chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysphagia, Ear discomfort, Hot flush
Clinical narrative: About 21 minutes after the shot  I felt a hot flash from my toes up to my head and I started to become unable to swallow. My ears felt as if they were going to burst out of my head and started getting worse.  I could still breathe but couldn?t swallow hardly at all.  My mouth felt really dry.  I was rushed to the ER by my boss and they gave me a steroid injection and a bit later gave me  two Benadryl that I had a difficult time swallowing.  They kept me there for a couple hours and releases me as I told them that I felt like I was able to swallow again and my ears felt normal again.  Followed up with my Dr. the next day.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered under minimum age
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Background: pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the facility has always used the doses before they approached the expiration date. This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles
Clinical narrative: Bigeminy.  Atenolol 50mg orally.  Resolved by morning.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Balance disorder, Chest pain, Fatigue, Influenza like illness
Clinical narrative: Severe itching for 3-1/2 weeks up to current date of 3/22/2012 (off and on) Occasional whole body tremors Flu-like feeling Fatigue Heart arrhythmia, palpitations and chest pain Off balance occasionally
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pruritus, Tremor
Clinical narrative: Severe itching for 3-1/2 weeks up to current date of 3/22/2012 (off and on) Occasional whole body tremors Flu-like feeling Fatigue Heart arrhythmia, palpitations and chest pain Off balance occasionally
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Balance disorder, Cardiac monitoring, Chest pain, Electrocardiogram
Clinical narrative: Severe itching for 3-1/2 weeks up to current date of 3/22/2012 (off and on) Occasional whole body tremors Flu-like feeling Fatigue Heart arrhythmia, palpitations and chest pain Off balance occasionally
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Fatigue, Feeling abnormal, Influenza like illness, Pruritus
Clinical narrative: Severe itching for 3-1/2 weeks up to current date of 3/22/2012 (off and on) Occasional whole body tremors Flu-like feeling Fatigue Heart arrhythmia, palpitations and chest pain Off balance occasionally
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Severe itching for 3-1/2 weeks up to current date of 3/22/2012 (off and on) Occasional whole body tremors Flu-like feeling Fatigue Heart arrhythmia, palpitations and chest pain Off balance occasionally
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Lethargy
Clinical narrative: chills, 24 hours;  painful joints, 24 hours; lethargy, 4 days; lack of appetite, 5 days.   By day 6 was back to normal.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Chromaturia, Dyskinesia, Gait disturbance
Clinical narrative: Fever 103.7,  chills, vomiting, jerking movements and tremors, back pain, unsteady gait, dark brown urine Fever was brought down with ice and Tylenol and time Jerking movements and unsteady gait continues to get  better with time , anti nausea. meds were called in to pharmacy,  back pain is getting better each day Urine has returned to normal color
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Fever 103.7,  chills, vomiting, jerking movements and tremors, back pain, unsteady gait, dark brown urine Fever was brought down with ice and Tylenol and time Jerking movements and unsteady gait continues to get  better with time , anti nausea. meds were called in to pharmacy,  back pain is getting better each day Urine has returned to normal color
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eating disorder, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: Mon-Tues 9:00pm-6:00am - paralyzed on back in full body pain, literally unable to move AT ALL Tues-Wed 6:00am-5:00am (next day) - able only to roll onto side; unable to get up except 2-3 times to bathroom; almost passed out one time; unable to keep down even sips of water; dry heaves; 100.8 fever; chills/fever; severe headache Wed-Sat - severe exhaustion; out of bed only occasionally and very briefly; able to keep down a little broth and then chicken soup; periodic chills, headache, nausea Sun-Mon - a little more improvement in all areas Tues - much better!  At some point, I developed Livedo reticularis in left calf. Went to urgent care on March 19. EKG normal. No DVT. Possibly caused by spasm. Saw physician today March 23.  Cause undetermined.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Livedo reticularis, Movement disorder, Nausea, Pain, Presyncope
