chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Chills, Dyspnoea, Fall, Feeling abnormal
Clinical narrative: Patient received the flu vaccine yesterday around 3:30pm . she  felt  fine after  getting it  except  her arm felt  a little sore. around 8 pm patient  went  on a walk with mom and started to feel a  little "chiiled"   a little later  she had a mild headache. when she got home she had  to go to the bathroom and when she  got up from the toilet she started to see dark spots both eyes and darkness in her lateral vision bilaterally.  Because of this , and she had never experienced this before, he  called out to her mom.  Dad heard her and  went to go see what was going on. He states when he saw her  she  was pale and looked a little dazed .   She then proceeeded to fall into his arms and  he  took her to the couch .  the episode lasted  very  briefly  and there was  no seizure like activity .  she  was a  little  anxious after the episode and  states  she  had a little dyspnea - dad  states she  was  anxious and  breathign fast  but no trouble breathign . when she calmed down she  then felt  fine and was back to her nml self .
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pain in extremity, Pallor, Respiratory rate increased, Visual impairment
Clinical narrative: Patient received the flu vaccine yesterday around 3:30pm . she  felt  fine after  getting it  except  her arm felt  a little sore. around 8 pm patient  went  on a walk with mom and started to feel a  little "chiiled"   a little later  she had a mild headache. when she got home she had  to go to the bathroom and when she  got up from the toilet she started to see dark spots both eyes and darkness in her lateral vision bilaterally.  Because of this , and she had never experienced this before, he  called out to her mom.  Dad heard her and  went to go see what was going on. He states when he saw her  she  was pale and looked a little dazed .   She then proceeeded to fall into his arms and  he  took her to the couch .  the episode lasted  very  briefly  and there was  no seizure like activity .  she  was a  little  anxious after the episode and  states  she  had a little dyspnea - dad  states she  was  anxious and  breathign fast  but no trouble breathign . when she calmed down she  then felt  fine and was back to her nml self .
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Exposure during pregnancy, Impaired work ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Received Tdap shot (unsure whether Adacel or Boostrix at time of filing report) on 12/04/2020 during appointment at 3:00 PM.  Tdap was indicated because I was 28 weeks pregnant at the time of the appointment.  My estimated due date is 02/24/2021 and I am currently 30 weeks pregnant at the time of this report.  When I got the shot, it didn't hurt any more than usual for any other vaccine that I have received.  Towards the evening, I started getting soreness in my arm.  By the morning of 12/05/2020, I could not move my arm very much and it was extremely sore.  I assumed it was just a normal reaction to the shot.  It seemed to get a little better over the next few days, but the pain never actually went away.  It just dulled.  On 12/12/2020, I began to become concerned because it had been a week since receiving the shot and I still was experiencing pain.  I noticed the pain was worse when I slept at night and my range of motion was becoming worse.  I tried taking Tylenol and icing the area, but the pain was only temporarily dulled.  I woke up throughout the early morning of 12/15/2020 with excruciating pain in my left shoulder and arm.  I called out of work and went to a doctor's office to be evaluated.  I was diagnosed with subacromial bursitis of the left shoulder.  Currently, I am wearing a sling to get through the work day and cannot move my arm much because it is too painful.  It is hard to function occupationally and I am having a hard time doing simple tasks, such as putting my clothes on and going to the bathroom.  I was told it would probably take weeks to heal and was referred to physical therapy in the meantime.  I am currently not sure if this will result in permanent damage or disability.  I am currently unable to perform all of my job duties and am limited to light desk work in the meantime until this injury has healed.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Limb discomfort, Loss of personal independence in daily activities, Pain
