chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: burning sensation; pain down arm after getting booster; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (burning sensation) and PAIN IN EXTREMITY (pain down arm after getting booster) 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 BURNING SENSATION (burning sensation) and PAIN IN EXTREMITY (pain down arm after getting booster). At the time of the report, BURNING SENSATION (burning sensation) and PAIN IN EXTREMITY (pain down arm after getting booster) 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
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: having mild symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (having mild symptoms) 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 (having mild symptoms). At the time of the report, VACCINATION COMPLICATION (having mild symptoms) 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.   Reporter reported that the patient is confused about getting the booster dose.  No concomitant and treatment drug information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise, Vaccination complication
Clinical narrative: Patient is not feeling well right now; weak; dizzy; having a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having a reaction), MALAISE (Patient is not feeling well right now), ASTHENIA (weak) and DIZZINESS (dizzy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2022, the patient experienced MALAISE (Patient is not feeling well right now). In January 2022, the patient experienced VACCINATION COMPLICATION (having a reaction), ASTHENIA (weak) and DIZZINESS (dizzy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (having a reaction), MALAISE (Patient is not feeling well right now), ASTHENIA (weak) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: complaining of pain in her arm area/upper arm area/lingering sore arm; pain in her shoulder area; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (complaining of pain in her arm area/upper arm area/lingering sore arm) and ARTHRALGIA (pain in her shoulder area) in a 37-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 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In December 2021, the patient experienced VACCINATION SITE PAIN (complaining of pain in her arm area/upper arm area/lingering sore arm) and ARTHRALGIA (pain in her shoulder area). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (complaining of pain in her arm area/upper arm area/lingering sore arm) and ARTHRALGIA (pain in her shoulder area) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Little bit of fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A, 007B21A and 060H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Little bit of fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. In May 2021, PYREXIA (Little bit of fever) had resolved.            It was reported that the patient experienced a little bit of fever the next day after the second shot. Reporter stated that it was around 17 to 18 hours later and it lasted for 24 hours.  No concomitant medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Headache
Clinical narrative: her blood pressure has fluctuated, and was recently 155/102; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (her blood pressure has fluctuated, and was recently 155/102) and HEADACHE (severe headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 047B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Hypertension (patient has a 30 year history of hypertension but no heart disease.) and Immunocompromised. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for Blood pressure, POTASSIUM CHLORIDE (K-TAB), ATENOLOL, MAGNESIUM OXIDE (MAGOX) and FOLIC ACID for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-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. In January 2022, the patient experienced BLOOD PRESSURE FLUCTUATION (her blood pressure has fluctuated, and was recently 155/102) and HEADACHE (severe headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE FLUCTUATION (her blood pressure has fluctuated, and was recently 155/102) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood pressure measurement: 155/102 (High) blood pressure has fluctuated, and was recently 155/102.         It was reported that over the last 4 days she has had a severe headache, her blood pressure has fluctuated, and was recently 155/102.    Patient took Tylenol as needed which has helped but has not make it go away totally  the patient fluctuations had stopped after stopping the chemotherapy but came back after getting the 3rd dose.   This case was linked to MOD-2022-451598 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Mobility decreased, Nasopharyngitis, Vaccination complication
Clinical narrative: He had cold chills and everything; cold chills and everything; sick; He had cold chills and everything; couldn't move, couldn't pick up anything; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't move, couldn't pick up anything), VACCINATION COMPLICATION (He had cold chills and everything), NASOPHARYNGITIS (cold chills and everything), ILLNESS (sick) and CHILLS (He had cold chills and everything) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A, 087A21A and 939905) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-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 05-Jan-2022, the patient experienced MOBILITY DECREASED (couldn't move, couldn't pick up anything). On an unknown date, the patient experienced VACCINATION COMPLICATION (He had cold chills and everything), NASOPHARYNGITIS (cold chills and everything), ILLNESS (sick) and CHILLS (He had cold chills and everything). At the time of the report, MOBILITY DECREASED (couldn't move, couldn't pick up anything), VACCINATION COMPLICATION (He had cold chills and everything), NASOPHARYNGITIS (cold chills and everything), ILLNESS (sick) and CHILLS (He had cold chills and everything) outcome was unknown.            