chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: BROKE OUT ON UPPER BODY LOOKED LIKE WELTS WHICH WAS SHOWING LIKE BODY REJECTING VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was reported that the patient's doctor had told that the patient's immune system was good. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced broke out on upper body looked like welts which was showing like body rejecting vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out on upper body looked like welts which was showing like body rejecting vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: VIRAL FEVER; 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced viral fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from viral fever on 22-JAN-2022. This report was non-serious.
Age: 0.92
Sex: M
Vaccine: TD
Symptoms: Injection site haemorrhage, Wrong product administered
Clinical narrative: Wrong Drug Administered; No adverse event; Minor Bleeding at Injection Site; An 11-month-old male patient mistakenly administered Td Vaccine (Lot #A126A) instead of SYNAGIS® (palvizumab). The administration error occurred on 22APR2021 at the patient's primary health care provider's office and the error was noted on the same day as administration. The total dose administered was 1.4mL (0.7mL IM into each thigh). The source of the report indicated that she made the error because she did not read the label closely, as opposed to label confusion. The source indicated there was minor bleeding at the injection sites but no other immediate reaction.  During the follow up call on 18May2021, the reporter indicated the patient was doing well and did not experience any adverse reactions. At the time of follow-up call patient still had not received SYNAGIS® (the intended drug product) but was expected to receive it soon. The patient's status is considered recovered and no further follow-up is needed.; Sender's Comments: The adverse event reported in this case was assessed as non-serious and not used as labeled.
Sex: U
Vaccine: TD
Symptoms: Vision blurred
Clinical narrative: Vision in left eye a little blurry; Left eye less clear than right eye; Medical assistant at Medical Group was drawing TdVAX shot from the vial and it accidently squirted into her left eye. Patient did not experienced any pain or redness. However, she felt that her left eye was little blurry and less clear than her right eye. Patient did not immediately flush the affected eye with water but did so a few minutes later. She was advised to seek medical attention and contact Poison Control Center. When patient reached out Center they provided her with the Td Safety Data Sheet (SDS).  Personnel also reached out to patient directly to learn more about her AE. Upon being asked for lot number for the Td, Patient mentioned that she do not know the lot number and she would not able to find it out since she threw away the bottle. Patient indicated that she needs to end the conversation and insisted that she would give a call back next day which she did not.; Sender's Comments: The adverse event reported in this case was assessed as unexpected, non-serious, and not used as labeled.
Age: 56.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Wrong product administered
Clinical narrative: Redness at injection site; Skin induration at injection site; Bubble / blister at injection site; Intended to administer tuberculin; On 30Nov2021, Nurse Practitioner called and reported that three patients, (Female age 56), (Female age 25), and (Female age 55) were incorrectly administered TDVAX (lot# A132A). A 0.72mL dose of TDVAX was administered to each patient via intradermal injection whereas the labeled dose of TDVAX is 0.5mL administered IM. The stated intent was to administer tuberculin testing. The errors were discovered approximately 5 minutes after the administration of TDVAX to the third patient who noted that the injection did not feel like TB test. Each patient was alerted to the error on the same day.   The next day, 30Nov2021, each patient reported injection site reactions. One patient noted redness at the injection site and the other two had slightly larger red areas with induration at the injection site. One developed a blister. did not specify which adverse reaction belonged to which patient.     Upon being asked about the site of administration, stated that it involved both left and right arms, without providing further details.  Requested to provide with the name of the facility where these events took place. Refused to disclose additional information and stated that she needed to talk with her lawyer.    Note: Three separate ICSRs have been submitted to VAERS for all three patients mentioned in this case.   1. ICSR Submission Name "US-MassBiologics-AE21-06" 2. ICSR Submission Name "US-MassBiologics-AE21-07" 3. ICSR Submission Name "US-MassBiologics-AE21-08"; Sender's Comments: The adverse event reported in this case was assessed as non-serious and not used as labeled.
Age: 25.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site vesicles, Wrong product administered
Clinical narrative: Redness at injection site; Skin induration at injection site; Bubble / blister at injection site; Intended to administer tuberculin; On 30Nov2021, Nurse Practitioner called and reported that three patients, (Female age 56), (Female age 25), and (Female age 55) were incorrectly administered TDVAX (lot# A132A). A 0.72mL dose of TDVAX was administered to each patient via intradermal injection whereas the labeled dose of TDVAX is 0.5mL administered IM. The stated intent was to administer tuberculin testing. The errors were discovered approximately 5 minutes after the administration of TDVAX to the third patient who noted that the injection did not feel like TB test. Each patient was alerted to the error on the same day.   The next day, 30Nov2021, each patient reported injection site reactions. One patient noted redness at the injection site and the other two had slightly larger red areas with induration at the injection site. One developed a blister. Did not specify which adverse reaction belonged to which patient.     Upon being asked about the site of administration, stated that it involved both left and right arms, without providing further details.  Requested to provide with the name of the facility where these events took place. Refused to disclose additional information and stated that she needed to talk with her lawyer.    Note: Three separate ICSRs have been submitted to VAERS for all three patients mentioned in this case.   1. ICSR Submission Name "US-MassBiologics-AE21-06" 2. ICSR Submission Name "US-MassBiologics-AE21-07" 3. ICSR Submission Name "US-MassBiologics-AE21-08"; Sender's Comments: The adverse event reported in this case was assessed as non-serious and not used as labeled.
