chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired Act-HIb, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Agency (Reference number- 00515355) and transmitted to Sanofi on 11-Mar-2021.  This case involves a one year old female patient who was administered a 0.5 ml dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ183AAQA; expiry date: 12-Feb-2021; Strength: standard, Single dose vial) via intramuscular route in unknown administration site for prophylactic vaccination on 22-Feb-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient's concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and HEPATITIS A VACCINE [HEPA] for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter stated, they administered an expired Act-HIB vaccine to a child that was expired for ten days. The reporter wanted to know if they need to revaccinate the patient. The reporter was not sure what site the vaccine was administered. They had to pull the shot out of the system because they had entered it as the wrong lot number. No further information was provided.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given an Adacel at the age of 8, no adverse event; Initial information regarding an unsolicited non-valid non-serious case was from a pharmacist via Global Medical Information (GMI) (Reference number- 00517032) and transmitted to Sanofi on 12-Mar-2021.  This case involves a 8 years old female patient who was given 0.5 ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number- U5472AA, expiration date- 15-Oct-2018) via unknown route in unknown administration site for prophylactic vaccination on an unknown date at the minute clinic (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to the patient.   It was an actual medication error due to inappropriate age at vaccine administration (same day latency).  Also stated that she was 12 now but she got the dose when she was 8 years old and reporter was asking if it was safe for her daughter to get an Adacel injection at age 12.   No laboratory data was reported  It was not reported whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abdominal pain, Joint swelling, Malaise, Pain, Pyrexia
Clinical narrative: achiness; vertigo for 2 weeks; was not able to get out of bed due to fever (101F); general malaise; joint swelling in joints and fingers; pain in abdomen; severe vertigo; Initial information regarding an unsolicited valid non-serious case received from other healthcare professional via Agency (Reference number- 00521425) and transmitted to Sanofi on 16-Mar-2021.  This case involves a female patient of unknown age who experienced joint swelling in joints and fingers (joint swelling), pain in abdomen (abdominal pain), severe vertigo (vertigo- first episode), was not able to get out of bed due to fever (101f- Fahrenheit) (pyrexia), achiness (pain), general malaise (malaise) and vertigo for 2 weeks (vertigo- second episode), after she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Past vaccination(s) included Fluzone and Adacel in 2013 (Fluzone Trivalent and Adacel vaccine in 2013, the patient experienced severe vertigo, joint swelling in joints and fingers, and pain in abdomen in 2013 and this was called in and reported in 2013).  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medications were not provided.  On an unknown date, the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On an unknown date, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On 16-Mar-2021, patient who experienced joint swelling in joints and fingers (joint swelling), pain in abdomen (abdominal pain) and severe vertigo (vertigo- first episode), (latency: unknown) following the administration of suspect vaccine.  On an unknown date, patient who was not able to get out of bed due to fever (101f) (pyrexia), achiness (pain), general malaise (malaise) and vertigo for 2 weeks (vertigo-  second episode), (latency: unknown) following the administration of suspect vaccine.  She was scheduled for a Moderna COVID (coronavirus disease) vaccine on 19-Mar-2021 and she wants to know if the Fluzone Trivalent vaccine match up with the Moderna Corona vaccine ingredients.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown, at the time of reporting.  There will be no information available regarding batch number in this case.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Vertigo
Clinical narrative: achiness; vertigo for 2 weeks; was not able to get out of bed due to fever (101F); general malaise; joint swelling in joints and fingers; pain in abdomen; severe vertigo; Initial information regarding an unsolicited valid non-serious case received from other healthcare professional via Agency (Reference number- 00521425) and transmitted to Sanofi on 16-Mar-2021.  This case involves a female patient of unknown age who experienced joint swelling in joints and fingers (joint swelling), pain in abdomen (abdominal pain), severe vertigo (vertigo- first episode), was not able to get out of bed due to fever (101f- Fahrenheit) (pyrexia), achiness (pain), general malaise (malaise) and vertigo for 2 weeks (vertigo- second episode), after she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Past vaccination(s) included Fluzone and Adacel in 2013 (Fluzone Trivalent and Adacel vaccine in 2013, the patient experienced severe vertigo, joint swelling in joints and fingers, and pain in abdomen in 2013 and this was called in and reported in 2013).  