chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hyperhidrosis, Hypertension, Insomnia
Clinical narrative: no appetite; can't fall asleep; have a surge of adrenaline and it is very bizarre; bad headaches; cant concentrate well; sudden inexplicable panic attack; strong waves of panic and anxiety; palpitations; brain fog; forgetfulness; chills; sweating; poor apetite; elevated resting heart rate; dry heaving; higher than normal blood pressure; This is a spontaneous report from a contactable consumer or other non-HCP. A 30-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955) via an unspecified route of administration, administered in Left Arm on 16Mar2021 12:15 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and none other medications the patient received within 2 weeks of vaccination. On 04Apr2021 14:00 the patient experienced sudden inexplicable panic attack, strong waves of panic and anxiety, palpitations, brain fog, forgetfulness, chills, sweating, poor appetite, elevated resting heart rate, dry heaving and higher than normal blood pressure. On an unspecified date the patient experienced no appetite, can't fall asleep, have a surge of adrenaline and it is very bizarre, bad headaches, cant concentrate well. No treatment received for the event. The outcome of event sudden inexplicable panic attack, strong waves of panic and anxiety, palpitations, brain fog, forgetfulness, chills, sweating, poor appetite, elevated resting heart rate, dry heaving, higher than normal blood pressure was not recovered and the outcome of event no appetite, can't fall asleep, have a surge of adrenaline and it is very bizarre, bad headaches, cant concentrate well was unknown   No follow-up attempts are needed. No further information is expected
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation abnormal, Memory impairment, Palpitations, Panic attack, Retching
Clinical narrative: no appetite; can't fall asleep; have a surge of adrenaline and it is very bizarre; bad headaches; cant concentrate well; sudden inexplicable panic attack; strong waves of panic and anxiety; palpitations; brain fog; forgetfulness; chills; sweating; poor apetite; elevated resting heart rate; dry heaving; higher than normal blood pressure; This is a spontaneous report from a contactable consumer or other non-HCP. A 30-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955) via an unspecified route of administration, administered in Left Arm on 16Mar2021 12:15 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and none other medications the patient received within 2 weeks of vaccination. On 04Apr2021 14:00 the patient experienced sudden inexplicable panic attack, strong waves of panic and anxiety, palpitations, brain fog, forgetfulness, chills, sweating, poor appetite, elevated resting heart rate, dry heaving and higher than normal blood pressure. On an unspecified date the patient experienced no appetite, can't fall asleep, have a surge of adrenaline and it is very bizarre, bad headaches, cant concentrate well. No treatment received for the event. The outcome of event sudden inexplicable panic attack, strong waves of panic and anxiety, palpitations, brain fog, forgetfulness, chills, sweating, poor appetite, elevated resting heart rate, dry heaving, higher than normal blood pressure was not recovered and the outcome of event no appetite, can't fall asleep, have a surge of adrenaline and it is very bizarre, bad headaches, cant concentrate well was unknown   No follow-up attempts are needed. No further information is expected
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: my chin & lips went numb and tingling, Like after dental Work done numb feeling.; my chin & lips went numb and tingling; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. A 34-year-old pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153) via an unspecified route of administration, administered in Arm Left on 23Apr2021 (at 34-years age) 10:45 as 1st dose, single dose for covid-19 immunization. Medical history included Chronic migraines, Known allergies: Mango, hazelnuts, gluten. Concomitant medications included ascorbic acid, calcium, colecalciferol, cyanocobalamin, folic acid, iron, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, zinc (PRENATAL S), biotin, magnesium, cetirizine hydrochloride (ZYRETIC), cyanocobalamin (B12), pyridoxine hydrochloride (B6) for within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 24Apr2021 at 22:30 PM, the patient experienced like after dental work done numb feeling, her chin & lips went numb and tingling. Patient experienced (36 hours after the vaccine) her chin & lips went numb and tingling. This went up the left side of her face then the right side of face up to her right eye. It lasted several hours. Like after dental Work done numb feeling. The mother reported she became pregnant