It was reported that the patient was taking diabetes medications.  The patient got the Moderna COVID-19 booster vaccine on 04-Jan-2022 at around 10:00 AM and around 12:00 that night the patient couldn't move and was put in a position where the patient couldn't pick up anything. The patient had cold chills and everything. It made the patient sick.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient given 2 doses for primary and a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given 2 doses for primary and a booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 11-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given 2 doses for primary and a booster dose). On 11-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient given 2 doses for primary and a booster dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: slight symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (slight symptoms) 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 VACCINATION COMPLICATION (slight symptoms). At the time of the report, VACCINATION COMPLICATION (slight symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration error,Moderna vaccine given to a 17 y/o patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: Pfizer on 08-May-2021 and Pfizer on 08-Jun-2021.Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. On 12-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration error,Moderna vaccine given to a 17 y/o patient). On 12-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration error,Moderna vaccine given to a 17 y/o patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported.No treatment details were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving doses from a vial that was taken out the day before; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses from a vial that was taken out the day before) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses from a vial that was taken out the day before). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (receiving doses from a vial that was taken out the day before) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving doses from a vial that was taken out the day before; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses from a vial that was taken out the day before) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses from a vial that was taken out the day before). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (receiving doses from a vial that was taken out the day before) had resolved.        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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Eczema
Clinical narrative: develop eczema and It still had not gone away; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (develop eczema and It still had not gone away) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A20A, 039K20A and 059E21A) 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) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ECZEMA (develop eczema and It still had not gone away). The patient was treated with LOSARTAN for Eczema, at a dose of 50 mg and LISINOPRIL for Eczema, at an unspecified dose and frequency. At the time of the report, ECZEMA (develop eczema and It still had not gone away) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: results not provided Results not provided.         No concomitant information was reported. Patient's weight provided was 160.  Patient stated that after the second shot, he started to develop eczema and hence visited the dermatologist and they did strip testing for allergies and couple injections for a steroid. Patient stated that the eczema has still not reduced and queried whether it was a normal effect. He disclosed that the doctor changed lisinopril to losartan 50mg in hopes that the eczema would reduce, but it did not.
Sex: U
Vaccine: COVID19
Symptoms: Depression, Mental disorder
Clinical narrative: mental breakdown; depression; This spontaneous case was reported by an other health care professional and describes the occurrence of MENTAL DISORDER (mental breakdown) and DEPRESSION (depression) 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 MENTAL DISORDER (mental breakdown) and DEPRESSION (depression). At the time of the report, MENTAL DISORDER (mental breakdown) and DEPRESSION (depression) outcome was unknown.        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.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Nausea
Clinical narrative: was really sick for 6 weeks; Nausea after 2nd dose; Chills after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was really sick for 6 weeks), NAUSEA (Nausea after 2nd dose) and CHILLS (Chills after 2nd dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040321A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-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. In 2021, the patient experienced ILLNESS (was really sick for 6 weeks), NAUSEA (Nausea after 2nd dose) and CHILLS (Chills after 2nd dose). At the time of the report, ILLNESS (was really sick for 6 weeks), NAUSEA (Nausea after 2nd dose) and CHILLS (Chills after 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  Patient has reported treatment for nausea with pills.  Patient removed the consent to check her medical records.   This case was linked to MOD-2022-451817 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2022: Non significant follow up was received which included non significant information in I narrative supplement.