chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Nasopharyngitis
Clinical narrative: Common cold like symptoms; Nasal congestion; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Common cold like symptoms), NASAL CONGESTION (Nasal congestion), CHILLS (Chills) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included HIV disease and Immunocompromised. Concomitant products included LORATADINE for Allergy, OMEPRAZOLE for Gastritis, ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE (TRIUMEQ) for HIV disease, CETIRIZINE for Itching, FISH OIL for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced NASOPHARYNGITIS (Common cold like symptoms), NASAL CONGESTION (Nasal congestion), CHILLS (Chills) and HEADACHE (Headache). In March 2021, NASOPHARYNGITIS (Common cold like symptoms) and HEADACHE (Headache) had resolved. At the time of the report, NASAL CONGESTION (Nasal congestion) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included Vitamin like Centrum. No treatment information was provided.   This case was linked to MOD-2022-438940 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Pruritus genital, Urticaria
Clinical narrative: break out in hives especially on his lower back; his skin became red and scratchy; itchiness; itchy sensation on his genitalia and all over his body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (break out in hives especially on his lower back), ERYTHEMA (his skin became red and scratchy), PRURITUS (itchiness) and PRURITUS GENITAL (itchy sensation on his genitalia and all over his body) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030h21b, 047c21a and 014c21a) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (break out in hives especially on his lower back), ERYTHEMA (his skin became red and scratchy), PRURITUS (itchiness) and PRURITUS GENITAL (itchy sensation on his genitalia and all over his body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (break out in hives especially on his lower back), ERYTHEMA (his skin became red and scratchy), PRURITUS (itchiness) and PRURITUS GENITAL (itchy sensation on his genitalia and all over his body) outcome was unknown.            The patient experienced symptoms after 10-11 days following booster dose. The patient started experienced break out in hives especially on his lower back, his skin became red and scratchy, itchiness itchy sensation on his genitalia and all over his body. No medical history was provided by the reporter.   This case was linked to MOD-2022-439116 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: a lingering headache; chills; fever; slight tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a lingering headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (slight tiredness) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced HEADACHE (a lingering headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (slight tiredness). At the time of the report, HEADACHE (a lingering headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (slight tiredness) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-438760, MOD-2022-438857 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: not feeling great; flu-like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (not feeling great) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 031B21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, 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 experienced MALAISE (not feeling great) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, MALAISE (not feeling great) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives after vaccination) 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 URTICARIA (Hives after vaccination). At the time of the report, URTICARIA (Hives after vaccination) 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 provided.  The patient had called to report her adverse events following vaccination mentions she knows a lot of people who are experiencing hives after vaccination.   This case was linked to MOD-2022-438713 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night; Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) and PRODUCT STORAGE ERROR in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) and PRODUCT STORAGE ERROR. On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) - At 10:12 am it was removed from the fridge, yesterday 03Jan2022. It was administered today, 04Jan2022, at 11:15 am and 11:30 am.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: So far very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (So far very sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067P214, 015M2 and 013L2) for COVID-19 vaccination.     The patient's past medical history included Hives and Urticaria. Previously administered products included for Product used for unknown indication: Iodine (Injected and rash appeared immediately) in 1990, Metoprolol (large blister on chest, and tiny thin blister down arm and legs) in 2014, Metoprolol (increased 25 milligram, large blister on chest and and tiny thin blister down arm and legs when dose was increased) in June 2020. Past adverse reactions to the above products included Blister with Metoprolol and Metoprolol; and Rash with Iodine. Concomitant products included AMLODIPINE, UBIDECARENONE (COQ 10), LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, MULTIVITAMIN [VITAMINS NOS], PRAVASTATIN and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, 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 experienced PAIN IN EXTREMITY (So far very sore arm). At the time of the report, PAIN IN EXTREMITY (So far very sore arm) outcome was unknown.            Concomitant drug included triple flex 50 plus PO 1 tablet by mouth twice a day for unknown indication and Ocuvite adult 50 plus 1 dosage form daily for unknown indication. No treatment medication was reported by reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night; Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) and PRODUCT STORAGE ERROR (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) and PRODUCT STORAGE ERROR (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) and PRODUCT STORAGE ERROR (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Localised infection, Product dose omission issue
