chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eye pruritus, Eye swelling, Fatigue, Headache
Clinical narrative: Eye swelling,  under eye swelling,  headaches,  fatigue, weakness,  itching around eyes, red  rash on both sides of my face,  eyelids  both swollen
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Swelling of eyelid
Clinical narrative: Eye swelling,  under eye swelling,  headaches,  fatigue, weakness,  itching around eyes, red  rash on both sides of my face,  eyelids  both swollen
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo, Vision blurred
Clinical narrative: Patient experienced dizziness, blurred vision, spinning room, etc.  Symptoms were akin to those she experienced with the flu shot.  Patient stayed all afternoon and received fluids and meclizine.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Depression, Fibromyalgia, Headache, Nausea
Clinical narrative: Pain on my extremities, unable to hold things with my hands, pain going down my left leg , pain from my neck down my arms, deep depression, strong flare up of my Fibromyalgia and Arthrities together, Severe Headaches and very weak no energy at all and vomiting, nauseated. Dr. stated the shot case a neurological disorder causing the reaction stated above.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Pain on my extremities, unable to hold things with my hands, pain going down my left leg , pain from my neck down my arms, deep depression, strong flare up of my Fibromyalgia and Arthrities together, Severe Headaches and very weak no energy at all and vomiting, nauseated. Dr. stated the shot case a neurological disorder causing the reaction stated above.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt was give high dose (vial not diluted with enough saline) and reported no adverse reaction 2 days after injection was given
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Myalgia
Clinical narrative: muscle soreness at site of injection
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, expiration date: May2021), via an unspecified route of administration in the left arm on 31Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination was done at a hospital. The patient's medical history included Reynold's syndrome (21 years old at diagnosis), Sjogren's (diagnosed at 30 years old), mixed connective tissue disease (diagnosed around 30 years old), and fibromyalgia (late 40s at diagnosis). There were no concomitant medications. The patient previously received a tetanus shot for immunization on an unspecified date and was allergic to the tetanus shot. This happened when she was 21 years old. The patient also got the new pneumonia shot on 12Jan2021 in her left arm for immunization at the age of 65 years old. The patient got her first dose of BNT162B2 on 31Jan2021. The patient stated she was supposed to get second vaccine 21Feb2021 but that she went to emergency room 13Feb2021 with extreme right eye pain and numbness in lip. She was diagnosed with Bell's palsy. The patient stated that she was not admitted to the hospital, and she just seen in the emergency room. It was reported that it initially worsened, that her eyes were definitely worse until a week later she was scheduled to see her physician and on Wednesday 17Feb2021 she started taking eye drops and now they have not gotten any worse. The doctor said it was not known if it was caused by the vaccine, and stated the patient has certain autoimmune problems Reynaud's, Sjorgen's and mixed connective tissue disorder, all diagnosed prior to vaccine. The patient had no family history relevant to the event. There were no relevant tests. The outcome of the event was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Starting roughly 9 hours after injection started to feel fatigued. When I woke up the next day I had a fever of 101.4. I got up for a few hours and then went back to bed from about 11am to 4pm. I took two Tylenol 8Hr caplets in the morning, two more about 5pm and one more about 9. I felt fatigued and had the chills most of that day. The next day I woke without a fever and didn't take Tylenol. About 1pm I started feeling fatigued and sweaty. I laid down and checked my temp which was around 99.6. I slept for a few hours and also took two Tylenol. The third day I woke feeling pretty good. No fever. However was tired in the afternoon and laid down for a few hours. Fourth day was fine all around
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Electrocardiogram normal
Clinical narrative: Patient c/o weakness and feeling dizzy, EMT notified at 12:20, EMT assessed patient, VSS 157/93 HR 97 RR 26 O2 98% BGM 129 at 1430. At 1440 146/95 HR 93 RR 18 O2 95%.  EMT did not administer any medications, EKG Normal sinus. Fire department recommended patient to hospital as she was alone and driving herself. Fire department escorted patient to hospital via ambulance as a precaution at 1456.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Flushing, Headache
Clinical narrative: Seconds after receiving vaccine my finger tips began to tingle and then body became hot, flushed, and heart palpitations with elevated BP. My head was pounding with heart beat. I began to see ?stars? and feeling lightheaded. Lasted 30min. They had me lay down and bend my knees. Then felt nausea. Drank water. After leaving I had intense shaking that eventually went away after about 30min.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Paraesthesia, Tremor, Visual impairment
