chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Spinal pain
Clinical narrative: She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spinal pain that elicits nausea; Headache that is worse at night/Headache worse at night time, sometimes gets better during the day/bad head ache; Body aches; Feeling crappy; Low grade fever; Pressure in the head; Terrible pain; Neck pain; This is a spontaneous report from a contactable other health professional (patient). A 43-yearsold female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Covid19 vaccine on 19Dec2020 and reported that at 36 hours she had body aches, feeling crappy, and low grade fever in Dec2020, she had since developed at headache that is worse at night, and spinal pain that elicits nausea. She suspected that she had an undiagnosed autoimmune disease. She was inquiring about duration of the reported AE's from clinical trials, and tried to decide how long she will feel this way. And going on 10 days and she's just struggling, bad headache and neck pain headache worse at night time, sometimes gets better during the day. Terrible pain and nausea. Any info on length of side effects: 36 hours- body aches feeling crappy. Low grade fever. Nausea with the spinal pain, pressure in the head. Difference in people with autoimmune issues- infertility - suspected autoimmune. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, there is no biological plausibility to implicate the suspect vaccine to the occurrence of the serious event autoimmune disease. More information such as medical history and concomitant medications and confirmative diagnostic workups are needed for full medial assessment.  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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram QT prolonged, Electrocardiogram ST segment abnormal, Flushing, Hypertension, Paraesthesia
Clinical narrative: employee getting Pfizer COVID19 vaccination.  about 10 min post injection developed feeling of flushing and ?"prickliness" on skin. no resp distress no swelling or rash seen.  VS taken and hypertension noted 170s/90s. normal O2sat and HR- NO prior medical hx of hypertension. Monitored for 30 min in vaccination clinic persistent hypertension.  Referred to ED for ongoing monitoring-still hypertensive but eval neg  referred to primary care provider for follow up
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring abnormal, Chest discomfort, Computerised tomogram head normal, Computerised tomogram thorax normal, Depressed mood
Clinical narrative: 12/19/20 MORNING AFTER: heartbeat skipping/ fatigue 12/20/20: skipping heartbeats/fatigue/sadness 12/21/20: Increased skipping heartbeats/fatigue/occasion need to caught my breathe 12/22/20: Heartbeat skipping every 3 beats/left arm and occasion left jaw pain/numbness/chest pressure in left/dizzness 12/22/20: Emergency room care needed
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram abnormal, Electrocardiogram ambulatory, Extrasystoles
Clinical narrative: 12/19/20 MORNING AFTER: heartbeat skipping/ fatigue 12/20/20: skipping heartbeats/fatigue/sadness 12/21/20: Increased skipping heartbeats/fatigue/occasion need to caught my breathe 12/22/20: Heartbeat skipping every 3 beats/left arm and occasion left jaw pain/numbness/chest pressure in left/dizzness 12/22/20: Emergency room care needed
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibrin D dimer increased, Full blood count normal, Hypoaesthesia, Pain in extremity
Clinical narrative: 12/19/20 MORNING AFTER: heartbeat skipping/ fatigue 12/20/20: skipping heartbeats/fatigue/sadness 12/21/20: Increased skipping heartbeats/fatigue/occasion need to caught my breathe 12/22/20: Heartbeat skipping every 3 beats/left arm and occasion left jaw pain/numbness/chest pressure in left/dizzness 12/22/20: Emergency room care needed
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative, Troponin normal, Ventricular extrasystoles
Clinical narrative: 12/19/20 MORNING AFTER: heartbeat skipping/ fatigue 12/20/20: skipping heartbeats/fatigue/sadness 12/21/20: Increased skipping heartbeats/fatigue/occasion need to caught my breathe 12/22/20: Heartbeat skipping every 3 beats/left arm and occasion left jaw pain/numbness/chest pressure in left/dizzness 12/22/20: Emergency room care needed
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, SARS-CoV-2 test negative
