chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Patient reported feeling sharp pain and burning during vaccine administration. At the time, she did not think anything of it. After the pain did not go away for several days, she sought medical attention. She was told to take ibuprofen, which eventually made her sick since she took a lot of it without much pain relief. She was just recently given a cortisone injection which helped significantly, and the doctor she saw recommended she tell us at the pharmacy about what happened so we could file the appropriate reports.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Cardiac failure, Computerised tomogram abnormal, Condition aggravated, Death
Clinical narrative: She developed a large pulmonary embolus, and she died on 3/17 at Hospital. She developed symptoms of SOB on 3/11, and was admitted to the hospital. She was initially stable and not requiring oxygen and was sent home on anticoagulation. However she returned the same day with worsening symptoms, troponin now elevated, and ECHO showing signs of right heart strain. Embolus on imaging had increased in just over days from previous CT scan. She became pulseless and died despite resuscitative efforts. It is my opinion (Dr.) that she died of a pulmonary embolus, and an autopsy is pending.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Myocardial strain, Pulmonary embolism, Pulse absent
Clinical narrative: She developed a large pulmonary embolus, and she died on 3/17 at Hospital. She developed symptoms of SOB on 3/11, and was admitted to the hospital. She was initially stable and not requiring oxygen and was sent home on anticoagulation. However she returned the same day with worsening symptoms, troponin now elevated, and ECHO showing signs of right heart strain. Embolus on imaging had increased in just over days from previous CT scan. She became pulseless and died despite resuscitative efforts. It is my opinion (Dr.) that she died of a pulmonary embolus, and an autopsy is pending.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Resuscitation, Troponin increased
Clinical narrative: She developed a large pulmonary embolus, and she died on 3/17 at Hospital. She developed symptoms of SOB on 3/11, and was admitted to the hospital. She was initially stable and not requiring oxygen and was sent home on anticoagulation. However she returned the same day with worsening symptoms, troponin now elevated, and ECHO showing signs of right heart strain. Embolus on imaging had increased in just over days from previous CT scan. She became pulseless and died despite resuscitative efforts. It is my opinion (Dr.) that she died of a pulmonary embolus, and an autopsy is pending.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Large rash at injection site   got shot in rear,  Hydroxyzine Pam, Triamcinolone Acetonide Cream USP  Rash cleared up in 5 days
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pyrexia
Clinical narrative: Fever, severe pain in arm and shoulder joint
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Laboratory test normal, Magnetic resonance imaging head, Ophthalmological examination normal
Clinical narrative: acute vertical diplopia
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Vaccination error
Clinical narrative: VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Agonal respiration, Eye movement disorder, Feeling hot, Glassy eyes, Loss of consciousness
Clinical narrative: Patient received their vaccine and sat in a chair, within approx. two minutes the patient told another patient they felt hot, I was already walking to the patient to check on them,. The patient's eyes were glazed, Almost immediately the patients eyes rolled back in his head. I shook his arm and shouted to him , he was unresponsive with agonal breaths.. I shouted for help from the other nurses. RNs came immediately. We moved him to the floor, called for an epinephrine injection to be prepared, I began to prepare the site for epinephrine injection to his thigh, nurse checked for pulse... at this time the patient was still unresponsive with agonal breaths... no pulse was felt so compressions were commenced by RN. Nurse gave approx. 15 compressions to the patients chest ,  the patient spontaneously  began to recover. Carotid and radial pulses were felt at this time. Breathing returned to normal. While this was occurring, we called a code blue and 911 was activated. By the time 911 responded the patient was fully conscious , alert and responsive. He could tell us his name and how he felt prior to this incident. The patient was transferred via a  stretcher by EMS 911 and RN accompanied him to the ER to give a report. The timeframe for being pulseless and having agonal breaths lasted no more than 30-40 seconds. Patient denied any history of a seizure disorder. No  epinephrine or IM Benadryl were administered at the incident site by the responding staff due to the spontaneous recovery.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient received their vaccine and sat in a chair, within approx. two minutes the patient told another patient they felt hot, I was already walking to the patient to check on them,. The patient's eyes were glazed, Almost immediately the patients eyes rolled back in his head. I shook his arm and shouted to him , he was unresponsive with agonal breaths.. I shouted for help from the other nurses. RNs came immediately. We moved him to the floor, called for an epinephrine injection to be prepared, I began to prepare the site for epinephrine injection to his thigh, nurse checked for pulse... at this time the patient was still unresponsive with agonal breaths... no pulse was felt so compressions were commenced by RN. Nurse gave approx. 