chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pain
Clinical narrative: Exhausted for a couple of weeks afterward each shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 16:00 (Lot number: Er2613) at the age of 49 years as dose 2, single and administration date 18Mar2021 09:00 (Lot number: Er2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Apr2021), described as "Exhausted for a couple of weeks afterward each shot". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: Exhausted for a couple of weeks afterward each shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 16:00 (Lot number: Er2613) at the age of 49 years as dose 2, single and administration date 18Mar2021 09:00 (Lot number: Er2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Apr2021), described as "Exhausted for a couple of weeks afterward each shot". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Peripheral swelling, Pruritus, SARS-CoV-2 test negative, Urticaria
Clinical narrative: swelling area on left palm under first digit as well as her left thumb swelling.; right palm developed hive/swelling.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 11:15 (Lot number: 331308A) at the age of 16 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Vaccination history included: Pfizer (Dose Number: 2, Batch/Lot No: EW0177), administration date: 08Jun2021, when the patient was 15 years old, for COVID-19 immunization. Pfizer (Dose Number: 1, Batch/Lot No: EW0169), administration date: 18May2021, when the patient was 15 years old, for COVID-19 immunization.  The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 28Dec2021 11:30, outcome "not recovered", described as "swelling area on left palm under first digit as well as her left thumb swelling."; URTICARIA (non-serious) with onset 28Dec2021 11:30, outcome "not recovered", described as "right palm developed hive/swelling.". The events "swelling area on left palm under first digit as well as her left thumb swelling." and "right palm developed hive/swelling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, urticaria.  Additional information: if other vaccine in four weeks: No, If covid prior vaccine: No. The reporter reporting this about daughter. Patient was taken to pharmacy on 28Dec2021 for her booster shot of Pfizer (3 shot) and observed with safe administration by pharmacy. They remained in store and 5 minutes later, Pt became alarmed and showed rapidly swelling area on left palm under first digit as well as her left thumb swelling. She had no respiratory distress, no GI distress, no wheezing. The reporter had Benadryl in purse and immediately gave her 25 mg Benadryl and calmly observed her. Then her right palm developed hive/swelling. Again, no trouble breathing. She remained in store for about 10 more minutes to make sure she did not need to call 911. Patient was taken to home and called PCP and was able to get appointment for 4:15pm. She was taken to PCP for evaluation. He recommended Zyrtec 10 mg 1-2 times per day and to use Benadryl for breakthrough hives. Today, 30Dec2021 she has hives again however no respiratory distress. Referral made to Allergist. AE treatment included Zyrtec, Benadryl, PCP Visit, Allergist Future Appt. Covid test post vaccination: included Nasal Swab, covid test name post vaccination, Abbott-Afinity, covid test date=28Dec2021, covid test result was Negative.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Urticaria
Clinical narrative: swelling area on left palm under first digit as well as her left thumb swelling.; right palm developed hive/swelling.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 11:15 (Lot number: 331308A) at the age of 16 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Vaccination history included: Pfizer (Dose Number: 2, Batch/Lot No: EW0177), administration date: 08Jun2021, when the patient was 15 years old, for COVID-19 immunization. Pfizer (Dose Number: 1, Batch/Lot No: EW0169), administration date: 18May2021, when the patient was 15 years old, for COVID-19 immunization.  The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 28Dec2021 11:30, outcome "not recovered", described as "swelling area on left palm under first digit as well as her left thumb swelling."; URTICARIA (non-serious) with onset 28Dec2021 11:30, outcome "not recovered", described as "right palm developed hive/swelling.". The events "swelling area on left palm under first digit as well as her left thumb swelling." and "right palm developed hive/swelling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, urticaria.  Additional information: if other vaccine in four weeks: No, If covid prior vaccine: No. The reporter reporting this about daughter. Patient was taken to pharmacy on 28Dec2021 for her booster shot of Pfizer (3 shot) and observed with safe administration by pharmacy. They remained in store and 5 minutes later, Pt became alarmed and showed rapidly swelling area on left palm under first digit as well as her left thumb swelling. She had no respiratory distress, no GI distress, no wheezing. The reporter had Benadryl in purse and immediately gave her 25 mg Benadryl and calmly observed her. Then her right palm developed hive/swelling. Again, no trouble breathing. She remained in store for about 10 more minutes to make sure she did not need to call 911. Patient was taken to home and called PCP and was able to get appointment for 4:15pm. She was taken to PCP for evaluation. He recommended Zyrtec 10 mg 1-2 times per day and to use Benadryl for breakthrough hives. Today, 30Dec2021 she has hives again however no respiratory distress. Referral made to Allergist. AE treatment included Zyrtec, Benadryl, PCP Visit, Allergist Future Appt. Covid test post vaccination: included Nasal Swab, covid test name post vaccination, Abbott-Afinity, covid test date=28Dec2021, covid test result was Negative.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dyspnoea, Electrocardiogram normal, Hypoaesthesia, Seizure
