chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Blood disorder
Clinical narrative: some blood problems around the heart; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD DISORDER (some blood problems around the heart) 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 BLOOD DISORDER (some blood problems around the heart). At the time of the report, BLOOD DISORDER (some blood problems around the heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Patient mentions Moderna has been link to some blood problems around the heart   This case was linked to MOD-2022-437569, MOD-2022-437577, MOD-2022-437756, MOD-2022-437770 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Mass, Neck mass, Urticaria
Clinical narrative: One week after my Moderna booster  on 1/4/22I had a flare up of hives. These come and and go all over my body including my face. I started getting hives about a month after my 2nd dose of Moderna, but they were in control with daily Zyrtec and were  mostly non-existent.  This time, the hives are worse. They are appearing in more locations on my body. In addition, I had lumps on both sides of the back of my next, and behind my ears for 12 hours one day. Yesterday I had an appointment with my doctor who put me on a strict regimen of Zyrtec, Pepcid (2 times a day) and Benadryll at night. If they are not better in a few days, she may give me steroids.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Arm was sore; rash locally at the injection site that lasted a week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE RASH (rash locally at the injection site that lasted a week) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 0361321A) 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) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE RASH (rash locally at the injection site that lasted a week). At the time of the report, VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE RASH (rash locally at the injection site that lasted a week) had resolved.            No concomitant medication was reported.  Treatment drugs included steroids.   This case was linked to MOD-2022-437867 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Temp excursion for 15 vials/supposed to be discarded last Jan1,2022; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Temp excursion for 15 vials/supposed to be discarded last Jan1,2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Temp excursion for 15 vials/supposed to be discarded last Jan1,2022). On 03-Jan-2022, PRODUCT STORAGE ERROR (Temp excursion for 15 vials/supposed to be discarded last Jan1,2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: slight fever,100f; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever,100f) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 043L20A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (blood pressure), Diabetes, Acid reflux (esophageal) and Urinary tract disorder (Urinary issues). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), RIVAROXABAN (XARELTO) for Anticoagulant therapy, PIOGLITAZONE HYDROCHLORIDE (ACTOS) for Diabetes, RAMIPRIL and TRIAMTERENE for Hypertension, DUTASTERIDE for Urinary tract disorder.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (slight fever,100f). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (slight fever,100f) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, Body temperature: 100.6 (High) 100.6 f.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Vaccine on 03Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (problems with the 2 Moderna shots) and feeling abnormal (she felt bad) in a female patient, of unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (problems with the 2 Moderna shots) and feeling abnormal (she felt bad). At the time of the report, vaccination complication (problems with the 2 Moderna shots) and feeling abnormal (she felt bad) outcome: unknown. Patient reported she had to ask someone to unscrew the top of water bottle for her to get a drink of water. No concomitant medication or treatment information provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Vaccine on 03Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-438074, MOD-2022-438047 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Vaccine on 03Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-438047, MOD-2022-438073 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose 10 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10 days after first dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016c21a and 020b20b) for COVID-19 vaccination.     Concurrent medical conditions included Cramps, Arthritis and Acid reflux (oesophageal).   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10 days after first dose). On 30-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10 days after first dose) had resolved.            Concomitant products include pills for cramps,pills for arthritis and acid reflects. No treatment information was provided.   This case was linked to MOD-2022-436032 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of accidental underdose (patient given 0.25mL of the Moderna vaccine as their first dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 0.25mL. On an unknown date, patient experienced an accidental underdose (patient given 0.25mL of the Moderna vaccine as their first dose). At the time of the report, accidental underdose (patient given 0.25mL of the Moderna vaccine as their first dose) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nasal congestion, Pyrexia
Clinical narrative: A little congestion; Running fever, staying in the 100's; bad headache; This spontaneous case was reported by a pharmacist and describes the occurrence of NASAL CONGESTION (A little congestion), PYREXIA (Running fever, staying in the 100's) and HEADACHE (bad headache) 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 NASAL CONGESTION (A little congestion), PYREXIA (Running fever, staying in the 100's) and HEADACHE (bad headache). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (A little congestion), PYREXIA (Running fever, staying in the 100's) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100's (High) staying in the 100's.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Treatment information for rest two events were not provided by the reporter.   Reporter did not allow further contact
