chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Computerised tomogram head, Confusional state, Disorientation, Magnetic resonance imaging head
Clinical narrative: Patient lost memory. Couldn't remember his job, his grandchildren's ages,etc.; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 05:00 PM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included known allergies: mango, no other medical history. No covid prior vaccination. The patient's concomitant medications in two weeks were none. No other vaccine in four weeks. The patient lost memory. Couldn't remember his job, his grandchildren's ages, etc. Adverse event state date/time on 04Mar2021 18:00. AE resulted in emergency room/department or urgent care, hospitalization (1 day). It was unknown if treatment was received for the event. Outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia
Clinical narrative: Patient lost memory. Couldn't remember his job, his grandchildren's ages,etc.; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 05:00 PM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included known allergies: mango, no other medical history. No covid prior vaccination. The patient's concomitant medications in two weeks were none. No other vaccine in four weeks. The patient lost memory. Couldn't remember his job, his grandchildren's ages, etc. Adverse event state date/time on 04Mar2021 18:00. AE resulted in emergency room/department or urgent care, hospitalization (1 day). It was unknown if treatment was received for the event. Outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Erythema, Fatigue
Clinical narrative: On 03/08/2021, the patient received the Moderna COVID-19 vaccine into her left arm at an outpatient center. She was observed for 15 minutes left asymtomatic upon discharge from the clinic. She got in her car and started driving home and within 5 minutes, she experienced flushing of her cheeks and itching on her chin. She pulled over, and looked in the mirror on her visor and she noted that she was developing hives and swelling on her face and it was spreading down her neck. She proceeded to return back to the community center where she had received her vaccine and was assessed by the medical staff, she was given Benadryl and monitored. She states her blood pressure was elevated upon arrival and she states she never became hypotensive. She returned home when stable and she continued to take antihistamines every 8 hours and she slept for the remainder of that day and the next. She reports she had a Tmax of 101.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Headache, Hypertension, Impaired work ability, Joint swelling
Clinical narrative: On 03/08/2021, the patient received the Moderna COVID-19 vaccine into her left arm at an outpatient center. She was observed for 15 minutes left asymtomatic upon discharge from the clinic. She got in her car and started driving home and within 5 minutes, she experienced flushing of her cheeks and itching on her chin. She pulled over, and looked in the mirror on her visor and she noted that she was developing hives and swelling on her face and it was spreading down her neck. She proceeded to return back to the community center where she had received her vaccine and was assessed by the medical staff, she was given Benadryl and monitored. She states her blood pressure was elevated upon arrival and she states she never became hypotensive. She returned home when stable and she continued to take antihistamines every 8 hours and she slept for the remainder of that day and the next. She reports she had a Tmax of 101.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Malaise, Nervousness, Oropharyngeal discomfort, Pain
Clinical narrative: On 03/08/2021, the patient received the Moderna COVID-19 vaccine into her left arm at an outpatient center. She was observed for 15 minutes left asymtomatic upon discharge from the clinic. She got in her car and started driving home and within 5 minutes, she experienced flushing of her cheeks and itching on her chin. She pulled over, and looked in the mirror on her visor and she noted that she was developing hives and swelling on her face and it was spreading down her neck. She proceeded to return back to the community center where she had received her vaccine and was assessed by the medical staff, she was given Benadryl and monitored. She states her blood pressure was elevated upon arrival and she states she never became hypotensive. She returned home when stable and she continued to take antihistamines every 8 hours and she slept for the remainder of that day and the next. She reports she had a Tmax of 101.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Peripheral swelling, Pruritus, Pyrexia, Urticaria
Clinical narrative: On 03/08/2021, the patient received the Moderna COVID-19 vaccine into her left arm at an outpatient center. She was observed for 15 minutes left asymtomatic upon discharge from the clinic. She got in her car and started driving home and within 5 minutes, she experienced flushing of her cheeks and itching on her chin. She pulled over, and looked in the mirror on her visor and she noted that she was developing hives and swelling on her face and it was spreading down her neck. She proceeded to return back to the community center where she had received her vaccine and was assessed by the medical staff, she was given Benadryl and monitored. She states her blood pressure was elevated upon arrival and she states she never became hypotensive. She returned home when stable and she continued to take antihistamines every 8 hours and she slept for the remainder of that day and the next. She reports she had a Tmax of 101.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Flushing, Pruritus, Swelling face, Urticaria
