chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Memory impairment
Clinical narrative: she can't focus, getting forgetful and she feels its a side effect from the vaccine.; she can't focus, getting forgetful and she feels its a side effect from the vaccine; This is a spontaneous report from a contactable consumer via medical information team. A female patient (Reporter's friend) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter's friend got the vaccine too. She was fine but now she said she could not focus, getting forgetful on an unspecified date and she feels it was a side effect from the vaccine. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Head discomfort, Headache, Hypoaesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient reported numbness occuring from cheeck bone upward to the head, pain radiating from the left arm to the knee on the same side with the injection. feeling heavy on the head and fatigue overall. pt reported these symptoms have improved a bit.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient reported numbness occuring from cheeck bone upward to the head, pain radiating from the left arm to the knee on the same side with the injection. feeling heavy on the head and fatigue overall. pt reported these symptoms have improved a bit.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: she said she had mild scratchiness, slight swelling of tongue previously w the 2nd covid vaccine, which went away w benadryl without further issues. same happened again this morning, pt was not concerned and wanted Moderna. after 5 minutes, slight swelling of tongue, gave her 2 tablets of 25mg Benadryl, feeling better right away, totally fine after the 30 min wait time. called her again in the evening and she said she is perfectly fine.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Injection site pain, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt passed out fell on the floor face down paramedics took the pt to the hospital
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test, Upper-airway cough syndrome, Wheezing
Clinical narrative: Cough, Wheezing, Post Nasal Drip,
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Gout, Magnetic resonance imaging, Musculoskeletal stiffness
Clinical narrative: Stiff left leg. Initially in able to walk.  Seemed lije gout.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Period started 7 days early, after second vaccine. My period is extremely regular. I had my first covid vaccine 12 weeks ago and it started early then too and then went back to being regular.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 1st shot. Itchy bumps on arms and hands.  2nd shot. Hives  Treatment, after 2nd shot. 24hour non drowsy antihistamine for 1 day. I still have hives. Going to take it again today.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye swelling, Mouth swelling, Pharyngeal swelling, Swelling face
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: throat felt itchy/swollen; benadryl resolved feeling
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: throat felt itchy/swollen; benadryl resolved feeling
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pruritus, Musculoskeletal stiffness, Myalgia
Clinical narrative: Headache, muscle aches first 3 days after the shot  8 days after shot my arm started hurting really bad it was swollen, day 9 woke up with a round  red circle at injection site and it was very stiff and itchy
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Headache, muscle aches first 3 days after the shot  8 days after shot my arm started hurting really bad it was swollen, day 9 woke up with a round  red circle at injection site and it was very stiff and itchy
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli, Vision blurred
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving vaccine, she was still seated. Pharmacist and pharmacy tech sat with patient while dad got her a drink. Once she was awake she remembered what happened, said her vision was still a bit blurry. Pharmacist and dad sat with her. She laid down and after a few minutes she felt back to normal and could see clearly. Patient & dad declined BP reading. Stated she was nervous previous to shot and this has happened with other immunizations/procedures in the past.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Hypotension, Syncope
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Additional Details: Fainted and lost consciousness for 1 minute, woke up and came to confused.  was given water, blood pressure measured and monitored.  eventually felt fine enough to go home.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cluster headache, Heart rate increased, Myalgia
Clinical narrative: 9 hours after the shot I began to experience extreme chills, extremeties (hands and toes where ice cold).  Approximately 12 hours after the shot, I woke up with a heart rate 130-140s, with a sensation that my heart was going to cut down into my chest.  I had a fever of 102.1.  After vagal maneuvers I was able to bring my heart rate down to 70-80s which still lasted for a couple hours.  The sad thing is that my resting heart rate walking around is 50-52 bpm, and I've never experience anything like this before in my life.  I'm sure I've now induced some myocarditis.  Upon waking this morning 16 hours after the shot, I have an extreme cluster headache with difficulty looking forward with my vision and severe muscle aches as if I've worked out for hours at a time.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Peripheral coldness, Pyrexia, Visual impairment