15 compressions to the patients chest ,  the patient spontaneously  began to recover. Carotid and radial pulses were felt at this time. Breathing returned to normal. While this was occurring, we called a code blue and 911 was activated. By the time 911 responded the patient was fully conscious , alert and responsive. He could tell us his name and how he felt prior to this incident. The patient was transferred via a  stretcher by EMS 911 and RN accompanied him to the ER to give a report. The timeframe for being pulseless and having agonal breaths lasted no more than 30-40 seconds. Patient denied any history of a seizure disorder. No  epinephrine or IM Benadryl were administered at the incident site by the responding staff due to the spontaneous recovery.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headed, rested, hydrated, felt better
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain in extremity, Tinnitus
Clinical narrative: I was awakened by spastic chills, severe headache, pain in my hands hips and ankles, and loud tinitus.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Patient received her 1st Pfizer vaccination dose at 12:37PM. Patient was seated in the vaccination waiting area for her 15 minutes observation window. About 5 minutes after vaccination the patient fainted and fell out of her chair on to the ground. She hit her head on the wall behind her, and ground when falling. Pharmacy staff immediately went to check on patient. She was found to be breathing, but unresponsive for about 20 seconds. 911 was called immediately by another employee. She was positioned lying on the ground with her feet up and came to consciousness quickly. Once awake patient was alert, verbal, and seemed to have a normal mental status. She reported no respiratory issues, no throat or lip symptoms, and no itching or hives. She states that she felt fine other than her head hurting from the fall. She reported no symptoms prior to waking up on the ground. She was speaking in full sentences, responsive, and had a strong, steady pulse at 98 bpm and a normal respiratory rate. No hives, swelling were observed. Patient reported she was a type 1 diabetic and her blood sugar was found to be normal (approx. 145) after she was able to sit. No medications were administered on site as she did not report any additional symptoms indicative of anaphylaxis. The ambulance and local PD arrived quickly. She was walked outside for observation and appeared to be taken away in the ambulance.  The patient was not reached for a follow-up call to check in on her later the same afternoon.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lip swelling, Swollen tongue
Clinical narrative: Patient complained of having trouble breathing following receiving her vaccine.  When observed her bottom lip was swollen and swelling of her tongue was noted.  An epi pen was administered and 911 was called.  She was monitored and vitals were assessed until an ambulance arrived and was able to transport her to the hospital
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: 102 fever; chills; night sweats; extreme fatigue; brain fog; sore muscles and joints. Started 12 hours after injection. Resolved between 11am-2pm ET on 3/21, so lasted less than 24 hours before resolving.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: 102 fever; chills; night sweats; extreme fatigue; brain fog; sore muscles and joints. Started 12 hours after injection. Resolved between 11am-2pm ET on 3/21, so lasted less than 24 hours before resolving.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Severe itching followed by Rash at the injection site. Swelling, pain and warmth at the left arm.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: patient fainted after receiving vaccine. patient was transported to hospital and has recovered
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Moderna Covid-19 shot given 1/3/21 in patient's left deltoid.  On 01/24/21 patient came to the pharmacy stating that he has experienced numbness/tingling in his right fingers and thumb since he received his first dose.  It started with numbness in his pinky finger and progressed over the course of several days to each finger and thumb. This occurred more than once since the first dose was given. However, patient states that this has not happened anymore within the last week. Patient denies any kind of injury, pinched nerve, etc in his right hand/fingers and states he never had this occur to him at any other time in his life.  Patient was scheduled for some type of procedure, however the physician will not perform the procedure until the source of the numbness is discovered.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Blood creatine phosphokinase normal, Blood culture, Blood immunoglobulin G
Clinical narrative: fever, chills, myalgia, arthralgia
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin M, Blood iron decreased, Blood thyroid stimulating hormone, Chest X-ray normal, Chills
Clinical narrative: fever, chills, myalgia, arthralgia
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Culture urine, Electrocardiogram normal, Full blood count normal, HIV test, Hepatitis viral test
