chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered more than 42 days post first shot; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 42 days post first shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 42 days post first shot). On 18-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 42 days post first shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided. This is a case of Inappropriate Schedule of Vaccination concerning a 65-year-old female patient, with no relevant medical history, who experienced no other adverse events. The event occurred the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-377773 (Patient Link).; Sender's Comments: This is a case of Inappropriate Schedule of Vaccination concerning a 65-year-old female patient, with no relevant medical history, who experienced no other adverse events. The event occurred the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: 35 patients exposed to vaccine from which vial may have been punctured more than 20 times; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 22, 2021, patient administered expired product (doses administered past the published expiry date). On Oct 22, 2021, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt rcvd adult dose of Covid-19 Pfizer vaccine.  Unable to reach parent x 2 days.  Left voicemail x2.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Chills, Computerised tomogram head, Electrocardiogram, Fatigue
Clinical narrative: Hot flashes, headache, fatigue chills, skin tingling, internal tingling throughout body, left arm/leg/mouth numbness, tingling, new onset anxiety, panic attacks.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hot flush, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging spinal
Clinical narrative: Hot flashes, headache, fatigue chills, skin tingling, internal tingling throughout body, left arm/leg/mouth numbness, tingling, new onset anxiety, panic attacks.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Panic attack, Paraesthesia, Paraesthesia oral
Clinical narrative: Hot flashes, headache, fatigue chills, skin tingling, internal tingling throughout body, left arm/leg/mouth numbness, tingling, new onset anxiety, panic attacks.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Pruritus
Clinical narrative: Patient reported itchy arm and cotton-like mouth.  Patient was give 10ml of children's benadryl.  After 10 minutes she felt a tiny bit better.  Another 10ml of children's benadryl was admnister.  After waiting another 20 minutes, the patient reported feeling much better.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided. It was reported that vaccine was removed from freezer at 8 am on 25-OCT-2021.
Age: 33.0
Sex: M
Vaccine: UNK
Symptoms: Chest X-ray, Fatigue, Full blood count, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Fatigue
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Meningitis bacterial
Clinical narrative: The day after patient received the vaccine, she had severe headache. She was sent to ER on 11/07/2021 .Culture was drawn and she was discharged home. On 11/09/2021, hospital notified patient that she had bacterial meningitis.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Red, swollen, hot patch on arm
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Inflammation, Pain
Clinical narrative: Severe inflammation, upset stomach, severe body pains and weakness.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Fatigue, Insulin resistance, Limb discomfort
Clinical narrative: Thurs, Nov 4 2:45pm first vaccine dose. Only minor arm discomfort for Thursday and Friday. Some fatigue on Saturday and Sunday. By Monday afternoon, November 8 she started having unexplained high blood sugar reading (via cgm). This continues for three full days so far and caused her to miss one day of online school. It is if there is massive insulin resistance -- that we giver her insulin to cover meals but the insulin does not act how it normally does (we switched pods and insulin bottles to ensure it was not an equipment issue). She is 10 and has some puberty hormonal bg swings but we have not seen anything like this. The insulin, though supposed to start to take effect in 15 minutes is taking many hours. By then we have over corrected and then she crashes low. In comparison to previous weeks, she is far above her average time in range, average bg number and standard deviation with 176bg, 51% in range , 10% very high and 60 SD.  The week before in comparison was 150bg, 65% in rance, 1% very high and 42SD. These numbers do not show the immense fear and exhaustion that this has caused. We just want people to be aware that for Type 1 kids there may be a delayed amount of bg highs and lows due to increased insulin resistance. As T1D parents we always expect bg swings with any medicine or vaccine but this has been very different and social media searches indicate this is happening to others though overlooked and underreported as this is considered a 'normal' response. But the severity needs to be noted. My kiddo should never be 400+ after eating anything if she has insulin on board. It is very scary and just want someone to know. We hope this wears off soon. Thank you.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PATIENT IS IMMUNOCOMPROMISED . SHE  WAS ADMINISTERED    DOSE # 3  OF MODERNA VACCINE 0.25ML INSTEAD OF 0.5ML ON 11-11-21
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: shooting pain to elbow about 4 days after administration. Feels most of the pain in the elbow region and when extending the left arm the pain is more severe.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Rash
