chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Somnolence
Clinical narrative: had to sleep a lot; didn't want to eat food; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (had to sleep a lot), DECREASED APPETITE (didn't want to eat food), FATIGUE (tired) and HEADACHE (headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 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. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (had to sleep a lot), DECREASED APPETITE (didn't want to eat food), FATIGUE (tired) and HEADACHE (headache). At the time of the report, SOMNOLENCE (had to sleep a lot), DECREASED APPETITE (didn't want to eat food), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2022-439146, MOD-2022-439198 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: dental abscess; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH ABSCESS (dental abscess) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced TOOTH ABSCESS (dental abscess). The patient was treated with AMOXICILLIN from December 2021 to 15-Dec-2021 for Dental abscess, at a dose of 500 mg. At the time of the report, TOOTH ABSCESS (dental abscess) outcome was unknown.            Dental abscess which was shown in the Xray.  No Concomitant medication was reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration, Nausea
Clinical narrative: Felt light headed for a few minutes after receiving the booster dose; Nauseated for a few minutes after receiving the booster dose; Received booster less than 6 months after the second dose  of the primary series.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed for a few minutes after receiving the booster dose), NAUSEA (Nauseated for a few minutes after receiving the booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster less than 6 months after the second dose  of the primary series.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced DIZZINESS (Felt light headed for a few minutes after receiving the booster dose), NAUSEA (Nauseated for a few minutes after receiving the booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster less than 6 months after the second dose  of the primary series.). On 03-Jan-2022, DIZZINESS (Felt light headed for a few minutes after receiving the booster dose), NAUSEA (Nauseated for a few minutes after receiving the booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster less than 6 months after the second dose  of the primary series.) 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-2022-439261 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: booster vaccine administered from a vial 33 days since it was moved to refrigeration from being frozen; booster vaccine that was administered from a COVID-19 vaccine vial that was still prior to its expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (booster vaccine administered from a vial 33 days since it was moved to refrigeration from being frozen) and EXPIRED PRODUCT ADMINISTERED (booster vaccine that was administered from a COVID-19 vaccine vial that was still prior to its expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) 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 PRODUCT STORAGE ERROR (booster vaccine administered from a vial 33 days since it was moved to refrigeration from being frozen) and EXPIRED PRODUCT ADMINISTERED (booster vaccine that was administered from a COVID-19 vaccine vial that was still prior to its expiration date). At the time of the report, PRODUCT STORAGE ERROR (booster vaccine administered from a vial 33 days since it was moved to refrigeration from being frozen) and EXPIRED PRODUCT ADMINISTERED (booster vaccine that was administered from a COVID-19 vaccine vial that was still prior to its expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Dermographia; Broke into hives all over his body;  noted to pop up and disappear and would re appear in other parts of the body - arms, legs, etc.; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke into hives all over his body;  noted to pop up and disappear and would re appear in other parts of the body - arms, legs, etc.), PRURITUS (Itchy) and MECHANICAL URTICARIA (Dermographia) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 036B21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-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 (Broke into hives all over his body;  noted to pop up and disappear and would re appear in other parts of the body - arms, legs, etc.) and PRURITUS (Itchy). On an unknown date, the patient experienced MECHANICAL URTICARIA (Dermographia). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, URTICARIA (Broke into hives all over his body;  noted to pop up and disappear and would re appear in other parts of the body - arms, legs, etc.), PRURITUS (Itchy) and MECHANICAL URTICARIA (Dermographia) had not resolved.            No concomitant product use was provided.  The patient broke into hives all over his body on either 05-Dec-2021 or 06-Dec-2021. He had an appointment with an immunologist on 4-Jan-2021.   This case was linked to MOD-2022-439286 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pruritus, Tinnitus, Urticaria
Clinical narrative: Incredibly itchy; Developed hives in random places in body, hives behind ears, back of head and neck/reappeared in different parts of the body; Ringing in left ear; Flu-like sickness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Incredibly itchy), URTICARIA (Developed hives in random places in body, hives behind ears, back of head and neck/reappeared in different parts of the body), TINNITUS (Ringing in left ear) and INFLUENZA LIKE ILLNESS (Flu-like sickness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 028L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (Developed hives in random places in body, hives behind ears, back of head and neck/reappeared in different parts of the body) and TINNITUS (Ringing in left ear). December 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like sickness). On an unknown date, the patient experienced PRURITUS (Incredibly itchy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and HYDROCORTISONE for Hives, at an unspecified dose and frequency. In December 2021, TINNITUS (Ringing in left ear) and INFLUENZA LIKE ILLNESS (Flu-like sickness) had resolved. At the time of the report, PRURITUS (Incredibly itchy) outcome was unknown and URTICARIA (Developed hives in random places in body, hives behind ears, back of head and neck/reappeared in different parts of the body) was resolving.            