Clinical narrative: On 03/08/2021, the patient received the Moderna COVID-19 vaccine into her left arm at an outpatient center. She was observed for 15 minutes left asymtomatic upon discharge from the clinic. She got in her car and started driving home and within 5 minutes, she experienced flushing of her cheeks and itching on her chin. She pulled over, and looked in the mirror on her visor and she noted that she was developing hives and swelling on her face and it was spreading down her neck. She proceeded to return back to the community center where she had received her vaccine and was assessed by the medical staff, she was given Benadryl and monitored. She states her blood pressure was elevated upon arrival and she states she never became hypotensive. She returned home when stable and she continued to take antihistamines every 8 hours and she slept for the remainder of that day and the next. She reports she had a Tmax of 101.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Swelling face, Vaccination site pain
Clinical narrative: Facial swelling, red hot cheeks.  I took one Benedryl tablet and heat & redness subsided.  24 hours later swelling was gone.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Swelling face
Clinical narrative: Facial swelling, red hot cheeks.  I took one Benedryl tablet and heat & redness subsided.  24 hours later swelling was gone.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: 10 minutes after shot experienced vagovasal episode.  Had a headache, sore muscles, and tiredness for 3 days after shot. Experienced a low grade fever and chills the 4th day on and off.  Experienced brain fog for about 6 days.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Chills, Computerised tomogram, Electrocardiogram, Fatigue
Clinical narrative: 10 minutes after shot experienced vagovasal episode.  Had a headache, sore muscles, and tiredness for 3 days after shot. Experienced a low grade fever and chills the 4th day on and off.  Experienced brain fog for about 6 days.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pregnancy test, Presyncope
Clinical narrative: 10 minutes after shot experienced vagovasal episode.  Had a headache, sore muscles, and tiredness for 3 days after shot. Experienced a low grade fever and chills the 4th day on and off.  Experienced brain fog for about 6 days.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: 10 minutes after shot experienced vagovasal episode.  Had a headache, sore muscles, and tiredness for 3 days after shot. Experienced a low grade fever and chills the 4th day on and off.  Experienced brain fog for about 6 days.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest discomfort, Choking sensation, Computerised tomogram neck, Drug screen negative
Clinical narrative: Difficulty swallowing; Shortness of breath; Big rash; A spontaneous report was received from a consumer  concerning a 18-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes.  The patient's medical history was not provided. Concomitant medications reported were birth control pill for drug use for unknown indication.  On 9 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced the event shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes.  Treatment details included went to the emergency room (ER), epinephrine, diphenhydramine, and dexamethasone..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Fibrin D dimer normal, Hypersensitivity, Intensive care, Rash
Clinical narrative: Difficulty swallowing; Shortness of breath; Big rash; A spontaneous report was received from a consumer  concerning a 18-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes.  The patient's medical history was not provided. Concomitant medications reported were birth control pill for drug use for unknown indication.  On 9 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced the event shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes.  Treatment details included went to the emergency room (ER), epinephrine, diphenhydramine, and dexamethasone..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Sinus tachycardia, Tachycardia
Clinical narrative: Difficulty swallowing; Shortness of breath; Big rash; A spontaneous report was received from a consumer  concerning a 18-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes.  The patient's medical history was not provided. Concomitant medications reported were birth control pill for drug use for unknown indication.  On 9 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced the event shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes.  Treatment details included went to the emergency room (ER), epinephrine, diphenhydramine, and dexamethasone..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Rash
