chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm hurt; small ache/achy; flu-like symptoms; it was a small ache and not as hot to the touch; tired; body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), PAIN (small ache/achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (it was a small ache and not as hot to the touch) and FATIGUE (tired) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Exposure to tobacco (smelling cigarette smoke every day for the past 3 to 4 months.) and Cancer surgery (Thyroid cancer surgery) on 29-Apr-2021. Concurrent medical conditions included Immunocompromised and AFib. Concomitant products included METOPROLOL, ATORVASTATIN and APIXABAN (ELIQUIS) for AFib, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (arm hurt), PAIN (small ache/achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (it was a small ache and not as hot to the touch), FATIGUE (tired), MYALGIA (body aches) and PYREXIA (low grade fever). In July 2021, PAIN IN EXTREMITY (arm hurt), PAIN (small ache/achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (it was a small ache and not as hot to the touch), FATIGUE (tired), MYALGIA (body aches) and PYREXIA (low grade fever) had resolved.            No treatments medications was reported.   This case was linked to MOD-2022-463070, MOD-2022-463121 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Vaccination site pain
Clinical narrative: arm hurting a little bit.; 4 months after her 3rd shot, she got a 4th shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm hurting a little bit.) and EXTRA DOSE ADMINISTERED (4 months after her 3rd shot, she got a 4th shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909 and 026LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, received fourth 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 21-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (4 months after her 3rd shot, she got a 4th shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm hurting a little bit.). On 21-Dec-2021, EXTRA DOSE ADMINISTERED (4 months after her 3rd shot, she got a 4th shot) had resolved. At the time of the report, VACCINATION SITE PAIN (arm hurting a little bit.) outcome was unknown.            No concomitant medication and treatment information was reported. She stated that she did not have any side effects aside from her arm hurting a little bit. She was also directly exposed to someone who had COVID-19 but she did not get COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, CD4 lymphocytes increased, Erythema, Fatigue, Mass
Clinical narrative: raised small red lump on right shoulder, a bit itchy; raised small red lump on right shoulder, a bit itchy; raised small red lump on right shoulder, a bit itchy; patient felt a little tired after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (raised small red lump on right shoulder, a bit itchy), MASS (raised small red lump on right shoulder, a bit itchy), PRURITUS (raised small red lump on right shoulder, a bit itchy) and FATIGUE (patient felt a little tired after second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U7A21A and 0U5B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Osteoporosis. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, IBANDRONATE SODIUM for Osteoporosis.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (patient felt a little tired after second dose). In November 2021, the patient experienced ERYTHEMA (raised small red lump on right shoulder, a bit itchy), MASS (raised small red lump on right shoulder, a bit itchy) and PRURITUS (raised small red lump on right shoulder, a bit itchy). On 10-Apr-2021, FATIGUE (patient felt a little tired after second dose) had resolved. At the time of the report, ERYTHEMA (raised small red lump on right shoulder, a bit itchy), MASS (raised small red lump on right shoulder, a bit itchy) and PRURITUS (raised small red lump on right shoulder, a bit itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Biopsy: results not available (Inconclusive) Results not available. On 16-Dec-2021, CD4 lymphocytes increased: high (High) increased.         No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: raised small red lump on right shoulder, a bit itchy; raised small red lump on right shoulder, a bit itchy; raised small red lump on right shoulder, a bit itchy; patient felt a little tired after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (raised small red lump on right shoulder, a bit itchy), MASS (raised small red lump on right shoulder, a bit itchy), PRURITUS (raised small red lump on right shoulder, a bit itchy) and FATIGUE (patient felt a little tired after second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U7A21A and 0U5B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Osteoporosis. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, IBANDRONATE SODIUM for Osteoporosis.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (patient felt a little tired after second dose). In November 2021, the patient experienced ERYTHEMA (raised small red lump on right shoulder, a bit itchy), MASS (raised small red lump on right shoulder, a bit itchy) and PRURITUS (raised small red lump on right shoulder, a bit itchy). On 10-Apr-2021, FATIGUE (patient felt a little tired after second dose) had resolved. At the time of the report, ERYTHEMA (raised small red lump on right shoulder, a bit itchy), MASS (raised small red lump on right shoulder, a bit itchy) and PRURITUS (raised small red lump on right shoulder, a bit itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Biopsy: results not available (Inconclusive) Results not available. On 16-Dec-2021, CD4 lymphocytes increased: high (High) increased.         No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache after 13 days of my booster vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache after 13 days of my booster vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after 13 days of my booster vaccine). At the time of the report, HEADACHE (Headache after 13 days of my booster vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16-Dec-2021 vial was initially stored in the refrigerator. 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15-Jan-2022.  The vial did not undergone any temperature excursions.  Concomitant medication was not provided.  Treatment information was not provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16 Dec 2021 vial was initially stored in the refrigerator. The Moderna Covid-19 Vaccine was given past the beyond use date of 15 Jan 2022. The vial did not undergone any temperature excursions.  No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   5 doses were given past beyond use of 15-Jan-2022 to 5 patients from 3 vials. On 16-Dec-2021 the vial was initially stored in the refrigerator. The vial does not undergo to any temperature excursions.  Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date). On 25-Jan-2022, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The vial was used past the beyond use date of 15-Jan-2022. On 16-Dec-2021, the vial was initially stored in refrigerator. The vial did not undergo any temperature excursion issues.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, Nasopharyngitis