Clinical narrative: Exanthematous rash around site of injection that was noticed 2 days after administration of the third dose of Moderna. No rash was noticed after the first two doses of Moderna.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Streptococcus test negative
Clinical narrative: Sore Throat and Fatigue.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reported swollen eyes, warm, redness, and very itchy at injection site. The redness spread to above elbow area. Redness and swelling decreased over the course of 5 days.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.    No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Removed from freezer 8 am, 25-OCT-2021
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; fever (102.5ºF); shivers. Subsided around 5 pm that evening.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Red blood cell sedimentation rate increased, Urticaria, White blood cell count increased
Clinical narrative: urticarial rash and polyarthralgias 11 days after vaccination
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Injection site pain, Pain
Clinical narrative: Around 5pm I noticed some slight body aches, joint pain, and soreness/tenderness at the injection site.  Around 6pm I started to feel fatigued. Around 9pm, I started having diarrhea.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Hyperhidrosis
Clinical narrative: heavy chest pain ,increase sweating, dizzy , felt like fainted
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: Rapid beating of heart, felt like an anxiety attack, woke up with slight shortness of breath around 12:45am in bed. I had mild and very infrequent chest pain earlier in week but attributed  it to possibly from soreness from exercise, but cannot be certain. I have had anxiety attacks in past but not within last month. The timing of this incidence was just within 96 hours of receiving moderna booster vaccine.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pain
Clinical narrative: Terrible chills. Pain on average
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Dry throat, Erythema, Pruritus, Throat irritation
Clinical narrative: Patient received a flu shot at 9am.  At roughly 10:30am, patient reported being itchy on her wrists and chest.  I administered 50mg of diphenhydramine IM in the right deltoid at roughly 10:40am due to patient stating the reaction was getting worse.  At about 10:55am, she stated she was going to go to the hospital due to increased redness and itching on her chest.  At that point, she said her throat was dry and scratchy.  She was talking normally and I did not observe any signs of anaphylaxis so I did not administer any epinephrine.  I offered to sit with her to observe symptoms but she still wanted to drive to the hospital.  I told her she couldn't drive but I did offer to call 911 if she thought that was necessary.  Patient did want 911 called.  The fire department arrived about 3-4 minutes later, they interviewed the patient, looked at her throat and did not visually observe any signs of anaphylaxis.  The ambulance then arrived and the patient stopped talking to the fire department and went over to them.  They put her in the back and were going to administer a dose of diphenhydramine but I spoke up to let them know she had already received 50mg.  They thanked me for the information and then shut the back of the vehicle and proceeded to transport her to the hospital.  Outcome after patient arrived at hospital is unknown at this time.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Itchy red bumps (about 8 or 9) that develop a head and break open. Breast and chest area.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: Uncontrollable head jerking started this evening a few hours after he got the vaccine
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Nasal discomfort, Nasal dryness, Paraesthesia
Clinical narrative: After about 3 days I started having a bad Headache, tingling in my body and cold patches in mybody. My noise was also dry and irritated.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: THERE WAS NO ADVERSE EVENT-THE CLIENT WAS DOSED WITH A PEDIATRIC PFIZER DOSE RATHER THAN THE FULL DOSE A 12 YEAR OLD SHOULD HAVE BEEN GIVEN.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: After receiving the booster vaccine, I have had a constant feeling of chest tightness and shortness of breath. It has not affected my ability to complete my daily activities, but I do have a constant feeling as though my chest is heavy.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Apathy, Asthenia, Coordination abnormal, Pain, Temporomandibular joint syndrome
Clinical narrative: TMJ disorder lasting about 6 weeks, couldn?t open my mouth for two days.  Throbbing painful tooth that had a crown put on lasting about 4 weeks.  Diminished hand/eye coordination (duration unknown).  Inability to process information after reading (duration unknown)  Bilateral tinnitus (ongoing since second dose)  Diminished motivation and decrease in physical strength (ongoing)
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thinking abnormal, Tinnitus, Toothache, X-ray normal
Clinical narrative: TMJ disorder lasting about 6 weeks, couldn?t open my mouth for two days.  Throbbing painful tooth that had a crown put on lasting about 4 weeks.  Diminished hand/eye coordination (duration unknown).  Inability to process information after reading (duration unknown)  Bilateral tinnitus (ongoing since second dose)  Diminished motivation and decrease in physical strength (ongoing)
