chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pain
Clinical narrative: STOMACH PAIN; BODY PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced stomach pain, body pain, chills, fever, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, body pain, headache, stomach pain and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: STOMACH PAIN; BODY PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced stomach pain, body pain, chills, fever, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, body pain, headache, stomach pain and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Renal pain
Clinical narrative: GENERAL MUSCLE ATROPHY TYPE FEELING; KIDNEY PAIN; BEEN DOWN; MASSIVE HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced general muscle atrophy type feeling, kidney pain, been down, and massive headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the been down, kidney pain, massive headaches and general muscle atrophy type feeling was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Tremor
Clinical narrative: BODY ACHES; TREMOR; CHILLS; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 143 pounds, and height was 61 inches. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergy and no history of illicit drug use. The patient was previously treated with methylphenidate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042172117, and expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced body aches. On 06-AUG-2021, the patient experienced tremor. On 06-AUG-2021, the patient experienced chills. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 06-AUG-2021, and had not recovered from chills, and tremor. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: HAND AND FOUR FINGERS NUMB; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 07-AUG-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced hand and four fingers numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hand and four fingers numb was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: FEVER; MUSCLE ACHES; LOCAL SITE INJECTION PAIN; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fever, muscle aches, local site injection pain, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, muscle aches, local site injection pain, nausea and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: neighbors got sick; 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 VACCINATION COMPLICATION (neighbors got sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (neighbors got sick). At the time of the report, VACCINATION COMPLICATION (neighbors got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness, swelling, and pain around the injection site; Redness, swelling, and pain around the injection site; Redness, swelling, and pain around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness, swelling, and pain around the injection site), VACCINATION SITE SWELLING (Redness, swelling, and pain around the injection site) and VACCINATION SITE PAIN (Redness, swelling, and pain around the injection site) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness, swelling, and pain around the injection site), VACCINATION SITE SWELLING (Redness, swelling, and pain around the injection site) and VACCINATION SITE PAIN (Redness, swelling, and pain around the injection site). At the time of the report, ERYTHEMA (Redness, swelling, and pain around the injection site) and VACCINATION SITE SWELLING (Redness, swelling, and pain around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD21-024106, MOD21-024134 (E2B Linked Report).; Sender's Comments:  MOD21-024106: MOD21-024134:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with COVID19 after 1st dose of Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID19 after 1st dose of Moderna COVID19 vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 COVID-19 (Diagnosed with COVID19 after 1st dose of Moderna COVID19 vaccine). At the time of the report, COVID-19 (Diagnosed with COVID19 after 1st dose of Moderna COVID19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patient received 0.25ml dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received 0.25ml dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 25-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (patient received 0.25ml dose). On 25-Mar-2021, ACCIDENTAL UNDERDOSE (patient received 0.25ml dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report refers to a case of accidental underdose for mRNA-1273, lot # 017B21A with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273, lot # 017B21A with no associated AEs.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Confusional state, Dizziness, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; Lightheadedness; fatigue; confusion; usually hypoglycemic but this time around his blood work showed a little lower sugar then usual.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), DIZZINESS (Lightheadedness), FATIGUE (fatigue), CONFUSIONAL STATE (confusion) and BLOOD GLUCOSE DECREASED (usually hypoglycemic but this time around his blood work showed a little lower sugar then usual.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypoglycemia, Sleep apnea, Sjogren's and Interstitial lung disease.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), DIZZINESS (Lightheadedness), FATIGUE (fatigue), CONFUSIONAL STATE (confusion) and BLOOD GLUCOSE DECREASED (usually hypoglycemic but this time around his blood work showed a little lower sugar then usual.). At the time of the report, DYSPNOEA (shortness of breath), DIZZINESS (Lightheadedness), FATIGUE (fatigue), CONFUSIONAL STATE (confusion) and BLOOD GLUCOSE DECREASED (usually hypoglycemic but this time around his blood work showed a little lower sugar then usual.) outcome was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Face oedema, Herpes zoster, Nausea
Clinical narrative: dizzy; constantly laying in bed; two big bumps on forehead; nausea; vomiting; Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (constantly laying in bed), FACE OEDEMA (two big bumps on forehead), HERPES ZOSTER (Shingles) and NAUSEA (nausea) in a 71-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.     Concomitant products included VITAMINS NOS for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced DIZZINESS (dizzy), ASTHENIA (constantly laying in bed), FACE OEDEMA (two big bumps on forehead), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with ONDANSETRON at an unspecified dose and frequency and BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), ASTHENIA (constantly laying in bed), FACE OEDEMA (two big bumps on forehead), HERPES ZOSTER (Shingles), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  Patient has been treated with pain medications.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter salutation updated, Treatment medication updated, Added new event Shingles.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dizzy; constantly laying in bed; two big bumps on forehead; nausea; vomiting; Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (constantly laying in bed), FACE OEDEMA (two big bumps on forehead), HERPES ZOSTER (Shingles) and NAUSEA (nausea) in a 71-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.     Concomitant products included VITAMINS NOS for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced DIZZINESS (dizzy), ASTHENIA (constantly laying in bed), FACE OEDEMA (two big bumps on forehead), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with ONDANSETRON at an unspecified dose and frequency and BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), ASTHENIA (constantly laying in bed), FACE OEDEMA (two big bumps on forehead), HERPES ZOSTER (Shingles), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  Patient has been treated with pain medications.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter salutation updated, Treatment medication updated, Added new event Shingles.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Patient states that she started experiencing itchy; Swollen; Red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Patient states that she started experiencing itchy), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), CLOPIDOGREL BISULFATE (PLAVIX), LEVOTHYROXINE, ASPIRIN [ACETYLSALICYLIC ACID], METFORMIN and GABAPENTIN for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Patient states that she started experiencing itchy), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE PRURITUS (Patient states that she started experiencing itchy), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Retching, Vaccination site bruising, Vomiting
Clinical narrative: Dry heaves; vomiting; pain in the arm; Bruise at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE BRUISING (Bruise at vaccination site), RETCHING (Dry heaves) and VOMITING (vomiting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE BRUISING (Bruise at vaccination site). On an unknown date, the patient experienced RETCHING (Dry heaves) and VOMITING (vomiting). On 08-Apr-2021, PAIN IN EXTREMITY (pain in the arm) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruise at vaccination site), RETCHING (Dry heaves) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-080186 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Added events (Dry heaves, vomiting ).; Sender's Comments:  MOD21-080186:Husband's case
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: covid arm; lump at the site of the injection; warm to touch; swelling at the site of the injection; mild itching at the site of the injection; pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), VACCINATION SITE MASS (lump at the site of the injection), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swelling at the site of the injection) and VACCINATION SITE PRURITUS (mild itching at the site of the injection) 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.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE MASS (lump at the site of the injection), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swelling at the site of the injection), VACCINATION SITE PRURITUS (mild itching at the site of the injection) and VACCINATION SITE PAIN (pain at the site of the injection). On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (swelling at the site of the injection) and VACCINATION SITE PAIN (pain at the site of the injection) outcome was unknown and VACCINATION SITE MASS (lump at the site of the injection), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE PRURITUS (mild itching at the site of the injection) was resolving.            No concomitant medication were reported. Treatment included 2 Tylenol and the patient reported that the symptoms are gradually getting better.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: covid arm; lump at the site of the injection; warm to touch; swelling at the site of the injection; mild itching at the site of the injection; pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), VACCINATION SITE MASS (lump at the site of the injection), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swelling at the site of the injection) and VACCINATION SITE PRURITUS (mild itching at the site of the injection) 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.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE MASS (lump at the site of the injection), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swelling at the site of the injection), VACCINATION SITE PRURITUS (mild itching at the site of the injection) and VACCINATION SITE PAIN (pain at the site of the injection). On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (swelling at the site of the injection) and VACCINATION SITE PAIN (pain at the site of the injection) outcome was unknown and VACCINATION SITE MASS (lump at the site of the injection), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE PRURITUS (mild itching at the site of the injection) was resolving.            No concomitant medication were reported. Treatment included 2 Tylenol and the patient reported that the symptoms are gradually getting better.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: A little sore at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (A little sore at the injection site) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Cardiac thrombosis. Concurrent medical conditions included Hypertension. Concomitant products included SOTALOL for Arrhythmia, VALSARTAN (DIOVAN) for Hypertension, RIVAROXABAN (XARELTO) for Thrombosis.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2020, the patient experienced INJECTION SITE PAIN (A little sore at the injection site). On 23-Dec-2020, INJECTION SITE PAIN (A little sore at the injection site) 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.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Medical history, concomitant medications, outcome of the event were updated.; Reporter's Comments: This case concerns a 55 year old male subject, who experienced the listed event of sore at the injection site. The event occurred  on 21 DEC 2020, 30-40 minutes after first dose of IP.  The event was considered ongoing as of 28 DEC 2020. The event was considered related to IP due to temporal association. However, it might be explained due to the way of administration. Further details are requested to the reporter.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Sore Arm; Elevated temp from normal; Body Aches; Fatigue; Cold chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore Arm), PYREXIA (Elevated temp from normal), MYALGIA (Body Aches), FATIGUE (Fatigue) and CHILLS (Cold chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Pre-diabetic (Borderline) and Drug allergy (Augmentin). Concomitant products included THYROID (ARMOUR THYROID), CETIRIZINE HYDROCHLORIDE, CYANOCOBALAMIN (VITAMIN B12), ZINC, IODINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), IBUPROFEN (ADVIL [IBUPROFEN]), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 23-Dec-2020 at 2:38 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020 at 11:59 PM, the patient experienced VACCINATION SITE PAIN (Sore Arm), PYREXIA (Elevated temp from normal), MYALGIA (Body Aches), FATIGUE (Fatigue) and CHILLS (Cold chills). At the time of the report, VACCINATION SITE PAIN (Sore Arm), PYREXIA (Elevated temp from normal), MYALGIA (Body Aches), FATIGUE (Fatigue) and CHILLS (Cold chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-050544 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow-up information provided second dose therapy date. On 11-May-2021: Outcome of the event is updated.Dose-2 information is added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case concerns a 34 year old male subject with a medical history of hypothyroidism, borderline pre-diabetic, and Augmentin allergy, who experienced the listed events of body aches, sore arm, fatigue, cold chills, and elevated temp from normal. The events occurred  on the same day after receiving the first dose of IP. The event´s outcome are unknown. The reporter did not provide the causality assessment. The events were considered possibly related to IP. Further clarification is required.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Headache, Vaccination site pain
Clinical narrative: Dizziness, headache, and soreness at the injection site. Three hours after the injection the dizziness started again which caused her to fall and injure herself, scraped up her knees, hands, and injured her shoulder; Fall; Headache; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, headache, and soreness at the injection site. Three hours after the injection the dizziness started again which caused her to fall and injure herself, scraped up her knees, hands, and injured her shoulder), FALL (Fall), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q11J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced DIZZINESS (Dizziness, headache, and soreness at the injection site. Three hours after the injection the dizziness started again which caused her to fall and injure herself, scraped up her knees, hands, and injured her shoulder), FALL (Fall), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injection site). On 22-Dec-2020, FALL (Fall) had resolved with sequelae. At the time of the report, DIZZINESS (Dizziness, headache, and soreness at the injection site. Three hours after the injection the dizziness started again which caused her to fall and injure herself, scraped up her knees, hands, and injured her shoulder), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: No new information received. A request to provide patient identifiers was received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The event: fall is unlikely related. This case concerns a 64-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot Q11J20A), and who experienced dizziness, headache, injection site pain, and fall.  The events of dizziness, headache and injection site pain were considered possibly related to the vaccine due to the temporal relationship, while the event of fall was considered unlikely related to the vaccine and more likely explained by the dizziness.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Nausea
Clinical narrative: Headache; Swelling at the injection site; Nausea; A spontaneous report was received from a consumer, a 48 year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced nausea, headache, and swelling at the injection site.    The patient's medical history, as provided by the reporter included inflammatory arthritis and autoimmune disorder. Products known to have been used by the patient, within two weeks prior to the event, included leflunomide.    On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020 and experienced nausea after the vaccine. She stated that she also experienced swelling at the injection site and it is not getting better. The patient reported that on 25 Dec 2020, she had a headache. She stated that the nausea was worse on 26 Dec 2020.   No treatment medication was taken at the time.   Action taken with mRNA-1273 in response to the events was not reported.   The events, nausea, headache, and swelling at the injection site, were considered not resolved.; Reporter's Comments: This case concerns a 48-year-old female who experienced NS expected events of injection site swelling, headache, nausea.  Event onset the same day as the first dose of mRNA-1273. Treatment not reported. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Chills, Fatigue, Pain
Clinical narrative: Fever; Tired; Chills; Body aches/body hurts; Temp was nonexistent; A spontaneous report was received from a nurse concerning a 48-years-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced body aches/body hurts, temp was nonexistent, chills, fever, and tired.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right shoulder for prophylaxis of COVID-19 infection.   On 23 Dec 2020, after returning home at night, the patient experienced body aches, chills, and her temp was nonexistent.  On 24 Dec 2020, the patient woke up not feeling good, and her temperature was 99.8 degrees Fahrenheit. Later that day her temperature was 101.8 degrees Fahrenheit. At the time of her report, she was tired, experiencing chills, her body hurt, and her temperature was 100.8 degrees Fahrenheit.   Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the event(s) was not provided.   The events, body aches/body hurts, chills, fever, and tired, and temp was nonexistent were considered not resolved.; Reporter's Comments: This case concerns a 48-year-old female who experienced NS unexpected events of pain, body temperature abnormal and NS expected events of fever, chills, fatigue.  Event onset the same days as the first dose of mRNA-1273. Treated with paracetamol. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Tired; Chills; Body aches/body hurts; Temp was nonexistent; A spontaneous report was received from a nurse concerning a 48-years-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced body aches/body hurts, temp was nonexistent, chills, fever, and tired.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right shoulder for prophylaxis of COVID-19 infection.   On 23 Dec 2020, after returning home at night, the patient experienced body aches, chills, and her temp was nonexistent.  On 24 Dec 2020, the patient woke up not feeling good, and her temperature was 99.8 degrees Fahrenheit. Later that day her temperature was 101.8 degrees Fahrenheit. At the time of her report, she was tired, experiencing chills, her body hurt, and her temperature was 100.8 degrees Fahrenheit.   Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the event(s) was not provided.   The events, body aches/body hurts, chills, fever, and tired, and temp was nonexistent were considered not resolved.; Reporter's Comments: This case concerns a 48-year-old female who experienced NS unexpected events of pain, body temperature abnormal and NS expected events of fever, chills, fatigue.  Event onset the same days as the first dose of mRNA-1273. Treated with paracetamol. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 37-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in April 2017, Live birth (Full term) on 20-Apr-2018 and Alcohol use (glass every 2 weeks). Concurrent medical conditions included Migraine (Intermittent) since 2003. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), MAGNESIUM, DOCUSATE and PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Aug-2020 and the estimated date of delivery was 25-May-2021. On 26-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 26-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2020, Pregnancy test: positive (Positive) positive.     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.   The previous pregnancy included 1 live birth on 20 Apr 2018 and 1 miscarriage on Apr 2017. Treatment information was not provided.   Reporter did not allow further contact; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site warmth, Lymphadenopathy, Muscle fatigue, Nausea
Clinical narrative: Could feel the heat coming of my arm; injection site muscle constricting; Injection site nerve pain; Throat also starting to swell; Arm swelling which progressed over the week,Arm doubled in size; Arm welted and itchy; Allergic reaction; fever; lymph node swell; redness at injection site; nausea; visual disturbance and distortions; seems like room was spinning; hardness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE INDURATION (hardness near injection site) and LYMPHADENOPATHY (lymph node swell) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), VACCINATION SITE INDURATION (hardness near injection site), LYMPHADENOPATHY (lymph node swell), VACCINATION SITE ERYTHEMA (redness at injection site) and NAUSEA (nausea). On 24-Dec-2020, the patient experienced HYPERSENSITIVITY (Allergic reaction). On 23-Dec-2020, VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), VACCINATION SITE INDURATION (hardness near injection site), LYMPHADENOPATHY (lymph node swell) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown and NAUSEA (nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case concerns a 27-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), and who experienced the listed events of lymphadenopathy, nausea, injection site erythema, and injection site swelling, and the  unlisted events of visual impairment, motion sickness, and seems like room was spinning.  The events were considered possibly related to the vaccine due to the temporal relationship and the known safety profile.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: No specific follow-up information recorded. On 31-Mar-2021: HCP information added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Peripheral swelling, Pharyngeal swelling, Pruritus, Pyrexia
Clinical narrative: Could feel the heat coming of my arm; injection site muscle constricting; Injection site nerve pain; Throat also starting to swell; Arm swelling which progressed over the week,Arm doubled in size; Arm welted and itchy; Allergic reaction; fever; lymph node swell; redness at injection site; nausea; visual disturbance and distortions; seems like room was spinning; hardness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE INDURATION (hardness near injection site) and LYMPHADENOPATHY (lymph node swell) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), VACCINATION SITE INDURATION (hardness near injection site), LYMPHADENOPATHY (lymph node swell), VACCINATION SITE ERYTHEMA (redness at injection site) and NAUSEA (nausea). On 24-Dec-2020, the patient experienced HYPERSENSITIVITY (Allergic reaction). On 23-Dec-2020, VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), VACCINATION SITE INDURATION (hardness near injection site), LYMPHADENOPATHY (lymph node swell) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown and NAUSEA (nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case concerns a 27-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), and who experienced the listed events of lymphadenopathy, nausea, injection site erythema, and injection site swelling, and the  unlisted events of visual impairment, motion sickness, and seems like room was spinning.  The events were considered possibly related to the vaccine due to the temporal relationship and the known safety profile.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: No specific follow-up information recorded. On 31-Mar-2021: HCP information added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.