Clinical narrative: Cold; Fall; Could not walk; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), FALL (Fall) and GAIT DISTURBANCE (Could not walk) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient's past medical history was not reported.  Concurrent medical conditions included Multiple sclerosis.    On 16-Apr-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, the patient experienced NASOPHARYNGITIS (Cold), FALL (Fall) and GAIT DISTURBANCE (Could not walk). At the time of the report, NASOPHARYNGITIS (Cold), FALL (Fall) and GAIT DISTURBANCE (Could not walk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Rebound effect, Serum ferritin, Vaccination complication, Visual impairment
Clinical narrative: similar things after the vaccine/still having her adverse reaction; double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern; Steroids made her vision much much worse, significantly worse; There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (similar things after the vaccine/still having her adverse reaction), DIPLOPIA (double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern), VISUAL IMPAIRMENT (Steroids made her vision much much worse, significantly worse) and REBOUND EFFECT (There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.) 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 VACCINATION COMPLICATION (similar things after the vaccine/still having her adverse reaction), DIPLOPIA (double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern), VISUAL IMPAIRMENT (Steroids made her vision much much worse, significantly worse) and REBOUND EFFECT (There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.). At the time of the report, VACCINATION COMPLICATION (similar things after the vaccine/still having her adverse reaction), DIPLOPIA (double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern), VISUAL IMPAIRMENT (Steroids made her vision much much worse, significantly worse) and REBOUND EFFECT (There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Serum ferritin: low (Low) Low. On an unknown date, Vitamin D: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had an MRI and was reported she would have lumbar puncture to verify the MRI results. She was been taking supplements for low vitamin D and ferratin, but after several months, they were still really low. Steroids made her vision much much worse, significantly worse. There was a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal. Her doctor stated this events were from the vaccine. Patient was being seen primarily by her neuroophthalmologist for many months. Doctor did not recommend her taking another shot of Moderna.  Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D
Clinical narrative: similar things after the vaccine/still having her adverse reaction; double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern; Steroids made her vision much much worse, significantly worse; There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (similar things after the vaccine/still having her adverse reaction), DIPLOPIA (double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern), VISUAL IMPAIRMENT (Steroids made her vision much much worse, significantly worse) and REBOUND EFFECT (There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.) 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 VACCINATION COMPLICATION (similar things after the vaccine/still having her adverse reaction), DIPLOPIA (double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern), VISUAL IMPAIRMENT (Steroids made her vision much much worse, significantly worse) and REBOUND EFFECT (There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.). At the time of the report, VACCINATION COMPLICATION (similar things after the vaccine/still having her adverse reaction), DIPLOPIA (double vision/doesn't follow any typical patterns from any of the textbooks, it's a unique pattern), VISUAL IMPAIRMENT (Steroids made her vision much much worse, significantly worse) and REBOUND EFFECT (There is a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Serum ferritin: low (Low) Low. On an unknown date, Vitamin D: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had an MRI and was reported she would have lumbar puncture to verify the MRI results. She was been taking supplements for low vitamin D and ferratin, but after several months, they were still really low. Steroids made her vision much much worse, significantly worse. There was a slow rebound effect. When she gets off steroids, it very slowly improves but never to normal. Her doctor stated this events were from the vaccine. Patient was being seen primarily by her neuroophthalmologist for many months. Doctor did not recommend her taking another shot of Moderna.  Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe Headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Severe Headaches) 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 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced HEADACHE (Severe Headaches). At the time of the report, HEADACHE (Severe Headaches) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Scab, Urticaria
Clinical narrative: hives on arms legs, back of my neck  hive started on right wrist; Looks crusty; rash, rash on arms, rash on legs, rash on back of my neck,rash started on right wrist; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on arms legs, back of my neck  hive started on right wrist), SCAB (Looks crusty) and RASH (rash, rash on arms, rash on legs, rash on back of my neck,rash started on right wrist) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 046B21A and 0121A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy, Penicillin allergy and Drug allergy (erythromycin).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives on arms legs, back of my neck  hive started on right wrist), SCAB (Looks crusty) and RASH (rash, rash on arms, rash on legs, rash on back of my neck,rash started on right wrist). The patient was treated with HYDROCORTISONE (CORTIZONE 10) for Product use for unknown indication, at an unspecified dose and frequency; AVENA SATIVA FLUID EXTRACT (AVEENO) for Product use for unknown indication, at an unspecified dose and frequency and PARAFFIN (VASELINE [PARAFFIN]) for Product use for unknown indication, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on arms legs, back of my neck  hive started on right wrist), SCAB (Looks crusty) and RASH (rash, rash on arms, rash on legs, rash on back of my neck,rash started on right wrist) had not resolved.            No concomitant medications were reported  Patient stated that events were fade and if she wash in hot water they come up again. She used cortisone cream, nothing seems to take it away.