Clinical narrative: Mon-Tues 9:00pm-6:00am - paralyzed on back in full body pain, literally unable to move AT ALL Tues-Wed 6:00am-5:00am (next day) - able only to roll onto side; unable to get up except 2-3 times to bathroom; almost passed out one time; unable to keep down even sips of water; dry heaves; 100.8 fever; chills/fever; severe headache Wed-Sat - severe exhaustion; out of bed only occasionally and very briefly; able to keep down a little broth and then chicken soup; periodic chills, headache, nausea Sun-Mon - a little more improvement in all areas Tues - much better!  At some point, I developed Livedo reticularis in left calf. Went to urgent care on March 19. EKG normal. No DVT. Possibly caused by spasm. Saw physician today March 23.  Cause undetermined.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Retching
Clinical narrative: Mon-Tues 9:00pm-6:00am - paralyzed on back in full body pain, literally unable to move AT ALL Tues-Wed 6:00am-5:00am (next day) - able only to roll onto side; unable to get up except 2-3 times to bathroom; almost passed out one time; unable to keep down even sips of water; dry heaves; 100.8 fever; chills/fever; severe headache Wed-Sat - severe exhaustion; out of bed only occasionally and very briefly; able to keep down a little broth and then chicken soup; periodic chills, headache, nausea Sun-Mon - a little more improvement in all areas Tues - much better!  At some point, I developed Livedo reticularis in left calf. Went to urgent care on March 19. EKG normal. No DVT. Possibly caused by spasm. Saw physician today March 23.  Cause undetermined.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate increased
Clinical narrative: Had AFib a couple days after receiving first shot of the Moderna vaccine. Heart felt like it was beating out of my chest, took a EKG on my watch, and it said that I had AFib heart rhythm.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: IMMEDIATELY AFTER DOSE WAS ADMINISTERED PATIENT COMPLAINED OF DIZZINESS WHILE SEATED. IMMUNIZING TECHNICIAN IMMEDIATELY CAME AND NOTIFIED ME, AT WHICH POINT I ENTERRED OUR VACCINATION ROOM AND KNELT DOWN NEXT TO SEATED PATIENT.  HE CONFIRMED THAT HE FELT REALLY DIZZY AT WHICH POINT I ENCOURAGED HIM TO SIT BACK IN THE SEAT AND RELAX AND I WOULD STAND BY HIM. WITHIN APROX 5 MINUTES OF VACCINATION PATIENT FAINTED IN THE CHAIR AT WHICH POINT EMS WAS CONTACTED. WITHIN APROX 30 SECONDS PATIENT STARTED TO REGAIN CONCIOUSNESS (NOTED BY EYE, MUSCLE MOVEMENT) OVER THE COURSE OF THE NEXT FEW MINUTES PATIENT SLOWLY BECAME ALERT AND ORIENTED AT WHICH POINT EMS ARRIVED AND TOOK OVER HIS CARE. AFTER APROX 15 MINUTES OF CARE FROM EMS PATIENT OPTED TO GO HOME WITH HIS DRIVER. I CONTACTED THE PATIENT AT APROX 130 TO CHECK IN ON HIM AND HE ADVISED ME HE WAS FEELING NORMAL AND THANKED US FOR HELPING HIM THROUGH HIS FAINTING EPISODE.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Peripheral coldness
Clinical narrative: headache, dizzy, happens with every vaccine for him, sweaty cool skin 98/60, 86,18, 96%
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Shortly after receiving the vaccine, the patient passed out. I ran out to him and shook him after having someone call 911. He regained consciousness after about 45-60 seconds. EMT checked his pulse and blood pressure and released him.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Vaginal haemorrhage
Clinical narrative: Irregular vaginal bleeding & menstrual type cramps. Started approximately 48 hours after receiving vaccine. Has continued on & off since receiving vaccine, usually lasting 1-2 days, then stopping for 2-4 days.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: C/o tightness in the right side of her jaw.no swelling,itchiness,shortness of breath. No history of an allergic reaction. History of diabetes,anemia.paramedics to evaluate
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coagulation time, Thrombophlebitis, Ultrasound Doppler
Clinical narrative: Bilateral greater saphenous vein thrombophlebitis
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Pharyngeal swelling
