chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Shingles after months of 2nd dose administration; shingles; rash on neck and shoulder; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th August 2021, between 8 and 10 months after receiving Shingrix, 370 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in the left arm. In approximately November 2020, the patient received 2nd dose of Shingrix in in the left arm. The patient stated that her rash started on the left side of her neck and left shoulder. The patient stated she was diagnosed with shingles on 1st September 2021. The patient stated, health care professional started her Valacyclovir 1gm, three times a day for 7 days. The reporter did not consent to follow-up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Notalgia paraesthetica
Clinical narrative: Notalgia Paresthetica; This case was reported by a consumer via call center representative and described the occurrence of notalgia paresthetica in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number ap545, expiry date 25th January 2023) for prophylaxis.   On 2nd August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th August 2021, 8 days after receiving Shingrix, the patient experienced notalgia paresthetica. On an unknown date, the outcome of the notalgia paresthetica was unknown.   It was unknown if the reporter considered the notalgia paresthetica to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and developed nostalgia paresthetica. The patient was referred to health care professional. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: After 3 years plans to receive second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago from the date of reporting, in the dose of 0.5 ml, intramuscularly in unknown deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. At the time of reporting, the patient planned to receive 2nd dose. The patient declined to provide demographics and provide information. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Injected with only the adjuvant; Injected with only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number 4n2ab, expiry date 10th February 2023) for prophylaxis.   On 1st September 2021, the patient received Shingrix. On 1st September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only adjuvant of Shingrix without the powder component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No adverse event was reported. No patient's identifiers were provided. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Coma, Death, Headache, Seizure
Clinical narrative: COMA; FITTING; SEVERE HEADACHES (WORSEN NEXT DAY); DIED; This spontaneous report received from a patient social media via a company representative concerned a male 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 not reported, batch number: Unknown, expiry: Unknown) dose was not reported, frequency time 1 total administered on 27-AUG-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 27-AUG-2021, after vaccination the patient instantly got severe headaches, even worst next day (28-AUG-2021). On 29-AUG-2021, patient started fitting in hospital and on 30-AUG-2021, she was in coma and was hospitalized (days unspecified). On 31-AUG-2021, the patient died from unknown cause of death. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of died on 31-AUG-2021, and had not recovered from severe headaches (worsen next day), coma, and fitting. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210902754.; Sender's Comments: V0: 20210902775-covid-19 vaccine ad26.cov2.s-died, coma, fitting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210902775-Covid-19 vaccine ad26.cov2.s-severe headache. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Infusion site warmth, Injection site pain, Peripheral coldness
Clinical narrative: SKIN AROUND IT COLD; VERY PAINFUL AT INJECTION SITE; HOTSPOT AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 30-AUG-2021, the patient experienced hotspot at injection site. On 30-AUG-2021, the patient experienced very painful at injection site. On an unspecified date, the patient experienced skin around it cold. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from hotspot at injection site, very painful at injection site, and skin around it cold. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Sinusitis
Clinical narrative: SINUS INFECTION; AFFECTED BY BAROMETRIC PRESSURE AND EXPERIENCED JOINT PAIN/THROBBING WHEN A STORM COMES THROUGH; TIRED; FELT FATIGUED; This spontaneous report received from a patient and concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for covid-19 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: adalimumab (solution for injection, subcutaneous, batch number: 1140349 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis; and methotrexate ( batch number: UNKNOWN expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Concomitant medications included leflunomide. On an unspecified date, the patient experienced sinus infection, affected by barometric pressure and experienced joint pain/throbbing when a storm comes through, tired, and felt fatigued. The action taken with covid-19 vaccine was not applicable. The patient recovered from sinus infection, and tired, and had not recovered from affected by barometric pressure and experienced joint pain/throbbing when a storm comes through, and felt fatigued. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE SIDE EFFECTS FROM VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe side effects from vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of severe side effects from vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: SEEING BLACK SPOTS ALL AROUND; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced seeing black spots all around. The action taken with covid-19 vaccine was not applicable. The outcome of seeing black spots all around was not reported. This report was non-serious. This case, from the same reporter is linked to 20210912958 and 20210913421.