Clinical narrative: Shortness of breath; Fast heart rate with just activity/increased heart rate; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received her 1st dose of BNT162B2 lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 10:00 at 0.3 mL, single (0.3ml constituted dose) on left deltoid for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fast heart rate with just activity, shortness of breath. It was further reported that she had a fast heart rate and shortness of breath after receiving the vaccine. Reporter seriousness for Shortness of breath was Medically significant. This patient reported shortness of breath that resolved within hours and fast heart rate with just activity. Fast heart rate with just activity: In the morning around 08:00. It had resolved. Shortness of breath: In the morning as well. Resolved by the evening. Vaccination Facility Type was Hospital and Vaccine Administered . There was no additional vaccines administered on same date of Pfizer Suspect that caller was aware of. The adverse events didn't Require A Visit To. Relevant Tests: Did a COVID-19 test and it was negative. patient should not get a second dose. Wanted to know if this was true. Caller further reported that the patient receiving the COVID-19 vaccine experienced shortness of breath and an increased heart rate for a prolonged period, and was now stable. Caller saw recommendation from the indicating that the patient should not receive the second dose of the vaccine, and wanted to validate the information. The case safety report was considered as non-serious by the reporter in the further reported information. The outcome of the events was recovered on 20Dec2020.  Follow-up (22Dec2020): new information received from this same contactable nurse (patient, Nurse, RN) included reporter identify (also the reporter) and event details.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event shortness of breath cannot be excluded.  The follow-up information received does not alter the previous company clinical evaluation.  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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperpyrexia, Injection site pain, Pain, Parosmia
Clinical narrative: Fever up to 120F; Bodyaches; Headache; dulled taste and smell; dulled taste and smell; Pain at the injection site; This is a spontaneous report from a contactable other HCP. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (reported as COVID 19 vaccine), intramuscular on 27Dec2020 12:00PM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU) on 16Dec2020 at right arm. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced fever up to 120F, bodyaches, headache, dulled taste and smell, pain at the injection site on 27Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the event hyperpyrexia cannot be excluded based on compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Taste disorder
Clinical narrative: Fever up to 120F; Bodyaches; Headache; dulled taste and smell; dulled taste and smell; Pain at the injection site; This is a spontaneous report from a contactable other HCP. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (reported as COVID 19 vaccine), intramuscular on 27Dec2020 12:00PM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU) on 16Dec2020 at right arm. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced fever up to 120F, bodyaches, headache, dulled taste and smell, pain at the injection site on 27Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the event hyperpyrexia cannot be excluded based on compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Feeling abnormal, Feeling cold, Heart rate increased, Hypoaesthesia
Clinical narrative: Started with airway swelling, body cold and clammy, given Epi I.M, Pepcid, and placed on monitor, after some time HR jumped to 120 and started to feel weird inside, placed on oxygen and given Benadryl I.V along with Decadron P.O, out for 2 hours wake up feeling freezing  and numb in my extremities,  Asked for more blankets to find out that my coworkers can't understand me and telling me that I'm speaking in my mother tongue language, i was admitted to the hospital that day
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Language disorder, Respiratory tract oedema
Clinical narrative: Started with airway swelling, body cold and clammy, given Epi I.M, Pepcid, and placed on monitor, after some time HR jumped to 120 and started to feel weird inside, placed on oxygen and given Benadryl I.V along with Decadron P.O, out for 2 hours wake up feeling freezing  and numb in my extremities,  Asked for more blankets to find out that my coworkers can't understand me and telling me that I'm speaking in my mother tongue language, i was admitted to the hospital that day
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pain, Pyrexia, Tachycardia
Clinical narrative: Extreme Tachycardia (HR 160-180s) for over 12 hours Uncontrolled cold shakes for over three hours Fever for 24 hours Fatigue for 3+ days Tiredness 3+ days Body aches 3+ days Uncontrolled migraine over 48hrs
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Extreme Tachycardia (HR 160-180s) for over 12 hours Uncontrolled cold shakes for over three hours Fever for 24 hours Fatigue for 3+ days Tiredness 3+ days Body aches 3+ days Uncontrolled migraine over 48hrs
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Paraesthesia, Taste disorder