No relevant concomitant medications were reported.  Treatment information included Antihistamines.   This case was linked to MOD-2022-439515 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: The patient felt tired tired after second dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (The patient felt tired tired after second dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced FATIGUE (The patient felt tired tired after second dose). At the time of the report, FATIGUE (The patient felt tired tired after second dose) outcome was unknown.            The patient received her second Moderna Covid-19 vaccine dose in her left arm shoulder deltoid muscle. No treatment information was provided by the reporter. No Concomitant medicines were reported.   This case was linked to MOD-2022-439232, MOD-2022-439271 (Patient Link).   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Sensation of foreign body, Somnolence
Clinical narrative: flu like symptoms; The vaccine felt like it stayed in my right side (right arm and right leg specifically); Since I started eating and got a lot of sleep; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SENSATION OF FOREIGN BODY (The vaccine felt like it stayed in my right side (right arm and right leg specifically)), SOMNOLENCE (Since I started eating and got a lot of sleep) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), SENSATION OF FOREIGN BODY (The vaccine felt like it stayed in my right side (right arm and right leg specifically)), SOMNOLENCE (Since I started eating and got a lot of sleep) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), SENSATION OF FOREIGN BODY (The vaccine felt like it stayed in my right side (right arm and right leg specifically)), SOMNOLENCE (Since I started eating and got a lot of sleep) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. After the first dose the patient had flu like symptoms. Chills. The vaccine felt like it stayed in right side. Right arm and right leg specifically. Since the patient started eating and got a lot of sleep the effects got better. No treatment information provided.   This case was linked to MOD-2022-439232, MOD-2022-439261 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered from vial >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered from vial >12 hours post puncture) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J and J vaccine (First dose). Past adverse reactions to the above products included No adverse event with J and J vaccine.    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 (dose administered from vial >12 hours post puncture). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (dose administered from vial >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The vail was initially stored in refrigerator on 03 JAN 2022 and first punctured on 03 JAN 2022 at 2:10 PM  and administered on 4JAN2022 around 11:00 AM. Vial was stored in room temperature. The vial did not undergo any temperature excursions.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sinusitis
Clinical narrative: She had nerve tingling; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (She had nerve tingling) and SINUSITIS (Sinus infection) 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 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (She had nerve tingling) and SINUSITIS (Sinus infection). The patient was treated with AZITHROMYCIN (Z-PAK) ongoing since an unknown date for Sinus infection, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (She had nerve tingling) had not resolved and SINUSITIS (Sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. Patient stated that the nerve tingling that is ongoing was at random.. The patient was due for the 2nd dose on Monday but cancelled due to sinus infection, said it was mandated to get the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: received a 0.25ml dose as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received a 0.25ml dose as a second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (received a 0.25ml dose as a second dose). At the time of the report, ACCIDENTAL UNDERDOSE (received a 0.25ml dose as a second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: General side effects after 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (General side effects after 1st and 2nd dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (General side effects after 1st and 2nd dose). At the time of the report, VACCINATION COMPLICATION (General side effects after 1st and 2nd dose) outcome was unknown.            Patient stated that she is not on any concomitant medications and it was unspecified after dose-2 or booster dose. Patient stated that the side effects are relatively under control and it was unspecified clearly, whether this side effects belongs to dose-1, 2 side effects or after booster dose side effects. Patient also reported that she got covid as she tested positive on 27Dec2021 and stated is coughing and mentioned that side effects even more frustrating.   This case was linked to MOD-2022-439467, MOD-2022-439047 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received 4 Full doses of the Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received 4 Full doses of the Vaccine) 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.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced EXTRA DOSE ADMINISTERED (received 4 Full doses of the Vaccine). In September 2021, EXTRA DOSE ADMINISTERED (received 4 Full doses of the Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.   This case was linked to MOD-2021-422916 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). In February 2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.            No concomitant medications were reported.  Treatment information was not provided. 12 hours after receiving second dose of vaccine patient had flu like symptoms which lasted for 24 hours.   