chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: mild fatigue in the 24 hours after the shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild fatigue in the 24 hours after the shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Foramen ovale patent and Menopause. Concomitant products included ACETYLSALICYLIC ACID (ECOTRIN) from 01-Aug-2019 to an unknown date for Foramen ovale patent, PROGESTERONE from 01-Oct-2020 to an unknown date and ESTRADIOL (VIVELLE DOT) from 01-Oct-2020 to an unknown date for Menopause, ASCORBIC ACID, CALCIUM, MAGNESIUM, SILICONES NOS, VITAMIN D NOS (OSTEO [ASCORBIC ACID;CALCIUM;MAGNESIUM;SILICONES NOS;VITAMIN D NOS]) from 01-Oct-2018 to an unknown date for Multi-vitamins deficiency.    On 06-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FATIGUE (mild fatigue in the 24 hours after the shot). At the time of the report, FATIGUE (mild fatigue in the 24 hours after the shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications was provided.   This case was linked to MOD-2022-469525, MOD-2022-461325 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pain, Pyrexia
Clinical narrative: moderate to severe malaise for almost 48 hours; aches; fever up to 103; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (moderate to severe malaise for almost 48 hours), PAIN (aches), PYREXIA (fever up to 103) and CHILLS (Chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Foramen ovale patent since 01-Aug-2019, Menopause since 01-Oct-2020 and Multi-vitamin deficiency since 01-Oct-2018. Concomitant products included ACETYLSALICYLIC ACID (ECOTRIN) from 01-Aug-2019 to an unknown date for Foramen ovale patent, PROGESTERONE from 01-Oct-2020 to an unknown date and ESTRADIOL (VIVELLE DOT) from 01-Oct-2020 to an unknown date for Menopause, ASCORBIC ACID, CALCIUM, MAGNESIUM, SILICONES NOS, VITAMIN D NOS (OSTEO [ASCORBIC ACID;CALCIUM;MAGNESIUM;SILICONES NOS;VITAMIN D NOS]) from 01-Oct-2018 to an unknown date for Multi-vitamin deficiency.   On 06-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (moderate to severe malaise for almost 48 hours), PAIN (aches), PYREXIA (fever up to 103) and CHILLS (Chills). At the time of the report, MALAISE (moderate to severe malaise for almost 48 hours) had resolved and PAIN (aches), PYREXIA (fever up to 103) and CHILLS (Chills) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: up to 103 (High) up to 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported   This case was linked to MOD-2022-469510, MOD-2022-461325 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood, Overdose, Screaming
Clinical narrative: body is screaming overdose; may have been given a full 0.5ml as a booster/body is screaming overdose; Down for nine days; This spontaneous case was reported by an other health care professional and describes the occurrence of SCREAMING (body is screaming overdose), DEPRESSED MOOD (Down for nine days) and OVERDOSE (may have been given a full 0.5ml as a booster/body is screaming overdose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced SCREAMING (body is screaming overdose), DEPRESSED MOOD (Down for nine days) and OVERDOSE (may have been given a full 0.5ml as a booster/body is screaming overdose). At the time of the report, SCREAMING (body is screaming overdose) outcome was unknown and DEPRESSED MOOD (Down for nine days) and OVERDOSE (may have been given a full 0.5ml as a booster/body is screaming overdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  It was reported that patient had no problem with first two shots (doses).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer vaccine (Patient received the Pfizer vaccine for primary vaccination series) and Pfizer vaccine. Past adverse reactions to the above products included No adverse drug reaction with Pfizer vaccine and Pfizer vaccine.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm) outcome was unknown.            Concomitant medications and treatment information were not provided by reporter. The patient had a sore injection site left arm.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling abnormal, Pruritus, Urticaria
Clinical narrative: hives breaking out/hives were quite large; miserable; 10 days later the back of my head itching; burning feeling; neck was red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (10 days later the back of my head itching), BURNING SENSATION (burning feeling), ERYTHEMA (neck was red), URTICARIA (hives breaking out/hives were quite large) and FEELING ABNORMAL (miserable) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), VITAMIN D3, UBIDECARENONE (COQ-10), ZINC, VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], ACETYLSALICYLIC ACID (ASPIRIN 81) and MONTELUKAST for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PRURITUS (10 days later the back of my head itching), BURNING SENSATION (burning feeling) and ERYTHEMA (neck was red). On an unknown date, the patient experienced URTICARIA (hives breaking out/hives were quite large) and FEELING ABNORMAL (miserable). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) in November 2021 for Adverse event, at a dose of UNK, as necessary; PREDNISONE in November 2021 for Adverse event, at an unspecified dose and frequency and CORTISONE in November 2021 for Hives, at an unspecified dose and frequency. At the time of the report, PRURITUS (10 days later the back of my head itching) and URTICARIA (hives breaking out/hives were quite large) had not resolved and BURNING SENSATION (burning feeling), ERYTHEMA (neck was red) and FEELING ABNORMAL (miserable) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Medical history information was reported.   Other concomitant medications included Wixela 250/50, cholestoff, prostate plus.  Patient went to the provider who prescribed some steroids (prednisone) as a 5 day course and antihistamines which helped but they still stayed. Patient has it on his legs, shin, feet, armpits, down his arms, back, hairline, face. They put patient on stronger prednisone and took it for 10 days. They have dissipated a little over the next month. They show up mainly in the morning. Patient still has them but not as severe. They pop up when he has pressure on his skin. Patient stated will probably not take another booster shot. Patient would have to be convinced into it.   This case was linked to MOD-2022-470215 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Moderna COVID-19 vaccine on 20Dec2020 and the second on 27Jan2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 20Dec2020 and the second on 27Jan2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 939903) for COVID-19 vaccination.     Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), COLECALCIFEROL (VITAMIN D3), PHYTOSTEROLS NOS (CHOLESTOFF ORIGINAL), UBIDECARENONE (COQ-10), ZINC, VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]), MULTIVITAMIN [VITAMINS NOS], ASCORBIC ACID (VITAMIN C ACID), ACETYLSALICYLIC ACID (ASPIRIN 81) and MONTELUKAST for an unknown indication.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 20Dec2020 and the second on 27Jan2021). On 27-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 20Dec2020 and the second on 27Jan2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications were reported.  The additional concomitant products included prostate plus   This case was linked to MOD-2022-470206 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rotator cuff syndrome
Clinical narrative: She had rotator cuff damage in her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (She had rotator cuff damage in her shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (She had rotator cuff damage in her shoulder). At the time of the report, ROTATOR CUFF SYNDROME (She had rotator cuff damage in her shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The reporter stated that the patient experienced the same thing after their vaccinations. The patient three months after their shot had rotator cuff damage in their shoulder, but never had previous history of it either.  No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The first and second dose of Moderna is greater than 30 days/first dose on 21 Mar 2021, second dose on 2 Feb 2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first and second dose of Moderna is greater than 30 days/first dose on 21 Mar 2021, second dose on 2 Feb 2022) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FK9729) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first and second dose of Moderna is greater than 30 days/first dose on 21 Mar 2021, second dose on 2 Feb 2022). On 02-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first and second dose of Moderna is greater than 30 days/first dose on 21 Mar 2021, second dose on 2 Feb 2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. Treatment information was not provided. Patient had no medication history and no allergy.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: given the half dose booster before receiving a third primarydose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given the half dose booster before receiving a third primarydose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (given the half dose booster before receiving a third primarydose). At the time of the report, ACCIDENTAL UNDERDOSE (given the half dose booster before receiving a third primarydose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported. It was reported that few patients who claimed they were  immunocompromised were given the half dose booster before receiving a third primary dose.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I'm not sure if we administered an expired vaccine to a patient in Nov; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I'm not sure if we administered an expired vaccine to a patient in Nov) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I'm not sure if we administered an expired vaccine to a patient in Nov). In November 2021, EXPIRED PRODUCT ADMINISTERED (I'm not sure if we administered an expired vaccine to a patient in Nov) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Friend who felt sick after her first dose of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Friend who felt sick after her first dose of the Moderna Covid-19 vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Friend who felt sick after her first dose of the Moderna Covid-19 vaccine.). At the time of the report, ILLNESS (Friend who felt sick after her first dose of the Moderna Covid-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient given 0.25 ml for the 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 ml for the 3rd dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 045A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 ml for the 3rd dose). On 18-Nov-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 ml for the 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vaccination site rash
