chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: GOING THROUGH THE SAME PAIN ALL THE TIME; UNABLE TO FUNCTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced going through the same pain all the time, and unable to function. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to function, and going through the same pain all the time. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: VACCINE INJURY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 11-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injury was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: LONG COVID WITHOUT CONTRACTING COVID; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced long covid without contracting covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of long covid without contracting covid was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: EXTREMELY SICK; AWFUL; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose was not reported, 1 total administered on an unspecified date in 2022 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in 2022, a very next day after booster vaccination the patient was extremely sick and also patient was awful (Dose number in series 2). It was reported as "I received the COVID booster this year and the very next day I was extremely sick. I don't think I will get anymore boosters. That was awful". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extremely sick and awful was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Dry skin, Off label use
Clinical narrative: DRY PATCH ON THE VACCINE SIGHT ON THE ARM; OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media and concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received two doses (first and second dose) of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with two doses of covid-19 vaccine (dose number in series 1). The patient previously received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for Covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with third dose of covid-19 vaccine ad26. cov2.s (dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was off label use (off label dosing frequency) and revaccination with different covid-19 vaccine (dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced dry patch to the vaccine sight on the arm (Dose number in series 3). It was reported that patient visited physician office. The reporter stated "I have had all the vaccine including the booster the only reaction I have had is a dry patch on the vaccine sight on my arm from the forth vaccine doctor said it should go away but it hasn't". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry patch on the vaccine sight on the arm, and the outcome of off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20221244567.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: DIFFERENT TYPES OF SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced different types of side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of different types of side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20221244677.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Inflammatory pain
Clinical narrative: SO MUCH PAIN AND INFLAMMATION; CAN'T WALK SOME TIMES; KNEES ARE A PAINFUL MESS; 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. The patient's past medical history included: covid-19. 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced so much pain and inflammation, can't walk some times, and knees are a painful mess. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the knees are a painful mess, so much pain and inflammation and can't walk some times was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: Graves disease (under control). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. which was off label use (off label dosing frequency, dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. Reporter stated that, "I have Graves under control had 2 j j vac and 1 booster now blood clots on thinners but hurt all over mostly my lower back". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20221242050 (dose number in series 3).
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No Adverse Event) in a 6-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No Adverse Event) 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 considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported.  The 6 year old patient was accidentally administered with the first primary dose of the Moderna Covid 19 vaccine on 04-Dec-2022 from a vial that expired on 25-Nov-2022.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.; No adverse event; patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.), EXPIRED PRODUCT ADMINISTERED (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022. ) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022. ). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.), EXPIRED PRODUCT ADMINISTERED (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022. ) and NO ADVERSE EVENT (No adverse event) 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.) and EXPIRED PRODUCT ADMINISTERED (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022. ).    No relevant concomitant medications were reported. It was reported that the administrator mistake was that they looked at the expiration date of a bivalent vaccine instead. Date the vial was initially stored in the refrigerator was on 15 Dec 2022. The vial haven't undergone any temperature excursions. No treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Fatigue, Feeling abnormal, Illness
Clinical narrative: covid 19; congestion; experienced brain fog; anxious; sick; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19), NASAL CONGESTION (congestion), FEELING ABNORMAL (experienced brain fog), ANXIETY (anxious) and ILLNESS (sick) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had already tested positive for Covid-19 before receiving the vaccines). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 11-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced COVID-19 (covid 19), NASAL CONGESTION (congestion), FEELING ABNORMAL (experienced brain fog), ANXIETY (anxious), ILLNESS (sick) and FATIGUE (very fatigued). At the time of the report, COVID-19 (covid 19), NASAL CONGESTION (congestion), FEELING ABNORMAL (experienced brain fog), ANXIETY (anxious) and FATIGUE (very fatigued) had resolved and ILLNESS (sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2022, SARS-CoV-2 test: she tested positive for Covid-19 on 02Jun2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test
Clinical narrative: covid 19; congestion; experienced brain fog; anxious; sick; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19), NASAL CONGESTION (congestion), FEELING ABNORMAL (experienced brain fog), ANXIETY (anxious) and ILLNESS (sick) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had already tested positive for Covid-19 before receiving the vaccines). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 11-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced COVID-19 (covid 19), NASAL CONGESTION (congestion), FEELING ABNORMAL (experienced brain fog), ANXIETY (anxious), ILLNESS (sick) and FATIGUE (very fatigued). At the time of the report, COVID-19 (covid 19), NASAL CONGESTION (congestion), FEELING ABNORMAL (experienced brain fog), ANXIETY (anxious) and FATIGUE (very fatigued) had resolved and ILLNESS (sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2022, SARS-CoV-2 test: she tested positive for Covid-19 on 02Jun2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I had taken the Moderna Bivalent Vaccine 07Dec2022. I was diagnosed with Covid on 15Dec2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had taken the Moderna Bivalent Vaccine 07Dec2022. I was diagnosed with Covid on 15Dec2022) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced COVID-19 (I had taken the Moderna Bivalent Vaccine 07Dec2022. I was diagnosed with Covid on 15Dec2022). At the time of the report, COVID-19 (I had taken the Moderna Bivalent Vaccine 07Dec2022. I was diagnosed with Covid on 15Dec2022) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment medication information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth, Mouth ulceration
Clinical narrative: experienced extremely dry mouth; severe mouth ulcers; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (experienced extremely dry mouth) and MOUTH ULCERATION (severe mouth ulcers) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (experienced extremely dry mouth) and MOUTH ULCERATION (severe mouth ulcers). At the time of the report, DRY MOUTH (experienced extremely dry mouth) and MOUTH ULCERATION (severe mouth ulcers) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Three weeks ago patient received the Moderna bivalent booster and almost immediately experienced extremely dry mouth and severe mouth ulcers which lasted almost 3 weeks. It was recommended that patient received next booster in three months. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Dec-2022: Live significant follow up appended.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: she states that an expired dose was administered to 1 patient or maybe 2 patients; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (she states that an expired dose was administered to 1 patient or maybe 2 patients) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (she states that an expired dose was administered to 1 patient or maybe 2 patients) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (she states that an expired dose was administered to 1 patient or maybe 2 patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (she states that an expired dose was administered to 1 patient or maybe 2 patients).    No concomitant medication information was reported. It was Unknown patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient accidentally received an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient accidentally received an expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) Unknown. On 15-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient accidentally received an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient accidentally received an expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient accidentally received an expired Moderna vaccine). No concomitant  and treatment medication information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Live Follow up- Significant information include suspect product change from MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) to Spikevax and narrative updated.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient received last booster on April 2022. Patient would like to know if he could now receive the new booster or how long must wait. No treatment information was provided.   Reporter did not allow further contact
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Expired product administered, No adverse event
Clinical narrative: 0.3 ml instead of 0.5ml; patient received an Expired dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (0.3 ml instead of 0.5ml), EXPIRED PRODUCT ADMINISTERED (patient received an Expired dose) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. On 15-Dec-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.3 ml instead of 0.5ml), EXPIRED PRODUCT ADMINISTERED (patient received an Expired dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (0.3 ml instead of 0.5ml), EXPIRED PRODUCT ADMINISTERED (patient received an Expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (0.3 ml instead of 0.5ml) and EXPIRED PRODUCT ADMINISTERED (patient received an Expired dose).    Relevant concomitant medications were not reported.  Treatment information was not provided. The vial was stored post puncture in room temperature. The vial was not undergo any temperature excursions.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a dose of the Moderna COVID-19 bivalent vaccine today, 16DEC2022, already received a dose 2NOV2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna COVID-19 bivalent vaccine today, 16DEC2022, already received a dose 2NOV2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 042H22A, 032M20A, 036B21A1, 065F21A, 011B22A and 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2022, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna COVID-19 bivalent vaccine today, 16DEC2022, already received a dose 2NOV2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna COVID-19 bivalent vaccine today, 16DEC2022, already received a dose 2NOV2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna COVID-19 bivalent vaccine today, 16DEC2022, already received a dose 2NOV2022).    No concomitant medication information was reported. No treatment medication information was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: 3" diameter rash on the left arm injection site is itching; Rash on ankle/ Rash spread to elbows and knees; 3" diameter rash on the left arm injection site is itching; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (3" diameter rash on the left arm injection site is itching), RASH (Rash on ankle/ Rash spread to elbows and knees) and VACCINATION SITE RASH (3" diameter rash on the left arm injection site is itching) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced VACCINATION SITE PRURITUS (3" diameter rash on the left arm injection site is itching), RASH (Rash on ankle/ Rash spread to elbows and knees) and VACCINATION SITE RASH (3" diameter rash on the left arm injection site is itching). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (3" diameter rash on the left arm injection site is itching) had not resolved and RASH (Rash on ankle/ Rash spread to elbows and knees) and VACCINATION SITE RASH (3" diameter rash on the left arm injection site is itching) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that there was no parental vaccine exposure.  Patient previously received 4 Moderna monovalent doses (2 primary and 2 booster).  On 02-Dec-2022, patient received a Bivalent Booster and noticed a rash on ankle on Monday.  In one week the rash spread to elbows and knees, 3 inch diameter rash on the left arm injection site was itching. Patient used hydrocortisone topical and some sunburn products.  Patient not visited the doctor.  On the day of reporting, the rash was improving.   This case was linked to MOD-2022-688926 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: Patient received 4 Pfizer vaccine and first dose moderna; Interchange of vaccine products; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 IMMUNISATION (Patient received 4 Pfizer vaccine and first dose moderna), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (Patient received 4 Pfizer vaccine and first dose moderna), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, COVID-19 IMMUNISATION (Patient received 4 Pfizer vaccine and first dose moderna), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (Patient received 4 Pfizer vaccine and first dose moderna) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products).    No concomitant medications were reported. Patient received 4 Pfizer vaccine and 1 Moderna monovalent vaccine. No treatment information was reported.   Reporter did not allow further contact
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Someone was supposed to get Moderna Bivalent & received the Moderna Monovalent instead; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Someone was supposed to get Moderna Bivalent & received the Moderna Monovalent instead) and NO ADVERSE EVENT (no adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063B22A) for COVID-19 prophylaxis.     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 18-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Someone was supposed to get Moderna Bivalent & received the Moderna Monovalent instead). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Someone was supposed to get Moderna Bivalent & received the Moderna Monovalent instead) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Someone was supposed to get Moderna Bivalent &amp; received the Moderna Monovalent instead).    No relevant concomitant medications were reported.  No treatment information was provided.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Dosage: 0.25 ml; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Dosage: 0.25 ml) and NO ADVERSE EVENT (No adverse event) in a 50-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Dosage: 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Dosage: 0.25 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Dosage: 0.25 ml). Concomitant Medication use information was not provided by reporter. The patient initial was reported as 1 patient. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Wrong technique in device usage process
Clinical narrative: few drops leaked out during administration; few drops leaked out during administration; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (few drops leaked out during administration), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (few drops leaked out during administration) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE (Do you have information about previous COVID-19 vaccination doses?Answer:2 previous doses) and COVID-19 VACCINE (Do you have information about previous COVID-19 vaccination doses?Answer:2 previous doses). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.    On 19-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Dec-2022, the patient experienced ACCIDENTAL UNDERDOSE (few drops leaked out during administration), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (few drops leaked out during administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (few drops leaked out during administration), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (few drops leaked out during administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (few drops leaked out during administration) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (few drops leaked out during administration).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.  For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient tested positive for covid and went to doctor to get medication. He only had 2 Moderna vaccines.   Treatment information was not provided.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; 4 year old patient received a dose of the Moderna COVID-19 Vaccine Bivalent for 6 years and older (0.25 mL) instead of the 2nd dose of the primary series.; Patient received dose 1 on 26Sep2022 and dose 2 on 16Dec2022; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 year old patient received a dose of the Moderna COVID-19 Vaccine Bivalent for 6 years and older (0.25 mL) instead of the 2nd dose of the primary series.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26Sep2022 and dose 2 on 16Dec2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 16-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (4 year old patient received a dose of the Moderna COVID-19 Vaccine Bivalent for 6 years and older (0.25 mL) instead of the 2nd dose of the primary series.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26Sep2022 and dose 2 on 16Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 year old patient received a dose of the Moderna COVID-19 Vaccine Bivalent for 6 years and older (0.25 mL) instead of the 2nd dose of the primary series.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26Sep2022 and dose 2 on 16Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (4 year old patient received a dose of the Moderna COVID-19 Vaccine Bivalent for 6 years and older (0.25 mL) instead of the 2nd dose of the primary series.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26Sep2022 and dose 2 on 16Dec2022).    No concomitant drug information was provided.  Patient had received dose 1 of Moderna COVID-19 vaccine (monovalent) on 26Sep2022.  Patient had not experienced any adverse events. No treatment drug information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19/coughed twice, had a stuffy nose, and was tired/exhausted and stayed in bed for the 2 days and her throat felt a little scratchy after the test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19/coughed twice, had a stuffy nose, and was tired/exhausted and stayed in bed for the 2 days and her throat felt a little scratchy after the test) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (lot number 011A21A) on 20-Mar-2021, Moderna COVID-19 Vaccine (lot number 032M20A) on 17-Apr-2021, Moderna COVID-19 Vaccine (lot number 058H21A and 1st booster) on 05-Dec-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Seasonal allergy, Allergy (Allergy for Yellow Jacket) and Allergy to venom (Allergy for Wasp Venom).    On 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2022,  after starting , the patient experienced COVID-19 (covid 19/coughed twice, had a stuffy nose, and was tired/exhausted and stayed in bed for the 2 days and her throat felt a little scratchy after the test). At the time of the report, COVID-19 (covid 19/coughed twice, had a stuffy nose, and was tired/exhausted and stayed in bed for the 2 days and her throat felt a little scratchy after the test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2022, SARS-CoV-2 test: Positive. On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. It was reported that patient had COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccines. She coughed twice, had a stuffy nose, and was tired. These are all regular symptoms for her. She was exhausted and stayed in bed for the 2 days and her throat felt a little scratchy after the test.  No treatment information provided.