This case was linked to MOD-2022-439259 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives everywhere on her body, i.e. on her arms, hands, torso, chest, and occasionally on her face.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives everywhere on her body, i.e. on her arms, hands, torso, chest, and occasionally on her face.) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Nov-2021, the patient experienced URTICARIA (Developed hives everywhere on her body, i.e. on her arms, hands, torso, chest, and occasionally on her face.). At the time of the report, URTICARIA (Developed hives everywhere on her body, i.e. on her arms, hands, torso, chest, and occasionally on her face.) outcome was unknown.            Concomitant medication use was unknown. Treatment information was unknown. It was  reported that the patient experienced the symptoms 10 hours after the booster. she was seeing an allergist as well.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives in different part of body; itching in armpit; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives in different part of body) and PRURITUS (itching in armpit) 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 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives in different part of body) and PRURITUS (itching in armpit). At the time of the report, URTICARIA (hives in different part of body) and PRURITUS (itching in armpit) had not resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.  Reporter describes hives in back area which crawl back to chin area   This case was linked to MOD-2022-439506, MOD-2022-439651 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed break down in hives in different part of body.Describes hives in back area which crawl back to chin area. Itching in armpit; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed break down in hives in different part of body.Describes hives in back area which crawl back to chin area.) and PRURITUS (Itching in armpit) 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 URTICARIA (Developed break down in hives in different part of body.Describes hives in back area which crawl back to chin area.) and PRURITUS (Itching in armpit). At the time of the report, URTICARIA (Developed break down in hives in different part of body.Describes hives in back area which crawl back to chin area.) and PRURITUS (Itching in armpit) had not resolved.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2022-439650, MOD-2022-439506 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got Pfizer vaccine and then a third dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer vaccine and then a third dose of Moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant in October 2021. Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included Adverse reaction with Pfizer.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer vaccine and then a third dose of Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer vaccine and then a third dose of Moderna) had resolved.            After the transplant patient did an antigen test, in November 2021 and patient had some immunity, 2.90 or something. patients doctor told to get revaccinated from scratch on the 3rd month since patients transplant.  No concomitant medication was reported.  No treatment medication use was reported
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: really got sick on the 2 shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really got sick on the 2 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really got sick on the 2 shot). At the time of the report, ILLNESS (really got sick on the 2 shot) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment information was provided.  Consumer posted on social media that patient was scared to get booster because patient got really sick after the second shot.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (benign tumor in front of right ear & help fund the process to figure out why mine shrank from the size of a nickel to the size of a BB with someone else's.) 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 THERAPEUTIC RESPONSE UNEXPECTED (benign tumor in front of right ear & help fund the process to figure out why mine shrank from the size of a nickel to the size of a BB with someone else's.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (benign tumor in front of right ear & help fund the process to figure out why mine shrank from the size of a nickel to the size of a BB with someone else's.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on my right lower arm; It is very itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives on my right lower arm) and PRURITUS (It is very itchy) 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 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2022, the patient experienced URTICARIA (Hives on my right lower arm) and PRURITUS (It is very itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on my right lower arm) and PRURITUS (It is very itchy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient got their Moderna booster shot on 30-Dec-2021 in their left arm and on 02-Jan-2021 got hives on their right lower arm and it was very itchy. The patient took Benadryl and said that it doesn't work.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Oesophageal discomfort, Rash, Urticaria
Clinical narrative: experienced something in esophageal cavity; like an air bubble in the chest; On the trunk of her body, they are raised streaks; broke out into hives on her hands,body broke out in hives,delayed urticaria, hives are circles on her face, that are purple; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (broke out into hives on her hands,body broke out in hives,delayed urticaria, hives are circles on her face, that are purple), OESOPHAGEAL DISCOMFORT (experienced something in esophageal cavity), CHEST DISCOMFORT (like an air bubble in the chest) and RASH (On the trunk of her body, they are raised streaks) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2022, the patient experienced URTICARIA (broke out into hives on her hands,body broke out in hives,delayed urticaria, hives are circles on her face, that are purple). On an unknown date, the patient experienced OESOPHAGEAL DISCOMFORT (experienced something in esophageal cavity), CHEST DISCOMFORT (like an air bubble in the chest) and RASH (On the trunk of her body, they are raised streaks). The patient was treated with FAMOTIDINE for Hives, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and TRIAMCINOLONE (topical) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out into hives on her hands,body broke out in hives,delayed urticaria, hives are circles on her face, that are purple), OESOPHAGEAL DISCOMFORT (experienced something in esophageal cavity), CHEST DISCOMFORT (like an air bubble in the chest) and RASH (On the trunk of her body, they are raised streaks) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Peripheral swelling, Vaccination complication
