chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anti-RNA polymerase III antibody negative, Asthenia, C-reactive protein normal, Hypoaesthesia, Radiculitis brachial
Clinical narrative: numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported 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: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported 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: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brachial plexus injury, Computerised tomogram neck, Fine motor skill dysfunction, Grip strength decreased, Hypoaesthesia
Clinical narrative: numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported 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: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Impaired work ability, Muscular weakness
Clinical narrative: numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported 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: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anaphylactic shock, Blood gases, Blood lactic acid, Blood test
Clinical narrative: Developed nausea and shortness of breath approximately 5 minutes within receiving COVID Pfizer vaccination. Emergency team responded and noted increased work of breath, cough, nausea, and rash so administered Benadryl and IM epi. Patient was taken to the emergency department and eventually admitted to the ICU where she received fluids, continuous albuterol nebulizations, epinephrine continuous infusion, methylprednisolone, ondansetron, and famotidine to treat her symptoms.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Fatigue, Heart rate increased
Clinical narrative: Developed nausea and shortness of breath approximately 5 minutes within receiving COVID Pfizer vaccination. Emergency team responded and noted increased work of breath, cough, nausea, and rash so administered Benadryl and IM epi. Patient was taken to the emergency department and eventually admitted to the ICU where she received fluids, continuous albuterol nebulizations, epinephrine continuous infusion, methylprednisolone, ondansetron, and famotidine to treat her symptoms.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Developed nausea and shortness of breath approximately 5 minutes within receiving COVID Pfizer vaccination. Emergency team responded and noted increased work of breath, cough, nausea, and rash so administered Benadryl and IM epi. Patient was taken to the emergency department and eventually admitted to the ICU where she received fluids, continuous albuterol nebulizations, epinephrine continuous infusion, methylprednisolone, ondansetron, and famotidine to treat her symptoms.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Intensive care, Nausea, Rash
Clinical narrative: Developed nausea and shortness of breath approximately 5 minutes within receiving COVID Pfizer vaccination. Emergency team responded and noted increased work of breath, cough, nausea, and rash so administered Benadryl and IM epi. Patient was taken to the emergency department and eventually admitted to the ICU where she received fluids, continuous albuterol nebulizations, epinephrine continuous infusion, methylprednisolone, ondansetron, and famotidine to treat her symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood test, Disturbance in attention, Dizziness, Electrocardiogram
Clinical narrative: Extreme dizziness/ vertigo with difficulty walking
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Urine analysis
Clinical narrative: Extreme dizziness/ vertigo with difficulty walking
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Gait disturbance
Clinical narrative: Extreme dizziness/ vertigo with difficulty walking
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Urine analysis normal, Vertigo
Clinical narrative: Extreme dizziness/ vertigo with difficulty walking
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Eye movement disorder, Gait inability, Vision blurred
Clinical narrative: Extreme dizziness/ vertigo with difficulty walking
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Dyspnoea, Heart rate decreased
Clinical narrative: Anaphylaxis after receiving vaccine. Nausea, shortness of breath, syncope, unconscious. Was given epinephrine on site. Transported by ambulance to hospital, then later transported to another facility for admission.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Anaphylaxis after receiving vaccine. Nausea, shortness of breath, syncope, unconscious. Was given epinephrine on site. Transported by ambulance to hospital, then later transported to another facility for admission.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Chest X-ray, Computerised tomogram head, Dyspnoea
Clinical narrative: Anaphylaxis after receiving vaccine. Nausea, shortness of breath, syncope, unconscious. Was given epinephrine on site. Transported by ambulance to hospital, then later transported to another facility for admission.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Loss of consciousness, Nausea, Syncope