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medications were not provided.  On an unknown date, the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On an unknown date, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On 16-Mar-2021, patient who experienced joint swelling in joints and fingers (joint swelling), pain in abdomen (abdominal pain) and severe vertigo (vertigo- first episode), (latency: unknown) following the administration of suspect vaccine.  On an unknown date, patient who was not able to get out of bed due to fever (101f) (pyrexia), achiness (pain), general malaise (malaise) and vertigo for 2 weeks (vertigo-  second episode), (latency: unknown) following the administration of suspect vaccine.  She was scheduled for a Moderna COVID (coronavirus disease) vaccine on 19-Mar-2021 and she wants to know if the Fluzone Trivalent vaccine match up with the Moderna Corona vaccine ingredients.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown, at the time of reporting.  There will be no information available regarding batch number in this case.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Condition aggravated, Decreased appetite
Clinical narrative: Approximately 48 or 49 hours after getting the first vaccination shot is when all the adverse conditions began to occur.    I was taking extra strength Tylenol every 3 1/2 hours which would barely minimize any of the problems !!!!     I usually have a body temp of 96.7, but started with a continuous 99.6 to 99.9 fever (six days) and had horrible chills for 4 days.   In addition, I suffered from severe headaches, nose bleeds, nausea, stomach discomfort, total lack of appetite,  EXTREME joint pain from head to toes, EXTREME sensitivity and pain on all skin surfaces (couldn't stand the weight of covers on me and could feel the texture of clothings' materials),  never before sciatica pain down right leg, totally flared up the pain in feet (from previous reaction to Levaquin) to a point of not being able to walk on feet, pain in and around both arm pits,    My blood pressure went totally out of control and kept going up to 190s.     All these "over the top" adverse conditions continued for 6 days --- then on day 7 and 8 they began to let up and I experienced what I would call more like regular "flu like symptoms"  It was as if any flaw or tolerable pre-existing discomforts I have had anywhere in my body were extremely exaggerated .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: Approximately 48 or 49 hours after getting the first vaccination shot is when all the adverse conditions began to occur.    I was taking extra strength Tylenol every 3 1/2 hours which would barely minimize any of the problems !!!!     I usually have a body temp of 96.7, but started with a continuous 99.6 to 99.9 fever (six days) and had horrible chills for 4 days.   In addition, I suffered from severe headaches, nose bleeds, nausea, stomach discomfort, total lack of appetite,  EXTREME joint pain from head to toes, EXTREME sensitivity and pain on all skin surfaces (couldn't stand the weight of covers on me and could feel the texture of clothings' materials),  never before sciatica pain down right leg, totally flared up the pain in feet (from previous reaction to Levaquin) to a point of not being able to walk on feet, pain in and around both arm pits,    My blood pressure went totally out of control and kept going up to 190s.     All these "over the top" adverse conditions continued for 6 days --- then on day 7 and 8 they began to let up and I experienced what I would call more like regular "flu like symptoms"  It was as if any flaw or tolerable pre-existing discomforts I have had anywhere in my body were extremely exaggerated .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pyrexia, Sciatica, Sensitive skin, Sensory disturbance
Clinical narrative: Approximately 48 or 49 hours after getting the first vaccination shot is when all the adverse conditions began to occur.    I was taking extra strength Tylenol every 3 1/2 hours which would barely minimize any of the problems !!!!     I usually have a body temp of 96.7, but started with a continuous 99.6 to 99.9 fever (six days) and had horrible chills for 4 days.   In addition, I suffered from severe headaches, nose bleeds, nausea, stomach discomfort, total lack of appetite,  EXTREME joint pain from head to toes, EXTREME sensitivity and pain on all skin surfaces (couldn't stand the weight of covers on me and could feel the texture of clothings' materials),  never before sciatica pain down right leg, totally flared up the pain in feet (from previous reaction to Levaquin) to a point of not being able to walk on feet, pain in and around both arm pits,    My blood pressure went totally out of control and kept going up to 190s.     All these "over the top" adverse conditions continued for 6 days --- then on day 7 and 8 they began to let up and I experienced what I would call more like regular "flu like symptoms"  It was as if any flaw or tolerable pre-existing discomforts I have had anywhere in my body were extremely exaggerated .
