chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction
Clinical narrative: Covid Arm; arm was red/red area the size of a 3 by 5 card appeared in the area of the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE REACTION (Covid Arm) and VACCINATION SITE ERYTHEMA (arm was red/red area the size of a 3 by 5 card appeared in the area of the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm) and VACCINATION SITE ERYTHEMA (arm was red/red area the size of a 3 by 5 card appeared in the area of the injection site). At the time of the report, VACCINATION SITE REACTION (Covid Arm) and VACCINATION SITE ERYTHEMA (arm was red/red area the size of a 3 by 5 card appeared in the area of the injection site) outcome was unknown.            No concomitant medication was reported. Reporter did not remember which arm that the patient received Modern vaccine.  No treatment medication was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Body temperature, Delusion, Pyrexia
Clinical narrative: became agitated; delusional; patient got a temperature of 102 degrees Farenheight/fever did return the next morning.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AGITATION (became agitated), DELUSION (delusional) and PYREXIA (patient got a temperature of 102 degrees Farenheight/fever did return the next morning.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 001A21A and 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced AGITATION (became agitated), DELUSION (delusional) and PYREXIA (patient got a temperature of 102 degrees Farenheight/fever did return the next morning.). At the time of the report, AGITATION (became agitated), DELUSION (delusional) and PYREXIA (patient got a temperature of 102 degrees Farenheight/fever did return the next morning.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, Body temperature: 102 102 degrees Fahrenheit.         No Concomitant medication were reported.  The patient thought that he had to go somewhere wearing a suit and started putting a suit on. The patient went to the hospital and was given anti inflammatories. The patient's fever was brought under control and he was sent home with advice from the emergency room physician that the fever might return the next morning. The fever did return the next morning.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Follow up contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05; This spontaneous case was reported by a non-health professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05). At the time of the report, INCORRECT DOSE ADMINISTERED (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05) outcome was unknown.            No concomitant medications were provided by the reporter.  Patient got booster dose.  No treatment information was provided.   This case was linked to MOD-2022-607602 (Patient Link).
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Incorrect dose administered, Product preparation error
Clinical narrative: 2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna.; Vaccine with 0.2 mL dose was administered to a 2 years child; Vaccine with 0.2 mL dose was administered to 1 child that was 2 years; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Vaccine with 0.2 mL dose was administered to 1 child that was 2 years), PRODUCT PREPARATION ERROR (2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna.) and ACCIDENTAL UNDERDOSE (Vaccine with 0.2 mL dose was administered to a 2 years child) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2022 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .2 milliliter. On 08-Jul-2022 at 8:00 AM, the patient experienced INCORRECT DOSE ADMINISTERED (Vaccine with 0.2 mL dose was administered to 1 child that was 2 years) and ACCIDENTAL UNDERDOSE (Vaccine with 0.2 mL dose was administered to a 2 years child). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna.). At the time of the report, INCORRECT DOSE ADMINISTERED (Vaccine with 0.2 mL dose was administered to 1 child that was 2 years), PRODUCT PREPARATION ERROR (2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna.) and ACCIDENTAL UNDERDOSE (Vaccine with 0.2 mL dose was administered to a 2 years child) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient race was reported. Patient was not diagnosed or tested positive with Covid-19.  Concomitant medications details were not reported by the reporter.  The vaccine was administered after being diluted by the Pfizer COVID-19 vaccine diluent, 2.2 mL of 0.9 percent sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna.   No adverse reaction reported at the time of the report.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-610051 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE.     The patient's past medical history included SARS-CoV-2 infection. Concurrent medical conditions included Penicillin allergy.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE in 2021 at an unspecified dose and frequency. In 2021, ANAPHYLACTIC REACTION (Anaphylaxis) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be related.    Concomitant medication not provided.  Patient had swelling of tongue, flushing, tightness of the arm, poor range of motion in her head after taking vaccine which was assesses as anaphylaxis by National Institute of Allergy and Infectious Diseases /Food Allergy and Anaphylaxis Network criteria.  Company comment: This literature non-study case concerns a 30-year-old female patient, with history of penicillin allergy, who experienced the serious (medically significant) expected event of anaphylactic reaction that occurred 15 minutes after receiving the first dose of mRNA-1273 vaccine. Patient experienced swelling of tongue, flushing, tightness of the arm and poor motion in her head. She was treated with epinephrine and the event resolved within 20 minutes. Patient's history of drug allergy (penicillin) could be considered a risk factor for developing anaphylactic reaction. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-610053 (E2B Linked Report).; Sender's Comments: This literature non-study case concerns a 30-year-old female patient, with history of penicillin allergy, who experienced the serious (medically significant) expected event of anaphylactic reaction that occurred 15 minutes after receiving the first dose of mRNA-1273 vaccine. Patient experienced swelling of tongue, flushing, tightness of the arm and poor motion in her head. She was treated with epinephrine and the event resolved within 20 minutes. Patient's history of drug allergy (penicillin) could be considered a risk factor for developing anaphylactic reaction. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-610053:38 year female
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was administered on 08-Jul-22 and Second dose was administered on 13-Jul-22; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 08-Jul-22 and Second dose was administered on 13-Jul-22) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Jul-2022 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .2 milliliter. On 13-Jul-2022 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 08-Jul-22 and Second dose was administered on 13-Jul-22). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 08-Jul-22 and Second dose was administered on 13-Jul-22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was not diagnosed or tested positive with Covid-19. No concomitant medications were reported. No treatment medications were reported. No adverse event were at that time.   This case was linked to MOD-2022-609975 (Patient Link).
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 6 month to 5 year old vial used to be given to an 8 year old/0.25 dose was given; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (6 month to 5 year old vial used to be given to an 8 year old/0.25 dose was given) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (6 month to 5 year old vial used to be given to an 8 year old/0.25 dose was given). At the time of the report, INCORRECT DOSE ADMINISTERED (6 month to 5 year old vial used to be given to an 8 year old/0.25 dose was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Chills, Contusion, Feeling hot
Clinical narrative: Armpit was warm to the touch; Armpit and top of arm hurts and bruised; Bruising underneath left arm and outside of the breast; Hurts to lift left arm; Slept all day; Did not feel well; Whole left arm, underneath the arm and pain in arm and soreness; Severe, severe, chills; Breast hurt to touch; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Armpit was warm to the touch), BREAST PAIN (Breast hurt to touch), MALAISE (Did not feel well), CONTUSION (Bruising underneath left arm and outside of the breast) and MOBILITY DECREASED (Hurts to lift left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 045J21A, 044B21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Anxiety. Concomitant products included FLUOXETINE for Anxiety, LOSARTAN for Hypertension, CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for Routine health maintenance.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 16-Jul-2022 at 9:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 16-Jul-2022, the patient experienced BREAST PAIN (Breast hurt to touch) and PAIN IN EXTREMITY (Whole left arm, underneath the arm and pain in arm and soreness). 16-Jul-2022, the patient experienced CHILLS (Severe, severe, chills). On 17-Jul-2022, the patient experienced MALAISE (Did not feel well) and SOMNOLENCE (Slept all day). On 18-Jul-2022, the patient experienced CONTUSION (Bruising underneath left arm and outside of the breast) and MOBILITY DECREASED (Hurts to lift left arm). On 19-Jul-2022, the patient experienced FEELING HOT (Armpit was warm to the touch) and AXILLARY PAIN (Armpit and top of arm hurts and bruised). On 17-Jul-2022, SOMNOLENCE (Slept all day) had resolved. At the time of the report, FEELING HOT (Armpit was warm to the touch), BREAST PAIN (Breast hurt to touch), MALAISE (Did not feel well), CONTUSION (Bruising underneath left arm and outside of the breast), MOBILITY DECREASED (Hurts to lift left arm), AXILLARY PAIN (Armpit and top of arm hurts and bruised), PAIN IN EXTREMITY (Whole left arm, underneath the arm and pain in arm and soreness) and CHILLS (Severe, severe, chills) had not resolved.            Patient had no known allergy. It was reported that patient has never been diagnosed or tested positive for COVID-19.   Patient was taking women's vitamin as concomitant product.  Patient received the second Moderna booster dose on16-Jul-2022.  Reaction did not cause patient to take medical care. Symptoms had not improved or worsened.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Pain in extremity, Somnolence