Age: 55.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site vesicles, Wrong product administered
Clinical narrative: Redness at injection site; Skin induration at injection site; Bubble / blister at injection site; Intended to administer tuberculin; On 30Nov2021, Nurse Practitioner and reported that three patients, (Female age 56), (Female age 25), and (Female age 55) were incorrectly administered TDVAX (lot# A132A). A 0.72mL dose of TDVAX was administered to each patient via intradermal injection whereas the labeled dose of TDVAX is 0.5mL administered IM. The stated intent was to administer tuberculin testing. The errors were discovered approximately 5 minutes after the administration of TDVAX to the third patient who noted that the injection did not feel like TB test. Each patient was alerted to the error on the same day.   The next day, 30Nov2021, each patient reported injection site reactions. One patient noted redness at the injection site and the other two had slightly larger red areas with induration at the injection site. One developed a blister. Nurse did not specify which adverse reaction belonged to which patient.     Upon being asked about the site of administration, nurse stated that it involved both left and right arms, without providing further details.  It was requested of nurse to provide with the name of the facility where these events took place. Nurse refused to disclose additional information and stated that she needed to talk with her lawyer.    Note: Three separate ICSRs have been submitted to VAERS for all three patients mentioned in this case.   1. ICSR Submission Name "US-MassBiologics-AE21-06" 2. ICSR Submission Name "US-MassBiologics-AE21-07" 3. ICSR Submission Name "US-MassBiologics-AE21-08"; Sender's Comments: The adverse event reported in this case was assessed as non-serious and not used as labeled.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients; Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) had resolved. Not Provided      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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Having covid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Having covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Having covid). At the time of the report, COVID-19 (Having covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a patient  of unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), after receiving second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report  No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a patient  of unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), after receiving second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: died of blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (died of blood clots) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (died of blood clots) (seriousness criteria death and medically significant). The reported cause of death was blood clots. It is unknown if an autopsy was performed.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient developed a red circle on the lower inside part of the arm of the injection, Now it is more like a bigger bruise, like a bleed and it is painful and hurts. Caller also state the patient's fingers were tingling and this was also very painful. It was reported that patient died of blood clots after 30 days of vaccination.  Company Comment: This is a spontaneous case concerning  a female patient of unknown age, with no known medical history, who experienced the unexpected fatal event of thrombosis. The events occurred approximately on an unknown day after the third dose (booster) of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reported casuse of death was blood clots. It is unknown if autopsy was performed. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-452725 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age, with no known medical history, who experienced the unexpected fatal event of thrombosis. The events occurred approximately on an unknown day after the third dose (booster) of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reported casuse of death was blood clots. It is unknown if autopsy was performed. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Reported Cause(s) of Death: blood clots
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vasodilatation
Clinical narrative: she had excessive dilation of blood vessels on the right arm injection site all the way down to the fingers; This spontaneous case was reported by a consumer and describes the occurrence of VASODILATATION (she had excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced VASODILATATION (she had excessive dilation of blood vessels on the right arm injection site all the way down to the fingers). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-Aug-2021, VASODILATATION (she had excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.  Company comment: This is a spontaneous case concerning a 78-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers). The event vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) occurred the same day after the first dose of mRNA-1273 vaccine administration with approximately 4 days duration. No reported treatment information. The outcome of the event vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) was resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-455229 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 78-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers). The event vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) occurred the same day after the first dose of mRNA-1273 vaccine administration with approximately 4 days duration. No reported treatment information. The outcome of the event vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) was resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Dementia Alzheimer's type, Gait inability