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Headache, Injection site pain
Clinical narrative: Pressure and pain in my chest.  Did not appear until 3/21/21, along with headache.  Only issue since 3/18/21 shot, until then, was sore arm where shot was given.  Chest discomfort not quite as bad today, but still lingers some.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: Event: Pain at injection site, dizziness, nausea. Treatment: Rest, Outcome: symptoms dissipated
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: patient admitted with pontine Stroke
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Myalgia, Tenderness
Clinical narrative: Left arm extremely  tender,  arm and leg muscles sore,  low grade 99.2 temp and massive headache from nose to back iofhead
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: patient presented to the ER with severe generalized muscle pain.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Vomiting
Clinical narrative: Chills, puke, sweat, headache, body aches
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Blood test, Computerised tomogram normal, Cystitis, Fall
Clinical narrative: pt states that 11 hours after taking the 2nd dose she collapsed falling to the floor and was paralyzed and  had urinary incontinence for 20 hours.  EMT came to put pt back in bed.  EMT came once again and put pt in wheelchair to get her to  a car so she can be taken to Hospital ER.  They did blood work which potassium was low, urinalysis test showed bladder infection, and CT was normal.  Pt released after 4 hours and told to FU w/ her neurologist.  Pt saw Neuro Dr. on 3/17/2021 said she must have had some sort of reaction to the vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokalaemia, Paralysis, Syncope, Urinary incontinence, Urine analysis abnormal
Clinical narrative: pt states that 11 hours after taking the 2nd dose she collapsed falling to the floor and was paralyzed and  had urinary incontinence for 20 hours.  EMT came to put pt back in bed.  EMT came once again and put pt in wheelchair to get her to  a car so she can be taken to Hospital ER.  They did blood work which potassium was low, urinalysis test showed bladder infection, and CT was normal.  Pt released after 4 hours and told to FU w/ her neurologist.  Pt saw Neuro Dr. on 3/17/2021 said she must have had some sort of reaction to the vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Chills lasting over an hour , fever, 101.3  exhaustion, headache
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, SARS-CoV-2 test positive
Clinical narrative: Patient immediately felt pain/burning on injection site, and started having muscle pain the next day and continues to have muscle pain.  The pain occurs when she retracts her left arm behind her back.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness postural, Headache, Hyperhidrosis
Clinical narrative: COULD NOT LIFT ARM,  DIZZINESS WHEN LYING DOWN,  SEVERE VOMITING,  DIARRHEA,  HEADACHE,  SWEATS,  CHILLS,
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: COULD NOT LIFT ARM,  DIZZINESS WHEN LYING DOWN,  SEVERE VOMITING,  DIARRHEA,  HEADACHE,  SWEATS,  CHILLS,
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Upper lip swollen,  mild symptoms otherwise
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Palpitations, Skin warm, Tongue eruption
Clinical narrative: Racing Heartbeat/Weakness -- half hour after injection; resolved on it's own Rash on ride side of torso -- rash was not noticed until several hours later (it was warm to the touch, was not raised not raised but more like sunburn and turned white upon pressing) and then resolved; rash reappeared on March 18 and resolved  *photos available upon request
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Rash erythematous
Clinical narrative: Racing Heartbeat/Weakness -- half hour after injection; resolved on it's own Rash on ride side of torso -- rash was not noticed until several hours later (it was warm to the touch, was not raised not raised but more like sunburn and turned white upon pressing) and then resolved; rash reappeared on March 18 and resolved  *photos available upon request
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like for 24 hours.  Starting at 8am I was very lethargic. Absolutely no energy. Progressed to terrible headache, had slight fever and chills. After sleeping from 1pm 3/18 to 6am 3/19 I awoke and felt 100 percent better. Still felt a little tired throughout Sunday 3/20 but not to the point that I couldn't function.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia, Somnolence
Clinical narrative: Flu like for 24 hours.  Starting at 8am I was very lethargic. Absolutely no energy. Progressed to terrible headache, had slight fever and chills. After sleeping from 1pm 3/18 to 6am 3/19 I awoke and felt 100 percent better. Still felt a little tired throughout Sunday 3/20 but not to the point that I couldn't function.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Vertigo
Clinical narrative: This dose intensified my vertigo symptoms. I have been dealing with it for about a month now and it was mostly resolved. The night I got my 2nd dose my symptoms came back full force. They are getting better again but the dizziness was intense for about 6 days.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea
Clinical narrative: light headed, nausea, chills,
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: Slight pre-cold symptoms: cough, slightly runny nose, occasional sneeze.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Injection site pain, Paraesthesia, Pruritus
Clinical narrative: 33y/o male reports itching on the bottom of both feet at ~17min post-Pfizer vaccination into the left arm on 3/17/21. He states that he has h/o allergic reactions that typically present this way. He reports pain at injection site that he rates as a 3/10. He has associated itching/tingling sensation that he rates as a 2/10. He also feels flushed/heat in his face. He denies throat discomfort/swelling, difficulty breathing, shortness of breath, chest pain, palpitations, blurry vision, dizziness, lip/tongue swelling, or nasal congestion. Patient reports resolved sensations at 35min post-injection.  He reports h/o allergic reactions to river water, Chantix, Zyrtec and seasonal allergies. He states that he has never needed epinephrine and his past symptoms resolved without intervention and he was monitored.  Physical Exam: BP; 155/110 Cardiac: regular heart rate and rhythm. Radial Pulse 2+ Lungs: Clear to auscultation bilaterally Skin: no rash, erythema, or injection site redness/swelling  Plan: Patient reported symptoms resolved at 35min after injection and left clinic. He was advised to call 911 if he develops any allergic reactions or respiratory issues including hives, difficulty breathing, chest pain, or throat/lip/tongue swelling.   He was also informed that his blood pressure was high and that he would need to follow up with his PCP. Patient reports that it typically rises when he speaks to providers.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: At 11:40 am Patient was facing right side. Left arm hang along side waist. Left arm cleaned with alcohol prep in a circle motion from enter to outer. Syringe filled with Jannsen (J&J) vaccines 0.5 ml was inserted in Patient's arm. I aspirated to make sure I wasn't in a vessel. Syringe filled with blood and I immediately pulled out and call for help. Site showed no signs of redness, swelling, or bruising.  Patient stated she was fine and wasn't in any way in pain. Vaccines wasn't injected. Syringe was placed in sharps. Patient spoke with (lead) after observing and wanted to proceed with injection in the right arm.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient came in to clinic today stating she got the second dose of COVID vaccine on Friday, March 19, 2021 and noticed she got a rash on her shoulders and lower back on Saturday morning. Patient stated she noticed a rash was one of the side effects listed on the paper she got at time of vaccine. Patient has never gotten a reaction to vaccines in the past or to the first dose of COVID vaccine. Provider ordered 10mg of Dexamethazone and I administered it in pt right deltoid. Pt wait x15mins and left clinic with no adverse reactions that were observed within the clinic.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Initial dose was Moderna, recieved Pfizer booster. No adverse reaction noted.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Vision blurred
Clinical narrative: Feeling hot, dizzy, blurred vision
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Pain, Pyrexia
Clinical narrative: The first evening was a little uncomfortable. The next day was very uncomfortable--fever, shivers, body ache--no concentration possible; aspirin didn't seem to help;  only a good night's sleep. The next morning was almost normal and by midday completely normal.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache
Clinical narrative: on 3/18 blood pressure rose to 153/69 pulse 62.   No other symptoms.  Next morning 3/19 134/84 p 64.  by late afternoon was back up to 157/82 p 61.  Had bad headache.   3/20 @ 9:20 am 135/77 p 60.  3/20 @ 9:39pm 149/67 p64.  mild headaches.  3/21 9:30am 140/79 p64.  Went for a run, 30 mins after the run @2:33pm 135/80 p77.  Did not take evening reading on 3/21, but had mild headache in the evening.   3/22 @ 8:39 am 137/79 p 63.  no headache.  took motrin each day for headache.  Took benedryl at night to sleep.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Platelet count decreased
Clinical narrative: Platelets gone
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema
Clinical narrative: Redness in face , cough
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant ringing in both ears since the day of the injection.  It does seem louder on day5 then it had been.  I have not tried to treat.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Moderna COVID-19 Vaccine  swollen and tender to touch around injection site and in armpit if same arm in first 24 hours after vaccination. swollen armpit lasted for 3 days. tenderness in armpit has lasted since injection.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspepsia, Feeling abnormal, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Normal initial stick pain, but immediately intensified and went  down my arm.  I got up and walked back over to my waiting chair and my Husband got up and received his vaccine.    Besides the pain in my left arm,  I started feeling weird tingling sensations and spaced out.  When my Husband sat back down next to me,  my stomach had a burning sensation and I felt slightly nauseated.  Then I felt like I was about to faint.  My Husband and the Staff kept me from falling, The Staff brought ice packs to put on my neck.  They said I turned white and profusely sweat.   I don't remember all of it, my Husband filled in the blanks.  I started feeling better and we left @4:30.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pallor, Paraesthesia