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 POSITIVE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, peanuts allergy, and non-alcohol user, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, the patient experienced covid-19 positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of covid-19 positive was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old adolescent received the Moderna vaccine by mistake; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old adolescent received the Moderna vaccine by mistake) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 053C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old adolescent received the Moderna vaccine by mistake). On 06-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old adolescent received the Moderna vaccine by mistake) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not reported  It was reported that patient experienced no adverse events as a result of Moderna vaccine administration.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up received, added second dose information and facility type information added.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A patient who is outside of 42 hour window for his 2nd dose of Moderna/more than 35 days passed since the first dose and patient did not receive the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient who is outside of 42 hour window for his 2nd dose of Moderna/more than 35 days passed since the first dose and patient did not receive the second dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient who is outside of 42 hour window for his 2nd dose of Moderna/more than 35 days passed since the first dose and patient did not receive the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient who is outside of 42 hour window for his 2nd dose of Moderna/more than 35 days passed since the first dose and patient did not receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received and reporter information added, patient demographics added, product start and batch number, vaccine facility updated.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2.5 months post first vaccine and has not received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2.5 months post first vaccine and has not received the second dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disability.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2.5 months post first vaccine and has not received the second dose). On 29-Jul-2021, PRODUCT DOSE OMISSION ISSUE (2.5 months post first vaccine and has not received the second dose) had resolved.            Concomitant medication were not reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Patient's relevant history updated.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Husband 3rd dose - not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Husband 3rd dose - not immunocompromised) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third 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 EXTRA DOSE ADMINISTERED (Husband 3rd dose - not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (Husband 3rd dose - not immunocompromised) had resolved.            The concomitant medications were not reported. It was reported that the patient, who was over 80 years of age at time of vaccination and was not immunocompromised, had received third dose of vaccine (No date, dose, lot number or route of administration was reported for third dose). No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up received on 03 Sep 2021 included no new information.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Lung disorder, Pruritus, Rash
Clinical narrative: VACCINATION SITE  PAIN; tiredness; viral rash; very sick; lung issues; Weird rash all over my body/around my trunk area at the top of my butt/on the top of my foot; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE PAIN (VACCINATION SITE  PAIN), FATIGUE (tiredness), VIRAL RASH (viral rash) and ILLNESS (very sick) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced PRURITUS (itching). On an unknown date, the patient experienced VACCINATION SITE PAIN (VACCINATION SITE  PAIN), FATIGUE (tiredness), VIRAL RASH (viral rash), ILLNESS (very sick), LUNG DISORDER (lung issues) and RASH (Weird rash all over my body/around my trunk area at the top of my butt/on the top of my foot). The patient was treated with PREDNISONE at a dose of 1 dosage form and TRIAMCINOLONE (AMCORT [TRIAMCINOLONE]) at a dose of 1 dosage form. At the time of the report, PRURITUS (itching), VACCINATION SITE PAIN (VACCINATION SITE  PAIN), FATIGUE (tiredness), VIRAL RASH (viral rash), ILLNESS (very sick), LUNG DISORDER (lung issues) and RASH (Weird rash all over my body/around my trunk area at the top of my butt/on the top of my foot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported.   This case was linked to MOD-2021-294347, MOD-2021-294347 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain, Viral rash