Clinical narrative: 9 hours after the shot I began to experience extreme chills, extremeties (hands and toes where ice cold).  Approximately 12 hours after the shot, I woke up with a heart rate 130-140s, with a sensation that my heart was going to cut down into my chest.  I had a fever of 102.1.  After vagal maneuvers I was able to bring my heart rate down to 70-80s which still lasted for a couple hours.  The sad thing is that my resting heart rate walking around is 50-52 bpm, and I've never experience anything like this before in my life.  I'm sure I've now induced some myocarditis.  Upon waking this morning 16 hours after the shot, I have an extreme cluster headache with difficulty looking forward with my vision and severe muscle aches as if I've worked out for hours at a time.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Syncope, she passed out almost immediately upon receiving the injection. She?s never passed out before.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in the right lower leg, approximately midway between the knee and the ankle (but not affecting either joint) lasting about 10 seconds at a time, and occurring at varying intervals.  Intervals can be as short as 2 and a half minutes, and as long as several hours.  When the intervals are short, the pain is relatively intense and can feel like the bone is breaking.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: ABOUT 6 HOURS AFTER RECEIVING SHOT MY LEFT ARM WAS SLIGHTLY SORE BUT NOT BAD. iT WAS SORER THE NEXT MORNING BY ABOUT DOUBLE, BUT STILL NOT EXCRUTIATING. JUST MADE IT DIFFICULT TO RAISE MY ARM OVER MY HEAD TO REMOVE MY T-SHIRT. BY THE MORNING OF THE 2ND DAY (~42 HOURS AFTER GETTING THE SHOT) THE ARM WAS ONLY MILDLY SORE BY ABOUT HALF AND RAISING MY ARM WAS NOT BIG DEAL. NO HEADACHES LIKE I HAD AFTER THE FIRST OR SECOND DOSE JUST OVER 6 MONTHS EARLIER.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram abnormal, Anticoagulant therapy, Chest pain, Computerised tomogram thorax abnormal, Deep vein thrombosis
Clinical narrative: Patient presented with 1 week of chest pain, hemoptysis, and worsening dyspnea and pain w/ inspiration over the past week. Found to have extensive occlusive DVT within the left common femoral, femoral, popliteal and posterior tibial veins on US Duplex and Acute bilateral pulmonary embolism with moderate to large amount of clot burden with suggestion of mild right heart strain. Pt had no personal history or family history of prior venous embolisms or clotting disorders. Pt was healthy and active with no inciting factors save for the J&J covid-19 vaccine. pt was admitted to the hospital and started on a heparin gtt with further workup pending.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Haemoptysis, Myocardial strain, Painful respiration, Pulmonary embolism
Clinical narrative: Patient presented with 1 week of chest pain, hemoptysis, and worsening dyspnea and pain w/ inspiration over the past week. Found to have extensive occlusive DVT within the left common femoral, femoral, popliteal and posterior tibial veins on US Duplex and Acute bilateral pulmonary embolism with moderate to large amount of clot burden with suggestion of mild right heart strain. Pt had no personal history or family history of prior venous embolisms or clotting disorders. Pt was healthy and active with no inciting factors save for the J&J covid-19 vaccine. pt was admitted to the hospital and started on a heparin gtt with further workup pending.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: Patient presented with 1 week of chest pain, hemoptysis, and worsening dyspnea and pain w/ inspiration over the past week. Found to have extensive occlusive DVT within the left common femoral, femoral, popliteal and posterior tibial veins on US Duplex and Acute bilateral pulmonary embolism with moderate to large amount of clot burden with suggestion of mild right heart strain. Pt had no personal history or family history of prior venous embolisms or clotting disorders. Pt was healthy and active with no inciting factors save for the J&J covid-19 vaccine. pt was admitted to the hospital and started on a heparin gtt with further workup pending.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Hypertension, Rash
Clinical narrative: Double vision,high blood pressure,bad rash
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Disturbance in attention, Impaired work ability, Loss of personal independence in daily activities, Sleep disorder, Stress