Clinical narrative: Difficulty swallowing; Shortness of breath; Big rash; A spontaneous report was received from a consumer  concerning a 18-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes.  The patient's medical history was not provided. Concomitant medications reported were birth control pill for drug use for unknown indication.  On 9 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced the event shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes.  Treatment details included went to the emergency room (ER), epinephrine, diphenhydramine, and dexamethasone..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, shortness of breath, difficulty breathing, tightness on the throat, difficulty swallowing, big rash in forehead and under her eyes was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed a painful hives on bottoms of feet, hives later traveled to tops of feet, legs, hands and arms. Pain in feet lasting 5-7 days causing pain with pressure/walking. Hives/rash at the site of the injection also appeared at the same time (day 7 after vaccine) Evaluated by Clinic allergy as well as emergency dept. Felt to be an adverse reaction to COVID vaccine- recommended not receiving 2nd dose.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Developed a painful hives on bottoms of feet, hives later traveled to tops of feet, legs, hands and arms. Pain in feet lasting 5-7 days causing pain with pressure/walking. Hives/rash at the site of the injection also appeared at the same time (day 7 after vaccine) Evaluated by Clinic allergy as well as emergency dept. Felt to be an adverse reaction to COVID vaccine- recommended not receiving 2nd dose.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse reaction, Injection site rash, Injection site urticaria, Limb discomfort, Pain in extremity
Clinical narrative: Developed a painful hives on bottoms of feet, hives later traveled to tops of feet, legs, hands and arms. Pain in feet lasting 5-7 days causing pain with pressure/walking. Hives/rash at the site of the injection also appeared at the same time (day 7 after vaccine) Evaluated by Clinic allergy as well as emergency dept. Felt to be an adverse reaction to COVID vaccine- recommended not receiving 2nd dose.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Developed a painful hives on bottoms of feet, hives later traveled to tops of feet, legs, hands and arms. Pain in feet lasting 5-7 days causing pain with pressure/walking. Hives/rash at the site of the injection also appeared at the same time (day 7 after vaccine) Evaluated by Clinic allergy as well as emergency dept. Felt to be an adverse reaction to COVID vaccine- recommended not receiving 2nd dose.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: Took the Pfizer vaccine and  within two days,  swollen eyes and face.   My face has been swollen since then   I look like I have chipmunk cheeks, how long will this take before it goes away.  It is over a month The eyes  are sometimes swollen , but not as much,  just bags under my eyes   Is there  any other suggestions besides ice on face and taking  allegro,  and benedryl,  that will make the swelling go down permantly
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: Took the Pfizer vaccine and  within two days,  swollen eyes and face.   My face has been swollen since then   I look like I have chipmunk cheeks, how long will this take before it goes away.  It is over a month The eyes  are sometimes swollen , but not as much,  just bags under my eyes   Is there  any other suggestions besides ice on face and taking  allegro,  and benedryl,  that will make the swelling go down permantly
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye infection, Eye swelling, Hunger, Hypertension, Magnetic resonance imaging
Clinical narrative: Took the Pfizer vaccine and  within two days,  swollen eyes and face.   My face has been swollen since then   I look like I have chipmunk cheeks, how long will this take before it goes away.  It is over a month The eyes  are sometimes swollen , but not as much,  just bags under my eyes   Is there  any other suggestions besides ice on face and taking  allegro,  and benedryl,  that will make the swelling go down permantly
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin tightness, Swelling face, Vaccination site pain, Weight, Weight increased
Clinical narrative: Took the Pfizer vaccine and  within two days,  swollen eyes and face.   My face has been swollen since then   I look like I have chipmunk cheeks, how long will this take before it goes away.  It is over a month The eyes  are sometimes swollen , but not as much,  just bags under my eyes   Is there  any other suggestions besides ice on face and taking  allegro,  and benedryl,  that will make the swelling go down permantly
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Pt received COVID-19 vaccine on 03/04/21. Developed COVID-19 symptoms on 03/11. Went to the ER and tested positive for COVID-19 on 03/13/21 and was admitted to hospital.   Instructed by Health Department to fill this out.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt received COVID-19 vaccine on 03/04/21. Developed COVID-19 symptoms on 03/11. Went to the ER and tested positive for COVID-19 on 03/13/21 and was admitted to hospital.   Instructed by Health Department to fill this out.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram head