Clinical narrative: Normal initial stick pain, but immediately intensified and went  down my arm.  I got up and walked back over to my waiting chair and my Husband got up and received his vaccine.    Besides the pain in my left arm,  I started feeling weird tingling sensations and spaced out.  When my Husband sat back down next to me,  my stomach had a burning sensation and I felt slightly nauseated.  Then I felt like I was about to faint.  My Husband and the Staff kept me from falling, The Staff brought ice packs to put on my neck.  They said I turned white and profusely sweat.   I don't remember all of it, my Husband filled in the blanks.  I started feeling better and we left @4:30.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Sore arm for 5 days, bad headache, fever, chills, body aches, congestion, flu-like symptoms, fatigue
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: Sore arm for 5 days, bad headache, fever, chills, body aches, congestion, flu-like symptoms, fatigue
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: Patient received the COVID vaccine at clinic.  While being monitored, patient stated that his "throat felt scratchy".  Patient was administered 50mg of Benadryl.  Blood pressure was 159/87. Patient was monitored for 45 minutes.  Patient stated that his throat no longer felt scratchy.  Patient's wife was able to drive him home.  Patient was advised to follow up with PCP and go to ER is symptoms returned.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Fatigue, Headache
Clinical narrative: Lightheadedness, chills, fever, headache, body aches, fatigue, cough, injection sight pain
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Lightheadedness, chills, fever, headache, body aches, fatigue, cough, injection sight pain
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: DISCOVERED 2 LARGE AREAS AT THE BACK OF MY HEAD WHERE HAIR WAS MISSING- ALOPECIA, WHICH HAS SLOWLY INCREASED IN SIZE SINCE THEN.  HAD SECOND DOSE VACCINE ON 03/19/2021  (WILL CONTINUE TO MONITOR  FOR ADDITIONAL HAIR LOSS)
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: My left arm muscle located on underarm between elbow and injection site, halfway between elbow and injection site higher up became extremely sore to the touch and prevented me from lifting my arm to preform functions.  Today is much better and function has mostly returned. The reason I am reporting is because I just (jan.29 2021) tore my rotator cuff on right  shoiulder and the loss of function is similar. Function is returning on left arm so no worried, the right shoulder will need shoulder replacement surgery.  But that was the effect on this adverse event. Loss of function to left arm about 3 days with improvement after 36 hours. Kind of a delayed response, so not sure its related. But I didn't injure the left so probably related.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dysarthria, Echocardiogram, Magnetic resonance imaging, Transient ischaemic attack
Clinical narrative: Slurred speech event for 15 seconds while working. Continued elevated DDimer and other various clothing labs post event. TIA event with continued hypercoagulation
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: pt had a seizure while waiting on observation area she reports her family was with her and told her about seizures medical staff alerted and 911 called. pt awoke from seizure and declined to go to ER reports she felt okay. unclear if generalized seizure.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Dyspnoea, Echocardiogram abnormal
Clinical narrative: 1st dose 1/19/21 resulted in 72 hours with fever 102, body aches, chills, headache, coughing, shortness of breath, extreme fatigue.  Symptoms resolved pretty abruptly at 72 hours. 2nd dose 2/12/21.  Again symptoms within 12 hours.  fever up to 103, chills, headache, extreme fatigue, body aches, coughing, increased oxygen demand.  Initial symptoms lingered over 14 days.  On 2/25 was prescribed 20mg prednisone for 5 days which resulted in slight improvement.  Then continued to slowly decline again with increased fatigue, chest pain,  more shortness of breath.  Saw pulmonologist on 3/10.  Referred to cardiologist and echo on 3/11 with concern for heart failure.  Echo on 3/11 showed acute right sided heart failure, new diagnosis.  Cardiologist and pulmonologist both state that I reacted with severe symptoms to first dose of vaccine but recovered.  2nd dose I just could not recover from and with my compromised lungs from post-acute covid syndrome, wound up with heart failure.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, Respiratory disorder