Clinical narrative: mild seizure; upset stomach; trouble breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2022 12:00 (Lot number: Ph8030) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: Within 5 minutes of injection he complained of SEIZURE (medically significant) with onset 09Jan2022 12:00, outcome "recovered", described as "mild seizure" that lasted 1-2 minutes, ABDOMINAL DISCOMFORT (non-serious) with onset 09Jan2022 12:00, outcome "unknown", described as "upset stomach"; DYSPNOEA (non-serious) with onset 09Jan2022 12:00, outcome "unknown", described as "trouble breathing". The events "mild seizure", "upset stomach" and "trouble breathing" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of seizure, abdominal discomfort, dyspnoea. No known allergies. No other vaccine in four weeks. No other medications in two weeks. Patient had COVID prior vaccination. Did not tested COVID post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Seizure
Clinical narrative: mild seizure; upset stomach; trouble breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2022 12:00 (Lot number: Ph8030) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: Within 5 minutes of injection he complained of SEIZURE (medically significant) with onset 09Jan2022 12:00, outcome "recovered", described as "mild seizure" that lasted 1-2 minutes, ABDOMINAL DISCOMFORT (non-serious) with onset 09Jan2022 12:00, outcome "unknown", described as "upset stomach"; DYSPNOEA (non-serious) with onset 09Jan2022 12:00, outcome "unknown", described as "trouble breathing". The events "mild seizure", "upset stomach" and "trouble breathing" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of seizure, abdominal discomfort, dyspnoea. No known allergies. No other vaccine in four weeks. No other medications in two weeks. Patient had COVID prior vaccination. Did not tested COVID post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: mild seizure; upset stomach; trouble breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2022 12:00 (Lot number: Ph8030) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: Within 5 minutes of injection he complained of SEIZURE (medically significant) with onset 09Jan2022 12:00, outcome "recovered", described as "mild seizure" that lasted 1-2 minutes, ABDOMINAL DISCOMFORT (non-serious) with onset 09Jan2022 12:00, outcome "unknown", described as "upset stomach"; DYSPNOEA (non-serious) with onset 09Jan2022 12:00, outcome "unknown", described as "trouble breathing". The events "mild seizure", "upset stomach" and "trouble breathing" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of seizure, abdominal discomfort, dyspnoea. No known allergies. No other vaccine in four weeks. No other medications in two weeks. Patient had COVID prior vaccination. Did not tested COVID post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: mild seizure; upset stomach; trouble breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2022 12:00 (Lot number: Ph8030) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: Within 5 minutes of injection he complained of SEIZURE (medically significant) with onset 09Jan2022 12:00, outcome "recovered", described as "mild seizure" that lasted 1-2 minutes, ABDOMINAL DISCOMFORT (non-serious) with onset 09Jan2022 12:00, outcome "unknown", described as "upset stomach"; DYSPNOEA (non-serious) with onset 09Jan2022 12:00, outcome "unknown", described as "trouble breathing". The events "mild seizure", "upset stomach" and "trouble breathing" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of seizure, abdominal discomfort, dyspnoea. No known allergies. No other vaccine in four weeks. No other medications in two weeks. Patient had COVID prior vaccination. Did not tested COVID post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Patient was given pediatric dose. Patient is 12 years old therefore qualifies for adult dose.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given pediatric dose. Patient is 12 years old therefore qualifies for adult dose.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chronic pigmented purpura, Rash
Clinical narrative: left deltoid area is still very sore five weeks after injection; Unable to left above my shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 (Batch/Lot number: unknown) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart Problems" (unspecified if ongoing), notes: Heart Problems; "known allergies: Contrast Dye" (unspecified if ongoing), notes: known allergies: Contrast Dye. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose brand: Pfizer EN6205,, Location of injection: Arm Left), administration date: 05Mar2021, for COVID-19 Immunization, reaction(s): "rash", "arthritis pain"; Bnt162b2 (Dose Number: 1, prev dose brand: Pfizer EM9810, Location of injection: Arm Left), administration date: 11Feb2021, for COVID-19 Immunization, reaction(s): "rash", "arthritis pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Nov2021, outcome "not recovered", described as "left deltoid area is still very sore five weeks after injection"; MOVEMENT DISORDER (non-serious) with onset 26Nov2021, outcome "not recovered", described as "Unable to left above my shoulder". Therapeutic measures were not taken as a result of vaccination site pain, movement disorder.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received hypertension medicines within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Vaccination site pain
