chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with MILVAX concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  The Joint Base Medical Staff and the Medical Squadron Commander were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Resolution Specialist and MILVAX, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling around eyes that resolved after 20 minutes
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Migraine
Clinical narrative: Started with nausea, next day had joint pain, fatigue and nausea with diarrhea and fever of 101F. Day 3 had muscle pain, fatigue and severe diarrhea and fever of 100 F with acetaminophen started around the clock. Day 4 had migraine and nausea and diarrhea and fever of 100F. Day 5 has diarrhea throughout night approx every 30 minutes and extreme fatigue and headache. Symptoms have not yet subsided. One day 5 post vaccine.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Started with nausea, next day had joint pain, fatigue and nausea with diarrhea and fever of 101F. Day 3 had muscle pain, fatigue and severe diarrhea and fever of 100 F with acetaminophen started around the clock. Day 4 had migraine and nausea and diarrhea and fever of 100F. Day 5 has diarrhea throughout night approx every 30 minutes and extreme fatigue and headache. Symptoms have not yet subsided. One day 5 post vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Small red, raised area at site of injection. Warm to touch
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Lymphadenopathy
Clinical narrative: I have developed a swollen/painful lymph node under my Lt armpit area.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with Health Authority concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  Chief, Medical Staff and the Commander were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Healthcare Resolution Specialist and Health Authority, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: 2 days after vaccination client noticed lesions on right buttock. Diagnosed with Shingles 1/7/21. Rx Acyclovir by Internal Medicine MD.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Multiple allergies, Pruritus, Urticaria
Clinical narrative: patient developed hives on heck, erythema/redness all up arms and neck, itchy on arms and feels warm behind ears. patient reports she has had many allergies (non-drug) in the past and has received allergy shots.  patient received Famotidine and Prednisone in ED and discharged home
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches and pain at the injection.  Treatment is Tylenol. Patient will continue to monitor
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with program concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: The clinic, Medical Staff and the office were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with AFMRA Risk Management, the NCR Market Healthcare Resolution Specialist and program, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.  Note: this patient was one of two who declined a second dose.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pruritus, Injection site rash, Limb discomfort
Clinical narrative: Sore arm for 36hrs, followed by pain in right armpit 2-4 days post injection.  7 days after injection, developed an itchy rash at the injection site that continues to grow in size and is now 4" x 3" in diameter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: 3pm, day after vaccine, general malaise, fatigue, body aches, no fever. Slept for 2.5 hours and woke up feeling better. Went to bed early and feel fine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: 12 hours from vaccine #2, I started with rigors, myalgias/arthralgias, severe headache, temperature 100-101, nasal congestion, and profound fatigue.  Symptoms resolved after 36 hours with Tylenol/Advil and supportive care.  Sent for COVID Rapid PCR which was negative; missed 1 day of work.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Myalgia, Nasal congestion, SARS-CoV-2 test negative
Clinical narrative: 12 hours from vaccine #2, I started with rigors, myalgias/arthralgias, severe headache, temperature 100-101, nasal congestion, and profound fatigue.  Symptoms resolved after 36 hours with Tylenol/Advil and supportive care.  Sent for COVID Rapid PCR which was negative; missed 1 day of work.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Hypertension, Paraesthesia, Peripheral coldness
Clinical narrative: elevated Blood Pressure 154/104, Heart Rate 57; arm numbness/tingling, arm cold to touch
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body aches, chills, headaches, refused MD follow up at time of report
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Unevaluable event
Clinical narrative: None stated.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Began feeling light headed the evening of the vaccine, overnight developed shaking chills, fever of 104 with headache. Took ibuprofen which brought temperature down to 99. Still (on day 2) having some sweats & nausea.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Began feeling light headed the evening of the vaccine, overnight developed shaking chills, fever of 104 with headache. Took ibuprofen which brought temperature down to 99. Still (on day 2) having some sweats & nausea.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Rash vesicular
