chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt. received the first COVID vaccine (Pfizer, lot # EW0182 and use by date is 05/13/21 at 0930am) around 1123am.  LVN, administered the Pfizer vaccine and approximately 10 seconds after the vaccine was administered, the patient became pale and the patient loss consciousness for approximately 4 seconds. LVN ensured that the patient did not fall off the chair while RN (and Co-Lead), RN (Lead Vaccinator), and EMT observer, immediately ran to assist LVN with assisting the patient to the ground. The patient was alert and oriented when the nurses assisted him to the floor and had him lie in a supine position with his legs elevated.  The patient was alert and oriented to person, place, time, and situation. Vital signs were immediately taken at 1124 when the patient was supine on the ground with his legs elevated: blood pressure of 112/58 (right arm, supine) , heart rate of 48 beats per minute, respiratory rate of 16 breaths per minute, and 100% oxygen saturation at room air. The patient denied any headache, nausea, or dizziness. The patient was moved to the gravity chair and was placed in Fowler's position. The patient was given Gatorade, as the patient did not eat or drink anything prior to being vaccinated. Vitals were taken at 1131: BP 114/78 (Right arm, sitting) , 66 beats per minute, 16 breaths per minute, and 100% oxygen saturation at room air. Alert and oriented to person, place, time, and situation. Denied any history of fainting . Denied taking any medications or having any chronic medical conditions. The patient continued drinking Gatorade and was offered a granola bar, the patient did not have any known allergies to medications, foods, or dust. At 1141, vitals were retaken, BP 122/87 (Right arm, sitting), HR 63, RR 16, and 100% oxygen saturation at room air. The patient denied any chest pain, shortness of breath, lightheadedness, dizziness, or headache. The patient ate a breakfast biscuit at 1148. At 1153 the patient was positioned from a Fowler's position to sitting upright in the gravity chair. Instructed the patient to have a friend or family member drive him home, the patient then called a friend to transport him home. RN, went over the V-Safe app with the patient and instructed him to eat breakfast and drink fluids the next time he arrived for his 2nd Pfizer vaccine. RN also instructed him to inform the vaccinator the next time he is vaccinated (for his second dose), to inform him/her about his history of fainting with his first dose. The patient's vitals were taken  at 1158 when he was sitting upright, BP: 138/80 (right arm), HR 67, RR 15, and oxygen saturation at 99%. RN instructed the patient about ER precautions and to follow up with his primary care provider. The patient's vital signs were taken a final time at 1210, BP 122/78, RR 16, HR 67, and 100% oxygen saturation at room air. The patient's ride arrived on site around 1215, and the patient had a steady and even gait when ambulating to the vehicle, where he was driven home by a friend.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt recieved her dose at 11, by 5 pm she had diarrhea, tunnel vision.  5/6 thru: fever 101.6, migraine. Took aleve, benadryl and tylenol 5/7 Fri : Fever on and off around 99.6 temp 5/8 Sat: Migraine was very severe 5/9 Sunday was better, Monday..injection site became red.  5/11 Tue: raise and hard injection site.  5/12 Wed: tunnel fision , diarrhea, can't concentrate 5/13: Went to PMD, had a temp of 95.3,  she feels like she is freezing.  PMD prescribed cephalexin 500mg for possible cellulitis.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Pain of skin, Pyrexia, Tunnel vision
Clinical narrative: Pt recieved her dose at 11, by 5 pm she had diarrhea, tunnel vision.  5/6 thru: fever 101.6, migraine. Took aleve, benadryl and tylenol 5/7 Fri : Fever on and off around 99.6 temp 5/8 Sat: Migraine was very severe 5/9 Sunday was better, Monday..injection site became red.  5/11 Tue: raise and hard injection site.  5/12 Wed: tunnel fision , diarrhea, can't concentrate 5/13: Went to PMD, had a temp of 95.3,  she feels like she is freezing.  PMD prescribed cephalexin 500mg for possible cellulitis.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Feeling cold, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt recieved her dose at 11, by 5 pm she had diarrhea, tunnel vision.  5/6 thru: fever 101.6, migraine. Took aleve, benadryl and tylenol 5/7 Fri : Fever on and off around 99.6 temp 5/8 Sat: Migraine was very severe 5/9 Sunday was better, Monday..injection site became red.  5/11 Tue: raise and hard injection site.  5/12 Wed: tunnel fision , diarrhea, can't concentrate 5/13: Went to PMD, had a temp of 95.3,  she feels like she is freezing.  PMD prescribed cephalexin 500mg for possible cellulitis.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Pyrexia, Tunnel vision
Clinical narrative: Pt recieved her dose at 11, by 5 pm she had diarrhea, tunnel vision.  5/6 thru: fever 101.6, migraine. Took aleve, benadryl and tylenol 5/7 Fri : Fever on and off around 99.6 temp 5/8 Sat: Migraine was very severe 5/9 Sunday was better, Monday..injection site became red.  5/11 Tue: raise and hard injection site.  5/12 Wed: tunnel fision , diarrhea, can't concentrate 5/13: Went to PMD, had a temp of 95.3,  she feels like she is freezing.  PMD prescribed cephalexin 500mg for possible cellulitis.