Clinical narrative: PATIENT PRESENTED TOOBSERVATION NURSE WITH INCREASED DIFFICULTY SWALLOWING AND SENSATION OF SWOLLEN THROAT.  VITAL SIGNS WERE OBTAINED OF BP 142/96, P - 101, R - 14, SPO2 - 99%.  DIPHENHYDRAMINE 25 mg ADMINISTERED ORALLY PER ON SITE MEDICAL PROVIDER.  MONITORING OF PATIENT CONTINUED FOR 15 MINUTES WHEN PATIENT NOTED INCREASED DIFICULTY SWALLOWING.  VITAL SIGNS OBTAINED BP 132/ 94, P - 98, R- 14, SPO2 - 97%.  PROVIDER ORDER AND PATIENT WAS GIVEN 10 mg DEXAMETHASONE PO.  MONITORING OF PATIENT CONTINUED PATIENT REPORTS DECREASE IN SYMPTOMS.   PATIENTED RELEASED TO HOME
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: PATIENT PRESENTED TOOBSERVATION NURSE WITH INCREASED DIFFICULTY SWALLOWING AND SENSATION OF SWOLLEN THROAT.  VITAL SIGNS WERE OBTAINED OF BP 142/96, P - 101, R - 14, SPO2 - 99%.  DIPHENHYDRAMINE 25 mg ADMINISTERED ORALLY PER ON SITE MEDICAL PROVIDER.  MONITORING OF PATIENT CONTINUED FOR 15 MINUTES WHEN PATIENT NOTED INCREASED DIFICULTY SWALLOWING.  VITAL SIGNS OBTAINED BP 132/ 94, P - 98, R- 14, SPO2 - 97%.  PROVIDER ORDER AND PATIENT WAS GIVEN 10 mg DEXAMETHASONE PO.  MONITORING OF PATIENT CONTINUED PATIENT REPORTS DECREASE IN SYMPTOMS.   PATIENTED RELEASED TO HOME
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever of 102.5 orally, fever and chills, uncontrolled shaking, several muscle pain for appx 24 hours.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling
Clinical narrative: As described over the phone by patients sister. Left thigh is "kind of blue". Right thigh is normal. Left foot is swollen. This stared the morning of 3/23 according to the sister. I advised that the patient seek medical attention.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: I received the shot at 8:30 AM.  No reaction until around 12:30PM when I noticed mild soreness in my arm muscle where I received the shot.  Then around 5:30PM I became progressively fatigued and very mildly feverish.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy heat rash type bumpy rash over chest, neck, upper arms, forehead showed up 5 days post injection
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Patient had some itching in the left arm and mild rash 5 minutes after the immunization . Gave 25 ml of benadryl. The benadryl relieved the rash and itch. Patient sat and was observed for another 45 minutes and rash/itch went away.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Malaise
Clinical narrative: Headache, joint pain, malaise and fatigue, decreased appetite. Started within 12 hours of vaccine administered, lasted 24 hours.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Dizziness, Dyspnoea, Fall
Clinical narrative: Pt recieved 1st Pfizer vaccine on 2/25/21 and her 2nd one on 3/18/21 Pt went to the ER on 3/23 via 911 in full cardiac arrest Per daugher, she c/o lightheaded this A< she came out of her room snad fell down, was vomitting and labored breathing paramedics were called, she went to Hospital and later died
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pt recieved 1st Pfizer vaccine on 2/25/21 and her 2nd one on 3/18/21 Pt went to the ER on 3/23 via 911 in full cardiac arrest Per daugher, she c/o lightheaded this A< she came out of her room snad fell down, was vomitting and labored breathing paramedics were called, she went to Hospital and later died
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Headache x 3 days post injection .  Treated with OTC Tylenol 500mg, 1/2 cup caffeine.  Swollen lymph node in left armpit starting 2 days post vaccination. Cleansed area with soap and water. Applying warm compress daily. Avoiding deodorant to area.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Ultrasound scan
Clinical narrative: Skipped period cycle. I'm very regular and have never skipped a period.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Pain, Tongue discomfort
Clinical narrative: The patient reported that he had a burning sensation on the front part of his tongue, a chemical taste in his mouth, feeling achy, and he lost his taste the same day he received the first dose of his vaccine.  He said that most of the side effects resolved by the next day.  The burning sensation on his tongue has persisted during the month.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Series started with Pfizer and completed 28 days later with Moderna
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site muscle weakness, Injection site pain, Tenderness