Clinical narrative: fever, chills, myalgia, arthralgia
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Myalgia, Pyrexia, Rheumatoid factor negative, Treponema test
Clinical narrative: fever, chills, myalgia, arthralgia
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary system X-ray, Vitamin B12 normal, Vitamin D
Clinical narrative: fever, chills, myalgia, arthralgia
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA - SIRVA is a shoulder injury triggered by the incorrect injection of a vaccine
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Unexplained vaginal bleeding. I do not ever bleed. I?ve been in birth control since 17 and no bleeding past my 20s aside from postpartum month (yes I got pregnant on the very first ovulation after I came off birth control and went back on after my baby) nothing has changed in diet or stress as I?m chronically ill and am used to being home and mask wearing.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Adverse event was administration error. Patient received their first dose of Moderna at the  Clinic and then came to our clinic a week later where she received a dose of Pfizer. She filled out a questionnaire indicating she had not received a COVID vaccine previously and her vaccine record was not viewable in our EMR.  We are still trying to reach the patient to understand her reasoning for seeking two vaccines so close together. We are recommending that she not receive any further COVID vaccines at this time.  Please let me know if there is different recommendations.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Eyelid function disorder, Feeling abnormal, Presyncope
Clinical narrative: Pt has history of anaphylaxis, carries Epi pen. Complained of feeling odd, similar to how she felt before previous anaphylactic reaction.  Place pt on cot, code green called.  Paramedics assessed BP 162/102, HR 106, GLUCOSE 114.  Attempted to sit pt up had near syncopal episode, rapid eye fluttering BP 172/126.  PT was transported to hospital.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Migraine, Nausea, Pain
Clinical narrative: migraine with body aches, nausea, shortness of breath
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vomiting
Clinical narrative: Patient's daughter reports that ever since patient received the vaccine she has been intermittently ill. She has experienced general malaise and vomiting for a few days, then recovers, then gets ill again. The cycle has repeated about 3 times since her vaccination. Advised patient to make an appointment with her doctor to rule out any other contributing causes.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Swollen tongue and throat
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fall, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Patient received vaccine while seated and had no problems.  She stood up and walked several feet to the observation seating area and had a seat. A few minutes later she fainted and fell out of the chair onto the floor. We helped her up to a sitting position and gave her a bottle of water and an ice pack.  The right side of her forehead appeared red from apparent hit on the floor when she fainted.  We had her wait on the floor for about 30 minutes to ensure she remained conscious.  Patient reported an ache on her forehead at site of hit.  She was also sweating and reported feeling hot. Patient had a partner with her who agreed to escort her to an urgent care clinic in the same building as the pharmacy. Store manager in charge took the patient to the urgent care clinic by wheelchair to be examined.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient received vaccine while seated and had no problems.  She stood up and walked several feet to the observation seating area and had a seat. A few minutes later she fainted and fell out of the chair onto the floor. We helped her up to a sitting position and gave her a bottle of water and an ice pack.  The right side of her forehead appeared red from apparent hit on the floor when she fainted.  We had her wait on the floor for about 30 minutes to ensure she remained conscious.  Patient reported an ache on her forehead at site of hit.  She was also sweating and reported feeling hot. Patient had a partner with her who agreed to escort her to an urgent care clinic in the same building as the pharmacy. Store manager in charge took the patient to the urgent care clinic by wheelchair to be examined.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Condition aggravated, Fatigue, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: After the first vaccine, patient had a severe headache and some fatigue for about 24 hours, but after the second vaccine she has a major ME/CFS relapse and has been unable to get out of bed or care for herself in any way for the past two weeks.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Post viral fatigue syndrome
Clinical narrative: After the first vaccine, patient had a severe headache and some fatigue for about 24 hours, but after the second vaccine she has a major ME/CFS relapse and has been unable to get out of bed or care for herself in any way for the past two weeks.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath that improved after observation.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram, Fatigue, Gait inability, Wheezing
