chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vaccine was transferred from the Freezer to the Refrigerator on 24JAN2022 and administered on 09Mar2022; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) and PRODUCT STORAGE ERROR (Date the vaccine was transferred from the Freezer to the Refrigerator on 24JAN2022 and administered on 09Mar2022) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vaccine was transferred from the Freezer to the Refrigerator on 24JAN2022 and administered on 09Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) and PRODUCT STORAGE ERROR (Date the vaccine was transferred from the Freezer to the Refrigerator on 24JAN2022 and administered on 09Mar2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, COVID-19, Condition aggravated, Coronavirus test, Drug ineffective
Clinical narrative: getting up to go to the bathroom about every hour; It started getting worse; had a strain of coronavirus in December 2021 right before holiday/tested positive with coronavirus; Lack of drug effect; had a sinus infection/coughing from sinus infection; she was in bed; lung infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (lung infection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ATORVASTATIN for an unknown indication.    Concomitant products included METFORMIN, RAMIPRIL and ATENOLOL for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, 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 started ATORVASTATIN (unknown route) at an unspecified dose. In 2021, the patient experienced PNEUMONIA (lung infection) (seriousness criterion medically significant), SINUSITIS (had a sinus infection/coughing from sinus infection) and BED REST (she was in bed). In December 2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (had a strain of coronavirus in December 2021 right before Christmas/tested positive with coronavirus). On an unknown date, the patient experienced POLLAKIURIA (getting up to go to the bathroom about every hour) and CONDITION AGGRAVATED (It started getting worse). At the time of the report, PNEUMONIA (lung infection), DRUG INEFFECTIVE (Lack of drug effect), SINUSITIS (had a sinus infection/coughing from sinus infection), BED REST (she was in bed), POLLAKIURIA (getting up to go to the bathroom about every hour), COVID-19 (had a strain of coronavirus in December 2021 right before holiday/tested positive with coronavirus) and CONDITION AGGRAVATED (It started getting worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Laboratory test: results not provided Results not provided. In December 2021, Coronavirus test: positive (Positive) Positive.         It was reported that the patient had tests and was sent home with 2 prescriptions, and was asked to stay home and quarantine. She was in bed. She was therefore unable to get her booster dose at that time. After starting Atorvastatin, about a month into it, she had to get up about every hour to go to the bathroom. For example, if she went to bed at 10 PM, she got up at 11:30 PM to go the bathroom, and about every hour from then on. It was reported that the patient did not experience any symptoms after receiving first two doses of the Moderna COVID-19 vaccine.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pneumonia, Pollakiuria, Sinusitis
Clinical narrative: getting up to go to the bathroom about every hour; It started getting worse; had a strain of coronavirus in December 2021 right before holiday/tested positive with coronavirus; Lack of drug effect; had a sinus infection/coughing from sinus infection; she was in bed; lung infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (lung infection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ATORVASTATIN for an unknown indication.    Concomitant products included METFORMIN, RAMIPRIL and ATENOLOL for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, 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 started ATORVASTATIN (unknown route) at an unspecified dose. In 2021, the patient experienced PNEUMONIA (lung infection) (seriousness criterion medically significant), SINUSITIS (had a sinus infection/coughing from sinus infection) and BED REST (she was in bed). In December 2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (had a strain of coronavirus in December 2021 right before Christmas/tested positive with coronavirus). On an unknown date, the patient experienced POLLAKIURIA (getting up to go to the bathroom about every hour) and CONDITION AGGRAVATED (It started getting worse). At the time of the report, PNEUMONIA (lung infection), DRUG INEFFECTIVE (Lack of drug effect), SINUSITIS (had a sinus infection/coughing from sinus infection), BED REST (she was in bed), POLLAKIURIA (getting up to go to the bathroom about every hour), COVID-19 (had a strain of coronavirus in December 2021 right before holiday/tested positive with coronavirus) and CONDITION AGGRAVATED (It started getting worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Laboratory test: results not provided Results not provided. In December 2021, Coronavirus test: positive (Positive) Positive.         It was reported that the patient had tests and was sent home with 2 prescriptions, and was asked to stay home and quarantine. She was in bed. She was therefore unable to get her booster dose at that time. After starting Atorvastatin, about a month into it, she had to get up about every hour to go to the bathroom. For example, if she went to bed at 10 PM, she got up at 11:30 PM to go the bathroom, and about every hour from then on. It was reported that the patient did not experience any symptoms after receiving first two doses of the Moderna COVID-19 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient got COVID after their 2 doses; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (patient got COVID after their 2 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (patient got COVID after their 2 doses). At the time of the report, COVID-19 (patient got COVID after their 2 doses) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  The pharmacist asked whether the patient could still receive the booster dose even after contracting COVID disease.