Clinical narrative: Seconds after receiving vaccine my finger tips began to tingle and then body became hot, flushed, and heart palpitations with elevated BP. My head was pounding with heart beat. I began to see ?stars? and feeling lightheaded. Lasted 30min. They had me lay down and bend my knees. Then felt nausea. Drank water. After leaving I had intense shaking that eventually went away after about 30min.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pruritus
Clinical narrative: 4 inch by 3.5 inch swelling at injection site,  extremely itchy
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: Patient has been nauseated every day since receiving her Moderna vaccine. It will happen 1-2 times per day, and lasts for several hours. It comes and goes, has vomited only once last week. Eating fine, denies diarrhea or constipation; is not pregnant and did do pregnancy tests and were negative. A week after vaccination she said there was a huge red ring around the site of her injection; was hot, and swollen and hard. She said the next morning it was gone. Ginger ale and Tums help her tummy. She is due on March 10th for her 2nd dose, but she is not sure if she should get the second one.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: multiple pulmonary emboli; This is a spontaneous report from a non-contactable consumer (patient's wife) via Medical Information team. A 72-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 10Feb2021 at a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date were unknown) on 19Jan2021 and experienced gradually being short of breath, which was further described as "he would walk for 50 yards and he would be huffing and puffing." The patient's medical history and concomitant medications were not reported. It was further reported that about 8 days after the first one, the patient started noticing gradually being short of breath. He would walk for 50 yards and he would be huffing and puffing, which was unusual, because he could walk a lot. It gradually got worse and then after the second one, it continued to get worse and he finally ended up in the hospital for 3 days with multiple pulmonary emboli on an unspecified date. The reporter was asking if this had been reported with the vaccine. The patient was hospitalized for the event multiple pulmonary emboli on an unspecified date for 3 days. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Fatigue, Headache, Myalgia
Clinical narrative: I was briefly  hospitalized for covid19 in early December of 2020. Vaccine side effects included ALL of the  symptoms of the real thing. Fatigue, head ache, muscle and joint pain, slight nausea, fever of 100 degrees.  I would like to know if the second vaccination is necessary.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I was briefly  hospitalized for covid19 in early December of 2020. Vaccine side effects included ALL of the  symptoms of the real thing. Fatigue, head ache, muscle and joint pain, slight nausea, fever of 100 degrees.  I would like to know if the second vaccination is necessary.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Bullseye rash, itching
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: When I got the vaccine I got an instant pain in my arm and into my neck, then an intense headache between my eyes above my nose, I was flush and sweaty, nauseous. Then had a bad  headache on the top of my head, then soon I had left side facial numbness . Light sensitivity
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Photophobia
Clinical narrative: When I got the vaccine I got an instant pain in my arm and into my neck, then an intense headache between my eyes above my nose, I was flush and sweaty, nauseous. Then had a bad  headache on the top of my head, then soon I had left side facial numbness . Light sensitivity
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Turned VERY red and hot.  Knot, a lot of Swelling.  Spread to 6x5 inches, hurt, sore and lasted 5 weeks.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Hypersensitivity, Throat tightness
Clinical narrative: Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They developed throat closing, angioedema, and perioral cyanosis. They were treated by EMS on site with epinephrine, diphenhydramine, methylprednisolone, ondansetron, and normal saline fluids. They were transported to emergency department. During reexamination, the patient?s symptoms improved and they were discharged to home.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram
Clinical narrative: Brain bleed; This is a spontaneous report from a contactable consumer (patient himself). An elderly male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 6201), via an unspecified route of administration at Right arm on 17Feb2021 13:30 (at unknown age) at single dose for Covid-19 immunization. Medical history included Hydrocephalus. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. Other vaccine same date product was None. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) on 26Jan2021 04:30 P.M at Right arm, for COVID-19 immunization. The patient experienced Brain bleed on 18Feb2021 16:00. AE resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 4 days. The patient underwent lab tests and procedures which included CT scan (computerised tomogram): unknown results on Feb2021. Treatment reported as CT scan/observation. The outcome of the event was Recovering.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Dizziness, Fatigue, Headache
Clinical narrative: Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Muscular weakness, Nausea, Pyrexia, Syncope
Clinical narrative: Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Blood test, Syncope, Therapeutic response unexpected, Vision blurred