Clinical narrative: Patient reporting tenderness when moving arm. Patient reports 0/10 at rest. 5/10 if raised above head. Patient states he feels weaker in that arm since the injection. Patient assessed in office and refused any imagining or treatment. Provider believes a nerve is affected/irritated after injection. there is no redness, no mass, no other symptoms besides pain and weakness, only in the affected arm. Patient contacted us to let us know.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Oropharyngeal pain, Throat irritation
Clinical narrative: Patient reported her throat felt itchy and a little sore. Vitals stable, slightly hypertensive but patient has hypertension and skipped her meds this morning. She usually takes loratadine, lisinopril, atenolol. She was given 10mg of sublingual Zyrtec. Patient wanted to leave facility. Doctor assessed patient, no wheezing, no worsening of symptoms. Patient ambulated home with son and said she would use her epi-pen at home if needed.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Started itching a few minutes after received the shot. Felt slight shortness of breath but wasn?t sure if I was having panic attack or reaction. Took Benadryl and used inhaler and that helped. Around 2pm started having cramps as id period was on but it?s not due for a week. Took advil, it helped. Around 5:30pm severe abdominal cramps, nausea, went to bathroom several times. Arm, neck and shoulder pain. Dizziness and just feel weird. If gets worse tonight will go to ER, if same or better will call doctor in the morning
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Muscle spasms, Nausea, Neck pain, Pain in extremity
Clinical narrative: Started itching a few minutes after received the shot. Felt slight shortness of breath but wasn?t sure if I was having panic attack or reaction. Took Benadryl and used inhaler and that helped. Around 2pm started having cramps as id period was on but it?s not due for a week. Took advil, it helped. Around 5:30pm severe abdominal cramps, nausea, went to bathroom several times. Arm, neck and shoulder pain. Dizziness and just feel weird. If gets worse tonight will go to ER, if same or better will call doctor in the morning
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Started itching a few minutes after received the shot. Felt slight shortness of breath but wasn?t sure if I was having panic attack or reaction. Took Benadryl and used inhaler and that helped. Around 2pm started having cramps as id period was on but it?s not due for a week. Took advil, it helped. Around 5:30pm severe abdominal cramps, nausea, went to bathroom several times. Arm, neck and shoulder pain. Dizziness and just feel weird. If gets worse tonight will go to ER, if same or better will call doctor in the morning
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck pain, Pain in extremity, Pruritus
Clinical narrative: Started itching a few minutes after received the shot. Felt slight shortness of breath but wasn?t sure if I was having panic attack or reaction. Took Benadryl and used inhaler and that helped. Around 2pm started having cramps as id period was on but it?s not due for a week. Took advil, it helped. Around 5:30pm severe abdominal cramps, nausea, went to bathroom several times. Arm, neck and shoulder pain. Dizziness and just feel weird. If gets worse tonight will go to ER, if same or better will call doctor in the morning
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Near syncope treated oral glucose and IV fluids. Transport to local ED.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache, Myalgia, Pain
Clinical narrative: Last one night and one day: body muscle pain, headache, belly pain, fever, chill.  Took Advil for painkilling.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Last one night and one day: body muscle pain, headache, belly pain, fever, chill.  Took Advil for painkilling.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Product administered to patient of inappropriate age
Clinical narrative: Patient received a vaccine not indicated for 16 years of age. Patient felt a little tired on 3/22 and then this morning she was ok, per mom.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Background: Pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the Pharmacy MOB has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Pain, Paraesthesia
Clinical narrative: All over stinging, tingling some numbness. Face ,arms,torso,legs Started after leaving pharmacy. Took benadryl. Continued through next day.  Didn't worsen, but still continues. Some stinging like bug bites. Nerve pain