Clinical narrative: left deltoid area is still very sore five weeks after injection; Unable to left above my shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 (Batch/Lot number: unknown) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart Problems" (unspecified if ongoing), notes: Heart Problems; "known allergies: Contrast Dye" (unspecified if ongoing), notes: known allergies: Contrast Dye. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose brand: Pfizer EN6205,, Location of injection: Arm Left), administration date: 05Mar2021, for COVID-19 Immunization, reaction(s): "rash", "arthritis pain"; Bnt162b2 (Dose Number: 1, prev dose brand: Pfizer EM9810, Location of injection: Arm Left), administration date: 11Feb2021, for COVID-19 Immunization, reaction(s): "rash", "arthritis pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Nov2021, outcome "not recovered", described as "left deltoid area is still very sore five weeks after injection"; MOVEMENT DISORDER (non-serious) with onset 26Nov2021, outcome "not recovered", described as "Unable to left above my shoulder". Therapeutic measures were not taken as a result of vaccination site pain, movement disorder.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received hypertension medicines within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Pain, Rash
Clinical narrative: rash formed above knee on day 4; Extreme right knee pain with swelling and joint stiffness; Extreme right knee pain with swelling and joint stiffness; Extreme right knee pain with swelling and joint stiffness; could not stand up or walk without pain for 5 days; could not stand up or walk without pain for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 14:15 (Lot number: FJ1614) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Covid prior vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EW0158, Location of injection: Right Arm, Vaccine Administration Time: 05:30 PM), administration date: 14Apr2021, when the patient was 59 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: ER8730, Location of injection: Left Arm, Vaccine Administration Time: 05:30 PM), administration date: 24Mar2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: JOINT SWELLING (disability), ARTHRALGIA (disability), JOINT STIFFNESS (disability) all with onset 07Jan2022 22:00, outcome "recovering" and all described as "Extreme right knee pain with swelling and joint stiffness"; GAIT DISTURBANCE (disability) with onset 07Jan2022 22:00, outcome "recovered" (Jan2022), PAIN (disability) with onset 07Jan2022 22:00, outcome "recovered" and all described as "could not stand up or walk without pain for 5 days"; RASH (disability) with onset 11Jan2022, outcome "recovering", described as "rash formed above knee on day 4". Therapeutic measures were taken as a result of joint swelling, arthralgia, pain. Therapeutic measures were not taken as a result of joint stiffness, gait disturbance, rash. Follow-up attempts are completed. No further information is expected. .
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Joint stiffness, Joint swelling, Pain
Clinical narrative: rash formed above knee on day 4; Extreme right knee pain with swelling and joint stiffness; Extreme right knee pain with swelling and joint stiffness; Extreme right knee pain with swelling and joint stiffness; could not stand up or walk without pain for 5 days; could not stand up or walk without pain for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 14:15 (Lot number: FJ1614) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Covid prior vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EW0158, Location of injection: Right Arm, Vaccine Administration Time: 05:30 PM), administration date: 14Apr2021, when the patient was 59 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: ER8730, Location of injection: Left Arm, Vaccine Administration Time: 05:30 PM), administration date: 24Mar2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: JOINT SWELLING (disability), ARTHRALGIA (disability), JOINT STIFFNESS (disability) all with onset 07Jan2022 22:00, outcome "recovering" and all described as "Extreme right knee pain with swelling and joint stiffness"; GAIT DISTURBANCE (disability) with onset 07Jan2022 22:00, outcome "recovered" (Jan2022), PAIN (disability) with onset 07Jan2022 22:00, outcome "recovered" and all described as "could not stand up or walk without pain for 5 days"; RASH (disability) with onset 11Jan2022, outcome "recovering", described as "rash formed above knee on day 4". Therapeutic measures were taken as a result of joint swelling, arthralgia, pain. Therapeutic measures were not taken as a result of joint stiffness, gait disturbance, rash. Follow-up attempts are completed. No further information is expected. .
