chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: developed rash on the right side of his neck; cough; pain on the right side of his neck; pain at the injection site; had redness; had swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER).   On 18th February 2021, the patient received the 1st dose of Shingrix. In February 2021, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, erythema, swelling, rash, cough and neck pain. On an unknown date, the outcome of the injection site pain, erythema, swelling and rash were recovered/resolved and the outcome of the cough and neck pain were unknown.   It was unknown if the reporter considered the injection site pain, erythema, swelling, rash, cough and neck pain to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for himself. The patient received the first dose of the Pfizer COVID-19 vaccine in his left arm and received the first dose of the Shingrix vaccine in his right deltoid.  He initially had redness and swelling, which were the size of a dollar coin, and pain at the injection site in the right deltoid.  He stated the redness, swelling and pain at the injection site resolved in four days. He stated he developed pain and rash on the right side of his neck which has now moved down to the right side down his chest.  He was scheduled to get the second dose of the Pfizer COVID-19 vaccine on Wednesday, 23rd February 2021, but he developed a cough so the COVID-19 second dose was postponed and he also got a COVID-19 test done which came back negative for COVID. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: developed rash on the right side of his neck; cough; pain on the right side of his neck; pain at the injection site; had redness; had swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER).   On 18th February 2021, the patient received the 1st dose of Shingrix. In February 2021, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, erythema, swelling, rash, cough and neck pain. On an unknown date, the outcome of the injection site pain, erythema, swelling and rash were recovered/resolved and the outcome of the cough and neck pain were unknown.   It was unknown if the reporter considered the injection site pain, erythema, swelling, rash, cough and neck pain to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for himself. The patient received the first dose of the Pfizer COVID-19 vaccine in his left arm and received the first dose of the Shingrix vaccine in his right deltoid.  He initially had redness and swelling, which were the size of a dollar coin, and pain at the injection site in the right deltoid.  He stated the redness, swelling and pain at the injection site resolved in four days. He stated he developed pain and rash on the right side of his neck which has now moved down to the right side down his chest.  He was scheduled to get the second dose of the Pfizer COVID-19 vaccine on Wednesday, 23rd February 2021, but he developed a cough so the COVID-19 second dose was postponed and he also got a COVID-19 test done which came back negative for COVID. The reporter consented to follow up.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tenderness
Clinical narrative: Upper arm tender for 2 days
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received Moderna  Covid 19 Vaccine 0.5mg IM on 3/19/2021. But per documentation in  EHRS the patient already  received Covid 19 Pfizer on 1/29/21 as 1st dose and  another Covid 19 Pfizer  on 2/19/21 as 2nd dose.  Patient is stable, asymptomatic and has no complains   from 3/19 up to the present
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Loss of consciousness, Metabolic function test, Presyncope
Clinical narrative: Morning after receiving vaccine patient experienced transient near syncope. Was non-responsive for up to a minute. Needed to be held up in her seat.  Paramedics were called and found her BP and pulse normal and normal neurologic exam.  Was transported to ED and had clinical evaluation and was released to home having fully recovered even prior to arrival in ED.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: PATIENT DIED AT HOME ON 03/19/2021
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Cough, Dyspnoea, Headache
Clinical narrative: Chest pains shortness of breath, headache, backpain  and coughing.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Feeling abnormal
Clinical narrative: client complained of feeling "foggy and strange "  after receiving vaccine.  He was reclined in his seat and monitored for confusion.  He was released when symptoms improved.  Blood Pressure 128/87 Pulse 84 and oxygen saturation 100%
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Heart rate increased, Nausea
