chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Feeling jittery, Palpitations
Clinical narrative: Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Basophil count normal, Blood glucose normal, Blood potassium decreased, Blood test normal
Clinical narrative: Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone decreased, Chest X-ray normal, Dizziness, Electrocardiogram normal, Feeling abnormal
Clinical narrative: Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Heart rate increased, Immediate post-injection reaction, Impaired driving ability, Tremor
Clinical narrative: Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant patient received the GARDASIL 9 injection; No other AE was given; This spontaneous report was received from a Licensed Practical Nurse who was reporting on currently 22-year-old female patient. She was pregnant, and hers last menstruation period was on 07-APR-2020 and estimated delivery date was 05-FEB-2021. There was no information about the patient's medical history, drug reactions or allergies and concomitant therapies provided.  On 22-DEC-2020, the patient was intramuscularly vaccinated with dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe (dose, anatomical location and strength were not provided; lot number 1602284 was confirmed to be valid, expiration date was not reported but upon internal validation process, it was established as 26-SEP-2021) for prophylaxis (patient experienced exposure during pregnancy). Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 37 week. At the time of the report the patient did not delivered yet. She did not experienced other adverse events. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Feeling hot, Hyperhidrosis
Clinical narrative: hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021,  she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021,  she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac flutter, Chest discomfort, Discomfort, Dizziness, Dyspnoea
Clinical narrative: hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021,  she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush, Hyperhidrosis, Hypersensitivity, Impaired work ability, Injection site pain
Clinical narrative: hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021,  she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Palpitations, Sensory disturbance, Throat tightness
Clinical narrative: hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021,  she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chills, Facial discomfort, Feeling hot, Heart rate increased
Clinical narrative: hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021,  she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush, Hyperhidrosis, Hypersensitivity, Impaired work ability, Palpitations
Clinical narrative: hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021,  she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Throat tightness
Clinical narrative: hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021,  she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 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.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Two days after vaccine c/o swollen ankle and excruciating pain at left knee. Has hx of injury to knee years ago.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling, X-ray
Clinical narrative: Two days after vaccine c/o swollen ankle and excruciating pain at left knee. Has hx of injury to knee years ago.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, Periorbital oedema, Pruritus, Rash
Clinical narrative: 24 hours after receiving the vaccine I developed a rash on my face, minor swelling to face and peri-orbital edema.  48 hours later the rash and swelling were worse 72 hours later rash and swelling same as 48 hours but now with itching, resolved the next day. benadryl taken all 3 nights.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Swelling face
Clinical narrative: 24 hours after receiving the vaccine I developed a rash on my face, minor swelling to face and peri-orbital edema.  48 hours later the rash and swelling were worse 72 hours later rash and swelling same as 48 hours but now with itching, resolved the next day. benadryl taken all 3 nights.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periorbital oedema, Pruritus, Rash, Swelling face
Clinical narrative: 24 hours after receiving the vaccine I developed a rash on my face, minor swelling to face and peri-orbital edema.  48 hours later the rash and swelling were worse 72 hours later rash and swelling same as 48 hours but now with itching, resolved the next day. benadryl taken all 3 nights.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Swelling
Clinical narrative: 7-days following vaccination, employee developed redness and swelling of injection site, denies itching, or pain to area
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 7-days following vaccination, employee developed redness and swelling of injection site, denies itching, or pain to area
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Blister, Crying, Erythema, Mechanical urticaria
Clinical narrative: isolated hives/generalized hives; generalized itching/itchy from head to toe; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; This is a spontaneous report from a contactable physician. A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 30Dec2020 to 30Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included contact dermatitis. There were no concomitant medications. The reporter stated that the patient had mentioned that she had contact dermatitis for several months now and before taking the COVID-19 vaccine, it has settled within a month. 6-12 hours after getting the COVID-19 vaccine, her contact dermatitis had worsened dramatically on 30Dec2020. She was prescribed high dose topical steroids by her doctor. She also developed generalized itching and isolated hives on 12Jan2021. She is trying to avoid systemic corticosteroids because it might affect the vaccine. She is also taking antihistamines but she said these interventions don't seem to be working. Stated that it has not responded to anything. The patient also stated stated that she has not taken steroids because her second dose is due in a week. Stated that the doctors do not think that it is due to the vaccine but due to reactivation (immune system reactivity) of something that had happened. Stated that they are treating it with high dose topical steroids, pepcid and hydroxyzine. Wanted to see if there was information on this sort of reaction and if they had guidance on the second shot. Had the Pfizer BioNTech Covid 19 vaccine. Outcome of the events urticaria and pruritus was not recovered while outcome of the remaining events was recovering.; Sender's Comments: The reported generalized itching and isolated hives occurred 13 days after the first dose of COVID 19 vaccine, BNT162B2.  Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect. However, the pre-existing contact dermatitis might have provided alternative explanation towards 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 RA, IEC, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: isolated hives/generalized hives; generalized itching/itchy from head to toe; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; This is a spontaneous report from a contactable physician. A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 30Dec2020 to 30Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included contact dermatitis. There were no concomitant medications. The reporter stated that the patient had mentioned that she had contact dermatitis for several months now and before taking the COVID-19 vaccine, it has settled within a month. 6-12 hours after getting the COVID-19 vaccine, her contact dermatitis had worsened dramatically on 30Dec2020. She was prescribed high dose topical steroids by her doctor. She also developed generalized itching and isolated hives on 12Jan2021. She is trying to avoid systemic corticosteroids because it might affect the vaccine. She is also taking antihistamines but she said these interventions don't seem to be working. Stated that it has not responded to anything. The patient also stated stated that she has not taken steroids because her second dose is due in a week. Stated that the doctors do not think that it is due to the vaccine but due to reactivation (immune system reactivity) of something that had happened. Stated that they are treating it with high dose topical steroids, pepcid and hydroxyzine. Wanted to see if there was information on this sort of reaction and if they had guidance on the second shot. Had the Pfizer BioNTech Covid 19 vaccine. Outcome of the events urticaria and pruritus was not recovered while outcome of the remaining events was recovering.; Sender's Comments: The reported generalized itching and isolated hives occurred 13 days after the first dose of COVID 19 vaccine, BNT162B2.  Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect. However, the pre-existing contact dermatitis might have provided alternative explanation towards 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 RA, IEC, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dermatitis contact, Pruritus, Urticaria
Clinical narrative: isolated hives/generalized hives; generalized itching/itchy from head to toe; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; This is a spontaneous report from a contactable physician. A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 30Dec2020 to 30Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included contact dermatitis. There were no concomitant medications. The reporter stated that the patient had mentioned that she had contact dermatitis for several months now and before taking the COVID-19 vaccine, it has settled within a month. 6-12 hours after getting the COVID-19 vaccine, her contact dermatitis had worsened dramatically on 30Dec2020. She was prescribed high dose topical steroids by her doctor. She also developed generalized itching and isolated hives on 12Jan2021. She is trying to avoid systemic corticosteroids because it might affect the vaccine. She is also taking antihistamines but she said these interventions don't seem to be working. Stated that it has not responded to anything. The patient also stated stated that she has not taken steroids because her second dose is due in a week. Stated that the doctors do not think that it is due to the vaccine but due to reactivation (immune system reactivity) of something that had happened. Stated that they are treating it with high dose topical steroids, pepcid and hydroxyzine. Wanted to see if there was information on this sort of reaction and if they had guidance on the second shot. Had the Pfizer BioNTech Covid 19 vaccine. Outcome of the events urticaria and pruritus was not recovered while outcome of the remaining events was recovering.; Sender's Comments: The reported generalized itching and isolated hives occurred 13 days after the first dose of COVID 19 vaccine, BNT162B2.  Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect. However, the pre-existing contact dermatitis might have provided alternative explanation towards 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 RA, IEC, as appropriate.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Feeling abnormal, Hypoaesthesia, Vision blurred
Clinical narrative: I am blurry and it's sort of a vision thing where I can't see everything quite right, it's blurry; A little bit of brain fog not quite thinking everything correctly; Sometimes it feels like my legs aren't quite there; My senses aren't quite right; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246), on 07Jan2021 at SINGLE DOSE on upper left arm for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported. The patient was blurry and it's sort of a vision thing where she can't see everything quite right, it's blurry and a little bit of brain fog not quite thinking everything correctly and sometimes it feels like her legs aren't quite there like her senses aren't quite right. Treatment was no.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Vision blurred
Clinical narrative: I am blurry and it's sort of a vision thing where I can't see everything quite right, it's blurry; A little bit of brain fog not quite thinking everything correctly; Sometimes it feels like my legs aren't quite there; My senses aren't quite right; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246), on 07Jan2021 at SINGLE DOSE on upper left arm for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported. The patient was blurry and it's sort of a vision thing where she can't see everything quite right, it's blurry and a little bit of brain fog not quite thinking everything correctly and sometimes it feels like her legs aren't quite there like her senses aren't quite right. Treatment was no.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hypertension, Paraesthesia, Paralysis
Clinical narrative: heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. 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: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Choking sensation, Eyelid function disorder, Heart rate increased, Palpitations
Clinical narrative: heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. 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: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Paralysis, Speech disorder
Clinical narrative: heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. 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.