Clinical narrative: My sight started to go; started getting blurry and I can't see my phone to find number and it lasted about an hour my sight came back; sudden my sight started to go; blurry; ever since then my smell has been back; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: E9262), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included high blood pressure, over weight, lost my sense of smell, border line diabetic and a heart condition that is hereditary it has to deal with the elasticity of the vessels; all from unspecified date and unknown if ongoing. The patient was administered first dose of BNT162B2 (lot number: EH9899) on unspecified date for COVID-19 immunization and experienced the regular signs, a little bit of a headache, little dizziness in the morning, and cognitively was little not there for about an hour. Concomitant medication included lisinopril, metformin hydrochloride (ROBUSTIN) and vitamins. The patient stated, "for the second shot the 2nd day I was at school letting kids out and all of a sudden my sight started to go. It started getting blurry and I got back into the building and my Principal said let's just call the doctors, I said I can't see my phone to get, find his number. They took care of that for me and it lasted about an hour and hour and half and my sight came back. That's was the only negative and the positive thing happened, I have lost my sense of smell 10 years ago from taking a prescription for high blood pressure I mean diabetes (unspecified medication). Within a month I lost complete smell of everything, for 10 years I have not been able to smell a thing. The day I lost my lost my sight for little while, that day on the way home I was driving pass a restaurant with my windows up and I could smell barbeque sauce, pass an Italian restaurant and I could smell Italian food, and ever since then my smell has been back. I don't know I am not complaining at all, I am just telling something that, the doctors says I haven't heard of that, so that I thought you should know." The patient had bloodwork done with unknown results on unspecified date. The outcome of the events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Fungal infection, Taste disorder
Clinical narrative: stools have been weird looking and smelly, like yeast; stools have been weird looking and smelly, like yeast; coffee (which is what has been tasting weird), tasted so gross; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 37-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3302, Expiry date: unknown), at 37 years of age via an unspecified route of administration on Left arm on 01Feb2021 at single dose for COVID-19 immunisation. Medical history was none. Concomitant medication included multivitamin (unspecified) and estradiol (ESTROGEN) as a supplement within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (Lot number: EJ1685, Expiry date: unknown) on 07Jan2021 at 09:30 AM on left arm for COVID-19 immunisation and experienced Exactly two weeks after the first vaccine I started smelling cigarette smoke and a sweet garlicky smell. Things tasted a little funny, but I mostly noticed it with coffee. Patient also had known allergies to clindamycin and Sulfa. The patient stated that, things tasted a little funny, but I mostly noticed it with coffee. I didn't think about the COVID shot, I just thought maybe I had a cold. Then exactly two weeks after the second, my coffee (which is what has been tasting weird), tasted so gross I had to throw it out in Feb2021. That's when I put it all together that it is probably from the vaccine. Then the more I research that sweet garlic is actually yeast I am smelling. Then I realized since all this has started by in Feb2021 stools have been weird looking and smelly, like yeast and sure enough I googled it and it looks similar. My co-worker is having a yeast infection also, but it is only in her mouth. The patient received treatment for the events with diflucan 150mg a 20-week cycle. The reporter considered the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.; Sender's Comments: Based on temporal relationship, the causality between the suspect 'BNT162B2' and the reported 'stools have been weird looking and smelly, like yeast' cannot be completely excluded. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, auditory, Hypoacusis
Clinical narrative: Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 57-year-old female patient received first dose of bnt162b2 (BNT162B2,COVID 19, brand: Pfizer BioNTech, lot number: EL3247), via an unspecified route of administration on 17Feb2021 15:45 on Left arm at single dose for covid-19 immunisation. Medical history included high cholesterol from an unknown date and unknown if ongoing.  Concomitant medication included rosuvastatin, zinc, ascorbic acid (VITAMINS C), ergocalciferol (VIT D), fish oil and Occuv. The patient experienced unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing (medically significant) on 20Feb2021 11:45AM with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown. She is not pregnant. Facility type vaccine was workplace clinic. No other vaccine in four weeks. Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. Known allergies was none.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported auditory hallucinations cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Nausea