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Hypoaesthesia
Clinical narrative: @10:48am Patient reported chest tightness and face numbness right after receiving the vaccine, c/o headache and that she felt like she was rocking.  Benadryl was given, @10:51am provider evaluated patient and after 45 minutes of observation patient was still not feeling well. 11:25am
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Paraesthesia
Clinical narrative: Shortness of breath Increased heart rate Left arm tingling
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Background: pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the MOB has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin lesion, Skin swelling
Clinical narrative: Itchy, swollen lesion on arm beginning 1 week after vaccination. Started small and looked like a rash, the. grew to almost cover bicep in  2 days - no longer looking like a rash but a defined circular red lesion. Now, on the third day, the swelling has subsided and it is no longer itching, but is still slightly red.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Computerised tomogram, Disorientation
Clinical narrative: Received vaccine and observed without incident. Pt was seen attempting to enter his car and was disoriented and unable to open the door. Per report, he also had expressive aphasia at that time. An ambulance was called and patient was transported to local hospital for further evaluation.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Exposure during pregnancy, Fatigue, Injection site pain
Clinical narrative: Symptoms included chills, elevated temperature (99.3), fatigue, aches, pain at injection site. was 33 weeks pregnant at time of second dose of Pfizer vaccine. Symptoms subsided by the morning of 3/18/2021 with no other symptoms returning.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Symptoms included chills, elevated temperature (99.3), fatigue, aches, pain at injection site. was 33 weeks pregnant at time of second dose of Pfizer vaccine. Symptoms subsided by the morning of 3/18/2021 with no other symptoms returning.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Flushing, Pharyngeal swelling, Throat irritation
Clinical narrative: Subjective sense of throat swelling/swallowing. Vitals stable but flushed and elevated BP
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Lethargy, Lymphadenopathy
Clinical narrative: High fever, chills, lethargy, malaise, body aches, and baseball size swollen lymph nodes on head (behind ear) and in armpit of left arm.  All symptoms lasted 36 hours. This is Tuesday after the shot on Thursday and I am still very tired and weak and I still have swollen lymph nodes, but not as big.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: High fever, chills, lethargy, malaise, body aches, and baseball size swollen lymph nodes on head (behind ear) and in armpit of left arm.  All symptoms lasted 36 hours. This is Tuesday after the shot on Thursday and I am still very tired and weak and I still have swollen lymph nodes, but not as big.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Lymph node pain, Pain in extremity
Clinical narrative: Sore arm 2 days/3rd day started with pain right side lymph nodes, next day pain on both sides of lymph nodes and then couldn't swallow having a hard time eating and the pain was really hard the swelling got real large underneath my chin and bottom part about my neck, had to go-to my doctor today for swelling in pain and both sides of the throat look like white pus on inside of my mouth and also just wanted to note my wife after the first day she felt like she had the a fever for two days chills and everything and eventually that went away for her. My doctor put me on amoxicillin today or no it was a penicillin and it's $875 milligrams twice a day. She thinks it was just tonsillitis but still having problems doing a lot of salt water ibuprofen aspirin drinking lots of chicken noodle soup so I hope that helps you out
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: Elevated heart rate, temp of 102, chills, headache, muscle and joint pain, fatigue
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Elevated heart rate, temp of 102, chills, headache, muscle and joint pain, fatigue
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling, Ultrasound scan