Clinical narrative: VACCINATION SITE  PAIN; tiredness; viral rash; very sick; lung issues; Weird rash all over my body/around my trunk area at the top of my butt/on the top of my foot; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE PAIN (VACCINATION SITE  PAIN), FATIGUE (tiredness), VIRAL RASH (viral rash) and ILLNESS (very sick) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced PRURITUS (itching). On an unknown date, the patient experienced VACCINATION SITE PAIN (VACCINATION SITE  PAIN), FATIGUE (tiredness), VIRAL RASH (viral rash), ILLNESS (very sick), LUNG DISORDER (lung issues) and RASH (Weird rash all over my body/around my trunk area at the top of my butt/on the top of my foot). The patient was treated with PREDNISONE at a dose of 1 dosage form and TRIAMCINOLONE (AMCORT [TRIAMCINOLONE]) at a dose of 1 dosage form. At the time of the report, PRURITUS (itching), VACCINATION SITE PAIN (VACCINATION SITE  PAIN), FATIGUE (tiredness), VIRAL RASH (viral rash), ILLNESS (very sick), LUNG DISORDER (lung issues) and RASH (Weird rash all over my body/around my trunk area at the top of my butt/on the top of my foot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported.   This case was linked to MOD-2021-294347, MOD-2021-294347 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Rash, Skin lesion
Clinical narrative: Consumer has two types of skin lesions; type 1 is in patches and tiny bumpy itching and burning; she developed skin rash in the face, scalp, back, neck, on the chest, arms, and fingers/ tiny bumpy itching; burning like crazy; red cone shape which looks like chicken pox; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning like crazy), ERYTHEMA (red cone shape which looks like chicken pox), SKIN LESION (Consumer has two types of skin lesions; type 1 is in patches and tiny bumpy itching and burning) and RASH (she developed skin rash in the face, scalp, back, neck, on the chest, arms, and fingers/ tiny bumpy itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced BURNING SENSATION (burning like crazy), ERYTHEMA (red cone shape which looks like chicken pox) and RASH (she developed skin rash in the face, scalp, back, neck, on the chest, arms, and fingers/ tiny bumpy itching). On an unknown date, the patient experienced SKIN LESION (Consumer has two types of skin lesions; type 1 is in patches and tiny bumpy itching and burning). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning like crazy), ERYTHEMA (red cone shape which looks like chicken pox) and RASH (she developed skin rash in the face, scalp, back, neck, on the chest, arms, and fingers/ tiny bumpy itching) had not resolved and SKIN LESION (Consumer has two types of skin lesions; type 1 is in patches and tiny bumpy itching and burning) outcome was unknown.            No concomitant medication was reported.  biopsy was done on one of the patch lesions   This case was linked to MOD-2021-294343 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Rash pustular, Rash vesicular
Clinical narrative: Blistery rash; Rash is present in the arms, back and neck whit puss emanating from it; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (Blistery rash) and RASH PUSTULAR (Rash is present in the arms, back and neck whit puss emanating from it) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (He  was hospitalized due to Covid19 in December at intensive care for 5 weeks in January previous to the first dose of the Moderna vaccine.) in December 2020. Concurrent medical conditions included Diabetes mellitus and Hypertension.   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 RASH VESICULAR (Blistery rash) and RASH PUSTULAR (Rash is present in the arms, back and neck whit puss emanating from it). At the time of the report, RASH VESICULAR (Blistery rash) and RASH PUSTULAR (Rash is present in the arms, back and neck whit puss emanating from it) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Night sweats
Clinical narrative: night sweats; hot flashes during the day; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats) and HOT FLUSH (hot flashes during the day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Menopause. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and COLLAGEN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats) and HOT FLUSH (hot flashes during the day). At the time of the report, NIGHT SWEATS (night sweats) and HOT FLUSH (hot flashes during the day) outcome was unknown.            Sees an Endocrinologist for her night sweats and hot flashes and has been post menopausal for 15 yrs. She has no thyroid. Prenatal multi vitamin was used as concomitant.  No treatment medications was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache; Felt really tired; Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Very sore arm), HEADACHE (Headache) and FATIGUE (Felt really tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Skin cancer. Concurrent medical conditions included Crohn's disease and COPD.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (Very sore arm). On 19-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Felt really tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Tiredness and Myalgia, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Tiredness, Headache and Myalgia, at an unspecified dose and frequency. On 21-Mar-2021, HEADACHE (Headache) and FATIGUE (Felt really tired) had resolved. At the time of the report, MYALGIA (Very sore arm) had resolved.            No concomitant medications were reported. Patient reports a recent antibody test on an unknown date that was inconclusive.   This case was linked to MOD-2021-295029 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: very sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (very sore arm.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Skin cancer. Concurrent medical conditions included Crohn's disease and COPD.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (very sore arm.). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (very sore arm.) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  After the first dose she had a very sore arm which was no worse than a tetanus shot.  Patient reports a recent antibody test on an unknown date that was inconclusive.   This case was linked to MOD-2021-295023 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose given wasn't completely thawed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Dose given wasn't completely thawed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose given wasn't completely thawed). At the time of the report, PRODUCT STORAGE ERROR (Dose given wasn't completely thawed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Rash