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the second dose of the Moderna mRNA-1273 vaccine. The start date of the event was not provided. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-511612 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the second dose of the Moderna mRNA-1273 vaccine. The start date of the event was not provided. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 79.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, Malaise
Clinical narrative: Energy decreased/ Energy level does limit daily activities; Energy level does limit daily activities/ Activities of daily living impaired; Not feeling well/ Feeling Unwell/Does not feel better after resting; Fatigue/ symptoms of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Energy decreased/ Energy level does limit daily activities), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Energy level does limit daily activities/ Activities of daily living impaired), MALAISE (Not feeling well/ Feeling Unwell/Does not feel better after resting) and FATIGUE (Fatigue/ symptoms of fatigue) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ENZALUTAMIDE (XTANDI) for Prostate cancer.    No Medical History information was reported.   In July 2021, the patient started ENZALUTAMIDE (XTANDI) (Oral) 160 milligram once a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Energy decreased/ Energy level does limit daily activities), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Energy level does limit daily activities/ Activities of daily living impaired), MALAISE (Not feeling well/ Feeling Unwell/Does not feel better after resting) and FATIGUE (Fatigue/ symptoms of fatigue). At the time of the report, ASTHENIA (Energy decreased/ Energy level does limit daily activities), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Energy level does limit daily activities/ Activities of daily living impaired), MALAISE (Not feeling well/ Feeling Unwell/Does not feel better after resting) and FATIGUE (Fatigue/ symptoms of fatigue) outcome was unknown.            No concomitant medications were reported.  It was reported that patient had level 2 out of 10 fatigue. Patient had no symptoms of hand-foot syndrome. Patient again reported moderate fatigue and selected 6 out of 10 for fatigue level. MD told the patient to hold off on Enzalutamide for a week and then call to Follow Up and decide on dose restart (around 21-Dec-2021). The patient was prescribed with 1 tablet of enzalutamide daily.  No specific treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: Lymph nodes swollen; Booster shot in her shoulder/HCP sanitized with alcohol her side bicep and applied the vaccine/HCP is not manipulation the vaccine correctly/carried the vaccine in pocket; Receiving her Booster shot in her shoulder and never receiving a vaccine so high; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swollen), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Booster shot in her shoulder/HCP sanitized with alcohol her side bicep and applied the vaccine/HCP is not manipulation the vaccine correctly/carried the vaccine in pocket) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Receiving her Booster shot in her shoulder and never receiving a vaccine so high) in a 52-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph nodes swollen), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Booster shot in her shoulder/HCP sanitized with alcohol her side bicep and applied the vaccine/HCP is not manipulation the vaccine correctly/carried the vaccine in pocket) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Receiving her Booster shot in her shoulder and never receiving a vaccine so high). At the time of the report, LYMPHADENOPATHY (Lymph nodes swollen), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Booster shot in her shoulder/HCP sanitized with alcohol her side bicep and applied the vaccine/HCP is not manipulation the vaccine correctly/carried the vaccine in pocket) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Receiving her Booster shot in her shoulder and never receiving a vaccine so high) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient received Booster shot. Patient  has no allergies. Treatment information was not provided.   This case was linked to MOD-2022-511971 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Lower respiratory tract infection
Clinical narrative: Infection in chest; Chest discomfort/tightening of the chest; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (Infection in chest), CHEST DISCOMFORT (Chest discomfort/tightening of the chest) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Clot blood (Blood clot in leg but was before vaccination.) and DVT.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Infection in chest), CHEST DISCOMFORT (Chest discomfort/tightening of the chest) and HEADACHE (Headache). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Infection in chest), CHEST DISCOMFORT (Chest discomfort/tightening of the chest) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he was not having allergies to medications, food and other products. Patient was not tested positive Covid-19. The patient have not received other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient was taking unspecified medications for blood clots. The adverse events had not cause patient to seek medical care and patient wanted to let a few days pass to see how he was feeling. The patient was taking unspecified medications for his chest infection.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Complex regional pain syndrome