while taking bnt162b2. The mother was 15 Weeks pregnant at the onset of the event. last menstrual date was 05Jan2021. The mother was due to deliver on 12Oct2021. Patient did not received treatment for events. The outcome of events was recovered on Apr2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient reported that on 11Apr2021 (about 4 days after the first dose), she developed COVID-19; This is a spontaneous report from Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that on 11Apr2021 (about 4 days after the first dose), she developed COVID-19. Patient was asking if it is okay for her to push through with the scheduled second dose of the Pfizer COVID-19 vaccine today (28Apr2021). The patient underwent lab tests and procedures which included COVID-19 test: positive on 11Apr2021.  Outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain in extremity, Paraesthesia, Urticaria
Clinical narrative: Outbreak, looked like hives, on her torso and stomach area, after the first vaccine:; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, Expiration date was not reported), via an unspecified route of administration on 03Mar2021 14:00 as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. On 03Mar2021, the patient experienced outbreak, looked like hives, on her torso and stomach area, with sequelae after the first dose, chills after first and second vaccine, injection site sore after first and second vaccine, Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine (Patient visited office). she would like to know about percentages in age groups who have experienced any numbness and tingling, and if there are any correlation with developing blood clots of this, and also, she wanted to know if she needs further medical attention and to prevent a serious outcome. The outcome of the event was recovered for urticaria on 21Mar2021, the outcome of chills was unknown. Vaccination site pain, Hypoaesthesia Paraesthesia was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Outbreak, looked like hives, on her torso and stomach area, after the first vaccine:; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, Expiration date was not reported), via an unspecified route of administration on 03Mar2021 14:00 as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. On 03Mar2021, the patient experienced outbreak, looked like hives, on her torso and stomach area, with sequelae after the first dose, chills after first and second vaccine, injection site sore after first and second vaccine, Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine (Patient visited office). she would like to know about percentages in age groups who have experienced any numbness and tingling, and if there are any correlation with developing blood clots of this, and also, she wanted to know if she needs further medical attention and to prevent a serious outcome. The outcome of the event was recovered for urticaria on 21Mar2021, the outcome of chills was unknown. Vaccination site pain, Hypoaesthesia Paraesthesia was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Nodule, Vaccination site bruising
Clinical narrative: Bruising/ In the area where he got he vaccine he has bruising the size of a silver dollar; The muscle to the left of the injection site would not relax; Report knot in arm; This is a spontaneous report from a contactable consumer (patient). A 38-Years-Old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number: not reported),via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation. Medical history included I get sick when the weather changes. The patient's concomitant medications were not reported. It was reported that particular side effect site 4 days ago. Bruising. Healthy.  Norovirus. Two days ago he was doing one arm lateral lifts. He can do 40.  Normally he can do that every day.  Left arm.  Muscles don't want to loosen up. 25lbs.  At the injection site. 250 lbs.  Don't need weight. Patient  haven't had a vaccine since 18 years. His body automatically adapts. He get sick when the weather changes. Report knot in arm. It was reported that when the caller was doing lateral lifts with 25 pound weights, his muscle started to ball up in that area and he has bruising at the injection site all on left side. The patient clarifies the details provided from the CEP agent. The patient was vaccinated 4 days ago, maybe 3 days ago, with his first dose of the covid vaccine. The caller was doing one arm lateral lifts with 25 pound weights, and he usually does 35 to 40 pound weights, he was taking it easy. Normally the patient can do that every day with no problem. In the area where the caller got the vaccine, he has bruising the size of a silver dollar. The muscle to the left of the injection site would not relax, the muscle now fights the caller when he tries to use it. The muscles in the patient's left arm have all relaxed, except for that one. Patient explained the effects of the vaccine. From how the patient understands it, vaccines hijack the muscle that they are in and make crowns. It could mean that its hijacking the muscle and corrupting the cells in the patient's arm muscle which is causing this but he is unsure because he is not a doctor. Patient asked is this normal for the muscle to not want to relax. How long will this last. The patient received his second dose of the covid vaccine a couple of days ago. When the patient was doing lateral lifts with 25 pound weights, his muscle started to ball up in that area and he has bruising at the injection site all on left side. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Eyelid disorder, Facial asymmetry, Grip strength decreased, Hypoaesthesia oral
Clinical narrative: Possibly/suspected bell's pulsy; inability to make full smile on the right side; Numbness in on right side of tongue; loss of grip strength in right hand; unable to fully close right eye; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: zho179), the first dose via unspecified route of administration in left arm on 08May2021 at 13:00 as single dose for COVID-19 immunisation. The relevant medical history was not reported. Concomitant medications were reported as none. On 11May2021, the patient experienced numbness in on right side of tongue, inability to make full smile on the right side, loss of grip strength in right hand. No other symptoms presented. Possibly/suspected bell's pulsy unable to fully close right eye. No treatment received for the events. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the events was not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Pfizer vaccine was given, but first dose was Moderna.  Second dose should also have been Moderna.  Therefore, this was a medication error.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, Blood lactic acid, C-reactive protein, Computerised tomogram head, Full blood count
Clinical narrative: Fevers, facial swelling   Dx: Soft tissue swelling overlying the anterior maxilla, greater towards the left, consistent with cellulitis  secondary to odontogenic infection. Abscess overlying the facial side of the left anterior maxilla at the  level of the roots of the 1st and 2nd incisors measuring 0.7 x 0.4 x 1.3 cm. 1.4 x 0.8 cm periapical  cyst of the left maxillary 1st and 2nd incisors.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Mouth cyst, Pyrexia, Swelling face
Clinical narrative: Fevers, facial swelling   Dx: Soft tissue swelling overlying the anterior maxilla, greater towards the left, consistent with cellulitis  secondary to odontogenic infection. Abscess overlying the facial side of the left anterior maxilla at the  level of the roots of the 1st and 2nd incisors measuring 0.7 x 0.4 x 1.3 cm. 1.4 x 0.8 cm periapical  cyst of the left maxillary 1st and 2nd incisors.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Depressed level of consciousness, Dizziness, Feeling cold
Clinical narrative: 2nd Moderna shot given 5/31/21 at 12:49 pm. By 1:00  pharmacy tech saw that pt. had a large, red, swollen area surrounding inj site. Pt. complained of dizziness and extremely itchy upper arm. Pt reported no difficulty breathing. Had pt lower her head while staying seated. 1:00 pm bp 131/92 pulse 76. Pt then reported increasing dizziness. Had pt. lie on floor with lower legs up resting on chair. 1:05 pm bp 142/102 pulse73. Pt's alertness was decreased compared to before shot. Called 911 around this time. 1:10 pm bp 148/101 pulse 76. Still no difficulty breathing  when asked. Then at 1:12 pm pt. complained of being cold throughout whole body. 1:14 pm pt. started to perspire. Pt. was brought a light blanket and covered. 1:15 pm pt. started to shiver. Ambulance personnel arrived, assessed pt. and transported her to e.d. shortly thereafter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: 2nd Moderna shot given 5/31/21 at 12:49 pm. By 1:00  pharmacy tech saw that pt. had a large, red, swollen area surrounding inj site. Pt. complained of dizziness and extremely itchy upper arm. Pt reported no difficulty breathing. Had pt lower her head while staying seated. 1:00 pm bp 131/92 pulse 76. Pt then reported increasing dizziness. Had pt. lie on floor with lower legs up resting on chair. 1:05 pm bp 142/102 pulse73. Pt's alertness was decreased compared to before shot. Called 911 around this time. 1:10 pm bp 148/101 pulse 76. Still no difficulty breathing  when asked. Then at 1:12 pm pt. complained of being cold throughout whole body. 1:14 pm pt. started to perspire. Pt. was brought a light blanket and covered. 1:15 pm pt. started to shiver. Ambulance personnel arrived, assessed pt. and transported her to e.d. shortly thereafter.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Chest pain, tightness