Clinical narrative: 1st dose 1/19/21 resulted in 72 hours with fever 102, body aches, chills, headache, coughing, shortness of breath, extreme fatigue.  Symptoms resolved pretty abruptly at 72 hours. 2nd dose 2/12/21.  Again symptoms within 12 hours.  fever up to 103, chills, headache, extreme fatigue, body aches, coughing, increased oxygen demand.  Initial symptoms lingered over 14 days.  On 2/25 was prescribed 20mg prednisone for 5 days which resulted in slight improvement.  Then continued to slowly decline again with increased fatigue, chest pain,  more shortness of breath.  Saw pulmonologist on 3/10.  Referred to cardiologist and echo on 3/11 with concern for heart failure.  Echo on 3/11 showed acute right sided heart failure, new diagnosis.  Cardiologist and pulmonologist both state that I reacted with severe symptoms to first dose of vaccine but recovered.  2nd dose I just could not recover from and with my compromised lungs from post-acute covid syndrome, wound up with heart failure.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Right ventricular failure
Clinical narrative: 1st dose 1/19/21 resulted in 72 hours with fever 102, body aches, chills, headache, coughing, shortness of breath, extreme fatigue.  Symptoms resolved pretty abruptly at 72 hours. 2nd dose 2/12/21.  Again symptoms within 12 hours.  fever up to 103, chills, headache, extreme fatigue, body aches, coughing, increased oxygen demand.  Initial symptoms lingered over 14 days.  On 2/25 was prescribed 20mg prednisone for 5 days which resulted in slight improvement.  Then continued to slowly decline again with increased fatigue, chest pain,  more shortness of breath.  Saw pulmonologist on 3/10.  Referred to cardiologist and echo on 3/11 with concern for heart failure.  Echo on 3/11 showed acute right sided heart failure, new diagnosis.  Cardiologist and pulmonologist both state that I reacted with severe symptoms to first dose of vaccine but recovered.  2nd dose I just could not recover from and with my compromised lungs from post-acute covid syndrome, wound up with heart failure.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Started noticing 2 big red dots/bumps on right cheek on Saturday 3/20.  Dots/bumps continued to appear - all along hairline by Saturday night - and more on cheeks under eyes & across nose - biggest one is on side next to right eye.  Did not change anything this week to include diet, meds, exercise routine - so only connection I can make is the vaccine.  This AM 3/22 dots/bumps are very noticeable, all over forehead now and a few more have appeared randomly on face - have not found elsewhere
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Headache, chills, body ache/fatigue
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This is a prisoner in our Treatment Program with a diagnosis of Schizophrenia.  He has Hyperlipidemia as a medical diagnoses.  This prisoner forgot that he had received his first vaccine on 03/10/2021 and got in line and received his second dose within 10 days.  Prisoner was assessed after realization was made on incident.  No medical complaints or issues.  Weekly monitoring will continue for 3 weeks.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: A rash developed on my upper left arm around the site of the injection.  Started about 36 hours after injection and has receded to some extent now.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Pyrexia, Tremor
Clinical narrative: Fatigue, 99.5 fever, uncontrollable shaking, chills, nausea, shortness of breath while moving,  after COVID vaccine
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Within 24 hours of vaccination, onset of severe headache, body aches, fatigue and fever of 102 F lasting approximately 48-72 hours. Injection site became hot, itchy and swollen and redness grew to approximately 4-5 inches across. Used warm compress and ice pack on arm. Took Acetaminophen for fever and pain management. Arm is improving but still swollen, red  and sore on day 4 but other symptoms have subsided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Within 24 hours of vaccination, onset of severe headache, body aches, fatigue and fever of 102 F lasting approximately 48-72 hours. Injection site became hot, itchy and swollen and redness grew to approximately 4-5 inches across. Used warm compress and ice pack on arm. Took Acetaminophen for fever and pain management. Arm is improving but still swollen, red  and sore on day 4 but other symptoms have subsided.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pruritus, Rash, Urticaria
Clinical narrative: Rash and hives, itchy and swollen lymph node on right neck - appeared approximately 24 hours after second dose of vaccine.  Received one shot of steroid and prescribed a 6 day dose of oral steroid.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: fever,  body aches, pain in arm where injected, swelling on arm where injected, headache, moderate fatigue, chills, 12- 14 hours
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever,  body aches, pain in arm where injected, swelling on arm where injected, headache, moderate fatigue, chills, 12- 14 hours