Age: 16.0
Sex: M
Vaccine: FLUC4
Symptoms: Vaccination site pain
Clinical narrative: Pain at the administration site after receiving the vaccine; This spontaneous case was received on 18-Sep-2020 from a pharmacist via agency (reference number: SEQW20-01973) and concerned a 16-year-old male patient.  The patient's medical history and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with Flucelvax QIV  (influenza vaccine, subunit influenza virus vaccine polyvalent; indication, dose, anatomical location and route of administration: not reported). The batch number was not reported.  On the same day, after receiving Flucelvax QIV, the patient experienced pain at the administration site.  The outcome of 'vaccination site pain' was not reported.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the event as non-serious.  This case is linked to case 202004570 due to the same reporter.  Company comment: The event of 'vaccination site pian' is assessed as related to Flucelvax QIV.; Sender's Comments: The event of vaccination site pian' is assessed as related to Flucelvax QIV.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyspnoea, Influenza virus test negative, SARS-CoV-2 test negative
Clinical narrative: Shortness of breath; This spontaneous case was received on 18-Sep-2020 from a pharmacist via agency (reference number: SEQW20-01973) and concerned a 36-year-old male patient.  The patient's medical history and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; indication, dose, anatomical location and route of administration: not reported). The batch number was not reported.  On the same day, after receiving Flucelvax QIV, the patient experienced shortness of breath. The patient went to medical doctor (MD) and was tested for flu and COVID-19, which came back negative. MD said it was a reaction to the vaccine (did not specify) and patient was sent home with Benadryl (diphenhydramine hydrochloride).   The outcome of shortness of breath was not reported.  The reporter did not provide a causality assessment to Flucelvax QIV, however the was MD said it a reaction to the vaccine (did not specify).   The reporter assessed the event as non-serious.   This case is linked to case 202004569 due to the same reporter.  Company comment: The patient developed dyspnea on the same day after receiving the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: MD said it was a reaction to the vaccine (did not specify).; Sender's Comments: The patient developed dyspnoea on the same day after receiving the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: patient felt fainting after vaccine ,was placed down on the floor and was awake until paramedics arrived and checked patient and started to feel better and left the store with a family member
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Gait disturbance, Inflammation, Loss of consciousness, Night sweats
Clinical narrative: Two and half weeks after receiving the vaccine I woke up in the middle of the night sweating, with intense vertigo, could not walk without holding on to the walls, passed out.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Two and half weeks after receiving the vaccine I woke up in the middle of the night sweating, with intense vertigo, could not walk without holding on to the walls, passed out.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Facial pain, Fatigue
Clinical narrative: Worst pain ever right side of my face, starting from my right Jaw, coming up all the way to my front head with a duration of almost 2 hours (04/10/2021, about 11:00 pm until 1:00 am), fever every night with night sweats since 04/09/2021, followed by body chills, sharp headache similar to first episode of 04/10/2021, light headed, dizziness since vaccine was taken, always very tired, no energy at all,  since vaccine was taken, I lost all my energy, my body is always on fire inside, my life is not going to be the same after I took this Covid 19 vaccine on 04/09/2021
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Night sweats, Pain in jaw, Pyrexia
Clinical narrative: Worst pain ever right side of my face, starting from my right Jaw, coming up all the way to my front head with a duration of almost 2 hours (04/10/2021, about 11:00 pm until 1:00 am), fever every night with night sweats since 04/09/2021, followed by body chills, sharp headache similar to first episode of 04/10/2021, light headed, dizziness since vaccine was taken, always very tired, no energy at all,  since vaccine was taken, I lost all my energy, my body is always on fire inside, my life is not going to be the same after I took this Covid 19 vaccine on 04/09/2021
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder, Rash
Clinical narrative: I got some bumps inside my mouth,  and a little bit of rash.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever for two days, swollen lymph node under arm pit on left arm for six days
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Dysgeusia, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Fever temperature fluctuating sweats vomiting  nausea metal taste in mouth