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: Day after extreme fatigue and joint pain, chills for 5 days. It has been over a month and have continued joint pain and bouts of exhaustion. I had covid and this is worse than having it.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Headache-Mild, Systemic: Joint Pain-Severe
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Headache-Mild, Systemic: Joint Pain-Severe
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Scab
Clinical narrative: First dose: breaking out with rash; itching was incredible; rash got so bad she had scabs all over; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Mar2021 (Batch/Lot Number: EN6204) as 1st dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and mini stroke. Concomitant medications included blood pressure medicine and a blood thinner. Past drug included unspecified steroids in the past, flu vaccine, pneumonia vaccine, and her shingles vaccine and never had any reaction. On an unspecified date, 2 weeks later, the patient experienced first dose: breaking out with rash, itching was incredible, and rash got so bad she had scabs all over. The patient was going through this from last 6 weeks. She has had this rash for 6 weeks. Her husband was rubbing lotion on her back and he told her she needed to go to the doctor. Her rash was causing itching so bad she had scabs everywhere. She got an appointment with her primary care doctor maybe on 12Apr2021 or 13Apr2021. She thought she might have seen her primary care twice that week. She shared her concern with her primary care doctor that this rash might be because of the Covid 19 vaccine. Her doctor told her she didn't think it was caused by the Covid 19 vaccine. Her primary care doctor put her on steroids and the rash wasn't improving so she was sent to the dermatologist and was put on another round of steroids. Being on the steroids for so long made her crazy. She's taken steroids in the past but this time she was on steroids for almost a month. The first bout of steroids wasn't enough to get rid of the rash. She received second dose on 16Apr2021 (after her doctor suggested to take it) and the second vaccine accelerated the rash and made the rash even worse. She has seen her doctors, took prednisone twice and 4 different kind of creams for the rash and it was coming back again. She wanted to know how long it can last. She was on the steroids for so long she was losing her mind. She was prescribed 4 or 5 different creams. If someone could have felt her skin, she can't say it felt like leather, she can't even describe the way her skin felt. The patient had no additional vaccines administered on the same day of Pfizer vaccine. Prior Vaccinations (within 4 weeks) was none and no events following prior vaccinations. The event rash required a visit to the physician office. Outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Pruritus, Throat tightness
Clinical narrative: 3 days after my second shot I had an extremely red and swollen arm at the site and all around arm. I also had tightness of my throat and some itching. I went to the ED as it was a Saturday afternoon. I saw a PA. I don?t remember his name. He thought I was having a mild allergic reaction and said the arm was actually a ?normal ? response to Moderna.  They gave me 50 mg Benadryl and watched me for 1hr. My throat improved and I was advised to take Benadryl for the next few days.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin swelling, Urticaria
Clinical narrative: Severe hives and itching; Large areas of hive-like swelling and itching on arms, legs, hips; Large areas of hive-like swelling and itching on arms, legs, hips; This is a spontaneous report from a contactable consumer (patient reported for himself). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EWO168, expiry date not reported), via an unspecified route of administration, administered in left arm on 12May2021 12:00 (at the age of 51 years old) as second dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received the first dose of BNT162B2 for covid-19 immunization (at the age of 51 years old) on 21Apr2021 12:00 PM (lot EWO171) administered in the left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store. Patient experienced severe hives and itching began on Saturday, 15May2021 (three days after the second dose) at 08:00 AM, which were described as large areas of hive-like swelling and itching on arms, legs, hips. They have gotten worse; Benadryl provides only short-term relief. Since the vaccination, the patient has been tested for COVID-19. As per reporter, the events were not serious by the reporter (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The events were reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Swelling face, Swollen tongue
