chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Myalgia
Clinical narrative: heavy breakthrough bleedings  when she woke up on the mornings; aches,soreness; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (heavy breakthrough bleedings  when she woke up on the mornings) and MYALGIA (aches,soreness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039l20a, 029k21a and 052a21a) for COVID-19 vaccination.     "No medical history was provided by the reporter.".  Concomitant products included GABAPENTIN, VALSARTAN, CARVEDILOL, FLECAINIDE ACETATE (TAMBOCOR) and APIXABAN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (heavy breakthrough bleedings  when she woke up on the mornings) and MYALGIA (aches,soreness). At the time of the report, INTERMENSTRUAL BLEEDING (heavy breakthrough bleedings  when she woke up on the mornings) and MYALGIA (aches,soreness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (well controlled hypertension).    On 14-Jan-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 MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.  No concomitant medication was provided.   This case was linked to MOD-2021-337525, MOD-2021-337574 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received expired vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006B21A) for COVID-19 immunization. No medical history reported. In 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 8, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 8, 2021, patient administered expired product (received expired vaccine). At the time of the report, administered expired product (received expired vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: worried because she can't work; feeling feverish; Body pain; Headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (worried because she can't work), PYREXIA (feeling feverish), MYALGIA (Body pain), HEADACHE (Headaches) and CHILLS (chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (worried because she can't work), PYREXIA (feeling feverish), MYALGIA (Body pain), HEADACHE (Headaches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (worried because she can't work), PYREXIA (feeling feverish), MYALGIA (Body pain), HEADACHE (Headaches) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes antidepressant.    This case was linked to MOD-2021-337515 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: she faint twice after her second dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (she faint twice after her second dose of Moderna vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (she faint twice after her second dose of Moderna vaccine) (seriousness criterion medically significant). At the time of the report, SYNCOPE (she faint twice after her second dose of Moderna vaccine) outcome was unknown.            Patient is worried about the booster dose.  No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: This case concerns an unknown age, female patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred right away after receiving the second dose of mRNA 1273 vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing will be given. The reporter assessed the events as related to the product.; Sender's Comments: This case concerns an unknown age, female patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred right away after receiving the second dose of mRNA 1273 vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing will be given. The reporter assessed the events as related to the product.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: a red lump on the injection site and that is warm to the touch; warm to the touch; felling that their arm is killing them; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a red lump on the injection site and that is warm to the touch), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE PAIN (felling that their arm is killing them) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048121A and 020f21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced VACCINATION SITE MASS (a red lump on the injection site and that is warm to the touch), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE PAIN (felling that their arm is killing them). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (a red lump on the injection site and that is warm to the touch), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE PAIN (felling that their arm is killing them) outcome was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus
Clinical narrative: itching/ feels like poison ivy; really bad headache/ still getting headaches; sore arm/ it is still sore to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/ it is still sore to the touch), PRURITUS (itching/ feels like poison ivy) and HEADACHE (really bad headache/ still getting headaches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore arm/ it is still sore to the touch) and HEADACHE (really bad headache/ still getting headaches). On 27-Sep-2021, the patient experienced PRURITUS (itching/ feels like poison ivy). The patient was treated with ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE (BUTALBITAL, ASPIRIN AND CAFFEINE) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm/ it is still sore to the touch), PRURITUS (itching/ feels like poison ivy) and HEADACHE (really bad headache/ still getting headaches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-337858 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Vaccination complication
Clinical narrative: started to feel under the weather; sweated it out; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERHIDROSIS (sweated it out) and VACCINATION COMPLICATION (started to feel under the weather) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 939902) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High blood pressure).   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced HYPERHIDROSIS (sweated it out). On 17-Sep-2021 at 2:00 AM, the patient experienced VACCINATION COMPLICATION (started to feel under the weather). The patient was treated with PARACETAMOL (TYLENOL) on 17-Sep-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (sweated it out) outcome was unknown and VACCINATION COMPLICATION (started to feel under the weather) was resolving.            No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Acute myeloid leukaemia, Anaphylactic reaction, Night sweats, Weight, Weight decreased
Clinical narrative: relapse from 0% immature blast cells back to 25 %/AML; Nasty anaphylactic reactions; Night sweats; weight loss; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE MYELOID LEUKAEMIA (relapse from 0% immature blast cells back to 25 %/AML) and ANAPHYLACTIC REACTION (Nasty anaphylactic reactions) 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.     Concurrent medical conditions included Acute myeloid leukemia (AML). Concomitant products included VENETOCLAX (VENCLEXTA) and DECITABINE (DACOGEN) for an unknown indication.    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 ACUTE MYELOID LEUKAEMIA (relapse from 0% immature blast cells back to 25 %/AML) (seriousness criterion medically significant), ANAPHYLACTIC REACTION (Nasty anaphylactic reactions) (seriousness criterion medically significant), NIGHT SWEATS (Night sweats) and WEIGHT DECREASED (weight loss). At the time of the report, ACUTE MYELOID LEUKAEMIA (relapse from 0% immature blast cells back to 25 %/AML), ANAPHYLACTIC REACTION (Nasty anaphylactic reactions), NIGHT SWEATS (Night sweats) and WEIGHT DECREASED (weight loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: loss (Low) weight loss.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter.  The patient had weigh loss, night sweats, nasty anaphylactic reactions, relapse from  0% immature blast cells back to 25%.  Company comment: This case concerns a patient with unknown name, date of birth and gender, with no previous relevant medical history, who experienced the expected event of Anaphylactic reaction, night sweat and AML reaggravated. . The event occurred after the dose of Spikevax. The rechallenge was not applicable since no information about the first dose or  the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a patient with unknown name, date of birth and gender, with no previous relevant medical history, who experienced the expected event of Anaphylactic reaction, night sweat and AML reaggravated. . The event occurred after the dose of Spikevax. The rechallenge was not applicable since no information about the first dose or  the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Visual impairment
Clinical narrative: Accelerated hearing loss; Accelerated sight loss; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Accelerated hearing loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Macular degeneration, Hearing loss (lifelong hearing loss) and Vision abnormal.  In February 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 DEAFNESS (Accelerated hearing loss) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Accelerated sight loss). At the time of the report, DEAFNESS (Accelerated hearing loss) and VISUAL IMPAIRMENT (Accelerated sight loss) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications were provided.   No treatment medications were provided.  Company Comment - This case concerns a unknown-year-old, female patient with relevant medical history of Hearing loss (lifelong hearing loss). The patient experienced unlisted serious event of Deafness unspecified days after the after first dose of Spikevax. Patient experienced AEs after first dose and no information about the first dose is available rechallenge is not applicable as no additional dosing will be given. The reporter did not provide causality.  The patient Concurrent medical conditions of Hearing loss (lifelong hearing loss ) is a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a unknown-year-old, female patient with relevant medical history of Hearing loss (lifelong hearing loss). The patient experienced unlisted serious event of Deafness unspecified days after the after first dose of Spikevax. Patient experienced AEs after first dose and no information about the first dose is available rechallenge is not applicable as no additional dosing will be given. The reporter did not provide causality.  The patient Concurrent medical conditions of Hearing loss (lifelong hearing loss ) is a confounder. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Thermal burn
Clinical narrative: left shoulder burned; headache; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (left shoulder burned) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced THERMAL BURN (left shoulder burned) and HEADACHE (headache). At the time of the report, THERMAL BURN (left shoulder burned) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment information provided. After first dose patient had a headache and left shoulder burned.   This case was linked to MOD-2021-338406, MOD-2021-338407 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine; vials were in refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (vials were in refrigerator for over 30 days) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (vials were in refrigerator for over 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (vials were in refrigerator for over 30 days) 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.   Concomitant medications was not provided by the reporter Treatment information was not provided  A part-time Pharmacist called 30SEP2021 to report that expired doses of the Moderna vaccine was administered to 25 patients.  This was patient's 1st dose. The vials were in refrigerator for over 30 days.     Lot number(s) 037F21A, Expiration date: 01FEB2022~ Number of doses/vials - 27SEP2021 1 vials of 14 doses, 29SEP2021, 1 vial, 11 doses Date the vial was initially stored in the refrigerator:   24AUG2021 Date(s) of administration of vaccine, 27SEP2021 and 29SEP2021 Did the vial undergo any temperature excursions? No If yes, go to "temperature excursion" section and ask list of questions - N/A   This case was linked to MOD-2021-338604 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Pain in extremity, Product dose omission issue
Clinical narrative: anxiety; He never went back for his second dose; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), ANXIETY (anxiety) and PRODUCT DOSE OMISSION ISSUE (He never went back for his second dose) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On an unknown date, the patient experienced ANXIETY (anxiety) and PRODUCT DOSE OMISSION ISSUE (He never went back for his second dose). On 08-May-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, ANXIETY (anxiety) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He never went back for his second dose) 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 medications reported. The patient had started to take anxiety medication after his first vaccine.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Foot deformity, Gait disturbance, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: foot weird looking; difficulty in walking; intense itching on the archway of her foot; tightening pain; swelling and bumps; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (intense itching on the archway of her foot), PAIN IN EXTREMITY (tightening pain), PERIPHERAL SWELLING (swelling and bumps), FOOT DEFORMITY (foot weird looking) and GAIT DISTURBANCE (difficulty in walking) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M201A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRURITUS (intense itching on the archway of her foot), PAIN IN EXTREMITY (tightening pain) and PERIPHERAL SWELLING (swelling and bumps). On an unknown date, the patient experienced FOOT DEFORMITY (foot weird looking) and GAIT DISTURBANCE (difficulty in walking). At the time of the report, PRURITUS (intense itching on the archway of her foot), PAIN IN EXTREMITY (tightening pain), PERIPHERAL SWELLING (swelling and bumps), FOOT DEFORMITY (foot weird looking) and GAIT DISTURBANCE (difficulty in walking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-338463 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site pain
Clinical narrative: They called it hives; They were very itchy/everything was still itchy; small chicken pox type eruptions started on her neck, spread down to her trunk, then all the way down to the knee; the injection site hurt a little/still had injection site pain.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (They called it hives), PRURITUS (They were very itchy/everything was still itchy), RASH (small chicken pox type eruptions started on her neck, spread down to her trunk, then all the way down to the knee) and VACCINATION SITE PAIN (the injection site hurt a little/still had injection site pain.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The patient's past medical history included Cancer (NOS) (history of cancer twice but only received chemo once).Concurrent medical conditions included mixed connective tissue disease (autoimmune disease).On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (They called it hives), PRURITUS (They were very itchy/everything was still itchy), RASH (small chicken pox type eruptions started on her neck, spread down to her trunk, then all the way down to the knee) and VACCINATION SITE PAIN (the injection site hurt a little/still had injection site pain.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (They called it hives), PRURITUS (They were very itchy/everything was still itchy) and RASH (small chicken pox type eruptions started on her neck, spread down to her trunk, then all the way down to the knee) had resolved and VACCINATION SITE PAIN (the injection site hurt a little/still had injection site pain.) had not resolved. Concomitant medications were not provided. It was reported that after the second dose the injection site hurt a little, then 5 days later small chicken pox type eruptions started on her neck, spread down to her trunk, then all the way down to the knee. They were very itchy and mostly toward the center of her body. She took Benadryl, everything was still itchy, so she went to the emergency room. They called it hives, gave her a steroid, Pepcid and Benadryl and within 3 hours the itching went away and within 5 or 6 hours everything went away, although still had injection site pain. This case was linked to MOD-2021-338296 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-338542, MOD-2021-338560 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported. No treatment was reported.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that  vial did not undergo any temperature excursions.  On 24-Aug-2021, vaccine was stored in refrigerator.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 24-Aug-2021, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-337484 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2021-337484:Master case (same reporter)
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Mobility decreased, Pain in extremity
Clinical narrative: both of my legs were very much painful; I could hardly walk; I could hardly do anything; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (both of my legs were very much painful), GAIT DISTURBANCE (I could hardly walk) and MOBILITY DECREASED (I could hardly do anything) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 PAIN IN EXTREMITY (both of my legs were very much painful), GAIT DISTURBANCE (I could hardly walk) and MOBILITY DECREASED (I could hardly do anything). At the time of the report, PAIN IN EXTREMITY (both of my legs were very much painful), GAIT DISTURBANCE (I could hardly walk) and MOBILITY DECREASED (I could hardly do anything) outcome was unknown.            No concomitant medication is reported No treatement of medication is reported
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Oedema peripheral
Clinical narrative: Edema on both legs from feet to knees after 2nd dose; Fever; Shivering Chills; Severe Headaches; Fatigue; Nausea after 2nt dose; Vomiting after 2nt dose; This spontaneous case was reported by a nurse and describes the occurrence of OEDEMA PERIPHERAL (Edema on both legs from feet to knees after 2nd dose), PYREXIA (Fever), CHILLS (Shivering Chills), HEADACHE (Severe Headaches) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-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 OEDEMA PERIPHERAL (Edema on both legs from feet to knees after 2nd dose), PYREXIA (Fever), CHILLS (Shivering Chills), HEADACHE (Severe Headaches), FATIGUE (Fatigue), NAUSEA (Nausea after 2nt dose) and VOMITING (Vomiting after 2nt dose). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (Edema on both legs from feet to knees after 2nd dose), PYREXIA (Fever), CHILLS (Shivering Chills), HEADACHE (Severe Headaches), FATIGUE (Fatigue), NAUSEA (Nausea after 2nt dose) and VOMITING (Vomiting after 2nt dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-338733 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Edema on both legs from feet to knees after 2nd dose; Fever; Shivering Chills; Severe Headaches; Fatigue; Nausea after 2nt dose; Vomiting after 2nt dose; This spontaneous case was reported by a nurse and describes the occurrence of OEDEMA PERIPHERAL (Edema on both legs from feet to knees after 2nd dose), PYREXIA (Fever), CHILLS (Shivering Chills), HEADACHE (Severe Headaches) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-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 OEDEMA PERIPHERAL (Edema on both legs from feet to knees after 2nd dose), PYREXIA (Fever), CHILLS (Shivering Chills), HEADACHE (Severe Headaches), FATIGUE (Fatigue), NAUSEA (Nausea after 2nt dose) and VOMITING (Vomiting after 2nt dose). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (Edema on both legs from feet to knees after 2nd dose), PYREXIA (Fever), CHILLS (Shivering Chills), HEADACHE (Severe Headaches), FATIGUE (Fatigue), NAUSEA (Nausea after 2nt dose) and VOMITING (Vomiting after 2nt dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-338733 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Confusional state
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of moderate confusion and adverse reaction in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced moderate confusion and adverse reaction. At the time of the report, moderate confusion and adverse reaction outcome: unknown.  The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Got the pfizer and then the moderna; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got the pfizer and then the moderna) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Vaccination: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got the pfizer and then the moderna). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Got the pfizer and then the moderna) had resolved.            No concomitant drug information was provided.  It was reported that the patient received vaccines from a health authority, but recently moved.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: A patient that received a dose from a vial that had been punctured more than 12 hours; Received dose from vial punctured more than 12 hours before/punctured for more than 12 hours (about 11 hours after the 12 hour period).; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient that received a dose from a vial that had been punctured more than 12 hours) and PRODUCT STORAGE ERROR (Received dose from vial punctured more than 12 hours before/punctured for more than 12 hours (about 11 hours after the 12 hour period).) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient that received a dose from a vial that had been punctured more than 12 hours) and PRODUCT STORAGE ERROR (Received dose from vial punctured more than 12 hours before/punctured for more than 12 hours (about 11 hours after the 12 hour period).). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (A patient that received a dose from a vial that had been punctured more than 12 hours) and PRODUCT STORAGE ERROR (Received dose from vial punctured more than 12 hours before/punctured for more than 12 hours (about 11 hours after the 12 hour period).) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Oedema peripheral
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of cluster headaches, vaccination complication (general side effects), peripheral edema (edema in both legs from feet to knees), fatigue and nausea in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011J20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Dec 31, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced cluster headaches, vaccination complication (general side effects), peripheral edema (edema in both legs from feet to knees), fatigue, nausea, vomiting, pyrexia (fever after 2nd dose) and chills (shivering chills). At the time of the report, cluster headaches, vaccination complication (general side effects), peripheral edema (edema in both legs from feet to knees), fatigue, nausea, vomiting, pyrexia (fever after 2nd dose) and chills (shivering chills) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-338654 (patient link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication, Vomiting
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of cluster headaches, vaccination complication (general side effects), peripheral edema (edema in both legs from feet to knees), fatigue and nausea in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011J20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Dec 31, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced cluster headaches, vaccination complication (general side effects), peripheral edema (edema in both legs from feet to knees), fatigue, nausea, vomiting, pyrexia (fever after 2nd dose) and chills (shivering chills). At the time of the report, cluster headaches, vaccination complication (general side effects), peripheral edema (edema in both legs from feet to knees), fatigue, nausea, vomiting, pyrexia (fever after 2nd dose) and chills (shivering chills) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-338654 (patient link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fall, Headache
Clinical narrative: Headache; Fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension and TREPROSTINIL for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 28-Jul-2021, the patient TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .25 mg every eight hours and TREPROSTINIL (Oral) dosage was changed to 2 mg every eight hours. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1 mg every eight hours On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.5 mg every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2 mg every eight hours and TREPROSTINIL (Oral) 2.5 mg every eight hours. and TREPROSTINIL (Oral) dosage was changed to 3 mg every eight hours. On 09-Sep-2021, the patient experienced FALL (Fall). On an unknown date, the patient experienced HEADACHE (Headache). In September 2021, FALL (Fall) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Computerised tomogram: normal (normal) did not break anything.         No treatment information was provided. No concomitant medication was provided