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash formed above knee on day 4; Extreme right knee pain with swelling and joint stiffness; Extreme right knee pain with swelling and joint stiffness; Extreme right knee pain with swelling and joint stiffness; could not stand up or walk without pain for 5 days; could not stand up or walk without pain for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 14:15 (Lot number: FJ1614) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Covid prior vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EW0158, Location of injection: Right Arm, Vaccine Administration Time: 05:30 PM), administration date: 14Apr2021, when the patient was 59 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: ER8730, Location of injection: Left Arm, Vaccine Administration Time: 05:30 PM), administration date: 24Mar2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: JOINT SWELLING (disability), ARTHRALGIA (disability), JOINT STIFFNESS (disability) all with onset 07Jan2022 22:00, outcome "recovering" and all described as "Extreme right knee pain with swelling and joint stiffness"; GAIT DISTURBANCE (disability) with onset 07Jan2022 22:00, outcome "recovered" (Jan2022), PAIN (disability) with onset 07Jan2022 22:00, outcome "recovered" and all described as "could not stand up or walk without pain for 5 days"; RASH (disability) with onset 11Jan2022, outcome "recovering", described as "rash formed above knee on day 4". Therapeutic measures were taken as a result of joint swelling, arthralgia, pain. Therapeutic measures were not taken as a result of joint stiffness, gait disturbance, rash. Follow-up attempts are completed. No further information is expected. .
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Palpitations, Troponin increased
Clinical narrative: Vaccine associated myocarditis
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Electrocardiogram PR segment depression, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myocarditis
Clinical narrative: Vaccine associated myocarditis
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased, Sinus tachycardia, Troponin I increased, Vaccination complication
Clinical narrative: Vaccine associated myocarditis
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Illness, Tremor, Vomiting
Clinical narrative: Approx 8-10 min after vaccine administration, I vomited and remained nauseated for 24 hours. Pallor was present. Approx 4 hours in I had shortness of breath and some cyanosis around my mouth (blue lips as well). I had been sweeping. I stopped and went to lie down. I had a can of ?Oxygen in a can?. I took in some of that over the course of  30 minuets.  I started to develop chest pain that I initially attributed to anxiety. But, had felt general malaise the entire time. The chest pain got severe enough I called the ER. I preformed my own ECG and submitted it to the ER. It looked good. My saturation was WNL as well as the rest of my vitals. I started with fairly severe body aches by 11 pm. Those steadily increased and by 2:30-3 PM on the 20th I was in clinic receiving IV fluids and IM pain medication. I struggled with SOB and went in for a COVID swab on Monday 1/24/22. This came out positive. I had been tested the day of my vaccination and had been testing every other day for over a week. 1/25/22 the sob got severe enough I started a prednisone pack I had left over and text my provider about starting that. By the next afternoon, the sob and tightness in my chest began to improve. I am still experiencing fatigue and spinal pain (which I got with my first bout of COVID and each vaccination).
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest pain, Cyanosis, Dyspnoea, Malaise
Clinical narrative: Approx 8-10 min after vaccine administration, I vomited and remained nauseated for 24 hours. Pallor was present. Approx 4 hours in I had shortness of breath and some cyanosis around my mouth (blue lips as well). I had been sweeping. I stopped and went to lie down. I had a can of ?Oxygen in a can?. I took in some of that over the course of  30 minuets.  I started to develop chest pain that I initially attributed to anxiety. But, had felt general malaise the entire time. The chest pain got severe enough I called the ER. I preformed my own ECG and submitted it to the ER. It looked good. My saturation was WNL as well as the rest of my vitals. I started with fairly severe body aches by 11 pm. Those steadily increased and by 2:30-3 PM on the 20th I was in clinic receiving IV fluids and IM pain medication. I struggled with SOB and went in for a COVID swab on Monday 1/24/22. This came out positive. I had been tested the day of my vaccination and had been testing every other day for over a week. 1/25/22 the sob got severe enough I started a prednisone pack I had left over and text my provider about starting that. By the next afternoon, the sob and tightness in my chest began to improve. I am still experiencing fatigue and spinal pain (which I got with my first bout of COVID and each vaccination).