Clinical narrative: My face swelled; my tongue swelled; I couldn't feel my face or my tongue for 4 days; I couldn't feel my face or my tongue for 4 days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that they received the vaccine on 21Apr2021 and her husband was fine; her on the other hand, her face swelled, her tongue swelled she couldn't feel her face or her tongue for 4 days and they were swollen for four days from an unspecified date. She reported it to the pharmacy where she had the shot at, all they told her was to go to the hospital, she don't have the insurance she can't go to the hospital. They sent her a notification that she need to come and get the second one and she didn't go because she was afraid that the reaction could be worst. The patient did not recover from the events.  Information on lot/batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: moderate pain in left arm following first injection; This is a spontaneous report from the contactable nurses.  An 86-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular administered on arm left on 03Mar2021 11:00 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE for COVID-19 immunization at the urgent care facility.  Ongoing medical history included cerebrovascular disease, dementia, essential hypertension, type II diabetes mellitus (DM), constipation and pain. Concomitant medications included senna acutifolia (SENNA ACUTIFOLIA) taken for constipation from an unspecified start date and ongoing; acetylsalicylic acid [ASPIRIN (E.C.)] taken for cerebrovascular accident (also reported as decrease stroke risk) from an unspecified start date and ongoing; glimepiride (GLIMEPIRIDE) taken for type 2 diabetes mellitus from an unspecified start date and ongoing; ibuprofen (IBUPROFEN) taken for pain from an unspecified start date and ongoing; and losartan (LOSARTAN), amlodipine (AMLODIPINE), and metoprolol succinate (METOPROLOL SUCCINATE) all three taken for blood pressure/essential hypertension from unknown dates. On 03Mar2021 11:00, the patient had moderate pain in left arm following first injection. The event was considered as serious (life threatening and persistent/ significant disability/ incapacity). Outcome of the event was not recovered.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported vaccination site pain.  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  Committees and Investigators, as appropriate.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Enterocolitis haemorrhagic, Hypoaesthesia, Influenza like illness, Irritable bowel syndrome
Clinical narrative: Doctors are suspecting I might have mucous or blood colitis, we are just not sure; Hands, both right-left hand and wrist, right-left foot and ankles and toes, heels, right-left knees are numb; Burning sensation; Doctors are suspecting I might have mucous or blood colitis, we are just not sure; Shooting pain like flu; This is spontaneous report from contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, (patient not sure if it's right arm or left arm) on 13Mar2021 (Batch/Lot Number: EP7534) as 1ST DOSE, SINGLE, for covid-19 immunisation. The patient took the second dose on 04Apr2021 (Batch/Lot Number: ER8732). The patient medical history and concomitant medications were not reported. The patient stated that "I wanted to report about suspected side effects to covid-19 shot. I'm not sure if it's the Covid-19 shot or not or has to do with it but I wanted it to be documented may there's some coincidence, you can tell me about. All extremities hands, both right-left hand and wrist, right-left foot and ankles and toes, heels, right-left knees are numb. Burning sensation, shooting pain kind of like flu but no body temperature change, body temperature is 97.7 down there, it's been occurring now past my 2nd shot." The patient later corrected it as," It's 5-10 days after the 1st shot." When paraphrased, the consumer stated," I've got a number of doctors working on trying to figure out what's wrong with me. So, if we cannot find anymore answers then I'm sure, I'll contact Pfizer. I don't know if it has anything to do with the shot or not, I don't even know if the side-effects are from Pfizer or not. Doctors are suspecting I might have mucous or blood colitis, we are just not sure." When asked for the anatomical Site of administration of Vaccine: The patient stated, "I'm not sure if it's my right arm or left arm." For the event start date: patient stated, "18 or 19 June, somewhere around there. I am not sure. (pending clarification)" The patient also added: "Do you guys also report to VAERS? I don't know my physician asked to say, if you guys report to VAERS, otherwise I should call VAERS and report my symptoms." The outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, SARS-CoV-2 antibody test