Clinical narrative: Received Tdap shot (unsure whether Adacel or Boostrix at time of filing report) on 12/04/2020 during appointment at 3:00 PM.  Tdap was indicated because I was 28 weeks pregnant at the time of the appointment.  My estimated due date is 02/24/2021 and I am currently 30 weeks pregnant at the time of this report.  When I got the shot, it didn't hurt any more than usual for any other vaccine that I have received.  Towards the evening, I started getting soreness in my arm.  By the morning of 12/05/2020, I could not move my arm very much and it was extremely sore.  I assumed it was just a normal reaction to the shot.  It seemed to get a little better over the next few days, but the pain never actually went away.  It just dulled.  On 12/12/2020, I began to become concerned because it had been a week since receiving the shot and I still was experiencing pain.  I noticed the pain was worse when I slept at night and my range of motion was becoming worse.  I tried taking Tylenol and icing the area, but the pain was only temporarily dulled.  I woke up throughout the early morning of 12/15/2020 with excruciating pain in my left shoulder and arm.  I called out of work and went to a doctor's office to be evaluated.  I was diagnosed with subacromial bursitis of the left shoulder.  Currently, I am wearing a sling to get through the work day and cannot move my arm much because it is too painful.  It is hard to function occupationally and I am having a hard time doing simple tasks, such as putting my clothes on and going to the bathroom.  I was told it would probably take weeks to heal and was referred to physical therapy in the meantime.  I am currently not sure if this will result in permanent damage or disability.  I am currently unable to perform all of my job duties and am limited to light desk work in the meantime until this injury has healed.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine that was was expired on 08/08/2020 Patient was monitored for 15 min, no adverse effect. Dr.  in office was informed,  and Patient parents are going to be contacted in regards, to f/u
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Painful abdominal cramping, nausea, diarrhea
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture stool, Culture stool negative, Diarrhoea
Clinical narrative: Diarrhea started 5 days after vaccination date: green, mucous,  no blood.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Dizziness, Dyspnoea, Injection site pain
Clinical narrative: Patient complained of feeling dizzy, anxious, shortness of breath. Did have some pain with injection. Did have mask on while waiting standard 15 minutes.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Seizure like phenomena
Clinical narrative: Associate received vaccine at 12:15 pm and was monitored for 15 minutes. After 15 minutes, associate went to check out table. While at check out table, associate fell to ground and was experiencing seizure like activity. Supportive treatment was administerd and associate was transferred to ED.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: PATIENT HAD A FAINTING SPELL, BUT DID NOT COMPLETELY PASS OUT. PATIENT LAID DOWN FOR 3O MORE MINUTES.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizziness that lasted for about an hour.  Weakness, extreme fatigue lasted the rest of the day.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Starting 12/16, she had experienced fever, headache and nausea, as well as local arm pain.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Wheezing
Clinical narrative: Feeling flush and wheezing when walking.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Premature delivery
Clinical narrative: Tdap vaccine - not sure which specific one. 7 months pregnant with twins -delivered them 3 weeks later on 7/21/2018
Age: 21.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Symptoms began 1 day ago, are reported to be severe. Location is right upper arm. Aggravating factors include MMR/ Varicella vaccine.  Associated symptoms include itching, burning, redness and swelling in the injection site.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Patient was in observation area after admistration of covid vaccine.  At 15 Minute mark patient stated throat felt tight and like it was closing up.  Assesment of patient showed tongue PWD, vital signs as follows.  97.6, 118/72, 66 pulse and 100% pulse oxygenation.  Observed patient for 15 minutes more, gave patient water and monitored for full 30 minutes.  Breathing normal at this time.  States feeling better. Discharged  and advised to monitor throughout night and if worse go to emergency room.  Patient agreed and stated understanding.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site rash, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever for 2 days highest being 101.4, body aches, headache, swollen and  rash from injection site to elbow, Took benedryl for 2 days, rash and swelling stayed for about 3 to 4 days.