Clinical narrative: Shingles left flank, mild case so far
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Limb discomfort
Clinical narrative: Developed a very sore arm about 36 hours post injection.  About 48 hours post injection developed swelling; redness; itching and pain at injection site.   Acetaminophen used but ineffective.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site discomfort
Clinical narrative: Awoke at 7:30am with increased injection site soreness in upper L arm and a headache with fatigue, symptoms resolved after I took a single dose of naproxen sodium 220 mg at 2pm and currently feel no side effects
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Vertigo
Clinical narrative: Vertigo, diapharesis, nausea
Age: 26.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Product storage error
Clinical narrative: Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Impact: A minimum of six patients received invalidated vaccine. Consultation with Agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  Medical Staff and the Staff were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Specialist and Agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: 1/7/2021  Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with ibuprofren and tylenol 1/8/2021  Took more ibuprofren at 4am, 'feel just fine'. *I think that severity of the symptoms, which i was expecting, the 2nd dose was more 'hard hitting' then the first; More side affects with muscle and joint pain.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initially had localized redness, tenderness and swelling at injection site.  This resolved and came back 7 days later, although with less pain and increased warmth to the injection site.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation, Product storage error
Clinical narrative: Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  The Medical Staff and the Medical Squadron Commander were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Market Healthcare Resolution Specialist and agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.  Note: this is one of the two patients who will defer a repeat dose and proceed to 2nd dose at 28 days
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever of 102 degrees F. or higher  (temp was 102 degrees  2 hours after taking ibuprofen), shaking chills, headache, nausea, severe generalized body aches.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in left ancillary and into the left breast.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling hot, Flushing, Paraesthesia oral, Urticaria
Clinical narrative: Clinic Manager reports that EE received first dose Covid-19. EE reports that after 15 minutes EE became unwell and was sweating. EE reports that EE was seen in clinic by providers and had elevated blood pressure and hives
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Hyperhidrosis, Malaise, Urticaria
Clinical narrative: Clinic Manager reports that EE received first dose Covid-19. EE reports that after 15 minutes EE became unwell and was sweating. EE reports that EE was seen in clinic by providers and had elevated blood pressure and hives
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: patient "did not feel right"
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Developed fever, chills that evening, achiness, headache, arm pain through 1/7/21 evening. Was to the point of being unable to function and leave couch which is unusual for her.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Developed fever, chills that evening, achiness, headache, arm pain through 1/7/21 evening. Was to the point of being unable to function and leave couch which is unusual for her.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation, Product storage error
Clinical narrative: Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with Agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  Agency, Medical Staff and Others were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Resolution Specialist and Agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
Sex: F
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: she received PNEUMOVAX 23 "every year"; No additional adverse events reported; This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. Since unknown dates, the patient was vaccinated with doses of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection , every year (dose, route of administration, anatomical localization, lot # and expiration date were unknown) for prophylaxis. No additional adverse events reported.   This is one of two case reports from the same reporter.; Sender's Comments:  US-009507513-2012USA005988:
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: V ARlV AX was administered to his 19 year old son today 1/5/2020 at 12: 15 PM via intramuscular route; No additional AE; This spontaneous report was received from a physician reporting for his son and refers to a 19-year-old male patient. His concurrent conditions included allergy to diary products. His concomitant therapies and previous drug reactions were unknown.  On 05-JAN-2021 at 12:15, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) via intramuscular route (strength, dose, lot #  and expiration date were not provided) as a booster of varicella virus vaccine live (oka/merck) (VARIVAX) based on titer levels. The vaccine was administered in an inappropriate route as it should have been administered subcutaneously. There was no treatment given for the event. There were no additional adverse events (AE) reported. No further information was provided. The outcome of the event was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Sinusitis