Clinical narrative: Anaphylaxis after receiving vaccine. Nausea, shortness of breath, syncope, unconscious. Was given epinephrine on site. Transported by ambulance to hospital, then later transported to another facility for admission.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: Moderna COVID?19 Vaccine EUA Moderna vaccine vial was opened on 12/30/2020, and the vial was placed back into the fridge later that afternoon, like 2-3 hours after puncture. The opened vial was reused for this patient the next morning for an injection when it should have been discarded. No adverse events occurred
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Moderna COVID?19 Vaccine EUA Moderna vaccine vial was opened on 12/30/2020, and the vial was placed back into the fridge later that afternoon, like 2-3 hours after puncture. The opened vial was reused for this patient the next morning for an injection when it should have been discarded. No adverse events occurred
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Erythema, Hypoaesthesia, Injection site urticaria, Pain
Clinical narrative: She had a vaccine on 12/24 and was fine.   On 12/31 she had onset of hives on the Left arm below the injection site . She was seen twice in the ED , was given a course of Keflex In case it was developing cellulitis- however was told it was likely a delayed reaction.   For the next few days she had tingling and pin in the arm.        She is now feeling fine.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Pruritus, Skin induration
Clinical narrative: She had a vaccine on 12/24 and was fine.   On 12/31 she had onset of hives on the Left arm below the injection site . She was seen twice in the ED , was given a course of Keflex In case it was developing cellulitis- however was told it was likely a delayed reaction.   For the next few days she had tingling and pin in the arm.        She is now feeling fine.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Tachycardia
Clinical narrative: She had a vaccine on 12/24 and was fine.   On 12/31 she had onset of hives on the Left arm below the injection site . She was seen twice in the ED , was given a course of Keflex In case it was developing cellulitis- however was told it was likely a delayed reaction.   For the next few days she had tingling and pin in the arm.        She is now feeling fine.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site urticaria, Paraesthesia, Skin reaction
Clinical narrative: She had a vaccine on 12/24 and was fine.   On 12/31 she had onset of hives on the Left arm below the injection site . She was seen twice in the ED , was given a course of Keflex In case it was developing cellulitis- however was told it was likely a delayed reaction.   For the next few days she had tingling and pin in the arm.        She is now feeling fine.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Anxiety, Blood test, Burning sensation, Central nervous system lesion
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Differential white blood cell count, Dizziness, Dysphagia, Ear pain
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Erythema, Flushing, Full blood count, Headache
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging brain abnormal, Metabolic function test
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Palpitations, Paraesthesia, Paraesthesia oral, Peripheral swelling
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic shock, Blood test, Burning sensation, Central nervous system lesion, Chest X-ray
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain, Electrocardiogram, Emotional distress, Feeling abnormal, Flushing
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hypertension, Magnetic resonance imaging brain abnormal, Palpitations, Paraesthesia
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia oral, Pharyngeal swelling, Post-traumatic stress disorder, SARS-CoV-2 test positive, Speech disorder
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Patient reported adverse reaction as anaphylaxis that began 45 minutes after she left the vaccine clinic (patient was observed for 15 mins so the reaction would have been 1 hour after receiving the vaccine).  Patient did not present to our facility for treatment, she went to Emergency Room and was subsequently admitted 12/23-12/26.  I do not have details of her reaction or hospitalization.  That information would need to be provided by Health
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal discomfort, Paraesthesia oral
Clinical narrative: Anaphylactic reaction
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: 5 minutes after receiving vaccine pt felt flushed and had palpitations and trouble breathing. They hooked her up to a monitor. Rhythm was sinus tach with HR 130. O2 was 99%. Episode lasted 7 minutes and then symptoms completely resolved. She feels fine since then.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Flushing, Palpitations, Sinus tachycardia