Clinical narrative: dizziness; weakness; nausea; rapid heart rate; This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included heart disorder.   In January 2021, the patient received the 1st dose of Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced dizziness, weakness, nausea and heart rate increased. On an unknown date, the outcome of the dizziness, weakness, nausea and heart rate increased were recovered/resolved.   It was unknown if the reporter considered the dizziness, weakness, nausea and heart rate increased to be related to Shingrix.  Additional details were reported as follows: The patient received the vaccine approximately 2 months prior to the report at the pharmacy. The patient had experience dizziness, weakness, nausea and rapid heart rate and presented on the same day as the vaccine administration and symptoms lasted for 24 hours. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Skin warm
Clinical narrative: Round red rash circle on arm, hot, itchy
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Palpitations
Clinical narrative: Pt received first dose of the Pfizer covid19 vaccine at 1014.  Immediately after pt stated feeling anxious, dizzy and  like her heart was pounding.  Pt was monitored, provided water and was released at 1140 after symptoms went away.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Exposure during pregnancy, Fatigue, Headache
Clinical narrative: Estimated due date: 09/04/2021  I felt fine that afternoon after the vaccine and just felt a little more tired than usual when I arrived home at night. Around 12:30AM I felt feverish, and body aches, severe headache and chills that woke me up. Took Tylenol. Felt like I had the flu. Next day kept treating with Tylenol as needed and the fatigue, body aches and low energy persisted along with headache but by night time I was feeling somewhat  better. Next day I was much better that I could work from home. Still felt a little fatigued other symptoms subsided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sleep disorder
Clinical narrative: Estimated due date: 09/04/2021  I felt fine that afternoon after the vaccine and just felt a little more tired than usual when I arrived home at night. Around 12:30AM I felt feverish, and body aches, severe headache and chills that woke me up. Took Tylenol. Felt like I had the flu. Next day kept treating with Tylenol as needed and the fatigue, body aches and low energy persisted along with headache but by night time I was feeling somewhat  better. Next day I was much better that I could work from home. Still felt a little fatigued other symptoms subsided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Pt developed shortness of breath after vaccine, diphenhydramine was administered orally with no improvement, EpiPen 0.3mg given and pt went to hospital.  Pt was seen in ER and given  5 day course of prednisone and advised to continue to take diphenhydramine ever 6 hours
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: 65 year old male received the 1st dose of the Pfizer COVID-19 Vaccine Lot# EN6205 at an unspecified park in county on 03/08/2021 @ 11:00. The evening of 03/08/2021 the pt started experiencing body chills, low-grade fever (<100 F), and headache. Pt describes headache as coming and going 2-3 times a day. Pt takes Tylenol 1-2 times a day. The low grade fever (<100 F) dissipated 03/17/2021. Headaches and body chills are still occurring. Pt called primary doctor for medical care, doctor  directed the pt to the CDC. Pt takes Amlodipine, Lisinopril, Rosuvastatin, and Gemfibrozil. Pt is diagnosed with Hypertension and Dyslipidemia. Pt denies allergies. Pt was advised to seek medical care due to the length the pt was been experiencing symptoms. SPI was consulted and Dr. was notified.  Date and time adverse event started:  Low-grade fever (<100 F): Started 03/08/2021 Evening - Stopped 03/17/2021 Headache and body chills: Started 03/08/2021 Evening - Still occurring  Pt called primary doctor for medical care, doctor directed the pt to the CDC.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: shortness of breath Covid-19
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Was diagnosed with bell's palsy; A spontaneous report was received from a physician concerning a 64-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced one weak eye and was diagnosed with Bell's palsy.  The patient's medical history and concomitant medications were not provided by the reporter.  On 26 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly in the deltoid muscle of an unknown arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient had one weak eye.  On 28 Dec 2020, the patient went to the urgent care, was diagnosed with Bell's palsy. The event Bell's palsy was found to be medically significant.  Treatment medications reported were steroids and valacyclovir.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of Bell's palsy 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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Swollen tongue
Clinical narrative: EUA Pfizer-BioNtech vaccine patient presented to ER the next day following covid-19 immunization with angioedema. She experienced tongue swelling. Her airway is open and and patent and and she denies other allergic symptoms such as rash or pruritis