Clinical narrative: Armpit was warm to the touch; Armpit and top of arm hurts and bruised; Bruising underneath left arm and outside of the breast; Hurts to lift left arm; Slept all day; Did not feel well; Whole left arm, underneath the arm and pain in arm and soreness; Severe, severe, chills; Breast hurt to touch; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Armpit was warm to the touch), BREAST PAIN (Breast hurt to touch), MALAISE (Did not feel well), CONTUSION (Bruising underneath left arm and outside of the breast) and MOBILITY DECREASED (Hurts to lift left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 045J21A, 044B21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Anxiety. Concomitant products included FLUOXETINE for Anxiety, LOSARTAN for Hypertension, CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for Routine health maintenance.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 16-Jul-2022 at 9:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 16-Jul-2022, the patient experienced BREAST PAIN (Breast hurt to touch) and PAIN IN EXTREMITY (Whole left arm, underneath the arm and pain in arm and soreness). 16-Jul-2022, the patient experienced CHILLS (Severe, severe, chills). On 17-Jul-2022, the patient experienced MALAISE (Did not feel well) and SOMNOLENCE (Slept all day). On 18-Jul-2022, the patient experienced CONTUSION (Bruising underneath left arm and outside of the breast) and MOBILITY DECREASED (Hurts to lift left arm). On 19-Jul-2022, the patient experienced FEELING HOT (Armpit was warm to the touch) and AXILLARY PAIN (Armpit and top of arm hurts and bruised). On 17-Jul-2022, SOMNOLENCE (Slept all day) had resolved. At the time of the report, FEELING HOT (Armpit was warm to the touch), BREAST PAIN (Breast hurt to touch), MALAISE (Did not feel well), CONTUSION (Bruising underneath left arm and outside of the breast), MOBILITY DECREASED (Hurts to lift left arm), AXILLARY PAIN (Armpit and top of arm hurts and bruised), PAIN IN EXTREMITY (Whole left arm, underneath the arm and pain in arm and soreness) and CHILLS (Severe, severe, chills) had not resolved.            Patient had no known allergy. It was reported that patient has never been diagnosed or tested positive for COVID-19.   Patient was taking women's vitamin as concomitant product.  Patient received the second Moderna booster dose on16-Jul-2022.  Reaction did not cause patient to take medical care. Symptoms had not improved or worsened.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Got the shot it turned into a sore & and it won't heal.; That area is tender and the sore is about the size of a pea; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Got the shot it turned into a sore & and it won't heal.) and VACCINATION SITE PAIN (That area is tender and the sore is about the size of a pea) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Got the shot it turned into a sore & and it won't heal.) and VACCINATION SITE PAIN (That area is tender and the sore is about the size of a pea). At the time of the report, VACCINATION SITE PAIN (Got the shot it turned into a sore & and it won't heal.) and VACCINATION SITE PAIN (That area is tender and the sore is about the size of a pea) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. Got the vaccine this past winter in February or March. Where Patient got the shot it turned into a sore and it was not healed. Patient went to doctor, and it gave a salve which had not helped. That area was tender, and the sore was about the size of a pea. patient talked to the doctor, and now planning on seeing a dermatologist next.   Reporter did not allow further contact
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Product administration interrupted
Clinical narrative: Time lapse after initial dose Moderna; had health complication/had a flare up; This spontaneous case was reported by an other health care professional and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (had health complication/had a flare up) and PRODUCT ADMINISTRATION INTERRUPTED (Time lapse after initial dose Moderna) in a 23-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products.  The patient's past medical history included COVID-19 on 18-Nov-2021.    On 01-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In April 2022, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (had health complication/had a flare up). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Time lapse after initial dose Moderna). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (had health complication/had a flare up) was resolving and PRODUCT ADMINISTRATION INTERRUPTED (Time lapse after initial dose Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Symptom was reported as improved.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2022: Live significant follow-up received and included reporter's phone number, patient demographics updated and vaccination date updated and newevent general physical health deterioration added.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Expired vaccine dose administered to 1 patient/It was a booster dose/Gave a patient booster dose of covid vaccine from a vial that was punctured for 24 hours/Dose administered greater than 12 hours post puncture; Patient received 2nd booster dose as 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/It was a booster dose/Gave a patient booster dose of covid vaccine from a vial that was punctured for 24 hours/Dose administered greater than 12 hours post puncture) and ACCIDENTAL OVERDOSE (Patient received 2nd booster dose as 0.5ml) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 032F21A, 026A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Levofloxacin).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/It was a booster dose/Gave a patient booster dose of covid vaccine from a vial that was punctured for 24 hours/Dose administered greater than 12 hours post puncture) and ACCIDENTAL OVERDOSE (Patient received 2nd booster dose as 0.5ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/It was a booster dose/Gave a patient booster dose of covid vaccine from a vial that was punctured for 24 hours/Dose administered greater than 12 hours post puncture) and ACCIDENTAL OVERDOSE (Patient received 2nd booster dose as 0.5ml) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was reported that number of doses or vials was 1. The vial was initially stored in the refrigerator on 30-Jun-2022. The vial was first punctured on 13-Jul-2022 at 8am. Vaccine was administrated on 14-Jul-2022 earlier than noon. The vial was stored post puncture in room temperature. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was around 24 hours.The vial was not exposed to room temperature for more than 24 hours.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt like it knocked her out; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt like it knocked her out) in a 36-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced FEELING ABNORMAL (felt like it knocked her out). At the time of the report, FEELING ABNORMAL (felt like it knocked her out) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2022: The recent significant live follow up contains concomitant medication added.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range), PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 049l21a and 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-May-2022 at 10:30 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022 at 11:56 AM, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022 at 11:56 AM,  after starting mRNA-1273 (Spikevax), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range), PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. Patient received 2 full doses. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The patient reports his left injection site arm feeling sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The patient reports his left injection site arm feeling sore) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 prophylaxis.     Concomitant products included DULOXETINE and GABAPENTIN for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced VACCINATION SITE PAIN (The patient reports his left injection site arm feeling sore). At the time of the report, VACCINATION SITE PAIN (The patient reports his left injection site arm feeling sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was provided by reporter.   This case was linked to MOD-2022-610135 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Oral lichen planus
Clinical narrative: had oral lichen planus; This spontaneous case was reported by a patient and describes the occurrence of ORAL LICHEN PLANUS (had oral lichen planus) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 36C21A and 016C21A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis. No medical history related to mentioned AE and both acute and chronic illnesses at the time of vaccination. There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergic reaction to bee sting. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE BESILATE (NORVASC), PRAVASTATIN SODIUM (PRAVACHOL) and METOPROLOL SUCCINATE (TOPROL XL) for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced ORAL LICHEN PLANUS (had oral lichen planus). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, ORAL LICHEN PLANUS (had oral lichen planus) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had biopsy on 19-May-2022 and he did not know if it was related or not to the vaccine. The AE did not cause patient to seek medical care. The patient did not experienced a similar event in the past. Reported that symptoms were improved.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Abnormal (atypical)  trigeminal neuralgia; This spontaneous case was reported by a patient and describes the occurrence of TRIGEMINAL NEURALGIA (Abnormal (atypical)  trigeminal neuralgia) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A2AB, 033F21A, 24M20A and 027L20A) for COVID-19 prophylaxis.     Patient had no relevant past medical history and No allergies. Patient had never diagnosed with positive covid test or Covid 19.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced TRIGEMINAL NEURALGIA (Abnormal (atypical)  trigeminal neuralgia). The patient was treated with OXCARBAZEPINE (TRILEPTAL) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, TRIGEMINAL NEURALGIA (Abnormal (atypical)  trigeminal neuralgia) outcome was unknown.            It was reported that patient had received 2 primary series doses and 2 booster doses of Moderna vaccine all in recommended time frame.  The patient stated that he had an adverse impact (event) related to the 2nd booster dose and wanted to report that he had abnormal (atypical) trigeminal neuralgia.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We had a dose of Moderna Covid-19 that was given after it expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a dose of Moderna Covid-19 that was given after it expired) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a dose of Moderna Covid-19 that was given after it expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a dose of Moderna Covid-19 that was given after it expired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. It was reported that vial was initially stored in the refrigerator on 27 Jun 2022 and vial did not undergo any temperature excursions. It was unknown whether patient had Allergies and ever had COVID positive test or diagnosis. It was unknown whether patient was given other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was unknown AE cause patient to seek medical care. It was unknown whether the patient experienced a similar event in the past. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: possible doses administered after expiration date of Moderna vial; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible doses administered after expiration date of Moderna vial) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible doses administered after expiration date of Moderna vial). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible doses administered after expiration date of Moderna vial) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Off label use, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: sleeping more than usual; arm pain; fever; A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose; A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (sleeping more than usual), PAIN IN EXTREMITY (arm pain), PYREXIA (fever), ACCIDENTAL OVERDOSE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose) and OFF LABEL USE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose) in a 19-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Jul-2022, the patient experienced SOMNOLENCE (sleeping more than usual), PAIN IN EXTREMITY (arm pain), PYREXIA (fever), ACCIDENTAL OVERDOSE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose) and OFF LABEL USE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Fever, at an unspecified dose and frequency; IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleeping more than usual), PAIN IN EXTREMITY (arm pain), PYREXIA (fever), ACCIDENTAL OVERDOSE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose) and OFF LABEL USE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that this vaccine is not authorized for this population, but it was approved for use in people 12 years of age and older.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Immunisation reaction
Clinical narrative: Patient said he had no energy to do anything; Patient said that he was beat and tired; started having severe after effects on him last night; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (started having severe after effects on him last night), ASTHENIA (Patient said he had no energy to do anything) and FATIGUE (Patient said that he was beat and tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064A22A, 939904, 023C21A and 016C21A) for COVID-19 prophylaxis.     Patient had No allergies, and no other medical history was reported. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as No.  The patient's past medical history included COVID-19 (Positive Covid test) in January 2021. Concomitant products included ATORVASTATIN CALCIUM (AVASTATIN), METOPROLOL SUCCINATE, OXYBUTYNIN CHLORIDE, MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HCL), AMLODIPINE BESYLATE, WARFARIN and GABAPENTIN for an unknown indication.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, the patient experienced IMMUNISATION REACTION (started having severe after effects on him last night). On 19-Jul-2022, the patient experienced ASTHENIA (Patient said he had no energy to do anything) and FATIGUE (Patient said that he was beat and tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (started having severe after effects on him last night) outcome was unknown and ASTHENIA (Patient said he had no energy to do anything) and FATIGUE (Patient said that he was beat and tired) had not resolved.            Patient concomitant medication was reported as Revamptin for an unknown indication.  It was reported that patient had received his 2nd booster dose of the Moderna COVID-19 vaccine and on 18-Jul-2022, patient started having severe aftereffects on him during the night. Today, on 19-Jul-2022, he is beat and tired. He says that he has no energy to do anything.   Patient did not went to ER and was not hospitalized due to the events Beat and Tired/no energy and patient symptoms (Beat and Tired/no energy )were worsened.   This case was linked to MOD-2021-090388, MOD-2021-163737 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was placed in the refrigerator on 16-Jun-2022 with a use by date of 17-Jul-2022 and was administered on 19-Jul-2022; Moderna dose administered to patient after use by date of 17-Jul-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after use by date of 17-Jul-2022) and PRODUCT STORAGE ERROR (Vial was placed in the refrigerator on 16-Jun-2022 with a use by date of 17-Jul-2022 and was administered on 19-Jul-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after use by date of 17-Jul-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was placed in the refrigerator on 16-Jun-2022 with a use by date of 17-Jul-2022 and was administered on 19-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after use by date of 17-Jul-2022) and PRODUCT STORAGE ERROR (Vial was placed in the refrigerator on 16-Jun-2022 with a use by date of 17-Jul-2022 and was administered on 19-Jul-2022) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The vial did not undergo any temperature excursions.  No treatment medication information provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: received doses from vials affected by a temperature excursion; received doses from vials affected by a temperature excursion; received doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received doses from vials affected by a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (received doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 049l21a and 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-May-2022 at 10:41 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022 at 12:02 PM, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022 at 12:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received doses from vials affected by a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (received doses from vials affected by a temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (received doses from vials affected by a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (received doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient had received full dose for both doses. Patient received doses from 1st and 6th vials. It was reported that 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range.  It was reported that no adverse event occurred at time of administration or were reported thereafter.  Treatment medication was not provided by the reporter.