Clinical narrative: rash on my legs, no itching; head is feeling numb, no pain, but something I can not describe but with numbness and it is going down lower on my head; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my legs, no itching) and HYPOAESTHESIA (head is feeling numb, no pain, but something I can not describe but with numbness and it is going down lower on my head) 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 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced RASH (rash on my legs, no itching) and HYPOAESTHESIA (head is feeling numb, no pain, but something I can not describe but with numbness and it is going down lower on my head). At the time of the report, RASH (rash on my legs, no itching) and HYPOAESTHESIA (head is feeling numb, no pain, but something I can not describe but with numbness and it is going down lower on my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: 17 year-old patient received Moderna's first dose; Patient didn't receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year-old patient received Moderna's first dose) and PRODUCT DOSE OMISSION ISSUE (Patient didn't receive second dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year-old patient received Moderna's first dose) and PRODUCT DOSE OMISSION ISSUE (Patient didn't receive second dose). On 02-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year-old patient received Moderna's first dose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient didn't receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported Treatment was not specified  Age was recorded as received from health authority. Unable to clarify or confirm.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Vaccination site bruising, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Injection site warm to the touch; The patient said it spread from the injection site and there was a bruise/The area was the size a tangerine; The fingers of the left hand started swelling and almost had to have the wedding ring cut off; Joints are swelling; The injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE BRUISING (The patient said it spread from the injection site and there was a bruise/The area was the size a tangerine), PERIPHERAL SWELLING (The fingers of the left hand started swelling and almost had to have the wedding ring cut off), JOINT SWELLING (Joints are swelling) and VACCINATION SITE ERYTHEMA (The injection site red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-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 VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE BRUISING (The patient said it spread from the injection site and there was a bruise/The area was the size a tangerine), PERIPHERAL SWELLING (The fingers of the left hand started swelling and almost had to have the wedding ring cut off), JOINT SWELLING (Joints are swelling) and VACCINATION SITE ERYTHEMA (The injection site red). At the time of the report, VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE BRUISING (The patient said it spread from the injection site and there was a bruise/The area was the size a tangerine), PERIPHERAL SWELLING (The fingers of the left hand started swelling and almost had to have the wedding ring cut off), JOINT SWELLING (Joints are swelling) and VACCINATION SITE ERYTHEMA (The injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Fatigue, Headache, Laryngitis, Nausea
Clinical narrative: left arm is very very sore; laryngitis; very very fatigue; nauseated; throw up several times; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGITIS (laryngitis), PAIN IN EXTREMITY (left arm is very very sore), FATIGUE (very very fatigue), NAUSEA (nauseated) and VOMITING (throw up several times) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN, ESCITALOPRAM OXALATE (LEXAPRO), SIMVASTATIN, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced FATIGUE (very very fatigue), NAUSEA (nauseated), VOMITING (throw up several times) and HEADACHE (slight headache). On 23-Aug-2021, the patient experienced LARYNGITIS (laryngitis). On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm is very very sore). At the time of the report, LARYNGITIS (laryngitis), PAIN IN EXTREMITY (left arm is very very sore), FATIGUE (very very fatigue), NAUSEA (nauseated), VOMITING (throw up several times) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Blood glucose: high (High) very High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Relevant concomitant medications also includes unspecified Vitamins. Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: left arm is very very sore; laryngitis; very very fatigue; nauseated; throw up several times; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGITIS (laryngitis), PAIN IN EXTREMITY (left arm is very very sore), FATIGUE (very very fatigue), NAUSEA (nauseated) and VOMITING (throw up several times) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN, ESCITALOPRAM OXALATE (LEXAPRO), SIMVASTATIN, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced FATIGUE (very very fatigue), NAUSEA (nauseated), VOMITING (throw up several times) and HEADACHE (slight headache). On 23-Aug-2021, the patient experienced LARYNGITIS (laryngitis). On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm is very very sore). At the time of the report, LARYNGITIS (laryngitis), PAIN IN EXTREMITY (left arm is very very sore), FATIGUE (very very fatigue), NAUSEA (nauseated), VOMITING (throw up several times) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Blood glucose: high (High) very High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Relevant concomitant medications also includes unspecified Vitamins. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Decreased appetite, Diarrhoea, Fatigue, Myalgia