Clinical narrative: immunocompromised.; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (her mother) who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date at UNKNOWN SINGLE DOSE and then at unknown date via an unspecified route of administration at UNKNOWN SINGLE DOSE both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient received both doses of the Pfizer Covid vaccine and she did not have any antibodies. She stated that her mother was immunocompromised. The laboratory data included SARS-COV-2 Antibody test negative on an unknown date.  Outcome of the event was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Rhinorrhoea
Clinical narrative: very serious headache; Really bad runny nose; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration on 15May2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took First Dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiration date: 31Jul2021) on 24Apr2021 for Covid-19 immunisation. Patient experienced runny nose on16may2021. On 18may2021, he had headache and next morning wake up with more serious headache (very serious headache). The outcome of the event was unknown.   Follow attempts are needed; information about lot/batch number cannot be obtained.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Seizure
Clinical narrative: 11-year-old male patient received BNT162B2; 11-year-old male patient received BNT162B2; My son had a seizure 4 hours after receiving his first dose of the Pfizer vaccine.; This is a spontaneous report from a non-contactable consumer (patient's father). An 11-year-old male patient (reporter's son) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 17May2021 03:00 PM (at the age of 11-year-old) as 1st dose, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient's father stated that his son had a seizure 4 hours after receiving his first dose of the Pfizer vaccine (onset date also reported as 17May2021 20:30). The event resulted in emergency room/department or urgent care visit. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved for "seizure" and unknown for the other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, SARS-CoV-2 test, Weight
Clinical narrative: blood sugar spiked/blood sugar went up; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 03Apr2021 (at the age of 52-year-old), as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included heart surgery on unknown date of 2010, covid-19 on 24Apr2020, cardiac rheumatism, feel agitated on unknown date of Apr2020 and spent 15 days in the hospital from unknown date of Apr2020 to unknown date of May2020. The patient's concomitant medications were not reported. The patient past drug included Oxygen from unknown date of Apr2020 to unknown date of Apr2020. The patient experienced blood sugar spiked/blood sugar went up on an unspecified date. The patient stated that she received both doses of Pfizer Covid vaccine and after her first dose she noticed that her blood sugar spiked but she handled it with insulin. Stated that she had open heart surgery in 2010. Stated that she had Covid last year and feels the same now (feel agitated like when I had Covid). Stated that she came back negative. Stated that she had Covid on 24Apr2020 and she spent 15 days in the hospital and was left at home with oxygen for one month. Stated when she had Covid was 209 and she has lost 30 pounds. Clarified that she lost weight before the vaccine and she lost weight and was at 186. Stated that she had the first dose on 03Apr2021. Stated that she was at 111 before the first dose and at 287 at 9pm. Stated there was not that much discomfort with the first shot. The seriousness criteria of the event were reported as serious (medically significant) by the reporter. The patient underwent lab tests and procedures which included glucose test: I am fine and COVID test: negative on unspecified date. Therapeutic measures were taken as a result of blood sugar spiked/blood sugar went up (blood glucose increased). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Headache, Hepatic failure, Pain, Pain in extremity
Clinical narrative: Joint Pain, 2-3x worse than her normal joint pain, her arthritis is noticeably worse, knees, lower back, large joints, and her hands are the worst; Left arm instantly hurt the second she got it, it hurt before she even got out of the parking lot.; Fever; Headache; Liver Failure; Body Aches; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164; Expiration Date: 31Aug2021) via an unspecified route of administration in left arm in Apr2021, as single dose for COVID-19 immunization. Medical history included Cushing's syndrome from 2007 to ongoing, Adrenalectomy (Right) in Dec2007, ongoing Osteoarthritis (joint pain), hypersensitive to chemicals, ongoing Arthritis (joint pain), short memory. Concomitant medications were not reported. Prior Vaccinations (within 4 weeks) were None. Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021) in right arm in 2021 (at age of 53-year-old) for COVID-19 immunization and also took avalox and experienced tachycardia which almost killed her (years ago). Patient stated after the second shot she had fever, body aches, headache and all the list of horrible side effects for 2 days all in Apr2021. Left arm instantly hurt the second she got it in Apr2021, it hurt before she even got out of the parking lot. Patient states what has not subsided was the joint pain. Patient states she had arthritis, Osteoarthritis caused by her Cushing's Syndrome. Patient states her medications that she uses to manage her arthritis are not stopping the joint pain. Patient stated her joint pain was 2-3x worse than her normal joint pain and also bad as it was before the vaccine and her arthritis was noticeably worse, knees, lower back, large joints, and her hands are the worst and her hands and she usually doesn't feel it much in her hands. Patient states she tested and tested to see if it was the weather and no it wasn't her joints are significantly worse and her usual treatment isn't very effective. States she was pretty sure it was from the vaccine. Patient states anyhow, she reported that her joint pain was worse after having Covid. Patient states the achiness and pain in her joints lasted and never got better, her pain was 2-3x what she was normally used to and the medicine was not making a dent in the pain level. Treatments were Occasional Tylenol. CBD (cannabidiol) and THC (tetrahydrocannabinol), but they are not working. Patient stated she rarely takes Tylenol in case of Liver Failure in Apr2021. Patient states her body rejects chemicals and she has to eat organic food. The outcome of event liver failure was unknown, joint pain and arthritis aggravated were not recovered, while remaining events were recovered in 2021.   Batch/Lot number was obtained. Further information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Joint Pain, 2-3x worse than her normal joint pain, her arthritis is noticeably worse, knees, lower back, large joints, and her hands are the worst; Left arm instantly hurt the second she got it, it hurt before she even got out of the parking lot.; Fever; Headache; Liver Failure; Body Aches; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164; Expiration Date: 31Aug2021) via an unspecified route of administration in left arm in Apr2021, as single dose for COVID-19 immunization. Medical history included Cushing's syndrome from 2007 to ongoing, Adrenalectomy (Right) in Dec2007, ongoing Osteoarthritis (joint pain), hypersensitive to chemicals, ongoing Arthritis (joint pain), short memory. Concomitant medications were not reported. Prior Vaccinations (within 4 weeks) were None. Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021) in right arm in 2021 (at age of 53-year-old) for COVID-19 immunization and also took avalox and experienced tachycardia which almost killed her (years ago). Patient stated after the second shot she had fever, body aches, headache and all the list of horrible side effects for 2 days all in Apr2021. Left arm instantly hurt the second she got it in Apr2021, it hurt before she even got out of the parking lot. Patient states what has not subsided was the joint pain. Patient states she had arthritis, Osteoarthritis caused by her Cushing's Syndrome. Patient states her medications that she uses to manage her arthritis are not stopping the joint pain. Patient stated her joint pain was 2-3x worse than her normal joint pain and also bad as it was before the vaccine and her arthritis was noticeably worse, knees, lower back, large joints, and her hands are the worst and her hands and she usually doesn't feel it much in her hands. Patient states she tested and tested to see if it was the weather and no it wasn't her joints are significantly worse and her usual treatment isn't very effective. States she was pretty sure it was from the vaccine. Patient states anyhow, she reported that her joint pain was worse after having Covid. Patient states the achiness and pain in her joints lasted and never got better, her pain was 2-3x what she was normally used to and the medicine was not making a dent in the pain level. Treatments were Occasional Tylenol. CBD (cannabidiol) and THC (tetrahydrocannabinol), but they are not working. Patient stated she rarely takes Tylenol in case of Liver Failure in Apr2021. Patient states her body rejects chemicals and she has to eat organic food. The outcome of event liver failure was unknown, joint pain and arthritis aggravated were not recovered, while remaining events were recovered in 2021.   Batch/Lot number was obtained. Further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage, Haemorrhage
Clinical narrative: major bleed; GI bleed; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of 77-year-old) (Lot Number: EN6200) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included first time she experienced bleeding was in 2013 because of aspirin. Stated that she decided it was a good idea to take baby aspirin so she took it on her own. She was told don't ever take aspirin ever again and she didn't have any problem until Nov2020. That was the first incident, in 2013, that told her she should not take blood thinner. They took her off the blood thinner in Nov2020. She had been taking aspirin. She lost half her blood; she lost it two settings. She sat down to take a bowel movement and was told she lost half of her blood. Not sure when she started Aspirin but she stopped it in 2013. It was mentioned that she could take aspirin. She was on a low dose of Eliquis for atrial fibrillation for prevention of a blood clots or heart attack.  she had bleeding in the last year. The one that was the most was back in Nov2020; it was more pronounced. Mentioned that she went in on 12Nov2020 for the bleeding and then had to go back in because her legs were swelling. She stopped taking Eliquis in Nov2020 and from then until Apr2021 she had no bleeding. It was several years ago when she was diagnosed. She was riding her bike in the neighborhood, and felt too tired so she stopped at the doctor and went in and told them she felt weird, they couldn't get her BP and took her to the hospital and her heart rate was sky high like 250. They said she might had to have electric. She didn't have any pain but states she was psychologically freaked out by everyone running around. Mentioned that, she was first placed on dronedarone (MULTAQ) 400mg twice daily to treat her atrial fibrillation; she can't remember the year. After taking it as prescribed for some time she got atrial fibrillation again. She was told by the doctor it had lost its efficacy. Concomitant medications included Fenofibrate taken for blood cholesterol, Metoprolol succinate taken for blood pressure, Vitamins NOS, Ferrous Sulfate taken for anemia, Vitamin D3 all are ongoing. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EL3246) on 06Feb2021 in arm left for covid-19 immunization. It was reported that, On 25Feb2021 she received her second dose of the Pfizer-BioNtech Covid-19 vaccine, on 19Apr2021 she had a major bleed and GI bleed (Hospitalization) on 19Apr2021. The patient was hospitalized for major bleed and GI bleed from 19Apr2021 to 21Apr2021. Outcome of the events was unknown.  No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Pulmonary embolism/ two large blood clots, one in each lung; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on an unspecified date (Lot Number: EP6955) as single dose for COVID-19 immunisation.  Medical history included high blood pressure and cholesterol abnormal, both from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19.  The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 28Feb2021 at 08:00 (Lot Number: EN6202) as single dose for COVID-19 immunization. On 29Apr2021 at 07:00, roughly one month after second dose of vaccine, the patient couldn't breathe, sweating profusely, accelerated heart rate and chest tightness. He was diagnosed with a pulmonary embolism. He had two large blood clots, one in each lung. The events were serious, it required emergency surgery to save his life. The patient spent 2 days in ICU (Intensive Care Unit) and 3 additional days in the hospital. The doctors told to the patient that they had never seen blood clots like those and that large. The patient reported that he is now on blood thinners. The patient outcome of the event was recovering.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood pressure increased, Chest discomfort, Dyspnoea, Heart rate increased
Clinical narrative: Pulmonary embolism/ two large blood clots, one in each lung; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on an unspecified date (Lot Number: EP6955) as single dose for COVID-19 immunisation.  Medical history included high blood pressure and cholesterol abnormal, both from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19.  The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 28Feb2021 at 08:00 (Lot Number: EN6202) as single dose for COVID-19 immunization. On 29Apr2021 at 07:00, roughly one month after second dose of vaccine, the patient couldn't breathe, sweating profusely, accelerated heart rate and chest tightness. He was diagnosed with a pulmonary embolism. He had two large blood clots, one in each lung. The events were serious, it required emergency surgery to save his life. The patient spent 2 days in ICU (Intensive Care Unit) and 3 additional days in the hospital. The doctors told to the patient that they had never seen blood clots like those and that large. The patient reported that he is now on blood thinners. The patient outcome of the event was recovering.