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: After 3 hours of vaccine, extreme diarrhea lasting 1 evening. Normal stools the next day. Normal activity until 03/20/2021. 03/20/201 had coffee at 6:30 am didn?t feel good. Didn?t take meds, had 2-3 hours nausea, had fluids, then vomited. No food for a day and a half. Had soup on the 21st and tuna and had more diarrhea that night and Monday morning. Other side effects include chills, brain fog, body aches in the back and legs, rash development on left knuckle, itchy head and body, slight headache. The red spot where the needle went into the left arm. Temperature 98.4. blood pressure 140/90 pulse rate 80.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Nausea, Pain in extremity, Pruritus, Rash
Clinical narrative: After 3 hours of vaccine, extreme diarrhea lasting 1 evening. Normal stools the next day. Normal activity until 03/20/2021. 03/20/201 had coffee at 6:30 am didn?t feel good. Didn?t take meds, had 2-3 hours nausea, had fluids, then vomited. No food for a day and a half. Had soup on the 21st and tuna and had more diarrhea that night and Monday morning. Other side effects include chills, brain fog, body aches in the back and legs, rash development on left knuckle, itchy head and body, slight headache. The red spot where the needle went into the left arm. Temperature 98.4. blood pressure 140/90 pulse rate 80.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: After 3 hours of vaccine, extreme diarrhea lasting 1 evening. Normal stools the next day. Normal activity until 03/20/2021. 03/20/201 had coffee at 6:30 am didn?t feel good. Didn?t take meds, had 2-3 hours nausea, had fluids, then vomited. No food for a day and a half. Had soup on the 21st and tuna and had more diarrhea that night and Monday morning. Other side effects include chills, brain fog, body aches in the back and legs, rash development on left knuckle, itchy head and body, slight headache. The red spot where the needle went into the left arm. Temperature 98.4. blood pressure 140/90 pulse rate 80.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: 3:15 pm Injection, c/o dizziness afterwards and feeling weak.  Advised by Paramedics to wait in observation a bit longer.  Skin w/d, no diff breathing.  3:55 pm stated "feeling better".  Advised if dizziness returns pull over safety and dial 911.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Electrocardiogram normal, Full blood count normal, Influenza like illness
Clinical narrative: 1/11 vaccination; followed with flu like symptoms; 'run over by a freight train'. I took Tylenol and it went away. 1/16 2am, I woke up in my sleep. R sided chest pain; hurt to breathe in. Wouldn't go away. 7:30 I went to ER. The pain didn't subside. EKG; negative  1/18 I went to work at urgent care. After 1 hour, it still hurt to breathe. I ended up putting self on list for urgent care.  1/19 PCM; she ordered a chest CT. Steroids, antibiotics.  16-19 was the duration of chest pain tapered off after the antibiotics, steroids. I stayed the Prednisone for 9 days.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: 1/11 vaccination; followed with flu like symptoms; 'run over by a freight train'. I took Tylenol and it went away. 1/16 2am, I woke up in my sleep. R sided chest pain; hurt to breathe in. Wouldn't go away. 7:30 I went to ER. The pain didn't subside. EKG; negative  1/18 I went to work at urgent care. After 1 hour, it still hurt to breathe. I ended up putting self on list for urgent care.  1/19 PCM; she ordered a chest CT. Steroids, antibiotics.  16-19 was the duration of chest pain tapered off after the antibiotics, steroids. I stayed the Prednisone for 9 days.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Hypotension, Malaise, Syncope
Clinical narrative: Patient received her 1st dose of Covid-19 Pfizer vaccine, lot #ER2613, today at 1:19pm at the Vaccination clinic. While waiting in the parking lot, patient got medic's attention and was not feeling well. Patient reported to have a syncopal episode around 1:30pm with low blood pressure and low heart rate. Medics started IV with IV fluids, which stabilized patient's vital signs. Patient was transported to the hospital.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Immunisation
Clinical narrative: Vaccinator attempted to administer vaccine lot #ER8732. Vaccine was prepared in a needle and syringe used by immunology clinic, not regularly used by the COVID-19 clinic. Needle bent and did not penetrate pt skin when vaccinator began to administer. A small amount of vaccine was wasted on pt skin. Another vaccine was obtained in needle and syringe used by COVID-19 Vaccine clinic and administered without issue.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Feeling hot, Haemorrhage, Hyperhidrosis