Clinical narrative: Left bell's palsy; Headache; Fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 58-year-old female patient received the second dose of BNT162B2 (lot number: EL1284), via an unspecified route of administration, administered in right arm on 06Jan2021 (at the age of 58-year-old) as single dose for COVID-19 immunization. Medical history included breast cancer, psoriasis, diabetes type 2, hbp (high blood pressure), hyperlipidemia. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously received the first dose of BNT162B2 (lot number: EH9899) via an unspecified route of administration, administered in right arm on 17Dec2020 09:30 (also reported as 08:30) (at the age of 58-year-old) at single dose for COVID-19 immunization. The patient previously took salbutamol (ALBUTEROL) and experienced allergies. The patient experienced left bell's palsy on 23Feb2021 06:00; and headache and fever both on an unspecified date.  The event left bell's palsy resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized on unspecified date due to left bell's palsy. No COVID prior vaccination and the patient was not COVID tested post vaccination. The outcome of the event left bell's palsy was recovering and the outcome of other events was unknown.; Sender's Comments: A contributory role of BNT162B2 to event bell's palsy cannot be excluded based on temporal association and known safety profile. 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: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Headache, Pyrexia
Clinical narrative: Left bell's palsy; Headache; Fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 58-year-old female patient received the second dose of BNT162B2 (lot number: EL1284), via an unspecified route of administration, administered in right arm on 06Jan2021 (at the age of 58-year-old) as single dose for COVID-19 immunization. Medical history included breast cancer, psoriasis, diabetes type 2, hbp (high blood pressure), hyperlipidemia. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously received the first dose of BNT162B2 (lot number: EH9899) via an unspecified route of administration, administered in right arm on 17Dec2020 09:30 (also reported as 08:30) (at the age of 58-year-old) at single dose for COVID-19 immunization. The patient previously took salbutamol (ALBUTEROL) and experienced allergies. The patient experienced left bell's palsy on 23Feb2021 06:00; and headache and fever both on an unspecified date.  The event left bell's palsy resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized on unspecified date due to left bell's palsy. No COVID prior vaccination and the patient was not COVID tested post vaccination. The outcome of the event left bell's palsy was recovering and the outcome of other events was unknown.; Sender's Comments: A contributory role of BNT162B2 to event bell's palsy cannot be excluded based on temporal association and known safety profile. 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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient developed delayed rash on 3/14 after having Moderna injection on 3/8.  Rash was in same arm as injection.  Arm is red, swollen, warm, and painful.  Symptoms have lasted until 3/19 but are improving slightly.  No symptomatic symptoms.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash, Skin reaction
Clinical narrative: Patient developed delayed rash on 3/14 after having Moderna injection on 3/8.  Rash was in same arm as injection.  Arm is red, swollen, warm, and painful.  Symptoms have lasted until 3/19 but are improving slightly.  No symptomatic symptoms.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm
Clinical narrative: Patient developed delayed rash on 3/14 after having Moderna injection on 3/8.  Rash was in same arm as injection.  Arm is red, swollen, warm, and painful.  Symptoms have lasted until 3/19 but are improving slightly.  No symptomatic symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash erythematous, Swelling
Clinical narrative: Diffuse erythematous raised blanchable wheals most consistent with acute urticaria, likely d/t vaccine reaction. Pt received 4 vaccines day prior to rash appearing and MMRV was the only new vaccine administered.   Timeline and symptoms not consistent with anaphylaxis, pt still eligible to receive remaining series of shots, reassurance provided.  Red flag/seek ER symptoms reviewed with mother. Self limited, no medication required, can continue Benadryl if desires to. Mother agreeable with plan.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, HEPA, HIBV, MMRV, PNC13
Symptoms: Erythema, Pallor, Rash erythematous, Rash papular, Urticaria
Clinical narrative: Diffuse erythematous raised blanchable wheals most consistent with acute urticaria, likely d/t vaccine reaction. Pt received 4 vaccines day prior to rash appearing and MMRV was the only new vaccine administered.   Timeline and symptoms not consistent with anaphylaxis, pt still eligible to receive remaining series of shots, reassurance provided.  Red flag/seek ER symptoms reviewed with mother. Self limited, no medication required, can continue Benadryl if desires to. Mother agreeable with plan.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Chest discomfort, Chills, Confusional state, Diarrhoea
Clinical narrative: person carries her own epi pen. She was reporting feeling flushed, chest heaviness. transported via EMS for observation on site
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Head discomfort, Headache, Muscle twitching, Pain
Clinical narrative: person carries her own epi pen. She was reporting feeling flushed, chest heaviness. transported via EMS for observation on site
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: person carries her own epi pen. She was reporting feeling flushed, chest heaviness. transported via EMS for observation on site
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Flushing
Clinical narrative: person carries her own epi pen. She was reporting feeling flushed, chest heaviness. transported via EMS for observation on site
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Head discomfort, Nausea
Clinical narrative: After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness resolved. Slight nausea when leaving felt much better. VS 168/90; 73; 97%SaO2