Clinical narrative: rash very itchy; another 5 days it spread whole chest and torso back other arm shoulder flared up; within 5 days left shoulder where I had the shot rashed out; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash very itchy), RASH (another 5 days it spread whole chest and torso back other arm shoulder flared up) and VACCINATION SITE RASH (within 5 days left shoulder where I had the shot rashed out) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 032L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced RASH PRURITIC (rash very itchy), RASH (another 5 days it spread whole chest and torso back other arm shoulder flared up) and VACCINATION SITE RASH (within 5 days left shoulder where I had the shot rashed out). The patient was treated with LEVOCETIRIZINE at a dose of 5 mg for about two weeks. At the time of the report, RASH PRURITIC (rash very itchy), RASH (another 5 days it spread whole chest and torso back other arm shoulder flared up) and VACCINATION SITE RASH (within 5 days left shoulder where I had the shot rashed out) had not resolved.            No concomitant medication were reported.  The patient stated he has been taken levocetirizine 5 mg for about two weeks. Before that, he was taking an over-the-counter antihistamine. The levocetirizine seems to help more, but it's not taking it away.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dry mouth, Dysarthria, Dysgeusia, Fatigue
Clinical narrative: Difficulty putting on a sentence; Fatigue; Lose Weight; having out of this world thoughts; dry mouth; Nausea; head on vice; Headache; Pain; Period started  which supposed to be not because she has a regular cycle; Diarrhea; Metallic taste in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Difficulty putting on a sentence), FATIGUE (Fatigue), WEIGHT DECREASED (Lose Weight), FEELING ABNORMAL (having out of this world thoughts) and DRY MOUTH (dry mouth) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced DIARRHOEA (Diarrhea) and DYSGEUSIA (Metallic taste in the mouth). On 12-Aug-2021, the patient experienced MENSTRUAL DISORDER (Period started  which supposed to be not because she has a regular cycle). On an unknown date, the patient experienced DYSARTHRIA (Difficulty putting on a sentence), FATIGUE (Fatigue), WEIGHT DECREASED (Lose Weight), FEELING ABNORMAL (having out of this world thoughts), DRY MOUTH (dry mouth), NAUSEA (Nausea), TINNITUS (head on vice), HEADACHE (Headache) and PAIN (Pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at a dose of 325mg daily and KETOROLAC TROMETHAMINE (TORADOL) for Pain, at a dose of injection. At the time of the report, DYSARTHRIA (Difficulty putting on a sentence), FATIGUE (Fatigue), WEIGHT DECREASED (Lose Weight), FEELING ABNORMAL (having out of this world thoughts), DRY MOUTH (dry mouth), NAUSEA (Nausea), TINNITUS (head on vice), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in the mouth), MENSTRUAL DISORDER (Period started  which supposed to be not because she has a regular cycle), HEADACHE (Headache) and PAIN (Pain) outcome was unknown.            Lot number 003C21A was given by vaccination provider over the phone but was not mentioned if it is the first or second dose lot number. The doctor prescribed Antibiotics.  Patient not clearly mentioned the events occurred after first dose or second dose of Moderna vaccine however all events added in case.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2022: Follow up received - Additional events were added.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Menstrual disorder, Nausea, Pain
Clinical narrative: Difficulty putting on a sentence; Fatigue; Lose Weight; having out of this world thoughts; dry mouth; Nausea; head on vice; Headache; Pain; Period started  which supposed to be not because she has a regular cycle; Diarrhea; Metallic taste in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Difficulty putting on a sentence), FATIGUE (Fatigue), WEIGHT DECREASED (Lose Weight), FEELING ABNORMAL (having out of this world thoughts) and DRY MOUTH (dry mouth) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced DIARRHOEA (Diarrhea) and DYSGEUSIA (Metallic taste in the mouth). On 12-Aug-2021, the patient experienced MENSTRUAL DISORDER (Period started  which supposed to be not because she has a regular cycle). On an unknown date, the patient experienced DYSARTHRIA (Difficulty putting