Age: 29.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: Fatigue, nausea, muscle aches
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Drainage, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: The Patient was given her vaccine on October 27th in the afternoon. The shot itself was not painful.  At first, The Patient arm was sore so I gave her Tylenol. Later that evening she complained of her hand swelling so I gave her Advil. Her hand had gotten so swollen that she could not bend her fingers. The next day we had a virtual visit with the physician who suggested The Patient start taking Benadryl. I gave her Benadryl throughout the day but it was not helping with the swelling. On Friday, we went into the doctor's office and they prescribed a steroid to take. She took it, along with Benadryl, for 7 days and the swelling did not improve. On November 6, we saw an allergist, Dr. who did not believe it was an allergy. She told The Patient to keep her arm as elevated as possible to help bring down the swelling. The swelling came down significantly within 24 hours; however, her hand was still tender and not able to bend her fingers. Over the next week, I could see a drainage under the skin (no visible fluid) and after about another week her  hand looked normal. Now, in early-mid December her hand is much improved - about 95% functional (still a bit tender if she applies pressure)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache, body aches, low grade fever (99.3 F)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: headache, tiredness  nausea ,dizziness ,lethargic, hives on the 4th day in her belly and back and itchy and she also got hives in her face but went away the following day. on 9 day got chills and she had not left the bed for nothing had no energy pt said . the arm and local area of injection was fine no pain no redness to the point that she did not take the band aid off till the day she reported the event on 12/15/20
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Nausea, Pruritus, Urticaria
Clinical narrative: headache, tiredness  nausea ,dizziness ,lethargic, hives on the 4th day in her belly and back and itchy and she also got hives in her face but went away the following day. on 9 day got chills and she had not left the bed for nothing had no energy pt said . the arm and local area of injection was fine no pain no redness to the point that she did not take the band aid off till the day she reported the event on 12/15/20
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Severe muscle aches  Diarrhea  Headaches  Feverish  Nauseous Left arm super sore Sore throat
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe muscle aches  Diarrhea  Headaches  Feverish  Nauseous Left arm super sore Sore throat
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Rash
Clinical narrative: I developed a new rash on my torso and have had three bouts of diarrhea.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness to injection site
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: left arm swelling with pain for more than two weeks. Pt had pain preventing ADL's, including sleep. Pt could not make a fist for a few days.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray limb
Clinical narrative: left arm swelling with pain for more than two weeks. Pt had pain preventing ADL's, including sleep. Pt could not make a fist for a few days.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: myalgia, joint pain, local site pain
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hyperhidrosis, Loss of consciousness, Malaise, Orthostatic hypotension
Clinical narrative: Within and hour and a half of receiving developed tinnitus in both ears lasting 6 hours. The night after receiving vaccine also developed orthostatic hypotension and started to pass out but caught myself with an assisted fall.  Fever(102 F with temporal and oral thermometer) body aches/sweats/general malaise lasting close to 24 hours after receiving vaccine. Fever/aches treated with acetaminophen.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tinnitus
Clinical narrative: Within and hour and a half of receiving developed tinnitus in both ears lasting 6 hours. The night after receiving vaccine also developed orthostatic hypotension and started to pass out but caught myself with an assisted fall.  Fever(102 F with temporal and oral thermometer) body aches/sweats/general malaise lasting close to 24 hours after receiving vaccine. Fever/aches treated with acetaminophen.
Age: 77.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Pyrexia, Rash erythematous, Swelling
Clinical narrative: Sweling, red spots and high fever for 2 days.
Age: 77.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Sweling, red spots and high fever for 2 days.
Age: 57.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Very painful administration.  Seemed too high on the shoulder. I was seated- nurse administering was standing.  Could not lift my arm by that evening.  Severe pain.  Urgent care on November 30.  Course of steroids- could then lift arm halfway.  No effect on pain.  High density ultrasound 12/08/2020 showed 2 tears- moderate fluid in bursa.  Never had a shoulder issue before. EVER.  Without steroids ROM decreased again.  Severe pain persists. Messaging MD for cortisone injection.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Immediately after injection of vaccination her left deltoid started swelling. Complains of pain at injection site. No other complaints. Applied ice. She took Tylenol and Benedryl. Stayed 30 minutes after vaccination without further complaint.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Feeling hot, Flushing, Headache