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pallor, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Approx 8-10 min after vaccine administration, I vomited and remained nauseated for 24 hours. Pallor was present. Approx 4 hours in I had shortness of breath and some cyanosis around my mouth (blue lips as well). I had been sweeping. I stopped and went to lie down. I had a can of ?Oxygen in a can?. I took in some of that over the course of  30 minuets.  I started to develop chest pain that I initially attributed to anxiety. But, had felt general malaise the entire time. The chest pain got severe enough I called the ER. I preformed my own ECG and submitted it to the ER. It looked good. My saturation was WNL as well as the rest of my vitals. I started with fairly severe body aches by 11 pm. Those steadily increased and by 2:30-3 PM on the 20th I was in clinic receiving IV fluids and IM pain medication. I struggled with SOB and went in for a COVID swab on Monday 1/24/22. This came out positive. I had been tested the day of my vaccination and had been testing every other day for over a week. 1/25/22 the sob got severe enough I started a prednisone pack I had left over and text my provider about starting that. By the next afternoon, the sob and tightness in my chest began to improve. I am still experiencing fatigue and spinal pain (which I got with my first bout of COVID and each vaccination).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blister, Drug ineffective, Eczema, Herpes zoster
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 64 year-old male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number unknown), for COVID-19 Immunization, reaction(s): "blister", "eczema", "Started affecting my one eye", "Initially got some kind of covid in the fall and triggered."; Bnt162b2 (Dose number unknown), for COVID-19 immunization, reaction(s): "anaphylactic", "Initially got some kind of covid in the fall and triggered.", "shingles", "I have a spot by nose and eyebrow", "itches", "skin rash", "looks like hives". The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Really flared up and trouble controlling it". Additional information: It was reported that, this has been going on 3 or 4 months now. About two months actually went to ER type place. HCP thought Eczema blister like shingles. Controlling it with Gabapentin, Benadryl and some Eczema. Started affecting my one eye. Initially got some kind of covid in the fall and triggered. Booster two weeks ago. Really flared up and trouble controlling it. 64. Shingles shot. I would. This checks every box in the books for shingles. Every time patient went to the doctor rash under control. Patient would describe it as anaphylactic. It looks like hives. Benadryl does help with the itches. Generally, you get that as soon as they got the shot. Patient can't believe it's eczema. Patient have a spot by nose and eyebrow. Doesn't seem like Eczema. Patient got Medicare and shouldn't have any trouble. May be gone or it may be worse. If happens to die off, patient going to run down and get the shingles vaccine. Patient was putting off the booster. Got the booster two weeks ago. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200037715 Same patient, different dose and events
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Macule, Ocular discomfort, Pruritus, Rash, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 64 year-old male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number unknown), for COVID-19 Immunization, reaction(s): "blister", "eczema", "Started affecting my one eye", "Initially got some kind of covid in the fall and triggered."; Bnt162b2 (Dose number unknown), for COVID-19 immunization, reaction(s): "anaphylactic", "Initially got some kind of covid in the fall and triggered.", "shingles", "I have a spot by nose and eyebrow", "itches", "skin rash", "looks like hives". The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Really flared up and trouble controlling it". Additional information: It was reported that, this has been going on 3 or 4 months now. About two months actually went to ER type place. HCP thought Eczema blister like shingles. Controlling it with Gabapentin, Benadryl and some Eczema. Started affecting my one eye. Initially got some kind of covid in the fall and triggered. Booster two weeks ago. Really flared up and trouble controlling it. 64. Shingles shot. I would. This checks every box in the books for shingles. Every time patient went to the doctor rash under control. Patient would describe it as anaphylactic. It looks like hives. Benadryl does help with the itches. Generally, you get that as soon as they got the shot. Patient can't believe it's eczema. Patient have a spot by nose and eyebrow. Doesn't seem like Eczema. Patient got Medicare and shouldn't have any trouble. May be gone or it may be worse. If happens to die off, patient going to run down and get the shingles vaccine. Patient was putting off the booster. Got the booster two weeks ago. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200037715 Same patient, different dose and events