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Numbness in left arm and left hand, heat waves, chills, sweating of palms and feet, lightheaded, dizziness, restlessness. Began within 5 minutes of getting the vaccine. After about 4 hours, initial symptoms went away. For the next 48 hours, chills, body aches, fatigue, and left arm soreness.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Hot flush, Hyperhidrosis
Clinical narrative: Numbness in left arm and left hand, heat waves, chills, sweating of palms and feet, lightheaded, dizziness, restlessness. Began within 5 minutes of getting the vaccine. After about 4 hours, initial symptoms went away. For the next 48 hours, chills, body aches, fatigue, and left arm soreness.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Restlessness
Clinical narrative: Numbness in left arm and left hand, heat waves, chills, sweating of palms and feet, lightheaded, dizziness, restlessness. Began within 5 minutes of getting the vaccine. After about 4 hours, initial symptoms went away. For the next 48 hours, chills, body aches, fatigue, and left arm soreness.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Pharyngeal swelling, Pruritus, Sensation of foreign body
Clinical narrative: 3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfizer COVID vaccine on 3/17/21. She attended the Vaccination Clinic. Her appointment was at 1:35 PM. She states she had no symptoms that day. However, she woke up on 3/18/21 with two small hives in groin area which were itchy. By late afternoon her lips became tingly and she developed itchy hives on her arms which then spread to her trunk. By evening her lips with swollen. She took 2 tabs of Benadryl at 9:30 PM and went to bed. She woke up at 3:00 AM with her lips doubled in size and she felt like there was something stuck in her throat. She took two more tabs of Benadryl and went back to bed. She woke up on 3/20/21 with her throat feeling better and no more swelling of the lips. However, the hives remained spread over her arms and trunk. She called her PCP (who she had not seen in eight years) to report her allergic response and they did not want to see her in the office but encouraged her to go to ER or Urgent Care. Patient stated that she felt better by then and did not go to ER or Urgent Care. RN encouraged patient to go to Urgent Care due to seriousness of the original allergic response. Patient instructed to go to ER if symptoms such as the swollen lips or difficulty swallowing resume as they are more severe allergic signs and may require more urgent medical care. Patient verbalized understanding. Patient also encouraged to follow up with PCP and get a referral for allergy testing as appropriate. Patient states she will follow up with physician prior to her next dose of the Pfizer vaccine in 21 days. Patient also states that she has filled out a VAERS report of her own (Report # 366931).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: 3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfizer COVID vaccine on 3/17/21. She attended the Vaccination Clinic. Her appointment was at 1:35 PM. She states she had no symptoms that day. However, she woke up on 3/18/21 with two small hives in groin area which were itchy. By late afternoon her lips became tingly and she developed itchy hives on her arms which then spread to her trunk. By evening her lips with swollen. She took 2 tabs of Benadryl at 9:30 PM and went to bed. She woke up at 3:00 AM with her lips doubled in size and she felt like there was something stuck in her throat. She took two more tabs of Benadryl and went back to bed. She woke up on 3/20/21 with her throat feeling better and no more swelling of the lips. However, the hives remained spread over her arms and trunk. She called her PCP (who she had not seen in eight years) to report her allergic response and they did not want to see her in the office but encouraged her to go to ER or Urgent Care. Patient stated that she felt better by then and did not go to ER or Urgent Care. RN encouraged patient to go to Urgent Care due to seriousness of the original allergic response. Patient instructed to go to ER if symptoms such as the swollen lips or difficulty swallowing resume as they are more severe allergic signs and may require more urgent medical care. Patient verbalized understanding. Patient also encouraged to follow up with PCP and get a referral for allergy testing as appropriate. Patient states she will follow up with physician prior to her next dose of the Pfizer vaccine in 21 days. Patient also states that she has filled out a VAERS report of her own (Report # 366931).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: 3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfizer COVID vaccine on 3/17/21. She attended the Vaccination Clinic. Her appointment was at 1:35 PM. She states she had no symptoms that day. However, she woke up on 3/18/21 with two small hives in groin area which were itchy. By late afternoon her lips became tingly and she developed itchy hives on her arms which then spread to her trunk. By evening her lips with swollen. She took 2 tabs of Benadryl at 9:30 PM and went to bed. She woke up at 3:00 AM with her lips doubled in size and she felt like there was something stuck in her throat. She took two more tabs of Benadryl and went back to bed. She woke up on 3/20/21 with her throat feeling better and no more swelling of the lips. However, the hives remained spread over her arms and trunk. She called her PCP (who she had not seen in eight years) to report her allergic response and they did not want to see her in the office but encouraged her to go to ER or Urgent Care. Patient stated that she felt better by then and did not go to ER or Urgent Care. RN encouraged patient to go to Urgent Care due to seriousness of the original allergic response. Patient instructed to go to ER if symptoms such as the swollen lips or difficulty swallowing resume as they are more severe allergic signs and may require more urgent medical care. Patient verbalized understanding. Patient also encouraged to follow up with PCP and get a referral for allergy testing as appropriate. Patient states she will follow up with physician prior to her next dose of the Pfizer vaccine in 21 days. Patient also states that she has filled out a VAERS report of her own (Report # 366931).