on a sentence), FATIGUE (Fatigue), WEIGHT DECREASED (Lose Weight), FEELING ABNORMAL (having out of this world thoughts), DRY MOUTH (dry mouth), NAUSEA (Nausea), TINNITUS (head on vice), HEADACHE (Headache) and PAIN (Pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at a dose of 325mg daily and KETOROLAC TROMETHAMINE (TORADOL) for Pain, at a dose of injection. At the time of the report, DYSARTHRIA (Difficulty putting on a sentence), FATIGUE (Fatigue), WEIGHT DECREASED (Lose Weight), FEELING ABNORMAL (having out of this world thoughts), DRY MOUTH (dry mouth), NAUSEA (Nausea), TINNITUS (head on vice), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in the mouth), MENSTRUAL DISORDER (Period started  which supposed to be not because she has a regular cycle), HEADACHE (Headache) and PAIN (Pain) outcome was unknown.            Lot number 003C21A was given by vaccination provider over the phone but was not mentioned if it is the first or second dose lot number. The doctor prescribed Antibiotics.  Patient not clearly mentioned the events occurred after first dose or second dose of Moderna vaccine however all events added in case.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2022: Follow up received - Additional events were added.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Weight decreased
Clinical narrative: Difficulty putting on a sentence; Fatigue; Lose Weight; having out of this world thoughts; dry mouth; Nausea; head on vice; Headache; Pain; Period started  which supposed to be not because she has a regular cycle; Diarrhea; Metallic taste in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Difficulty putting on a sentence), FATIGUE (Fatigue), WEIGHT DECREASED (Lose Weight), FEELING ABNORMAL (having out of this world thoughts) and DRY MOUTH (dry mouth) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced DIARRHOEA (Diarrhea) and DYSGEUSIA (Metallic taste in the mouth). On 12-Aug-2021, the patient experienced MENSTRUAL DISORDER (Period started  which supposed to be not because she has a regular cycle). On an unknown date, the patient experienced DYSARTHRIA (Difficulty putting on a sentence), FATIGUE (Fatigue), WEIGHT DECREASED (Lose Weight), FEELING ABNORMAL (having out of this world thoughts), DRY MOUTH (dry mouth), NAUSEA (Nausea), TINNITUS (head on vice), HEADACHE (Headache) and PAIN (Pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at a dose of 325mg daily and KETOROLAC TROMETHAMINE (TORADOL) for Pain, at a dose of injection. At the time of the report, DYSARTHRIA (Difficulty putting on a sentence), FATIGUE (Fatigue), WEIGHT DECREASED (Lose Weight), FEELING ABNORMAL (having out of this world thoughts), DRY MOUTH (dry mouth), NAUSEA (Nausea), TINNITUS (head on vice), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in the mouth), MENSTRUAL DISORDER (Period started  which supposed to be not because she has a regular cycle), HEADACHE (Headache) and PAIN (Pain) outcome was unknown.            Lot number 003C21A was given by vaccination provider over the phone but was not mentioned if it is the first or second dose lot number. The doctor prescribed Antibiotics.  Patient not clearly mentioned the events occurred after first dose or second dose of Moderna vaccine however all events added in case.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2022: Follow up received - Additional events were added.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported by the reporter.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Limb injury, Magnetic resonance imaging, Pain, Vaccination complication
Clinical narrative: For about 3 weeks, his right arm where he got it was in really bad shape; He had a difficult time eating for about 3 weeks; one with shoulder injury, it started in August, but got a whole lot worse; pain; booster, which didn't go so well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (For about 3 weeks, his right arm where he got it was in really bad shape), FEEDING DISORDER (He had a difficult time eating for about 3 weeks), LIMB INJURY (one with shoulder injury, it started in August, but got a whole lot worse), PAIN (pain) and VACCINATION COMPLICATION (booster, which didn't go so well) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (For about 3 weeks, his right arm where he got it was in really bad shape), FEEDING DISORDER (He had a difficult time eating for about 3 weeks), LIMB INJURY (one with shoulder injury, it started in August, but got a whole lot worse), PAIN (pain) and VACCINATION COMPLICATION (booster, which didn't go so well). The patient was treated with CORTISONE on 24-Jan-2022 for Adverse event, at a dose of Shot in his right arm. At the time of the report, VACCINATION SITE DISCOMFORT (For about 3 weeks, his right arm where he got it was in really bad shape), FEEDING DISORDER (He had a difficult time eating for about 3 weeks), PAIN (pain) and VACCINATION COMPLICATION (booster, which didn't go so well) outcome was unknown and LIMB INJURY (one with shoulder injury, it started in August, but got a whole lot worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: not provided Not provided. On an unknown date, X-ray: not provided Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  For about 3 weeks, his right arm where he got it was in really bad shape. He had a difficult time eating for about 3 weeks. Then on 24-Jan-2022, he got the cortisone shot in his right arm, which relieved the pain. The patient stated he was not be the only one with shoulder injury. It started in august, but got a whole lot worse. The pain got really bad during Christmas time. There was one point where it was so painful.   This case was linked to MOD-2021-302108, MOD-2022-470224 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, X-ray