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever temperature fluctuating sweats vomiting  nausea metal taste in mouth
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 yearold male presented for 2nd shot of moderna, parent notified and signed waiver for client to receive dose. client and father made aware vaccine not approved for under 18 and advised to visit pcp for further consultation. moderna notified. monitored no adverse reaction identified, stable.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Day after vaccination: extreme fatigue and headache 3 Days after vaccination: fatigue and headache still present, but now experiencing nausea
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: PT  PASSED OUT AND FELL TO FLOOR FROM THE CHAIR SHE WAS SITTING IN.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: Covid arm on day 7. Whole body itchy Taking tylenol
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope
Clinical narrative: PATIENT WARNED ME THAT HE HAS A NEEDLE PHOBIA, I GAVE HIM THE VACCINE, HE TOLD ME THAT HE DID BETTER THAN OTHER TIMES, HE STAYED SITTING ON THE CHAIR, THEN HE SAID THAT HE FEEL NAUSEATED AND WANTS COLD WATER, THEN HE FAINTED, I CALLED FOR HELP, HIS MOM WAS OUTSIDE THE CLINIC IN THE LOBBY, WE CALLED HER, WE ALSO CALLED 911. HE STARTED WAKING UP AFTER LIKE 5 MINUTES, 911 WERE HERE AND CHECKED HIM, HE WAS OK, ALL HIS VITAL SIGHNS WERE NORMAL, HE LEFT THE PHARMACY WALKING WITH HIS DAD AND MOM.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Aneurysm, Asthenia, Computerised tomogram abnormal, Echocardiogram, Fall
Clinical narrative: I fell while helping my neighbor move a box into her apartment. When I tried to get back up, I found I had no strength in my left arm.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: I fell while helping my neighbor move a box into her apartment. When I tried to get back up, I found I had no strength in my left arm.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dysstasia, Flushing, Gait disturbance
Clinical narrative: 1 and 1/2 days after my 2nd COVID-19 Vaccine, Sunday 3/20/2021, I had a weakening feeling in my right hip and some pain. The following morning, Monday, as I got up to get ready for work I could barely stand and had to use the wall for support to get to the nearby bathroom. It was difficult to sit down to go to use the toilet and I struggled to get up. I was flushed and nauseous from the extreme pain in my right hip. My husband was very concerned and I struggled back to bed, telling him I couldn't go to work like this. I reported a sick day and contacted the teacher I work with. During the rest of the week the pain got worse. I got an appointment to see my provide on Tuesday, 3/23/2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Joint swelling, Nausea, Walking aid user, X-ray limb normal
Clinical narrative: 1 and 1/2 days after my 2nd COVID-19 Vaccine, Sunday 3/20/2021, I had a weakening feeling in my right hip and some pain. The following morning, Monday, as I got up to get ready for work I could barely stand and had to use the wall for support to get to the nearby bathroom. It was difficult to sit down to go to use the toilet and I struggled to get up. I was flushed and nauseous from the extreme pain in my right hip. My husband was very concerned and I struggled back to bed, telling him I couldn't go to work like this. I reported a sick day and contacted the teacher I work with. During the rest of the week the pain got worse. I got an appointment to see my provide on Tuesday, 3/23/2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray of pelvis and hip normal
Clinical narrative: 1 and 1/2 days after my 2nd COVID-19 Vaccine, Sunday 3/20/2021, I had a weakening feeling in my right hip and some pain. The following morning, Monday, as I got up to get ready for work I could barely stand and had to use the wall for support to get to the nearby bathroom. It was difficult to sit down to go to use the toilet and I struggled to get up. I was flushed and nauseous from the extreme pain in my right hip. My husband was very concerned and I struggled back to bed, telling him I couldn't go to work like this. I reported a sick day and contacted the teacher I work with. During the rest of the week the pain got worse. I got an appointment to see my provide on Tuesday, 3/23/2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Flushing, Gingival swelling
Clinical narrative: Sore and swollen gums, dizziness, fatigue, red and flushed face
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: low-grade fever, chills, and possibly back aches
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Heart rate increased, Rash, Rash pruritic
Clinical narrative: Many rashes in my legs , face, some are big. It bothers all the time and scratches a lot. I am tired, having headaches at times, and accelerated heart beat sometimes.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash papular
Clinical narrative: Developed a raised, very painful, hot to the touch red rash under the injection site on my arm 2 days after the shot. No medical treatment. The rash has slowly decreased in size, pain, and heat but is still present 4 days later.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blindness unilateral, Ophthalmological examination abnormal, Thrombosis
Clinical narrative: My mother had her first Moderna COVID-19 vaccination on March 1st.  On March 10th, she suffered a blood clot in her eye that caused the eye to lose vision.  Her eye doctor said she is now permanently legally blind in that eye....  I do not know if the blood clot was caused by the vaccine, but I am reporting it in case there is a correlation.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: Fast heart rate and SOB w/HA and fatigue x 2 days, started 1700 yesterday after receiving J&J vaccine in AM yesterday, reports SOB upon exertion and "long-winded conversation"; denies any dizziness; last dose 325mg ASA with 500mg Tylenol at 0900.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis
Clinical narrative: Fast heart rate and SOB w/HA and fatigue x 2 days, started 1700 yesterday after receiving J&J vaccine in AM yesterday, reports SOB upon exertion and "long-winded conversation"; denies any dizziness; last dose 325mg ASA with 500mg Tylenol at 0900.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: HA, bodyache and chills since he got a J&J 10am this morning. Also having some left side pain without urinary issues or trauma. Has not taken any meds. Denies chest pain, difficult breathing.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Pain, Physical examination
Clinical narrative: c/o sharp chest pain which radiating to L lower chest and body ache since J&J shot yesterday 1700. denies took any meds.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Migraine, Photophobia
Clinical narrative: Unbearable migraines daily and sensitivity to the light including full body loosing strength when my episodes occur.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Headache
Clinical narrative: PT stats she got the COVID-19 vaccine yesterday and since then has been coughing with a headache W/chest pain. PT was told to come to the ER by her command. PT denies taking medication.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Cardioversion, Death, Dyspnoea, Haematemesis
Clinical narrative: On 5/12/2021 patient was complaining of generalized body aches, later in the morning when going to a pain management clinic, patient subsequently became nauseous and vomited several times during the course of the day. Reportedly had episode of dark emesis as well. Patient was then found by family around 10pm unresponsive, pale, w/ difficulty breathing, EMS was called, patient was found to be in cardiac arrest in asystole. Patient possibly had v-fib during transport and was defibrillated twice before becoming asystolic again. Patient was subsequently pronounced dead in the Emergency Department on 5/12/21 at 11:04pm.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pallor, Unresponsive to stimuli, Vomiting
Clinical narrative: On 5/12/2021 patient was complaining of generalized body aches, later in the morning when going to a pain management clinic, patient subsequently became nauseous and vomited several times during the course of the day. Reportedly had episode of dark emesis as well. Patient was then found by family around 10pm unresponsive, pale, w/ difficulty breathing, EMS was called, patient was found to be in cardiac arrest in asystole. Patient possibly had v-fib during transport and was defibrillated twice before becoming asystolic again. Patient was subsequently pronounced dead in the Emergency Department on 5/12/21 at 11:04pm.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea
Clinical narrative: Major Migraine headaches  with nausea started on May 7, 2021, additional migraines on May 9, 2021, May 11, 2021 continuing through May 12, 2021.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: severe sounds in my head   tinnitus!! crickets, swooshing, loud noises
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Starting roughly 10 days after my second shot, I began to experience shingles pain along the nerve which has historically been affected in previous Shingles episodes.  This has so far continued for 3 days.   The pain is mild, no evidence of a rash.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: COVID arm . Large red circle big lump hurts to be touched at injection site
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: THE CLIENT IS ONLY 17 YRS OLD AND THE VACCINE IS ONLY FOR 18 YRS AND OVER
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular, Pregnancy test negative
