chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of pain in extremity (extremely sore) and erythema (red arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030L20A and 002A21A) for COVID-19 immunization. No medical history reported. On Jan 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (extremely sore) and erythema (red arm). At the time of the report, pain in extremity (extremely sore) and erythema (red arm) outcome: unknown. The reporter did not provide any causality assessments, concomitant product use or treatment information. Action taken with mRNA-1273 in response to the events: not applicable. This case linked to MOD-2021-209795 (patient link).
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Lots of snot; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Lots of snot), PYREXIA (Fever) and VOMITING (Vomiting) in a 19-year-old patient of an unknown 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 RHINORRHOEA (Lots of snot), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, RHINORRHOEA (Lots of snot), PYREXIA (Fever) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) fever.   Action taken with mRNA-1273 in response to the events was not applicable.     No concomitant medication reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: The patient was sick for 4 days/sick for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The patient was sick for 4 days/sick for 4 days) 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 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced VACCINATION COMPLICATION (The patient was sick for 4 days/sick for 4 days). On 20-May-2021, VACCINATION COMPLICATION (The patient was sick for 4 days/sick for 4 days) had resolved.            The patient received their first and second doses of the Moderna COVID-19 vaccine on 16-Apr-2021 and 16-May-2021, respectively.  Reportedly, the patient was sick for 4 days post receiving their second dose starting from 16-May-2021 and recovered on 20-May-2021.  No Concomitant product use was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up was received on 07-jun-2021 and contains no significant information.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Rash
Clinical narrative: It is itching really bad; He hasn't received 2nd dose yet; Rash/ rash on right leg/ spread to knees, feet, arms, and his belly; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He hasn't received 2nd dose yet), RASH (Rash/ rash on right leg/ spread to knees, feet, arms, and his belly) and PRURITUS (It is itching really bad) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced RASH (Rash/ rash on right leg/ spread to knees, feet, arms, and his belly). On 26-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (He hasn't received 2nd dose yet). On an unknown date, the patient experienced PRURITUS (It is itching really bad). The patient was treated with TRIAMCINOLONE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (He hasn't received 2nd dose yet), RASH (Rash/ rash on right leg/ spread to knees, feet, arms, and his belly) and PRURITUS (It is itching really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included flex pen for diabetes and other BP medications.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Covered with plaque psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Covered with plaque psoriasis) 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 PSORIASIS (Covered with plaque psoriasis). At the time of the report, PSORIASIS (Covered with plaque psoriasis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction
Clinical narrative: COVID arm after the 2nd dose; Red rash on her right arm where she got the vaccine after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm after the 2nd dose) and VACCINATION SITE RASH (Red rash on her right arm where she got the vaccine after the 2nd dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, PRAVASTATIN, MELOXICAM, HYDROXYZINE and GABAPENTIN for an unknown indication.   On 03-Jun-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 VACCINATION SITE REACTION (COVID arm after the 2nd dose) and VACCINATION SITE RASH (Red rash on her right arm where she got the vaccine after the 2nd dose). At the time of the report, VACCINATION SITE REACTION (COVID arm after the 2nd dose) and VACCINATION SITE RASH (Red rash on her right arm where she got the vaccine after the 2nd dose) outcome was unknown.            The patient did not experience side effects after the 1st dose. Patient didn't take any treatment medications but applied an ice pack to the area.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: i got my first moderna shot mid april lost the vaccine card is it too late for me to get my; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (i got my first moderna shot mid april lost the vaccine card is it too late for me to get my) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (i got my first moderna shot mid april lost the vaccine card is it too late for me to get my). At the time of the report, PRODUCT DOSE OMISSION ISSUE (i got my first moderna shot mid april lost the vaccine card is it too late for me to get my) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>42 days of not receiving second Moderna Covid-19 vaccine 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 19-Apr-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 PRODUCT DOSE OMISSION ISSUE (>42 days of not receiving second Moderna Covid-19 vaccine dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>42 days of not receiving second Moderna Covid-19 vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness, Peripheral swelling, Pyrexia
Clinical narrative: GOT STIFFNESS IN HANDS AND FEET; HIGH FEVER; RIGHT ARM SWELLED UP; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (GOT STIFFNESS IN HANDS AND FEET), PERIPHERAL SWELLING (RIGHT ARM SWELLED UP) and PYREXIA (HIGH FEVER) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (RIGHT ARM SWELLED UP). In April 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (GOT STIFFNESS IN HANDS AND FEET) and PYREXIA (HIGH FEVER). On 06-Mar-2021, PERIPHERAL SWELLING (RIGHT ARM SWELLED UP) had resolved. In April 2021, PYREXIA (HIGH FEVER) had resolved. In 2021, MUSCULOSKELETAL STIFFNESS (GOT STIFFNESS IN HANDS AND FEET) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Little headache after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Little headache after the 1st dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity reaction (NOS). Concurrent medical conditions included Diabetes mellitus and Drug allergy (long history of allergies to certain medication).    On 30-Apr-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced HEADACHE (Little headache after the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Little headache after the 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported taking many unspecified concomitant medications for unknown conditions. She reported a history of anaphylactic shock after the administration of an unspecified pneumonia vaccine.   This case was linked to MOD-2021-209026 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Patient demographics updated. Relevant history added.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood glucose, Blood pressure measurement, Pain in extremity, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (large burning welt where ther injection was) and PAIN IN EXTREMITY (arm hurt and was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Muscle spasms, Dysautonomia, Lung disorder (Frozen Lungs) and Bladder infection. Previously administered products included for an unreported indication: botox (doctor injected into paraspinous muscles to stop muscle spasms). Concurrent medical conditions included Paralyzed (Patient was already paralyzed from  an intramedullary, Spinal cord, tumor.), Headache (Constant Headache) and Hypertension. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (large burning welt where ther injection was) and PAIN IN EXTREMITY (arm hurt and was sore). At the time of the report, URTICARIA (large burning welt where ther injection was) and PAIN IN EXTREMITY (arm hurt and was sore) had resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: high (High) high. On an unknown date, Blood glucose: low (Low) low. On an unknown date, Blood pressure measurement: high (High) high. Concomitant medication included a monthly infusion of Intravenous immunoglobulin (IVIG). Patient had phone visits with G.I, Pulmonologist, Dermatologist, PCP, and Neurologist several times. Pulmonologist thought patient had Long Hauler Syndrome. Patient was never tested for COVID. Patient reported that Moderna Vaccine and monthly IVIG infusions helped to get rid of the botox, after suffering extreme symptoms for 6.5 Months.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Dizziness, Nausea, Panic attack
Clinical narrative: Dizziness; Anxiety; Panic attack; Autoimmune disease, that exacerbated; I immediately had nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ANXIETY (Anxiety), PANIC ATTACK (Panic attack), CONDITION AGGRAVATED (Autoimmune disease, that exacerbated) and NAUSEA (I immediately had nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, Autoimmune disorder and Allergy NOS (Allergens). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for Depression, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Dizziness), ANXIETY (Anxiety), PANIC ATTACK (Panic attack), CONDITION AGGRAVATED (Autoimmune disease, that exacerbated) and NAUSEA (I immediately had nausea). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Vertigo, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; IBUPROFEN at a dose of 200 milligram three times a day and PARACETAMOL (TYLENOL) at a dose of 1000 milligram. At the time of the report, DIZZINESS (Dizziness), PANIC ATTACK (Panic attack), CONDITION AGGRAVATED (Autoimmune disease, that exacerbated) and NAUSEA (I immediately had nausea) outcome was unknown and ANXIETY (Anxiety) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-209616 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received on 09-JUL-2021 and contains no significant information. patient reported I'm feeling better and it took 2 months and a lot of green tea with anti inflammatories.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: administered Moderna vaccine to male patient which pre-drawn more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (administered Moderna vaccine to male patient which pre-drawn more than 24 hours) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045b21a and 027b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021 at 4:25 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (administered Moderna vaccine to male patient which pre-drawn more than 24 hours). At the time of the report, PRODUCT ADMINISTRATION ERROR (administered Moderna vaccine to male patient which pre-drawn more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-significant follow-up
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: lump under her armpit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump under her armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (lump under her armpit). At the time of the report, AXILLARY MASS (lump under her armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.  Additional information reported include that the patient had lump under the armpit for 3 weeks.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: We got COVID after both vaccines December/January this may 31th.  Please advise; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (We got COVID after both vaccines December/January this may 31th.  Please advise) 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 December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced COVID-19 (We got COVID after both vaccines December/January this may 31th.  Please advise). At the time of the report, COVID-19 (We got COVID after both vaccines December/January this may 31th.  Please advise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided by the reporter. No lab data was provided by the reporter   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rotator cuff syndrome
Clinical narrative: Rotator cuff tendonitis; pain in shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (Rotator cuff tendonitis) and ARTHRALGIA (pain in shoulders) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since 19-Jul-2017, Seasonal allergic rhinitis (acute seasonal allergic rhinitis.) and Hypercholesteraemia on 19-Jul-2017. Concurrent medical conditions included Pollen allergy, Grass allergy, Allergy to animal (allergic to cats), Allergy to animals (rabbit hair) and Pollen allergy (pine tree pollen allergy.). Concomitant products included CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC-D) for Allergy, ATORVASTATIN from 17-Jul-2017 to an unknown date for Cholesterol, BUPROPION from 09-Dec-2020 to an unknown date for Depression, LEVOTHYROXINE from 17-Jul-2017 to an unknown date for Thyroiditis.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff tendonitis) and ARTHRALGIA (pain in shoulders). At the time of the report, ROTATOR CUFF SYNDROME (Rotator cuff tendonitis) and ARTHRALGIA (pain in shoulders) was resolving.            treatment to the events not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: slight increase in itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slight increase in itching) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease (Slight increase in hand tremors and balance condition) since 20-Jun-2017, Restless leg syndrome, High cholesterol, Hypothyroidism (low thyroid) and GERD. Concomitant products included PANTOPRAZOLE for GERD, SIMVASTATIN for High cholesterol, LEVOTHYROXINE for Hypothyroidism, RASAGILINE from 20-Jun-2017 to an unknown date for Parkinson's disease, ROPINIROLE for Restless leg syndrome.   On 20-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021 at 10:30 AM, 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 PRURITUS (slight increase in itching). At the time of the report, PRURITUS (slight increase in itching) had resolved.      Treatment information not provided for 2nd dose.   This case was linked to MOD-2021-010087 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Product dose omission issue, Pruritus
Clinical narrative: itching like fire; swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.; The doctor advised he should not take the second vaccine shot; red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse; general bad feelings; fever / temperature ranged between 100.8 to 101.2.; bad chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (general bad feelings), RASH ERYTHEMATOUS (red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse), PRURITUS (itching like fire), SWELLING (swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.) and PYREXIA (fever / temperature ranged between 100.8 to 101.2.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FEELING ABNORMAL (general bad feelings), PYREXIA (fever / temperature ranged between 100.8 to 101.2.) and CHILLS (bad chills). On 21-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse). On an unknown date, the patient experienced PRURITUS (itching like fire), SWELLING (swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.) and PRODUCT DOSE OMISSION ISSUE (The doctor advised he should not take the second vaccine shot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram; VALACYCLOVIR [VALACICLOVIR] at a dose of 1 gram; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 1 dosage form and HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (general bad feelings), RASH ERYTHEMATOUS (red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse), PRURITUS (itching like fire), SWELLING (swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.), PYREXIA (fever / temperature ranged between 100.8 to 101.2.), CHILLS (bad chills) and PRODUCT DOSE OMISSION ISSUE (The doctor advised he should not take the second vaccine shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100.8-101.2 (High) temperature ranged between 100.8 to 101.2.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Swelling
Clinical narrative: itching like fire; swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.; The doctor advised he should not take the second vaccine shot; red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse; general bad feelings; fever / temperature ranged between 100.8 to 101.2.; bad chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (general bad feelings), RASH ERYTHEMATOUS (red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse), PRURITUS (itching like fire), SWELLING (swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.) and PYREXIA (fever / temperature ranged between 100.8 to 101.2.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FEELING ABNORMAL (general bad feelings), PYREXIA (fever / temperature ranged between 100.8 to 101.2.) and CHILLS (bad chills). On 21-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse). On an unknown date, the patient experienced PRURITUS (itching like fire), SWELLING (swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.) and PRODUCT DOSE OMISSION ISSUE (The doctor advised he should not take the second vaccine shot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram; VALACYCLOVIR [VALACICLOVIR] at a dose of 1 gram; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 1 dosage form and HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (general bad feelings), RASH ERYTHEMATOUS (red rash in his hair and down his forehead in a "V" to the top of his nose / rash was getting worse), PRURITUS (itching like fire), SWELLING (swelling and spreading down to the bridge of his nose, over his eye lids and on both sides of his face in front of his ears.), PYREXIA (fever / temperature ranged between 100.8 to 101.2.), CHILLS (bad chills) and PRODUCT DOSE OMISSION ISSUE (The doctor advised he should not take the second vaccine shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100.8-101.2 (High) temperature ranged between 100.8 to 101.2.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Blood pressure fluctuation, Chills, Condition aggravated, Dizziness
Clinical narrative: extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse; erratic blood pressure that's high and low.; "as if her mind is all over the place."; nausea; headache; chills; was in bed for the first 24 hours.; extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse), HEADACHE (headache), CHILLS (chills), BEDRIDDEN (was in bed for the first 24 hours.) and CONDITION AGGRAVATED (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse). On 04-Mar-2021, the patient experienced HEADACHE (headache), CHILLS (chills), BEDRIDDEN (was in bed for the first 24 hours.) and NAUSEA (nausea). On 11-Mar-2021, the patient experienced CONDITION AGGRAVATED (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse), BLOOD PRESSURE FLUCTUATION (erratic blood pressure that's high and low.) and THINKING ABNORMAL ("as if her mind is all over the place."). On 04-Feb-2021, DIZZINESS (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse) had resolved. On 04-Mar-2021, HEADACHE (headache) and BEDRIDDEN (was in bed for the first 24 hours.) had resolved. At the time of the report, CONDITION AGGRAVATED (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse), BLOOD PRESSURE FLUCTUATION (erratic blood pressure that's high and low.) and THINKING ABNORMAL ("as if her mind is all over the place.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.   This case was linked to MOD-2021-209818 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Thinking abnormal
Clinical narrative: extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse; erratic blood pressure that's high and low.; "as if her mind is all over the place."; nausea; headache; chills; was in bed for the first 24 hours.; extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse), HEADACHE (headache), CHILLS (chills), BEDRIDDEN (was in bed for the first 24 hours.) and CONDITION AGGRAVATED (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse). On 04-Mar-2021, the patient experienced HEADACHE (headache), CHILLS (chills), BEDRIDDEN (was in bed for the first 24 hours.) and NAUSEA (nausea). On 11-Mar-2021, the patient experienced CONDITION AGGRAVATED (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse), BLOOD PRESSURE FLUCTUATION (erratic blood pressure that's high and low.) and THINKING ABNORMAL ("as if her mind is all over the place."). On 04-Feb-2021, DIZZINESS (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse) had resolved. On 04-Mar-2021, HEADACHE (headache) and BEDRIDDEN (was in bed for the first 24 hours.) had resolved. At the time of the report, CONDITION AGGRAVATED (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse), BLOOD PRESSURE FLUCTUATION (erratic blood pressure that's high and low.) and THINKING ABNORMAL ("as if her mind is all over the place.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.   This case was linked to MOD-2021-209818 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Malaise, Nausea
Clinical narrative: Loss of appetite; Feel sick; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), MALAISE (Feel sick) and NAUSEA (Nauseous) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), MALAISE (Feel sick) and NAUSEA (Nauseous). At the time of the report, DECREASED APPETITE (Loss of appetite), MALAISE (Feel sick) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past 6 hour Vial puncture expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past 6 hour Vial puncture expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) 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 EXPIRED PRODUCT ADMINISTERED (Received vaccine past 6 hour Vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past 6 hour Vial puncture expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Received vaccine past 6 hour Vial puncture expiry) to be not applicable.    Ten male patients received vaccine past the expiry date. Possible date of vaccinations suspected are 4-Mar-2021, 6-Mar-2021, 9-Mar-2021, 15-Mar-2021, 18-Mar-2021, 19-Mar-2021, 22-Mar-2021.Among them, 6 patients received 2nd dose and this case was created for them.   No concomitant medications were reported.  No treatment information was reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Influenza like illness
Clinical narrative: Terrible flu like symptom; Shingles; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Terrible flu like symptom) and HERPES ZOSTER (Shingles) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Terrible flu like symptom) and HERPES ZOSTER (Shingles). At the time of the report, INFLUENZA LIKE ILLNESS (Terrible flu like symptom) and HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.   This case was linked to MOD-2021-209810 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: he was diagnosed with shingles 3 days later; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (he was diagnosed with shingles 3 days later) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (he was diagnosed with shingles 3 days later). At the time of the report, HERPES ZOSTER (he was diagnosed with shingles 3 days later) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter's coworker was diagnosed with shingles. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-209808 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Generalized aching; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Generalized aching) and HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Ankylosing spondylitis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 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 started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In May 2021, the patient experienced PAIN (Generalized aching) and HEADACHE (Headache). At the time of the report, PAIN (Generalized aching) and HEADACHE (Headache) 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. Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness while preparing her meal; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness while preparing her meal) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (dizziness while preparing her meal). On 04-Feb-2021, DIZZINESS (dizziness while preparing her meal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-209805 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) 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: Vaccination complication
Clinical narrative: Delayed reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 (Delayed reaction). At the time of the report, VACCINATION COMPLICATION (Delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect after the 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect after the vaccine). At the time of the report, VACCINATION COMPLICATION (Side effect after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Illness, Muscular weakness
Clinical narrative: recieved 1 dose and i have been sick for 5 weeks now; shortness of breath; left hand is really  weak; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (recieved 1 dose and i have been sick for 5 weeks now), DYSPNEA (shortness of breath), MUSCULAR WEAKNESS (left hand is really  weak) and CHILLS (Chills) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (recieved 1 dose and i have been sick for 5 weeks now), DYSPNEA (shortness of breath), MUSCULAR WEAKNESS (left hand is really  weak) and CHILLS (Chills). At the time of the report, ILLNESS (recieved 1 dose and i have been sick for 5 weeks now), DYSPNEA (shortness of breath), MUSCULAR WEAKNESS (left hand is really  weak) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Follow up document received contains no new information