Clinical narrative: patient got a sinus infection; Initial information was received on 05-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.   This case involves a patient of unknown age who got a sinus infection (sinusitis), while patient received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) it was reported that patient got a flu shot 7 years ago, never been so sick in patients life. Had not got a flu shot since and had not been that sick since. Use to never get sick in the fall or spring until the stupid shot, now ever year around the fall and spring patient got a sinus infection (sinusitis).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on lot number was requested for this case.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK had been administered to 11 pediatric patients (with no adverse event); Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 16 years old male patient for whom it was reported that Flublok had been administered to 11 pediatric patients (with no adverse event) (Product administered to patient of inappropriate age), while he received vaccine influenza quadrivalent recombinant vaccine (Flublok QIV).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 22-Dec-2020, the patient received a dose of suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 mL once via intramuscular route (lot number: UJ509AA, expiry date: 05-Oct-2020) as prophylactic vaccination in the right deltoid.  On an unknown date (latency unknown) after taking the suspect, it was reported that Flublok had been administered to 11 pediatric patients (with no adverse event) (Product administered to patient of inappropriate age) (intensity: not applicable).  No laboratory test was reported.  Action taken was reported as not applicable. Corrective treatment was not reported. Outcome was reported as not applicable for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.    No further information was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry throat, Headache, Heart rate increased, Hypoaesthesia
Clinical narrative: dizziness at first that lasted half hour along with heart rate increase, and slight headache. an hour after injection, body aches, lethargic, a stronger headache, injection sight (left arm) was very sore. Later, aprox 3-4 hours,  as  symptoms subsided  (headache, body aches, lethargic, heart rate returned to normal a few hours after injection), a new symptoms arise with numbness in my left leg from the knee down to my foot ,injection sight  and arm soreness, and the back of my throat felt "funny" and dry it lasted aprox an hour (fyi: drank plenty of water throughout these symptoms).  I took my normal medication. Went to sleep. Woke up and numbness was gone.  Injection sight is still a bit sore but not as intense. I am feeling well today with little or no symptoms at all.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Pain, Pain in extremity, Throat irritation
Clinical narrative: dizziness at first that lasted half hour along with heart rate increase, and slight headache. an hour after injection, body aches, lethargic, a stronger headache, injection sight (left arm) was very sore. Later, aprox 3-4 hours,  as  symptoms subsided  (headache, body aches, lethargic, heart rate returned to normal a few hours after injection), a new symptoms arise with numbness in my left leg from the knee down to my foot ,injection sight  and arm soreness, and the back of my throat felt "funny" and dry it lasted aprox an hour (fyi: drank plenty of water throughout these symptoms).  I took my normal medication. Went to sleep. Woke up and numbness was gone.  Injection sight is still a bit sore but not as intense. I am feeling well today with little or no symptoms at all.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Itching, redness, Swelling, warmth, discomfort in left arm that started 7 days after vaccine was given. Much better now but still with smaller area of sight redness and slight itching
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation, Product storage error
Clinical narrative: Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  The Medical Staff and the Medical Squadron Commander were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Healthcare Resolution Specialist and agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Local reaction, Muscle tightness