Clinical narrative: He missed the second shot/Missed 2nd shot  more than 6 months post first shot; About one month later, his leg was infected again; This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (About one month later, his leg was infected again) and PRODUCT DOSE OMISSION ISSUE (He missed the second shot/Missed 2nd shot  more than 6 months post first shot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination.     The patient's past medical history included Leg infection (He has a Prostatic leg which caused infection in the left leg prior to vaccination.) in 2021. Concurrent medical conditions included Leg prosthesis user.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced LOCALISED INFECTION (About one month later, his leg was infected again). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He missed the second shot/Missed 2nd shot  more than 6 months post first shot). At the time of the report, LOCALISED INFECTION (About one month later, his leg was infected again) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He missed the second shot/Missed 2nd shot  more than 6 months post first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.  Patient had a Prostatic Leg which caused infection in the left leg prior to vaccination. While he was in the hospital, they administered the first dose of Moderna COVID-19 vaccine to him. About one month later, his leg was infected again and he went back to the same hospital. He missed the second shot. He stated that his leg infection had nothing to do with the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms for a couple of days) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms for a couple of days). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms for a couple of days) had resolved.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2022-439005 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster doses given > 12 hour post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses given > 12 hour post puncture) 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 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses given > 12 hour post puncture). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (booster doses given > 12 hour post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The doses were drawn up into syringes prior to administration. The patient's date of birth and previous COVID19 vaccinations were unknown.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-439461, MOD-2022-438972 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Rash pruritic, Urticaria
Clinical narrative: Doctor told her it was an allergic reaction/bad allergic reaction; Such terrible hives; Rash was itchy; rash in different parts of her body, like torso, feet and it was terrible on her hands; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Such terrible hives), RASH PRURITIC (Rash was itchy), RASH (rash in different parts of her body, like torso, feet and it was terrible on her hands) and HYPERSENSITIVITY (Doctor told her it was an allergic reaction/bad allergic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Dec-2021, the patient experienced URTICARIA (Such terrible hives), RASH PRURITIC (Rash was itchy) and RASH (rash in different parts of her body, like torso, feet and it was terrible on her hands). On an unknown date, the patient experienced HYPERSENSITIVITY (Doctor told her it was an allergic reaction/bad allergic reaction). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Such terrible hives), RASH PRURITIC (Rash was itchy), RASH (rash in different parts of her body, like torso, feet and it was terrible on her hands) and HYPERSENSITIVITY (Doctor told her it was an allergic reaction/bad allergic reaction) had resolved.            No concomitant medication reported.   This case was linked to MOD-2022-438991 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives (urticaria); This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives (urticaria)) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives (urticaria)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 01-Jan-2022 for Hives, at an unspecified dose and frequency; HYDROCORTISONE for Hives, at an unspecified dose and frequency; PREDNISONE for Hives, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives (urticaria)) was resolving.            No concomitant medication was reported. On 03Jan2022, the patient went to the doctor as it was going out of control real quick.  Patient joined a Facebook group, called Chronic Spontaneous Urticaria after COVID19 vaccine Support Group and heard that a lot of people having a similar reaction
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mechanical urticaria, Pruritus, Swelling of eyelid, Urticaria