Clinical narrative: Late menstrual cycle. My cycle is very regular, the same flow every month, coming on the 25th day and rarely late. I only had spotting on what would've been the first day of my period. The spotting occurred for 2 days and that was it - no regular flow. I'm still waiting for my regular period to come. It's now almost 5 days late. I've read on many social media boards that this is happening to a lot of women. Please make the information about late/abnormal periods public knowledge!
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: The day after the shot I noticed a redness and swelling around the vaccination site. It's hard to the touchy and itchy. It feels and looks like a huge welt.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Persistent intermittent HA.  No prior hx of HA and no other aggrevating factors other than vaccine.  Also new arthralgias.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: Within 5-10 minutes of receiving second dose, I felt extremely dizzy, nauseated, VERY weak, confused, and feverish. I began sweating profusely and had to lay down outside for 30 minutes before feeling well enough to stand. At that time, I reentered the store and told them of my frightening symptoms and they asked me to wait until I felt better. In this time,  blood pressure was checked by (excellent) staff and pharmacist that gave the shot, and it was low but rose to normal within the hour and I was able to make the short drive home.  I was entirely surprised by this reaction and was pretty scared at losing control of my body like that, I have never experienced anything quite so acutely intense.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Within 5-10 minutes of receiving second dose, I felt extremely dizzy, nauseated, VERY weak, confused, and feverish. I began sweating profusely and had to lay down outside for 30 minutes before feeling well enough to stand. At that time, I reentered the store and told them of my frightening symptoms and they asked me to wait until I felt better. In this time,  blood pressure was checked by (excellent) staff and pharmacist that gave the shot, and it was low but rose to normal within the hour and I was able to make the short drive home.  I was entirely surprised by this reaction and was pretty scared at losing control of my body like that, I have never experienced anything quite so acutely intense.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Computerised tomogram abdomen normal, Computerised tomogram normal, Computerised tomogram thorax
Clinical narrative: Several hours after Covid vaccine pt developed his classic sickle cell crisis symptoms of severe pain and was hospitalized 3/ 27 to 3/ 31 with sickle cell crisis. No clinical evidence of thrombosis, treated with IV hydration and oxygen and improved in several days. Had a previous h/o sickle cell crisis and hospitalization while taking oral typhoid vaccine in 2017. After discharge, 5 days later had onset of chest pain, returned to ER, Chest CT negative for embolus, D- Dimer > 18,000. No clinical evidence of clot. pt hydrated again / O2 but was able to go home.  Covid negative by PCR during both episodes.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Electrocardiogram normal, Fibrin D dimer, Pain, SARS-CoV-2 test negative
Clinical narrative: Several hours after Covid vaccine pt developed his classic sickle cell crisis symptoms of severe pain and was hospitalized 3/ 27 to 3/ 31 with sickle cell crisis. No clinical evidence of thrombosis, treated with IV hydration and oxygen and improved in several days. Had a previous h/o sickle cell crisis and hospitalization while taking oral typhoid vaccine in 2017. After discharge, 5 days later had onset of chest pain, returned to ER, Chest CT negative for embolus, D- Dimer > 18,000. No clinical evidence of clot. pt hydrated again / O2 but was able to go home.  Covid negative by PCR during both episodes.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Sickle cell anaemia with crisis
Clinical narrative: Several hours after Covid vaccine pt developed his classic sickle cell crisis symptoms of severe pain and was hospitalized 3/ 27 to 3/ 31 with sickle cell crisis. No clinical evidence of thrombosis, treated with IV hydration and oxygen and improved in several days. Had a previous h/o sickle cell crisis and hospitalization while taking oral typhoid vaccine in 2017. After discharge, 5 days later had onset of chest pain, returned to ER, Chest CT negative for embolus, D- Dimer > 18,000. No clinical evidence of clot. pt hydrated again / O2 but was able to go home.  Covid negative by PCR during both episodes.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Hyperhidrosis, Hypersomnia, Loss of consciousness
Clinical narrative: 10 minutes after receiving injection felt body heating up like blood was boiling, sweating eventually passed out.   8 weeks later still low energy levels and llengthy sleeping times
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Became sore, achey, flueish and tired that night. Sore arm.   Next 10 days was extremely tired although other initial symptoms cleared up in 36 hours after shot.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right leg pain. Front of leg from the hip to the knee cap.