Clinical narrative: For about 3 weeks, his right arm where he got it was in really bad shape; He had a difficult time eating for about 3 weeks; one with shoulder injury, it started in August, but got a whole lot worse; pain; booster, which didn't go so well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (For about 3 weeks, his right arm where he got it was in really bad shape), FEEDING DISORDER (He had a difficult time eating for about 3 weeks), LIMB INJURY (one with shoulder injury, it started in August, but got a whole lot worse), PAIN (pain) and VACCINATION COMPLICATION (booster, which didn't go so well) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (For about 3 weeks, his right arm where he got it was in really bad shape), FEEDING DISORDER (He had a difficult time eating for about 3 weeks), LIMB INJURY (one with shoulder injury, it started in August, but got a whole lot worse), PAIN (pain) and VACCINATION COMPLICATION (booster, which didn't go so well). The patient was treated with CORTISONE on 24-Jan-2022 for Adverse event, at a dose of Shot in his right arm. At the time of the report, VACCINATION SITE DISCOMFORT (For about 3 weeks, his right arm where he got it was in really bad shape), FEEDING DISORDER (He had a difficult time eating for about 3 weeks), PAIN (pain) and VACCINATION COMPLICATION (booster, which didn't go so well) outcome was unknown and LIMB INJURY (one with shoulder injury, it started in August, but got a whole lot worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: not provided Not provided. On an unknown date, X-ray: not provided Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  For about 3 weeks, his right arm where he got it was in really bad shape. He had a difficult time eating for about 3 weeks. Then on 24-Jan-2022, he got the cortisone shot in his right arm, which relieved the pain. The patient stated he was not be the only one with shoulder injury. It started in august, but got a whole lot worse. The pain got really bad during Christmas time. There was one point where it was so painful.   This case was linked to MOD-2021-302108, MOD-2022-470224 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Experienced swollen lymph nodes under his right armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes antihistamine. No concomitant medications were reported.   This case was linked to MOD-2022-464121, MOD-2022-464124 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2022-468520, MOD-2022-468516 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Skin disorder, Suspected COVID-19
Clinical narrative: Patient experienced some patches on upper and lower legs; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4237019-00.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Jan2021 (Batch/Lot number: unknown) as dose 1, single, administration date 31Jan2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Jan2022, outcome "recovering" and all described as "COVID-19"; SKIN DISORDER (non-serious) with onset 14Jan2022, outcome "not recovered", described as "Patient experienced some patches on upper and lower legs". The action taken for adalimumab was unknown. Clinical course: The patient experienced some patches on upper and lower legs and covid-19 with Humira (Adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Did event abate after stopping drug: NA. Concomitant drugs and dates of administration (exclude those used to treat event): Concomitant drugs not reported. Other relevant history: Not reported.  The reporter's causality for the event(s) with (HUMIRA) Adalimumab of 'some patches on upper and lower legs' was reasonable possibility and of 'covid-19' was no reasonable possibility.  The reporter's causality for the event(s) with PFIZER BIONTECH COVID-19 VACCINE of 'some patches on upper and lower legs' was not reported and of 'covid-19' was possible.