Clinical narrative: Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/2021  Patient/Date: 3/18/2021  Subjective:  a 47 y.o. male who was seen at SVH COVID Vaccine Clinic today for his first  dose of the COVID Pt is a 47 y.o. male who was seen at COVID Vaccine Clinic for his first does of COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt received shot and complained of being hot and sweaty. He was laid on the floor in injection room 5, with his feet elevated, some water was given and once pt was feeling better he was transferred to the ER bay for observation. He refused a wheelchair and walked to the bay with help. After sitting for awhile we cooled down and he was allowed to leave. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness, and hot and sweaty: CONT negative, HENT negative, Eyes negative, Respiratory negative, Skin negative, GI negative, Musculo negative,  Previous Reactions: None, Objective: Vitals - There were no vitals filed for this visit. Physical Exam - Constitutional: Appearance - He is well-developed. HENT: Head -Normocephalic and atraumatic. Right Ear- External ear normal. Left Ear: External ear normal. Nose - Nose normal. Eyes - Conjunctiva/sclera: Conjunctivae normal. Pupils - Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm - Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort - Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General -Normal range of motion. Cervical backN -normal range of motion and neck supple. Skin: Coloration: Skin is pale. Neurological: Mental Status - He is alert and oriented to person, place, and time. Assessment/Plan: Treatment include - water and snacks. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash). Pt was released at 3:26, he was accompanied by his wife. APRN Electronically Signed 3/18/2021 3:19 PM
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site irritation, Injection site rash, Pain in extremity, Vaccination complication
Clinical narrative: Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/2021  Patient/Date: 3/18/2021  Subjective:  a 47 y.o. male who was seen at SVH COVID Vaccine Clinic today for his first  dose of the COVID Pt is a 47 y.o. male who was seen at COVID Vaccine Clinic for his first does of COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt received shot and complained of being hot and sweaty. He was laid on the floor in injection room 5, with his feet elevated, some water was given and once pt was feeling better he was transferred to the ER bay for observation. He refused a wheelchair and walked to the bay with help. After sitting for awhile we cooled down and he was allowed to leave. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness, and hot and sweaty: CONT negative, HENT negative, Eyes negative, Respiratory negative, Skin negative, GI negative, Musculo negative,  Previous Reactions: None, Objective: Vitals - There were no vitals filed for this visit. Physical Exam - Constitutional: Appearance - He is well-developed. HENT: Head -Normocephalic and atraumatic. Right Ear- External ear normal. Left Ear: External ear normal. Nose - Nose normal. Eyes - Conjunctiva/sclera: Conjunctivae normal. Pupils - Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm - Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort - Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General -Normal range of motion. Cervical backN -normal range of motion and neck supple. Skin: Coloration: Skin is pale. Neurological: Mental Status - He is alert and oriented to person, place, and time. Assessment/Plan: Treatment include - water and snacks. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash). Pt was released at 3:26, he was accompanied by his wife. APRN Electronically Signed 3/18/2021 3:19 PM
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Vaccination complication
Clinical narrative: 3/21/2021   Mr. Silverman was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  Tingling around moutn.   Assessment : Time of assessment 1748 Alert and oriented. No rash , swelling around mouth, or redness.   Actions taken:      There were no vitals filed for this visit.patient refused, voiced that he had an EPI pen.   Medications administered: No medication administered.   Disposition:The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/21/2021  5:28 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER2613
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: He began to feel tingling to his tongue and lips.  He notes no shortness of breath.  No itching.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Cellulitis; Arm is hot; Arm is itching; Arm is swelling; A spontaneous report was received from a consumer concerning a 68-year-old ,female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, arm swelling/vaccination site swelling, arm itching/vaccination site pruritus and arm hot/vaccination site warmth.  The patient's medical history was not provided. Concomitant medications were not provided.  On 2 Jan 2021, approximately 11 days prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021 the patient reported her arm was swelling, itching and hot. On 14 Jan 2021, she reported she went to the ER and was diagnosed with cellulitis.  Treatment information includes antibiotic (Keflex) and steroid (prednisone). Lab tests were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, cellulitis, arm swelling, arm itching and arm hot were considered 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: SOB, chest tightness, dizziness
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest X-ray normal, Echocardiogram normal, Scan myocardial perfusion
Clinical narrative: Rapid Atrial Fibrillation occured 12 hours after first injection of Pfizer vaccine.  I had no prior history of any cardiac events.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 17 years old and was given Moderna vaccine instead of the Pfizer vaccine for the second dose. Patients first Pfizer dose was on 02-19-2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Peripheral swelling, SARS-CoV-2 test negative
Clinical narrative: My arm was swollen for a couple days after (which I expected) receiving the vaccine. Then on saturday night after dinner and dessert (all things I've eaten recently so nothing new) I began swelling in my lips and under my right eye. I took 6 doses of off-brand benadryl and it would only decrease the swelling by very small increments. My breathing was alright, but to this day as of 03/22/2021 my lips are still slightly puffy.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pharyngeal swelling, Pruritus, Swollen tongue
Clinical narrative: Within 5 minutes of receiving the vaccination, I experienced a pain moving up both sides of my neck followed by swelling of my throat and tongue.  This lasted for about an hour, with no impediment in my ability to breathe.  About 4 to 5 hours after the vaccination, my head and face began to itch.  At that time, I took one 25 mg benadryl and the itching subsided.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Brachial plexopathy, Joint range of motion decreased, Pain in extremity
Clinical narrative: Significant arm pain started within a few hours of receiving the vaccine.  Pain became so severe it restricted range of motion.  Pain has improved slightly initially but has remained constant since then.  Patient has been referred to neurology for an evaluation of brachial plexopathy.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache, Hypoaesthesia
Clinical narrative: Bells palsy; Numbness in face; Pain in head; A spontaneous report  was received from a consumer (patient), a 70-year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and developed Bell's palsy (facial paralysis), pain in head (headache) and numbness in face (hypoaesthesia).  The patient did not report medical history. Concomitant medications were also not reported.  On 03 Feb 2021, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, after administering the vaccine, the patient developed headache followed by numbness on face on 09 Feb 2021. On 11 Feb 2021, the patient was diagnosed with Bell's palsy. No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, headache, numbness in face and Bell's palsy, were considered as 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: PATIENT RECEIVED MODERNA VACCINE INSTEAD OF PFIZER VACCINE BY NURSE.  ONCE THIS WAS MADE AWARE TO THIS NURSE, NURSE NOTIFIED COORDINATING NURSE. THIS NURSE CALLED PATIENT TO ADVISE, ALSO ADVISED SECOND DOSE MUST BE PFIZER.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Pain in extremity
Clinical narrative: Light-headed, headache, strong ache in left wrist and fingers and along left leg.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Shortness of breath Covid-19
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chills, Computerised tomogram, Dyspnoea
Clinical narrative: Ringing in the ears, headaches, throat hurts when I breath in (swollen glands), shortness of breath, fevers, sweats, chills, jaw pain, sore body
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: Ringing in the ears, headaches, throat hurts when I breath in (swollen glands), shortness of breath, fevers, sweats, chills, jaw pain, sore body
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw, Pyrexia, SARS-CoV-2 test, Tinnitus
Clinical narrative: Ringing in the ears, headaches, throat hurts when I breath in (swollen glands), shortness of breath, fevers, sweats, chills, jaw pain, sore body
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pyrexia, Vomiting
Clinical narrative: Fever , Chills,  headache, vomiting starting at 11:30 pm day of vaccination.  Headache was not as bad after taking Tylenol.  Most symptoms were gone by Monday morning but then had diarrhea.  Thought it was over but still had diarrhea as of 2:30 Monday.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; A spontaneous report was received from a consumer who was a 59-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy (facial paralysis).   The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 12 Jan 2021, approximately seven days prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 19 Jan 2021, the patient developed Bell's palsy. As per patient, there was loss of taste, his eyeball was not moving, he had facial pain and he could not raise right side of his lips. The patient stated that his symptoms were still on going at the time of report. Both his PCP and neurologist can not confirm this is not related to vaccine.  Treatment for the event included a seven-day course of Valtrex and Prednisone.   Action taken with mRNA-1273 in response to the event was not provided.  The event, Bell's palsy, was considered not recovered/not resolved.; 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Myalgia