Clinical narrative: diarrhea; feels very sinusy but nose is not running; it feels like when you have an allergy; cold like symptoms mainly in nose and eyes; pain; loss of appetite; fatigue; body aches/arm was sore; runned a fever of a 100; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), DECREASED APPETITE (loss of appetite), NASOPHARYNGITIS (cold like symptoms mainly in nose and eyes), DIARRHOEA (diarrhea) and SINUS DISORDER (feels very sinusy but nose is not running) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A, 27A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included CLONAZEPAM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced PAIN (pain), DECREASED APPETITE (loss of appetite), FATIGUE (fatigue), MYALGIA (body aches/arm was sore) and PYREXIA (runned a fever of a 100). On 21-Aug-2021, the patient experienced NASOPHARYNGITIS (cold like symptoms mainly in nose and eyes), SINUS DISORDER (feels very sinusy but nose is not running) and ALLERGY TO VACCINE (it feels like when you have an allergy). On 23-Aug-2021, the patient experienced DIARRHOEA (diarrhea). On 21-Aug-2021, DECREASED APPETITE (loss of appetite) and PYREXIA (runned a fever of a 100) had resolved. On 22-Aug-2021, PAIN (pain) and MYALGIA (body aches/arm was sore) had resolved. On 24-Aug-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, NASOPHARYNGITIS (cold like symptoms mainly in nose and eyes), SINUS DISORDER (feels very sinusy but nose is not running), ALLERGY TO VACCINE (it feels like when you have an allergy) and FATIGUE (fatigue) outcome was unknown.     Patient is immunocompromised since she had her spleen removed  No treatment information was received   This case was linked to MOD-2021-295308 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pyrexia, Sinus disorder
Clinical narrative: diarrhea; feels very sinusy but nose is not running; it feels like when you have an allergy; cold like symptoms mainly in nose and eyes; pain; loss of appetite; fatigue; body aches/arm was sore; runned a fever of a 100; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), DECREASED APPETITE (loss of appetite), NASOPHARYNGITIS (cold like symptoms mainly in nose and eyes), DIARRHOEA (diarrhea) and SINUS DISORDER (feels very sinusy but nose is not running) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A, 27A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included CLONAZEPAM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced PAIN (pain), DECREASED APPETITE (loss of appetite), FATIGUE (fatigue), MYALGIA (body aches/arm was sore) and PYREXIA (runned a fever of a 100). On 21-Aug-2021, the patient experienced NASOPHARYNGITIS (cold like symptoms mainly in nose and eyes), SINUS DISORDER (feels very sinusy but nose is not running) and ALLERGY TO VACCINE (it feels like when you have an allergy). On 23-Aug-2021, the patient experienced DIARRHOEA (diarrhea). On 21-Aug-2021, DECREASED APPETITE (loss of appetite) and PYREXIA (runned a fever of a 100) had resolved. On 22-Aug-2021, PAIN (pain) and MYALGIA (body aches/arm was sore) had resolved. On 24-Aug-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, NASOPHARYNGITIS (cold like symptoms mainly in nose and eyes), SINUS DISORDER (feels very sinusy but nose is not running), ALLERGY TO VACCINE (it feels like when you have an allergy) and FATIGUE (fatigue) outcome was unknown.     Patient is immunocompromised since she had her spleen removed  No treatment information was received   This case was linked to MOD-2021-295308 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Punctured vial greater than 12 hours in refrigerator; punctured vial greater than 12 hours in refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (punctured vial greater than 12 hours in refrigerator) and PRODUCT STORAGE ERROR (Punctured vial greater than 12 hours in refrigerator) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (punctured vial greater than 12 hours in refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial greater than 12 hours in refrigerator). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (punctured vial greater than 12 hours in refrigerator) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Punctured vial greater than 12 hours in refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter  Treatment information was not provided.  Cross-Linked with Case Numbers: MOD21-134712, MOD21-134781, MOD21-134783, MOD21-134784, MOD21-134785, MOD21-134787.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Swelling
Clinical narrative: Right side of neck is swollen; Feel lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Right side of neck is swollen) and DIZZINESS (Feel lightheaded) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Right side of neck is swollen) and DIZZINESS (Feel lightheaded). At the time of the report, SWELLING (Right side of neck is swollen) and DIZZINESS (Feel lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication were not reported.  No treatment information was mentioned by the reporter.