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This is a prisoner in our Resident Treatment Program with a diagnosis of Unspecified schizophrenia.  He has no medical diagnoses.  This prisoner forgot that he had received his first vaccine on 03/10/2021 and got in line with the National Guard and received his second dose within 10 days.  Prisoner was assessed after realization was made on incident.  No medical complaints or issues.  Weekly monitoring will continue for 3 weeks.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased
Clinical narrative: Elevated heart rate
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Elevated heart rate
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus
Clinical narrative: Legs started itching after 1 day Arms and body started itching day 2 Lymph nodes starting swelling day 2  Itching still remains as does the swollen lymph nodes
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Joint range of motion decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: Extreme immobilizing pain in arm. Could not lift arm for two days. Pain in arm radiated when I walked. Up my neck and down my back
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Swelling
Clinical narrative: Patient called regarding possible reaction to Janseen COVID vaccine on Friday.  Patient stated between 2:00 pm and 2:30 pm on Friday he started experiencing  joint pain in his left wrist that felt like he "sprained" his wrist.  Patient denies any injury.  Patient also noted some slight swelling in this area.  Patient took Aleve and stated the symptoms went away mid-morning on Saturday.  He denies any other symptoms.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram head, Dizziness, Electrocardiogram normal, Feeling cold
Clinical narrative: Blacked out completely while driving home on the highway about 50 minutes after the vaccine was administered with no reactions during the observed waiting period..  After awakening, nauseated, vomiting,  woozy, dizzy,  felt extremely cold, drained, somewhat unclear. Friend in vehicle was able to get to the steering wheel and we went off road into trees and grass on the side of the road several hundred feet until she was able to stop the vehicle. I did not come to until after the vehicle stopped. First responders came, reports made.  Examined and tests done at Emergency room.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Haematology test, Impaired driving ability, Laboratory test normal, Loss of consciousness, Mental impairment
Clinical narrative: Blacked out completely while driving home on the highway about 50 minutes after the vaccine was administered with no reactions during the observed waiting period..  After awakening, nauseated, vomiting,  woozy, dizzy,  felt extremely cold, drained, somewhat unclear. Friend in vehicle was able to get to the steering wheel and we went off road into trees and grass on the side of the road several hundred feet until she was able to stop the vehicle. I did not come to until after the vehicle stopped. First responders came, reports made.  Examined and tests done at Emergency room.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Road traffic accident, Vomiting
Clinical narrative: Blacked out completely while driving home on the highway about 50 minutes after the vaccine was administered with no reactions during the observed waiting period..  After awakening, nauseated, vomiting,  woozy, dizzy,  felt extremely cold, drained, somewhat unclear. Friend in vehicle was able to get to the steering wheel and we went off road into trees and grass on the side of the road several hundred feet until she was able to stop the vehicle. I did not come to until after the vehicle stopped. First responders came, reports made.  Examined and tests done at Emergency room.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Low-grade fever, chills, nausea, muscle ache, extreme fatigue. Treated with ibuprofen.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph nodes in neck and under arm,  treatment was motrin 600 mgs q6hrs from 2/18/21-02/22/21 returned to work on 02/23 lymph nodes still slightly enlarged as of today, 03/22/21
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph nodes in neck and under arm,  treatment was motrin 600 mgs q6hrs from 2/18/21-02/22/21 returned to work on 02/23 lymph nodes still slightly enlarged as of today, 03/22/21
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Glassy eyes, Injection site pain, Neck pain, Paraesthesia oral
Clinical narrative: pain from vaccine site up back of neck, tingling lips and glassy eyes
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, Headaches, body aches and extreme tiredness.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Arm and shoulder pain in left arm. Difficulty lifting arm, aching in shoulder and arm. No treatment but it's been going on for 3 weeks since the vaccine.  Today it seemed a lot better but this is 25 days later. Definitely still some achiness there though so the outcome is unknown.  My concern is if the vaccine went into the muscle and was it effective?  I am supposed to get my second dose later this week and I want to make sure the first dose was injected properly and effectively.  I can live with the pain although it is frustrating.  I just want to be sure I'm protected with the first dose and am ok to move on to second dose. Hoping someone can help me with this.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Rash