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (very advanced Alzheimer's disease), BEDRIDDEN (can't move to get out of the bed, bed bound) and GAIT INABILITY (stopped walking completely) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Alzheimer's disease (Diagnosed 10 years ago). In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DEMENTIA ALZHEIMER'S TYPE (very advanced Alzheimer's disease). In July 2021, the patient experienced BEDRIDDEN (can't move to get out of the bed, bed bound) and GAIT INABILITY (stopped walking completely). The patient was treated with Hospice care for Dementia Alzheimer's type and Hospice care for Bedridden. At the time of the report, DEMENTIA ALZHEIMER'S TYPE (very advanced Alzheimer's disease), BEDRIDDEN (can't move to get out of the bed, bed bound) and GAIT INABILITY (stopped walking completely) had not resolved. Company comment: This is a spontaneous case concerning a male patient of an unknown age with Alzheimer´s disease (diagnosed ten years ago), who experienced the non-serious unexpected events "very advanced Alzheimer´s disease", after receiving second dose of mRNA-1273. The reporter assessed the event as unlikely related to the vaccine .The benefit-risk relationship of mRNA-1273 is not affected by this report. Concomitant medications were not provided. It was reported that one year ago patient was able to move around with help, now he can't move to get out of the bed and is under hospice care. It was also reported that none of the events were related to Moderna COVID-19 vaccines received by the patient. Reporter did not allow further contact. Sender's Comments: Company comment: This is a spontaneous case concerning a male patient of an unknown age with Alzheimer´s disease (diagnosed ten years ago), who experienced the non-serious unexpected events "very advanced Alzheimer´s disease", after receiving second dose of mRNA-1273. The reporter assessed the event as unlikely related to the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile dysfunction; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (Erectile dysfunction) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ERECTILE DYSFUNCTION (Erectile dysfunction) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (Erectile dysfunction) outcome was unknown.            No concomitant medications were reported. No treatment information was provided by the reporter.  Two months after the second shot, patient started having erectile dysfunction. Patient wanted to know the incidence of this side effect. Patient was not seen by the doctor for this, but an appointment was made.  Both doses were injected into the upper arm.  Company comment: This case concerns a 26-year-old male patient with no medical history provided who experienced serious unexpected event of Erectile dysfunction. The event occurred approximately two months after the second dose of the mRNA-1273 vaccine. At the time of the report, the outcome of the event was unknown and no information regarding the clinical course of the event was provided. No information regarding patient's medical history, concomitant medications nor treatment medications was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 26-year-old male patient with no medical history provided who experienced serious unexpected event of Erectile dysfunction. The event occurred approximately two months after the second dose of the mRNA-1273 vaccine. At the time of the report, the outcome of the event was unknown and no information regarding the clinical course of the event was provided. No information regarding patient's medical history, concomitant medications nor treatment medications was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Swelling, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ARTHRITIS (Arthritic reaction), VACCINATION SITE REACTION (Arm reaction, a muscular reaction) and SWELLING (Some sort of swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-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 ARTHRITIS (Arthritic reaction), VACCINATION SITE REACTION (Arm reaction, a muscular reaction) and SWELLING (Some sort of swelling). At the time of the report, ARTHRITIS (Arthritic reaction), VACCINATION SITE REACTION (Arm reaction, a muscular reaction) and SWELLING (Some sort of swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Company comment: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected non serious event/AESI of Arthritis after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course, medical assessment and treatment provided. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. This case was linked to MOD-2022-455761 (Patient Link). Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected non serious event/AESI of Arthritis after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course, medical assessment and treatment provided. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: received 2 doses of the Moderna Covid-19 Vaccine after which they both caught COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received 2 doses of the Moderna Covid-19 Vaccine after which they both caught COVID) 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 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 COVID-19 (received 2 doses of the Moderna Covid-19 Vaccine after which they both caught COVID). At the time of the report, COVID-19 (received 2 doses of the Moderna Covid-19 Vaccine after which they both caught COVID) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-456345 (Patient Link).   Reporter did not allow further contact  Company comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, the patient received 2 doses of the Moderna Covid-19 Vaccine after which she caught COVID. No exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, the patient received 2 doses of the Moderna Covid-19 Vaccine after which she caught COVID. No exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received 2 doses of the Moderna Covid-19 Vaccine after which they both caught Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received 2 doses of the Moderna Covid-19 Vaccine after which they both caught Covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (received 2 doses of the Moderna Covid-19 Vaccine after which they both caught Covid). At the time of the report, COVID-19 (received 2 doses of the Moderna Covid-19 Vaccine after which they both caught Covid) 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 relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-456336 (Patient Link).  Company comment: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, the patient received 2 doses of the Moderna Covid-19 Vaccine after which he caught COVID. No exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, the patient received 2 doses of the Moderna Covid-19 Vaccine after which he caught COVID. No exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got COVID delta; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (got COVID delta) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID delta). At the time of the report, COVID-19 (got COVID delta) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: Company comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, after two doses of vaccine the patient got Covid delta. No exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, after two doses of vaccine the patient got Covid delta. No exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: someone has pneumonia right now; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (someone has pneumonia right now) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (someone has pneumonia right now). At the time of the report, PNEUMONIA (someone has pneumonia right now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. As reported, the patient had it all and now has Covid. The patient also told: '' keep your stupid shots.''  