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 3-decade-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The reported cause of death was Heart attack. It is unknown if an autopsy was performed.            No concomitant and treatment medication was reported by patient.   This case was linked to MOD-2022-438341, MOD-2022-438342, MOD-2022-438339, MOD-2022-438336, MOD-2022-438340 (Patient Link).; Reported Cause(s) of Death: Heart attack
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: covered in sweat; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (covered in sweat) and DIZZINESS (dizzy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 038K20A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal and Blood pressure high.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced HYPERHIDROSIS (covered in sweat) and DIZZINESS (dizzy). At the time of the report, HYPERHIDROSIS (covered in sweat) and DIZZINESS (dizzy) outcome was unknown.            The patient's took medicines for cholesterol and high blood pressure.  Patient did not take any medication for the symptoms.  It was reported that the patient woke up 20 minutes ago covered in sweat and was dizzy.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We administered the Moderna booster dose to a patient past the12 hours expiration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered the Moderna booster dose to a patient past the12 hours expiration) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 040B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We administered the Moderna booster dose to a patient past the12 hours expiration). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (We administered the Moderna booster dose to a patient past the12 hours expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Exposure to communicable disease, General symptom, Laboratory test
Clinical narrative: mild symptoms; exposed 10 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of GENERAL SYMPTOM (mild symptoms) and EXPOSURE TO COMMUNICABLE DISEASE (exposed 10 days ago) 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. In December 2021, the patient experienced GENERAL SYMPTOM (mild symptoms) and EXPOSURE TO COMMUNICABLE DISEASE (exposed 10 days ago). At the time of the report, GENERAL SYMPTOM (mild symptoms) and EXPOSURE TO COMMUNICABLE DISEASE (exposed 10 days ago) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, Laboratory test: positive (Positive) tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was exposed 10 days ago and had mild symptoms 7 days ago which were almost gone.  The patient enquired about receiving the booster dose.  No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Rash, Sluggishness, Thirst
Clinical narrative: feeling very thirsty; dizziness; a rash from her neck down to her shoulder; hot & cold sensation; feeling very sluggish; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (feeling very thirsty), SLUGGISHNESS (feeling very sluggish), DIZZINESS (dizziness), RASH (a rash from her neck down to her shoulder) and CHILLS (hot & cold sensation) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039a21a and 027a21a) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS] and INTERFERON BETA-1A (AVONEX) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SLUGGISHNESS (feeling very sluggish). On 23-Dec-2021, the patient experienced THIRST (feeling very thirsty), DIZZINESS (dizziness), RASH (a rash from her neck down to her shoulder) and CHILLS (hot & cold sensation). At the time of the report, THIRST (feeling very thirsty), SLUGGISHNESS (feeling very sluggish), DIZZINESS (dizziness), RASH (a rash from her neck down to her shoulder) and CHILLS (hot & cold sensation) outcome was unknown.            As treatment the patient was taken allergy pills and put ointment on the rash.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Vaccination complication
Clinical narrative: runny nose; temperature of 99.3°F; covid arm: red; 3 inch bulge size in injection arm,2 inch bulge size in the arm were they had put the Moderna under skin to test allergy; Exuberant immune response; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), VACCINATION COMPLICATION (Exuberant immune response), VACCINATION SITE REACTION (Covid arm), PYREXIA (temperature of 99.3°F) and VACCINATION SITE ERYTHEMA (covid arm: red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Overweight, Diabetes and Iodine allergy (iodine in shellfish).    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (Exuberant immune response), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE ERYTHEMA (covid arm: red) and VACCINATION SITE SWELLING (3 inch bulge size in injection arm,2 inch bulge size in the arm were they had put the Moderna under skin to test allergy). On an unknown date, the patient experienced RHINORRHOEA (runny nose) and PYREXIA (temperature of 99.3°F). At the time of the report, RHINORRHOEA (runny nose), VACCINATION COMPLICATION (Exuberant immune response), VACCINATION SITE REACTION (Covid arm), PYREXIA (temperature of 99.3°F), VACCINATION SITE ERYTHEMA (covid arm: red) and VACCINATION SITE SWELLING (3 inch bulge size in injection arm,2 inch bulge size in the arm were they had put the Moderna under skin to test allergy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 (High) 99.3°F. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative on Sunday.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She had 1 Moderna COVID-19 vaccine on 02Dec2021 and was due for her second one on Thursday 06Jan2022 but her husband has COVID so she is quarantined now and won't be able to get the second dose on 06Jan2022. She had anaphylaxis before to another injection so when she got the Moderna shot they watched her for over 2 hours, but she did not have reactions then. From that past anaphylaxis they had determined she had allergy to iodine in shellfish. Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2022-438841 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: runny nose; temperature of 99.3°F; covid arm: red; 3 inch bulge size in injection arm,2 inch bulge size in the arm were they had put the Moderna under skin to test allergy; Exuberant immune response; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), VACCINATION COMPLICATION (Exuberant immune response), VACCINATION SITE REACTION (Covid arm), PYREXIA (temperature of 99.3°F) and VACCINATION SITE ERYTHEMA (covid arm: red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Overweight, Diabetes and Iodine allergy (iodine in shellfish).    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (Exuberant immune response), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE ERYTHEMA (covid arm: red) and VACCINATION SITE SWELLING (3 inch bulge size in injection arm,2 inch bulge size in the arm were they had put the Moderna under skin to test allergy). On an unknown date, the patient experienced RHINORRHOEA (runny nose) and PYREXIA (temperature of 99.3°F). At the time of the report, RHINORRHOEA (runny nose), VACCINATION COMPLICATION (Exuberant immune response), VACCINATION SITE REACTION (Covid arm), PYREXIA (temperature of 99.3°F), VACCINATION SITE ERYTHEMA (covid arm: red) and VACCINATION SITE SWELLING (3 inch bulge size in injection arm,2 inch bulge size in the arm were they had put the Moderna under skin to test allergy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 (High) 99.3°F. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative on Sunday.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She had 1 Moderna COVID-19 vaccine on 02Dec2021 and was due for her second one on Thursday 06Jan2022 but her husband has COVID so she is quarantined now and won't be able to get the second dose on 06Jan2022. She had anaphylaxis before to another injection so when she got the Moderna shot they watched her for over 2 hours, but she did not have reactions then. From that past anaphylaxis they had determined she had allergy to iodine in shellfish. Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2022-438841 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Mechanical urticaria, Pruritus
Clinical narrative: itched; she had skin writing dermatographia; Had injury to thumb and thought it was due to this injury; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itched), MECHANICAL URTICARIA (she had skin writing dermatographia) and LIMB INJURY (Had injury to thumb and thought it was due to this injury) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMITRIPTYLINE and MULTIVITAMIN GUMMY BEARS for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced MECHANICAL URTICARIA (she had skin writing dermatographia) and LIMB INJURY (Had injury to thumb and thought it was due to this injury). On an unknown date, the patient experienced PRURITUS (itched). In June 2021, MECHANICAL URTICARIA (she had skin writing dermatographia) and LIMB INJURY (Had injury to thumb and thought it was due to this injury) had resolved. At the time of the report, PRURITUS (itched) outcome was unknown.      No treatment information was provided.   This case was linked to MOD-2022-438426 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: A patient who is immunocompromised (solid organ transplant) received a booster dose instead of a full 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient who is immunocompromised (solid organ transplant) received a booster dose instead of a full 3rd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Solid organ transplant. Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (A patient who is immunocompromised (solid organ transplant) received a booster dose instead of a full 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (A patient who is immunocompromised (solid organ transplant) received a booster dose instead of a full 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient received a booster dose instead of a full 3rd dose. It has been 6 months since completion of the primary series.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Pyrexia
Clinical narrative: Sick for one or two days; Being unusually tired; Chills; Fever; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Sick for one or two days), FATIGUE (Being unusually tired), CHILLS (Chills) and PYREXIA (Fever) 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 ILLNESS (Sick for one or two days), FATIGUE (Being unusually tired), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, ILLNESS (Sick for one or two days), FATIGUE (Being unusually tired), CHILLS (Chills) and PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2022-438428, MOD-2022-438430 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: a little bit sick; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (a little bit sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (a little bit sick). At the time of the report, ILLNESS (a little bit sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not under any medication.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-438418, MOD-2022-438430 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Urticaria
Clinical narrative: Hives in her body/Hives started in her back and stomach, then in her ankles and forehead/Hives come and go and appear in big patches/Hives appeared in her arm and face on her eyes, shin,thighs, calves and neck; Behind her ear it was really hot/Ear was burning out/Ear was really hot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA and EAR DISCOMFORT in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067821A, 026120A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced EAR DISCOMFORT. On 24-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA. The patient was treated with BENADRYL for Hives, at an unspecified dose and frequency and ZYRTEC for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA and EAR DISCOMFORT had not resolved.            No relevant concomitant medications were reported. It was reported that on 24-Dec-2021 the patient started hives in her back and stomach, then in her ankles and forehead. Her ear was burning out, really hot. The patient repeated that behind her ear it was really hot. The hives came and go, and appear in big patches. Then they disappear, and reappear all over the body. The hives appeared in her arm and face, on her eyes, shin, thighs, calves, and neck. Symptoms was still ongoing.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; Arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Arm pain at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] and SPIRONOLACTONE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Arm pain at injection site). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Arm pain at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No medical history reported by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-438549, MOD-2022-438572, MOD-2022-438548 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (urticaria) 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 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (urticaria). At the time of the report, URTICARIA (urticaria) had not resolved.            Patient had urticaria since approx 10 days post booster shot 03-Dec-2021. No concomitant medications were provided. No treatment medications were provided
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed hives and itchiness all over his body.; If he applies any pressure or lightly scratch his arm or any spot on his body he would break out in hives at the spot.  It will raise up in hives in that area.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Developed hives and itchiness all over his body.) and URTICARIA (If he applies any pressure or lightly scratch his arm or any spot on his body he would break out in hives at the spot.  It will raise up in hives in that area.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2022, the patient experienced PRURITUS (Developed hives and itchiness all over his body.) and URTICARIA (If he applies any pressure or lightly scratch his arm or any spot on his body he would break out in hives at the spot.  It will raise up in hives in that area.). At the time of the report, PRURITUS (Developed hives and itchiness all over his body.) and URTICARIA (If he applies any pressure or lightly scratch his arm or any spot on his body he would break out in hives at the spot.  It will raise up in hives in that area.) outcome was unknown.            No concomitant medication were reported. No treatment details were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; Arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Arm pain at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] and SPIRONOLACTONE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Arm pain at injection site). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Arm pain at injection site) outcome was unknown.            No treatment details were reported for the events occurred after specified Dose 2.   This case was linked to MOD-2022-438540 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: not immunocompromised and received 100 mcg for booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (not immunocompromised and received 100 mcg for booster dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06ZE21A, D11L21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 mcg. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 23-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (not immunocompromised and received 100 mcg for booster dose). On 23-Aug-2021, ACCIDENTAL OVERDOSE (not immunocompromised and received 100 mcg for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The reporter stated she and her husband were given the third shot, the booster, in late August. They both received a full dose of 100 mcg. It was the same as the first. The HCP stated that she was immunocompromised, but her husband was not.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Swelling
Clinical narrative: Severe sore throat post booster; Swelling on left side of neck post booster; This spontaneous case was reported by a pharmacist and describes the occurrence of OROPHARYNGEAL PAIN (Severe sore throat post booster) and SWELLING (Swelling on left side of neck post booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Severe sore throat post booster) and SWELLING (Swelling on left side of neck post booster). At the time of the report, OROPHARYNGEAL PAIN (Severe sore throat post booster) and SWELLING (Swelling on left side of neck post booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient's son has Covid for the second time.  No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever; arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and INJECTION SITE PAIN (arm pain at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and SPIRONOLACTONE (SPIRONOLACTON) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever) and INJECTION SITE PAIN (arm pain at injection site). At the time of the report, PYREXIA (Fever) and INJECTION SITE PAIN (arm pain at injection site) outcome was unknown.            Patient took anti itch cream as treatment.   This case was linked to MOD-2022-438540, MOD-2022-438549 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: a cold/cold-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (a cold/cold-like symptoms) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (a cold/cold-like symptoms). At the time of the report, NASOPHARYNGITIS (a cold/cold-like symptoms) had not resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Arm a little sore; Low grade fever (32C); Headache; Body aches (back and neck); Nausea; Can feel her glands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a little sore), PYREXIA (Low grade fever (32C)), HEADACHE (Headache), MYALGIA (Body aches (back and neck)) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 020B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm a little sore), PYREXIA (Low grade fever (32C)), HEADACHE (Headache), MYALGIA (Body aches (back and neck)), NAUSEA (Nausea) and LYMPHADENOPATHY (Can feel her glands). At the time of the report, PAIN IN EXTREMITY (Arm a little sore), PYREXIA (Low grade fever (32C)), HEADACHE (Headache), MYALGIA (Body aches (back and neck)), NAUSEA (Nausea) and LYMPHADENOPATHY (Can feel her glands) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 32 (High) 32C.         No concomitant medications were reported. No treatment information were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm a little sore; Low grade fever (32C); Headache; Body aches (back and neck); Nausea; Can feel her glands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a little sore), PYREXIA (Low grade fever (32C)), HEADACHE (Headache), MYALGIA (Body aches (back and neck)) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 020B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm a little sore), PYREXIA (Low grade fever (32C)), HEADACHE (Headache), MYALGIA (Body aches (back and neck)), NAUSEA (Nausea) and LYMPHADENOPATHY (Can feel her glands). At the time of the report, PAIN IN EXTREMITY (Arm a little sore), PYREXIA (Low grade fever (32C)), HEADACHE (Headache), MYALGIA (Body aches (back and neck)), NAUSEA (Nausea) and LYMPHADENOPATHY (Can feel her glands) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 32 (High) 32C.         No concomitant medications were reported. No treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick for almost 10 DAYS; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for almost 10 DAYS) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ILLNESS (sick for almost 10 DAYS). At the time of the report, ILLNESS (sick for almost 10 DAYS) had resolved.            No concomitant medication information was provided.  No treatment medication were provided.