Clinical narrative: First event - Rash on chest and torso 2 days after vaccination (3-10-21). Slight itchiness. Went away after about 2 days.  Second event - rash on beck and arms, aching in bones 2 weeks after vaccination (3-22-21). Went away after a few hours.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Rash
Clinical narrative: Evening  of 3/5 I had chills and headache and then overnight I also developed body aches.  Started to feel better by afternoon of 3/6 but tired rest of day. Felt fine by late evening on 3/6. On about 3/8 I developed a rash on my inner elbow of right arm and still have that rash today
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Syringe issue, Underdose
Clinical narrative: Malfunction of the needle, 2 nd dose administered because less than half of vaccine was given
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles, taking valacyclovir.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Pneumonia
Clinical narrative: patient's care giver said approximately week after 1st dose patient was ttested positive and later admitted to hospital with pneumonia complications. patient  was discharged after treatment
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: PATIENT STATED SHE WAS DIZZY AND WITHIN ONE MINUTE HAD PASSED OUT.   911 WAS CALLED AND EMS CAME TO PHARMACY TO CHECK HER OUT.  SHE CAME TO QUICKLY AND WAS SWEATING AND "OUT OF IT".  SHE WAS ABLE TO SPEAK AND DRINK WATER BY THE TIME THEY ARRIVED.  SHE RECOVERED AND SPENT AN ADDITIONAL 30 MINUTES IN THE PHARMACY AREA FOR OBSERVATION.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: ACUTE HERPES ZOSTER RASH ON THE OPPOSITE SIDE FROM INJECTION OF  THE VACCINE SITE
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives/Rash, so far 4x's. Dr.  is prescribing a steroid medication trying to stop the re-occurrence.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Gait disturbance, Loss of consciousness
Clinical narrative: Vaccinated at 8:30AM.  Abrupt onset on extreme dizziness at 11AM.  Passed out for 4 hours in a recliner at Noon.  When awoke at 4PM was unable to sit, stand, or walk.  Had to crawl to bathroom.  Symptoms largely abated by 7PM.  Was able to participate in 2 hours of outdoor vigorous racket sports the following morning.  No apparent residual effects.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact, Injection site rash, Rash
Clinical narrative: Contact dermatitis. at site of shot, which has progressed to the entire left side of arm and torso
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash papular, Skin warm
Clinical narrative: Approximately 18 hours after the injection, noticed a red, raised rash on left arm around the injection site. Rash has grown larger and spread down the arm towards the elbow. Rash is hot to the touch and swollen. It does not itch but is uncomfortable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: both feet/toes are numbish.  (skin ) and now seems to be going up into the side of lower shin.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever 102degrees for two days following vaccine, general achiness, site injection soreness, flu-like feelings
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms for 12 hours; just took ibuprofen and drank water
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident Expired at facility on Hospice services on 3/21/21
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Skin discolouration
Clinical narrative: Bruising spots legs and stomach area
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Body aches, headache, injection site pain, arm pit of arm injected was extremely sore, fatigue, nauseous, dizziness,
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Body aches, headache, injection site pain, arm pit of arm injected was extremely sore, fatigue, nauseous, dizziness,
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Fatigue, Headache
Clinical narrative: breathing difficulties, chills, headache, loss of appetite, extreme fatigue
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: The first thing I noticed was sore throat, lymph nodes on my neck (both sides) was swollen. It felt like I had the mumps and this was the worse sore throat I ever experienced could barely swallow water. I had a low grade fever went to clinic for Covid,Strep (results negative). My symptoms lasted for 36 hrs.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Chills, Cough, Fatigue, Headache
Clinical narrative: Woke up next day with injection site and underarm pain that moved also to lymph node and breast swelling and pain.  Early that evening chills, fever, body aches, headache,  & dry cough that lasted most of the night.  The following day fatigue, runny nose, body aches, headache, swollen lymph node/breast area & arm tenderness continued.  The third day following the shot less fatigue, but still swollen area with pain and less headache.  Today, (day 4) minor headache, injection area, under arm and side of breast is still quite tender and swollen.  Research articles (U of MN, medRxiv services, etc.) indicate a 2nd shot may not be needed?????