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Peripheral swelling, Rash pruritic, Sensation of foreign body, Swelling of eyelid
Clinical narrative: 3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfizer COVID vaccine on 3/17/21. She attended the Vaccination Clinic. Her appointment was at 1:35 PM. She states she had no symptoms that day. However, she woke up on 3/18/21 with two small hives in groin area which were itchy. By late afternoon her lips became tingly and she developed itchy hives on her arms which then spread to her trunk. By evening her lips with swollen. She took 2 tabs of Benadryl at 9:30 PM and went to bed. She woke up at 3:00 AM with her lips doubled in size and she felt like there was something stuck in her throat. She took two more tabs of Benadryl and went back to bed. She woke up on 3/20/21 with her throat feeling better and no more swelling of the lips. However, the hives remained spread over her arms and trunk. She called her PCP (who she had not seen in eight years) to report her allergic response and they did not want to see her in the office but encouraged her to go to ER or Urgent Care. Patient stated that she felt better by then and did not go to ER or Urgent Care. RN encouraged patient to go to Urgent Care due to seriousness of the original allergic response. Patient instructed to go to ER if symptoms such as the swollen lips or difficulty swallowing resume as they are more severe allergic signs and may require more urgent medical care. Patient verbalized understanding. Patient also encouraged to follow up with PCP and get a referral for allergy testing as appropriate. Patient states she will follow up with physician prior to her next dose of the Pfizer vaccine in 21 days. Patient also states that she has filled out a VAERS report of her own (Report # 366931).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: 3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfizer COVID vaccine on 3/17/21. She attended the Vaccination Clinic. Her appointment was at 1:35 PM. She states she had no symptoms that day. However, she woke up on 3/18/21 with two small hives in groin area which were itchy. By late afternoon her lips became tingly and she developed itchy hives on her arms which then spread to her trunk. By evening her lips with swollen. She took 2 tabs of Benadryl at 9:30 PM and went to bed. She woke up at 3:00 AM with her lips doubled in size and she felt like there was something stuck in her throat. She took two more tabs of Benadryl and went back to bed. She woke up on 3/20/21 with her throat feeling better and no more swelling of the lips. However, the hives remained spread over her arms and trunk. She called her PCP (who she had not seen in eight years) to report her allergic response and they did not want to see her in the office but encouraged her to go to ER or Urgent Care. Patient stated that she felt better by then and did not go to ER or Urgent Care. RN encouraged patient to go to Urgent Care due to seriousness of the original allergic response. Patient instructed to go to ER if symptoms such as the swollen lips or difficulty swallowing resume as they are more severe allergic signs and may require more urgent medical care. Patient verbalized understanding. Patient also encouraged to follow up with PCP and get a referral for allergy testing as appropriate. Patient states she will follow up with physician prior to her next dose of the Pfizer vaccine in 21 days. Patient also states that she has filled out a VAERS report of her own (Report # 366931).
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Meningitis aseptic, Mental status changes, Pyrexia
Clinical narrative: Sudden High Fever after 10 days and lost cognition of self and others around in few minutes. Did not recognize anyone and self. Did not respond to anything but conscious and awake. The patient did not eat or drink anything and did to open mouth. Paramedics was called in to take him tot he hospital. Fever did not subside for 20 hrs even after admission tot he hospital. Regained cognition of everything after 3 days. Was on Anti-viral, Anti-Bacterial and steroids for about 5 days .
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cognitive disorder, Lumbar puncture, Magnetic resonance imaging, Pyrexia
Clinical narrative: Sudden High Fever after 10 days and lost cognition of self and others around in few minutes. Did not recognize anyone and self. Did not respond to anything but conscious and awake. The patient did not eat or drink anything and did to open mouth. Paramedics was called in to take him tot he hospital. Fever did not subside for 20 hrs even after admission tot he hospital. Regained cognition of everything after 3 days. Was on Anti-viral, Anti-Bacterial and steroids for about 5 days .