Clinical narrative: Patient received covid-19 vaccine. 20+ minutes later patient states she began feeling flushed and nauseous. Patient states she look at her injection site, and it was hot and red. Local reaction approx. 2 inches x 2 inches. Dr. ordered 25 mg oral Benadryl. Vitals stable at 1840 133/88, 66 for pulse and regular, SPO2 99% on room air, respirations 20. Patient continued having complaints of light headedness and nausea. 1850 119/79, 74, 99% RA. Dr. states patient may depart from clinic if able to sit up and walk out, patient given instructions go to ED in symptoms progress. 1857 120/82, 70, 99.4. Patient's face becomes flushed and hot on left side, patient states she is shaky, and does not feel well at all. 1905 patient transferred to ED on 2L O2 for further evaluation and workup. Narrative ER Medical decision making narrative: Accu-Chek was obtained noting a glucose to be at 80. She received IV fluids as well as Solu-Medrol Benadryl and IV Pepcid.  She also received IV Tylenol as she developed a headache while in the emergency department.  Headache resolved and she was able to ambulate without assistance.  Requested to go home states she felt much improved near normal.   Clinical Impression:  Adverse reaction to drug Patient Education:  Anaphylaxis (ED)
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Malaise, Nausea
Clinical narrative: Patient received covid-19 vaccine. 20+ minutes later patient states she began feeling flushed and nauseous. Patient states she look at her injection site, and it was hot and red. Local reaction approx. 2 inches x 2 inches. Dr. ordered 25 mg oral Benadryl. Vitals stable at 1840 133/88, 66 for pulse and regular, SPO2 99% on room air, respirations 20. Patient continued having complaints of light headedness and nausea. 1850 119/79, 74, 99% RA. Dr. states patient may depart from clinic if able to sit up and walk out, patient given instructions go to ED in symptoms progress. 1857 120/82, 70, 99.4. Patient's face becomes flushed and hot on left side, patient states she is shaky, and does not feel well at all. 1905 patient transferred to ED on 2L O2 for further evaluation and workup. Narrative ER Medical decision making narrative: Accu-Chek was obtained noting a glucose to be at 80. She received IV fluids as well as Solu-Medrol Benadryl and IV Pepcid.  She also received IV Tylenol as she developed a headache while in the emergency department.  Headache resolved and she was able to ambulate without assistance.  Requested to go home states she felt much improved near normal.   Clinical Impression:  Adverse reaction to drug Patient Education:  Anaphylaxis (ED)
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient received covid-19 vaccine. 20+ minutes later patient states she began feeling flushed and nauseous. Patient states she look at her injection site, and it was hot and red. Local reaction approx. 2 inches x 2 inches. Dr. ordered 25 mg oral Benadryl. Vitals stable at 1840 133/88, 66 for pulse and regular, SPO2 99% on room air, respirations 20. Patient continued having complaints of light headedness and nausea. 1850 119/79, 74, 99% RA. Dr. states patient may depart from clinic if able to sit up and walk out, patient given instructions go to ED in symptoms progress. 1857 120/82, 70, 99.4. Patient's face becomes flushed and hot on left side, patient states she is shaky, and does not feel well at all. 1905 patient transferred to ED on 2L O2 for further evaluation and workup. Narrative ER Medical decision making narrative: Accu-Chek was obtained noting a glucose to be at 80. She received IV fluids as well as Solu-Medrol Benadryl and IV Pepcid.  She also received IV Tylenol as she developed a headache while in the emergency department.  Headache resolved and she was able to ambulate without assistance.  Requested to go home states she felt much improved near normal.   Clinical Impression:  Adverse reaction to drug Patient Education:  Anaphylaxis (ED)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysphagia, Tearfulness
Clinical narrative: Patient feeling very anxious before and after vaccination. Described having difficulty swallowing water shortly (~15 min) post vaccination. Patient was tearful but breathing normally. Walked under her own power from the pharmacy down to the Emergency Room for anxiety over anaphylaxis. Given dose of Vistaril in ER.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: Patient has a sore arm
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Local pain and swelling of the injection site
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Oropharyngeal pain
Clinical narrative: Pfizer Covid 19 EUA Pt reported arm heavyness and sore throat. Pt self medicated benadryl then alert staff. Monitered times one hour and reported no worsening of symptoms.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Local Pain and swelling of the injection site
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Head discomfort
Clinical narrative: Scratching head, redness to hands
Age: 65.0
Sex: F
Vaccine: TTOX
Symptoms: Headache, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Headaches, severe muscular pain in arm could not lift arm overhead, bleeding at site 5-7  days post site, did not last long, continued pain in left arm upper posterior portion and at times scapula Saw MD and Pharmacist... pain continues to today. Believe it is inflammation cannot understand why. considering MRI
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspepsia, Urticaria
Clinical narrative: Following the first shot in the series of the Gardasil vaccine on 10/20/2006, within a week, I broke out in hives on my back that were unexplainable.  I went to the doctor, they told me to take Benadryl and apply Cortisone cream.  There were no other causes for the hives such as clothing, soap, detergent, etc.  The hives would come back up on different parts of my body for the following weeks. I received my second shot in the series on 1/19/2007, the hives have gotten worse and continue to stay longer and cover more of my body.  I then received the final dose on 5/7/2007.  From this point, I have seen a dermatologist, several allergists, an infectious disease specialist regarding why I am having systemic hives that are not controlled by allergy medications.  I underwent many tests and procedures including a biopsy of my skin hive, and a test that came back as markers for Lupus were present.    I was taking several allergy medications, Predisone steroids long term, and  Zantac for the awful heartburn and indigestion that felt like I was having a heart attack- I also have dental enamel damage from those years of intense acid indigestion. I was prescribed an epipen because my throat and tongue would swell up so bad.  My face would swell so much that I couldn't see due to my eyes being swollen shut.  I could not walk because the hives covered the bottoms of my feet.  I spent the last part of my high school career and much of the first part of my college life miserable and covered in hives.  I also gained 40-50 pounds due to the steroids I had to take daily.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased
Clinical narrative: Patient called 12/16/2020. Patient said she got the flu shot on 11/23/2020 and had pain at injection site and shoulder pain and less range of motion in     left shoulder.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pt got vaccine had sore arm, next day all over joint pain was concerned on 12/16/2020 that joint pain was still there + very bad + occuring in all joints. He stated he called his dr. was told to take motrin
Age: 75.0
Sex: F
Vaccine: FLUA4, FLUA3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Rash
Clinical narrative: Pt had a rash over entire body the day after the vaccination and had to take an oral course of steroids and topical
Age: 75.0
Sex: F
Vaccine: FLUA4, FLUA3
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Pt had a rash over entire body the day after the vaccination and had to take an oral course of steroids and topical
Age: 75.0
Sex: F
Vaccine: FLUA4, FLUA3
Symptoms: Rash
Clinical narrative: Pt had a rash over entire body the day after the vaccination and had to take an oral course of steroids and topical
Age: 57.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Erythema, Ligament pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported symptoms of pain, redness,  swelling at injection site. Continued  lateral shoulder and arm pain.  Also with pain right hip/leg starting after vaccine administered.
Age: 57.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Sleep disorder
Clinical narrative: Patient reported symptoms of pain, redness,  swelling at injection site. Continued  lateral shoulder and arm pain.  Also with pain right hip/leg starting after vaccine administered.
Age: 57.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient reported symptoms of pain, redness,  swelling at injection site. Continued  lateral shoulder and arm pain.  Also with pain right hip/leg starting after vaccine administered.
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased
Clinical narrative: complained of substantial arm pain for an extended period of time / arm was sore for about 2 weeks following vaccination; This spontaneous report was received from a pharmacist and refers to a 71-year-old not pregnant female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter, intramuscularly, lot # T017385, expiration date was reported as 01-SEP-2001, and upon internal validation established as 01-SEP-2021, in the right deltoid for prophylaxis. On 20-NOV-2020, the patient experienced substantial arm pain for an extended period of time. Her arm was sore for about 2 weeks following vaccination. The pharmacist stated that they give a lot of the vaccine and have never had people complain about the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) being so painful after administration. The outcome of the event was reported as unknown. The causality assessment between the event and the suspect therapy was not provided.     This is one of two reports received from the same reporter.