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: Immunocompromised; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2022 and was forwarded to Moderna on 28-Jan-2022.    This spontaneous case was reported by a physician and describes the occurrence of IMMUNODEFICIENCY (Immunocompromised) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 IMMUNODEFICIENCY (Immunocompromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Immunocompromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. It was reported that the patient received his first 2 primary doses without issue. He then received a 3rd dose of the vaccine 5 months later as a 0.25mL dosage and the patient was now immunocompromised and was asking about the 4th dose of the vaccine. Would it be possible to administer an additional booster dose although the 3rd primary series dose was administered at a different dosage. Treatment information was not provided.  Unknown dates of administration. No patient information available. No known symptoms or treatments. Colleague she has been discussing this with stated it was an "increasingly common question." She thinks this may indicate that this could have occurred with more than one patient.  This is a regulatory case concerning a male patient of unknown age with no medical history reported, who experienced the unexpected event of immunodeficiency. The event and the received dose of mRNA -1273 vaccine occurred on an unknown date. Immunodeficiency was reported as medically significant and at the time of report  the outcome was still unknown. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a regulatory case concerning a male patient of unknown age with no medical history reported, who experienced the unexpected event of immunodeficiency. The event and the received dose of mRNA -1273 vaccine occurred on an unknown date. Immunodeficiency was reported as medically significant and at the time of report  the outcome was still unknown. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus, Urticaria
Clinical narrative: Itching; hives; have allergies; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), URTICARIA (hives) and ALLERGY TO VACCINE (have allergies) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), URTICARIA (hives) and ALLERGY TO VACCINE (have allergies). At the time of the report, PRURITUS (Itching), URTICARIA (hives) and ALLERGY TO VACCINE (have allergies) outcome was unknown.     Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes under his right armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes under his right armpit) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.  No Medical History information was reported.  On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes under his right armpit). The patient was treated with PREDNISONE for Swollen lymph nodes, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes under his right armpit) had resolved.  Concomitant medication of the patient was not reported.  A few days later, the patient experienced the adverse event. The event lasted about a week to 10 days.  The patient also received antihistamine as corrective treatment.   This case was linked to MOD-2022-464106, MOD-2022-464124 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: He broke out with hives all over his body; hands got pretty swollen; chills; fever; Experienced swollen lymph nodes under his right armpit, after Booster dose of the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (He broke out with hives all over his body), PERIPHERAL SWELLING (hands got pretty swollen), CHILLS (chills), LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit, after Booster dose of the Moderna) and PYREXIA (fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 025C21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit, after Booster dose of the Moderna). On 13-Jan-2022, the patient experienced URTICARIA (He broke out with hives all over his body), PERIPHERAL SWELLING (hands got pretty swollen), CHILLS (chills) and PYREXIA (fever). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (He broke out with hives all over his body), PERIPHERAL SWELLING (hands got pretty swollen), CHILLS (chills), LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit, after Booster dose of the Moderna) and PYREXIA (fever) was resolving.            No concomitant medication was provided. Treatment medication included unspecified Antihistamine. It was reported that, 9 days later he broke out with hives all over his body, fever, chills and his hands got pretty swollen.   This case was linked to MOD-2022-464106, MOD-2022-464121 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Joint swelling, Peripheral swelling, Vaccination site induration, Vaccination site swelling