Clinical narrative: Swelling inside collar bone area on side of injection. Possibly lymph node. First time noticing swelling is approximately 7 days after 1st injection.  Over the next 3 weeks, swelling decreased to almost normal until 2nd dose.  After that, swelling was noticed approximately 48 hours later and correlated vaccine with swelling. Between the 1st and 2nd dose, I visited MD, Physical Therapists, Massage therapist.  Other symptoms included popping of collar bone when shrugging shoulder.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Electrocardiogram normal, Electroencephalogram normal, Laboratory test normal, Loss of consciousness
Clinical narrative: 1st Moderna shot was 1/4/21.  Had a syncope episode/potential seizure on 1/13/21 - unwitnessed loss of consciousness for a short period of time with loss of urinary continence.   2nd Moderna COVID shot on 1/29/21 with no reactions.  My doctors evaluating me did not consider this as a COVID vaccine reaction, even though it did occur after the first vaccination.  I am a nurse with a doctorate degree and do not believe the seizure was the reaction of the COVID vaccine.  I was under extreme amounts of stress at work at the time.  I also have a prior medical history of syncope episodes when I was a teenager (25+ years ago).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Seizure, Syncope, Urinary incontinence
Clinical narrative: 1st Moderna shot was 1/4/21.  Had a syncope episode/potential seizure on 1/13/21 - unwitnessed loss of consciousness for a short period of time with loss of urinary continence.   2nd Moderna COVID shot on 1/29/21 with no reactions.  My doctors evaluating me did not consider this as a COVID vaccine reaction, even though it did occur after the first vaccination.  I am a nurse with a doctorate degree and do not believe the seizure was the reaction of the COVID vaccine.  I was under extreme amounts of stress at work at the time.  I also have a prior medical history of syncope episodes when I was a teenager (25+ years ago).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: I received the shot around noon 3/16 and by 10:30pm my blood sugar was 414.  I am type 1 Diabetic and inject insulin by pen.  I do not have a CGM, I have to test manually.  Today is 3/23 and the first four days of the injection, my sugars were in the 400's.  The last three days they have been in the high 200's.  Yesterday my endocrinologist had me increase my long-acting insulin.  I have bloodwork Friday and I have an appointment with her 4/2.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Chills, Computerised tomogram normal, Diarrhoea
Clinical narrative: 1. metallic taste in mouth - 7 days 2. Arm sore at injection site - 4 days 3. Tongue felt swollen-2 days 4. Jaw felt locked--8 days 5. nauseous--20 days 6. diahrreah 2 days a week apart 7. Loose bowels--8 days 8 sharp pain in left ear--4 days 9. vomiting--2 days 10. extremem fatigue--21 days 11. stomach bloated severely--4 days 12. sever headache--8 days, even woke me at 3 am 2 times 13. joints and muscles ache--12 days 14. Chills--4 days; developed a week after the vaccine 15. Extremely stuffy nose and somewhat runny, felt like someone punched me in the face the first 4 days--28 days on and off 16. severe stiff neck--started stared day 14 of vaccine--5 days 17. dizzy and vertigo--started a week after the vaccine, lasted until the Epley Maneuveur done on March 16
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Ear pain, Facial pain, Fatigue
Clinical narrative: 1. metallic taste in mouth - 7 days 2. Arm sore at injection site - 4 days 3. Tongue felt swollen-2 days 4. Jaw felt locked--8 days 5. nauseous--20 days 6. diahrreah 2 days a week apart 7. Loose bowels--8 days 8 sharp pain in left ear--4 days 9. vomiting--2 days 10. extremem fatigue--21 days 11. stomach bloated severely--4 days 12. sever headache--8 days, even woke me at 3 am 2 times 13. joints and muscles ache--12 days 14. Chills--4 days; developed a week after the vaccine 15. Extremely stuffy nose and somewhat runny, felt like someone punched me in the face the first 4 days--28 days on and off 16. severe stiff neck--started stared day 14 of vaccine--5 days 17. dizzy and vertigo--started a week after the vaccine, lasted until the Epley Maneuveur done on March 16
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Musculoskeletal stiffness, Myalgia, Nasal congestion