Clinical narrative: Heavy chest/tightness, wheezing, not able to walk far, exhausted from walking and wheezing. Used my inhaler every two hours and no relief. Kept getting worse. Tried Mucinex liquid Severe Chest Congestion and Sudafed.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site swelling, Muscular weakness, Pain
Clinical narrative: Pain and swelling at injection site.    Redness traveled down to bicep area.   Pain, weakness, in the bicep , red and blotches on skin over top of bicep
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Pain and swelling at injection site.    Redness traveled down to bicep area.   Pain, weakness, in the bicep , red and blotches on skin over top of bicep
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Rash
Clinical narrative: Nausea at first, dizziness, rash on top of head
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Face flushed
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: The PA-C who patient sees per daughter in law said the PA suspects the vaccine given 2/15/2021 may have caused the stroke that occurred on 3/12/2021.  Although, the patient had TIA three months prior.  The PA-C from the Clinic in the area.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Nausea
Clinical narrative: Nausea, dizziness, numbness face and right arm, headache
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product dispensing issue
Clinical narrative: Patient was given a full dose of Janssen COVID19 Vaccine. However, it was the 6th dose pulled from a 5 dose vial. pt has no complaints
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Faeces pale, Feeling drunk, Nausea
Clinical narrative: vaccinated at 1:46, 30 minute after observation, client reported feeling "drunk" and experiencing altered mental state with dizziness and nausea, became clammy and lost color in face, aid called to client and VSS were HR 144, BP palp 154, blood glucose was 96.  Client drank drank juice and water and reported improvement of symptoms. A friend came to drive her home to rest.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: bad stomach ache
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Hyperthyroidism
Clinical narrative: pt is associate I gave pt the covid shot. About 45 mins later she said she felt dizzy and wanted to check her blood pressure. Her blood pressure was 161/101 with pulse 86 right arm. She said she has condition of hyperthyroidism but not taking any meds for it. Then i checked pressure again and it was 164/105 with pulse 85 in left arm. She stayed for 30 mins, then she checked her pressure again with a different pressure machine. This time her pressure was 184/105 with pulse 67 right arm. Then we tried the other machine with consistent elevated pressure of 172/110. She continued to feel dizzy. We called ambulance and they took her to hospital. She is fully conscious when they took her to hospital.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Hypersomnia, Pain
Clinical narrative: convulsions.  I woke up at about 3:15 with my body shaking and i could not control it.  this went on for about 1 hour.  I have never had this experience.  I literally could not function  because of the shkes.  the other reactions were, i slept from 4:30 +/- am till 5 pm,  when i had Covid i slept for over 5 days.  Other symptoms head ache, body aches, fatigue and lose of appetite.   I write this at day 3 after the shot, and have tiredness and want to sleep  It's like a compressed version of my Covid experience.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: convulsions.  I woke up at about 3:15 with my body shaking and i could not control it.  this went on for about 1 hour.  I have never had this experience.  I literally could not function  because of the shkes.  the other reactions were, i slept from 4:30 +/- am till 5 pm,  when i had Covid i slept for over 5 days.  Other symptoms head ache, body aches, fatigue and lose of appetite.   I write this at day 3 after the shot, and have tiredness and want to sleep  It's like a compressed version of my Covid experience.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fibrin D dimer, Pulmonary embolism
Clinical narrative: bilateral pulmonary emboli
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, but pt received a more potent dose. Pharmacist reconstituted with 0.8ml instead of 1.8ml.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Fatigue, Headache, Rash macular
Clinical narrative: Fever over 101 for several hours, severe headache primarily on right side, dizziness, red blotches on face, exhaustion.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received a third dose of the COVID vaccine. The second dose was administered two days prior on 3/22, and the first dose administered on 2/22. Upon realizing the error, the patient was contacted. He did not report any adverse effects, however he did not remember coming to the clinic or receiving any of the vaccines. Patient has a history of dementia. He was advised to seek medical attention for any severe symptoms that occur.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient was exhibiting shaking hands for 2-3 minutes; alert & oriented with no color change; able to verbalize; no SOB; vaccine given at 1:37 and exhibited s/s 5-10 minutes later; Vital signs BP 140-78, HR-90, O2 94%, no medication given; monitored for 30 minutes then released home.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Discomfort, Dizziness, Eye disorder, Hyperhidrosis, Speech disorder
Clinical narrative: pt stated he felt faint within a couple minutes of having the shots, sweated profusely, seemed to fade in and out of feeling well...he seemed to lose control of his eyes several times and mumbled jibberish once and his body got heavy but he came back fine....wife requested ems services b/c she was frightened at one point but once they arrived pt refused to go with them and denied treatment
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: No adverse event, but pt received a more potent dose. Pharmacist reconstituted with 0.8ml instead of 1.8ml.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Lightheaded, dizzy, 1 episode clear emesis,  Semi-fowlers position, rested, nausea, subsided, refused transport, felt better
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral herpes, Pyrexia, Sinus operation
Clinical narrative: Patient started with a fever of 102.5 approximately 48 hours after receiving shot. She alternated taking Tylenol & Aleve. Two days later her lips starting swelling with development of numerous fever blisters in mouth. She also had nasal drainage that caused fever blisters on outside of upper lip. She contacted her PCP who prescribed Valtrex for 10days.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Full blood count, Gingival bleeding, Hypoaesthesia
Clinical narrative: Numbness and tingling in feet and hands. Burning sensation all over body and muscle twitching  all over body. Roof of mouth burning. Tingling on lips and tongue. Bruising  and gum bleeding.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Muscle twitching, Nerve conduction studies, Oral discomfort, Paraesthesia
Clinical narrative: Numbness and tingling in feet and hands. Burning sensation all over body and muscle twitching  all over body. Roof of mouth burning. Tingling on lips and tongue. Bruising  and gum bleeding.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Numbness and tingling in feet and hands. Burning sensation all over body and muscle twitching  all over body. Roof of mouth burning. Tingling on lips and tongue. Bruising  and gum bleeding.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Chills, extreme soreness on left arm where I got the 2nd vaccine.  Hurt from my wrist, all the way up to my left shoulder across shoulder and up side of left neck, headaches, body aches, no appetite.  Extreme fatique. was up all night
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Chills, extreme soreness on left arm where I got the 2nd vaccine.  Hurt from my wrist, all the way up to my left shoulder across shoulder and up side of left neck, headaches, body aches, no appetite.  Extreme fatique. was up all night
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: During 15 minute observation time after patient received Moderna vaccination, she  developed slight rash upper back and forehead with itching.  Vital signs taken multiple times: 9:48 B/P 169/71, H R 102 , benadryl 25 mg po given.  9:53 am B/P 140/66 HR 95.  10 am B/P 153/70 HR 101.  10:15 am B/P 137/65 HR 94  Pulse Ox was consistently 100 % entire time.  Itching and rash subsided and patient was discharged home at 10:15 am
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Soreness in the vaccinated arm, persistent swelling through course of week. Likely delayed allergic response.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Culture throat negative, Diarrhoea
Clinical narrative: The day after the vaccine- chills and headaches-lasted for 3 days The symptoms worsened slowly & on 03/10/2021 presented: sore throat, cough, diarrhea, chest pains when coughing. Patient was tested for COVID-19 (PCR), for Strep (RST & THROAT CULTURE), Influenza A& B, EKG, CBC and Basic Metabolic.  Patient was treated with AMOXICILLIN for possible Strep until culture was available, ALBUTEROL INHALER & DEXAMETHASONE for bronchitis. *** This patient was Positive for COVID-19 in August 2020. She had the same symptoms as in March.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Full blood count normal, Headache, Influenza A virus test negative, Influenza B virus test
Clinical narrative: The day after the vaccine- chills and headaches-lasted for 3 days The symptoms worsened slowly & on 03/10/2021 presented: sore throat, cough, diarrhea, chest pains when coughing. Patient was tested for COVID-19 (PCR), for Strep (RST & THROAT CULTURE), Influenza A& B, EKG, CBC and Basic Metabolic.  Patient was treated with AMOXICILLIN for possible Strep until culture was available, ALBUTEROL INHALER & DEXAMETHASONE for bronchitis. *** This patient was Positive for COVID-19 in August 2020. She had the same symptoms as in March.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: The day after the vaccine- chills and headaches-lasted for 3 days The symptoms worsened slowly & on 03/10/2021 presented: sore throat, cough, diarrhea, chest pains when coughing. Patient was tested for COVID-19 (PCR), for Strep (RST & THROAT CULTURE), Influenza A& B, EKG, CBC and Basic Metabolic.  Patient was treated with AMOXICILLIN for possible Strep until culture was available, ALBUTEROL INHALER & DEXAMETHASONE for bronchitis. *** This patient was Positive for COVID-19 in August 2020. She had the same symptoms as in March.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure decreased, Bone pain, Chills, Dizziness postural