Clinical narrative: Localized reaction to injection site with swelling, redness, and tightness at site.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Induration, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema, itchiness and warmth around the injection site. No pain. Slight induration.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Impaired work ability, Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: Had my 1st Moderna COVID-19  vaccine at 0745,  on 12/30/20. On 1/6/20 at approximately 0400 while taking a showering I noticed a hematoma on Left Deltoid area. During the day of 1/6/20, my Left Deltoid area became increasingly red, swollen & painful. On Thursday, 1/7/20, the Left Deltoid area continued to increase in redness, warmth & swelling. I had the area of Left Deltoid marked with a skin marker at work on 1/7/20, during the day the redness & swelling increased beyond the skin marker. After work on 1/7/20, I went to an Urgent Care, I was diagnosed with Cellulitis and prescribed antibiotics. I also was unable to go work on Friday, 1/8/20, related to pain.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Had my 1st Moderna COVID-19  vaccine at 0745,  on 12/30/20. On 1/6/20 at approximately 0400 while taking a showering I noticed a hematoma on Left Deltoid area. During the day of 1/6/20, my Left Deltoid area became increasingly red, swollen & painful. On Thursday, 1/7/20, the Left Deltoid area continued to increase in redness, warmth & swelling. I had the area of Left Deltoid marked with a skin marker at work on 1/7/20, during the day the redness & swelling increased beyond the skin marker. After work on 1/7/20, I went to an Urgent Care, I was diagnosed with Cellulitis and prescribed antibiotics. I also was unable to go work on Friday, 1/8/20, related to pain.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia for 3 nights following
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. Injection site was swollen right after it was administered and red and warm to the touch for 5 days.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. Injection site was swollen right after it was administered and red and warm to the touch for 5 days.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. Injection site was swollen right after it was administered and red and warm to the touch for 5 days.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. Injection site was swollen right after it was administered and red and warm to the touch for 5 days.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Ear infection, Ear pain
Clinical narrative: Symptoms started 1/1/21 Pm.   Headache, ear ache, chills, fever.     COVID and influenza swabbed 1/5/21 both negative.   Symptoms continued ear infection 1/6/21, nausea and chest pain.    1/7/21 vomiting and diarrhea started.   Going in for COVID swab this am.  And seeing a provider.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Influenza virus test negative, Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Symptoms started 1/1/21 Pm.   Headache, ear ache, chills, fever.     COVID and influenza swabbed 1/5/21 both negative.   Symptoms continued ear infection 1/6/21, nausea and chest pain.    1/7/21 vomiting and diarrhea started.   Going in for COVID swab this am.  And seeing a provider.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Symptoms started 1/1/21 Pm.   Headache, ear ache, chills, fever.     COVID and influenza swabbed 1/5/21 both negative.   Symptoms continued ear infection 1/6/21, nausea and chest pain.    1/7/21 vomiting and diarrhea started.   Going in for COVID swab this am.  And seeing a provider.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chest pain, Computerised tomogram, Decreased appetite, Diarrhoea
Clinical narrative: Symptoms started 1/1/21 Pm.   Headache, ear ache, chills, fever.     COVID and influenza swabbed 1/5/21 both negative.   Symptoms continued ear infection 1/6/21, nausea and chest pain.    1/7/21 vomiting and diarrhea started.   Going in for COVID swab this am.  And seeing a provider.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Fatigue, Gastrointestinal disorder, Headache, Myalgia
Clinical narrative: Symptoms started 1/1/21 Pm.   Headache, ear ache, chills, fever.     COVID and influenza swabbed 1/5/21 both negative.   Symptoms continued ear infection 1/6/21, nausea and chest pain.    1/7/21 vomiting and diarrhea started.   Going in for COVID swab this am.  And seeing a provider.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain, Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Symptoms started 1/1/21 Pm.   Headache, ear ache, chills, fever.     COVID and influenza swabbed 1/5/21 both negative.   Symptoms continued ear infection 1/6/21, nausea and chest pain.    1/7/21 vomiting and diarrhea started.   Going in for COVID swab this am.  And seeing a provider.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with AGENCY concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  Agencies were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Healthcare Resolution Specialist and AGENCY, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Migraine
Clinical narrative: Cold Flashes Migraine
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: On the 8th day after the vaccine I soreness in the R deltoid, arm felt warm and when I looked there was a large red area with some raised redness. My arm was also itching. Day 9 the area was larger, but had the same itching, warmth,  redness and raised area, also had some hives on top of upper R shoulder. Day 10 the area was slightly smaller, still itching and tender. Taking 25mg Benadryl twice daily for the itching. This is day 10 as I turn this in.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: On the 8th day after the vaccine I soreness in the R deltoid, arm felt warm and when I looked there was a large red area with some raised redness. My arm was also itching. Day 9 the area was larger, but had the same itching, warmth,  redness and raised area, also had some hives on top of upper R shoulder. Day 10 the area was slightly smaller, still itching and tender. Taking 25mg Benadryl twice daily for the itching. This is day 10 as I turn this in.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: 5 minutes after receiving the Moderna COVID vaccine, patient reported numbness/tingling on the inside of his mouth and tongue. No changes in vitals. Patient given Benadryl 50 mg once. 20 minutes later, patient reported no symptoms. Monitored for an additional hour, no symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: On day 9 developed redness, itching, swelling, hardness, heat & pain at injection site