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: complained of substantial arm pain for an extended period of time / arm was sore for about 2 weeks following vaccination; This spontaneous report was received from a pharmacist and refers to a 71-year-old not pregnant female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter, intramuscularly, lot # T017385, expiration date was reported as 01-SEP-2001, and upon internal validation established as 01-SEP-2021, in the right deltoid for prophylaxis. On 20-NOV-2020, the patient experienced substantial arm pain for an extended period of time. Her arm was sore for about 2 weeks following vaccination. The pharmacist stated that they give a lot of the vaccine and have never had people complain about the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) being so painful after administration. The outcome of the event was reported as unknown. The causality assessment between the event and the suspect therapy was not provided.     This is one of two reports received from the same reporter.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Chest discomfort, Cold sweat, Condition aggravated, Dizziness, Panic attack
Clinical narrative: Basically after I took the vaccine I took the vaccine, about 10 min later, my heart was racing, I felt very hot and sweaty, hard time breathing, chest tightness, my hands were tingling, went to ER to be observed and although I would feel out of breath they said my oxygen was fine. My heart was racing. First my pulse was low, and then later on got very high. My BP was bouncing all over.  Now, I can't raise my left arm my arm hurts I can't move it very well and I feel fatigued.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Paraesthesia
Clinical narrative: Basically after I took the vaccine I took the vaccine, about 10 min later, my heart was racing, I felt very hot and sweaty, hard time breathing, chest tightness, my hands were tingling, went to ER to be observed and although I would feel out of breath they said my oxygen was fine. My heart was racing. First my pulse was low, and then later on got very high. My BP was bouncing all over.  Now, I can't raise my left arm my arm hurts I can't move it very well and I feel fatigued.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Chest discomfort, Dizziness, Dysphagia, Dyspnoea, Nausea
Clinical narrative: Basically after I took the vaccine I took the vaccine, about 10 min later, my heart was racing, I felt very hot and sweaty, hard time breathing, chest tightness, my hands were tingling, went to ER to be observed and although I would feel out of breath they said my oxygen was fine. My heart was racing. First my pulse was low, and then later on got very high. My BP was bouncing all over.  Now, I can't raise my left arm my arm hurts I can't move it very well and I feel fatigued.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Blood pressure fluctuation, Chest X-ray normal, Chest discomfort, Dyspnoea, Electrocardiogram normal
Clinical narrative: Basically after I took the vaccine I took the vaccine, about 10 min later, my heart was racing, I felt very hot and sweaty, hard time breathing, chest tightness, my hands were tingling, went to ER to be observed and although I would feel out of breath they said my oxygen was fine. My heart was racing. First my pulse was low, and then later on got very high. My BP was bouncing all over.  Now, I can't raise my left arm my arm hurts I can't move it very well and I feel fatigued.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Fatigue, Feeling hot, Heart rate decreased, Heart rate increased, Hyperhidrosis
Clinical narrative: Basically after I took the vaccine I took the vaccine, about 10 min later, my heart was racing, I felt very hot and sweaty, hard time breathing, chest tightness, my hands were tingling, went to ER to be observed and although I would feel out of breath they said my oxygen was fine. My heart was racing. First my pulse was low, and then later on got very high. My BP was bouncing all over.  Now, I can't raise my left arm my arm hurts I can't move it very well and I feel fatigued.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity, Palpitations, Paraesthesia, Pharyngeal swelling
Clinical narrative: Basically after I took the vaccine I took the vaccine, about 10 min later, my heart was racing, I felt very hot and sweaty, hard time breathing, chest tightness, my hands were tingling, went to ER to be observed and although I would feel out of breath they said my oxygen was fine. My heart was racing. First my pulse was low, and then later on got very high. My BP was bouncing all over.  Now, I can't raise my left arm my arm hurts I can't move it very well and I feel fatigued.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional adverse events reported; first dose of gardasil 9 on 6/5/2020 then 2nd dose was administered on 7/15/2020; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 05-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown). Then, on 15-JUL-2020, the second dose was administered. No additional adverse events were reported.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: schedule of vaccine; This spontaneous report was received from a medical assistant  and refers to a 15 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 25-SEP-2019, the patient was vaccinated with thefirst dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at a dose of 0.5 milliliter for prophylaxis. On 25-NOV-2019, the patient was vaccinated with thefirst dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at a dose of 0.5 milliliter for prophylaxis. Caller was requesting to know if patient will require a dose 3 related to the interval at which the previous doses were given.   2