Clinical narrative: Approximately 12 hours following the first dose I started to feel chills, headache, nauseated, fatigue, fever-101.2 F, intestinal issues, right arm pain, body aches.  The following day, I experienced the same, in addition to, extreme fatigue and dizziness upon standing and lower blood pressure. On Saturday, two days following, I experienced swollen lymph nodes in my lower neck and collarbone area, same side as the injection. I called my Dr. on Monday to ask them about it and they informed me to wait four weeks to see if they go down. It is now March 25 and I still feel headaches with neck tenderness and collarbone tenderness.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: Approximately 12 hours following the first dose I started to feel chills, headache, nauseated, fatigue, fever-101.2 F, intestinal issues, right arm pain, body aches.  The following day, I experienced the same, in addition to, extreme fatigue and dizziness upon standing and lower blood pressure. On Saturday, two days following, I experienced swollen lymph nodes in my lower neck and collarbone area, same side as the injection. I called my Dr. on Monday to ask them about it and they informed me to wait four weeks to see if they go down. It is now March 25 and I still feel headaches with neck tenderness and collarbone tenderness.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin, Pyrexia
Clinical narrative: Approximately 12 hours following the first dose I started to feel chills, headache, nauseated, fatigue, fever-101.2 F, intestinal issues, right arm pain, body aches.  The following day, I experienced the same, in addition to, extreme fatigue and dizziness upon standing and lower blood pressure. On Saturday, two days following, I experienced swollen lymph nodes in my lower neck and collarbone area, same side as the injection. I called my Dr. on Monday to ask them about it and they informed me to wait four weeks to see if they go down. It is now March 25 and I still feel headaches with neck tenderness and collarbone tenderness.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vial punctured at 9:04am; dose given to pt at 3:28pm (24 minutes past the 6 hour expiration point). Pt did not have any adverse effects
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Immediate post-injection reaction
Clinical narrative: dizziness, shortness of breath, rapid heart rate, immediately following injection.  Lasted for about 2 hours.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: No adverse event, but pt received a more potent dose. Pharmacist reconstituted with 0.8ml instead of 1.8ml.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vein rupture
Clinical narrative: Bruising on right side of body from broken blood vessel near carotid artery
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Balance disorder, Dizziness, Headache, Pain
Clinical narrative: severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/off balance, started ~12 hours after injection
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/off balance, started ~12 hours after injection
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient recieved first dose of of COVID-19 vaccine on 02/18/21  and was given the COVID-19 vaccine. When the patient returned late for a second dose on 03/25/21 the patient was given the other manufacturer COVID-19 vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Vaccination error
Clinical narrative: VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Throat irritation
Clinical narrative: A few minutes after receiving vaccine patient reported with itchy throat and tingling of neck and face. Previous history of anaphylaxis to bee stings. Gave 50mg Benadryl and bottle of water. Patient did not want Epi-pen until absolutely necessary because she said previously it took her down for 2 days. She had us call husband and sister and asked for EMS to be called. Still declined Epi-pen. EMS took her to (hospital).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Achy left arm, tenderness in left armpit, pins & needles feeling in left hand, discomfort extends to left chest & shoulder blade
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Impaired work ability, Myalgia, Vertigo
Clinical narrative: The first day I had chills and fatigue about 6 hours after the shot. The next morning I woke up and the room was spinning and I had severe muscle aches. I had to call off work. I went back to bed and slept 13 hours and then felt fine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Burns first degree, Dizziness, Feeling abnormal, Lacrimation increased, Throat tightness
Clinical narrative: Patient previously had an adverse reaction of throat tightness to the first dose of the Moderna covid vaccine. She had been counseled to discuss with her doctor about getting a second dose, and if cleared, to receive the second dose at a hospital facility. Patient reports that she discussed with her doctor, who advised her to wait for allergy testing, however the patient chose not to wait for the shipment and decided to proceed with receiving the second dose at the same location as the first dose.   Per patient, had taken two puffs of QVAR prior to second dose vaccination. 11:30am Time of administration of second dose 11:40am Adverse reaction began. Patient reports throat tightness, lightheadedness, foggy.  Denies trouble breathing, itching. Reports had breakfast. Two areas of erythema noted on her neck. No erythema on chest/trunk/arms/face/ears.   11:50pm BP 147/92, HR 91, O2 sat 99% 12:01pm Administered two tablets of 25mg diphenhydramine. 