Clinical narrative: dermographism, when any pressure is apply on their body it turns red.; broke out with hives all over their body; lip swelling; eyelid swelling; very itchy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of URTICARIA (broke out with hives all over their body), LIP SWELLING (lip swelling), SWELLING OF EYELID (eyelid swelling), PRURITUS (very itchy) and MECHANICAL URTICARIA (dermographism, when any pressure is apply on their body it turns red.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 049C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Dec-2021, the patient experienced URTICARIA (broke out with hives all over their body), LIP SWELLING (lip swelling), SWELLING OF EYELID (eyelid swelling) and PRURITUS (very itchy). On an unknown date, the patient experienced MECHANICAL URTICARIA (dermographism, when any pressure is apply on their body it turns red.). The patient was treated with CORTISONE on 31-Dec-2021 for Adverse event, at an unspecified dose and frequency; PREDNISONE on 31-Dec-2021 for Adverse event, at an unspecified dose and frequency and BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for Antihistamine therapy, at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out with hives all over their body) and PRURITUS (very itchy) had not resolved, LIP SWELLING (lip swelling) and SWELLING OF EYELID (eyelid swelling) had resolved and MECHANICAL URTICARIA (dermographism, when any pressure is apply on their body it turns red.) outcome was unknown.            No Concomitant medications were reported.  Patient stated that she experienced hives every day and very itchy, which come and go throughout the day, spread on the stomach and appeared in various parts of the body at different times. Patient stated that she have been taking Vertex, an antihistaminic and also visited urgent care on Friday 31-Dec-2021 where she got a cortisone shot and a prednisone course for 5 days. Patient also stated that she do not take any medication regularly and she was pregnant back when she received the first two shots of vaccine
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: flu; hives all over her body/dermatographia; Every place that I touch gets itchy; suffering from spontaneous urticaria / switch places: back of her skull and armpit, stomach. It moves around; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (suffering from spontaneous urticaria / switch places: back of her skull and armpit, stomach. It moves around), INFLUENZA (flu), MECHANICAL URTICARIA (hives all over her body/dermatographia) and PRURITUS (Every place that I touch gets itchy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced URTICARIA (suffering from spontaneous urticaria / switch places: back of her skull and armpit, stomach. It moves around) and PRURITUS (Every place that I touch gets itchy). On an unknown date, the patient experienced INFLUENZA (flu) and MECHANICAL URTICARIA (hives all over her body/dermatographia). The patient was treated with CETIRIZINE for Hives, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, URTICARIA (suffering from spontaneous urticaria / switch places: back of her skull and armpit, stomach. It moves around), MECHANICAL URTICARIA (hives all over her body/dermatographia) and PRURITUS (Every place that I touch gets itchy) outcome was unknown and INFLUENZA (flu) had resolved.            concomitant medication was not reported.  Initially after the booster, the patient felt like got the flu. After 24 hours, she was perfectly fine. Eleven days after, she started having hives all over her body. It's called dermatographia. Every place that she touches gets itchy and immediately becomes hives. It's like lines rather than dots. She's had this since 01Dec2021. It resolves in 20-30 minutes, but then it moves to a different place of the body. They switch places: back of her skull and armpit, stomach. It moves around.  The patient reports taking cetirizine, which takes care of the hives. As soon as it wears off, the hives come back. She also tried Benadryl and other antihistamines   This case was linked to MOD-2022-439068, MOD-2022-440881 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives / generalized, everywhere; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives / generalized, everywhere) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064H21A, 039K20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives / generalized, everywhere). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 5 days and LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, URTICARIA (hives / generalized, everywhere) had not resolved.            No Concomitant medication was reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Nasopharyngitis, Pain, Pyrexia, Vaccination complication
Clinical narrative: Expected reaction; She felt like she got the cold or flu; She felt like she got the cold or flu; Achy; Little bit fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Expected reaction), NASOPHARYNGITIS (She felt like she got the cold or flu), INFLUENZA (She felt like she got the cold or flu), PAIN (Achy) and PYREXIA (Little bit fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Expected reaction), NASOPHARYNGITIS (She felt like she got the cold or flu), INFLUENZA (She felt like she got the cold or flu), PAIN (Achy) and PYREXIA (Little bit fever). In 2021, PAIN (Achy) and PYREXIA (Little bit fever) had resolved. At the time of the report, VACCINATION COMPLICATION (Expected reaction), NASOPHARYNGITIS (She felt like she got the cold or flu) and INFLUENZA (She felt like she got the cold or flu) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-439044, MOD-2022-440881 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Hives/ Urticaria/ hives on the neck and abdomen then it spread from the neck and abdomen to everywhere/still having hives reaction; Itching on the scalp and ears/Itching; Allergies; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/ Urticaria/ hives on the neck and abdomen then it spread from the neck and abdomen to everywhere/still having hives reaction), PRURITUS (Itching on the scalp and ears/Itching) and HYPERSENSITIVITY (Allergies) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067FZ1A, 011A21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced PRURITUS (Itching on the scalp and ears/Itching) and HYPERSENSITIVITY (Allergies). On 02-Dec-2021, the patient experienced URTICARIA (Hives/ Urticaria/ hives on the neck and abdomen then it spread from the neck and abdomen to everywhere/still having hives reaction). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives/ Urticaria/ hives on the neck and abdomen then it spread from the neck and abdomen to everywhere/still having hives reaction), PRURITUS (Itching on the scalp and ears/Itching) and HYPERSENSITIVITY (Allergies) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. It's been a long time since patient was been on medications.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Influenza like illness