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 64 year-old male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number unknown), for COVID-19 Immunization, reaction(s): "blister", "eczema", "Started affecting my one eye", "Initially got some kind of covid in the fall and triggered."; Bnt162b2 (Dose number unknown), for COVID-19 immunization, reaction(s): "anaphylactic", "Initially got some kind of covid in the fall and triggered.", "shingles", "I have a spot by nose and eyebrow", "itches", "skin rash", "looks like hives". The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Really flared up and trouble controlling it". Additional information: It was reported that, this has been going on 3 or 4 months now. About two months actually went to ER type place. HCP thought Eczema blister like shingles. Controlling it with Gabapentin, Benadryl and some Eczema. Started affecting my one eye. Initially got some kind of covid in the fall and triggered. Booster two weeks ago. Really flared up and trouble controlling it. 64. Shingles shot. I would. This checks every box in the books for shingles. Every time patient went to the doctor rash under control. Patient would describe it as anaphylactic. It looks like hives. Benadryl does help with the itches. Generally, you get that as soon as they got the shot. Patient can't believe it's eczema. Patient have a spot by nose and eyebrow. Doesn't seem like Eczema. Patient got Medicare and shouldn't have any trouble. May be gone or it may be worse. If happens to die off, patient going to run down and get the shingles vaccine. Patient was putting off the booster. Got the booster two weeks ago. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200037715 Same patient, different dose and events
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 64 year-old male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number unknown), for COVID-19 Immunization, reaction(s): "blister", "eczema", "Started affecting my one eye", "Initially got some kind of covid in the fall and triggered."; Bnt162b2 (Dose number unknown), for COVID-19 immunization, reaction(s): "anaphylactic", "Initially got some kind of covid in the fall and triggered.", "shingles", "I have a spot by nose and eyebrow", "itches", "skin rash", "looks like hives". The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Really flared up and trouble controlling it". Additional information: It was reported that, this has been going on 3 or 4 months now. About two months actually went to ER type place. HCP thought Eczema blister like shingles. Controlling it with Gabapentin, Benadryl and some Eczema. Started affecting my one eye. Initially got some kind of covid in the fall and triggered. Booster two weeks ago. Really flared up and trouble controlling it. 64. Shingles shot. I would. This checks every box in the books for shingles. Every time patient went to the doctor rash under control. Patient would describe it as anaphylactic. It looks like hives. Benadryl does help with the itches. Generally, you get that as soon as they got the shot. Patient can't believe it's eczema. Patient have a spot by nose and eyebrow. Doesn't seem like Eczema. Patient got Medicare and shouldn't have any trouble. May be gone or it may be worse. If happens to die off, patient going to run down and get the shingles vaccine. Patient was putting off the booster. Got the booster two weeks ago. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200037715 Same patient, different dose and events
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP, patient's relative) from medical information team.  A female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "very tired ". Clinical course: Patient was very tired the next day after receiving her shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329174 Same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: can not see it on her hands and is 70% cleared up; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "psoriasis" (unspecified if ongoing), notes: Caller has had psoriasis for over 40 years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "can not see it on her hands and is 70% cleared up". Additional Information: The patient received 1st dose of Covid vaccine on Sunday. The patient has had psoriasis for over 40 years and within 24 hours of taking the vaccine, she cannot see it on her hands and is 70% cleared up on knees and below knees.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Eye pain, Headache, Injection site pain, Magnetic resonance imaging
Clinical narrative: Patient called us on January 25, 2022 after receiving her vaccine on November 2, 2021 stating that her arm/shoulder was still hurting her.  She stated the pain had initially gone away but returned and she had tingling down her arm to her fingers and up her neck that subsequently required and cortisone shot, xray and MRI.  Patient states it is from the vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Oral pain, Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Patient called us on January 25, 2022 after receiving her vaccine on November 2, 2021 stating that her arm/shoulder was still hurting her.  She stated the pain had initially gone away but returned and she had tingling down her arm to her fingers and up her neck that subsequently required and cortisone shot, xray and MRI.  Patient states it is from the vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Patient called us on January 25, 2022 after receiving her vaccine on November 2, 2021 stating that her arm/shoulder was still hurting her.  She stated the pain had initially gone away but returned and she had tingling down her arm to her fingers and up her neck that subsequently required and cortisone shot, xray and MRI.  Patient states it is from the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Headache
Clinical narrative: Passed out cold/lost consciousness; violently ill; really sweating; Vomited; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 021C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood test: antibodies (Inconclusive) Had antibodies and donated plasma.         Company comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the non-serious expected events loss of consciousness, illness and hyperhidrosis and expected vomiting and chills. The events occurred the next day after the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medications were reported. Patient did not take any medications for the symptom relief. Patient stayed in bed for 2 days to recover.   This case was linked to MOD-2022-460285 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the non-serious expected events loss of consciousness, illness and hyperhidrosis and expected vomiting and chills. The events occurred the next day after the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.