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really Sick), NAUSEA (Nausea after booster dose) and CHILLS (Chills after booster dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 040321A- "N4CAC/MC" and 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-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 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Really Sick), NAUSEA (Nausea after booster dose) and CHILLS (Chills after booster dose). At the time of the report, ILLNESS (Really Sick), NAUSEA (Nausea after booster dose) and CHILLS (Chills after booster dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient took pills for some nausea. Concomitant information was not provided. This case was linked to MOD-2022-451798 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2022: Follow-up information includes updated consent information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse effect to the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse effect to the booster shot) in a 63-year-old female patient 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 (adverse effect to the booster shot). At the time of the report, VACCINATION COMPLICATION (adverse effect to the booster shot) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 expired doses administered from a vial greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired doses administered from a vial greater than 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired doses administered from a vial greater than 12 hours post puncture). On 13-Jan-2022, EXPIRED PRODUCT ADMINISTERED (5 expired doses administered from a vial greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial was initially stored in the refrigerator on 10-Jan-2022, it was first punctured on 12-Jan-2022 at 03:45 pm and was kept in the refrigerator after punctured until it was administered. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to the room temperature was 8° to 25°C= 46° to 77°F. It was reported that 4 doses were booster doses and 1 dose was 2nd Moderna vaccine. No treatment medications were reported   This case was linked to MOD-2022-451915 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: starting to feel sick; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (starting to feel sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (starting to feel sick). At the time of the report, MALAISE (starting to feel sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17.5 year-old received first dose vaccine accidentally; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17.5 year-old received first dose vaccine accidentally) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17.5 year-old received first dose vaccine accidentally). On 14-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17.5 year-old received first dose vaccine accidentally) 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.   Reporter stated that she does not have any side effects.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: a little nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (a little nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006DZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced NAUSEA (a little nausea). At the time of the report, NAUSEA (a little nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was reporting some issues that they were experiencing after receiving the Moderna Covid-19 Vaccine. The patient had a little nausea.  No treatment information was provided.   This case was linked to MOD-2022-452013 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: developed hives/breaking out in hives all over; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed hives/breaking out in hives all over) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 027C21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovary.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced URTICARIA (developed hives/breaking out in hives all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and CORTISONE (topical) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (developed hives/breaking out in hives all over) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medication include birth control pills for polycystic ovary. And also reported has no new products added to their routine.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over my body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over my body) 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 third 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash all over my body). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA 12 HOUR) for Rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash all over my body) outcome was unknown.            No concomitant medications were reported.   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Random itching in the back of my neck and behind my ears. Then I notice I start to feel itchy on random parts of my body (arms, legs, chest, neck, butt) and when I itch it big welts start to form (hives). I also have noticed that the palms of my hands turn red and hot. This happens mostly in the morning and at night. Believed to happen more after I eat or go inside my apartment after being outside.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache  Body Aches Chills
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: chronic hives
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: Swollen lymph nodes in left clavicle area.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Feeling hot, Headache, Hyperhidrosis, Pallor