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Angina unstable, Cardiac murmur, Carotid artery stenosis, Coronary artery disease, Guillain-Barre syndrome
Clinical narrative: NO ADVERSE EVENT; pneumococcal vaccine on 17-JAN-2014 and 10-JUL-2015; This spontaneous report was received from a consumer, lawyer and a physician referring a 66-year-old female patient. The patient's concurrent conditions included hyperlipidemia. The patient's historical conditions included chicken pox, colonoscopy and esophagogastroduodenoscopy. The patient was a non-tobacco user. The patient's historical immunizations included influenza virus vaccine (unspecified) (reported as Influenza, seasonal, Injectable, trivalent) (on 02-OCT-2009, 21-SEP-2011, 02-OCT-2012 and 18-OCT-2013).  On 17-JAN-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccine (reported as pneumococcal polysaccharide, adult, 23 valent) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis; and on 10-JUL-2015, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (reported as pneumococcal conjugate 13 valent) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration). It was reported that the patient did not experienced any adverse reactions or side effects.  On an unspecified date in 2016, the pt experienced cardiac murmur and restless legs syndrome; on an unspecified day in July 2016, the pt experienced sleep disorder due to general medical condition, insomnia type; on 01-JUL-2016, the pt experienced acute polyneuropathy and Guillain-Barre syndrome; on an unspecified day in September 2016, the pt experienced coronary artery disease; on 27-SEP-2016, the pt experienced angina unstable and carotid artery stenosis; and on an unspecified day in January 2017, the pt experienced retinal tear (captured in reporting system # 2009USA011563).; Sender's Comments:  US-009507513-2009USA011563:
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Polyneuropathy, Restless legs syndrome, Retinal tear
Clinical narrative: NO ADVERSE EVENT; pneumococcal vaccine on 17-JAN-2014 and 10-JUL-2015; This spontaneous report was received from a consumer, lawyer and a physician referring a 66-year-old female patient. The patient's concurrent conditions included hyperlipidemia. The patient's historical conditions included chicken pox, colonoscopy and esophagogastroduodenoscopy. The patient was a non-tobacco user. The patient's historical immunizations included influenza virus vaccine (unspecified) (reported as Influenza, seasonal, Injectable, trivalent) (on 02-OCT-2009, 21-SEP-2011, 02-OCT-2012 and 18-OCT-2013).  On 17-JAN-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccine (reported as pneumococcal polysaccharide, adult, 23 valent) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis; and on 10-JUL-2015, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (reported as pneumococcal conjugate 13 valent) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration). It was reported that the patient did not experienced any adverse reactions or side effects.  On an unspecified date in 2016, the pt experienced cardiac murmur and restless legs syndrome; on an unspecified day in July 2016, the pt experienced sleep disorder due to general medical condition, insomnia type; on 01-JUL-2016, the pt experienced acute polyneuropathy and Guillain-Barre syndrome; on an unspecified day in September 2016, the pt experienced coronary artery disease; on 27-SEP-2016, the pt experienced angina unstable and carotid artery stenosis; and on an unspecified day in January 2017, the pt experienced retinal tear (captured in reporting system # 2009USA011563).; Sender's Comments:  US-009507513-2009USA011563:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: improperly stored GARDASIL 9 was administered to patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 23-NOV-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast ) (GARDASIL 9) (lot # 1637651 with expiration date 09-JUN-2022; dose and route were not provided) for prophylaxis (product storage error). The vaccine was exposed to temperature excursions of below 36 degrees Fahrenheit (26.2F) for 35 hours. There was no previous temperature excursion. A "data logger" was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Confusional state, Cough, Feeling abnormal, Hypersensitivity
Clinical narrative: Anaphylaxis reaction/severe allergic reaction; arm is still sore from the vaccine; This spontaneous report was received from a consumer refers to a 6-year-old male patient. The patient had no concomitant medications. The patient's pertinent medical history included immunocompromised. The patient was recently tested positive for celiac.  On 10-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# reported as F023835 was evaluated and changed to the valid lot # S023835, expiration date not reported, upon internal validation established as 18-MAY-2021; strength, dose and route were not reported) in the arm for prophylaxis.       On the same day within 2 minutes after receiving the vaccine, the patient had an anaphylaxis reaction. While at the doctor's office, the patient started coughing and clearing his throat a lot. The patient had a mask on, was coughing more with whole face swelling and broke out in a rash when got outside of the doctor's office. The patient had "snot coming from nose" and was wheezing and collapsed. The consumer took the patient back inside the doctor's office and reported one of the doctor's got an epinephrine hydrochloride (EPIPEN) and before administering the epinephrine hydrochloride (EPIPEN), the patient woke up and reported they did not need to use the epinephrine hydrochloride (EPIPEN). The reaction was short lived and the patient reacted well to the diphenhydramine hydrochloride (BENADRYL). After the patient woke up from the anaphylaxis reaction, they were very confused and off in space. The patient was having "face ticks" that were "very strange". The patient was not hospitalized, and his arm was still sore from the vaccine. By giving the patient diphenhydramine hydrochloride (BENADRYL) throughout the night to be sure the patient would not have another reaction. The patient was doing much better next day and recovered from the severe allergic reaction. The outcome of sore arm was not reported. The reporter considered sore arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between other events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, anaphylaxis reaction was determined to be medically significant.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Rash, Rhinorrhoea, Swelling face, Syncope