Clinical narrative: 5 minutes after receiving vaccine pt felt flushed and had palpitations and trouble breathing. They hooked her up to a monitor. Rhythm was sinus tach with HR 130. O2 was 99%. Episode lasted 7 minutes and then symptoms completely resolved. She feels fine since then.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine EUA  Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 12-31-20 at 3:38 pm.  Pfizer vaccine Lot EL0142.  0.3ml IM, left deltoid.  states felt dizzy after receiving injection. left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 1-1-21; knot grew to ~5x5 cm max size over 48 hrs. Itchy, but painful if tried to scratch. Took Benadryl 1-3-21, took Zyrtec 1-4-21. Evaluated at Employee Health on 1-5-21.  Some dizziness with position change. Exam: No fever. No orthostatism to BP. Pulse 77-- >94 from lying to standing. Left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Instructed to take OTC antihistamine (Zyrtec) daily until 7 days after symptoms resolve.  PMH significant for Covid 19 infection (positive test Oct. 28, 2020). Hospitalized 11-4-20 for decreased O2 saturation. Treated with Remdesivir. Post-Covid infection shortness of breath/dizziness.  A picture of the affected area is available if requested
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine EUA  Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 12-31-20 at 3:38 pm.  Pfizer vaccine Lot EL0142.  0.3ml IM, left deltoid.  states felt dizzy after receiving injection. left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 1-1-21; knot grew to ~5x5 cm max size over 48 hrs. Itchy, but painful if tried to scratch. Took Benadryl 1-3-21, took Zyrtec 1-4-21. Evaluated at Employee Health on 1-5-21.  Some dizziness with position change. Exam: No fever. No orthostatism to BP. Pulse 77-- >94 from lying to standing. Left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Instructed to take OTC antihistamine (Zyrtec) daily until 7 days after symptoms resolve.  PMH significant for Covid 19 infection (positive test Oct. 28, 2020). Hospitalized 11-4-20 for decreased O2 saturation. Treated with Remdesivir. Post-Covid infection shortness of breath/dizziness.  A picture of the affected area is available if requested
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine EUA  Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 12-31-20 at 3:38 pm.  Pfizer vaccine Lot EL0142.  0.3ml IM, left deltoid.  states felt dizzy after receiving injection. left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 1-1-21; knot grew to ~5x5 cm max size over 48 hrs. Itchy, but painful if tried to scratch. Took Benadryl 1-3-21, took Zyrtec 1-4-21. Evaluated at Employee Health on 1-5-21.  Some dizziness with position change. Exam: No fever. No orthostatism to BP. Pulse 77-- >94 from lying to standing. Left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Instructed to take OTC antihistamine (Zyrtec) daily until 7 days after symptoms resolve.  PMH significant for Covid 19 infection (positive test Oct. 28, 2020). Hospitalized 11-4-20 for decreased O2 saturation. Treated with Remdesivir. Post-Covid infection shortness of breath/dizziness.  A picture of the affected area is available if requested
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: 12/28/20: Within 90 minutes of vaccine, heart palpitations, upset stomach, lightheaded/ woozy, pain to injection site, unable to raise arm easily, diaphoretic.  12/29/20: continued with heart palpitations off and on, lost total control of my left hand for about 10 to 15 minutes large tremors. continued with pain at injection site, unable to raise arm easily.  Arm pain continued daily, occasional heart palpitations mostly within first 3 days of vaccine, continued to have weird sensation throughout my left arm w/ slight heaviness.  On 1/6/21: Left armpit swelling noted with pain that increased with touch, red- raised/swollen- hot area noted to left injection site. 1/7/21: Same symptoms but swelling to left armpit slightly better, still tender, still strange left arm sensation from shoulder to fingertips- not able to use hand/ arm at 100%- have difficulty holding things and typing with left hand periodically, still has swollen reddened warm area at injection site to left deltoid.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site warmth, Nausea, Palpitations, Tremor
Clinical narrative: 12/28/20: Within 90 minutes of vaccine, heart palpitations, upset stomach, lightheaded/ woozy, pain to injection site, unable to raise arm easily, diaphoretic.  12/29/20: continued with heart palpitations off and on, lost total control of my left hand for about 10 to 15 minutes large tremors. continued with pain at injection site, unable to raise arm easily.  Arm pain continued daily, occasional heart palpitations mostly within first 3 days of vaccine, continued to have weird sensation throughout my left arm w/ slight heaviness.  On 1/6/21: Left armpit swelling noted with pain that increased with touch, red- raised/swollen- hot area noted to left injection site. 1/7/21: Same symptoms but swelling to left armpit slightly better, still tender, still strange left arm sensation from shoulder to fingertips- not able to use hand/ arm at 100%- have difficulty holding things and typing with left hand periodically, still has swollen reddened warm area at injection site to left deltoid.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Axillary pain, Dizziness, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: 12/28/20: Within 90 minutes of vaccine, heart palpitations, upset stomach, lightheaded/ woozy, pain to injection site, unable to raise arm easily, diaphoretic.  12/29/20: continued with heart palpitations off and on, lost total control of my left hand for about 10 to 15 minutes large tremors. continued with pain at injection site, unable to raise arm easily.  Arm pain continued daily, occasional heart palpitations mostly within first 3 days of vaccine, continued to have weird sensation throughout my left arm w/ slight heaviness.  On 1/6/21: Left armpit swelling noted with pain that increased with touch, red- raised/swollen- hot area noted to left injection site. 1/7/21: Same symptoms but swelling to left armpit slightly better, still tender, still strange left arm sensation from shoulder to fingertips- not able to use hand/ arm at 100%- have difficulty holding things and typing with left hand periodically, still has swollen reddened warm area at injection site to left deltoid.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: 12/28/20: Within 90 minutes of vaccine, heart palpitations, upset stomach, lightheaded/ woozy, pain to injection site, unable to raise arm easily, diaphoretic.  12/29/20: continued with heart palpitations off and on, lost total control of my left hand for about 10 to 15 minutes large tremors. continued with pain at injection site, unable to raise arm easily.  Arm pain continued daily, occasional heart palpitations mostly within first 3 days of vaccine, continued to have weird sensation throughout my left arm w/ slight heaviness.  On 1/6/21: Left armpit swelling noted with pain that increased with touch, red- raised/swollen- hot area noted to left injection site. 1/7/21: Same symptoms but swelling to left armpit slightly better, still tender, still strange left arm sensation from shoulder to fingertips- not able to use hand/ arm at 100%- have difficulty holding things and typing with left hand periodically, still has swollen reddened warm area at injection site to left deltoid.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Motor dysfunction, Musculoskeletal disorder, Oedema peripheral, Pain in extremity, Palpitations
Clinical narrative: 12/28/20: Within 90 minutes of vaccine, heart palpitations, upset stomach, lightheaded/ woozy, pain to injection site, unable to raise arm easily, diaphoretic.  12/29/20: continued with heart palpitations off and on, lost total control of my left hand for about 10 to 15 minutes large tremors. continued with pain at injection site, unable to raise arm easily.  Arm pain continued daily, occasional heart palpitations mostly within first 3 days of vaccine, continued to have weird sensation throughout my left arm w/ slight heaviness.  On 1/6/21: Left armpit swelling noted with pain that increased with touch, red- raised/swollen- hot area noted to left injection site. 1/7/21: Same symptoms but swelling to left armpit slightly better, still tender, still strange left arm sensation from shoulder to fingertips- not able to use hand/ arm at 100%- have difficulty holding things and typing with left hand periodically, still has swollen reddened warm area at injection site to left deltoid.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Tenderness, Tremor
Clinical narrative: 12/28/20: Within 90 minutes of vaccine, heart palpitations, upset stomach, lightheaded/ woozy, pain to injection site, unable to raise arm easily, diaphoretic.  12/29/20: continued with heart palpitations off and on, lost total control of my left hand for about 10 to 15 minutes large tremors. continued with pain at injection site, unable to raise arm easily.  Arm pain continued daily, occasional heart palpitations mostly within first 3 days of vaccine, continued to have weird sensation throughout my left arm w/ slight heaviness.  On 1/6/21: Left armpit swelling noted with pain that increased with touch, red- raised/swollen- hot area noted to left injection site. 1/7/21: Same symptoms but swelling to left armpit slightly better, still tender, still strange left arm sensation from shoulder to fingertips- not able to use hand/ arm at 100%- have difficulty holding things and typing with left hand periodically, still has swollen reddened warm area at injection site to left deltoid.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: I received my vaccination at my place of work. Local pharmacy came in to administer them.  In less then a minute of recieving the vaccination I experienced a tightness in my chest and difficulty breathing.  I told my symptoms to the  pharmacist that was there.  I had to take my mask off due to the difficulty breathing.  