Clinical narrative: She received the 1st COVID vaccine Pfizer Lot #FL8095 exp 05/31/21 at 1440. Around 2:55 PM EMT Noticed the client's mother fanning the client. EMT responded and noticed perspiration above the client's lip and pallor of the client's face.  RN'S responded. The following was obtained with RN translating between Spanish and English. The client reported feeling a headache, hot, and sweaty to RN. Vitals obtained at 2:58PM were as follows: BP 100/60, HR 78, O2 100%. RN noted the client's chest moving, appearing as if the client was catching her breath. The client stated she was crying earlier and denied any trouble breathing. The client's mom stated she last ate breakfast at 10:00 AM. RN provided the client with crackers and a juice. The client began eating the crackers. The client ambulated unassisted with a steady gait to the anti-gravity chair and sat down in a high folwer's position. The client denied any dizziness or nausea while walking. The client continued eating the crackers and drinking the juice. RN noted a decrease in pallor on the client's face. Provided education to the client and her mother regarding possible adverse reactions and when to seek medical care. RN left the scene and Interpreter  responded. The following was obtained with Interpreter translating between Spanish and English. Repeat vitals obtained at 3:12PM were as follows: BP 96/60, HR 72, O2 100%. The client stated that she felt fine and denied any current headache or arm pain. Repeat vitals obtained at 3:22 PM were as follows: BP 96/62, HR 69, O2 100%. The client stated her symptoms had resolved. The client left the vaccination site at 3:23 PM ambulating unassisted with a steady gait.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test negative, Lip swelling, Swelling face
Clinical narrative: swollen lip, or lips.  When waking one very swollen lip. It might be half of one one day. The half or all of another. This happens at least twice weekly for the last 6 months. Always happens in the evening. Have changed all topicals and have been tested for allergies to foods.  Just got booster. Now both lips are swollen, quite large, and my left side of my face is swollen. It is not hot or painful. But I cannot move my lips naturally when this is occuring. That included speaking and closing my lips to drink.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatologic examination, Vitiligo
Clinical narrative: Vitiligo, recently diagnosed 1/11/22 . Lack of pigmentation began initially during summer, progressing to cover larger areas (inside of both arms)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache
Clinical narrative: After 5-10 minutes of injection,  patient complained of headaches and chest tightness. Blood pressure was measured, sbp 160. Patient refused 911 call.  After deep breathing and drinking water, patient felt better.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Headache, Herpes simplex test negative, Non-consummation
Clinical narrative: Acute vulvar ulcers that were bloody and passing presented 1 day after vaccination. Patient was tested for herpes (negative) and denies sexual activity. Covid 19 test was performed to rule out a covid infection. The patient had "normal" vaccination symptoms of headache, extreme body aches, and chills which resolved within 12 hours of vaccination. The vulvar ulcers presented as minor sores on one side which opened up and quickly spread to both sides of the vulva and grew larger and had dark fragile scabs that frequently opened up with puss and blood. The sores grew worse for about 4 days increasing pain in walking and sitting activities. After 4 days the condition stabilized and started to heal up around day 7. The ulcers were gone around day 10. The vaccine is the only change in the patients' health over the time of the adverse event and is thought to have triggered an autoimmune disease.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test negative, Scab, Ulcer haemorrhage, Vulval ulceration
Clinical narrative: Acute vulvar ulcers that were bloody and passing presented 1 day after vaccination. Patient was tested for herpes (negative) and denies sexual activity. Covid 19 test was performed to rule out a covid infection. The patient had "normal" vaccination symptoms of headache, extreme body aches, and chills which resolved within 12 hours of vaccination. The vulvar ulcers presented as minor sores on one side which opened up and quickly spread to both sides of the vulva and grew larger and had dark fragile scabs that frequently opened up with puss and blood. The sores grew worse for about 4 days increasing pain in walking and sitting activities. After 4 days the condition stabilized and started to heal up around day 7. The ulcers were gone around day 10. The vaccine is the only change in the patients' health over the time of the adverse event and is thought to have triggered an autoimmune disease.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: three days of fever. Highest 102.2, vomiting, severe body aches, headache, swollen glands and multiple canker sores in my mouth.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: three days of fever. Highest 102.2, vomiting, severe body aches, headache, swollen glands and multiple canker sores in my mouth.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus, Urticaria
Clinical narrative: Approx 9 days after receiving booster, experienced hives throughout various parts of body that progressively worsened.  Went to urgent care on Jan 15, 2022.  Was given an injection of prednisone, and a 3 day pill prescription.  Currently taking Claritin, Benadryl and prednisone, with vitamin d and zinc.  Some resolution but still experiencing flare ups.  Also immediately after booster, right ear tinnitus and partial hearing loss. Have not seen a doctor for that issue, yet.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: rectal bleeding the following day
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Pruritus, Urticaria
Clinical narrative: Hives on scalp, ears, eyes, neck, arms, hands, torso, buttocks, legs, feet - they appear sporadically with no triggers and remain for 15-20 minutes. They appear in lines, circular patterns, or big welts. Itching feeling is similar to bad mosquito bites. Scratching inflames skin and makes the hives unbearable.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Since December 24- I keep getting extremely itchy skin and hives. The reaction goes away after taking Zyrtec or Allegra but comes back next day. I hope this reaction goes away soon!