Clinical narrative: 1. metallic taste in mouth - 7 days 2. Arm sore at injection site - 4 days 3. Tongue felt swollen-2 days 4. Jaw felt locked--8 days 5. nauseous--20 days 6. diahrreah 2 days a week apart 7. Loose bowels--8 days 8 sharp pain in left ear--4 days 9. vomiting--2 days 10. extremem fatigue--21 days 11. stomach bloated severely--4 days 12. sever headache--8 days, even woke me at 3 am 2 times 13. joints and muscles ache--12 days 14. Chills--4 days; developed a week after the vaccine 15. Extremely stuffy nose and somewhat runny, felt like someone punched me in the face the first 4 days--28 days on and off 16. severe stiff neck--started stared day 14 of vaccine--5 days 17. dizzy and vertigo--started a week after the vaccine, lasted until the Epley Maneuveur done on March 16
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rhinorrhoea, Sleep disorder, Swollen tongue, Trismus
Clinical narrative: 1. metallic taste in mouth - 7 days 2. Arm sore at injection site - 4 days 3. Tongue felt swollen-2 days 4. Jaw felt locked--8 days 5. nauseous--20 days 6. diahrreah 2 days a week apart 7. Loose bowels--8 days 8 sharp pain in left ear--4 days 9. vomiting--2 days 10. extremem fatigue--21 days 11. stomach bloated severely--4 days 12. sever headache--8 days, even woke me at 3 am 2 times 13. joints and muscles ache--12 days 14. Chills--4 days; developed a week after the vaccine 15. Extremely stuffy nose and somewhat runny, felt like someone punched me in the face the first 4 days--28 days on and off 16. severe stiff neck--started stared day 14 of vaccine--5 days 17. dizzy and vertigo--started a week after the vaccine, lasted until the Epley Maneuveur done on March 16
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: 1. metallic taste in mouth - 7 days 2. Arm sore at injection site - 4 days 3. Tongue felt swollen-2 days 4. Jaw felt locked--8 days 5. nauseous--20 days 6. diahrreah 2 days a week apart 7. Loose bowels--8 days 8 sharp pain in left ear--4 days 9. vomiting--2 days 10. extremem fatigue--21 days 11. stomach bloated severely--4 days 12. sever headache--8 days, even woke me at 3 am 2 times 13. joints and muscles ache--12 days 14. Chills--4 days; developed a week after the vaccine 15. Extremely stuffy nose and somewhat runny, felt like someone punched me in the face the first 4 days--28 days on and off 16. severe stiff neck--started stared day 14 of vaccine--5 days 17. dizzy and vertigo--started a week after the vaccine, lasted until the Epley Maneuveur done on March 16
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Sore shoulder, fever of 101.2, chills
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Breath sounds abnormal, Disorientation, Dizziness, Erythema
Clinical narrative: Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared diaphoretic with mask down. He flagged down nurse and reported feeling hot/lightheaded. NP asked for BP machine, instructed patient to take slow deep breaths. Pt. reported he felt like he may lose consciousness. His eyes rolled and he became white/pale and appeared to stop breathing. Code assist called; didn't respond to sternal rub, but raspy breathing, weak/rapid pulse palpated; immediately transferred to the ground level without falling, 2 person assist. 9-1-1 called, BP machine didn't immediately work. As soon as his head was low, his face became bright red and he regained consciousness. He was disoriented briefly but then able to answer questions/oriented. BP elevated, HR 80s. BS 257. No s/s anaphylaxis. Hx of syncope r/t blood draw. Wife present and report hx of DM, HTN, Palpitations. He denied CP/SOB or palpitations. He had eaten and took regular medicine the morning. Paramedic arrived and patient was transported to the nearest ER. Pt. was later discharged.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Feeling hot, Heart rate increased, Hyperhidrosis, Loss of consciousness
Clinical narrative: Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared diaphoretic with mask down. He flagged down nurse and reported feeling hot/lightheaded. NP asked for BP machine, instructed patient to take slow deep breaths. Pt. reported he felt like he may lose consciousness. His eyes rolled and he became white/pale and appeared to stop breathing. Code assist called; didn't respond to sternal rub, but raspy breathing, weak/rapid pulse palpated; immediately transferred to the ground level without falling, 2 person assist. 9-1-1 called, BP machine didn't immediately work. As soon as his head was low, his face became bright red and he regained consciousness. He was disoriented briefly but then able to answer questions/oriented. BP elevated, HR 80s. BS 257. No s/s anaphylaxis. Hx of syncope r/t blood draw. Wife present and report hx of DM, HTN, Palpitations. He denied CP/SOB or palpitations. He had eaten and took regular medicine the morning. Paramedic arrived and patient was transported to the nearest ER. Pt. was later discharged.