Clinical narrative: Janssen COVID-19 EUA.  feeling weakness & dizziness, chills. cough and muscle ache in arm, shoulder and neck. congestion and runny nose with nausea for 10 days now.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Janssen COVID-19 EUA.  feeling weakness & dizziness, chills. cough and muscle ache in arm, shoulder and neck. congestion and runny nose with nausea for 10 days now.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Severe fatigue, headache, chills, sweats and diarrhea lasting until the morning of March 22, 2021.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, Chills, Confusional state, Death
Clinical narrative: Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chills, weakness and acute confusion ~ 3 days prior to admission.  Placed on NIPPV, steroids, convalescent plasma and antibiotics.  Patient died 2/24/2021
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Pyrexia, SARS-CoV-2 antibody test positive, SARS-CoV-2 test positive
Clinical narrative: Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chills, weakness and acute confusion ~ 3 days prior to admission.  Placed on NIPPV, steroids, convalescent plasma and antibiotics.  Patient died 2/24/2021
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mass, Tenderness
Clinical narrative: Large lump appeared in left armpit 3 days after Vaccine It is very sore to touch and hurts most of the day. Went to Dr. Told me to keep taking Tylenol and using a pain rub (Hemp Vana) on it. Said it should die down in 4 to 6 weeks.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyskinesia, Paraesthesia oral
Clinical narrative: About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a short time she experienced tingling in  lips. We moved her to the floor and laid her flat with head raised  as she began to experience uncontrolled movements in arms and legs (seizures?) I administered epinephrine for tightness in chest and tingling lips and 911 was  called. Rescue squad arrived stabilized  her and transported to hospital.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient attended a vaccine administration event with his mother on 19MAR2021. Patient completed our clinic's registration even though it was only offered to those 18 years and older. The patient made it to the vaccination station without the staff noticing that he was 17 years old. It was not until the patient was being registered into our clinic's EMR that the staff was made aware of his age. The patient's mother was contacted and stated there were no adverse reactions and that he was in school.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: throbbing pain in arm right after injection and low grade temp by feel. Then about 7-8 days later developed a deep cervical chain lymph node swollen.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: baseline tinnitus exacerbated following the 1st Covid vaccine; from low background noise to loud throbbing with heartbeat at rest to echo sound when I talk and so loud I am having trouble hearing.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Dyspnoea, Rash erythematous, Skin warm
Clinical narrative: When I got home to shower noticed  3 large spots, 2 appeared(upside down snowman) red in color and felt warm to touch. I contacted my doctor when into the walk in clinic stated it might be cellulitis told to take Allegra first if not better to fill prescription for Keflex.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: When I got home to shower noticed  3 large spots, 2 appeared(upside down snowman) red in color and felt warm to touch. I contacted my doctor when into the walk in clinic stated it might be cellulitis told to take Allegra first if not better to fill prescription for Keflex.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Feeling abnormal, Lymph node pain
Clinical narrative: Sore arm, muscle pain, swollen/painful axillary lymph nodes on the right side, fatigue, brain fog,  increased nerve pain, abdominal pain, diarrhea
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Neuralgia, Pain in extremity
Clinical narrative: Sore arm, muscle pain, swollen/painful axillary lymph nodes on the right side, fatigue, brain fog,  increased nerve pain, abdominal pain, diarrhea
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate decreased
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine EUA?  I noticed significantly lowered heartrate following the vaccine administration.  My average resting rate is 79 bpm, but on the 2nd night following the shot, my heart rate fell into the 30's for several days (shot on March 1, sleeping heart rate substantially drops at night March 3-7).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, COVID-19 pneumonia, Cardiac failure congestive, Renal failure