Clinical narrative: flu-like feeling; back pain; major headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like feeling), BACK PAIN (back pain) and HEADACHE (major headaches) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 007C21A) for COVID-19 vaccination.     Concomitant products included UBIDECARENONE (COQ10 [UBIDECARENONE]) and PROBIOTICS NOS for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like feeling), BACK PAIN (back pain) and HEADACHE (major headaches). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like feeling), BACK PAIN (back pain) and HEADACHE (major headaches) had resolved. Not Provided          No medical history was reported.  After booster dose the patient took Tylenol in the noon.    This case was linked to MOD-2021-415871 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Vision blurred
Clinical narrative: Constant eyelid twitching on right eye; Vision got blurry; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (Constant eyelid twitching on right eye) and VISION BLURRED (Vision got blurry) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Dec-2021, the patient experienced BLEPHAROSPASM (Constant eyelid twitching on right eye) and VISION BLURRED (Vision got blurry). At the time of the report, BLEPHAROSPASM (Constant eyelid twitching on right eye) and VISION BLURRED (Vision got blurry) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient isn't under any current regular or concomitant medication. Treatment information was unknown
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia
Clinical narrative: Flu-like feeling; Body aches; Major headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like feeling), MYALGIA (Body aches) and HEADACHE (Major headaches) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041c21A and 007c21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like feeling), MYALGIA (Body aches) and HEADACHE (Major headaches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like feeling), MYALGIA (Body aches) and HEADACHE (Major headaches) had resolved. Not Provided          Patient height was reported was 5.10 inches  Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-415874 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  The vial was removed from the freezer today 04-Jan-2022. HCP thought that the vaccine was supposed to be good for 6 months. After vaccination, she scanned the vial to write the expiration date on the vaccination card and noticed that the vaccine expired 11 days ago on 23-DEC-2021.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Issue with the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Issue with the booster shot) 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Issue with the booster shot). At the time of the report, VACCINATION COMPLICATION (Issue with the booster shot) had not resolved.            No Concomitant product use was reported.  During the call, the patient mentioned that there were more people with this issue with the booster shot and that the reaction was not going away.  No treatment information was provided.   This case was linked to MOD-2022-438837 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Pruritus, Sensation of foreign body
Clinical narrative: chronic spontaneous urticaria; extreme itchiness of his scalp,the rest of his body started with the extreme itchiness/It was on his thighs, groin, chest, feet, & the palms of his hands; the next day he had a lump in his throat that was like a wad of bread that won't go down when swallowing; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria), PRURITUS (extreme itchiness of his scalp,the rest of his body started with the extreme itchiness/It was on his thighs, groin, chest, feet, & the palms of his hands) and SENSATION OF FOREIGN BODY (the next day he had a lump in his throat that was like a wad of bread that won't go down when swallowing) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 030L20A and 042L20A) 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 20-Dec-2021, 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 experienced CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria), PRURITUS (extreme itchiness of his scalp,the rest of his body started with the extreme itchiness/It was on his thighs, groin, chest, feet, & the palms of his hands) and SENSATION OF FOREIGN BODY (the next day he had a lump in his throat that was like a wad of bread that won't go down when swallowing). At the time of the report, CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria), PRURITUS (extreme itchiness of his scalp,the rest of his body started with the extreme itchiness/It was on his thighs, groin, chest, feet, & the palms of his hands) and SENSATION OF FOREIGN BODY (the next day he had a lump in his throat that was like a wad of bread that won't go down when swallowing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant details were not reported by the reporter. Treatment details was not reported by the reporter. Ten days after the booster dose patient experienced extreme itchiness of his scalp after taking a shower.  He thought it might have been from the shampoo that caused it, so he took another shower.  After the 2nd shower the rest of his body started with the extreme itchiness.  It was on his thighs, groin, chest, feet, & the palms of his hands.  Also, the next day he had a lump in his throat that was like a wad of bread that won't go down when swallowing