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Immediate post-injection reaction, Pallor, Vomiting
Clinical narrative: Patient immediately went pale, felt dizzy and vomited multiple times. After sitting for 10 minutes and having a drink she felt significantly better but was still off balance for over 30 minutes after.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, at 8:00 am, patient administered expired product (doses administered past the published expiry date). On Oct 26, 2021, at 8:00 am, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient administered expired product (doses administered past the published expiry date). On Oct 26, 2021, administered expired product (doses administered past the published expiry date) resolved.  The reporter did not provide any causality assessments, concomitant medication or treatment information. Vaccine taken from freezer on Oct 26, 2021 at 8:00 am.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment  medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19  immunization. No medical history reported. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient administered expired product (doses administered past the published expiry date). On Oct 26, 2021, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. It was stated the vial was removed from freezer at 8 am, Oct 26, 2021. This case linked to MOD-2021-364617 (patient link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   it was reported that vaccine was removed from freezer at 8 am on 26-OCT-2021  No concomitant medication details was provided. No treatment medication details was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date/ Removed from freezer at 8am, on 25-10-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date/ Removed from freezer at 8am, on 25-10-2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date/ Removed from freezer at 8am, on 25-10-2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date/ Removed from freezer at 8am, on 25-10-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. Vaccine was removed from the freezer on 25-Oct-2021 at 08am.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). At the time of the report, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Coronary artery disease (CAD with stent), Hypertension (HTN), Polymyalgia rheumatica, Gout, GERD, Irritable bowel syndrome (IBS) and Blood cholesterol abnormal (Cholesterol). Concomitant products included ATORVASTATIN for Cholesterol, CLOPIDOGREL for Coronary artery disease, METFORMIN HYDROCHLORIDE (METFORMIN ER) and EMPAGLIFLOZIN (JARDIANCE) for Diabetes, PANTOPRAZOLE for GERD, LOSARTAN and HYDROCHLOROTHIAZIDE for Hypertension, CHOLESTYRAMINE and NORTRIPTYLINE for IBD, METOPROLOL for an unknown indication.    On 14-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021 at 9:00 AM, the patient experienced DIZZINESS (Dizzy). On 17-Feb-2021, DIZZINESS (Dizzy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided   This case was linked to MOD-2021-370410, MOD-2021-376997 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Significant Follow up received: Added additional reporter, HCP details,patient demographic details , medical history, concomitants, events information and narrative was updated accordingly. On 08-Nov-2021: Non significant follow up received on 08 NOV 2021
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant drugs were reported. no treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment details provided. No concomitant medications provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were provided.  No treatment medication was provided.  Nurse was providing information for 35 patients. A vial at their clinic was punctured 30 times. 10 patients were affected. Given the process in place at the vaccination clinic  and stated that it is not possible to identify the 10 patients who received the compromised vaccine. In addition to the information described above the Nurse Practitioner reports that 35 patients potentially were involved. The Nurse is calling with the names of the first 35 patients involved. All doses given are booster doses.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was reported by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021 at 8:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021 at 8:00 AM, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant drugs were reported. no treatment drugs were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided. REMOVED FROM FREEZER 8 AM, 10/15/21
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  Vial was removed from refrigerator on 15-Oct-2021, 08:00.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was provided. A vial was punctured 30 times at the clinic. 10 patients who were administered the vaccine were affected. No treatment medication details was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patients exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  A vial was punctured 30 times at the clinic. 10 patients who were administered the vaccine were affected.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  On 18-Oct-2021, the vial was removed from freezer at 8 AM.   This case was linked to MOD-2021-364617 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vaccine was removed from freezer on 18-Oct-2021 at 8am. No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vaccine was removed from freezer on 21-OCT-2021 at 8 am. No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.