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose was given 21 days after the first dose instead of the recommended 28 day interval.  Dose given too soon.  No harm noted.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Headache-Medium
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Headache, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Headache-Medium
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: At 12:35 PM mother hollered for help, patient was pale, skin was cold and clammy, and slight left side facial droop, facial droop resolved pretty quickly, Patient was given soda to drink and a squad was called for further evaluation, squad arrived at 12:57, vital signs was taken, BP 106/72, Spo2 100%, Pulse 76, Patient refused to go to hospital, patient left with family.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Facial paralysis, Pallor
Clinical narrative: At 12:35 PM mother hollered for help, patient was pale, skin was cold and clammy, and slight left side facial droop, facial droop resolved pretty quickly, Patient was given soda to drink and a squad was called for further evaluation, squad arrived at 12:57, vital signs was taken, BP 106/72, Spo2 100%, Pulse 76, Patient refused to go to hospital, patient left with family.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Hypoaesthesia, Hypoaesthesia oral, Swollen tongue, Throat tightness
Clinical narrative: on 3/4 went to ED w/ numbness in throat and rib cage pain.  Treated with prednisone, hydroxyzine/ atarax and discharged home
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: on 3/4 went to ED w/ numbness in throat and rib cage pain.  Treated with prednisone, hydroxyzine/ atarax and discharged home
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Pharyngeal hypoaesthesia
Clinical narrative: on 3/4 went to ED w/ numbness in throat and rib cage pain.  Treated with prednisone, hydroxyzine/ atarax and discharged home
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Extremity contracture, Myalgia, Pain in extremity
Clinical narrative: has arthritis but this made it worse; three fingers on the arm of the injection are not working...can't straighten them; Three fingers are really sore; Arm is swollen; Face is swelling; Joint pain (hip); Calves hurt; A spontaneous report was received from a 82-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events three fingers on the arm of the injection are not working, three fingers are really sore, can't straighten three fingers, has arthritis but this made it worse, arm is swollen, face is swelling, joint pain (hip) and calves hurt.  The patient's medical history included congestive heart failure, atrial fibrillation, arthritis and neuropathy on her feet.  Relevant concomitant medications were reported as apixaban, immunoglobulin injection every week and gabapentin.  On 15-JAN-2021, prior to the onset of the events, the consumer received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date, the consumer experienced the three fingers on the arm of the injection were not working and the three fingers were really sore and she could not straighten the three fingers.  Additionally, she reported that the vaccine had made her arthritis worse, that her arm was swollen, her face was swelling, she had  joint pain in her hip and her calves hurt as well.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events, three fingers on the arm of the injection are not working, three fingers are really sore, can't straighten three fingers, has arthritis but this made it worse, arm is swollen, face is swelling, joint pain (hip) and calves hurt, were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: has arthritis but this made it worse; three fingers on the arm of the injection are not working...can't straighten them; Three fingers are really sore; Arm is swollen; Face is swelling; Joint pain (hip); Calves hurt; A spontaneous report was received from a 82-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events three fingers on the arm of the injection are not working, three fingers are really sore, can't straighten three fingers, has arthritis but this made it worse, arm is swollen, face is swelling, joint pain (hip) and calves hurt.  The patient's medical history included congestive heart failure, atrial fibrillation, arthritis and neuropathy on her feet.  Relevant concomitant medications were reported as apixaban, immunoglobulin injection every week and gabapentin.  On 15-JAN-2021, prior to the onset of the events, the consumer received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date, the consumer experienced the three fingers on the arm of the injection were not working and the three fingers were really sore and she could not straighten the three fingers.  Additionally, she reported that the vaccine had made her arthritis worse, that her arm was swollen, her face was swelling, she had  joint pain in her hip and her calves hurt as well.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events, three fingers on the arm of the injection are not working, three fingers are really sore, can't straighten three fingers, has arthritis but this made it worse, arm is swollen, face is swelling, joint pain (hip) and calves hurt, were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: diagnosed with IBS; A spontaneous report was received from a consumer, who is a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed with irritable bowel syndrome (IBS).  The patient's medication history was not reported. No relevant concomitant medications were reported.  On an unspecified date, the patient received the second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection. On an unspecified date after receiving vaccine, the patient experienced body aches, fever and chills. She went into the emergency room and was diagnosed with irritable bowel syndrome. She was self-medicating with acetaminophen for alleviating her symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.