Clinical narrative: Left bicep, tricep doubled in size/It became swollen; Left elbow doubled in size/It became swollen; It became hot; Arm had a swelling ring that got hard at the injection site; Got hard at the injection site; The vaccine that was given to me was stored in a pre-filled syringe and that's the problem. It was exposed to latex during that time; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left bicep, tricep doubled in size/It became swollen), JOINT SWELLING (Left elbow doubled in size/It became swollen), FEELING HOT (It became hot), VACCINATION SITE SWELLING (Arm had a swelling ring that got hard at the injection site) and VACCINATION SITE INDURATION (Got hard at the injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Silicone allergy), Latex allergy, Insect sting allergy (Hornets allergy) and Smoke sensitivity (Smoke allergy).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced PERIPHERAL SWELLING (Left bicep, tricep doubled in size/It became swollen), JOINT SWELLING (Left elbow doubled in size/It became swollen), FEELING HOT (It became hot), VACCINATION SITE SWELLING (Arm had a swelling ring that got hard at the injection site), VACCINATION SITE INDURATION (Got hard at the injection site) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The vaccine that was given to me was stored in a pre-filled syringe and that's the problem. It was exposed to latex during that time). On 22-May-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The vaccine that was given to me was stored in a pre-filled syringe and that's the problem. It was exposed to latex during that time) had resolved. At the time of the report, PERIPHERAL SWELLING (Left bicep, tricep doubled in size/It became swollen), JOINT SWELLING (Left elbow doubled in size/It became swollen), FEELING HOT (It became hot), VACCINATION SITE SWELLING (Arm had a swelling ring that got hard at the injection site) and VACCINATION SITE INDURATION (Got hard at the injection site) had resolved.            Patient is allergic to a long list of things.  No Concomitant medication were reported.  It was reported that within 1 hour of getting the vaccine his arm had a swelling ring that got hard at the injection site and 8 hours following this his eft bicep, tricep, elbow doubled in size. It became hot and swollen.  It was reported that a doctor prescribed him antibiotics and his arm got better within 10 days.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: Left bicep, tricep doubled in size/It became swollen; Left elbow doubled in size/It became swollen; It became hot; Arm had a swelling ring that got hard at the injection site; Got hard at the injection site; The vaccine that was given to me was stored in a pre-filled syringe and that's the problem. It was exposed to latex during that time; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left bicep, tricep doubled in size/It became swollen), JOINT SWELLING (Left elbow doubled in size/It became swollen), FEELING HOT (It became hot), VACCINATION SITE SWELLING (Arm had a swelling ring that got hard at the injection site) and VACCINATION SITE INDURATION (Got hard at the injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Silicone allergy), Latex allergy, Insect sting allergy (Hornets allergy) and Smoke sensitivity (Smoke allergy).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced PERIPHERAL SWELLING (Left bicep, tricep doubled in size/It became swollen), JOINT SWELLING (Left elbow doubled in size/It became swollen), FEELING HOT (It became hot), VACCINATION SITE SWELLING (Arm had a swelling ring that got hard at the injection site), VACCINATION SITE INDURATION (Got hard at the injection site) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The vaccine that was given to me was stored in a pre-filled syringe and that's the problem. It was exposed to latex during that time). On 22-May-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The vaccine that was given to me was stored in a pre-filled syringe and that's the problem. It was exposed to latex during that time) had resolved. At the time of the report, PERIPHERAL SWELLING (Left bicep, tricep doubled in size/It became swollen), JOINT SWELLING (Left elbow doubled in size/It became swollen), FEELING HOT (It became hot), VACCINATION SITE SWELLING (Arm had a swelling ring that got hard at the injection site) and VACCINATION SITE INDURATION (Got hard at the injection site) had resolved.            Patient is allergic to a long list of things.  No Concomitant medication were reported.  It was reported that within 1 hour of getting the vaccine his arm had a swelling ring that got hard at the injection site and 8 hours following this his eft bicep, tricep, elbow doubled in size. It became hot and swollen.  It was reported that a doctor prescribed him antibiotics and his arm got better within 10 days.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Singulair. Past adverse reactions to the above products included No adverse event with Singulair.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient takes singular and hadn't took any until. No concomitant medications reported. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fear of death, Feeling abnormal, Insomnia