Clinical narrative: anaphylactic reaction from Covid vaccine; nausea; This is a spontaneous report from a contactable Other Health Professional (HCP). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown) on an unspecified date (unknown age at the time of vaccination), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received pegvisomant (SOMAVERT) and experienced nausea. Patient reported the following: pegvisomant 30 mg daily; five missed does due to anaphylactic reaction from Covid vaccine and missed doses (amount missed or dates unknown) due to nausea. MD aware. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available and the known product safety profile, a causal association between the reported event 'anaphylactic reaction' and the suspect product BNT162B2 cannot be completely excluded. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Peripheral swelling
Clinical narrative: passed away shortly after her vaccine; started dealing with signs that are common with a stroke; developed swelling in her arms; This is a spontaneous report from a contactable consumer report for grandmother. A 101-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EM9809) via an unspecified route of administration in left arm on 08Feb2021 04:30 AM at single dose for covid-19 immunisation. Medical history included elderly. No covid prior vaccination. No other vaccine in four weeks; No other medications in two weeks. On 12Feb2021 12:00 AM, patient passed away shortly after her vaccine. She started dealing with signs that are common with a stroke. Event considered Life threatening illness (immediate risk of death from the event). She also developed swelling in her arms. No treatment received, patient not recovered from stroke and swelling arm. The patient died on 12Feb2021. No covid tested post vaccination. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away shortly after her vaccine
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: died from COVID after receiving the two doses of the vaccine; COVID; This is a spontaneous report from a contactable consumer report for a friend. A patient of unspecified age and gender received first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) both via an unspecified route of administration on unspecified dates at single doses for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer mentioned her friend died from COVID after receiving the two doses of the vaccine. The patient died on an unspecified date. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died from COVID after receiving the two doses of the vaccine
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Ultrasound abdomen
Clinical narrative: Pain in arm/sore arm; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from another company (MFR. Control No.: 20K-163-3447228-00). A 35-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: e10142, expiry date: Mar2021), intramuscular on 11Jan2021 at single dose for covid-19 immunisation, adalimumab (HUMIRA), subcutaneous from Sep2019 to an unspecified date, 10Jun2020 to Jun2020 and 24Jun2020 and ongoing at 40 mg (40 mg, 1 in 1 wk) for Moderate to Severe Hidradenitis Suppurativa. Medical history included hyperlipidaemia, high cholesterol, depression, hypothyroidism, sleep apnea from an unknown date and unknown if ongoing, Down syndrome from 31Jan1985 to an unknown date, pneumonia from 1986 to 1986, open heart surgery in May1988, May1994 and Jul2012, acute respiratory distress syndrome from 08Dec2002 to 04Apr2003, aspiration pneumonia from 08Apr2003 to 15Apr2003 and clinical trial participant in 11Jan2021. Concomitant medication included atorvastatin at 20 mg for high cholesterol and hyperlipidemia, fluoxetine at 40 mg for depression, levothyroxine at 0.75 mg, 1 in 2 D for hypothyroidism and sleep apnea, colecalciferol (VITAMIN D3 1000) for supplement. The patient previously took Reglan and experienced vomiting, confusion and disorientation, Percocet and experienced vomiting and disorientation, Toradol and Zofran and experienced vomiting, confusion and disorientation; Humira for moderate to severe hidradenitis suppurativa in Sep2019 and experienced abdominal hernia on Nov2019 which resolved in 19Jun2020 and hidradenitis suppurativa breakout underarm and in groin area/hidradenitis suppurativa flare in Sep2019 which resolved on an unspecified date. The patient experienced pain in arm/sore arm on 12Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on an unspecified date, ultrasound abdomen: unknown results (Abdominal Hernia that needed surgical repair) on 11Jan2020.  The action taken in response to the event for adalimumab was dose not changed. The patient recovered from the event on 13Jan2021. The reporter assessed the event as probable to the drug and vaccine.; Sender's Comments: There is a reasonable possibility that the event pain in arm/sore arm was related to BNT162b2 based on known drug safety profile and close temporal relationship.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: (name) is now dead 2 days after receiving a COVID mRN shot; This is a spontaneous report from a non-contactable other non HCP. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient  is now dead 2 days after receiving a Covid mrn (as reported) shot in Jan2021. She died two days later, according to her mother.  28 year old daughter took the vaccine on a Tuesday (on 19Jan2021) and was dead by Thursday (on 21Jan2021). Outcome of event was fatal. Autopsy shows no other red flags (as reported). The reporter has assured us he will get to the bottom of this vaccine crap. Anything attached should be red flag (as reported).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: (name) is now dead 2 days after receiving a COVID mRN shot
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Malaise