Clinical narrative: onset of HA, nausea, tingling in fingers and strange taste in mouth approximately 10 min after receiving the vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Fear, Intensive care, Lip swelling
Clinical narrative: I don't remember a lot. I started itching on my chest and arms and I noticed welts on my forearms. The nurses that were there said it "looked like I was the point something percent". When I let them  know about the welts they walked me to the ER. I got walked back to a room and from there it went downhill, pretty fast. I couldn't breathe, my lips and mouth and tongue were swelling, I was given Epi a few times and then the Dr. said something about intubation and that's pretty much all I remember.  When I woke up I was on a ventilator in the ICU at hospital, I later found out I had to be transferred. I couldn't move or talk and I was scared.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical ventilation, Memory impairment, Mobility decreased, Mouth swelling, Pruritus
Clinical narrative: I don't remember a lot. I started itching on my chest and arms and I noticed welts on my forearms. The nurses that were there said it "looked like I was the point something percent". When I let them  know about the welts they walked me to the ER. I got walked back to a room and from there it went downhill, pretty fast. I couldn't breathe, my lips and mouth and tongue were swelling, I was given Epi a few times and then the Dr. said something about intubation and that's pretty much all I remember.  When I woke up I was on a ventilator in the ICU at hospital, I later found out I had to be transferred. I couldn't move or talk and I was scared.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Swollen tongue, Urticaria
Clinical narrative: I don't remember a lot. I started itching on my chest and arms and I noticed welts on my forearms. The nurses that were there said it "looked like I was the point something percent". When I let them  know about the welts they walked me to the ER. I got walked back to a room and from there it went downhill, pretty fast. I couldn't breathe, my lips and mouth and tongue were swelling, I was given Epi a few times and then the Dr. said something about intubation and that's pretty much all I remember.  When I woke up I was on a ventilator in the ICU at hospital, I later found out I had to be transferred. I couldn't move or talk and I was scared.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: burst blood vessel in left eye/blood in her eye; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899, expiry date 01Mar2021), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included ongoing rheumatoid arthritis for about 8 years. No known allergies. Patient didn't do relevant test. Concomitant medication included duloxetine hydrochloride (CYMBALTA) for rheumatoid arthritis for 2 years, sulfasalazine for rheumatoid arthritis for 4 months, it's unknown if they were ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine yesterday (23Dec2020), which she was very excited about, but today (24Dec2020) she woke up with a burst blood vessel in her left eye, she appears to have blood in her eye. This has never happened to her before. She knows this can occur with patients that have COVID but didn't know if it was a side effect to receiving the vaccine. Patient didn't receive treatment for the adverse event. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was not recovered. The relatedness between COVID vaccine and event "burst blood vessel in left eye" was related by reporter.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.; Sender's Comments: "Burst blood vessel in eye" is not uncommon in general population, and there are many causes of the event.  Considering temporal relationship, a contribution role of the injection of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported Eye haemorrhage cannot be excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Confusional state, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Around midnight I woke up and was extremely confused, felt like I had  pretty bad cold, had some hives and started having some shortness of breath, that it kept waking me up. I also got nauseous. Almost threw up but did not. Took Benadryl and felt better. Had fever 100F in the morning, felt very fatigued next day. Went to work and the symptoms came back and they were intensified. I could barely walk. Took Benadryl and they decided to wheel me to the ER. I was unable to talk, I did not make sense. They gave me Benadryl and made me wait in the ER. I had tachycardia my pulse was fine. My BP was jumping around. I never had problems with that.  At the ER they told me to take Benadryl and Pepcid for the next 3 days. My fever went down while I was at the ER. The next morning I checked it again and no more fever and I was feeling a lot better.  I also had a slight headache, not bad. I called my PCP and they do not think it might be a good idea to receive the 2nd dose.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Nausea, Pyrexia, Sleep disorder