I sat down and was trying to catch my breath.  Roughly 10 -15 minutes passes then my throat began to swell.  My extremities were feeling tingly and I was very dizzy.  I sat with my neck extended to maintain my airway until they could locate some benedryl.  My voice was wheezy when attempting to answer questions the pharmacist was asking.  The pharmacist wanted to administer the EpiPen but I would not allow her to because then they would have to call 911.  It took about 45 minutes in total to locate benedryl.  I took 50 mg.  Roughly 15 -20 minutes after taking the benedryl I was able to breath with ease.  I waited about another 15 minutes at the facility to ensure I was ok.  I was told I would not be recieving the second dose due to my anaphylactic reaction.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Paraesthesia, Pharyngeal swelling
Clinical narrative: I received my vaccination at my place of work. Local pharmacy came in to administer them.  In less then a minute of recieving the vaccination I experienced a tightness in my chest and difficulty breathing.  I told my symptoms to the  pharmacist that was there.  I had to take my mask off due to the difficulty breathing.  I sat down and was trying to catch my breath.  Roughly 10 -15 minutes passes then my throat began to swell.  My extremities were feeling tingly and I was very dizzy.  I sat with my neck extended to maintain my airway until they could locate some benedryl.  My voice was wheezy when attempting to answer questions the pharmacist was asking.  The pharmacist wanted to administer the EpiPen but I would not allow her to because then they would have to call 911.  It took about 45 minutes in total to locate benedryl.  I took 50 mg.  Roughly 15 -20 minutes after taking the benedryl I was able to breath with ease.  I waited about another 15 minutes at the facility to ensure I was ok.  I was told I would not be recieving the second dose due to my anaphylactic reaction.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: I received my vaccination at my place of work. Local pharmacy came in to administer them.  In less then a minute of recieving the vaccination I experienced a tightness in my chest and difficulty breathing.  I told my symptoms to the  pharmacist that was there.  I had to take my mask off due to the difficulty breathing.  I sat down and was trying to catch my breath.  Roughly 10 -15 minutes passes then my throat began to swell.  My extremities were feeling tingly and I was very dizzy.  I sat with my neck extended to maintain my airway until they could locate some benedryl.  My voice was wheezy when attempting to answer questions the pharmacist was asking.  The pharmacist wanted to administer the EpiPen but I would not allow her to because then they would have to call 911.  It took about 45 minutes in total to locate benedryl.  I took 50 mg.  Roughly 15 -20 minutes after taking the benedryl I was able to breath with ease.  I waited about another 15 minutes at the facility to ensure I was ok.  I was told I would not be recieving the second dose due to my anaphylactic reaction.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: redness, swelling and heat at the site of the injection x 7 days; hives on face and neck x 1 day
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Skin warm, Tenderness, Urticaria
Clinical narrative: redness, swelling and heat at the site of the injection x 7 days; hives on face and neck x 1 day
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: redness, swelling and heat at the site of the injection x 7 days; hives on face and neck x 1 day
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fine motor skill dysfunction, Hypoaesthesia, Paraesthesia
Clinical narrative: 9 days after the shot I developed symptoms of a brachial plexopathy including 1) posterior right shoulder pain 2) right arm weakness and 3) right arm paresthesias.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Muscular weakness, Paraesthesia
Clinical narrative: 9 days after the shot I developed symptoms of a brachial plexopathy including 1) posterior right shoulder pain 2) right arm weakness and 3) right arm paresthesias.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Dizziness, Dysphonia, Electrocardiogram abnormal
Clinical narrative: WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE  ED.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Rash, Throat irritation, Tremor
Clinical narrative: WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE  ED.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE  ED.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Heart rate abnormal, Nausea, Oropharyngeal discomfort
Clinical narrative: WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE  ED.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oedema peripheral