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: muscle aches; chills; fever; vomiting; diarrhea; fatigue; nausea; body aches all over; soreness in arm where shot was administered; soreness in arm where shot was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jul2021 12:00 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: EFFEXOR. The following information was reported: MYALGIA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "muscle aches"; CHILLS (non-serious) with onset 14Jul2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "fever"; VOMITING (non-serious) with onset 14Jul2021, outcome "not recovered", described as "vomiting"; DIARRHOEA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "diarrhea"; FATIGUE (non-serious) with onset 14Jul2021, outcome "not recovered", described as "fatigue"; NAUSEA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "nausea"; PAIN (non-serious) with onset 14Jul2021, outcome "not recovered", described as "body aches all over"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 14Jul2021, outcome "not recovered" and all described as "soreness in arm where shot was administered". Therapeutic measures were not taken as a result of myalgia, chills, pyrexia, vomiting, diarrhoea, fatigue, nausea, pain, pain in extremity, vaccination site pain.  Additional information: No other vaccine in four weeks. Other medications in two weeks included Effexor XR. No covid prior vaccination. Patient was not covid tested post vaccination. No known allergies.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: muscle aches; chills; fever; vomiting; diarrhea; fatigue; nausea; body aches all over; soreness in arm where shot was administered; soreness in arm where shot was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jul2021 12:00 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: EFFEXOR. The following information was reported: MYALGIA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "muscle aches"; CHILLS (non-serious) with onset 14Jul2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "fever"; VOMITING (non-serious) with onset 14Jul2021, outcome "not recovered", described as "vomiting"; DIARRHOEA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "diarrhea"; FATIGUE (non-serious) with onset 14Jul2021, outcome "not recovered", described as "fatigue"; NAUSEA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "nausea"; PAIN (non-serious) with onset 14Jul2021, outcome "not recovered", described as "body aches all over"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 14Jul2021, outcome "not recovered" and all described as "soreness in arm where shot was administered". Therapeutic measures were not taken as a result of myalgia, chills, pyrexia, vomiting, diarrhoea, fatigue, nausea, pain, pain in extremity, vaccination site pain.  Additional information: No other vaccine in four weeks. Other medications in two weeks included Effexor XR. No covid prior vaccination. Patient was not covid tested post vaccination. No known allergies.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Oropharyngeal discomfort, Throat irritation
Clinical narrative: Asthma attack; Discomfort itching of throat and sight; Discomfort itching of throat and sight; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jul2021 13:45 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe asthma" (unspecified if ongoing). Concomitant medication(s) included: DUPIXENT; TRELEGY; ADVAIR. Past drug history included: Iodine, reaction(s): "Iodine allergy"; Ceclor, reaction(s): "Ceclor allergy"; Niacin, reaction(s): "Niacin allergy". The following information was reported: ASTHMA (non-serious) with onset 20Jul2021 06:00, outcome "unknown", described as "Asthma attack"; OROPHARYNGEAL DISCOMFORT (non-serious), THROAT IRRITATION (non-serious) all with onset 20Jul2021 06:00, outcome "unknown" and all described as "Discomfort itching of throat and sight". The events "asthma attack", "discomfort itching of throat and sight" and "discomfort itching of throat and sight" were evaluated at the physician office visit. Therapeutic measures were taken as a result of asthma, oropharyngeal discomfort, throat irritation.  Additional information: Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Known allergies for iodine, ceclor, niacin. Other medical history was severe asthma. Other medications in two weeks were Dupixent, Trelegy, Advair. Adverse events were asthma attack, discomfort itching of throat and sight. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event treatment was Bendryl, rescue inhalation.  Follow-up attempts completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness; The Initial case was missing the following minimum criteria: ICH-unspecified AE. Upon receipt of follow-up information on 18Jan2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191; 005570; 159558). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (hospitalization) with onset 2021, outcome "unknown", described as "numbness". The event "numbness" was evaluated at the emergency room visit. Clinical course: The patient recently had the Pfizer COVID injection vaccine in Apr2021 and had a serious reaction to it where she went to hospital where they did all kinds of tests. The patient had complications with the shot and had to go to the emergency room and as a result she had additional medical bills that she wasn't anticipating. The patient added that the numbness and everything that she experienced after her first dose had come back. All the medical personnel have advised the caller that it is a good thing she didn't have a second dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed with COVID Remdesivir, Tylenol In-patient