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Flu-like symptoms; Her arm hurt after first dose; She was tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Her arm hurt after first dose) and FATIGUE (She was tired) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.  No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Her arm hurt after first dose) and FATIGUE (She was tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Her arm hurt after first dose) and FATIGUE (She was tired) 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.  Concomitant information was not provided. Treatment information was not provided.  This case was linked to MOD-2022-439197, MOD-2022-439198, MOD-2022-439188, MOD-2022-438764 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Maternal exposure during breast feeding, Mechanical urticaria, Pruritus, Skin discolouration
Clinical narrative: scalp was really itchy; Dermographism; They're not as bright red or itchy; they're more pink; her sister is breastfeeding; She gets flares and has several on the body going on at the same time; hives that started the night before/pressure hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives that started the night before/pressure hives), PRURITUS (scalp was really itchy), MECHANICAL URTICARIA (Dermographism), DERMATITIS (She gets flares and has several on the body going on at the same time) and SKIN DISCOLOURATION (They're not as bright red or itchy; they're more pink) in a 38-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.     The patient's past medical history included COVID-19.   On 15-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, the patient experienced URTICARIA (hives that started the night before/pressure hives) and DERMATITIS (She gets flares and has several on the body going on at the same time). On an unknown date, the patient experienced PRURITUS (scalp was really itchy), MECHANICAL URTICARIA (Dermographism), SKIN DISCOLOURATION (They're not as bright red or itchy; they're more pink) and MATERNAL EXPOSURE DURING BREAST FEEDING (her sister is breastfeeding). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives that started the night before/pressure hives), PRURITUS (scalp was really itchy), MECHANICAL URTICARIA (Dermographism), DERMATITIS (She gets flares and has several on the body going on at the same time), SKIN DISCOLOURATION (They're not as bright red or itchy; they're more pink) and MATERNAL EXPOSURE DURING BREAST FEEDING (her sister is breastfeeding) outcome was unknown.            No concomitant medication was reported. The patient explained that she has an identical twin sister and they didn't eat the same food, didn't use same detergent, and didn't live in same town. It was unusual for them to have the same physical thing.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: scalp was really itchy; Dermographism; They're not as bright red or itchy; they're more pink; her sister is breastfeeding; She gets flares and has several on the body going on at the same time; hives that started the night before/pressure hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives that started the night before/pressure hives), PRURITUS (scalp was really itchy), MECHANICAL URTICARIA (Dermographism), DERMATITIS (She gets flares and has several on the body going on at the same time) and SKIN DISCOLOURATION (They're not as bright red or itchy; they're more pink) in a 38-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.     The patient's past medical history included COVID-19.   On 15-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, the patient experienced URTICARIA (hives that started the night before/pressure hives) and DERMATITIS (She gets flares and has several on the body going on at the same time). On an unknown date, the patient experienced PRURITUS (scalp was really itchy), MECHANICAL URTICARIA (Dermographism), SKIN DISCOLOURATION (They're not as bright red or itchy; they're more pink) and MATERNAL EXPOSURE DURING BREAST FEEDING (her sister is breastfeeding). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives that started the night before/pressure hives), PRURITUS (scalp was really itchy), MECHANICAL URTICARIA (Dermographism), DERMATITIS (She gets flares and has several on the body going on at the same time), SKIN DISCOLOURATION (They're not as bright red or itchy; they're more pink) and MATERNAL EXPOSURE DURING BREAST FEEDING (her sister is breastfeeding) outcome was unknown.            No concomitant medication was reported. The patient explained that she has an identical twin sister and they didn't eat the same food, didn't use same detergent, and didn't live in same town. It was unusual for them to have the same physical thing.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Freezing phenomenon, Myalgia, Tremor
Clinical narrative: Shaking violently for 4 hours, after booster/Thought he was having a seizure, after booster; Freezing after booster; Body ache from the top of his head to the bottom of his toes after booster; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking violently for 4 hours, after booster/Thought he was having a seizure, after booster), FREEZING PHENOMENON (Freezing after booster) and MYALGIA (Body ache from the top of his head to the bottom of his toes after booster) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 039K20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (Open Heart Surgery 10 years ago.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced TREMOR (Shaking violently for 4 hours, after booster/Thought he was having a seizure, after booster), FREEZING PHENOMENON (Freezing after booster) and MYALGIA (Body ache from the top of his head to the bottom of his toes after booster). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking violently for 4 hours, after booster/Thought he was having a seizure, after booster), FREEZING PHENOMENON (Freezing after booster) and MYALGIA (Body ache from the top of his head to the bottom of his toes after booster) outcome was unknown.     No any concomitant medications were reported. Patient had Pacemaker on 2019. Patient does not had a medical history of seizures.