Arm where vaccine was given began to show a red slightly swollen outline around the vaccine site 8 days after vaccination. Redness and outline disappeared as the day went on but swelling and slight soreness was present on day 9
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle tightness, Pain
Clinical narrative: Started out as severe tension in neck then came home . I was feeling very tired. Went to bed at 10 pm and woke up at 2 am with full body aches. I had no temperature but mild chills
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Head/skull ache; nausea; diarrhea;  body weakness; chills;  low grad temp;  shortness of breathe.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Head/skull ache; nausea; diarrhea;  body weakness; chills;  low grad temp;  shortness of breathe.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Skin exfoliation
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: all the skin peeled from hands and black spots appeared on skin, recommended follow up with physician before admin 2nd dose
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: Pain in left arm, followed by torso tremors in the night that originated in left arm and spread to full torso.  Tremors seem to have abated in the morning.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Lethargy, Malaise
Clinical narrative: Patient got their Pfizer covid-19 vaccine and during the 15 minute post vaccination waiting was noticed to be lethargic and just didn't feel right.  Upon checking vitals it was determined that the patient's blood pressure was a little high, but all other vitals were fine.  Patient still said that he didn't feel right so EMS was called and the patient was transported to Hospital for further evaluation.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted while waiting 15 minutes after vacination patient has abrasions on chhek nose and forehead from carpet where he fell patient recoved quickly  staff cleaned wounds and gave water patients wife said he was better and just wanted to go home so they left the store patient walked out on own accord
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus to left ear, same side as injection
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Nausea, Pain in extremity
Clinical narrative: Extreme arm soreness, extreme fatigue, lightheadedness, mild nausea, mild breathing difficulties overnight