Clinical narrative: Around midnight I woke up and was extremely confused, felt like I had  pretty bad cold, had some hives and started having some shortness of breath, that it kept waking me up. I also got nauseous. Almost threw up but did not. Took Benadryl and felt better. Had fever 100F in the morning, felt very fatigued next day. Went to work and the symptoms came back and they were intensified. I could barely walk. Took Benadryl and they decided to wheel me to the ER. I was unable to talk, I did not make sense. They gave me Benadryl and made me wait in the ER. I had tachycardia my pulse was fine. My BP was jumping around. I never had problems with that.  At the ER they told me to take Benadryl and Pepcid for the next 3 days. My fever went down while I was at the ER. The next morning I checked it again and no more fever and I was feeling a lot better.  I also had a slight headache, not bad. I called my PCP and they do not think it might be a good idea to receive the 2nd dose.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Tachycardia, Urticaria
Clinical narrative: Around midnight I woke up and was extremely confused, felt like I had  pretty bad cold, had some hives and started having some shortness of breath, that it kept waking me up. I also got nauseous. Almost threw up but did not. Took Benadryl and felt better. Had fever 100F in the morning, felt very fatigued next day. Went to work and the symptoms came back and they were intensified. I could barely walk. Took Benadryl and they decided to wheel me to the ER. I was unable to talk, I did not make sense. They gave me Benadryl and made me wait in the ER. I had tachycardia my pulse was fine. My BP was jumping around. I never had problems with that.  At the ER they told me to take Benadryl and Pepcid for the next 3 days. My fever went down while I was at the ER. The next morning I checked it again and no more fever and I was feeling a lot better.  I also had a slight headache, not bad. I called my PCP and they do not think it might be a good idea to receive the 2nd dose.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Tunnel vision
Clinical narrative: lightheaded, dizzy, tunnel vision, sweaty, felt like passing out within minutes of receiving vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Pyrexia
Clinical narrative: Fever (102.5 - 103.9), Pulse - 118, O2 - 94, Stabbing chest pain, Mediastinum tightness
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Magnetic resonance imaging, Paraesthesia
Clinical narrative: After the 15 min monitoring, I went back to work 15 min later. the left side of my face started tingling which went to a numbing feeling down the left side of my body affecting my neck, shoulder, arm, elbow and up the upper left torso. My face and neck was numb for about 48 hrs and the rest came back to sensation within 24 hrs. D/T the numbness I was admitted into the hospital for a 24hr observation.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Eye pruritus, Lip swelling, Lymph node pain
Clinical narrative: With in five minutes I stared to itch around my face and eyes. Got dizzy and blurry vision when I stood up. My lips began to swell. Was given 50 mg Benadryl PO and watched for one hour. Never had difficulty breathing. Itchy continued for five days going away with Benadryl. Lymph nodes in arm pit of arm vaccine was in  swelled and hurt for two days. Spiked a fever the second day twice that was controlled with Tylenol.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Pyrexia, Vision blurred
Clinical narrative: With in five minutes I stared to itch around my face and eyes. Got dizzy and blurry vision when I stood up. My lips began to swell. Was given 50 mg Benadryl PO and watched for one hour. Never had difficulty breathing. Itchy continued for five days going away with Benadryl. Lymph nodes in arm pit of arm vaccine was in  swelled and hurt for two days. Spiked a fever the second day twice that was controlled with Tylenol.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dizziness, Hypersensitivity, Nausea
Clinical narrative: She reports that she had an adverse/allergic reaction to the Moderna COVID 19 vaccine. She received it on 12/30/20. LOT 037K201A. She was given a vaccine card with the lot information but no expiration date. Initially she had closing of throat/itchy sensation, tachycardia, nausea, hives, weakness, and feeling of near syncope. She was given Solumedrol, Benadryl, and Zofran immediately; which reversed the anaphylactic symptoms. She reports that she had dizziness, nausea, cough, tachycardia. She reports that the tachycardia has resolved. She is a healthcare worker-RN. TX=Prednisone, Albuterol, Benadryl, Pepcid.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Tachycardia, Throat irritation, Throat tightness, Urticaria
