chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Tremor
Clinical narrative: 1st, 2nd Local store, and 3rd booster local drugstore. Extreme headaches with loss of vision, ringing in both ears, fever, chills, muscle ache, nausea. Went to ER a few times for headache/vision loss and then on 2nd visit to ER had triple bypass in April, then 2 weeks later had blood loss that required a transfusion that I declined. Also having constant memory problems and shaking is worse than before vaccinations.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Chills, Headache, Nausea
Clinical narrative: Heart/chest pain (12 hours), extreme chills (2 hours), fever (9 hours), headache (12 hours), arm pain, pale face and nausea (12 hours).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, Pyrexia
Clinical narrative: Heart/chest pain (12 hours), extreme chills (2 hours), fever (9 hours), headache (12 hours), arm pain, pale face and nausea (12 hours).
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: event occurred after 2nd vaccine; breakthrough case admission
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after Janssen vaccine; breakthrough case admission
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient's first dose was a Pfizer COVID-19 vaccine and their second was a Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient's first dose was a Pfizer COVID-19 vaccine and their second was a Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient's first dose was a Pfizer COVID-19 vaccine and their second was a Moderna COVID-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient's first dose was a Pfizer COVID-19 vaccine and their second was a Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Condition aggravated, Dizziness, Electrocardiogram ambulatory abnormal, Extrasystoles
Clinical narrative: Dizziness, bradycardia and worsening of bigeminy.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Ventricular extrasystoles
Clinical narrative: Dizziness, bradycardia and worsening of bigeminy.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient given pediatric dose (5-11) when the age-appropriate dose was the adult dose (12+). This resulted in a lower-than-authorized dose administration error. Per guidelines, do not repeat dose and continue with schedule. No adverse reaction reported at this time.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and extreme itchiness all over my body nonstop for 2 months.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission;
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: event occurred after 2nd vaccine; breakthrough case admission
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: is a fever a normal side effect within 24 hours of administration?; This case was received via regulatory authority (Reference number: US-irms-MOD21-127285 ) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (is a fever a normal side effect within 24 hours of administration?) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (is a fever a normal side effect within 24 hours of administration?). At the time of the report, PYREXIA (is a fever a normal side effect within 24 hours of administration?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Lip oedema, Pruritus, Tongue oedema
Clinical narrative: Wednesday evening, developed edema to her upper lip and tongue. Shortly after, she experienced some difficulty breathing, and taken to ED. She was given prednisone and Benadryl. She continued to take those every day since seen (last given at 10 am). Thursday afternoon, she developed a rash to her full body. Urticaria and redness still present and itchy. Patient also developed N/V/D yesterday, and continues today. No new detergents, lotions or soaps. She recently used a new lip mask. No new food intakes. Of note, no reaction to the first two doses.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Wednesday evening, developed edema to her upper lip and tongue. Shortly after, she experienced some difficulty breathing, and taken to ED. She was given prednisone and Benadryl. She continued to take those every day since seen (last given at 10 am). Thursday afternoon, she developed a rash to her full body. Urticaria and redness still present and itchy. Patient also developed N/V/D yesterday, and continues today. No new detergents, lotions or soaps. She recently used a new lip mask. No new food intakes. Of note, no reaction to the first two doses.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient reported feeling itchy after the vaccination. According her, this happened with the first two doses as well. This was not disclosed to us before she received the vaccine. She was instructed to take Benadryl, which she purchased and told to take right away.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I scheduled my 8 year old daughter for her second covid vaccine appointment. She received the vaccine on 02/22/22 and on 02/24/22 I received a call from a Doctor to check on my daughter because she had received the wrong vaccine, he apologized and told me the made a mistake and gave my 8 year old daughter the shringrix vaccine. The vaccine should only be used on Adults over 50 and I don?t know what side effects this is going to cause my daughter this mistake should have never happened.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Normal side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Normal side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Normal side effects). At the time of the report, VACCINATION COMPLICATION (Normal side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement, Breast swelling, Breast tenderness, Lymph node pain, Lymphadenopathy
Clinical narrative: -Swollen, painful  lymph node in armpit  for one week after injection  -menstrual cycle came 2 weeks early that month (Jan) -Breasts swollen, enlarged at least one cup size and tender starting Feb 13th. -Menstrual cycle late in February, with  exaggerated and prolonged pre-menstrual symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Premenstrual syndrome
Clinical narrative: -Swollen, painful  lymph node in armpit  for one week after injection  -menstrual cycle came 2 weeks early that month (Jan) -Breasts swollen, enlarged at least one cup size and tender starting Feb 13th. -Menstrual cycle late in February, with  exaggerated and prolonged pre-menstrual symptoms.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admisson
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Fainting/Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported to me he had issues with injections and blood draws  before the vaccination. He said it is likely for him to feel clumsy and faint. He was monitored for 30 minutes. He was doing fine and left the building. He was not alone. He had someone with him during the whole process.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccination ; breakthrough case admission
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: First dose administered 3 day after BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose administered 3 day after BUD) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose administered 3 day after BUD). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose administered 3 day after BUD) 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 did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong dose of vaccine - too high.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong dose of vaccine - too high.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient inadvertently administered a half dose (0.25mL) of Moderna vaccine for the first dose (primary series). The mistake noticed upon vaccine administration. Informed patient and agreed to receive a second half dose (0.25mL) of the vaccine in order to achieve the full dose needed (0.5mL). Patient received both doses in the left arm as he requested. No adverse effects reported  after vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose not received between day 25-35 of the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not received between day 25-35 of the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not received between day 25-35 of the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not received between day 25-35 of the 1st dose) had resolved.        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.   Patient went for second dose Pharmacist declined to the patient information due to HIPPA.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lichenoid keratosis
Clinical narrative: Lichenoid Dermatitis / more than twenty bumps in number; This spontaneous case was reported by a consumer and describes the occurrence of LICHENOID KERATOSIS (Lichenoid Dermatitis / more than twenty bumps in number) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced LICHENOID KERATOSIS (Lichenoid Dermatitis / more than twenty bumps in number). At the time of the report, LICHENOID KERATOSIS (Lichenoid Dermatitis / more than twenty bumps in number) had not resolved.            No concomitant medications were reported.  It was reported that a week after patient got his second shot last 25-Jan-2021, a blue bump appeared on his hand. Three weeks after, it started to increase in number which appeared in his hands and legs both left and right. He said it comes in different sizes and described it as if covering the ankles for the big ones and same size as nail head for the small ones. He also added to have itchiness, swelling and pain when touched. He consulted his dermatologist last April and was first diagnosed as psoriasis. He also said that it flared up last May.  Later on, his doctor said it was not psoriasis and he had undergone biopsy and diagnosed him with Lichenoid Dermatitis. At the time of reporting, he estimates it to be more than twenty bumps in number. The old ones were now red in color and not pronounced as they were, and the new bumps still appears to be blue.  No treatment medications were reported.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: First dose administered 1 day after BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after) 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 did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling, Pruritus
Clinical narrative: Legs are swelling; Leg discomfort; Itchy legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Legs are swelling), LIMB DISCOMFORT (Leg discomfort) and PRURITUS (Itchy legs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042A18A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Legs are swelling), LIMB DISCOMFORT (Leg discomfort) and PRURITUS (Itchy legs). At the time of the report, PERIPHERAL SWELLING (Legs are swelling), LIMB DISCOMFORT (Leg discomfort) and PRURITUS (Itchy legs) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.  Lab details were not provided.  Patient also stated his legs are swelling, begin to have discomfort, itch, and feels like thrombosis. Declined to provide consent for HCP or any other information.  Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD-2021-279438 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Oedema peripheral, Vaccination site pain
Clinical narrative: Fluid in her stomach; Fluid in her legs; Still experiencing pain in her arm where she received the dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Fluid in her stomach), OEDEMA PERIPHERAL (Fluid in her legs) and VACCINATION SITE PAIN (Still experiencing pain in her arm where she received the dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 experienced ABDOMINAL DISCOMFORT (Fluid in her stomach), OEDEMA PERIPHERAL (Fluid in her legs) and VACCINATION SITE PAIN (Still experiencing pain in her arm where she received the dose). At the time of the report, ABDOMINAL DISCOMFORT (Fluid in her stomach), OEDEMA PERIPHERAL (Fluid in her legs) and VACCINATION SITE PAIN (Still experiencing pain in her arm where she received the dose) had not resolved.            No Concomitant medication were reported.  No treatment medication were reported.  Patient had never taken medicines or had any surgeries. She did not drink or smoke.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: First dose administered 1 day after BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after) 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 did not provide any causality assessments.   No Concomitant medication information was reported. No treatment medications were provided.Sender's Comments: This report refers to a case of Expired product administered for mRNA-1273, lot # 040C21A with no associated AEs.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: First dose administered 1 day after BUD (Day 31); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after BUD (Day 31)) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after BUD (Day 31)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after BUD (Day 31)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.       This case was linked to MOD-2021-279367 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Mixed series: Patient received the first dose as Moderna Covid19 Vaccine, and the second dose as Pfizer Covid19 Vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed series: Patient received the first dose as Moderna Covid19 Vaccine, and the second dose as Pfizer Covid19 Vaccine.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed series: Patient received the first dose as Moderna Covid19 Vaccine, and the second dose as Pfizer Covid19 Vaccine.). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed series: Patient received the first dose as Moderna Covid19 Vaccine, and the second dose as Pfizer Covid19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Little pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Varicose veins.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Little pain). At the time of the report, PAIN (Little pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-279410 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Have a fever that has not gone a way; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Have a fever that has not gone a way) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Have a fever that has not gone a way). At the time of the report, PYREXIA (Have a fever that has not gone a way) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Never recieved the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never recieved the second dose) 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 January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never recieved the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never recieved the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (very ill). At the time of the report, ILLNESS (very ill) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter..
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: outbreak of plaque psoriasis on his legs, elbows, and arms; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (outbreak of plaque psoriasis on his legs, elbows, and arms) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 032B21A) for COVID-19 vaccination.     Concomitant products included CLOBETASOL PROPIONATE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PSORIASIS (outbreak of plaque psoriasis on his legs, elbows, and arms). At the time of the report, PSORIASIS (outbreak of plaque psoriasis on his legs, elbows, and arms) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient had psoriatic arthritis pretty bad as a child but mostly outgrew it, with only occasional small outbreaks. Since the end the June, he developed a worsening outbreak of plaque psoriasis on his legs, elbows, and arms. He was using topical clobetasol propionate 0.05%, but it was not doing too much.  No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after more than 30 days in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter mentioned that the patients have not experienced any symptoms after receiving the vaccine and have not received any treatments.  No concomitant medications were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness of the arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness of the arm). At the time of the report, MYALGIA (soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant treatment was provided.  No treatment medication was provided.   This case was linked to MOD-2021-279611 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain, Vaccination site pain
Clinical narrative: sore stiff neck; sore arm; area of injection is tender and sore; stiff neck, stiff on right side; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck, stiff on right side), NECK PAIN (sore stiff neck), ARTHRALGIA (sore arm) and VACCINATION SITE PAIN (area of injection is tender and sore) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck, stiff on right side), ARTHRALGIA (sore arm) and VACCINATION SITE PAIN (area of injection is tender and sore). On an unknown date, the patient experienced NECK PAIN (sore stiff neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck, stiff on right side), NECK PAIN (sore stiff neck) and VACCINATION SITE PAIN (area of injection is tender and sore) outcome was unknown and ARTHRALGIA (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Additional information received: Non-serious event of sore stiff neck was added. Reference case ID added. Narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days; Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days). At the time of the report, PRODUCT STORAGE ERROR (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was reported.   This case was linked to MOD-2021-279505 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain at the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm pain at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported.   This case was linked to MOD-2021-279658 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pains every seen I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains every seen I got the shot) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pains every seen I got the shot). At the time of the report, CHEST PAIN (Chest pains every seen I got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days; two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days). At the time of the report, PRODUCT STORAGE ERROR (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date the vials were initially stored in the refrigerator: 02Jul2021 Date the vials were moved from freezer to refrigeration storage: 02Jul2021. No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-279492 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Pain
Clinical narrative: my chest feels a little tight; with a light pulsating pain in my right shoulder blade down to elbow; with a light pulsating pain in my right shoulder blade down to elbow; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (my chest feels a little tight), PAIN (with a light pulsating pain in my right shoulder blade down to elbow) and ARTHRALGIA (with a light pulsating pain in my right shoulder blade down to elbow) 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.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced CHEST DISCOMFORT (my chest feels a little tight), PAIN (with a light pulsating pain in my right shoulder blade down to elbow) and ARTHRALGIA (with a light pulsating pain in my right shoulder blade down to elbow). At the time of the report, CHEST DISCOMFORT (my chest feels a little tight), PAIN (with a light pulsating pain in my right shoulder blade down to elbow) and ARTHRALGIA (with a light pulsating pain in my right shoulder blade down to elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The events started after an hour of vaccine administration.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.; Sender's Comments: Based on the current information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Deviation from dosing schedule(he did not want second dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule(he did not want second dose)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule(he did not want second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule(he did not want second dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported  Treatment medication information was not reported   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: pain across shoulder and arm; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain across shoulder and arm) and SWELLING (swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain across shoulder and arm) and SWELLING (swelling). At the time of the report, PAIN IN EXTREMITY (pain across shoulder and arm) and SWELLING (swelling) outcome was unknown.            No concomitant medication were provided. No treatment drugs were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received the 2nd dose of the Moderna Covid-19 Vaccine after the 42 day mark from the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the 2nd dose of the Moderna Covid-19 Vaccine after the 42 day mark from the first dose) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the 2nd dose of the Moderna Covid-19 Vaccine after the 42 day mark from the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the 2nd dose of the Moderna Covid-19 Vaccine after the 42 day mark from the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was not provided.  No treatment medication was not provided.   Reporter did not allow further contact