Age: 87.0
Sex: F
Vaccine: UNK
Symptoms: Crying, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Day after shot patient reported being tired.  Patient has not regained normal daily functions possessed previous the shot.  Patient started picking up papers and putting them down as if she could not read them, day after shot.   She has not made a check in her check book since the shot.  Patient unable to carry out normal activities of daily living. Check book traced back to January 6, 2021 as last entry.  Patient started to cry every evening  starting January 8, 2021.  It is now May and perhaps there is slight recovery.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: About 10 minutes after receiving the 0.5 ml dose of the Jansen vaccine while the patient was waiting in observation, she had a brief (~10 second) LOC followed by a mini seizure. Patient was being observed by 2 EMTs and 3 nurses. Patient recovered quickly, had a strong pulse, steady breathing, and was aware and responsive.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Erythema, Injection site erythema, Limb discomfort, Muscular weakness
Clinical narrative: Immediate redness of arm surrounding the injection site.  Redness/blotchiness spread from arm across entire chest.  Legs felt heavy and weak.  Heart racing. Face red and may have been slightly swollen as well, as noted by medical staff.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Swelling face
Clinical narrative: Immediate redness of arm surrounding the injection site.  Redness/blotchiness spread from arm across entire chest.  Legs felt heavy and weak.  Heart racing. Face red and may have been slightly swollen as well, as noted by medical staff.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Immediate post-injection reaction, Tinnitus
Clinical narrative: Developer Tinnitus right after taking shots. At first it was very mild. But after taking my second shot, I feel like my tinnitus symptoms have worsened. I never had history of hearing problems before.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Mild fever of  99.8, fatigue,  body aches, headache, all fingers are cold, numb and tingling in both hands,  tightness in chest.  Started experiencing symptoms approximately 10 hours after receiving vaccine. Took 2 Tylenol and 2 Ibuprofen for treatment, plan to go to ER if symptoms worsen overnight.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: Mild fever of  99.8, fatigue,  body aches, headache, all fingers are cold, numb and tingling in both hands,  tightness in chest.  Started experiencing symptoms approximately 10 hours after receiving vaccine. Took 2 Tylenol and 2 Ibuprofen for treatment, plan to go to ER if symptoms worsen overnight.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, Computerised tomogram
Clinical narrative: Appendicitis
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Induration, Insomnia, Pain, Pain in extremity
Clinical narrative: Immediately after second dose, my upper left shoulder started to hurt. By 2 hours after, I felt a huge knot in my muscle. By the end of the day, I could not move my left arm due to the excruciating pain in my shoulder and upper arm. The pain was so severe I couldn?t sleep that night from the pain. Next morning I went to the doctor as I couldn?t stand the pain and was concerned something was extremely wrong.  There was fluid built up in my shoulder and my left arm was retaining water even down to my wrist and fingers. Doctor gave me NORCO for the pain. The NORCO didn?t help the pain so I stopped taking after one day. By day 3 I could start to move my arm about 15 degrees from my body without excruciating pain. Each day after day 3 has slowly gotten a little better but my pain has yet to go away.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Immediately after second dose, my upper left shoulder started to hurt. By 2 hours after, I felt a huge knot in my muscle. By the end of the day, I could not move my left arm due to the excruciating pain in my shoulder and upper arm. The pain was so severe I couldn?t sleep that night from the pain. Next morning I went to the doctor as I couldn?t stand the pain and was concerned something was extremely wrong.  There was fluid built up in my shoulder and my left arm was retaining water even down to my wrist and fingers. Doctor gave me NORCO for the pain. The NORCO didn?t help the pain so I stopped taking after one day. By day 3 I could start to move my arm about 15 degrees from my body without excruciating pain. Each day after day 3 has slowly gotten a little better but my pain has yet to go away.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia
Clinical narrative: PATIENT REQUESTED TO BE VACCINATED BY FIRST DOSE OF PFIZER BRAND VACCINE FOR COVID 19. VACCINATION HAPPENED AT AROUND 9:39 PM PST. FEW MINUTES AFTER VACCINATION, PATIENT REPORTED FEELING DIZZY. IMMEDIATELY AFTER THAT, HIS BODY STARTED TO EXPERIENCE JERKINGS AND HIS EYES SEEM TO POP OUT. THIS LASTED FOR AROUND 30 SECONDS. PATIENT REGAINED NORMAL STATE OF CONSCIOUSNESS AFTER THOSE 30 SECONDS. HE MENTIONED FEELING FINE. 911 WAS CALLED. PARAMEDICS CAME AT AROUND 10:40 PM. PATIENT WAS CLEARED TO BE NORMAL BY THEM AFTER WHICH HE LEFT THE FACILITY