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: On day 9 developed redness, itching, swelling, hardness, heat & pain at injection site
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cellulitis, Chills, Injection site erythema, Pain in extremity
Clinical narrative: Initially began with sore arm one day after vaccination (12/30),  The next Wednesday  (1/6), the vaccinated arm was sore, and later in the day developed small red areas near the vaccination area. The next morning the entire vaccination area was red, hot to the touch, swollen, and aching, and the redness had developed into an 11x7 cm area. The area continued to expand and later developed hives on chest, hips, legs in addition to joint pain (hips, left arm shoulder to wrist) and severe chills. Sought treatment and receive Keflex for cellulitis, since treatment the redness has improved but the area has continued to expand.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Vaccination site pain, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Initially began with sore arm one day after vaccination (12/30),  The next Wednesday  (1/6), the vaccinated arm was sore, and later in the day developed small red areas near the vaccination area. The next morning the entire vaccination area was red, hot to the touch, swollen, and aching, and the redness had developed into an 11x7 cm area. The area continued to expand and later developed hives on chest, hips, legs in addition to joint pain (hips, left arm shoulder to wrist) and severe chills. Sought treatment and receive Keflex for cellulitis, since treatment the redness has improved but the area has continued to expand.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cellulitis, Chills, Erythema, Pain
Clinical narrative: Initially began with sore arm one day after vaccination (12/30),  The next Wednesday  (1/6), the vaccinated arm was sore, and later in the day developed small red areas near the vaccination area. The next morning the entire vaccination area was red, hot to the touch, swollen, and aching, and the redness had developed into an 11x7 cm area. The area continued to expand and later developed hives on chest, hips, legs in addition to joint pain (hips, left arm shoulder to wrist) and severe chills. Sought treatment and receive Keflex for cellulitis, since treatment the redness has improved but the area has continued to expand.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Initially began with sore arm one day after vaccination (12/30),  The next Wednesday  (1/6), the vaccinated arm was sore, and later in the day developed small red areas near the vaccination area. The next morning the entire vaccination area was red, hot to the touch, swollen, and aching, and the redness had developed into an 11x7 cm area. The area continued to expand and later developed hives on chest, hips, legs in addition to joint pain (hips, left arm shoulder to wrist) and severe chills. Sought treatment and receive Keflex for cellulitis, since treatment the redness has improved but the area has continued to expand.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: a. Injection site tenderness which has improved in less than 24 hrs. b. chills, unquantified fever onset approximately 12 hrs after vaccine administration which improved with acetaminophen 1000mg once. Following morning, chills reappeared and improved with acetaminophen 1000mg once.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Feeling of despair, Flushing
Clinical narrative: sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness that occurred within 3 minutes of injection, no tachycardia, hypertension noted, no wheezing, lungs clear, no SOB, treated with Benadryl and Pepcid with close observation for 30 minutes
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: DAY 8 AFTER INJECTION- ITCHY, RED, SMALL WELT AT INJECTION SITE DAY 9-INCREASED SIZE OF REDNESS, WARM TO TOUCH, TENDER DAY 10- INCREASED AREA OF REDNESS, HOT TO TOUCH, MORE TENDER
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: DAY 8 AFTER INJECTION- ITCHY, RED, SMALL WELT AT INJECTION SITE DAY 9-INCREASED SIZE OF REDNESS, WARM TO TOUCH, TENDER DAY 10- INCREASED AREA OF REDNESS, HOT TO TOUCH, MORE TENDER
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysarthria, Headache, Hypoaesthesia oral, Lip swelling
Clinical narrative: Pt experiencing and c/o left nasal burning, left upper lip tingling progressing to numbness with slight swelling noted, scattered patchy hives to upper front chest, sharp HA above right eye, denies SOB, no acute respiratory distress noted or reported, slurring of words shortly after onset of other symptoms. Pt repeating "something ain't right". Pt received Moderna COVID vaccine at 4:35pm with no reactions or side effect noted within the post 15 and 30 minutes. EMS notified at 5:49pm. MD notifed and ordered Benadryl 50mg IM (given at 5:53pm), EpiPen and DepoMedrol 40mg IM if needed. No respiratory distess noted, pt denies SOB. EMS arrived and transported pt to ER.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nasal discomfort, Paraesthesia oral, Repetitive speech, Urticaria
