chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Constipation, Dyspepsia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), DYSPEPSIA (Bad digestive problem) and ABDOMINAL DISCOMFORT (Had a bad bowel movement) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis (Arthritis joint). On 30-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 CONSTIPATION (Constipation), DYSPEPSIA (Bad digestive problem) and ABDOMINAL DISCOMFORT (Had a bad bowel movement). At the time of the report, CONSTIPATION (Constipation), DYSPEPSIA (Bad digestive problem) and ABDOMINAL DISCOMFORT (Had a bad bowel movement) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication list was not provided. Treatment information was not provided. This case was linked to MOD-2021-190999.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: knee was sore; extreme fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee was sore) and FATIGUE (extreme fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00153352) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-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 ARTHRALGIA (knee was sore) and FATIGUE (extreme fatigue). At the time of the report, ARTHRALGIA (knee was sore) and FATIGUE (extreme fatigue) had resolved.            She stated that she did not report any adverse reaction. She is curious as to who could have reported this. She said she didn't have any reactions after the first shot. The knee pain happened before the vaccine. She said that she has a history of arthritis and that the sore knee doesn't have anything to do with the vaccine. The first shot was 01-Apr-2021 and not sometime in March. After the 2nd shot which was on 19-May-2021, she had extreme fatigue but she is fine now. She does not wish to be contacted further.   This case was linked to MOD-2021-089072, MOD-2021-089072 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: fatigue/tiredness; chills; soreness at the site of the injection after 2nd dose of Moderna Covid-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue/tiredness), CHILLS (chills) and VACCINATION SITE PAIN (soreness at the site of the injection after 2nd dose of Moderna Covid-19 vaccination) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C03C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced FATIGUE (fatigue/tiredness). 28-May-2021, the patient experienced CHILLS (chills) and VACCINATION SITE PAIN (soreness at the site of the injection after 2nd dose of Moderna Covid-19 vaccination). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg. At the time of the report, FATIGUE (fatigue/tiredness), CHILLS (chills) and VACCINATION SITE PAIN (soreness at the site of the injection after 2nd dose of Moderna Covid-19 vaccination) outcome was unknown.            No concomitant medications were provided.   This case was linked to MOD-2021-100454, MOD-2021-100454 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Tired; achy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Tired) and PAIN (achy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired) and PAIN (achy). At the time of the report, FATIGUE (Tired) and PAIN (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No current illness, lab data, allergies and historical condition was given. No concomitant and treatment medications was given.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received Moderna for 2nd Dose versus Pfizer as first dose; This spontaneous case was reported by a  and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna for 2nd Dose versus Pfizer as first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) 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 INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna for 2nd Dose versus Pfizer as first dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna for 2nd Dose versus Pfizer as first dose) outcome was unknown.            No concomitant and treatment medications were provided  Action taken with mRNA-1273 in response to the events was not Applicable.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder infection.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced BACK PAIN (back ache). At the time of the report, BACK PAIN (back ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use included blood pressure pill (not specified).  No treatment medications were reported.  It was reported that the patient developed a back ache which she thought was related to a bladder infection, however, her physician did not see an infection.  Consent was given for safety follow up.   This case was linked to MOD-2021-022622.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Feeding disorder
Clinical narrative: stomach pain; stomach felt swollen; couldn't eat for 10 hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISTENSION (stomach felt swollen) and FEEDING DISORDER (couldn't eat for 10 hours) 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 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISTENSION (stomach felt swollen) and FEEDING DISORDER (couldn't eat for 10 hours). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISTENSION (stomach felt swollen) and FEEDING DISORDER (couldn't eat for 10 hours) had resolved.            Conversation was held in Spanish. Patient prefers not to fill the ADR form. After the events reported she went to the otolaryngologist and was diagnosed with pharyngeal candidiasis. She is feeling better now after being on candida treatment for almost 8 weeks. Had the second vaccine shot on 10-Mar-21, she took Benadryl immediately after the shot and had no allergic symptoms, but experience stomach pain, couldn't ate for 10 hours and stomach felt swollen. She is feeling well now with no symptoms.   This case was linked to MOD-2021-038066 (Patient Link).
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Nausea
Clinical narrative: chills; nausea; Local Erythema; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea) and INJECTION SITE ERYTHEMA (Local Erythema) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Vomiting, Stomach cramps and Wheezing. Concurrent medical conditions included Crohns disease aggravated since July 2012, Allergy to molds, Drug allergy (Allergic to Demerol induced vomiting and pass out), Allergic reaction to antibiotics (Allergic to Augmentin) and Asthma. Concomitant products included MESALAZINE (LIALDA) for Crohn's, ESTRADIOL (VAGIFEM) from 2018 to an unknown date for Dryness of eyes, LANSOPRAZOLE (PREVACID) from 2000 to an unknown date for Reflux esophagitis, L-THYROXINE [LEVOTHYROXINE] for Thyroid disorder.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-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 CHILLS (chills), NAUSEA (nausea) and INJECTION SITE ERYTHEMA (Local Erythema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 27-Feb-2021 to 03-Mar-2021 at an unspecified dose and frequency and BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) 28-Feb-2001 at an unspecified dose and frequency. On 04-Mar-2021, CHILLS (chills), NAUSEA (nausea) and INJECTION SITE ERYTHEMA (Local Erythema) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-028875 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-Significant Follow-up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: received one Moderna COVID-19 vaccine dose that was stored in refrigerator beyond 30 day timeframe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received one Moderna COVID-19 vaccine dose that was stored in refrigerator beyond 30 day timeframe) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (received one Moderna COVID-19 vaccine dose that was stored in refrigerator beyond 30 day timeframe). At the time of the report, PRODUCT STORAGE ERROR (received one Moderna COVID-19 vaccine dose that was stored in refrigerator beyond 30 day timeframe) 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 product details was not reported.  Treatment details was not reported .  On 01Jun2021, 14 unknown patients each received one Moderna COVID-19 vaccine dose that was stored in refrigerator beyond 30 day timeframe. No additional adverse events reported; all fields apply to all patients.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 13-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data provided by reporter. No concomitant medication provided by reporter. No treatment medication provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Myalgia, Vaccination site reaction
Clinical narrative: chest pain after first dose; COVID arm; COVID arm after first dose; 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 CHEST PAIN (chest pain after first dose), VACCINATION SITE REACTION (COVID arm) and MYALGIA (COVID arm after first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain after first dose), VACCINATION SITE REACTION (COVID arm) and MYALGIA (COVID arm after first dose). At the time of the report, CHEST PAIN (chest pain after first dose), VACCINATION SITE REACTION (COVID arm) and MYALGIA (COVID arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment drug was reported.  Company comment: Very limited information regarding this event has been provided at this time.  Based on the current case data, this case has been classified as invalid (no identifiable patient data).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Based on the current case data, this case has been classified as invalid (no identifiable patient data).
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Armpit pain; 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 AXILLARY PAIN (Armpit pain) 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 AXILLARY PAIN (Armpit pain). At the time of the report, AXILLARY PAIN (Armpit pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data provided by reporter. No concomitant medication provided by reporter. No treatment medication provided by reporter.   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Headache, Secretion discharge, Sinus congestion
Clinical narrative: Stuck up sinus; Coughing; Chest congestion; Mucus in nose and throat; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Stuck up sinus), COUGH (Coughing), CHEST DISCOMFORT (Chest congestion), SECRETION DISCHARGE (Mucus in nose and throat) and HEADACHE (Headaches) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced SINUS CONGESTION (Stuck up sinus), COUGH (Coughing), CHEST DISCOMFORT (Chest congestion), SECRETION DISCHARGE (Mucus in nose and throat) and HEADACHE (Headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, SINUS CONGESTION (Stuck up sinus), COUGH (Coughing), CHEST DISCOMFORT (Chest congestion), SECRETION DISCHARGE (Mucus in nose and throat) and HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-192952, MOD-2021-193494 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR report received: Updated event outcome for all reported events. Patient had denied further follow-up
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion, Respiratory tract congestion, Sinus congestion
Clinical narrative: chest congestion; stuck up sinus; coughing; mucus in nose and throat; headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest congestion), SINUS CONGESTION (stuck up sinus), COUGH (coughing), NASAL CONGESTION (mucus in nose and throat) and HEADACHE (headaches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion), SINUS CONGESTION (stuck up sinus), COUGH (coughing), NASAL CONGESTION (mucus in nose and throat) and HEADACHE (headaches). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT CONGESTION (chest congestion), SINUS CONGESTION (stuck up sinus), COUGH (coughing), NASAL CONGESTION (mucus in nose and throat) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Patient was prescribed antibiotic by healthcare professional.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-193494 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Influenza like illness, Joint swelling
Clinical narrative: Watery with fluid inside; swelling on the side of the right palm below the little little finger up to the wrist; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), BLISTER (Watery with fluid inside) and JOINT SWELLING (swelling on the side of the right palm below the little little finger up to the wrist) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced BLISTER (Watery with fluid inside). an unknown date, the patient experienced JOINT SWELLING (swelling on the side of the right palm below the little little finger up to the wrist). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), BLISTER (Watery with fluid inside) and JOINT SWELLING (swelling on the side of the right palm below the little little finger up to the wrist) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Follow-up received on 29-JUL-2021 included no new information.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Initials updated, city and state name added. On 29-Jul-2021: Non-Significant Follow up was received. The patient responded to request for further information and reported he is willing to provide information via speaking with someone or via a form received in the mail, but not email.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Eye swelling, Lip swelling, Swelling of eyelid
Clinical narrative: Eyes swollen after receiving the Moderna Covid-19 vaccine; The left side of the bottom lip felt like it had been burned and is still swollen and to touch it, it burns; Half of her right eyelid was swollen and was real red, described as its being a reddish purple color.; Had kind of an itchy, burning feeling of the right eyelid; Itchy eye; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (the left side of the bottom lip felt like it had been burned and is still swollen and to touch it, it burns), SWELLING OF EYELID (Half of her right eyelid was swollen and was real red, described as its being a reddish purple color.), EYE IRRITATION (had kind of an itchy, burning feeling of the right eyelid), EYE PRURITUS (Itchy eye) and EYE SWELLING (Eyes swollen after receiving the Moderna Covid-19 vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blisters (Occasional fever blisters). Concomitant products included LISINOPRIL for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced SWELLING OF EYELID (Half of her right eyelid was swollen and was real red, described as its being a reddish purple color.), EYE IRRITATION (had kind of an itchy, burning feeling of the right eyelid) and EYE PRURITUS (Itchy eye). On 30-May-2021, the patient experienced LIP SWELLING (the left side of the bottom lip felt like it had been burned and is still swollen and to touch it, it burns). On an unknown date, the patient experienced EYE SWELLING (Eyes swollen after receiving the Moderna Covid-19 vaccine). The patient was treated with LYSINE ongoing since an unknown date for Swollen lips and Burning lips, at a dose of 1 dosage form. On 30-May-2021, SWELLING OF EYELID (Half of her right eyelid was swollen and was real red, described as its being a reddish purple color.) and EYE IRRITATION (had kind of an itchy, burning feeling of the right eyelid) had resolved. At the time of the report, LIP SWELLING (the left side of the bottom lip felt like it had been burned and is still swollen and to touch it, it burns) had not resolved, EYE PRURITUS (Itchy eye) had resolved and EYE SWELLING (Eyes swollen after receiving the Moderna Covid-19 vaccine) outcome was unknown.            Concomitant medication Cholesterol medicine and Acid Reflux medicine was reported by the patient.  Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: New event added in the event tab.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine leaked during administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00170848) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine leaked during administration). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine leaked during administration) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 doses given today after vial was punctured 30May2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021). On 01-Jun-2021, EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Had a month long itchiness in the left arm with the 1st dose; 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 PRURITUS (Had a month long itchiness in the left arm with the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Had a month long itchiness in the left arm with the 1st dose). At the time of the report, PRURITUS (Had a month long itchiness in the left arm with the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 doses given today after vial was punctured 30May2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021). On 01-Jun-2021, EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Hypertonia
Clinical narrative: High pitched tone in head; 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 HYPERTONIA (High pitched tone in head) 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 HYPERTONIA (High pitched tone in head). At the time of the report, HYPERTONIA (High pitched tone in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Productive cough
Clinical narrative: Productive cough (phlegm); Pain in left leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCTIVE COUGH (Productive cough (phlegm)) and PAIN IN EXTREMITY (Pain in left leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in left leg). On 26-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCTIVE COUGH (Productive cough (phlegm)). On 01-Jun-2021, PAIN IN EXTREMITY (Pain in left leg) had resolved. At the time of the report, PRODUCTIVE COUGH (Productive cough (phlegm)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The pharmacist recommended ibuprofen for pain in leg but the patient denied using it. The HCP did blood work 2 days before the shot and 2 days after the vaccination for comparison but no discrepancies were reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 4 months in between the two doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months in between the two doses) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months in between the two doses). On 31-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months in between the two doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The action taken with mRNA-1273 (MODERNA COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash macular, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching all over, here and there; red spots on chest; rash at injection site with itching; rash at injection site; Feverish feeling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over, here and there), RASH MACULAR (red spots on chest), VACCINATION SITE PRURITUS (rash at injection site with itching), VACCINATION SITE RASH (rash at injection site) and PYREXIA (Feverish feeling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching all over, here and there), RASH MACULAR (red spots on chest), VACCINATION SITE PRURITUS (rash at injection site with itching), VACCINATION SITE RASH (rash at injection site) and PYREXIA (Feverish feeling). At the time of the report, PRURITUS (Itching all over, here and there), RASH MACULAR (red spots on chest), VACCINATION SITE PRURITUS (rash at injection site with itching), VACCINATION SITE RASH (rash at injection site) and PYREXIA (Feverish feeling) outcome was unknown.            No concomitant medications were reported, No  treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Additional information received captured product details and event.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Oral herpes, Pyrexia
Clinical narrative: cold sore on lips; fever; 2 episodes of nose bleed, it is little bit but random; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (2 episodes of nose bleed, it is little bit but random), ORAL HERPES (cold sore on lips) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced EPISTAXIS (2 episodes of nose bleed, it is little bit but random). On an unknown date, the patient experienced ORAL HERPES (cold sore on lips) and PYREXIA (fever). At the time of the report, EPISTAXIS (2 episodes of nose bleed, it is little bit but random), ORAL HERPES (cold sore on lips) and PYREXIA (fever) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient administered vaccine beyond past use date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient administered vaccine beyond past use date). On 01-Jun-2021, EXPIRED PRODUCT ADMINISTERED (1 patient administered vaccine beyond past use date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up information received on 29 Jul 2021 contains significant information. Added patient details; Sender's Comments:  :MOD21-104689.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersomnia, Influenza like illness, Pyrexia
Clinical narrative: Felt like she had the flu; Slept a lot; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Sarcoma bone (sarcoma right femur), Cancer (blood cancer in left arm), Chemotherapy and Radiation therapy. Concomitant products included PIROXICAM (PAXIL [PIROXICAM]), ALPRAZOLAM (XANAX), ZOLPIDEM TARTRATE (AMBIEN) and VITAMINS NOS for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had the flu), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-240776 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes, Genital ulceration
Clinical narrative: recurrent Herpes genital ulcers; recurrent herpes genital ulcers; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL ULCERATION (recurrent Herpes genital ulcers) and GENITAL HERPES (recurrent herpes genital ulcers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     patient has no any medical history.  The patient's past medical history included No adverse event.    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 GENITAL ULCERATION (recurrent Herpes genital ulcers) and GENITAL HERPES (recurrent herpes genital ulcers). At the time of the report, GENITAL ULCERATION (recurrent Herpes genital ulcers) and GENITAL HERPES (recurrent herpes genital ulcers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient had a query that should she receive the 2nd dose while having the Herpes lesioins.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 diagnosis after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 diagnosis after vaccination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced COVID-19 (COVID-19 diagnosis after vaccination). The patient was treated with MONOCLONAL ANTIBODY 17-1A on 18-Mar-2021 at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19 diagnosis after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Administration site discomfort, Vaccination site pain
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of administration site discomfort (the doctor believes this dose might have hit the bone) and vaccination site pain (experiencing pain) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# not known) for COVID-19 immunization. No medical history reported. On Apr 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced administration site discomfort (the doctor believes this dose might have hit the bone) and vaccination site pain (experiencing pain). At the time of the report, administration site discomfort (the doctor believes this dose might have hit the bone) and vaccination site pain (experiencing pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported/provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My husband's arm was sore with both doses; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    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 PAIN IN EXTREMITY (My husband's arm was sore with both doses) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (My husband's arm was sore with both doses). At the time of the report, PAIN IN EXTREMITY (My husband's arm was sore with both doses) outcome was unknown.            no medication reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Erythema
Clinical narrative: Red knots on armpit / Knots are sometimes red; Knots on the right armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Knots on the right armpit) and ERYTHEMA (Red knots on armpit / Knots are sometimes red) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AXILLARY MASS (Knots on the right armpit). On an unknown date, the patient experienced ERYTHEMA (Red knots on armpit / Knots are sometimes red). At the time of the report, AXILLARY MASS (Knots on the right armpit) and ERYTHEMA (Red knots on armpit / Knots are sometimes red) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash on the wrist; 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 RASH (a rash on the wrist) 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) (Intramuscular) unknown. On an unknown date, the patient experienced RASH (a rash on the wrist). At the time of the report, RASH (a rash on the wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.