12:03pm  O2 sat 99%, HR 112. Appears teary-eyed, distressed about circumstances. Lungs clear to auscultation bilaterally, no stridor or use of accessory muscles.  12:08pm Neck erythema resolving.  12:11pm O2 sat 99%, HR 92, BP 143/97. Reports throat tightness feels the same, but not worse.  12:19pm O2 sat 99%, HR 94 12:28pm Reports throat still tight, but feeling much better. Affect and appearance much improved, no acute distress, lucid and conversational. No erythema on neck/chest/trunk/arms/face/ears.   12:35pm Patient declined offer to consider EMS if throat tightness not resolving. Patient has her own epi-pen. Provided counseling on s/s of anaphylaxis, training husband on use of epi-pen. Instructed to call 911 if symptoms worsen or have difficulty breathing.  12:45pm BP 145/88, HR 89, O2 sat 99% 12:49pm Discharged home.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site induration, Peripheral swelling
Clinical narrative: My left underarm area is swollen and feels soft. The same consistency as a water balloon.  There is some redness in my armpit as well. And the vaccination site is reddish and feels tougher than the rest of my arm or my right arm.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: Moderna COVID-19 vaccine   Developed  a severe rash on left side of my stomach with two blisters 1/2? diameter in size.  I was sitting in the sun on my deck for about 2 hours and was wearing a shirt that covered my stomach.  Rash disappeared after 3 days.  Blisters are still present but look better.  No medical treatment required
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: At approximately 7 days post first Moderna COVID vaccine she noticed redness, pain, swelling in her left arm at the injection site. Seen at urgent care as she did not have a PCP. They diagnosed cellulitis and put her on PO Keflex which she took. It looked better in 48 hours after starting antibiotic and looked completely resolved 7 after starting antibiotic.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 26 days after my first Moderna vaccination I developed Shingles. I talked to my sisters family and she also developed Shingles after a COVID vaccination.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Product preparation issue
Clinical narrative: No adverse event, but pt received a more potent dose. Pharmacist reconstituted with 0.8ml instead of 1.8ml.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I developed a rash ten minutes after receiving the second dose. On my neck and it trailed down to chest area. They took me to Urgent Care and they gave me Benadryl and the Rash went away.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pruritus, Rash erythematous, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: 4 inch by 2 inch red, hot, itchy rash area lasting 4 days.  Sinus congestion.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: 4 inch by 2 inch red, hot, itchy rash area lasting 4 days.  Sinus congestion.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Burning sensation, Diarrhoea, Erythema, Fatigue
Clinical narrative: On day 11 post shot I started to feel mildly nauseated. Next day nausea increased, as did muscle aches and pain - by early evening I had repeated bouts of uncontrollable vomiting and uncontrollable diarrhea [no cramps, no warning] that lasted most of the night.  I did have a fever briefly - got all red and felt like I was on fire - but that passed pretty quickly while the rest continued.   I had to stay up all night, any attempt to lie down triggered more vomiting.  By 3 in the morning I was ?on empty? and by 6 am could lie down.  Nausea took three more days to leave completely.  Muscle pain is resolving, almost gone.  I am resuming my meds [everything that went down before came right back up].  The only tummy pain was after hours of vomiting [muscle strain].   Today is the 25th and I?m still tired and a bit foggy but otherwise feel better.  I had a call with my doctor about this and she said I should report it so that?s what I?m doing.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Nausea, Pyrexia, Sleep disorder
Clinical narrative: On day 11 post shot I started to feel mildly nauseated. Next day nausea increased, as did muscle aches and pain - by early evening I had repeated bouts of uncontrollable vomiting and uncontrollable diarrhea [no cramps, no warning] that lasted most of the night.  I did have a fever briefly - got all red and felt like I was on fire - but that passed pretty quickly while the rest continued.   I had to stay up all night, any attempt to lie down triggered more vomiting.  By 3 in the morning I was ?on empty? and by 6 am could lie down.  Nausea took three more days to leave completely.  Muscle pain is resolving, almost gone.  I am resuming my meds [everything that went down before came right back up].  The only tummy pain was after hours of vomiting [muscle strain].   Today is the 25th and I?m still tired and a bit foggy but otherwise feel better.  I had a call with my doctor about this and she said I should report it so that?s what I?m doing.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: On day 11 post shot I started to feel mildly nauseated. Next day nausea increased, as did muscle aches and pain - by early evening I had repeated bouts of uncontrollable vomiting and uncontrollable diarrhea [no cramps, no warning] that lasted most of the night.  I did have a fever briefly - got all red and felt like I was on fire - but that passed pretty quickly while the rest continued.   I had to stay up all night, any attempt to lie down triggered more vomiting.  By 3 in the morning I was ?on empty? and by 6 am could lie down.  Nausea took three more days to leave completely.  Muscle pain is resolving, almost gone.  I am resuming my meds [everything that went down before came right back up].  The only tummy pain was after hours of vomiting [muscle strain].   Today is the 25th and I?m still tired and a bit foggy but otherwise feel better.  I had a call with my doctor about this and she said I should report it so that?s what I?m doing.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Depression, Disturbance in attention, Dyspnoea