Clinical narrative: She reports that she had an adverse/allergic reaction to the Moderna COVID 19 vaccine. She received it on 12/30/20. LOT 037K201A. She was given a vaccine card with the lot information but no expiration date. Initially she had closing of throat/itchy sensation, tachycardia, nausea, hives, weakness, and feeling of near syncope. She was given Solumedrol, Benadryl, and Zofran immediately; which reversed the anaphylactic symptoms. She reports that she had dizziness, nausea, cough, tachycardia. She reports that the tachycardia has resolved. She is a healthcare worker-RN. TX=Prednisone, Albuterol, Benadryl, Pepcid.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic neuritis, Deafness neurosensory, Dizziness, Ear discomfort, Hyperacusis
Clinical narrative: Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; sore arm; nerve related hearing loss; This is a spontaneous report from a contactable physician reporting for himself.  A 69-years-old male patient received bnt162b2 (BNT162B2; Lot : EKS730) vaccine , intramuscular in the left deltoid  on  21Dec2020 15:30 at single dose for covid-19 immunisation .  Medical history included atrial fibrillation from 2009.  There were no concomitant medications.  The patient stated he experienced sore arm on the same day 21Dec2020 and this was not a big deal. On 26Dec2020 the patient experienced sudden onset of acoustic neuritis without labyrinthitis, hyperacusis,  fullness in ears, dizziness and tinnitus . The patient also experienced nerve related hearing loss from Dec2020. Sore arm was considered non serious events, while the remaining were considered Important Medical Events. The outcome of nerve related hearing loss was recovered, the outcome of sore arm was unknown, while the outcome of the remaining events was recovering.; Sender's Comments: Based on the temporal association, it cannot be fully excluded that the vaccination with BNT162B2 might play a contributory role in the events onset.  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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; sore arm; nerve related hearing loss; This is a spontaneous report from a contactable physician reporting for himself.  A 69-years-old male patient received bnt162b2 (BNT162B2; Lot : EKS730) vaccine , intramuscular in the left deltoid  on  21Dec2020 15:30 at single dose for covid-19 immunisation .  Medical history included atrial fibrillation from 2009.  There were no concomitant medications.  The patient stated he experienced sore arm on the same day 21Dec2020 and this was not a big deal. On 26Dec2020 the patient experienced sudden onset of acoustic neuritis without labyrinthitis, hyperacusis,  fullness in ears, dizziness and tinnitus . The patient also experienced nerve related hearing loss from Dec2020. Sore arm was considered non serious events, while the remaining were considered Important Medical Events. The outcome of nerve related hearing loss was recovered, the outcome of sore arm was unknown, while the outcome of the remaining events was recovering.; Sender's Comments: Based on the temporal association, it cannot be fully excluded that the vaccination with BNT162B2 might play a contributory role in the events onset.  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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Paraesthesia oral
Clinical narrative: Tingling in lips 10 minutes after shot administered. Progressive numbness and mild drooping to right side of face (cheek, jaw, chin, neck, tongue, throat). Numbness in right arm down to 3rd, 4th and 5th fingers. Full function was still intact.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Flushing, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Rapid onset numbness/tingling and weakness/in my right hand up the arm, right foot, and left foot; Rapid onset numbness/tingling and weakness/in my right hand up the arm, right foot, and left foot; weakness 8 hours after the vaccine in my right hand up the arm, right foot, and left foot; flushing; This is a spontaneous report from a contactable pharmacist.  A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on the left arm on 22Dec2020 08:00 at single dose for COVID-19 immunisation.  The patient had no medical history. The patient's concomitant medications were not reported. The patient stated that on 22Dec2020, "rapid onset numbness/tingling and weakness 8 hours after the vaccine in my right hand up the arm, right foot, and left foot. I also had flushing that required 50mg of BENADRYL every 8 hours for 16 hours. The numbness and tingling has persisted since and I still have it today in my right hand and right foot. It comes and goes with no specific identifying factors. I was vaccinated in my left arm" (events reported as AE-resulted-in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage). The outcome of the events was recovering.; 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 events. 