chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient received an extra Moderna Covid-19 vaccine booster dose.; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received an extra Moderna Covid-19 vaccine booster dose.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 048L21A and 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (patient received an extra Moderna Covid-19 vaccine booster dose.). At the time of the report, EXTRA DOSE ADMINISTERED (patient received an extra Moderna Covid-19 vaccine booster dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 18-Nov-2021, the patient received first booster dose.  On 18-May-2022, the patient received second booster dose.  The reporter was not aware of any adverse reactions or side effects to the first dose. No side effects or adverse reactions were reported after second dose. The patient did not experience any known adverse events or side effects after first booster dose and second booster dose.  The patient received third booster dose on 05-Jul-2022 by mistake. The patient received a third vaccination booster dose where only 2 Moderna Covid-19 vaccination doses had been authorized for the non immunocompromised patient.  The vaccinating provider did not notice that the patient had recived her second Moderna Booster dose.  No other side effects or adverse events have been observed.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a vaccine that is expired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a vaccine that is expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a vaccine that is expired) outcome was unknown. No relevant concomitant medications were reported. It was reported that vaccine was expired on 05-JUL-2022. Treatment medication was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (got covid) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got covid). At the time of the report, COVID-19 (got covid) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Company comment-This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further clinical course, lab reports or treatment details were reported.  Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further clinical course, lab reports or treatment details were reported.  Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Minimal issues tolerating doses 1 and 2; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Minimal issues tolerating doses 1 and 2) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Minimal issues tolerating doses 1 and 2). At the time of the report, IMMUNISATION REACTION (Minimal issues tolerating doses 1 and 2) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-604306 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of AGEUSIA (Patient noticed that she lost her sense of taste of smell about a month after receiving her second dose) and ANOSMIA (lost her sense of taste of smell about a month after receiving her second dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 023M20 A) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Patient noticed that she lost her sense of taste of smell about a month after receiving her second dose) and ANOSMIA (lost her sense of taste of smell about  a month after receiving her second dose). At the time of the report, AGEUSIA (Patient noticed that she lost her sense of taste of smell about a month after receiving her second dose) and ANOSMIA (lost her sense of taste of smell about a month after receiving her second dose) outcome was unknown. On 19 NOV 2021 the patient received her first Moderna booster dose. Lot number is 013F21A expiration date is not known. Patient received the vaccine in her left arm and the patient reports no adverse reactions or side effects. No concomitant medications were reported. The patient was told by the local Health Dept. that the loss of smell and taste was related to the Moderna Covid-19 vaccine. The patient stated that she has seen advertisements on YouTube from Doctors who offer to get patients sense of taste or smell back after taking a Covid-19 vaccine. The patient stated that this was too expensive for her to do though. No treatment information was provided. Company Comment: This spontaneous case concerns a 76-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of Ageusia and Anosmia which occurred approximately a month after receiving the second dose of mRNA-1273 vaccine. No further details on clinical course, other lab test results were reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-604305 (Patient Link). Sender's Comments: This spontaneous case concerns a 76-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of Ageusia and Anosmia which occurred approximately a month after receiving the second dose of mRNA-1273 vaccine. No further details on clinical course, other lab test results were reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Inappropriate schedule of product administration, Pain