Clinical narrative: Pitting edema/Edema: It was her feet, ankles, and 3/4 way up her shins.; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiry date: Mar2021), intramuscular in the left deltoid on 17Dec2020 at 07:15 at single dose for COVID-19 immunization.  Medical history included ongoing neuralgia since 2003 (has nerve pain in her face and neck. It has never caused swelling and that she has had it for a long time. Symptoms started 17 years ago, became apparent in 2009), ongoing hypothyroidism since 2003 (Diagnosed about 17 years ago. Nothing has changed medication wise). The patient's concomitant medications were not reported.  The patient reported that she got the vaccine on 17Dec2020. On 25Dec2020, her shoes felt snug and by the next day she had 4 plus pitting edema. She could not fit in the shoes. She had the pitting edema for several days. She said that she went and bought compression stockings to help with the edema. It was her feet, ankles, and 3/4 way up her shins. It was more of the pedal area that was pitting. The patient further reported that she never had pitting edema before and the only thing new she had was the vaccine. Therapeutic measures were taken as a result of the event which included compression stockings. The patient was recovering from the event.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported event pitting edema. 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: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oedema, Oedema peripheral
Clinical narrative: Pitting edema/Edema: It was her feet, ankles, and 3/4 way up her shins.; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiry date: Mar2021), intramuscular in the left deltoid on 17Dec2020 at 07:15 at single dose for COVID-19 immunization.  Medical history included ongoing neuralgia since 2003 (has nerve pain in her face and neck. It has never caused swelling and that she has had it for a long time. Symptoms started 17 years ago, became apparent in 2009), ongoing hypothyroidism since 2003 (Diagnosed about 17 years ago. Nothing has changed medication wise). The patient's concomitant medications were not reported.  The patient reported that she got the vaccine on 17Dec2020. On 25Dec2020, her shoes felt snug and by the next day she had 4 plus pitting edema. She could not fit in the shoes. She had the pitting edema for several days. She said that she went and bought compression stockings to help with the edema. It was her feet, ankles, and 3/4 way up her shins. It was more of the pedal area that was pitting. The patient further reported that she never had pitting edema before and the only thing new she had was the vaccine. Therapeutic measures were taken as a result of the event which included compression stockings. The patient was recovering from the event.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported event pitting edema. 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: Chills, Dyspnoea, Heart rate increased, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Within 5 minutes of vaccination patient began to experience tachycardia and throat tightening. She was given 25 mg cap Benadryl PO and assistance was called when her heart rate reached 150 BPM about a minute later and further climbed to 188 BPM. She was transported to the Emergency Department where she was administered epinephrine, lorazepam, methylprednisolone, racepinephrine, and lactated ringers. She spent several hours in the Emergency Department and was discharged home but returned later that night at 06:00 PM for return of symptoms (tachycardia: 185 BPM, anxiety) and was administered Benadryl, solumedrol, Pepcid, Ativan, and Lactated Ringers. She was diagnosed with acute allergic reaction, nascent anaphylaxis, and panic attack. She went home again after this second ED visit.  On Monday, 1/4/21, the patient reported to Employee Health with resumption of symptoms. Calming techniques were discussed and she went to a quiet area for 15 minutes to compose herself. Employee Health Nurse referred patient to Employee Assistance Program for anxiety care.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oropharyngeal discomfort, Throat clearing, Throat tightness
Clinical narrative: Within 5 minutes of vaccination patient began to experience tachycardia and throat tightening. She was given 25 mg cap Benadryl PO and assistance was called when her heart rate reached 150 BPM about a minute later and further climbed to 188 BPM. She was transported to the Emergency Department where she was administered epinephrine, lorazepam, methylprednisolone, racepinephrine, and lactated ringers. She spent several hours in the Emergency Department and was discharged home but returned later that night at 06:00 PM for return of symptoms (tachycardia: 185 BPM, anxiety) and was administered Benadryl, solumedrol, Pepcid, Ativan, and Lactated Ringers. She was diagnosed with acute allergic reaction, nascent anaphylaxis, and panic attack. She went home again after this second ED visit.  On Monday, 1/4/21, the patient reported to Employee Health with resumption of symptoms. Calming techniques were discussed and she went to a quiet area for 15 minutes to compose herself. Employee Health Nurse referred patient to Employee Assistance Program for anxiety care.