Clinical narrative: Acute worsening of Complex regional pain syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of COMPLEX REGIONAL PAIN SYNDROME (Acute worsening of Complex regional pain syndrome) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Concurrent medical conditions included Complex regional pain syndrome Type I.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COMPLEX REGIONAL PAIN SYNDROME (Acute worsening of Complex regional pain syndrome) (seriousness criterion medically significant). At the time of the report, COMPLEX REGIONAL PAIN SYNDROME (Acute worsening of Complex regional pain syndrome) had resolved. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COMPLEX REGIONAL PAIN SYNDROME (Acute worsening of Complex regional pain syndrome) to be related.    Patient was diagnosed with CRPS type I who presented with acute worsening of symptoms after mRNA-based COVID-19 vaccination and their medical management.  Patient reported severe worsening of the right lower extremity, burning pain, color changes and temperature changes within 24 hours of first dose of mRNA COVID-19 Vaccination(Moderna).  The acute clinical worsening after mRNA-based COVID-19 vaccination was transient and effectively managed with adjustment of individualized therapy in all patients. However, clinicians should be aware of the possibility that there may be a clinical worsening CRPS after mRNA-based COVID-19 vaccination  Concomitant and Treatment medications were not reported. COMPANY COMMENT: This is a Literature non-study case concerning a 49-years-old female patient with clinical history of Complex regional pain syndrome who experienced the unexpected event of COMPLEX REGIONAL PAIN SYNDROME (Acute worsening) 1 days after 1st dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-512201 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is a Literature non-study case concerning a 49-years-old female patient with clinical history of Complex regional pain syndrome who experienced the unexpected event of COMPLEX REGIONAL PAIN SYNDROME (Acute worsening) 1 days after 1st dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Limb discomfort, Lip erythema, Lip pruritus, Lip swelling
Clinical narrative: COVID arm in both arms; 11 days after first shot large lips, red, warm, and itchy; 11 days after first shot large lips, red, warm, and itchy; 11 days after first shot large lips, red, warm, and itchy; 11 days after first shot large lips, red, warm, and itchy; Has stinging in first arm a couple times a week/Second arm stings 3 times daily; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm in both arms), LIP SWELLING (11 days after first shot large lips, red, warm, and itchy), LIP ERYTHEMA (11 days after first shot large lips, red, warm, and itchy), FEELING HOT (11 days after first shot large lips, red, warm, and itchy) and LIP PRURITUS (11 days after first shot large lips, red, warm, and itchy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (COVID arm in both arms), LIP SWELLING (11 days after first shot large lips, red, warm, and itchy), LIP ERYTHEMA (11 days after first shot large lips, red, warm, and itchy), FEELING HOT (11 days after first shot large lips, red, warm, and itchy), LIP PRURITUS (11 days after first shot large lips, red, warm, and itchy) and LIMB DISCOMFORT (Has stinging in first arm a couple times a week/Second arm stings 3 times daily). At the time of the report, VACCINATION SITE REACTION (COVID arm in both arms), LIP SWELLING (11 days after first shot large lips, red, warm, and itchy), LIP ERYTHEMA (11 days after first shot large lips, red, warm, and itchy), FEELING HOT (11 days after first shot large lips, red, warm, and itchy) and LIP PRURITUS (11 days after first shot large lips, red, warm, and itchy) had resolved and LIMB DISCOMFORT (Has stinging in first arm a couple times a week/Second arm stings 3 times daily) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. No treatment medication was provided.  The patient had received first shot of the vaccine 9 months ago. While reading FAQ L.3 (Clinical Trial side effects), the patient reported that the patient had most side effects all of those except for the nausea.  The patient had stinging in first arm a couple times in a week and rubbing it lightly makes it go away.  The patient's second arm stings 3 times daily. The patient rubs it lightly and it goes away. The patient felt like being stung by a mosquito and felt irritating. The stinging was less in first arm.   This case was linked to MOD-2022-512094 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm in both arms; 11 days after first shot large lips, red, warm, and itchy; 11 days after first shot large lips, red, warm, and itchy; 11 days after first shot large lips, red, warm, and itchy; 11 days after first shot large lips, red, warm, and itchy; Has stinging in first arm a couple times a week/Second arm stings 3 times daily; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm in both arms), LIP SWELLING (11 days after first shot large lips, red, warm, and itchy), LIP ERYTHEMA (11 days after first shot large lips, red, warm, and itchy), FEELING HOT (11 days after first shot large lips, red, warm, and itchy) and LIP PRURITUS (11 days after first shot large lips, red, warm, and itchy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (COVID arm in both arms), LIP SWELLING (11 days after first shot large lips, red, warm, and itchy), LIP ERYTHEMA (11 days after first shot large lips, red, warm, and itchy), FEELING HOT (11 days after first shot large lips, red, warm, and itchy), LIP PRURITUS (11 days after first shot large lips, red, warm, and itchy) and LIMB DISCOMFORT (Has stinging in first arm a couple times a week/Second arm stings 3 times daily). At the time of the report, VACCINATION SITE REACTION (COVID arm in both arms), LIP SWELLING (11 days after first shot large lips, red, warm, and itchy), LIP ERYTHEMA (11 days after first shot large lips, red, warm, and itchy), FEELING HOT (11 days after first shot large lips, red, warm, and itchy) and LIP PRURITUS (11 days after first shot large lips, red, warm, and itchy) had resolved and LIMB DISCOMFORT (Has stinging in first arm a couple times a week/Second arm stings 3 times daily) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. No treatment medication was provided.  The patient had received first shot of the vaccine 9 months ago. While reading FAQ L.3 (Clinical Trial side effects), the patient reported that the patient had most side effects all of those except for the nausea.  The patient had stinging in first arm a couple times in a week and rubbing it lightly makes it go away.  The patient's second arm stings 3 times daily. The patient rubs it lightly and it goes away. The patient felt like being stung by a mosquito and felt irritating. The stinging was less in first arm.   This case was linked to MOD-2022-512094 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Livedo reticularis
Clinical narrative: Livedo reticularis on bilateral knees; This literature-non-study case was reported in a literature article and describes the occurrence of LIVEDO RETICULARIS (Livedo reticularis on bilateral knees) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:      No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIVEDO RETICULARIS (Livedo reticularis on bilateral knees) (seriousness criterion medically significant). At the time of the report, LIVEDO RETICULARIS (Livedo reticularis on bilateral knees) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIVEDO RETICULARIS (Livedo reticularis on bilateral knees) to be related.    No concomitant and treatment medication were provided.  Company comment: This literature non-study case concerns a 65-year-old, female patient with no medical history reported, who experienced the unexpected serious (Medically significant) event of Livedo Reticularis (Livedo reticularis on bilateral knees), unspecified days after receiving third dose of mRNA-1273. Outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature non-study case concerns a 65-year-old, female patient with no medical history reported, who experienced the unexpected serious (Medically significant) event of Livedo Reticularis (Livedo reticularis on bilateral knees), unspecified days after receiving third dose of mRNA-1273. Outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: Covid arm in both arms; Second arm stings 3x daily. Rub it lightly and it goes away. Feels like being stung by a mosquito.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm in both arms) and VACCINATION SITE PAIN (Second arm stings 3x daily. Rub it lightly and it goes away. Feels like being stung by a mosquito.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Covid arm in both arms) and VACCINATION SITE PAIN (Second arm stings 3x daily. Rub it lightly and it goes away. Feels like being stung by a mosquito.). At the time of the report, VACCINATION SITE REACTION (Covid arm in both arms) outcome was unknown and VACCINATION SITE PAIN (Second arm stings 3x daily. Rub it lightly and it goes away. Feels like being stung by a mosquito.) had not resolved.      No concomitant medication was provided.  The patient had received second shot 8 months ago. While reading FAQ L.3 (Clinical Trial side effects), the patient reported that the patient had most side effects all of those except for the nausea.  The patient's second arm stings 3 times daily. The patient rubs it lightly and it goes away. The patient felt like being stung by a mosquito and felt irritating. The stinging was less in first arm.  No treatment medication was provided.   This case was linked to MOD-2022-512065 (Patient Link).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given more than 12 hour post-puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 033K21-2A and 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   It was reported that the vaccine was punctured on thursday morning 10-Mar-2022 at 9:24 AM. Date the vial was initially stored in the refrigerator was 10-Mar-2022 and the vial did not undergo any temperature excursions. Amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was very minimal (only taken out to draw the doses).  No treatment medication were provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given more than 12 hour post-puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 033K21-2A and 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   It was reported that the vaccine was punctured on thursday morning 10-Mar-2022 at 9:24 AM. Date the vial was initially stored in the refrigerator was 10-Mar-2022 and the vial did not undergo any temperature excursions. Amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was very minimal (only taken out to draw the doses).  No treatment medication were provided.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old patient receiving a dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old patient receiving a dose of the Moderna COVID19 vaccine) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old patient receiving a dose of the Moderna COVID19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old patient receiving a dose of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  HCP mentioned that a 14 year old patient received a 1st dose of the Moderna COVID19 vaccine outside  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Follow up received contain Non-significant information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given more that 12 hour post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given more that 12 hour post puncture) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 033K21-2A and 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given more that 12 hour post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given more that 12 hour post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   Reporter stated that the vial was initially stored in the refrigerator on 10-Mar-2022 and was first punctured on the same day of 10-Mar-2022 at 9:24 AM. The vial was then stored in the fridge after puncturing and the vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range was very minimal (only taken out to draw the doses).  No treatment medications were provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was punctured on 10-Mar-2022 at 9:24 and refrigerated post 12 hours puncture; Dose was given past 12 hour post-puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given past 12 hour post-puncture) and PRODUCT STORAGE ERROR (Vial was punctured on 10-Mar-2022 at 9:24 and refrigerated post 12 hours puncture) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 033K21-2A and 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given past 12 hour post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was punctured on 10-Mar-2022 at 9:24 and refrigerated post 12 hours puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given past 12 hour post-puncture) and PRODUCT STORAGE ERROR (Vial was punctured on 10-Mar-2022 at 9:24 and refrigerated post 12 hours puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Vial was initially stored in the refrigerator on 10-Mar-2022. Vial was punctured on 10-Mar-2022 at 9:24 and stored in fridge post puncture. Vial did not undergo any temperature excursion. For a very minimal time vial was exposed to room temperature (8 to 25 degree Celsius)  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 10-Mar-2022; Administered COVID-19 dose after the 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered COVID-19 dose after the 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 10-Mar-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered COVID-19 dose after the 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 10-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered COVID-19 dose after the 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 10-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Vial was initially stored in refrigerator on 08-Feb-2022. Vial did not undergo any temperature excursion.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2022-512525, MOD-2022-512526 (Patient Link).
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 patients received the expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received the expired) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received the expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received the expired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. It was reported that vaccine that shows on Moderna tx.com as expired August 14, 2021 but also expired on October 14, 2022. No Treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in her ears following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in her ears following vaccination) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039f21a, 020b21a and 036a21a) for COVID-19 vaccination.     The patient had no known allergies.  The patient's past medical history included Suspected COVID-19 (may be in Jan 2020 COVID type symptoms) in January 2020.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in her ears following vaccination). At the time of the report, TINNITUS (Ringing in her ears following vaccination) had not resolved.            The patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  It was reported that the patient had COVID-19 type symptoms might be in Jan-2020.  No concomitant medications were provided by the reporter.  The patient did not require any medical care for the reported event and had not experienced similar event in the past.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. It was reported that vaccine that shows on Moderna website as expired August 14, 2021 but also expired on October 14, 2022.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 26 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on website the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022.  No treatment information was provided.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 26 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022. No Treatment medication reported.
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was reported that when the lot number of Moderna COVID-19 vaccine of 010A21A is entered into the expiration date lot number look up finder on Moderna website the expiration date was on August 14, 2021. The reporter also mentioned that she has a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as October 14, 2022.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication reported.  Date of administration of vaccine was reported as 02 Feb 2022 and 02 Mar 2022. The Nurse says that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as October 14, 2022.  The nurse was sending a picture of the screenshot