Clinical narrative: Dose 1 taken on 29-Jan-2021 and dose 2 on 06-Mar-2021 (more than 35 days); Ache on bones; Pain; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Ache on bones), PAIN (Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 29-Jan-2021 and dose 2 on 06-Mar-2021 (more than 35 days)) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 032L620A) for COVID-19 prophylaxis.     Patient had no allergies (medications, food and other products) Patient never had COVID test or diagnosis No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes (No improvement or worsening) since 2000, Blood pressure high (No improvement or worsening) since 2000 and Anxiety. Concomitant products included SERTRALINE for Anxiety, METOPROLOL for Blood pressure high, ATORVASTATIN for Cholesterol, GLIPIZIDE, GABAPENTIN and METFORMIN for Diabetes, OMEPRAZOLE for Stomach discomfort, FINASTERIDE for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 29-Jan-2021 and dose 2 on 06-Mar-2021 (more than 35 days)). In 2021, the patient experienced BONE PAIN (Ache on bones) and PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Ache on bones) and PAIN (Pain) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 29-Jan-2021 and dose 2 on 06-Mar-2021 (more than 35 days)) outcome was unknown.            Indication for Finasteride was reported as for prostate and Omeprazole was for patient's stomach Patient did not experience similar events in the past   This case was linked to MOD-2022-604409, MOD-2022-604653 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Pain
Clinical narrative: Oxygen below 80; Couldn't breathe; Pain; diarrhea for 4 to 5 weeks; This spontaneous case was reported by a patient and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen below 80), DYSPNOEA (Couldn't breathe), PAIN (Pain) and DIARRHOEA (diarrhea for 4 to 5 weeks) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A27B, 037C21A, 032M20A and 032L620A) for COVID-19 vaccination.     Patient did not have allergies to medication, food and other products. Patient never had COVID positive test or diagnosis. No other vaccine taken by the patient within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes (No recent changes in status such as improvement or worsening.) since 2000, Blood pressure high (No recent changes in status such as improvement or worsening.) since 2000, Anxiety, Prostatic disorder, Blood cholesterol abnormal and Gastric disorder. Concomitant products included SERTRALINE for Anxiety, ATORVASTATIN for Blood cholesterol abnormal, METOPROLOL for Blood pressure high, GLIPIZIDE, GABAPENTIN and METFORMIN for Diabetes, OMEPRAZOLE for Gastric disorder, FINASTERIDE for Prostatic disorder.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, 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 experienced OXYGEN SATURATION DECREASED (Oxygen below 80), DYSPNOEA (Couldn't breathe), PAIN (Pain) and DIARRHOEA (diarrhea for 4 to 5 weeks). At the time of the report, OXYGEN SATURATION DECREASED (Oxygen below 80) and DYSPNOEA (Couldn't breathe) had not resolved and PAIN (Pain) and DIARRHOEA (diarrhea for 4 to 5 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: Below 80.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the vaccine in his left shoulder. The patient visited doctor for diarrhea who provided no treatment for his symptoms. The patient visited doctor for oxygen below 80 and could not breath and he was provided an Oxygen machine for breathing properly. Patient did not experience any similar events in past.   This case was linked to MOD-2022-604652, MOD-2022-604409 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a dose from an expired Moderna vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 037F21A, 032M20A and 024M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: HCP reports that seven patients received a dose from an expired Moderna vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP reports that seven patients received a dose from an expired Moderna vial) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A and 076C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP reports that seven patients received a dose from an expired Moderna vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP reports that seven patients received a dose from an expired Moderna vial) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Dosage text was reported as first booster and second booster dose.  Treatment information was not provided.
Age: 68.0
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 (seven patients received a dose from an expired Moderna vial.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 037F21A and 076C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Jul-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a dose from an expired Moderna vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 037F21A and 076C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration, Urticaria
Clinical narrative: had a bad reaction to the shots; hives all over; 1st dose on 16Jan2021 and 2nd dose on 23Feb2021; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a bad reaction to the shots) and URTICARIA (hives all over) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M207 and 011J20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced IMMUNISATION REACTION (had a bad reaction to the shots) (seriousness criterion hospitalization), URTICARIA (hives all over) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 16Jan2021 and 2nd dose on 23Feb2021). The patient was hospitalized on 23-Feb-2021 due to IMMUNISATION REACTION and URTICARIA. At the time of the report, IMMUNISATION REACTION (had a bad reaction to the shots), URTICARIA (hives all over) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 16Jan2021 and 2nd dose on 23Feb2021) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  Patient received the Moderna vaccine primary series on 16 Jan 2021 and 23 Feb 2021. Patient reported it previously because patient had a bad reaction to the shots, hives all over was in the hospital and the doctor has taken her out of work. Safety follow-up consent with patient and HCP was given as yes. COMPANY COMMENT: This is an spontaneous case concerning a 68-years-old female patient with no medical history reported who experienced the unexpected seriousness criterion hospitalization  events of immunization reaction and urticaria the same day after  2nd.  dose of  mRNA-1273 vaccine.  