chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received my second dose of moderna 7 days early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received my second dose of moderna 7 days early) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received my second dose of moderna 7 days early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received my second dose of moderna 7 days early) 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.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose was administered/received dose from vial punctured for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was administered/received dose from vial punctured for more than 12 hours) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022 at 1:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was administered/received dose from vial punctured for more than 12 hours). On 25-Jan-2022 at 1:30 PM, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered/received dose from vial punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on 13Jan2022. Date and time vial was first punctured was on 09:15 hrs on 24Jan2022. Post puncture the vial was refrigerated. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degrees C= 46 to 77 degrees F) was Less than 24 hours. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Follow up received includes Added patient details, Lot number of suspect, updated i narrative with product information. On 28-Jan-2022: Follow up received includes no new information.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: How long after testing positive can I receive my second shot?; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (How long after testing positive can I receive my second shot?) 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 SARS-COV-2 TEST POSITIVE (How long after testing positive can I receive my second shot?). At the time of the report, SARS-COV-2 TEST POSITIVE (How long after testing positive can I receive my second shot?) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) 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.   No concomitant medications were reported. No treatment medications were reported. It was enquired that how long after testing positive patient can receive second shot.  Company Comment: This case concerns a patient of unknown age and gender, who experienced the non-serious unexpected event of SARS-CoV-2 test positive (AESI). The event occurred unknown number of days after receiving the first dose of mRNA-1273 vaccine. Patient wanted to know how long after testing positive can the second shot be received. There was no available information regarding clinical course or treatment medication. At the time of the report, outcome of event was recovered/resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender, who experienced the non-serious unexpected event of SARS-CoV-2 test positive (AESI). The event occurred unknown number of days after receiving the first dose of mRNA-1273 vaccine. Patient wanted to know how long after testing positive can the second shot be received. There was no available information regarding clinical course or treatment medication. At the time of the report, outcome of event was recovered/resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccines were given after 12 hours of the bottle being out and punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given after 12 hours of the bottle being out and punctured) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given after 12 hours of the bottle being out and punctured). On 27-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given after 12 hours of the bottle being out and punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in the refrigerator on 13 Jan 2022. The vial was first punctured on 26 Jan 2022 at 8:20 AM. Reporter stated that the vial was stored at room temperature after it was punctured.  It was reported that the patient was on unspecified concomitant medication. No treatment medications were reported.   This case was linked to MOD-2022-464853 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Eyelid is swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Eyelid is swelling) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 022B21A and 017C21A) 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 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced SWELLING OF EYELID (Eyelid is swelling). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SWELLING OF EYELID (Eyelid is swelling) outcome was unknown.            Paitent had been stated that 2 hours after receiving the booster dose of the vaccine paitent noticed her eyelid had started to swell. She had not experienced any other symptoms. She took her regular medications. No Concomitant medication reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Injection site extravasation
Clinical narrative: some leaked out from the injection site/vaccine leaked out during administration; vaccine leaked out during administration; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE EXTRAVASATION (some leaked out from the injection site/vaccine leaked out during administration) and ACCIDENTAL UNDERDOSE (vaccine leaked out during administration) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022, the patient experienced INJECTION SITE EXTRAVASATION (some leaked out from the injection site/vaccine leaked out during administration) and ACCIDENTAL UNDERDOSE (vaccine leaked out during administration). On 28-Jan-2022, INJECTION SITE EXTRAVASATION (some leaked out from the injection site/vaccine leaked out during administration) and ACCIDENTAL UNDERDOSE (vaccine leaked out during administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient did not experienced any symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Suspect product batch number and patient demographics were added.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Ejection fraction, Ejection fraction decreased, Fatigue, Laboratory test
Clinical narrative: Ejection fraction rate went from 70 to 50; Stayed in bed for a couple days; Very fatigued/Felt rundown/Felt extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of EJECTION FRACTION DECREASED (Ejection fraction rate went from 70 to 50), BEDRIDDEN (Stayed in bed for a couple days) and FATIGUE (Very fatigued/Felt rundown/Felt extremely tired) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cardiovascular disorder.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EJECTION FRACTION DECREASED (Ejection fraction rate went from 70 to 50), BEDRIDDEN (Stayed in bed for a couple days) and FATIGUE (Very fatigued/Felt rundown/Felt extremely tired). At the time of the report, EJECTION FRACTION DECREASED (Ejection fraction rate went from 70 to 50) and FATIGUE (Very fatigued/Felt rundown/Felt extremely tired) outcome was unknown and BEDRIDDEN (Stayed in bed for a couple days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Laboratory test: results not reported (Inconclusive) Results not reported. On an unknown date, Ejection fraction: 70 (normal) 70 and 50 (abnormal) Ejection fraction rate went from 70 to 50.         No concomitant medications were reported. No treatment medications were reported.  It was reported that doctor did not think it was from the booster. There was no product complaint associated.  Company comment: This is a spontaneous case concerning a 24-year-old male patient with medical history of Cardiovascular disorder, who experienced the non-serious unexpected event of ejection fraction decreased (AESI) and other non-serious events. The event occurred on an unknown date after the booster dose of mRNA-1273. The ejection fraction went from 70 to 50, the outcome was unknown. The mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-464811, MOD-2022-466148, MOD-2022-465239 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 24-year-old male patient with medical history of Cardiovascular disorder, who experienced the non-serious unexpected event of ejection fraction decreased (AESI) and other non-serious events. The event occurred on an unknown date after the booster dose of mRNA-1273. The ejection fraction went from 70 to 50, the outcome was unknown. The mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 antibody test
Clinical narrative: immunocompromised but did not get a third primary series; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised but did not get a third primary series) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included APIXABAN (ELIQUIS), LEVOFLOXACIN, ATORVASTATIN, DILTIAZEM, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised but did not get a third primary series). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised but did not get a third primary series) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2022, SARS-CoV-2 antibody test: negative (Negative) less than Negative..         No treatment medication was provided. Patient stated that already had 2 primary doses and a booster and now is looking forward to get a 4th shot. Patient stated she is immunocompromised but did not get a third primary series.Patient blood work shows no antibodies.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Followup received: Added lab data and updated narrative supplement.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Chills, Illness, Pyrexia, Vaccination site erythema
Clinical narrative: Very Sick; Huge lump; Fever 102.8 Degree Fahrenheit; Chills; big red lump; received 0.5ml instead of 0.25ml dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very Sick), VACCINATION SITE MASS (Huge lump), PYREXIA (Fever 102.8 Degree Fahrenheit), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (big red lump) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004FZIA, 00B21A and 006MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Emphysema (taking Trelegy inhaler for emphysema.). Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Emphysema.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Oct-2021, the patient experienced ILLNESS (Very Sick), VACCINATION SITE MASS (Huge lump), PYREXIA (Fever 102.8 Degree Fahrenheit), CHILLS (Chills), VACCINATION SITE ERYTHEMA (big red lump) and ACCIDENTAL OVERDOSE (received 0.5ml instead of 0.25ml dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 12-Oct-2021, ACCIDENTAL OVERDOSE (received 0.5ml instead of 0.25ml dose) had resolved. On 14-Oct-2021, PYREXIA (Fever 102.8 Degree Fahrenheit) had resolved. On 16-Oct-2021, ILLNESS (Very Sick), VACCINATION SITE MASS (Huge lump), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (big red lump) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Oct-2021, Pyrexia: 102.8 degree fahrenheit (High) 102.8 Degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to HCP and was told to take Antihistamine for redness and ice pack on the injection site. Patient mentioned that she already reported to DOH and pharmacy about the dosage that was given to her last October.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Very Sick; Huge lump; Fever 102.8 Degree Fahrenheit; Chills; big red lump; received 0.5ml instead of 0.25ml dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very Sick), VACCINATION SITE MASS (Huge lump), PYREXIA (Fever 102.8 Degree Fahrenheit), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (big red lump) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004FZIA, 00B21A and 006MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Emphysema (taking Trelegy inhaler for emphysema.). Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Emphysema.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Oct-2021, the patient experienced ILLNESS (Very Sick), VACCINATION SITE MASS (Huge lump), PYREXIA (Fever 102.8 Degree Fahrenheit), CHILLS (Chills), VACCINATION SITE ERYTHEMA (big red lump) and ACCIDENTAL OVERDOSE (received 0.5ml instead of 0.25ml dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 12-Oct-2021, ACCIDENTAL OVERDOSE (received 0.5ml instead of 0.25ml dose) had resolved. On 14-Oct-2021, PYREXIA (Fever 102.8 Degree Fahrenheit) had resolved. On 16-Oct-2021, ILLNESS (Very Sick), VACCINATION SITE MASS (Huge lump), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (big red lump) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Oct-2021, Pyrexia: 102.8 degree fahrenheit (High) 102.8 Degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to HCP and was told to take Antihistamine for redness and ice pack on the injection site. Patient mentioned that she already reported to DOH and pharmacy about the dosage that was given to her last October.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective
Clinical narrative: The patient reported having Omicron; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient reported having Omicron) and DRUG INEFFECTIVE (Lack of efficacy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (The patient reported having Omicron) and DRUG INEFFECTIVE (Lack of efficacy). In January 2022, COVID-19 (The patient reported having Omicron) had resolved. At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high volume antibodies (High) high volume antibodies were found.         No concomitant medication details was provided. No treatment medication details was provided. The patient reported having Omicron for 5 days.  Company comment: This spontaneous case concerns a 81-year-old female patient with no medical history reported, who experienced the unexpected non serious AESI of COVID, approximately 9 months after the second dose of mRNA- 1273 vaccine and an appropriate schedule of vaccination. Additionally, Drug ineffective was considered. Omicron variant was reported, which resolved after 5 days. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-039332 (Patient Link).; Sender's Comments: This spontaneous case concerns a 81-year-old female patient with no medical history reported, who experienced the unexpected non serious AESI of COVID, approximately 9 months after the second dose of mRNA- 1273 vaccine and an appropriate schedule of vaccination. Additionally, Drug ineffective was considered.  Omicron variant was reported, which resolved after 5 days. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: Arm might be sore/arm is hurting; Running a fever of 100.4; Has not felt good since yesterday/not feeling good; When they gave him the shot, it hurts clear to the bone on his left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm might be sore/arm is hurting), FEELING ABNORMAL (Has not felt good since yesterday/not feeling good), BONE PAIN (When they gave him the shot, it hurts clear to the bone on his left arm) and PYREXIA (Running a fever of 100.4) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21D) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced FEELING ABNORMAL (Has not felt good since yesterday/not feeling good) and BONE PAIN (When they gave him the shot, it hurts clear to the bone on his left arm). On 28-Jan-2022, the patient experienced PYREXIA (Running a fever of 100.4). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm might be sore/arm is hurting). At the time of the report, PAIN IN EXTREMITY (Arm might be sore/arm is hurting), FEELING ABNORMAL (Has not felt good since yesterday/not feeling good) and PYREXIA (Running a fever of 100.4) had not resolved and BONE PAIN (When they gave him the shot, it hurts clear to the bone on his left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2022, Body temperature: 100.4 (High) fever of 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported. It was reported that patient had not done COVID-19 test.On 28 Jan 2022,the patient was not feeling good.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Hypokinesia, Pain in extremity
Clinical narrative: Can not use left arm after 2nd dose; Terrible pain left shoulder to hand, when using left arm, after 2nd shot; Hard time hearing even with the hearing Aid, after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Can not use left arm after 2nd dose), PAIN IN EXTREMITY (Terrible pain left shoulder to hand, when using left arm, after 2nd shot) and HYPOACUSIS (Hard time hearing even with the hearing Aid, after 2nd shot) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056H21A and 032H21A) for COVID-19 vaccination.     Concurrent medical conditions included Hearing aid user.   On 14-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, the patient experienced HYPOKINESIA (Can not use left arm after 2nd dose) and PAIN IN EXTREMITY (Terrible pain left shoulder to hand, when using left arm, after 2nd shot). 11-Jan-2022, the patient experienced HYPOACUSIS (Hard time hearing even with the hearing Aid, after 2nd shot). At the time of the report, HYPOKINESIA (Can not use left arm after 2nd dose), PAIN IN EXTREMITY (Terrible pain left shoulder to hand, when using left arm, after 2nd shot) and HYPOACUSIS (Hard time hearing even with the hearing Aid, after 2nd shot) outcome was unknown.            No concomitant medication reported No treatment medication reported
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.; right arm swelled up under the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.) and LYMPHADENOPATHY (right arm swelled up under the arm pit) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 017B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-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 RASH (a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.). December 2021, the patient experienced LYMPHADENOPATHY (right arm swelled up under the arm pit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. In December 2021, LYMPHADENOPATHY (right arm swelled up under the arm pit) had resolved. At the time of the report, RASH (a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  Patient stated that two days after receiving the booster dose, he experienced arm pit swelling under his right arm which lasted for about 24 hours. Two days after the swelling, he had rash which occurred every day all over his body.   This case was linked to MOD-2022-465007, MOD-2022-464998 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.; right arm swelled up under the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.) and LYMPHADENOPATHY (right arm swelled up under the arm pit) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 017B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-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 RASH (a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.). December 2021, the patient experienced LYMPHADENOPATHY (right arm swelled up under the arm pit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. In December 2021, LYMPHADENOPATHY (right arm swelled up under the arm pit) had resolved. At the time of the report, RASH (a rash on a daily basis all day long, rash comes and goes every day, rash is all over the body.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  Patient stated that two days after receiving the booster dose, he experienced arm pit swelling under his right arm which lasted for about 24 hours. Two days after the swelling, he had rash which occurred every day all over his body.   This case was linked to MOD-2022-465007, MOD-2022-464998 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: after doses 1 and 2, his arm hurt for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after doses 1 and 2, his arm hurt for a few days) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (after doses 1 and 2, his arm hurt for a few days). In 2021, PAIN IN EXTREMITY (after doses 1 and 2, his arm hurt for a few days) had resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2022-464998, MOD-2022-464955 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: after doses 1 and 2, his arm hurt for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after doses 1 and 2, his arm hurt for a few days) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (after doses 1 and 2, his arm hurt for a few days). In 2021, PAIN IN EXTREMITY (after doses 1 and 2, his arm hurt for a few days) had resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2022-464998, MOD-2022-464955 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a little tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced FATIGUE (a little tired). At the time of the report, FATIGUE (a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2022-465023, MOD-2022-465024 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After doses 1 and 2, his arm hurt for a few days.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After doses 1 and 2, his arm hurt for a few days.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (After doses 1 and 2, his arm hurt for a few days.). In 2021, PAIN IN EXTREMITY (After doses 1 and 2, his arm hurt for a few days.) 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 provided by the reporter. No treatment information was provided.   This case was linked to MOD-2022-465007, MOD-2022-464955 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Illness, Myalgia, Nausea
Clinical narrative: sick with fever; sinus pain; red hot circle blotches on her arm; sinus infection; dizziness; sick with fever; chills; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with fever), SINUS PAIN (sinus pain), RASH MACULAR (red hot circle blotches on her arm), SINUSITIS (sinus infection) and DIZZINESS (dizziness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced ILLNESS (sick with fever), SINUS PAIN (sinus pain), RASH MACULAR (red hot circle blotches on her arm), SINUSITIS (sinus infection), DIZZINESS (dizziness), PYREXIA (sick with fever), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Sinus infection, at an unspecified dose and frequency. In May 2021, ILLNESS (sick with fever), SINUS PAIN (sinus pain), RASH MACULAR (red hot circle blotches on her arm), SINUSITIS (sinus infection), DIZZINESS (dizziness), PYREXIA (sick with fever), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) had resolved.     No concomitant medications were reported. other treatment includes something for sinuses, Cold compress on her arm and all the symptoms was resolved after about 4-5 days.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular, Sinus pain, Sinusitis
Clinical narrative: sick with fever; sinus pain; red hot circle blotches on her arm; sinus infection; dizziness; sick with fever; chills; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with fever), SINUS PAIN (sinus pain), RASH MACULAR (red hot circle blotches on her arm), SINUSITIS (sinus infection) and DIZZINESS (dizziness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced ILLNESS (sick with fever), SINUS PAIN (sinus pain), RASH MACULAR (red hot circle blotches on her arm), SINUSITIS (sinus infection), DIZZINESS (dizziness), PYREXIA (sick with fever), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Sinus infection, at an unspecified dose and frequency. In May 2021, ILLNESS (sick with fever), SINUS PAIN (sinus pain), RASH MACULAR (red hot circle blotches on her arm), SINUSITIS (sinus infection), DIZZINESS (dizziness), PYREXIA (sick with fever), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) had resolved.     No concomitant medications were reported. other treatment includes something for sinuses, Cold compress on her arm and all the symptoms was resolved after about 4-5 days.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Lymphadenopathy, Pruritus, Skin discolouration, Urticaria
Clinical narrative: hives and "acute urticaria" all over her body; itchiness; lymph nodes were swollen; She could not lean her arm down at all, and could not leave it next to her body; The area under her armpit on the left side and on the side of her left breast turned black, blue, and humungous; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives and "acute urticaria" all over her body), PRURITUS (itchiness), HYPOKINESIA (She could not lean her arm down at all, and could not leave it next to her body), SKIN DISCOLOURATION (The area under her armpit on the left side and on the side of her left breast turned black, blue, and humungous) and VACCINATION SITE PAIN (arm pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 037C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced HYPOKINESIA (She could not lean her arm down at all, and could not leave it next to her body) and SKIN DISCOLOURATION (The area under her armpit on the left side and on the side of her left breast turned black, blue, and humungous). 21-Dec-2021, the patient experienced VACCINATION SITE PAIN (arm pain). On 22-Dec-2021, the patient experienced LYMPHADENOPATHY (lymph nodes were swollen). On 01-Jan-2022, the patient experienced URTICARIA (hives and "acute urticaria" all over her body). 01-Jan-2022, the patient experienced PRURITUS (itchiness). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives and "acute urticaria" all over her body), PRURITUS (itchiness), HYPOKINESIA (She could not lean her arm down at all, and could not leave it next to her body), SKIN DISCOLOURATION (The area under her armpit on the left side and on the side of her left breast turned black, blue, and humungous) and LYMPHADENOPATHY (lymph nodes were swollen) outcome was unknown and VACCINATION SITE PAIN (arm pain) had resolved.            No concomitant medications were reported. Itchiness got worse with scratching, and occur on her hands, feet, and scalp among other areas. Patient went to a dermatologist who advised her to use allergy medications. They also took blood work which appeared normal.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: hives and "acute urticaria" all over her body; itchiness; lymph nodes were swollen; She could not lean her arm down at all, and could not leave it next to her body; The area under her armpit on the left side and on the side of her left breast turned black, blue, and humungous; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives and "acute urticaria" all over her body), PRURITUS (itchiness), HYPOKINESIA (She could not lean her arm down at all, and could not leave it next to her body), SKIN DISCOLOURATION (The area under her armpit on the left side and on the side of her left breast turned black, blue, and humungous) and VACCINATION SITE PAIN (arm pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 037C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced HYPOKINESIA (She could not lean her arm down at all, and could not leave it next to her body) and SKIN DISCOLOURATION (The area under her armpit on the left side and on the side of her left breast turned black, blue, and humungous). 21-Dec-2021, the patient experienced VACCINATION SITE PAIN (arm pain). On 22-Dec-2021, the patient experienced LYMPHADENOPATHY (lymph nodes were swollen). On 01-Jan-2022, the patient experienced URTICARIA (hives and "acute urticaria" all over her body). 01-Jan-2022, the patient experienced PRURITUS (itchiness). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives and "acute urticaria" all over her body), PRURITUS (itchiness), HYPOKINESIA (She could not lean her arm down at all, and could not leave it next to her body), SKIN DISCOLOURATION (The area under her armpit on the left side and on the side of her left breast turned black, blue, and humungous) and LYMPHADENOPATHY (lymph nodes were swollen) outcome was unknown and VACCINATION SITE PAIN (arm pain) had resolved.            No concomitant medications were reported. Itchiness got worse with scratching, and occur on her hands, feet, and scalp among other areas. Patient went to a dermatologist who advised her to use allergy medications. They also took blood work which appeared normal.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: he got pretty sick after his 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he got pretty sick after his 1st dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (he got pretty sick after his 1st dose). At the time of the report, ILLNESS (he got pretty sick after his 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment medication was provided.   This case was linked to MOD-2022-465036 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Major headache; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (Major 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 HEADACHE (Major headache). At the time of the report, HEADACHE (Major headache) 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.   Concomitant products were not provided. Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Headache, Insomnia, Musculoskeletal stiffness, Neck pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (now she can barely turn her head to the right), EAR PAIN (pain under her right ear), NECK PAIN (pain at the top of the right side of the neck), INSOMNIA (cannot sleep because of a lot of pain still on her neck and under the right ear) and VACCINATION SITE PAIN (sore left arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Diabetes.Concomitant products included MELOXICAM for Arthritis, METFORMIN for Diabetes. On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EAR PAIN (pain under her right ear), NECK PAIN (pain at the top of the right side of the neck), VACCINATION SITE PAIN (sore left arm) and HEADACHE (headache). On 28-Jan-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (now she can barely turn her head to the right) and INSOMNIA (cannot sleep because of a lot of pain still on her neck and under the right ear). On 15-Jan-2022, HEADACHE (headache) had resolved. On 20-Jan-2022, VACCINATION SITE PAIN (sore left arm) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (now she can barely turn her head to the right), EAR PAIN (pain under her right ear), NECK PAIN (pain at the top of the right side of the neck) and INSOMNIA (cannot sleep because of a lot of pain still on her neck and under the right ear) had not resolved. The pain started first just during morning and night, but it was getting worse.No treatment had been given for her symptoms.This case was linked to MOD-2022-465200, MOD-2022-465201 (Patient Link).