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: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Rapid onset numbness/tingling and weakness/in my right hand up the arm, right foot, and left foot; Rapid onset numbness/tingling and weakness/in my right hand up the arm, right foot, and left foot; weakness 8 hours after the vaccine in my right hand up the arm, right foot, and left foot; flushing; This is a spontaneous report from a contactable pharmacist.  A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on the left arm on 22Dec2020 08:00 at single dose for COVID-19 immunisation.  The patient had no medical history. The patient's concomitant medications were not reported. The patient stated that on 22Dec2020, "rapid onset numbness/tingling and weakness 8 hours after the vaccine in my right hand up the arm, right foot, and left foot. I also had flushing that required 50mg of BENADRYL every 8 hours for 16 hours. The numbness and tingling has persisted since and I still have it today in my right hand and right foot. It comes and goes with no specific identifying factors. I was vaccinated in my left arm" (events reported as AE-resulted-in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage). The outcome of the events was recovering.; 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 events. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash/Hives day after vaccine  continual and increasing itching.  Takjng Zurtec and Benedryl
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chest discomfort, Chills, Dizziness, Dry mouth
Clinical narrative: Immediately after had a weird taste in my mouth felt dizzy and nauseous and got extreme cotton mouth?this lasted about 3-5 minutes. Continued to have intermittent cotton mouth throughout the day Within 7 hrs of getting the vaccine the back of my tongue hurt extremely bad and I acquired canker sores on my tongue and extreme fatigue. 12 hrs after I was racked with body aches, chills, fever, dizziness, nausea, headache. I did go to work for a couple of hours and was sent home just kept getting worse even after Tylenol Proceeded to have everything you can get with covid except a cough.. tight chest no real taste and all the above symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glossodynia, Headache, Nausea, Pain
Clinical narrative: Immediately after had a weird taste in my mouth felt dizzy and nauseous and got extreme cotton mouth?this lasted about 3-5 minutes. Continued to have intermittent cotton mouth throughout the day Within 7 hrs of getting the vaccine the back of my tongue hurt extremely bad and I acquired canker sores on my tongue and extreme fatigue. 12 hrs after I was racked with body aches, chills, fever, dizziness, nausea, headache. I did go to work for a couple of hours and was sent home just kept getting worse even after Tylenol Proceeded to have everything you can get with covid except a cough.. tight chest no real taste and all the above symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Taste disorder
Clinical narrative: Immediately after had a weird taste in my mouth felt dizzy and nauseous and got extreme cotton mouth?this lasted about 3-5 minutes. Continued to have intermittent cotton mouth throughout the day Within 7 hrs of getting the vaccine the back of my tongue hurt extremely bad and I acquired canker sores on my tongue and extreme fatigue. 12 hrs after I was racked with body aches, chills, fever, dizziness, nausea, headache. I did go to work for a couple of hours and was sent home just kept getting worse even after Tylenol Proceeded to have everything you can get with covid except a cough.. tight chest no real taste and all the above symptoms.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling cold, Heart rate increased, Hypertension
Clinical narrative: The onset of symptoms started around 9:15am. I experienced numbness and tingling to bilateral feet and lower legs. I experienced dizziness. I also experienced an increased heart rate (160s-170s BPM). I was hyperventilating and had difficulty with breathing. I was pale and cold.  I had uncontrollable shakes. My BP was a bit higher than my normal but not hypertensive.  I was given candy and juice after onset of symptoms. ( I did have an English muffin prior to receiving the vaccine). My symptoms subsided for some time but then came back about 15 minutes later. These symptoms continued to occur about every 15 minutes for a period of close to 2 hours. I was given Benadryl 50mg PO after the first hour of symptoms. I continued to experience the symptoms for up to about 45 minutes after being given Benadryl. My symptoms began to subside and eventually stopped after the 2 hour mark.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Hypoaesthesia, Pallor, Paraesthesia, Tremor