Clinical narrative: Anaphylaxis reaction/severe allergic reaction; arm is still sore from the vaccine; This spontaneous report was received from a consumer refers to a 6-year-old male patient. The patient had no concomitant medications. The patient's pertinent medical history included immunocompromised. The patient was recently tested positive for celiac.  On 10-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# reported as F023835 was evaluated and changed to the valid lot # S023835, expiration date not reported, upon internal validation established as 18-MAY-2021; strength, dose and route were not reported) in the arm for prophylaxis.       On the same day within 2 minutes after receiving the vaccine, the patient had an anaphylaxis reaction. While at the doctor's office, the patient started coughing and clearing his throat a lot. The patient had a mask on, was coughing more with whole face swelling and broke out in a rash when got outside of the doctor's office. The patient had "snot coming from nose" and was wheezing and collapsed. The consumer took the patient back inside the doctor's office and reported one of the doctor's got an epinephrine hydrochloride (EPIPEN) and before administering the epinephrine hydrochloride (EPIPEN), the patient woke up and reported they did not need to use the epinephrine hydrochloride (EPIPEN). The reaction was short lived and the patient reacted well to the diphenhydramine hydrochloride (BENADRYL). After the patient woke up from the anaphylaxis reaction, they were very confused and off in space. The patient was having "face ticks" that were "very strange". The patient was not hospitalized, and his arm was still sore from the vaccine. By giving the patient diphenhydramine hydrochloride (BENADRYL) throughout the night to be sure the patient would not have another reaction. The patient was doing much better next day and recovered from the severe allergic reaction. The outcome of sore arm was not reported. The reporter considered sore arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between other events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, anaphylaxis reaction was determined to be medically significant.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Throat clearing, Tic, Wheezing
Clinical narrative: Anaphylaxis reaction/severe allergic reaction; arm is still sore from the vaccine; This spontaneous report was received from a consumer refers to a 6-year-old male patient. The patient had no concomitant medications. The patient's pertinent medical history included immunocompromised. The patient was recently tested positive for celiac.  On 10-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# reported as F023835 was evaluated and changed to the valid lot # S023835, expiration date not reported, upon internal validation established as 18-MAY-2021; strength, dose and route were not reported) in the arm for prophylaxis.       On the same day within 2 minutes after receiving the vaccine, the patient had an anaphylaxis reaction. While at the doctor's office, the patient started coughing and clearing his throat a lot. The patient had a mask on, was coughing more with whole face swelling and broke out in a rash when got outside of the doctor's office. The patient had "snot coming from nose" and was wheezing and collapsed. The consumer took the patient back inside the doctor's office and reported one of the doctor's got an epinephrine hydrochloride (EPIPEN) and before administering the epinephrine hydrochloride (EPIPEN), the patient woke up and reported they did not need to use the epinephrine hydrochloride (EPIPEN). The reaction was short lived and the patient reacted well to the diphenhydramine hydrochloride (BENADRYL). After the patient woke up from the anaphylaxis reaction, they were very confused and off in space. The patient was having "face ticks" that were "very strange". The patient was not hospitalized, and his arm was still sore from the vaccine. By giving the patient diphenhydramine hydrochloride (BENADRYL) throughout the night to be sure the patient would not have another reaction. The patient was doing much better next day and recovered from the severe allergic reaction. The outcome of sore arm was not reported. The reporter considered sore arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between other events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, anaphylaxis reaction was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect; expired GARDASIL 9 was inadvertently administered; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  The pharmacist called to report that an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # R009615, expiration date 07-DEC-2020, (dose, route and anatomical location were not reported) was inadvertently administered to the patient on 12-DEC-2020 for prophylaxis. No additional adverse effect were reported.