Clinical narrative: Pt experiencing and c/o left nasal burning, left upper lip tingling progressing to numbness with slight swelling noted, scattered patchy hives to upper front chest, sharp HA above right eye, denies SOB, no acute respiratory distress noted or reported, slurring of words shortly after onset of other symptoms. Pt repeating "something ain't right". Pt received Moderna COVID vaccine at 4:35pm with no reactions or side effect noted within the post 15 and 30 minutes. EMS notified at 5:49pm. MD notifed and ordered Benadryl 50mg IM (given at 5:53pm), EpiPen and DepoMedrol 40mg IM if needed. No respiratory distess noted, pt denies SOB. EMS arrived and transported pt to ER.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Moderna vaccine.  Localized swelling, erythema, pruritus at injection site with pain and tenderness.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Allen's test, Base excess decreased, Blood bicarbonate normal, Blood pH normal, COVID-19 pneumonia
Clinical narrative: Developed SOB  and fatigue 1 day after vaccine, went to urgent care and tested positive for COVID at urgent care.  Returned to our ED after going to urgent care again on 1/7/21, had o2 sat of 84% on room air, impoved to 98 on 3 liters. Was transferred to another facility for admission.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Fatigue, Lung infiltration, PCO2 decreased
Clinical narrative: Developed SOB  and fatigue 1 day after vaccine, went to urgent care and tested positive for COVID at urgent care.  Returned to our ED after going to urgent care again on 1/7/21, had o2 sat of 84% on room air, impoved to 98 on 3 liters. Was transferred to another facility for admission.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: PO2 normal, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Developed SOB  and fatigue 1 day after vaccine, went to urgent care and tested positive for COVID at urgent care.  Returned to our ED after going to urgent care again on 1/7/21, had o2 sat of 84% on room air, impoved to 98 on 3 liters. Was transferred to another facility for admission.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait inability, Migraine, Nausea
Clinical narrative: VERY sore joint (couldn?t walk using my knees).  Very exhausted, migraine headache and slight nausea.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oral herpes, Pain, Pyrexia
Clinical narrative: At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep  around 530 am  started running a fever of 100.3 and had a severe headache and body aches. Fever went down with tylenol,  but had headache all day.  Fever did come back later in the day resolved with Tylenol. Next day fine  but did have cold sores inside mouth .  Head ache on 1/8 no fever or anything.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep  around 530 am  started running a fever of 100.3 and had a severe headache and body aches. Fever went down with tylenol,  but had headache all day.  Fever did come back later in the day resolved with Tylenol. Next day fine  but did have cold sores inside mouth .  Head ache on 1/8 no fever or anything.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Diarrhoea, SARS-CoV-2 test, Vomiting
Clinical narrative: Patient received his first Covid vaccine on 1/7/2021 at 12:00p. At 0000 on 1/8/2021 he started having vomiting, diarrhea, and chills. Pt had ambulance take him to ED. Pt given fluids and nausea medications and discharged home at 8:30a the same day. Pt discharged with nausea meds as well as pain meds. Covid test was collected at time of discharge.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness and swelling at the site of injection. The swelling was gradual and reached the size of a golf ball. It was also warm and painful to touch. The pain has receded, but there is redness and it appears the swelling has just spread out over the arm, instead of out like a golf ball.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site reaction, Muscle spasms, Nausea, Pain
Clinical narrative: 5-6 hours after vaccination, started having cramps at injection site. Vaccine given around 7:45am. Overnight, so 16-24 hours later spiking fevers to 103, severe body aches, headaches, nausea, and vomiting. Currently 26 hours out from vaccine and still having all symptoms.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: 5-6 hours after vaccination, started having cramps at injection site. Vaccine given around 7:45am. Overnight, so 16-24 hours later spiking fevers to 103, severe body aches, headaches, nausea, and vomiting. Currently 26 hours out from vaccine and still having all symptoms.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Eye swelling, Injection site nodule, Peripheral swelling
Clinical narrative: The evening of receiving the vaccine she experienced itching eyes.  The next morning her rt eye was swollen and she had red spots on face and forehead.   Her arm was swollen and she experienced a knot at the injection site.