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared diaphoretic with mask down. He flagged down nurse and reported feeling hot/lightheaded. NP asked for BP machine, instructed patient to take slow deep breaths. Pt. reported he felt like he may lose consciousness. His eyes rolled and he became white/pale and appeared to stop breathing. Code assist called; didn't respond to sternal rub, but raspy breathing, weak/rapid pulse palpated; immediately transferred to the ground level without falling, 2 person assist. 9-1-1 called, BP machine didn't immediately work. As soon as his head was low, his face became bright red and he regained consciousness. He was disoriented briefly but then able to answer questions/oriented. BP elevated, HR 80s. BS 257. No s/s anaphylaxis. Hx of syncope r/t blood draw. Wife present and report hx of DM, HTN, Palpitations. He denied CP/SOB or palpitations. He had eaten and took regular medicine the morning. Paramedic arrived and patient was transported to the nearest ER. Pt. was later discharged.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; worse around lymph nodes (axillary, neck, and inguinal). No rash, fever, shortness of breath, swelling of tongue/throat/lips, eye redness, palpitations, fever. Erythematous skin.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Deafness, Headache, Neck pain
Clinical narrative: March 15: 2:45pm Pfizer COVID vaccine 1 March 16; 6am - severe headache: treated with two Excedrins at 8am and then two more Excedrins at 6pm.  March 17: 10am - severe headache: treated with two Excedrins at 10am March 18: Upper neck and shoulder pain: untreated March 19: Upper neck and shoulder pain and hearing loss (approximately 50% hearing loss): untreated March 20: Upper neck and shoulder pain: treated with Arnicare Cream, hearing loss continues, untreated March 21 - 22: Upper neck and shoulder pain: treated with Arnicare Cream: hearing loss continues.  March 23: Upper neck and shoulder pain improved. Hearing loss continues. Notified Dr. (my primary physician)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Eustachian tube disorder, Eye inflammation, Eye irritation, Eye pain
Clinical narrative: Earrs: Swollen Eustachian tubes in both ears:   distorted hearing, amplified sound, equilibrium off.  Eyes: both eyes had irritation, then Left eye pain, inflammation and redness on the outer edge of eyeball.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Ocular hyperaemia
Clinical narrative: Earrs: Swollen Eustachian tubes in both ears:   distorted hearing, amplified sound, equilibrium off.  Eyes: both eyes had irritation, then Left eye pain, inflammation and redness on the outer edge of eyeball.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle spasms, Nausea, Nervousness
Clinical narrative: Until 03/20/2021 I had fever, chills, nausea, cramps, fatigue, body aches, sore arm, and felt shaky;  until 03/23/2021 I had all the previous except fever, chills and sore arm.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Until 03/20/2021 I had fever, chills, nausea, cramps, fatigue, body aches, sore arm, and felt shaky;  until 03/23/2021 I had all the previous except fever, chills and sore arm.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Background: pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the  MOB has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Rash pruritic, Urticaria
Clinical narrative: pruritis and urticarial rash immediately post vaccine administration; EPiPen 0.3mg IM & Benadryl 25mg PO administer, symptoms resolved
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Lymphadenopathy
Clinical narrative: chills, fatigue, weakness, diarrhea cramping  swollen glands
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: chills, fatigue, weakness, diarrhea cramping  swollen glands
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Per patient after she was monitor for 30 minutes in clinic for COVID-19 vaccine, she felt fine.  Per patient one hour after she received the vaccine, she had tingling on left side of face that lasted for 1-2 hours and it went away.  Per patient she did not follow up with her provider.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler
Clinical narrative: DVT of left upper extremity, unprovoked