Also, inappropriate schedule of product administration was noted in this case (more than 35 days between 1st. and 2nd. Doses). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 68-years-old female patient with no medical history reported who experienced the unexpected seriousness criterion hospitalization  events of immunization reaction and urticaria the same day after  2nd.  dose of  mRNA-1273 vaccine.  Also, inappropriate schedule of product administration was noted in this case (more than 35 days between 1st. and 2nd. Doses). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient recieved 1st dose on 01-Apr-2021 and second dose on 07-May-2021.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 1st dose on 01-Apr-2021 and second dose on 07-May-2021.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A, 043B21A and 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 1st dose on 01-Apr-2021 and second dose on 07-May-2021.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 1st dose on 01-Apr-2021 and second dose on 07-May-2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-604636 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Dose administered after 30-day Use By Date; Vial reached a maximum temperature of 15C for 1 hour & 43 minutes; Vial stored in refrigerator on 04-Apr-2022 and administered on 08-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial reached a maximum temperature of 15C for 1 hour & 43 minutes) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 04-Apr-2022 and administered on 08-Jul-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial reached a maximum temperature of 15C for 1 hour & 43 minutes) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 04-Apr-2022 and administered on 08-Jul-2022). On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial reached a maximum temperature of 15C for 1 hour & 43 minutes) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 04-Apr-2022 and administered on 08-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was initially stored in the refrigerator on 4-Apr-2022.  On 4-Apr-2022 after the vial was placed in the refrigerator to thaw, the refrigerator was left open and the vial reached a maximum temperature of 15C for 1 hour & 43 minutes. The Excursion tool was used at that time which gave the results involving the 24 cumulative time frame.  At the time of excursion storage condition was refrigerated.  The vial was stored in fridge currently.  Any vaccine state change after visual inspection was not sure.  One vial was impacted.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered that was outside the allowed time frame at  room temperature.; vial that had been set out at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered that was outside the allowed time frame at  room temperature.) and PRODUCT STORAGE ERROR (vial that had been set out at room temperature) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022 at 10:30 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced PRODUCT STORAGE ERROR (vial that had been set out at room temperature). On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered that was outside the allowed time frame at  room temperature.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered that was outside the allowed time frame at  room temperature.) and PRODUCT STORAGE ERROR (vial that had been set out at room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported. It was reported that the Moderna (red-capped) had been set out at room temperature on 7/Jul/22 at 9:40 AM.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Lymph node pain, Nausea, Pain in extremity
Clinical narrative: The patient came back feeling dizzy and weak.; Started feeling dizzy/ The patient came back feeling dizzy; Nauseated; Pain in the arm and lymph nodes around the neck and underarm; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (The patient came back feeling dizzy and weak.), DIZZINESS (Started feeling dizzy/ The patient came back feeling dizzy), NAUSEA (Nauseated), LYMPH NODE PAIN (Pain in the arm and lymph nodes around the neck and underarm) and PAIN IN EXTREMITY (Pain in the arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Two primary series), Pfizer (1st booster) and Pfizer (Two primary series). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 10-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced ASTHENIA (The patient came back feeling dizzy and weak.), DIZZINESS (Started feeling dizzy/ The patient came back feeling dizzy), NAUSEA (Nauseated), LYMPH NODE PAIN (Pain in the arm and lymph nodes around the neck and underarm) and PAIN IN EXTREMITY (Pain in the arm). At the time of the report, ASTHENIA (The patient came back feeling dizzy and weak.), DIZZINESS (Started feeling dizzy/ The patient came back feeling dizzy), NAUSEA (Nauseated), LYMPH NODE PAIN (Pain in the arm and lymph nodes around the neck and underarm) and PAIN IN EXTREMITY (Pain in the arm) outcome was unknown.            Concomitant medications were not reported. The patient had received second booster dose. It was reported that patient was fine yesterday and fine on morning (the day of reporting) and stated that patient had went for a walk and patient started to feel dizzy and nauseated. The patient came back from walk and started to feel dizzy and weak. The patient also had pain in the arm and lymph nodes around the neck and underarm. Treatment information was not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Fall, Presyncope
Clinical narrative: At night she went to the bathroom and fell; could not stand holding so had to crawl; Had to hold her hand to walk her to bed so she can lie down/ was feeling very weak/ had to crawl to the room and back to the bathroom/ Has been lying down since; felt like she was going to pass out; very dizzy after lunch/dizzy/ she fell due to being dizzy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FALL (At night she went to the bathroom and fell), DYSSTASIA (could not stand holding so had to crawl), ASTHENIA (Had to hold her hand to walk her to bed so she can lie down/ was feeling very weak/ had to crawl to the room and back to the bathroom/ Has been lying down since), PRESYNCOPE (felt like she was going to pass out) and DIZZINESS (very dizzy after lunch/dizzy/ she fell due to being dizzy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A, 001A21A, 012F21A and 051B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (At night she went to the bathroom and fell), DYSSTASIA (could not stand holding so had to crawl), ASTHENIA (Had to hold her hand to walk her to bed so she can lie down/ was feeling very weak/ had to crawl to the room and back to the bathroom/ Has been lying down since), PRESYNCOPE (felt like she was going to pass out) and DIZZINESS (very dizzy after lunch/dizzy/ she fell due to being dizzy). At the time of the report, FALL (At night she went to the bathroom and fell), DYSSTASIA (could not stand holding so had to crawl), ASTHENIA (Had to hold her hand to walk her to bed so she can lie down/ was feeling very weak/ had to crawl to the room and back to the bathroom/ Has been lying down since), PRESYNCOPE (felt like she was going to pass out) and DIZZINESS (very dizzy after lunch/dizzy/ she fell due to being dizzy) outcome was unknown.            No concomitant medications were reported. Treatment information was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous
Clinical narrative: broke out the first time with little red rash after the first dose; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (broke out the first time with little red rash after the first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 prophylaxis.     The patient's past medical history included Back surgery (3 years ago and that's the same place where the itchiness was located.). Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included EVOLOCUMAB (REPATHA) for Blood cholesterol abnormal.    On 15-Feb-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 RASH ERYTHEMATOUS (broke out the first time with little red rash after the first dose). At the time of the report, RASH ERYTHEMATOUS (broke out the first time with little red rash after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication also included blood pressure medicine unrelated to the vaccine.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-606193, MOD-2022-606195, MOD-2022-606199 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain
Clinical narrative: broke out the first time with little red rash after the first dose; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (broke out the first time with little red rash after the first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 prophylaxis.     The patient's past medical history included Back surgery (3 years ago and that's the same place where the itchiness was located.). Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included EVOLOCUMAB (REPATHA) for Blood cholesterol abnormal.    On 15-Feb-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 RASH ERYTHEMATOUS (broke out the first time with little red rash after the first dose). At the time of the report, RASH ERYTHEMATOUS (broke out the first time with little red rash after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication also included blood pressure medicine unrelated to the vaccine.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-606193, MOD-2022-606195, MOD-2022-606199 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous
Clinical narrative: achy; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  The patient's past medical history included Back surgery (on their back 3 years ago). Concurrent medical conditions included Cholesterol. Concomitant products included EVOLOCUMAB (REPATHA) for Cholesterol.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy) and HEADACHE (Headache). At the time of the report, PAIN (achy) and HEADACHE (Headache) had resolved.            Concomitant medication included blood pressure medication. No treatment reported   This case was linked to MOD-2022-606180, MOD-2022-606195, MOD-2022-606199 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain
Clinical narrative: achy; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  The patient's past medical history included Back surgery (on their back 3 years ago). Concurrent medical conditions included Cholesterol. Concomitant products included EVOLOCUMAB (REPATHA) for Cholesterol.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy) and HEADACHE (Headache). At the time of the report, PAIN (achy) and HEADACHE (Headache) had resolved.            Concomitant medication included blood pressure medication. No treatment reported   This case was linked to MOD-2022-606180, MOD-2022-606195, MOD-2022-606199 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Back surgery (3 years ago). Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included EVOLOCUMAB (REPATHA) for Cholesterol.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) First booster dose. In April 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            First booster dose: 22/Nov/2021 Lot#(first part of log unrecognizable)21A. Patient had surgery on their back 3 years ago and that was the same place where the itchiness was located. Patient took blood pressure medicine unrelated to the vaccine. No treatment information was provided.   This case was linked to MOD-2022-606180, MOD-2022-606193, MOD-2022-606199 (Patient Link). Company comment: This spontaneous case concerns a female patient of unknown age with current medical history of Hypertension and High cholesterol, who experienced the unexpected non-serious AESI of COVID-19. The event occurred approximately 5 months after administration of third dose of mRNA, the exact date of onset of the event was not specified, the initial two doses of unspecified brand were given approximately 8 months prior, the interval between the two doses is 28 days. The patient's current medical condition of Hypertension and High cholesterol could be confounders to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-606180, MOD-2022-606193, MOD-2022-606199 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient of unknown age with current medical history of Hypertension and High cholesterol, who experienced the unexpected non-serious AESI of COVID-19. The event occurred approximately 5 months after administration of third dose of mRNA, the exact date of onset of the event was not specified, the initial two doses of unspecified brand were given approximately 8 months prior, the interval between the two doses is 28 days. The patient's current medical condition of Hypertension and High cholesterol could be confounders to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: left back is itching. It's not broken out/being itchy; ack or arm is not red, won't stop, gets painful sometimes for a little while and then it'll go away; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (left back is itching. It's not broken out/being itchy) and PAIN IN EXTREMITY (ack or arm is not red, won't stop, gets painful sometimes for a little while and then it'll go away) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017A22A, 002B21A and 011M20A) for COVID-19 prophylaxis.     The patient's past medical history included Back surgery (3 years ago). Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included EVOLOCUMAB (REPATHA) for Blood cholesterol abnormal.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-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 10-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2022, the patient experienced PRURITUS (left back is itching. It's not broken out/being itchy) and PAIN IN EXTREMITY (ack or arm is not red, won't stop, gets painful sometimes for a little while and then it'll go away). The patient was treated with PARACETAMOL (TYLENOL) on 10-Jul-2022 at an unspecified dose and frequency. At the time of the report, PRURITUS (left back is itching. It's not broken out/being itchy) and PAIN IN EXTREMITY (ack or arm is not red, won't stop, gets painful sometimes for a little while and then it'll go away) outcome was unknown.            The patient also took unspecified blood pressure medication.  The itchiness was located on the same place where the patient had back surgery.   This case was linked to MOD-2022-606180, MOD-2022-606193, MOD-2022-606195 (Patient Link).
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: he woke up with delay onset of rash on his arm. It was pretty large, 3 inches by 2 inches of a rash where the injection site was; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE RASH (he woke up with delay onset of rash on his arm. It was pretty large, 3 inches by 2 inches of a rash where the injection site was) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced VACCINATION SITE RASH (he woke up with delay onset of rash on his arm. It was pretty large, 3 inches by 2 inches of a rash where the injection site was). At the time of the report, VACCINATION SITE RASH (he woke up with delay onset of rash on his arm. It was pretty large, 3 inches by 2 inches of a rash where the injection site was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not on any concomitant medication.  Patient received first dose of the pediatric Moderna COVID-19 vaccine. Rash was not raised. It was reported that no pain from the rash.  Batch/Lot number and expiration date was unknown.  Patient did not received any treatment.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COUGH (phlegm cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Bronchitis (yearly bronchitis when working in an office) and Cough (past before when patient gets sick (non Covid)). Concomitant products included PIROXICAM (ZICAM [PIROXICAM]) and CALCIUM ASCORBATE (VITAMIN C [CALCIUM ASCORBATE]) for an unknown indication. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2022, the patient experienced COUGH (phlegm cough). At the time of the report, COUGH (phlegm cough) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Negative) Negative. No treatment drugs were reported. Patient got the original vaccine apr2021 and the booster in Dec2021. Patient wants to know when the booster dose becomes effective, if it's a few days after or a few weeks. Patient going for a PCR test on 12Jul2022. Patient states she got tired with the 1st dose and was concerned with traveling if patient will be stuck with side effects if patient does get the booster before she leaves. It was reported that consent not obtained. This case was linked to MOD-2022-606275 (Patient Link). Reporter did not allow further contact