Clinical narrative: Ringing in ears noticed 2 days after 1st dose. It is always there, making it harder to concentrate and have trouble sleeping. Lack of sleep has affected my stress level and ability to perform my job and do chores at home. I have reported the progression of this on the V-SAFE site that has been sending me questionnaire since getting shot. I also reported it to my doctor during routine physical. I have not gotten a response for help with this condition. This was not mentioned as a possible side effect of vaccine, but was known to be a potential side effect. I had no other side effects. I have recently quit my job due to stress, so I no longer have healthcare.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears noticed 2 days after 1st dose. It is always there, making it harder to concentrate and have trouble sleeping. Lack of sleep has affected my stress level and ability to perform my job and do chores at home. I have reported the progression of this on the V-SAFE site that has been sending me questionnaire since getting shot. I also reported it to my doctor during routine physical. I have not gotten a response for help with this condition. This was not mentioned as a possible side effect of vaccine, but was known to be a potential side effect. I had no other side effects. I have recently quit my job due to stress, so I no longer have healthcare.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Affective disorder, Insomnia, Tinnitus
Clinical narrative: Ringing in ears noticed 2 days after 1st dose. It is always there, making it harder to concentrate and have trouble sleeping. Lack of sleep has affected my stress level and ability to perform my job and do chores at home. I have reported the progression of this on the V-SAFE site that has been sending me questionnaire since getting shot. I also reported it to my doctor during routine physical. I have not gotten a response for help with this condition. This was not mentioned as a possible side effect of vaccine, but was known to be a potential side effect. I had no other side effects. I have recently quit my job due to stress, so I no longer have healthcare.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anger, Disturbance in attention, Initial insomnia, Insomnia, Tinnitus
Clinical narrative: Ringing in ears noticed 2 days after 1st dose. It is always there, making it harder to concentrate and have trouble sleeping. Lack of sleep has affected my stress level and ability to perform my job and do chores at home. I have reported the progression of this on the V-SAFE site that has been sending me questionnaire since getting shot. I also reported it to my doctor during routine physical. I have not gotten a response for help with this condition. This was not mentioned as a possible side effect of vaccine, but was known to be a potential side effect. I had no other side effects. I have recently quit my job due to stress, so I no longer have healthcare.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash on arm where shot was injected
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Breakthrough menstruation bleeding
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: Oral ulcer inside bottom lip 3 days after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Jul2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included adenoids removed as child and C-section 9 years ago. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid; herbal nos; levoglutamide; lysine; magnesium; manganese; retinol; riboflavin; selenium; tocopherol; zinc (AIRBORNE), clonazepam (ZICAM),  colecalciferol (VIT D3), one a day womens vitamin (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. On 27Jul2021 at 12:00, 3 days after vaccine, the patient experienced oral ulcer inside bottom lip. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event oral ulcer inside bottom lip was not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Limb injury, Syncope, Vaccination site reaction
Clinical narrative: she could feel it moving down, like her arm and into my hand; she was having a reaction; I could feel it moving down, like my arm and into my hand and then I fainted; I felt like a warmth moving through my arm; my hand was punched and I was not able to like open it; This is a spontaneous report from a contactable consumer (Patient). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Age at vaccination 36 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 23Jul2021, patient received her first dose of vaccine few days ago, since she got it she felt like a warmth moving through her arm. They were like, she was good to go. She started walking and she did, she had fainted before from needle. So, she was like she was gonna sit down. She sat down and she could feel it moving down, like her arm and into my hand and then she fainted. Whenever she came to, they brought her an ice pack and her hand was punched and she was not able to like open it. She had used her other hand to open the one hand which was the hand that she received the shot in that arm and they were kind of concerned at first when they thought she was having a reaction. They asked all the questions, and everything seem to be okay, they said that they were going to report it but then she should check all before she get second dose. Outcome of events was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Migraine, Pain in jaw, SARS-CoV-2 test
Clinical narrative: really bad headache; jaw painful; It is a little sore in the back; migraines; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA7484), via an unspecified route on 26Jul2021 at 11:40 (at the age of 48-years) as dose 1, 0.3 ml single in the left arm for covid-19 immunisation. The patient medical history included Covid-19 on 11May2021 and migraines, allergies, nasal congestion, allergy and sinus from an unknown date and unknown if ongoing. The patient concomitant medications included fluticasone propionate (FLONASE), Azelastine for allergy and sinus, loratadine 10 mg, 1x/day for antiallergic therapy, Xylometazoline hydrochloride (SUDAFED) 30 mg as needed for nasal decongestant. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jul2021, the patient experienced really bad headache, jaw painful, little sore in the back and migraines. Reporter stated that really bad headache started early in the evening. States that it was not as bad now but was now towards the back. The jaw is still hurting and it started the same time as the headache. It was a little sore in the back. It had gotten a little better. Patient took Ibuprofen 800 and took Maxalt, that she takes for migraines. She does get migraines, it felt like that, but with the jaw pain, it was a little bit worse. She takes allergy medicines and does not know if that contributed at all. She takes all of these every day for allergies when they are really bad in the summer. The patient did not visited to emergency room or physician office. She had just been self medicating. The outcome of the events was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Barium swallow, Blood cholesterol, Blood test, Cardiac monitoring, Chest X-ray
Clinical narrative: pounding heart; trembling/shaking; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 31Mar2021 (at the age of 75 years) (Batch/Lot number unknown, reported as ER87(9 or 3)0) as a single dose for COVID-19 immunization. Medical history included ongoing discoid lupus, ongoing blood pressure high, ongoing spondylosis, ongoing allergies, ongoing diverticulitis, ongoing pre-diabetic, ongoing collapsed mitral valve and in 2019 she became diabetic, but when she went back to her doctor it had gone down so she is now back to pre-diabetes. On prior vaccinations (within 4 weeks), it was reported that the patient had a yearly physical on 03Mar2021, and patient was unsure as to whether or not she received a flu shot at that appointment. AEs following prior vaccinations was reported as nothing other than pains or a slight headache when she gets the flu shot and it really made her feel bad. Reporter thinks she took a Tylenol when she got home on 03Mar2021. Concomitant medication included cyanocobalamin (VITAMIN B12). No additional vaccines administered on same date of the Pfizer suspect. Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 10Mar2021 13:10 (lot number: EN6207) in the right arm and the glands in the patient's neck were swollen 4 days later, woke up racing and pounding heart on the morning of day 5, and has had that ever since. Patient also experienced having acid problems with gas, tightness in her chest, and little problem with reflux. Patient had been to the ER multiple times and she was told that it was not a side effect of the vaccine. Patient was hospitalized and put on monitor, had tests, etc, and found nothing wrong. After the second vaccination, the patient experienced pounding heart, shaking, and trembling. The event pounding heart was reported as serious with seriousness criteria: caused/prolonged hospitalization. Heart racing and pounding required a visit to the emergency room and physician office. Lab tests included heart monitor: nothing wrong, barium test: only saw a little problem with reflux (after the first dose), taking a lot of blood, EKG, and chest x-ray. Most of these tests occurred while she was in the hospital. After she was discharged and she was still having problems, she went back to her doctor's office to complain of the same things, so they did an EKG in the doctor's office, and it was fine; said she was not having a heart attack. Her doctor also told her that her cholesterol is excellent. Patient is having an upper GI on 10Aug2021 to see if it's coming from her stomach and is having a sleep study on the fifth of next month. Outcome of the events was not recovered.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations, Physical examination, Tremor
Clinical narrative: pounding heart; trembling/shaking; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 31Mar2021 (at the age of 75 years) (Batch/Lot number unknown, reported as ER87(9 or 3)0) as a single dose for COVID-19 immunization. Medical history included ongoing discoid lupus, ongoing blood pressure high, ongoing spondylosis, ongoing allergies, ongoing diverticulitis, ongoing pre-diabetic, ongoing collapsed mitral valve and in 2019 she became diabetic, but when she went back to her doctor it had gone down so she is now back to pre-diabetes. On prior vaccinations (within 4 weeks), it was reported that the patient had a yearly physical on 03Mar2021, and patient was unsure as to whether or not she received a flu shot at that appointment. AEs following prior vaccinations was reported as nothing other than pains or a slight headache when she gets the flu shot and it really made her feel bad. Reporter thinks she took a Tylenol when she got home on 03Mar2021. Concomitant medication included cyanocobalamin (VITAMIN B12). No additional vaccines administered on same date of the Pfizer suspect. Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 10Mar2021 13:10 (lot number: EN6207) in the right arm and the glands in the patient's neck were swollen 4 days later, woke up racing and pounding heart on the morning of day 5, and has had that ever since. Patient also experienced having acid problems with gas, tightness in her chest, and little problem with reflux. Patient had been to the ER multiple times and she was told that it was not a side effect of the vaccine. Patient was hospitalized and put on monitor, had tests, etc, and found nothing wrong. After the second vaccination, the patient experienced pounding heart, shaking, and trembling. The event pounding heart was reported as serious with seriousness criteria: caused/prolonged hospitalization. Heart racing and pounding required a visit to the emergency room and physician office. Lab tests included heart monitor: nothing wrong, barium test: only saw a little problem with reflux (after the first dose), taking a lot of blood, EKG, and chest x-ray. Most of these tests occurred while she was in the hospital. After she was discharged and she was still having problems, she went back to her doctor's office to complain of the same things, so they did an EKG in the doctor's office, and it was fine; said she was not having a heart attack. Her doctor also told her that her cholesterol is excellent. Patient is having an upper GI on 10Aug2021 to see if it's coming from her stomach and is having a sleep study on the fifth of next month. Outcome of the events was not recovered.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This is a spontaneous report from a contactable consumer. A contactable consumer reported different events for 3 patients. This is one of reports. This consumer reported for 14-year-old female patient (reporter's daughter) that, A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date (at the age of 14-years-old) as a dose number unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior Vaccination within four weeks were none. The patient had arm hurt on an unspecified date. Reporter stated that, my girls all their arms hurt (Further clarification wasn't available hence split not made), but none of their neck turn back you got to understand though they are young they are 14 and 16 ok their COVID shot. No Lab Tests were done. Reporter seriousness for the events were Unspecified. The outcome of the event was unknown.  QR comment: This might be a split however it was not made by the call handler as there was no information regarding the details of the other patients.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (who was also a patient) reported for a 16-years-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported ), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm hurt on an unspecified date. The event was non-serious. The outcome of the event arm hurt was unknown. Follow-up attempts are required; information about Lot/batch number will be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Derealisation, Diarrhoea, Feeling abnormal
Clinical narrative: sense of smell was heightened; she felt an out of body experience, like she was not really present or there; a weight in her chest, it's not pain; it tore her stomach up and she had loose bowels; stomach was on the fritz/it tore her stomach up and she had loose bowels; made her feel like she had coffee and feels like she is going to go through the roof; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1,single for covid-19 immunization.The patient medical history was not reported.There were no concomitant medications.The patient experienced her sense of smell was heightened, she felt an out of body experience, like she was not really present or there,a weight in her chest, it's not pain,it tore her stomach up and she had loose bowels, made her feel like she had coffee and feels like she is going to go through the roof on an unspecified date.The outcome of the event was unknown.The caller only provided her 1st name details.Caller declined to provide a mailing address or email.Caller stated that she was a nurses aide in a nursing home.The caller stated that her son asked her to drink lots of fluids and rest and stay quiet and that is what she is doing.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: sense of smell was heightened; she felt an out of body experience, like she was not really present or there; a weight in her chest, it's not pain; it tore her stomach up and she had loose bowels; stomach was on the fritz/it tore her stomach up and she had loose bowels; made her feel like she had coffee and feels like she is going to go through the roof; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1,single for covid-19 immunization.The patient medical history was not reported.There were no concomitant medications.The patient experienced her sense of smell was heightened, she felt an out of body experience, like she was not really present or there,a weight in her chest, it's not pain,it tore her stomach up and she had loose bowels, made her feel like she had coffee and feels like she is going to go through the roof on an unspecified date.The outcome of the event was unknown.The caller only provided her 1st name details.Caller declined to provide a mailing address or email.Caller stated that she was a nurses aide in a nursing home.The caller stated that her son asked her to drink lots of fluids and rest and stay quiet and that is what she is doing.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I have a lots of pain in my hand where I received the vaccination; It is too painful; This is a spontaneous report from a contactable consumer (patient, self-reporting). A patient of unspecified age and gender received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), unknown dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included allergic to preservatives (patient cannot take preservatives). The patient concomitant medications were not reported. The patient experienced had lots of pain in hand where received the vaccination; it is too painful. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Infective tenosynovitis, Pain in extremity
Clinical narrative: tendon inflamed; 2 days later developed extreme pain my my left ankle and calve.; 2 days later developed extreme pain my my left ankle and calve.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 (58-years-old at the time of vaccination), as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ticagrelor (BRILINTA), naproxen, chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX [CHONDROITIN SULFATE; GLUCOSAMINE HYDROCHLORIDE]), vitamin b complex, vitamin c, vitamin d3, acetylsalicylic acid (ASPIRIN LOW), atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021, the patient experienced Extreme pain in my right knee and thigh. Got the 2nd shot 04mar2021 and 2 days later developed extreme pain my left ankle and calve. Pain had not left yet (at the time of report). Therapeutic measures were taken as a result of tendon inflamed, 2 days later developed extreme pain my left ankle and calve as Prednisone and tramadol. Device Date was 29Jul2021. The clinical outcome of the event tendon inflamed was recovered in 2021 with Sequel, remaining all other events were not recovered at the time of the report.  The lot number for the vaccine, (PFIZER-BIONTECH COVID-19 VACCINE) was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder
Clinical narrative: cant eat; This is a spontaneous report from a contactable consumer. A 37-years-old male patient (reporter brother) received bnt162b2 (PFIZER COVID 19, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter called his parents his brother who was not blood related and, in another state, and 37 has similar symptoms-could not eat. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Hypoaesthesia, Migraine
Clinical narrative: he had numbness in his face; Migraine was so bad/Migraine was returning after 1st dose Covid vaccine; Migraine was so bad/Migraine was returning after 1st dose Covid vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 19 years old on 01Jul2021 (Batch/Lot Number: EW0180) as dose 2, single for covid-19 immunisation. Medical history included diabetes mellitus, allergy and migraine. Concomitant medication(s) included topiramate (TOPAMAC) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 (lot number: EW0177) on 10Jun2021 for covid-19 immunisation and experienced migraine, headache and numbness in the face. On an unspecified date, the patient experienced migraine. It was stated that migraine was returning after first dose of Covid vaccine that it was so bad he had numbness in his face. The patient received Tylenol and Ibuprofen but was not helping. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for a patient received from a Pfizer sponsored program COVAX US support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Medical history included covid-19 on an unknown date. The patient's concomitant medications were not reported. The reporter stated that someone in her family who had COVID after doing what she was told to do go the second dose of the vaccine and she was sick as a dog on an unspecified date. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Illness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: she was felt like she was going to die and that she did not feel good; fever; sick; my arm is swollen big. It's really, really painful/her arm is swollen very big like something eating inside of her arm; my arm is swollen big. It's really, really painful/her left arm is very painful like someone has a knife in her arm slicing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left, on 11Apr2021 as dose 1, single, then on 03May2021 as dose 2, single, both at the age of 57-years-old, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first Pfizer Covid vaccine 11Apr2021 and had swelling in arm and fever. Her swelling went down, and she decided to get her second Pfizer Covid shot on 03May2021. Her arm was swollen very big like something eating inside of her arm. Her arm was very painful like someone has a knife in her arm slicing. She had to miss a week of work. Clarified that the pain in her left arm lasted two days and no fever with the first dose. With the second one, she was sick. She felt like she was going to die and that she did not feel good. She cannot do something with left arm. If she does something heavy that it was painful in her hand. She explained she did not know what to do because had a lot of pain in her left arm. Clarified that second shot was on 03May2021. She had fever with the second dose. It was not getting better and was getting worse. It was hurting nonstop. She did not know what to do. Clarified that the arm involved both times was her left arm. The outcome of the events was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: she was felt like she was going to die and that she did not feel good; fever; sick; my arm is swollen big. It's really, really painful/her arm is swollen very big like something eating inside of her arm; my arm is swollen big. It's really, really painful/her left arm is very painful like someone has a knife in her arm slicing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left, on 11Apr2021 as dose 1, single, then on 03May2021 as dose 2, single, both at the age of 57-years-old, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first Pfizer Covid vaccine 11Apr2021 and had swelling in arm and fever. Her swelling went down, and she decided to get her second Pfizer Covid shot on 03May2021. Her arm was swollen very big like something eating inside of her arm. Her arm was very painful like someone has a knife in her arm slicing. She had to miss a week of work. Clarified that the pain in her left arm lasted two days and no fever with the first dose. With the second one, she was sick. She felt like she was going to die and that she did not feel good. She cannot do something with left arm. If she does something heavy that it was painful in her hand. She explained she did not know what to do because had a lot of pain in her left arm. Clarified that second shot was on 03May2021. She had fever with the second dose. It was not getting better and was getting worse. It was hurting nonstop. She did not know what to do. Clarified that the arm involved both times was her left arm. The outcome of the events was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Migraine
Clinical narrative: Severe migraine daily ever since my 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Jun2021 (Batch/Lot Number: EW0180; Expiration Date: 31Aug2021) as dose 2, single for covid-19 immunisation. Medical history included migraine. The patient used to suffer from migraine, her last migraine was probably about 3 years ago. The patient's concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0178, expiry: 31Aug2021) in the left arm on 28May2021 for COVID-19 immunization. The patient got her 2nd dose of the Pfizer vaccine and she was having a very severe migraine daily ever since her 2nd dose, it was administered on 18Jun2021, and she had migraine everyday ever since. It started like on the first day (18Jun2021). For a while, she was using Tylenol. About two weeks ago, she went to the emergency room and they gave her another medication, it was the generic one Fioricet, this is just the generic one. In the beginning, the patient was using Tylenol as well as Advil, sometimes she used ibuprofen. Once she went to emergency room, she got prescription of the generic Fioricet. The patient went through blood work as well as CAT scan, they didn't give the name of that, but they were checking for all the information level, everything came back to normal. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Severe headache; Diarrhoea; sore throat; runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FAT484), via an unspecified route of administration in arm right on 29Jul2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included asthma. The patient known allergies were reported as antibiotic bactrim, pears, corn, environment allergies. The other medications in two weeks were reported as yes. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient previously took bactrim and experienced drug hypersensitivity. On 29Jul2021, the patient experienced severe headache, diarrhoea, sore throat and runny nose. The patient received no treatment for the events. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Headache, Nasal congestion
Clinical narrative: Severe headache; Diarrhoea; sore throat; runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FAT484), via an unspecified route of administration in arm right on 29Jul2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included asthma. The patient known allergies were reported as antibiotic bactrim, pears, corn, environment allergies. The other medications in two weeks were reported as yes. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient previously took bactrim and experienced drug hypersensitivity. On 29Jul2021, the patient experienced severe headache, diarrhoea, sore throat and runny nose. The patient received no treatment for the events. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Severe headache; Diarrhoea; sore throat; runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FAT484), via an unspecified route of administration in arm right on 29Jul2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included asthma. The patient known allergies were reported as antibiotic bactrim, pears, corn, environment allergies. The other medications in two weeks were reported as yes. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient previously took bactrim and experienced drug hypersensitivity. On 29Jul2021, the patient experienced severe headache, diarrhoea, sore throat and runny nose. The patient received no treatment for the events. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.