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Influenza like illness, Joint swelling, Musculoskeletal stiffness
Clinical narrative: 2 days of flu-like symptoms and fever consistently around 102° after injection; joint swelling, aches, warmth, stiffness; redness, warmth to touch, and immense tenderness in arm followed by week-long pruritic rash about 4? below injection site; 2-4 minute long attacks of heart palpitations up to 8 times daily about two weeks after vaccination
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia, Rash pruritic, Tenderness
Clinical narrative: 2 days of flu-like symptoms and fever consistently around 102° after injection; joint swelling, aches, warmth, stiffness; redness, warmth to touch, and immense tenderness in arm followed by week-long pruritic rash about 4? below injection site; 2-4 minute long attacks of heart palpitations up to 8 times daily about two weeks after vaccination
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain in the upper left arm where shot was administered, starting 2 days after shot, lessening and then coming back much stronger after 1 week. Soreness and pain from shoulder to elbow. 3 Advil does not alleviate.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in left cheek And left tongue
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients. .; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history, and concomitant medications.  On 06-APR-2021 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD) with dose reported as 1 administered subcutaneously (lot number T031602 and expiration date 15-MAR-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002802: US-009507513-2104USA002803: US-009507513-2104USA002804: US-009507513-2104USA002807: US-009507513-2104USA002808: US-009507513-2104USA002809: US-009507513-2104USA002801: US-009507513-2104USA002800: US-009507513-2104USA002799: US-009507513-2104USA002805: US-009507513-2104USA002806:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD) with dose reported as 1 administered subcutaneously (lot number T031602 and expiration date 15-MAR-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions,pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD)  with dose reported as 1 administered subcutaneously (lot number T031602 and expiration date 15-MAR-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No additional AEs; a temperature excursion with ROTATEQ which was administered to a patient; This spontaneous report was received from medical assistant concerning to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 07-APR-2021, the vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 46.12 Fahrenheit (F) degrees at 5:00 pm. On 08-APR-2021 at 9:00 am, the temperature was 46.48 F degrees, and at 5:00 pm was 47.87 (units not reported). On the same date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 0.5 milliliter administered orally (lot number 1688825 has been verified to be valid; expiration date reported and validated as 24-NOV-2021) for prophylaxis (dose number and vaccination scheme were not provided). On 09-APR-2021 at 9:00 am, the temperature was 46.48 F degrees. The total frame time out of range was 48 hours in worst case scenario, there was no previous temperature excursion and the call was due to data logger. No additional adverse events (AEs) reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: no adverse events; dose of PEDVAXHIB was administered following temperature excursions; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 12-MAR-2021, the patient was vaccinated with a dose of improper stored vaccine haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (0.5 mL, lot number S030967 has been verified to be a valid lot number, expiration date reported as 15-MAR-2022, but upon internal validation established as 15-APR-2022; strength and route of administration were not reported) for prophylaxis. It was reported that the vaccine was stored under 49.29 Fahrenheit for 15 minutes and was detected by data logger. There was no previous temperature excursion. No additional adverse event or product quality complaints were reported. No additional information was provided.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered at inappropriate site
Clinical narrative: No additional AE details; administered to a 4 year old patient as IM and not subcutaneous; This spontaneous report was received from a agent referring to a 4-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.   On 31-MAR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) intramuscularly instead of subcutaneously, lot number T025509 and expiration date of 23-JAN-2022 for prophylaxis (dose and anatomical location were not reported). The reporter wanted to know if this could be considered a valid dose. No additional adverse events details.