Clinical narrative: Inability to move within 24 hours - lasting 48+ hours Vomiting Pain in left (shot) arm radiating to left breast Rash Headache on the first day Chest pain/tightness, consistent shortness of breath, worse with exertion Brain fog Fatigue Inability to concentrate Very acute depression in the first 3-4 days after the 2nd shot
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Fatigue, Feeling abnormal, Headache, Mobility decreased
Clinical narrative: Inability to move within 24 hours - lasting 48+ hours Vomiting Pain in left (shot) arm radiating to left breast Rash Headache on the first day Chest pain/tightness, consistent shortness of breath, worse with exertion Brain fog Fatigue Inability to concentrate Very acute depression in the first 3-4 days after the 2nd shot
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash, Vomiting
Clinical narrative: Inability to move within 24 hours - lasting 48+ hours Vomiting Pain in left (shot) arm radiating to left breast Rash Headache on the first day Chest pain/tightness, consistent shortness of breath, worse with exertion Brain fog Fatigue Inability to concentrate Very acute depression in the first 3-4 days after the 2nd shot
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; the patient is just starting the ROTATEQ series at 6 months old; This spontaneous report has been received from a medical assistant concerning a 6 months old patient of unknown gender.The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On 08-MAR-2021,  at the age of 6 months old , the patient started the series of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 2 milliliter for prophylaxis (Lot # and expiration date were not reported) (Product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: no additional adverse event; a patient was less than a full recommended dose because of needle leakage; a patient was less than a full recommended dose because of needle leakage; This spontaneous report was received from a customer referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 09-MAR-2021, a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin (rHA)) (strength and route were not provided; lot# was S039312 and expiration date was 04-DEC-2021) 1 dose with sterile diluent (strength and route were not provided; lot# was T005076 and expiration date was 04-OCT-2022) 1 dose was given to a patient, which was less than a full recommended dose for prophylaxis because of needle leakage (needle issue and underdose). No additional adverse event was reported (no adverse event).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles, including any and all of its sequelae; The information was received from a lawyer rand refers to a elderly male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-FEB-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) in a clinic for prophylaxis (dose, route of adminstration, lot # and expiration date were not reported). The patient was 64-years-old when he received zoster vaccine live (ZOSTAVAX) (reported as 65-years-old). As a result of his receipt of zoster vaccine live (ZOSTAVAX) in 2014, patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), patient was caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, the patient requires and/or will require more health care and services and did incur medical, health, he will int the future be required to obtain further medical and/or hospital care, attention and services. Patient also has suffered diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other loses and damages. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: she was also nonresponsive to pneumococcal vaccine; This information has been received from the authors in a published literature marketed article, entitled as stated below, referring to a 61-year-old female patient at reporting time. Her current conditions included the diagnosis of having common variable immunodeficiency (CVID). The authors did not provide further information on the patient's historical conditions, drugs, or vaccines, illnesses at vaccination, and concomitant medications of vaccines.    On an unspecified date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) for prophylaxis to which she was nonresponsive (therapy non-responder) (age at vaccination, formulation, concentration, dose number, dose, route and anatomical vaccination location, lot number, and expiration date were not provided).   The event therapy non-responder has been considered related to the pneumococcal vaccine (manufacturer unknown).     A copy of the published article is attached as further documentation of the patient's experience.