Clinical narrative: (name) is now dead 2 days after receiving a COVID mRN shot; This is a spontaneous report from a non-contactable other non HCP. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient  is now dead 2 days after receiving a Covid mrn (as reported) shot in Jan2021. She died two days later, according to her mother.  28 year old daughter took the vaccine on a Tuesday (on 19Jan2021) and was dead by Thursday (on 21Jan2021). Outcome of event was fatal. Autopsy shows no other red flags (as reported). The reporter has assured us he will get to the bottom of this vaccine crap. Anything attached should be red flag (as reported).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: (name) is now dead 2 days after receiving a COVID mRN shot
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: I was suffering from paralysis and numbness on the left side of my face.  I went to the ER and was diagnosed with Bell's Palsy; This is a spontaneous report from a non-contactable consumer (the patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration in left arm on 21Feb2021 11:30 a.m. at age of 31-year-old, at single dose for COVID-19 immunisation. The patient had history of frequent ear infections. Concomitant medication included fluticasone which was taken within 2 weeks of vaccination for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient reported when he woke up the next day after receiving the vaccine (22Feb2021), he found that he was suffering from paralysis and numbness on the left side of his face. He went to the emergency room (ER) and was diagnosed with Bell's Palsy. He had been experiencing some minor pain in his left ear beginning two days before he received the vaccine (i.e., three days before onset of facial paralysis), and this ear pain had continued as he continue to experience the palsy. Since visiting the ER, he had also seen a neurologist. The doctors he had seen do not necessarily think that the palsy resulted from receiving the vaccine. The onset date of the event "I was suffering from paralysis and numbness on the left side of my face. I went to the ER and was diagnosed with bell's palsy" was reported as 22Feb2021 09:00 a.m. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The event was non-serious (the event did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect). Oral steroid and antiviral drugs, eye ointment was received to treat the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: one died after the vaccine; This is a spontaneous report from a Pfizer-sponsored program. This contactable consumer reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter reported 3 females died post vaccination with the Pfizer-BioNTech COVID-19 vaccine. She explained one died after the vaccine on an unspecified date. She explained she had no additional details on the adverse event. The patient died on an unspecified date. It was not reported if an autopsy was performed.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: one died after the vaccine
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Dyspnoea, Echocardiogram
Clinical narrative: chest pain; Shortness of breath; This is a spontaneous report from a contactable other health professional (patient herself). A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 10Jan2021 (at the age of 45-years-old) in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient had no chronic illnesses and no allergies. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Other medications in two weeks was none. The patient previously took the first dose of bnt162b2 (Pfizer) on 21Dec2021 12:00 PM via intramuscular in left arm for COVID-19 immunization. The patient experienced chest pain and shortness of breath on 15Feb2021 01:00 (as reported). Clinical course: She took her second vaccine on 10Jan2021. Two weeks after the vaccine she was admitted to the hospital with chest pain and shortness of breath x2, one on 19Feb2021 (as reported) and the second time was 24Feb2021. On an unspecified date, all the blood works and CT (computerised tomogram) scan came back negative. She was a healthy individual until she took this vaccine. She also did Echocardiogram which came back negative. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). No treatment was received for events. Outcome of events were unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, chest pain and shortness of breath occurred 2 weeks following the second vaccine are more likely associated with coincidental medical conditions unlikely related to the vaccine use.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: HIBV, MMR
Symptoms: Product preparation issue
Clinical narrative: A patient had vaccinated with the wrong diluent for ActHIB and used the diluent used for MMR, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00493679) and transmitted to Sanofi on 25-Feb-2021.  This case involves a patient (unknown demographics) who had vaccinated with the wrong diluent for and HIB (PRP/T) VACCINE [ACT-HIB] and used the diluent used MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] (not produced by Sanofi Pasteur) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (Product preparation issue).   The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  The doctor stated that she had patients waiting so this is all the information she provided at the time of her call but she indicated that safety could follow up with her in terms of a phone call or something in writing.  This was a case of actual medication error due to inappropriate dilution of medication (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Expired product administered, Malaise, Nausea, Vomiting
Clinical narrative: Extreme dizziness; Vomiting; Nausea; Feeling sick; Felt like falling off her bed; This spontaneous case was received on 25-Feb-2021 from other non-health professional (consumer) via Med Communication (reference number: SEQW21-00811) and concerned a 52-year-old, female patient.  The patient's concurrent condition included that the patient was diabetic. The patient's concomitant medication included unspecified medication for diabetes.  On 13-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number was P100271298 and expiry date was reported as 13-Nov-2020 (matched to expiry date of 30-Jun-2021). The patient stated that she was given the vaccine that was going to expire. The pharmacy stated that the consumer had refused the vaccine at the time, but consumer stated that she had received it.  On the same date, after receiving Afluria Quadrivalent, the patient was feeling sick and felt extreme dizziness. The patient experienced nausea, vomiting and felt 'like falling off her bed'.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  Company comment: All events are assessed as related to Afluria Quadrivalent.; Sender's Comments: All events are assessed as related to Afluria Quadrivalent.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling
Clinical narrative: Patient experiencing swelling in palm of hands, patient report being tired. Initial V/S bp 140/80, HR 78, o2 sat 97% room air. Patient was observed for further evaluation, at 4:00 patient felt better and no complaints. Latest V/S is 110/70, o2 sat 97 on room air, P-79.  Patient was able to grip on both hands. Health education provided and instructed to call his PCP for further evaluation.  Patient left the premises with wife.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Evening of injection, at the injection site, it felt sore and warm to the touch.  Started to turn red.  Upon wakening the next morning, the site was warm, red, raised and itchy.  It looked like a red hive, about the size of a 50 cent piece and upper arm was slightly swollen.  Third day  the redness spread across the arm, warm, sore and swollen.  The redness was going down into the elbow to wrist area.  My arm was quite swollen.    I contacted my PCP, and had a video conference that day.  I also sent photos of my arm to a chart website.   He saw my arm and ordered Prednisone 20 mg for three days; as he felt it was an allergic reaction to the COVID injection.  Also was instructed to continue with Benadryl, Tylenol and ice.  It took nine days for everything to subside.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pruritus, Urticaria, Vaccination site erythema, Vaccination site pain
Clinical narrative: Evening of injection, at the injection site, it felt sore and warm to the touch.  Started to turn red.  Upon wakening the next morning, the site was warm, red, raised and itchy.  It looked like a red hive, about the size of a 50 cent piece and upper arm was slightly swollen.  Third day  the redness spread across the arm, warm, sore and swollen.  The redness was going down into the elbow to wrist area.  My arm was quite swollen.    I contacted my PCP, and had a video conference that day.  I also sent photos of my arm to a chart website.   He saw my arm and ordered Prednisone 20 mg for three days; as he felt it was an allergic reaction to the COVID injection.  Also was instructed to continue with Benadryl, Tylenol and ice.  It took nine days for everything to subside.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Evening of injection, at the injection site, it felt sore and warm to the touch.  Started to turn red.  Upon wakening the next morning, the site was warm, red, raised and itchy.  It looked like a red hive, about the size of a 50 cent piece and upper arm was slightly swollen.  Third day  the redness spread across the arm, warm, sore and swollen.  The redness was going down into the elbow to wrist area.  My arm was quite swollen.    I contacted my PCP, and had a video conference that day.  I also sent photos of my arm to a chart website.   He saw my arm and ordered Prednisone 20 mg for three days; as he felt it was an allergic reaction to the COVID injection.  Also was instructed to continue with Benadryl, Tylenol and ice.  It took nine days for everything to subside.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Body aches, fever, chills, muscle pain, headache, nausseau, fatigue,
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches, fever, chills, muscle pain, headache, nausseau, fatigue,
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Muscular weakness
Clinical narrative: Bell?s palsy. Left eye will not close and left mouth droopy with muscle weakness left side.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse events; He had 1st COVID19 (Pfizer) on Jan 27th which was only 7 days apart between two vaccines. CDC recommend separate out at least 14 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Myalgia, Nasopharyngitis
Clinical narrative: They started about 2:30 in the morning, I woke up chilled. I had the muscle and body aches and then I had the nausea and fatigue. I had a headache. Initially, I took 600 mg of Advil and seemed to help. But fever spiked 102.5 - symptoms get worse throughout the day. Advil brought down the fever some. Sleeping helped the most. These symptoms lasted about 48 hours. I missed a day and a half of work because of it.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: They started about 2:30 in the morning, I woke up chilled. I had the muscle and body aches and then I had the nausea and fatigue. I had a headache. Initially, I took 600 mg of Advil and seemed to help. But fever spiked 102.5 - symptoms get worse throughout the day. Advil brought down the fever some. Sleeping helped the most. These symptoms lasted about 48 hours. I missed a day and a half of work because of it.