Clinical narrative: Covid arm; Swollen arms; Problems to move; She had some minor knee pain that she attributed to age; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Covid arm), PERIPHERAL SWELLING (Swollen arms), MOBILITY DECREASED (Problems to move) and ARTHRALGIA (She had some minor knee pain that she attributed to age) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Atrial fibrillation.    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, the patient experienced VACCINATION COMPLICATION (Covid arm), PERIPHERAL SWELLING (Swollen arms), MOBILITY DECREASED (Problems to move) and ARTHRALGIA (She had some minor knee pain that she attributed to age). At the time of the report, VACCINATION COMPLICATION (Covid arm), PERIPHERAL SWELLING (Swollen arms), MOBILITY DECREASED (Problems to move) and ARTHRALGIA (She had some minor knee pain that she attributed to age) outcome 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 medications were reported.   This case was linked to MOD-2022-439753, MOD-2021-018093 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Osteoarthritis, Vaccination complication
Clinical narrative: More intense covid arm; Problems whit her knees that she attributed to osteoarthritis.; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (More intense covid arm) and OSTEOARTHRITIS (Problems whit her knees that she attributed to osteoarthritis.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Fibrillation atrial.    On 27-Dec-2021, 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 (More intense covid arm) and OSTEOARTHRITIS (Problems whit her knees that she attributed to osteoarthritis.). At the time of the report, VACCINATION COMPLICATION (More intense covid arm) and OSTEOARTHRITIS (Problems whit her knees that she attributed to osteoarthritis.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported   This case was linked to MOD-2022-439744, MOD-2021-018093 (Patient Link).
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old child may have gotten the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child may have gotten the Moderna vaccine) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FF2589.) for COVID-19 vaccination.  No Medical History information was reported.  On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child may have gotten the Moderna vaccine). On 09-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child may have gotten the Moderna vaccine) had resolved.     it was reported that the caller was the grandfather of a 12 years old granddaughter,patient He realized the previous doses may have come from Pfizer.So they were going to check with the vaccine provider. No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: my lower legs were aching; I experienced severe charlie horse cramping in one leg/It's very painful and has continued for 3 hours/The pain is more intense and feels like it; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (my lower legs were aching) and MUSCLE SPASMS (I experienced severe charlie horse cramping in one leg/It's very painful and has continued for 3 hours/The pain is more intense and feels like it) 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 05-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (my lower legs were aching) and MUSCLE SPASMS (I experienced severe charlie horse cramping in one leg/It's very painful and has continued for 3 hours/The pain is more intense and feels like it). At the time of the report, PAIN IN EXTREMITY (my lower legs were aching) and MUSCLE SPASMS (I experienced severe charlie horse cramping in one leg/It's very painful and has continued for 3 hours/The pain is more intense and feels like it) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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 COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) 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 treatment medications were reported. No Medical History information was reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Cardiac discomfort, Dyspnoea, Headache, Vaccination site pain
Clinical narrative: woke up the next morning with a slight headache; arm was really, really sore; heart was doing some weird things; a couple of weeks before getting second shot, it was hard to take deep breaths; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (heart was doing some weird things), DYSPNOEA (a couple of weeks before getting second shot, it was hard to take deep breaths), HEADACHE (woke up the next morning with a slight headache) and VACCINATION SITE PAIN (arm was really, really sore) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE for Back pain.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (woke up the next morning with a slight headache) and VACCINATION SITE PAIN (arm was really, really sore). In March 2021, the patient experienced CARDIAC DISCOMFORT (heart was doing some weird things) and DYSPNOEA (a couple of weeks before getting second shot, it was hard to take deep breaths). At the time of the report, CARDIAC DISCOMFORT (heart was doing some weird things), DYSPNOEA (a couple of weeks before getting second shot, it was hard to take deep breaths), HEADACHE (woke up the next morning with a slight headache) and VACCINATION SITE PAIN (arm was really, really sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Allergy test: results not provided Results not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported as before getting second shot it was hard to take deep breaths, and her heart was doing some weird things because of that she thought it could be allergies and got allergy testing. Treatment information was not provided by the reporter.   This case was linked to MOD-2022-439863 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Fibrin D dimer, Inflammation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like the patient was going to pass out), CHEST DISCOMFORT (12 hours after second shot, could feel heart rolling in chest), FEELING ABNORMAL (thought the patient was dying), INFLAMMATION (inflammation) and DYSPNOEA (had trouble continuously breathing/could not take a deep breath) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. Concomitant products included HYDROCODONE BITARTRATE (HYDROCODONE [HYDROCODONE BITARTRATE]) for Back pain. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PRESYNCOPE (felt like the patient was going to pass out), CHEST DISCOMFORT (12 hours after second shot, could feel heart rolling in chest) and FEELING ABNORMAL (thought the patient was dying). In April 2021, the patient experienced INFLAMMATION (inflammation) and DYSPNOEA (had trouble continuously breathing/could not take a deep breath). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) from April 2021 to 2021 for Breathing difficult, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLOVENT HFA) from 2021 to 2021 for Adverse event, at an unspecified dose and frequency. In 2021, INFLAMMATION (inflammation) and DYSPNOEA (had trouble continuously breathing/could not take a deep breath) had resolved. At the time of the report, PRESYNCOPE (felt like the patient was going to pass out), CHEST DISCOMFORT (12 hours after second shot, could feel heart rolling in chest) and FEELING ABNORMAL (thought the patient was dying) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: positive (Positive) Positive. On 06-Apr-2021, approximately 12 hours after the administration of the second shot, the patient felt like passing out and heart rolling down in chest. On 07-Apr-2021, the patient felt a little better but a little off. The patient was scared to death due to the booster dose. A couple of weeks after the second shot, the patient did not feel the need to use an inhaler at all. The reaction subsided over weeks after and now the patient does need an inhaler at all. The patient's D dimer was always positive but the patient did not have blood clots so the patient thought that it was caused by inflammation.The patient was scared to get Johnson and Johnson vaccine. The patient did not have factor 5.The patient was never diagnosed with myocarditis or pericarditis nor had a history of it. The patient did not have a history of COVID-19 infection. Flovent HFA was used for a couple of weeks thereafter. This case was linked to MOD-2022-439850, MOD-2022-439943, MOD-2022-439921 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like the patient was going to pass out), CHEST DISCOMFORT (12 hours after second shot, could feel heart rolling in chest), FEELING ABNORMAL (thought the patient was dying), INFLAMMATION (inflammation) and DYSPNOEA (had trouble continuously breathing/could not take a deep breath) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. Concomitant products included HYDROCODONE BITARTRATE (HYDROCODONE [HYDROCODONE BITARTRATE]) for Back pain. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PRESYNCOPE (felt like the patient was going to pass out), CHEST DISCOMFORT (12 hours after second shot, could feel heart rolling in chest) and FEELING ABNORMAL (thought the patient was dying). In April 2021, the patient experienced INFLAMMATION (inflammation) and DYSPNOEA (had trouble continuously breathing/could not take a deep breath). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) from April 2021 to 2021 for Breathing difficult, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLOVENT HFA) from 2021 to 2021 for Adverse event, at an unspecified dose and frequency. In 2021, INFLAMMATION (inflammation) and DYSPNOEA (had trouble continuously breathing/could not take a deep breath) had resolved. At the time of the report, PRESYNCOPE (felt like the patient was going to pass out), CHEST DISCOMFORT (12 hours after second shot, could feel heart rolling in chest) and FEELING ABNORMAL (thought the patient was dying) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: positive (Positive) Positive. On 06-Apr-2021, approximately 12 hours after the administration of the second shot, the patient felt like passing out and heart rolling down in chest. On 07-Apr-2021, the patient felt a little better but a little off. The patient was scared to death due to the booster dose. A couple of weeks after the second shot, the patient did not feel the need to use an inhaler at all. The reaction subsided over weeks after and now the patient does need an inhaler at all. The patient's D dimer was always positive but the patient did not have blood clots so the patient thought that it was caused by inflammation.The patient was scared to get Johnson and Johnson vaccine. The patient did not have factor 5.The patient was never diagnosed with myocarditis or pericarditis nor had a history of it. The patient did not have a history of COVID-19 infection. Flovent HFA was used for a couple of weeks thereafter. This case was linked to MOD-2022-439850, MOD-2022-439943, MOD-2022-439921 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight pain in the arm/experienced slight pain in the vaccinated arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight pain in the arm/experienced slight pain in the vaccinated arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cellulitis and Cancer.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Slight pain in the arm/experienced slight pain in the vaccinated arm). In February 2021, VACCINATION SITE PAIN (Slight pain in the arm/experienced slight pain in the vaccinated arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient is receiving cancer treatment currently. She is also receiving IV treatment for cellulitis. No treatment medications were reported.      This case was linked to MOD-2022-440018, MOD-2022-440019 (Patient Link).