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This 17-year-old patient inadvertently received 0.25 mL of Moderna which is approved for 18+. Patient was observed for 15 minutes with no adverse reactions.  This was the third dose for the patient; the first 2 doses were the Pfizer (purple cap) for 12+.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This 14-year-old patient inadvertently received 0.25mL of Moderna approved for 18+. Patient observed for 15 minutes with no adverse reactions. This was the third dose for the patient. The first 2 doses were Pfizer (purple cap) for 12+.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebral thrombosis, Computerised tomogram head abnormal, Death, Headache
Clinical narrative: Headache and Nausea started 01/02/2022; Patient found unresponsive 01/06/2022; CT scan and MRI showed massive blood clot in brain leading  to brain hemorrhage Patient died 01/10/2022
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Nausea, Unresponsive to stimuli
Clinical narrative: Headache and Nausea started 01/02/2022; Patient found unresponsive 01/06/2022; CT scan and MRI showed massive blood clot in brain leading  to brain hemorrhage Patient died 01/10/2022
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling & joint pain on left side of the body with whole body muscle weakness.  Muscle weakness lasted 5 days.  Joint swelling and pain was primarily in knee, elbow & lower leg/heel.  This pain started within 24 hours of vaccination and has been ongoing.  I stared a round of steroids.  This inflammation is totally new and unlike and previous episode of reactive arthritis.  I have not had a reactive arthritis event in over 10 years and take no related medication.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Body aches, headache, nausea, vomiting, fatiqued, sore throat
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Body aches, headache, nausea, vomiting, fatiqued, sore throat
Age: 28.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid positive
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site erythema, Injection site haematoma, Injection site oedema, Limb discomfort
Clinical narrative: Edema and erythema at injection site x 7 days  Hematoma at injection site x 10 days Swelling and knot in axillary/lymph node  area x  7 days Painful and heavy arm x 10 days Bruising x 3 days Treatment: Tylenol, Motrin, and warm compress
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Edema and erythema at injection site x 7 days  Hematoma at injection site x 10 days Swelling and knot in axillary/lymph node  area x  7 days Painful and heavy arm x 10 days Bruising x 3 days Treatment: Tylenol, Motrin, and warm compress
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Bacterial infection, Diarrhoea haemorrhagic
Clinical narrative: Symptoms: abdominal pain after food consumption, followed by bloody diarrhea, in which the blood is brightly red and is separated from the stool. Suspected that it is a bacterial infection based on the symptoms alone.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Hives and Dermatoghraphia that started 10 days after booster shot. The appear all over the body including face, ears and scalp, they do not go away no matter what. Symptoms ease after taking one Zyrtec a day but always return after 24 hours. Mine has been on going for more than two weeks now.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Had menstrual cycle for a month straight.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, COVID-19, Dyspepsia, Fatigue
Clinical narrative: Dose 1: slight nausea for 24hrs Dose 2: slight stomach upset/heartburn/tired Dose 3: intense hives and itching began 10 days after shot. Hives and dermatographia continue to occur multiple times daily/still have not resolved. intense esophageal pain and stomach pain believed to be heart burn or indigestion occurred on days 2-4/5.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oesophageal pain, Pruritus, SARS-CoV-2 test positive, Urticaria
Clinical narrative: Dose 1: slight nausea for 24hrs Dose 2: slight stomach upset/heartburn/tired Dose 3: intense hives and itching began 10 days after shot. Hives and dermatographia continue to occur multiple times daily/still have not resolved. intense esophageal pain and stomach pain believed to be heart burn or indigestion occurred on days 2-4/5.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Pain, Pruritus, Skin irritation
Clinical narrative: Remained asymptomatic after receiving moderna booster.  I was only sore around injection site. Approximately 10 days after receiving the  booster skin reactions and irritation occurred throughout my whole body. My skin felt uncontrollably itchy and after scratching that certain area my skin would flare up in raised red marks.  The red marks/patches would vary in size. Some were more localized and other times they would flare up and cover a larger portion of my body.  Sometimes the itchiness subsides quick but other times the itchiness is incontrollable and painful. There are no signs of a rash or bumps. I have been dealing with this skin reaction for a week now with no improvement. I have been taking Zyrtec daily and using topical hydrocortisone to stop the itching.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction, Skin swelling
Clinical narrative: Remained asymptomatic after receiving moderna booster.  I was only sore around injection site. Approximately 10 days after receiving the  booster skin reactions and irritation occurred throughout my whole body. My skin felt uncontrollably itchy and after scratching that certain area my skin would flare up in raised red marks.  The red marks/patches would vary in size. Some were more localized and other times they would flare up and cover a larger portion of my body.  Sometimes the itchiness subsides quick but other times the itchiness is incontrollable and painful. There are no signs of a rash or bumps. I have been dealing with this skin reaction for a week now with no improvement. I have been taking Zyrtec daily and using topical hydrocortisone to stop the itching.
Age: 0.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 7 month old patient received a dose of Kinrix; received a dose of Kinrix instead of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Kinrix in left thigh. The practice administrator reported a 7 month old patient received a dose of Kinrix instead of Pediarix, which led to  inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was linked with case US2022006656, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022006656:same reporter