Company comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the a dose of mRNA-1273. As reported, the patient had all shots and now has Covid. No exact administration dates or dose number was provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the a dose of mRNA-1273. As reported, the patient had all shots and now has Covid. No exact administration dates or dose number was provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives all over his body after booster/Hives inside the throat on & off after booster; Itchiness after booster; Rash all over his body after booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over his body after booster/Hives inside the throat on & off after booster), PRURITUS (Itchiness after booster) and RASH (Rash all over his body after booster) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 001C21A and 024C21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy.On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced URTICARIA (Hives all over his body after booster/Hives inside the throat on & off after booster), PRURITUS (Itchiness after booster) and RASH (Rash all over his body after booster). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency; CETIRIZINE for Hives, at an unspecified dose and frequency and LORATADINE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over his body after booster/Hives inside the throat on & off after booster) outcome was unknown, PRURITUS (Itchiness after booster) was resolving and RASH (Rash all over his body after booster) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. About 10 days after the booster, he started having Hives and Rash all over his body. Cortisone cream, did not work. He was prescribed Prednisone tablets for 2 weeks which helped to decrease frequency of rash and itchiness. When the Prednisone ran out, the rash came back. He also has Hives inside the throat on & off. He tried taking Cetirizine, and Loratadine which did not help. All Blood test were normal.No concomitant medication was provided by the reporter.This case was linked to MOD-2022-457608 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine given 12 hours after opening; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given 12 hours after opening) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) 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 EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given 12 hours after opening). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given 12 hours after opening) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Myalgia, Pain in extremity
Clinical narrative: legs are achy and sore as well as muscles; can't lift left arm; severe muscle aches/sore muscle; Joint tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs are achy and sore as well as muscles), HYPOKINESIA (can't lift left arm), MYALGIA (severe muscle aches/sore muscle) and ARTHRALGIA (Joint tenderness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04152A, 043B21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Hypertension.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (legs are achy and sore as well as muscles), HYPOKINESIA (can't lift left arm), MYALGIA (severe muscle aches/sore muscle) and ARTHRALGIA (Joint tenderness). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (legs are achy and sore as well as muscles), HYPOKINESIA (can't lift left arm), MYALGIA (severe muscle aches/sore muscle) and ARTHRALGIA (Joint tenderness) had not resolved.            It was reported that patient took Cholesterol medication and Blood pressure medication.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Diarrhoea, Lethargy, Pyrexia
Clinical narrative: knocked on my butt; lethargic; diarrhea; temperature of 104; threw up; This spontaneous case was reported by an other health care professional and describes the occurrence of CONFUSIONAL STATE (knocked on my butt), LETHARGY (lethargic), DIARRHOEA (diarrhea), PYREXIA (temperature of 104) and VOMITING (threw up) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Clotting disorder.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced CONFUSIONAL STATE (knocked on my butt), LETHARGY (lethargic), DIARRHOEA (diarrhea), PYREXIA (temperature of 104) and VOMITING (threw up). On 06-May-2021, VOMITING (threw up) had resolved. On 12-May-2021, CONFUSIONAL STATE (knocked on my butt), LETHARGY (lethargic), DIARRHOEA (diarrhea) and PYREXIA (temperature of 104) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) increased.     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.   She did not take any concomitant  medications or treatments.  Later in October, she experienced every single covid symptoms. She tested negative for covid twice, but did experience loss of taste and smell.   This case was linked to MOD-2022-458344 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: knocked on my butt; lethargic; diarrhea; temperature of 104; threw up; This spontaneous case was reported by an other health care professional and describes the occurrence of CONFUSIONAL STATE (knocked on my butt), LETHARGY (lethargic), DIARRHOEA (diarrhea), PYREXIA (temperature of 104) and VOMITING (threw up) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Clotting disorder.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced CONFUSIONAL STATE (knocked on my butt), LETHARGY (lethargic), DIARRHOEA (diarrhea), PYREXIA (temperature of 104) and VOMITING (threw up). On 06-May-2021, VOMITING (threw up) had resolved. On 12-May-2021, CONFUSIONAL STATE (knocked on my butt), LETHARGY (lethargic), DIARRHOEA (diarrhea) and PYREXIA (temperature of 104) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) increased.     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.   She did not take any concomitant  medications or treatments.  Later in October, she experienced every single covid symptoms. She tested negative for covid twice, but did experience loss of taste and smell.   This case was linked to MOD-2022-458344 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Doses administered more than 12(US) hours post puncture) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. The patient's past medical history included Pain. Concomitant products included IBUPROFEN for Pain, ALPRAZOLAM, ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VIT D3), GABAPENTIN, LAMOTRIGINE, METHYLPHENIDATE, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and NAPROXEN for an unknown indication. On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Doses administered more than 12(US) hours post puncture). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 Doses administered more than 12(US) hours post puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication were provided. This case was linked to MOD-2022-458512, MOD-2022-458470 (Patient Link).