Clinical narrative: Acute respiratory failure (CMS/HCC) CHF (congestive heart failure) (CMS/HCC) Renal insufficiency NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Pneumonia due to COVID-19 virus Covid-19
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Pruritus, Rash
Clinical narrative: Intense itching, rash, tingling, and numbness came on suddenly beginning in both hands, and moving quickly to arms, feet, torso, and then finally lips and tongue.  Had trouble speaking.  Took two Benadryl.  Then my husband called 911.  Two EMT people took my blood pressure a couple times and exygen level.  Then the attack started to go away, and my pressure returned to normal.  Then the EMT people left our home.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Intense itching, rash, tingling, and numbness came on suddenly beginning in both hands, and moving quickly to arms, feet, torso, and then finally lips and tongue.  Had trouble speaking.  Took two Benadryl.  Then my husband called 911.  Two EMT people took my blood pressure a couple times and exygen level.  Then the attack started to go away, and my pressure returned to normal.  Then the EMT people left our home.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Erythema, Lacrimation increased
Clinical narrative: hands swelling; right eye was involuntarily tearing; shaking; having a severe reaction, rash all over the body,extensive rash; red splashes all over their body except in their face and hands, smooth, not raised, not itchy,; fevers (102 ºF); chills/ felt a slight chill/ a little bit of chills; A spontaneous report was received from a Healthcare Professional concerning a 75-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a severe reaction, rash all over the body, chills, fevers (102 ºf), red splashes all over his body except in his face and hands, smooth, not raised, not itchy, shaking, right eye was involuntarily tearing and  hands swelling.  The patient's medical history included temporal arteritis ((4 years ago) which got inflamed and did not know the cause of it. The concomitant medications reported were Amlodipine 5 mg a day, Rapaflo 8 mg a day, Eliquis 5 mg twice a day, Flecainide 100 mg twice a day, and Metoprolol 25 mg a day (drug used for unknown indication).  On 15 Jan 2021 at about 10:45 am, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (lot batch: 012120A) via unknown for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient felt a slight chill. However  On 23 Jan 2021, the patient had a severe reaction, rash all over the body, chills, fevers (102 ºf) and suddenly about late afternoon 5 PM noticed an extensive rash, red splashes all over his body except in his face and hands, which were smooth, not raised, and not itchy. He started getting chills and fevers (temperature 102 ºF). On 24 Jan 2021, the patient experienced shaking and, on 25 Jan 2021, the right eye was involuntarily tearing and noticed swelling of hands. On an unknown date the patient visited the dermatologist for rash, and his biopsy was done for the same. but the results were unknown.  Relevant Lab data included,  COVID test Negative for rapid and PCR.  Blood and urine test were done on unknown date and blood test was normal.  Treatment details included Tylenol and prednisone 40 mg.  Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of events chills resolved. Other symptoms include rash all over the body, red splashes all over his body except in his face and hands, smooth, not raised, not itchy, and right eye was involuntarily tearing was Unknown.   The reporter assessed the events as related to the vaccine drug.; 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash, SARS-CoV-2 test negative, Tremor
Clinical narrative: hands swelling; right eye was involuntarily tearing; shaking; having a severe reaction, rash all over the body,extensive rash; red splashes all over their body except in their face and hands, smooth, not raised, not itchy,; fevers (102 ºF); chills/ felt a slight chill/ a little bit of chills; A spontaneous report was received from a Healthcare Professional concerning a 75-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a severe reaction, rash all over the body, chills, fevers (102 ºf), red splashes all over his body except in his face and hands, smooth, not raised, not itchy, shaking, right eye was involuntarily tearing and  hands swelling.  The patient's medical history included temporal arteritis ((4 years ago) which got inflamed and did not know the cause of it. The concomitant medications reported were Amlodipine 5 mg a day, Rapaflo 8 mg a day, Eliquis 5 mg twice a day, Flecainide 100 mg twice a day, and Metoprolol 25 mg a day (drug used for unknown indication).  On 15 Jan 2021 at about 10:45 am, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (lot batch: 012120A) via unknown for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient felt a slight chill. However  On 23 Jan 2021, the patient had a severe reaction, rash all over the body, chills, fevers (102 ºf) and suddenly about late afternoon 5 PM noticed an extensive rash, red splashes all over his body except in his face and hands, which were smooth, not raised, and not itchy. He started getting chills and fevers (temperature 102 ºF). On 24 Jan 2021, the patient experienced shaking and, on 25 Jan 2021, the right eye was involuntarily tearing and noticed swelling of hands. On an unknown date the patient visited the dermatologist for rash, and his biopsy was done for the same. but the results were unknown.  Relevant Lab data included,  COVID test Negative for rapid and PCR.  Blood and urine test were done on unknown date and blood test was normal.  Treatment details included Tylenol and prednisone 40 mg.  Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of events chills resolved. Other symptoms include rash all over the body, red splashes all over his body except in his face and hands, smooth, not raised, not itchy, and right eye was involuntarily tearing was Unknown.   The reporter assessed the events as related to the vaccine drug.; 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cerebrovascular accident, Dyspnoea, Gait disturbance, Impaired driving ability
Clinical narrative: After Modena vaccination first dose back of the hand  started allergy,  red large irregular spot allover, very itchy, both legs weak, couldn't lift leg when walking.  After 2nd dose allergy became much more severe.  Red large irregular spot also appeared allover body skin,  allover back, legs, arms. On March 6, 2021 the legs were too weak hard to go on stairs. On March 7, 2021 went to the ER. After discharged on March 9, 2021, left leg became weak, right leg more severe,  walking became unbalanced when had to walk.  All over body weak, palpitation short of breath during activity, had to lie down. I'm an acupuncture doctor, already couldn't work, couldn't drive.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Magnetic resonance imaging head abnormal, Muscular weakness, Palpitations, Pruritus
Clinical narrative: After Modena vaccination first dose back of the hand  started allergy,  red large irregular spot allover, very itchy, both legs weak, couldn't lift leg when walking.  After 2nd dose allergy became much more severe.  Red large irregular spot also appeared allover body skin,  allover back, legs, arms. On March 6, 2021 the legs were too weak hard to go on stairs. On March 7, 2021 went to the ER. After discharged on March 9, 2021, left leg became weak, right leg more severe,  walking became unbalanced when had to walk.  All over body weak, palpitation short of breath during activity, had to lie down. I'm an acupuncture doctor, already couldn't work, couldn't drive.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: After Modena vaccination first dose back of the hand  started allergy,  red large irregular spot allover, very itchy, both legs weak, couldn't lift leg when walking.  After 2nd dose allergy became much more severe.  Red large irregular spot also appeared allover body skin,  allover back, legs, arms. On March 6, 2021 the legs were too weak hard to go on stairs. On March 7, 2021 went to the ER. After discharged on March 9, 2021, left leg became weak, right leg more severe,  walking became unbalanced when had to walk.  All over body weak, palpitation short of breath during activity, had to lie down. I'm an acupuncture doctor, already couldn't work, couldn't drive.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Systemic itchy rash appearing 8 days post vaccine.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received the vaccine outside of the recommended age group of 18 years or age or older.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Fever and diarrhea  experienced on 01/14/2021.  I did go to the doctor and he did a Covid test and the result was positive.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Reported by EMS on site.  client had syncope following vaccine and was transported to a local hospital.  no  phone number given to this writer after the event.  EMS called at 11 am and arrived at 11.01.  blood pressure 101/68 pulse 71.  second reading was 108/76 and pulse 69.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain
Clinical narrative: 3/21/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  Chest pain, she reports that she is asthmatic .but does not have her inhaler.   Assessment : Time of assessment 1615pm Alert and oriented and Anxious. No visible respiratory issues, no wheezing or stridor heard.   Actions taken: took to stretcher, 1615 VS taken at 1615 BP- 144/58. P 84, O2 98%, 1625 recheck VS- BP- 114/65, P-74, O2- 94%, lying on stretcher family in the room, she reports feeling better.       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/21/2021  3:45 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc