chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Mammogram, Metastases to lymph nodes, Ultrasound scan
Clinical narrative: This spontaneous report was received from literature: Axillary Adenopathy after COVID-19 Vaccine: No Reason to Delay Screening Mammogram. This report concerned multiple patients. The objective of the study was to determine the outcomes of axillary lymphadenopathy after COVID-19 vaccination on breast imaging examinations. The patients height, and weight were not reported. The patients concurrent conditions included: lung cancer (one patient). The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced axillary lymphadenopathy, lymphoma and metastatic lung cancer, metastatic to axillary lymph node and four patients was diagnosed with metastatic breast cancer. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) had benign results and malignant results. Four patients were diagnosed with metastatic breast cancer, Mammogram (NR: not provided) lymphadenopathy, decreased lymph node size (follow-up examinations within 12 weeks, 25% were given Breast Imaging Reporting and Data System or BI-RADS, category 3 recommendations. No patients in the follow-up group were diagnosed with a subsequent malignancy), No malignancy, Mammogram (NR: not provided) lymphadenopathy, decreased lymph node size (15.7 weeks after the initial examinations, decreased lymph node size and were assessed as benign), No malignancy, Mammogram (NR: not provided) lymphadenopathy, decreased lymph node size, and Sonogram (NR: not provided) lymphadenopathy (identified lymphadenopathy and the average node measured as 1.8 cm (range, 0.54.2 cm). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the axillary lymphadenopathy, metastatic breast cancer, lymphoma, lung cancer metastatic and metastatic to axillary lymph node was not reported. The authors emphasized on there should be no delay in screening mammograms due to recent vaccination and there is variable time to resolution of reactive lymphadenopathy. Lymphadenopathy should be interpreted in the context of patient risk factors with vigilance in patients with concurrent suspicious mammographic findings in the ipsilateral breast. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220458141-COVID-19 VACCINE AD26.COV2.S-lung cancer metastatic, metastatic to axillary lymph node. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. (Confounding factor as pre-existing medical history) 20220458141-COVID-19 VACCINE AD26.COV2.S-metastatic breast cancer, lymphoma. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, Cardiac disorder, Oxygen saturation decreased, Weight increased
Clinical narrative: LOW ELECTRICITY IN HEART/ FLARED AND KICKED INTO GEAR; WEIGHT GAIN; LOW OXYGEN LEVELS; LOW ENERGY LEVELS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid 19, and concurrent conditions included: arthritis, and pre-existing heart condition (15 years prior), and other pre-existing medical conditions included: The patient was health care professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number unknown, expiry date: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced low electricity in heart/ flared and kicked into gear, weight gain, low oxygen levels, and low energy levels. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low electricity in heart/ flared and kicked into gear, weight gain, low oxygen levels, and low energy levels. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, 1 total administered on 24-MAR-2021 to right arm for prophylactic vaccination. Age at time of vaccination 43 years old. The patient received additional non-company suspect Moderna Covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 051F21A, expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2022, the patient experienced dry throat coded with suspected covid-19 infection (Dose number in series 2). Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 14-APR-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Negative (Dose number in series 2).  On 16-APR-2022, the patient felt crummy and also tested positive for COVID-19 by using JNJ supplied Binax now test kit, coded with suspected clinical vaccination failure (Dose number in series 1). It was reported that within 2 days on 18-APR-22 dry throat resolved and the patient felt 100 percent better (Dose number in series 2). On 19-APR-2022, the patient experienced loss of taste and recovered a week later (on 26-APR-2022)(Dose number in series 2). On 20-APR-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from suspected covid-19 infection on 26-APR-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000229316.; Sender's Comments: V0: 20220505772-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Fatigue, Gait disturbance, Grip strength decreased, Inappropriate schedule of product administration
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; DIFFICULTY IN WALKING; GRIP STRENGTH DECREASED; ACTIVITIES OF DAILY LIVING IMPAIRED; COVID-19; FATIGUE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on APR-2021, and received an additional second dose of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (Dose number in series 1).  Age at time of vaccination 55 years old.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number: 1159243) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On an unspecified date in APR-2021, the patient experienced fatigue (Dose number in series 1). On an unspecified date in 2021, the fatigue was resolved.  On an unspecified date in NOV-2021, the patient experienced covid-19 (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient received booster dose with non-company suspect vaccine elasomeran (Dose number in series 2) (form of admin not reported, intramuscular, batch number not reported) dose was not reported, administered on JAN-2022 for prophylactic vaccination.  On an unspecified date in JAN-2022, the patient had fatigue (Dose number in series 2).  On 26-APR-2022, the patient was struggling to walk (difficulty in walking), struggling to open things (grip strength decreased) and difficult time with typing (activities of daily living impaired) (Dose number in series 2). It was unknown if patient was involved in COVID-19 vaccine trial. The action taken with elasomeran was not reported. The patient recovered from fatigue in 2022, was recovering from difficulty in walking, grip strength decreased, and covid-19, and the outcome of activities of daily living impaired, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Loss of personal independence in daily activities, Off label use
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; DIFFICULTY IN WALKING; GRIP STRENGTH DECREASED; ACTIVITIES OF DAILY LIVING IMPAIRED; COVID-19; FATIGUE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on APR-2021, and received an additional second dose of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (Dose number in series 1).  Age at time of vaccination 55 years old.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number: 1159243) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On an unspecified date in APR-2021, the patient experienced fatigue (Dose number in series 1). On an unspecified date in 2021, the fatigue was resolved.  On an unspecified date in NOV-2021, the patient experienced covid-19 (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient received booster dose with non-company suspect vaccine elasomeran (Dose number in series 2) (form of admin not reported, intramuscular, batch number not reported) dose was not reported, administered on JAN-2022 for prophylactic vaccination.  On an unspecified date in JAN-2022, the patient had fatigue (Dose number in series 2).  On 26-APR-2022, the patient was struggling to walk (difficulty in walking), struggling to open things (grip strength decreased) and difficult time with typing (activities of daily living impaired) (Dose number in series 2). It was unknown if patient was involved in COVID-19 vaccine trial. The action taken with elasomeran was not reported. The patient recovered from fatigue in 2022, was recovering from difficulty in walking, grip strength decreased, and covid-19, and the outcome of activities of daily living impaired, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Mouth ulceration
Clinical narrative: MULTIPLE MOUTH ULCERS; This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-JAN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. Age at time of vaccination 44 years old. No concomitant medications were reported. On an unspecified date, the patient experienced multiple mouth ulcers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient had not recovered from multiple mouth ulcers. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pulmonary embolism, Thrombosis
Clinical narrative: BIG BLOOD CLOT; PRETTY BIG BLOOD CLOT THAT TRAVELLED TO LUNG AND CAUSED A LOT OF DAMAGE; ILL FOR THREE MONTHS; This spontaneous report received from a patient concerned a 47 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient did not have a family history of blood clot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had a really bad experience with the vaccine as she was ill for three months. Patient stated she had a pretty big blood clot, that travelled to her lung and that caused a lot of damage. The patient was hospitalized (date unspecified) for unspecified number of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ill for three months, and the outcome of pretty big blood clot that travelled to lung and caused a lot of damage and big blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20220511220-covid-19 vaccine ad26.cov2.s -Big blood clot , pretty big blood clot, that travelled to her lung and that caused a lot of damage. . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise
Clinical narrative: LEFT FOOT WAS FALLING ASLEEP; DID NOT FELT WELL; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient received additional covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 02-MAY-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2022, the patient experienced left foot was falling asleep. Patient did not want the vaccine but took it because she need to travel but she did not felt well to travel (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left foot was falling asleep, and the outcome of did not felt well was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: PAIN MIGRATE TO VARIOUS AREAS OF THE LOWER BODY (MOVES FROM ONE LEG TO THE OTHER); SEVERE PAIN IN BOTH LEGS (DULL DEEP PAIN LIKE A BROKEN BONE, PAIN IS AN OVERALL TIGHTNESS SIMILAR TO LACTIC ACID AS IF YOU HAD JUST RUN A MARATHON); VERY SHARP, STABBING PAIN IN THE MUSCLE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced pain migrate to various areas of the lower body (moves from one leg to the other). On MAY-2021, the patient experienced severe pain in both legs (dull deep pain like a broken bone, pain is an overall tightness similar to lactic acid as if you had just run a marathon). On MAY-2021, the patient experienced very sharp, stabbing pain in the muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain in both legs (dull deep pain like a broken bone, pain is an overall tightness similar to lactic acid as if you had just run a marathon), very sharp, stabbing pain in the muscle, and pain migrate to various areas of the lower body (moves from one leg to the other). This report was non-serious.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Weight increased
Clinical narrative: HEADACHES REGULARLY; HANDS, ARMS AND FEET NUMB RANDOMLY ALMOST EVERYDAY; TINGLING IN VACCINATED ARM; GAIN SIGNIFICANT AMOUNT OF WEIGHT; This spontaneous report received from a patient concerned a 4 decade old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was very healthy entire life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 4 decade old. No concomitant medications were reported.  On NOV-2021, the patient experienced gain significant amount of weight. On 02-NOV-2021, the patient experienced tingling in vaccinated arm, and hands, arms and feet numb randomly almost everyday. On an unspecified date, the patient experienced headaches regularly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches regularly, and hands, arms and feet numb randomly almost everyday, and the outcome of tingling in vaccinated arm and gain significant amount of weight was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hidradenitis, Illness, Increased tendency to bruise
Clinical narrative: OCCASIONAL HIDRADENITIS SUPPURITIVA FLARES; SICK; BRUISES EASILY; This spontaneous report received from a consumer via other manufacturer via a company representative concerned a 3 decade old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hidradenitis suppurativa. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 01 in total administered, on an unspecified date in AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: unknown, expiry: unknown) citrate free, dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa. Age at time of vaccination 21 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced occasional hidradenitis suppuritiva flares, sick, and bruises easily (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the sick, bruises easily and occasional hidradenitis suppuritiva flares was not reported. The patient received Moderna COVID-19 vaccine (elasomeran) (dose number in series 2) (form of admin was not reported, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, booster dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with Moderna COVID-19 vaccine (elasomeran) (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220515392.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED PRODUCT; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-MAR-2022) dose was not reported, administered on 24-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2022, the patient experienced administered expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired product was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via media via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose was not reported, administered on an unspecified date on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in  APR-2022, the patient experienced blood clot. Reporter stated that, "My Great Aunt had the 1 Shot Covid Vaccine in 2021. She suffered a blood clot last week, That forced her electric chair to maneuver onto a major highway. Update, My Great Aunt  is recovering from her 1 shot blood clot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220513851-covid-19 vaccine ad26.cov2.s-blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: she had the first two (Moderna) with her second dose of Moderna in May 2021 and currently on an OTC anti-inflammatory; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (she had the first two (Moderna) with her second dose of Moderna in May 2021 and currently on an OTC anti-inflammatory) 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.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had the first two (Moderna) with her second dose of Moderna in May 2021 and currently on an OTC anti-inflammatory). At the time of the report, IMMUNISATION REACTION (she had the first two (Moderna) with her second dose of Moderna in May 2021 and currently on an OTC anti-inflammatory) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient was on OTC anti-inflammatory. Patient stated she wants to know how long she has to be off it before she can get the booster shot.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: had cardiac monitor which showed PSVT, "muscle in heart not kicking on right; This spontaneous case was reported by a consumer and describes the occurrence of SUPRAVENTRICULAR TACHYCARDIA (had cardiac monitor which showed PSVT, "muscle in heart not kicking on right) 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.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient 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 SUPRAVENTRICULAR TACHYCARDIA (had cardiac monitor which showed PSVT, "muscle in heart not kicking on right). At the time of the report, SUPRAVENTRICULAR TACHYCARDIA (had cardiac monitor which showed PSVT, "muscle in heart not kicking on right) outcome was unknown.            No concomitant medication details was reported. He had heart palpitations for 2 months and no longer has cardiac symptom.  No treatment medication details was reported.  Company comment: This case concerns a male patient of unknown age, with no medical history reported, who experienced the adverse event of special interest of supraventricular tachycardia an unknown time after a dose of mRNA-1273. The patient received dose 1, 2 and 3 with mRNA-1273 vaccine, but it is unclear when the symptoms onset happened. Symptoms, such as heart palpitations, lasted for 2 months and then disappeared. Information regarding clinical evaluation and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-558252 (Patient Link).; Sender's Comments: This case concerns a male patient of unknown age, with no medical history reported, who experienced the adverse event of special interest of supraventricular tachycardia an unknown time after a dose of mRNA-1273. The patient received dose 1, 2 and 3 with mRNA-1273 vaccine, but it is unclear when the symptoms onset happened. Symptoms, such as heart palpitations, lasted for 2 months and then disappeared. Information regarding clinical evaluation and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: she had adverse symptoms/symptoms are increasingly worsening.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (she had adverse symptoms/symptoms are increasingly worsening.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022 at 10:00 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced IMMUNISATION REACTION (she had adverse symptoms/symptoms are increasingly worsening.). At the time of the report, IMMUNISATION REACTION (she had adverse symptoms/symptoms are increasingly worsening.) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported  Reporter stated that the symptoms were increasingly worsening.  No treatment medications were reported   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Active urinary tract infection after booster dose but before 2nd booster dose; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Active urinary tract infection after booster dose but before 2nd booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Active urinary tract infection after booster dose but before 2nd booster dose). At the time of the report, URINARY TRACT INFECTION (Active urinary tract infection after booster dose but before 2nd booster dose) outcome was unknown.            No concomitant medications were reported. The patient had received primary vaccination series and booster - Moderna. No treatment information was reported.   Reporter did not allow further contact
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vial was stored in the refrigerator the day before administration; expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. It was reported that, the vials was initially stored in refrigerator a day before the administration and vials did not undergo any temperature excursions. The patient had not reported any adverse reactions to this dose.  No information on treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow-up information received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Rosacea
Clinical narrative: rosacea has exacerbated/ skin keeps getting redder and redder; This spontaneous case was reported by a consumer and describes the occurrence of ROSACEA (rosacea has exacerbated/ skin keeps getting redder and redder) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Rosacea.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ROSACEA (rosacea has exacerbated/ skin keeps getting redder and redder). At the time of the report, ROSACEA (rosacea has exacerbated/ skin keeps getting redder and redder) had not resolved.            No concomitant information was reported.  The patient stated that she was calling about the Moderna booster shot. It was reported that since patient got the shot, the rosacea had exacerbated. Patient was unclear if the adverse event occurred after the second (primary) dose or first booster or second or booster dose.   No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: side effects after the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (side effects after the booster 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (side effects after the booster shot). At the time of the report, IMMUNISATION REACTION (side effects after the booster shot) outcome was unknown.            No concomitant information was reported. It was mentioned that the reporter knew someone else who had side effects after the booster shot.   No treatment information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: little red circle in left arm; itchy circle in left arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (little red circle in left arm) and PRURITUS (itchy circle in left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No allergies to medications, food and other products. No history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, DULOXETINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ERYTHEMA (little red circle in left arm) and PRURITUS (itchy circle in left arm). On 11-Feb-2021, ERYTHEMA (little red circle in left arm) and PRURITUS (itchy circle in left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient did not seek to medical care. The patient did not experience a similar event in the past. Patient do not have any allergies.Patient had no acute illness at the time of vaccination. No treatment information was provided by the reporter.   This case was linked to MOD-2022-559308 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea
Clinical narrative: Feeling very weak; slightly nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling very weak) and NAUSEA (slightly nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feeling very weak) and NAUSEA (slightly nauseous). At the time of the report, ASTHENIA (Feeling very weak) and NAUSEA (slightly nauseous) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient got half dose for third primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient got half dose for third primary dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient got half dose for third primary dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient got half dose for third primary dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included medications that suppresses immune system.  The patient that received the 2-dose series of Moderna in March 2021 and came back in November-2021 to receive a third dose, but it was a half booster dose. No treatment information was provided by the reporter.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm pain after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain after previous doses) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Start Date: 25 to 30 years ago Stop Date: 30 years ago (Improvement).), Hypertension, Hypercholesterolemia, Allergy to chemicals (Nitrates) and Reaction to monosodium glutamate ).    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain after previous doses). At the time of the report, VACCINATION SITE PAIN (arm pain after previous doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient had concomitant medications daily for high cholesterol and blood pressure. It was reported that patient was not immunocompromised. Patient neither diagnosed with COVID-19 nor tested positive. Treatment medications were not reported.   This case was linked to MOD-2022-559589, MOD-2022-559594, MOD-2022-559608 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain after previous doses) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Start Date: 25 to 30 years ago Stop Date: 30 years ago (Improvement).), Hypertension, Hypercholesterolemia, Allergy to chemicals (Nitrates) and Reaction to monosodium glutamate ).    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain after previous doses). At the time of the report, VACCINATION SITE PAIN (arm pain after previous doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient had concomitant medications daily for high cholesterol and blood pressure. It was reported that patient was not immunocompromised. Patient neither diagnosed with COVID-19 nor tested positive. Treatment medications were not reported.   This case was linked to MOD-2022-559589, MOD-2022-559594, MOD-2022-559608 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  The patient's past medical history included Cancer (Start Date: 25 to 30 years ago; Stop Date: 30 years ago; Recent change in status such as improvement or worsening: improvement). Concurrent medical conditions included Reaction to monosodium glutamate (MSG), Allergy to chemicals (nitrates), Blood pressure abnormal and High cholesterol.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was taking unspecified medication on daily basis for blood pressure and high cholesterol.  The patient did not seek medical care (office visit, Urgent care, ER, hospitalized) for the event.   This case was linked to MOD-2022-559342, MOD-2022-559589, MOD-2022-559594 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  The patient's past medical history included Cancer (Start Date: 25 to 30 years ago; Stop Date: 30 years ago; Recent change in status such as improvement or worsening: improvement). Concurrent medical conditions included Reaction to monosodium glutamate (MSG), Allergy to chemicals (nitrates), Blood pressure abnormal and High cholesterol.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was taking unspecified medication on daily basis for blood pressure and high cholesterol.  The patient did not seek medical care (office visit, Urgent care, ER, hospitalized) for the event.   This case was linked to MOD-2022-559342, MOD-2022-559589, MOD-2022-559594 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort
Clinical narrative: Legs were bothering me; after the booster shot, feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Legs were bothering me) and FATIGUE (after the booster shot, feeling tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Legs were bothering me) and FATIGUE (after the booster shot, feeling tired). At the time of the report, LIMB DISCOMFORT (Legs were bothering me) and FATIGUE (after the booster shot, feeling tired) outcome was unknown.            Concomitant drugs were not reported.  Treatment details were not given.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: sore arm; Small rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and RASH (Small rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 PAIN IN EXTREMITY (sore arm) and RASH (Small rash). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and RASH (Small rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact