chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Malaise, Pyrexia
Clinical narrative: not feeling well; Blood pressure went up/Blood pressure was high/At nighttime, his blood pressure goes up a little bit; Headache; Feeling a little feverish/Feels feverish once in a while; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well), HYPERTENSION (Blood pressure went up/Blood pressure was high/At nighttime, his blood pressure goes up a little bit), HEADACHE (Headache) and PYREXIA (Feeling a little feverish/Feels feverish once in a while) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 029D21A, 010A21A and 010M20A) for COVID-19 vaccination.     No allergies were reported.  The patient's past medical history included Heart attack and Stent placement in 2009. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL for Blood pressure high, ROSUVASTATIN and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-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 MALAISE (not feeling well), HYPERTENSION (Blood pressure went up/Blood pressure was high/At nighttime, his blood pressure goes up a little bit), HEADACHE (Headache) and PYREXIA (Feeling a little feverish/Feels feverish once in a while). The patient was treated with PARACETAMOL (TYLENOL) for Feverish and Headache, at an unspecified dose and frequency and METOPROLOL for Blood pressure high, at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well), HYPERTENSION (Blood pressure went up/Blood pressure was high/At nighttime, his blood pressure goes up a little bit), HEADACHE (Headache) and PYREXIA (Feeling a little feverish/Feels feverish once in a while) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High. On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Patient never had diagnosed with COVID. It was reported that patient went to the ER right away and they increase the dose of metoprolol to calm his blood pressure. Patient used to take metoprolol  25mg, 1 tablet in the morning and 1 tablet in the evening and now it is metoprolol 25mg 2 tablets in the morning and 2 tablets in evening.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: not feeling well; Blood pressure went up/Blood pressure was high/At nighttime, his blood pressure goes up a little bit; Headache; Feeling a little feverish/Feels feverish once in a while; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well), HYPERTENSION (Blood pressure went up/Blood pressure was high/At nighttime, his blood pressure goes up a little bit), HEADACHE (Headache) and PYREXIA (Feeling a little feverish/Feels feverish once in a while) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 029D21A, 010A21A and 010M20A) for COVID-19 vaccination.     No allergies were reported.  The patient's past medical history included Heart attack and Stent placement in 2009. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL for Blood pressure high, ROSUVASTATIN and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-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 MALAISE (not feeling well), HYPERTENSION (Blood pressure went up/Blood pressure was high/At nighttime, his blood pressure goes up a little bit), HEADACHE (Headache) and PYREXIA (Feeling a little feverish/Feels feverish once in a while). The patient was treated with PARACETAMOL (TYLENOL) for Feverish and Headache, at an unspecified dose and frequency and METOPROLOL for Blood pressure high, at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well), HYPERTENSION (Blood pressure went up/Blood pressure was high/At nighttime, his blood pressure goes up a little bit), HEADACHE (Headache) and PYREXIA (Feeling a little feverish/Feels feverish once in a while) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High. On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Patient never had diagnosed with COVID. It was reported that patient went to the ER right away and they increase the dose of metoprolol to calm his blood pressure. Patient used to take metoprolol  25mg, 1 tablet in the morning and 1 tablet in the evening and now it is metoprolol 25mg 2 tablets in the morning and 2 tablets in evening.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got a little sick with first and second shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Got a little sick with first and second shot) in a 94-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Flu: Flu shot (Given within 1 month prior to Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu shot.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got a little sick with first and second shot). At the time of the report, ILLNESS (Got a little sick with first and second shot) outcome was unknown.      No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-599999 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 positive on 28Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 positive on 28Apr2022) in a 76-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced COVID-19 (COVID-19 positive on 28Apr2022). At the time of the report, COVID-19 (COVID-19 positive on 28Apr2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Other vaccines were not given within 1 month prior to Moderna COVID-19 vaccine.   The patient did not experience a similar event in the past.  The event had caused patient to seek medical care.  Treatment details were not reported by the reporter.  Company comment: This is a spontaneous case concerning a 76-year-old female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The patient experienced COVID-19 one day after the first dose of mRNA-1273 (Spikevax) vaccine. No Concomitant or treatment medications details were provided. Outcome of the event was reported as resolved at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     This case was linked to MOD-2022-600165 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 76-year-old female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The patient experienced COVID-19 one day after the first dose of mRNA-1273 (Spikevax) vaccine. No Concomitant or treatment medications details were provided. Outcome of the event was reported as resolved at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Inappropriate schedule of product administration, Pruritus, Rash, Urticaria
Clinical narrative: COVID-19 positive on 28Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 positive on 28Apr2022) in a 76-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced COVID-19 (COVID-19 positive on 28Apr2022). At the time of the report, COVID-19 (COVID-19 positive on 28Apr2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Other vaccines were not given within 1 month prior to Moderna COVID-19 vaccine.   The patient did not experience a similar event in the past.  The event had caused patient to seek medical care.  Treatment details were not reported by the reporter.  Company comment: This is a spontaneous case concerning a 76-year-old female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The patient experienced COVID-19 one day after the first dose of mRNA-1273 (Spikevax) vaccine. No Concomitant or treatment medications details were provided. Outcome of the event was reported as resolved at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     This case was linked to MOD-2022-600165 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 76-year-old female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The patient experienced COVID-19 one day after the first dose of mRNA-1273 (Spikevax) vaccine. No Concomitant or treatment medications details were provided. Outcome of the event was reported as resolved at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: It's itching a lot; It's very uncomfortable.; Started getting a real bad rash; Started getting a real bad rash and hives on neck, chest, both arms, both thighs and back.; First dose adminstered on 28-Apr-2022 and second dose on 18-May-2022; This spontaneous case was reported by a patient and describes the occurrence of RASH (Started getting a real bad rash), URTICARIA (Started getting a real bad rash and hives on neck, chest, both arms, both thighs and back.), PRURITUS (It's itching a lot), DISCOMFORT (It's very uncomfortable.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose adminstered on 28-Apr-2022 and second dose on 18-May-2022) in a 76-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose adminstered on 28-Apr-2022 and second dose on 18-May-2022). On 27-Jun-2022, the patient experienced RASH (Started getting a real bad rash) and URTICARIA (Started getting a real bad rash and hives on neck, chest, both arms, both thighs and back.). On 05-Jul-2022, the patient experienced PRURITUS (It's itching a lot) and DISCOMFORT (It's very uncomfortable.). At the time of the report, RASH (Started getting a real bad rash), URTICARIA (Started getting a real bad rash and hives on neck, chest, both arms, both thighs and back.), PRURITUS (It's itching a lot) and DISCOMFORT (It's very uncomfortable.) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose adminstered on 28-Apr-2022 and second dose on 18-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient did not take any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  It was reported that patient Started getting a real bad rash and hives on neck, chest, both arms, both thighs and back. It's itching a lot. It's very uncomfortable.  The patient adverse events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized).  No treatment information was provided by the reporter.   This case was linked to MOD-2022-600006 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Inappropriate schedule of product administration, Pruritus, Rash, Urticaria
Clinical narrative: It's itching a lot; It's very uncomfortable.; Started getting a real bad rash; Started getting a real bad rash and hives on neck, chest, both arms, both thighs and back.; First dose adminstered on 28-Apr-2022 and second dose on 18-May-2022; This spontaneous case was reported by a patient and describes the occurrence of RASH (Started getting a real bad rash), URTICARIA (Started getting a real bad rash and hives on neck, chest, both arms, both thighs and back.), PRURITUS (It's itching a lot), DISCOMFORT (It's very uncomfortable.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose adminstered on 28-Apr-2022 and second dose on 18-May-2022) in a 76-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose adminstered on 28-Apr-2022 and second dose on 18-May-2022). On 27-Jun-2022, the patient experienced RASH (Started getting a real bad rash) and URTICARIA (Started getting a real bad rash and hives on neck, chest, both arms, both thighs and back.). On 05-Jul-2022, the patient experienced PRURITUS (It's itching a lot) and DISCOMFORT (It's very uncomfortable.). At the time of the report, RASH (Started getting a real bad rash), URTICARIA (Started getting a real bad rash and hives on neck, chest, both arms, both thighs and back.), PRURITUS (It's itching a lot) and DISCOMFORT (It's very uncomfortable.) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose adminstered on 28-Apr-2022 and second dose on 18-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient did not take any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  It was reported that patient Started getting a real bad rash and hives on neck, chest, both arms, both thighs and back. It's itching a lot. It's very uncomfortable.  The patient adverse events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized).  No treatment information was provided by the reporter.   This case was linked to MOD-2022-600006 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (ARTHRITIS IN HAND AND FEET) and PAIN IN EXTREMITY (SORE ARM) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (ARTHRITIS IN HAND AND FEET) and PAIN IN EXTREMITY (SORE ARM). At the time of the report, ARTHRITIS (ARTHRITIS IN HAND AND FEET) and PAIN IN EXTREMITY (SORE ARM) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided. Company comment: This is a spontaneous case concerns 73-years-old male patient with no medical history reported, who experienced the unexpected non-serious AESI event of Arthritis and expected non serious event of pain in extremity which occurred on unspecified day after receiving the third dose of mRNA-1273 vaccine in Oct 2021 and non-company product ADALIMUMAB (HUMIRA). Patient was not hospitalized, and treatment details and concomitant medications was not provided. The co-suspect product ADALIMUMAB remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. Sender's Comments: This is a spontaneous case concerns 73-years-old male patient with no medical history reported, who experienced the unexpected non-serious AESI event of Arthritis and expected non serious event of pain in extremity which occurred on unspecified day after receiving the third dose of mRNA-1273 vaccine in oct 2021 and non-company product ADALIMUMAB (HUMIRA). Patient was not hospitalized, and treatment details and concomitant medications was not provided. The co-suspect product ADALIMUMAB remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Skin disorder, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Skin disorder/SPOTS ON ELBOWS), PSORIASIS (CHRONIC PLAQUE PSORIASIS FLARE UP) and VACCINATION SITE PAIN (Vaccination site pain/ sore arm) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Plaque psoriasis. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced SKIN DISORDER (Skin disorder/SPOTS ON ELBOWS), PSORIASIS (CHRONIC PLAQUE PSORIASIS FLARE UP) and VACCINATION SITE PAIN (Vaccination site pain/ sore arm). At the time of the report, SKIN DISORDER (Skin disorder/SPOTS ON ELBOWS) and VACCINATION SITE PAIN (Vaccination site pain/ sore arm) outcome was unknown and PSORIASIS (CHRONIC PLAQUE PSORIASIS FLARE UP) had not resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant and treatment medications were reported.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Insomnia, Postural orthostatic tachycardia syndrome
Clinical narrative: Heart arrhythmias; Insomnia; POTS; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (Heart arrhythmias) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Heart arrhythmias) (seriousness criterion medically significant), INSOMNIA (Insomnia) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS). At the time of the report, ARRHYTHMIA (Heart arrhythmias), INSOMNIA (Insomnia) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS) had not resolved.            Patient stated that the company ruined the life when adverse events experienced 2 weeks after the booster dose. Patient mentioned 6 months after patient was still dealing with it. No concomitant medication information was reported. No treatment medication information was reported.  Company comment: This spontaneous case concerns a 24-years-old, unspecified gender with no medical history, who experienced the unexpected serious (medically significant) AESI event of arrhythmia and unexpected non serious AESI event postural orthostatic tachycardia syndrome, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. It is reported that 2 weeks after booster vaccination patient had adverse events lasted for 6 months. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 24-years-old, unspecified gender with no medical history, who experienced the unexpected serious (medically significant) AESI event of arrhythmia and unexpected non serious AESI event postural orthostatic tachycardia syndrome, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. It is reported that 2 weeks after booster vaccination patient had adverse events lasted for 6 months. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Joint stiffness, Sinus congestion, Skin discolouration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLORATION (SKIN DISCOLORATION TO UPPER BODY WITH SMALL DARKENED SKIN SPLOTCHES THAT COME AND GO), CONSTIPATION (Constipation), SINUS CONGESTION (Sinus congestion) and JOINT STIFFNESS (EPISODE OF INCREASED JOINT STIFFNESS) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SKIN DISCOLORATION (SKIN DISCOLORATION TO UPPER BODY WITH SMALL DARKENED SKIN SPLOTCHES THAT COME AND GO), CONSTIPATION (Constipation), SINUS CONGESTION (Sinus congestion) and JOINT STIFFNESS (EPISODE OF INCREASED JOINT STIFFNESS). At the time of the report, SKIN DISCOLORATION (SKIN DISCOLORATION TO UPPER BODY WITH SMALL DARKENED SKIN SPLOTCHES THAT COME AND GO) outcome was unknown and CONSTIPATION (Constipation), SINUS CONGESTION (Sinus congestion) and JOINT STIFFNESS (EPISODE OF INCREASED JOINT STIFFNESS) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant Drugs not reported. Co-suspect HUMIRA formulation was Solution for injection in pre-filled pen. The reporter's causality for the event of constipation, sinus congestion and skin discoloration to upper body with small, darkened skin splotches that come and go was not provided. The reporter causality for the event of episode of increased joint stiffness with Humira (Adalimumab) was no reasonable possibility. No treatment medication was provided by reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Illness, Myalgia
Clinical narrative: huge black and blue spot on arm; fever; chills; headache; body ache; vomiting violently; woke up violently ill/sick with each shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (woke up violently ill/sick with each shot), ERYTHEMA (huge black and blue spot on arm), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A772A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL for an unknown indication.    On 28-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (woke up violently ill/sick with each shot). On an unknown date, the patient experienced ERYTHEMA (huge black and blue spot on arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and VOMITING (vomiting violently). At the time of the report, ILLNESS (woke up violently ill/sick with each shot), ERYTHEMA (huge black and blue spot on arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and VOMITING (vomiting violently) outcome was unknown.            No treatment medication reported.  Consumer reported that after her second booster dose of the Moderna COVID-19 vaccine, she started to experience adverse reactions. She reported 12 hours after receiving the vaccine, she woke up violently ill. She reported she had been sick with each shot of the previous doses, like fever, chills, headache, body aches. She could not go to work. With the second booster dose, she had all those side effects and she was vomiting violently. She reported she had a huge black and blue spot on the arm.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: huge black and blue spot on arm; fever; chills; headache; body ache; vomiting violently; woke up violently ill/sick with each shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (woke up violently ill/sick with each shot), ERYTHEMA (huge black and blue spot on arm), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A772A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL for an unknown indication.    On 28-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (woke up violently ill/sick with each shot). On an unknown date, the patient experienced ERYTHEMA (huge black and blue spot on arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and VOMITING (vomiting violently). At the time of the report, ILLNESS (woke up violently ill/sick with each shot), ERYTHEMA (huge black and blue spot on arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and VOMITING (vomiting violently) outcome was unknown.            No treatment medication reported.  Consumer reported that after her second booster dose of the Moderna COVID-19 vaccine, she started to experience adverse reactions. She reported 12 hours after receiving the vaccine, she woke up violently ill. She reported she had been sick with each shot of the previous doses, like fever, chills, headache, body aches. She could not go to work. With the second booster dose, she had all those side effects and she was vomiting violently. She reported she had a huge black and blue spot on the arm.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (About 3 weeks after getting the first dose he began having psoriasis & it has gotten worse) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (with no lingering side effects including skin) in 2021 and COVID-19 (with no lingering side effects including skin) in January 2022.    On 22-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced PSORIASIS (About 3 weeks after getting the first dose he began having psoriasis & it has gotten worse). At the time of the report, PSORIASIS (About 3 weeks after getting the first dose he began having psoriasis & it has gotten worse) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient had no history of psoriasis or any skin problems. Concomitant product use was not provided by the reporter. Treatment included steroid cream and phototherapy. His doctor was trying to determine the root cause.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received booster 1 month after primary; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received booster 1 month after primary) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 083J21A and 083J21A) for COVID-19 vaccination.     Patient did not have allergies to medications, food and other products.    On 06-Apr-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 03-May-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 03-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received booster 1 month after primary). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received booster 1 month after primary) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was not taking other medication. It was reported that Patient did not report having side effects. The expiration dates were not provided. Patient HCP is unaware patient received the 1st booster a month after primary. No treatment information reported.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Asthenia, Dehydration, Joint swelling, Thyroid disorder
Clinical narrative: Dehydration; Thyroid disorder; Hair loss; Weakness; Swollen joints; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), THYROID DISORDER (Thyroid disorder), ALOPECIA (Hair loss), ASTHENIA (Weakness) and JOINT SWELLING (Swollen joints) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included COVID-19 in December 2020.   In March 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DEHYDRATION (Dehydration), THYROID DISORDER (Thyroid disorder), ALOPECIA (Hair loss), ASTHENIA (Weakness), JOINT SWELLING (Swollen joints) and VISION BLURRED (Blurred vision). At the time of the report, DEHYDRATION (Dehydration) outcome was unknown, THYROID DISORDER (Thyroid disorder) and ALOPECIA (Hair loss) was resolving and ASTHENIA (Weakness), JOINT SWELLING (Swollen joints) and VISION BLURRED (Blurred vision) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 25 25 pounds.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  The formulation of co-suspect was reported as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of thyroid problems, lost 25 lbs, weak, swollen joints, blurred vision, covid-19 and lost hair with Humira(adalimumab) was no reasonable possibility.  No treatment medication were reported.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vision blurred, Weight
Clinical narrative: Dehydration; Thyroid disorder; Hair loss; Weakness; Swollen joints; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), THYROID DISORDER (Thyroid disorder), ALOPECIA (Hair loss), ASTHENIA (Weakness) and JOINT SWELLING (Swollen joints) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included COVID-19 in December 2020.   In March 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DEHYDRATION (Dehydration), THYROID DISORDER (Thyroid disorder), ALOPECIA (Hair loss), ASTHENIA (Weakness), JOINT SWELLING (Swollen joints) and VISION BLURRED (Blurred vision). At the time of the report, DEHYDRATION (Dehydration) outcome was unknown, THYROID DISORDER (Thyroid disorder) and ALOPECIA (Hair loss) was resolving and ASTHENIA (Weakness), JOINT SWELLING (Swollen joints) and VISION BLURRED (Blurred vision) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 25 25 pounds.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  The formulation of co-suspect was reported as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of thyroid problems, lost 25 lbs, weak, swollen joints, blurred vision, covid-19 and lost hair with Humira(adalimumab) was no reasonable possibility.  No treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: MUSCLE ACHE WHEN WALKED UP HILL; FELT TIRED/FATIGUE/FEELING TIRED; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (MUSCLE ACHE WHEN WALKED UP HILL) and FATIGUE (FELT TIRED/FATIGUE/FEELING TIRED) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (MUSCLE ACHE WHEN WALKED UP HILL) and FATIGUE (FELT TIRED/FATIGUE/FEELING TIRED). At the time of the report, MYALGIA (MUSCLE ACHE WHEN WALKED UP HILL) and FATIGUE (FELT TIRED/FATIGUE/FEELING TIRED) had resolved.            The patient did not taken any concomitant drug.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of muscle ache when walked up hill and felt tired/fatigue with Skyrizi (Risankizumab) was a reasonable possibility.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: immunocompromised received a full dose for fourth dose; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (immunocompromised received a full dose for fourth dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (immunocompromised received a full dose for fourth dose). At the time of the report, OFF LABEL USE (immunocompromised received a full dose for fourth dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The physician stated he gave the order to give that patient a full dose (booster dose). Physician stated that the patient did not report any adverse effects. No treatment medication was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took first dose on 04-Feb-2021 and Second dose on 21-Mar-21; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 04-Feb-2021 and Second dose on 21-Mar-21) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Oct-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 04-Feb-2021 and Second dose on 21-Mar-21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 04-Feb-2021 and Second dose on 21-Mar-21) outcome was unknown.            Concomitant drugs were not reported.  Treatment details were not given.   This case was linked to MOD-2022-600558 (Patient Link).   Reporter did not allow further contact
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: The patient was immunocompromised and received full booster dose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (The patient was immunocompromised and received full booster dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OVERDOSE (The patient was immunocompromised and received full booster dose). At the time of the report, OVERDOSE (The patient was immunocompromised and received full booster dose) outcome was unknown.            Concomitant medications were not reported.  The patient was immunocompromised and got three full shot and went for the booster and received a full shot.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-600670 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600670:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: The patient was immunocompromised and received full booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (The patient was immunocompromised and received full booster dose.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OVERDOSE (The patient was immunocompromised and received full booster dose.). At the time of the report, OVERDOSE (The patient was immunocompromised and received full booster dose.) outcome was unknown.            Concomitant medications were not reported.  The patient was immunocompromised and got three full shot and went for the booster and received a full shot.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-600670 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600670:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: The patient was immunocompromised and received full booster dose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (The patient was immunocompromised and received full booster dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OVERDOSE (The patient was immunocompromised and received full booster dose). At the time of the report, OVERDOSE (The patient was immunocompromised and received full booster dose) outcome was unknown.            Concomitant medications were not reported.  The patient was immunocompromised and got three full shot and went for the booster and received a full shot.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-600669, US-MODERNATX, INC.-MOD-2022-600668 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600669:Same reporter US-MODERNATX, INC.-MOD-2022-600668:Same reporter
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Following vaccination with the second booster patient started to experience soreness in her arm/ pain in the arm for the first few days; fatigued/today 05Jul2022 she feels fatigued; developed a headache, a different kind of headache in a different part of her head/ 05Jul2022 she feels headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Following vaccination with the second booster patient started to experience soreness in her arm/ pain in the arm for the first few days), FATIGUE (fatigued/today 05Jul2022 she feels fatigued) and HEADACHE (developed a headache, a different kind of headache in a different part of her head/ 05Jul2022 she feels headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016b22a, 061e21a, 001b21a and 031l20a) for COVID-19 vaccination.     Patient had no medical history relating to mentioned adverse event. Patient had no acute or chronic illnesses at the time of vaccination. Patient has never had Covid positive test or diagnosis. Patient did not receive other vaccines one month prior to Moderna Covid-19 vaccines.  Concurrent medical conditions included Drug allergy (Allergy to Prozac).   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2022, the patient experienced FATIGUE (fatigued/today 05Jul2022 she feels fatigued) and HEADACHE (developed a headache, a different kind of headache in a different part of her head/ 05Jul2022 she feels headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Following vaccination with the second booster patient started to experience soreness in her arm/ pain in the arm for the first few days). At the time of the report, PAIN IN EXTREMITY (Following vaccination with the second booster patient started to experience soreness in her arm/ pain in the arm for the first few days) had resolved and FATIGUE (fatigued/today 05Jul2022 she feels fatigued) and HEADACHE (developed a headache, a different kind of headache in a different part of her head/ 05Jul2022 she feels headache) had not resolved.            Concomitant medications included three prescribed medications (unspecified). Patient took first and second booster dose. Patient did not seek medical care for the adverse event at the time of report, but would go next day if the symptoms persist. No treatment medication was reported.   This case was linked to MOD-2021-344605 (Patient Link).