Clinical narrative: Potential infection at injection site; More pain at injection site; Redness around the injection area that is about 4.5 inches long and 4.5 inches wide/ The redness appears to be spreading too; Chills and shivering; Felt strange; Arm felt like hammer; Unable to sleep at night; Pain like getting stabbed with pins was really bad; Aches and pain in her bones; she's scared to death; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Unable to sleep at night), PAIN (Pain like getting stabbed with pins was really bad), BONE PAIN (Aches and pain in her bones), VACCINATION SITE INFECTION (Potential infection at injection site) and FEAR OF DEATH (she's scared to death) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson & Johnson (First dose (Primary series)) on 10-Jul-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEAR OF DEATH (she's scared to death). On 25-Jan-2022, the patient experienced INSOMNIA (Unable to sleep at night), PAIN (Pain like getting stabbed with pins was really bad), BONE PAIN (Aches and pain in her bones), FEELING ABNORMAL (Felt strange), PAIN IN EXTREMITY (Arm felt like hammer) and CHILLS (Chills and shivering). On 26-Jan-2022, the patient experienced VACCINATION SITE INFECTION (Potential infection at injection site), VACCINATION SITE PAIN (More pain at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection area that is about 4.5 inches long and 4.5 inches wide/ The redness appears to be spreading too). At the time of the report, INSOMNIA (Unable to sleep at night), PAIN (Pain like getting stabbed with pins was really bad), BONE PAIN (Aches and pain in her bones), VACCINATION SITE INFECTION (Potential infection at injection site), FEAR OF DEATH (she's scared to death), FEELING ABNORMAL (Felt strange), PAIN IN EXTREMITY (Arm felt like hammer), VACCINATION SITE PAIN (More pain at injection site), VACCINATION SITE ERYTHEMA (Redness around the injection area that is about 4.5 inches long and 4.5 inches wide/ The redness appears to be spreading too) and CHILLS (Chills and shivering) outcome was unknown.            No concomitant and treatment medications were reported. Patient  put a large bandaid around the redness.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site erythema, Vaccination site infection, Vaccination site pain
Clinical narrative: Potential infection at injection site; More pain at injection site; Redness around the injection area that is about 4.5 inches long and 4.5 inches wide/ The redness appears to be spreading too; Chills and shivering; Felt strange; Arm felt like hammer; Unable to sleep at night; Pain like getting stabbed with pins was really bad; Aches and pain in her bones; she's scared to death; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Unable to sleep at night), PAIN (Pain like getting stabbed with pins was really bad), BONE PAIN (Aches and pain in her bones), VACCINATION SITE INFECTION (Potential infection at injection site) and FEAR OF DEATH (she's scared to death) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson & Johnson (First dose (Primary series)) on 10-Jul-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEAR OF DEATH (she's scared to death). On 25-Jan-2022, the patient experienced INSOMNIA (Unable to sleep at night), PAIN (Pain like getting stabbed with pins was really bad), BONE PAIN (Aches and pain in her bones), FEELING ABNORMAL (Felt strange), PAIN IN EXTREMITY (Arm felt like hammer) and CHILLS (Chills and shivering). On 26-Jan-2022, the patient experienced VACCINATION SITE INFECTION (Potential infection at injection site), VACCINATION SITE PAIN (More pain at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection area that is about 4.5 inches long and 4.5 inches wide/ The redness appears to be spreading too). At the time of the report, INSOMNIA (Unable to sleep at night), PAIN (Pain like getting stabbed with pins was really bad), BONE PAIN (Aches and pain in her bones), VACCINATION SITE INFECTION (Potential infection at injection site), FEAR OF DEATH (she's scared to death), FEELING ABNORMAL (Felt strange), PAIN IN EXTREMITY (Arm felt like hammer), VACCINATION SITE PAIN (More pain at injection site), VACCINATION SITE ERYTHEMA (Redness around the injection area that is about 4.5 inches long and 4.5 inches wide/ The redness appears to be spreading too) and CHILLS (Chills and shivering) outcome was unknown.            No concomitant and treatment medications were reported. Patient  put a large bandaid around the redness.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On 27-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is on concomitant medication but did not specify. No treatment details were reported.   This case was linked to MOD-2022-464871 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Booster Vaccine administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster Vaccine administered >12 hours post puncture) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 37C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022 at 8:10 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022 at 8:10 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster Vaccine administered >12 hours post puncture). On 28-Jan-2022 at 8:10 AM, EXPIRED PRODUCT ADMINISTERED (Expired Booster Vaccine administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that a 46-year-old patient received an expired booster dose of Moderna COVID-19 vaccine more than 12 hours after puncture on 28-Jan-2022. The date the vial was initially stored in the refrigerator was unknown, but it was less than 30 days.   The date and time the vial first punctured was 27-Jan-2022 at 8 AM and the date and time of administration of vaccine was 28-Jan-2022 at 8:10 AM. The vial was stored in the refrigerator post puncture. It was also reported that the vial didn't undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was N/A because it was kept in the refrigerator post puncture.  No treatment information was provided.