Clinical narrative: The onset of symptoms started around 9:15am. I experienced numbness and tingling to bilateral feet and lower legs. I experienced dizziness. I also experienced an increased heart rate (160s-170s BPM). I was hyperventilating and had difficulty with breathing. I was pale and cold.  I had uncontrollable shakes. My BP was a bit higher than my normal but not hypertensive.  I was given candy and juice after onset of symptoms. ( I did have an English muffin prior to receiving the vaccine). My symptoms subsided for some time but then came back about 15 minutes later. These symptoms continued to occur about every 15 minutes for a period of close to 2 hours. I was given Benadryl 50mg PO after the first hour of symptoms. I continued to experience the symptoms for up to about 45 minutes after being given Benadryl. My symptoms began to subside and eventually stopped after the 2 hour mark.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate increased, Urticaria
Clinical narrative: Allergic reaction: after 10-15 min, got hives on arms and face, felt dizzy, fast heart rate (116), rigors. The  urgent response team started iv fluid 1L, gave solumedrol (IV) and Benadryl (IM). Paramedics transferred me to ER (which was downstairs in hospital). After 1 hour the hives faded and gone by 2h. They kept me for observation for 5h.  I did not have any difficulty breathing, did not receive Epi.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Restlessness, Wheezing
Clinical narrative: Patient has a history of anaphylaxis reaction to Latex. Patient states she was intubated over this in the past. Pfizer-BioNTech vaccine given for Covid-19, 20 minutes later patient c/o dizziness. Patient placed on cot and starting wheezing and being short of breath. Lungs sound tight and wheezy throughout. 1052 - Epi 0.3mg IM given in Right Deltoid 1053 - Benadryl 50mg IM given in Left Deltoid 1054 - Patient getting restless and starts feeling chest tightness. Epi 0.3mg IM given in Right Deltoid Code Green Team arrived. BP 197/126, HR 88, RR 44, blood sugar 109 1058 - Patient getting wheezing and short of breath again. Epi 0.3mg IM given in Right Deltoid and Benadryl 50mg IM given in Left Deltoid. 1059 - Patient transferred to ED on stretcher, escorted by ICU RN and ICU MD. Patient stabilized in the ED and was given prescriptions for prednisone, epinephrine pen, diphenhydramine, and famotidine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Chest discomfort, Discomfort, Dizziness
Clinical narrative: Started out as just a sore arm around the injection site. Within 12 hours, I began to develop right sided rib pain along with pain with ROM of right arm. Around 11am on 12/30/2020, I developed right sided chest pressure, that radiated to the medial side of my left shoulder blade, and the medial side of my right shoulder blade.  Pressure/pain also felt in the right breast. The pressure was a 7/10 on pain scale. Constant pressure, with intermittent, sudden increase in pressure 10/10.  Sweating, nausea, and dizziness associated with sudden increase of pressure. Seen at ER around 1500-1600. Noticeable change to ECG, with occasional SOB.  On 12/31/2020, I awoke to significant swelling to all areas of pain the previous day.  Swelling also noted in right axillary region. Seen by PCP and sent back to ED.  Four days of Benadryl and muscle relaxers for pain, with very little decrease in swelling.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Injection site pain, Joint range of motion decreased, Lymphadenitis
Clinical narrative: Started out as just a sore arm around the injection site. Within 12 hours, I began to develop right sided rib pain along with pain with ROM of right arm. Around 11am on 12/30/2020, I developed right sided chest pressure, that radiated to the medial side of my left shoulder blade, and the medial side of my right shoulder blade.  Pressure/pain also felt in the right breast. The pressure was a 7/10 on pain scale. Constant pressure, with intermittent, sudden increase in pressure 10/10.  Sweating, nausea, and dizziness associated with sudden increase of pressure. Seen at ER around 1500-1600. Noticeable change to ECG, with occasional SOB.  On 12/31/2020, I awoke to significant swelling to all areas of pain the previous day.  Swelling also noted in right axillary region. Seen by PCP and sent back to ED.  Four days of Benadryl and muscle relaxers for pain, with very little decrease in swelling.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Nausea, Swelling
Clinical narrative: Started out as just a sore arm around the injection site. Within 12 hours, I began to develop right sided rib pain along with pain with ROM of right arm. Around 11am on 12/30/2020, I developed right sided chest pressure, that radiated to the medial side of my left shoulder blade, and the medial side of my right shoulder blade.  Pressure/pain also felt in the right breast. The pressure was a 7/10 on pain scale. Constant pressure, with intermittent, sudden increase in pressure 10/10.  Sweating, nausea, and dizziness associated with sudden increase of pressure. Seen at ER around 1500-1600. Noticeable change to ECG, with occasional SOB.  On 12/31/2020, I awoke to significant swelling to all areas of pain the previous day.  Swelling also noted in right axillary region. Seen by PCP and sent back to ED.  Four days of Benadryl and muscle relaxers for pain, with very little decrease in swelling.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Painful respiration, Splenomegaly, Tenderness
Clinical narrative: On the night of the vaccine she had increasing joint pain in knees and shoulders. Starting the next day she was having left lower rib area pain that was getting progressively worse. Left upper quadrant abdominal pain to palpation. Symptoms have improved but are still present.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal tenderness, Arthralgia, Injection site joint pain, Musculoskeletal chest pain
Clinical narrative: On the night of the vaccine she had increasing joint pain in knees and shoulders. Starting the next day she was having left lower rib area pain that was getting progressively worse. Left upper quadrant abdominal pain to palpation. Symptoms have improved but are still present.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient was feeling some numbness in her arm, dizziness and heart rate increased.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Hypoaesthesia
Clinical narrative: Patient was feeling some numbness in her arm, dizziness and heart rate increased.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Disturbance in attention, Eczema, Emotional disorder, Insomnia, Learning disorder
Clinical narrative: She stopped sleeping through the night immediately following her vaccinations.  She started waking up multiple times a night screaming every single night.  This went on nightly until she was treated for the vaccine injury.  She also developed eczema, sensory processing disorder, a speech delay, difficulty with emotional regulation, and the inability to sit still and focus.    Since we had no idea her issues were being caused by her body's inability to detox the heavy metals in the vaccines she received, she went on to receive 4 doses of both the DTaP and HIB vaccines.  When she was 3.5, we did a heavy metal detox with her under the supervision of her medical provider.  Two week into the detox, all of her above-mentioned symptoms disappeared completely overnight.  She currently has markers of dyslexia and other learning challenges, and it is unclear to us whether or not these things are lingering effects of her vaccine injury.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Sensory processing disorder, Sleep terror, Speech disorder
Clinical narrative: She stopped sleeping through the night immediately following her vaccinations.  She started waking up multiple times a night screaming every single night.  This went on nightly until she was treated for the vaccine injury.  She also developed eczema, sensory processing disorder, a speech delay, difficulty with emotional regulation, and the inability to sit still and focus.    Since we had no idea her issues were being caused by her body's inability to detox the heavy metals in the vaccines she received, she went on to receive 4 doses of both the DTaP and HIB vaccines.  When she was 3.5, we did a heavy metal detox with her under the supervision of her medical provider.  Two week into the detox, all of her above-mentioned symptoms disappeared completely overnight.  She currently has markers of dyslexia and other learning challenges, and it is unclear to us whether or not these things are lingering effects of her vaccine injury.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Headache,  muscle pain on the site  of injection,  chills, nausea, fever. Started time 01.03.2021 8:15pm.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: High fever (104.2 degrees) at present, fatigue, chills
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: Blood pressure and pulse rate increased to 164/64, 85
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: 1/1/2020: Residents was found unresponsive. Pronounced deceased at 6:02pm
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Heart rate increased, Nausea
Clinical narrative: Approximately 11:00pm on 12/29/20:  Hives/itching on bilateral hands/wrists/forearms/lower legs/ankes, red face/swelling on face, rapid pulse, headache, nausea, extreme fatigue.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Approximately 11:00pm on 12/29/20:  Hives/itching on bilateral hands/wrists/forearms/lower legs/ankes, red face/swelling on face, rapid pulse, headache, nausea, extreme fatigue.