Age: 70.0
Sex: M
Vaccine: MMR
Symptoms: Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: No additional AE.; Patient was administered M-M-R II by intramuscular route; This spontaneous report was received from a pharmacist and refers to a 70 years old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-APR-2021 at "noon", the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), by intramuscular route for prophylaxis (dose, lot# and expiration date were not reported). No additional adverse event was reported. No product quality complaint (PQC) was involved.
Age: 39.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no additional AE; pediatric dose of V AQT A was administered to a 36 year old patient rather than the adult dose; This spontaneous report was received from a medical assistant concerning a 36 years old patient. No medical history, concurrent condition or concomitant therapy was reported.    On 29-APR-2021, pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (at the dose of 0.5 ml; route, lot# and expiry date were not reported) was administered to the patient rather than the adult dose (product administered to patient of inappropriate age) as prophylaxis. No additional adverse event (AE) was reported.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Anaphylactic shock
Clinical narrative: reaction and thought that maybe it could have been a bad batch; reaction and thought that maybe it could have been a bad batch; anaphylactic shock; This spontaneous report was received from a consumer via Pfizer refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  Approximately in 2009 (reported as "when she was 4 years old"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, frequency, route, vaccination site and lot# were not provided), for prophylaxis.  Other suspect therapies included varicella virus vaccine live (oka/merck)(manufacturer unknown) (dose, frequency, route, vaccination site and lot# were not provided), for prophylaxis.  Approximately in 2009, the patient experienced anaphylactic shock, doctors were never sure of which ingredients may have caused the allergic reaction and thought that maybe it could have been a bad batch.  At the time of reporting, the outcome of anaphylactic shock was unknown.    The reporter considered anaphylactic shock to be related to varicella virus vaccine live (Oka/Merck)(Manufacturer unknown) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(Manufacturer unknown).    Upon internal Review, anaphylactic shock was determined to be medically significant.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No adverse event; temperature excursion on ROTATEQ and PEDVAXHIB; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 03-MAY-2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1694406, expiration date 08-DEC-2021, orally for prophylaxis (dose and vaccination scheme frequency were not reported), and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #T011167 expiration date 27-MAY-2022 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No additional adverse events were reported.   The rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was stored in a temperature of 36 degree Fahrenheit (°F) to 46°F (80°F) for 4 hours, 24 minutes as recorded by a data logger. There was no previous temperature excursion reported.  The haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was stored in a temperature of 36°F to 46°F (80°F) for 4 hours, 24 minutes as recorded by a data logger. There was a previous temperature excursion of 36°F to 46°F (68.4°F) for 3 hours.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Vision Problems; Information has been received from a lawyer regarding a case in litigation and refers to a currently 67 or 68-years-old patient (pt.) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-SEP-2016, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as subsequently), the pt. was treated by health care providers (HCP) for vision problems (visual impairment). The pt. claimed damages as a result of injuries to itself. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).