chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Inappropriate schedule of product administration, Lymph node pain
Clinical narrative: Wait a long time after getting the first dose to get the second one; Extreme pain under her arm pit in lymph nodes in left arm, and really painful; Extreme pain under her arm pit in lymph nodes in left arm, and really painful; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Extreme pain under her arm pit in lymph nodes in left arm, and really painful), LYMPH NODE PAIN (Extreme pain under her arm pit in lymph nodes in left arm, and really painful) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wait a long time after getting the first dose to get the second one) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00321-2A and 004D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wait a long time after getting the first dose to get the second one). In January 2022, the patient experienced AXILLARY PAIN (Extreme pain under her arm pit in lymph nodes in left arm, and really painful) and LYMPH NODE PAIN (Extreme pain under her arm pit in lymph nodes in left arm, and really painful). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 13-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wait a long time after getting the first dose to get the second one) had resolved. At the time of the report, AXILLARY PAIN (Extreme pain under her arm pit in lymph nodes in left arm, and really painful) and LYMPH NODE PAIN (Extreme pain under her arm pit in lymph nodes in left arm, and really painful) outcome was unknown.            No Concomitant product use was reported.  The patient received the first dose of the Moderna vaccine on 17-Jul-2021 and second vaccine on 13-Jan-2022. The patient mentioned that they did waited a long time after getting the first dose to get the second one and reported that after the second dose, the patient was experiencing extreme pain under their arm pit in lymph nodes in left arm, and really painful. The patient was taking Tylenol which helped a little and ibuprofen. The patient reported not being on any concomitant medications for any other health conditions. Reportedly, the patient stated that if they feel like it was not getting better, then the patient would reach out to their doctor.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia, Swelling
Clinical narrative: arm soreness; swelling; lymph nodes swelled in her armpit/swelled lymph nodes on her neck and groin/lymph nodes are getting swelled again; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), SWELLING (swelling), PYREXIA (fever) and LYMPHADENOPATHY (lymph nodes swelled in her armpit/swelled lymph nodes on her neck and groin/lymph nodes are getting swelled again) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028k21a, 046b21a and 008b21-2a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-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 PYREXIA (fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness), SWELLING (swelling) and LYMPHADENOPATHY (lymph nodes swelled in her armpit/swelled lymph nodes on her neck and groin/lymph nodes are getting swelled again). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 12-Jan-2022 for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) on 13-Jan-2022 for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), SWELLING (swelling), PYREXIA (fever) and LYMPHADENOPATHY (lymph nodes swelled in her armpit/swelled lymph nodes on her neck and groin/lymph nodes are getting swelled again) outcome was unknown.            No Concomitant medications were provided.  Patient took anti inflammatory and felt better. Patient experienced fever on the 12th and 13th Jan 2022.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Follow up received contains NNI.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Disease, 6 months after 2nd dose; Positive PCR ,6 months after 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 Disease, 6 months after 2nd dose) and DRUG INEFFECTIVE (Positive PCR ,6 months after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021, the patient experienced COVID-19 (COVID-19 Disease, 6 months after 2nd dose). 31-Dec-2021, the patient experienced DRUG INEFFECTIVE (Positive PCR ,6 months after 2nd dose). At the time of the report, COVID-19 (COVID-19 Disease, 6 months after 2nd dose) and DRUG INEFFECTIVE (Positive PCR ,6 months after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.  Company Comment: This case refers to a male patient of unspecified age with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 8 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case refers to a male patient of unspecified age with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 8 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Swelling
Clinical narrative: My neck is swollen; hurting on the side of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING (My neck is swollen) and INJECTION SITE PAIN (hurting on the side of injection) 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 SWELLING (My neck is swollen) and INJECTION SITE PAIN (hurting on the side of injection). At the time of the report, SWELLING (My neck is swollen) and INJECTION SITE PAIN (hurting on the side of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: covid arm; warm; itchy; red circle about 4-5 inches in diameter; not very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and VACCINATION SITE PAIN (not very sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, ENALAPRIL, GABAPENTIN, HYDROCHLOROTHIAZIDE, PROPRANOLOL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and VACCINATION SITE PAIN (not very sore). On 23-Apr-2021, VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and VACCINATION SITE PAIN (not very sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2022-451927, MOD-2022-451928 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Nausea
Clinical narrative: Menstrual issues, two cycles; A little nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUATION IRREGULAR (Menstrual issues, two cycles) and NAUSEA (A little nausea) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 006DZ1A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ASPIRIN [ACETYLSALICYLIC ACID] 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 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (A little nausea). In October 2021, the patient experienced MENSTRUATION IRREGULAR (Menstrual issues, two cycles). At the time of the report, MENSTRUATION IRREGULAR (Menstrual issues, two cycles) and NAUSEA (A little nausea) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that, the patient started having some menstrual issues after receiving the second dose. She states that she had always been regular, but now she had two cycles on Oct-2021, two cycles on Nov-2021 and two cycles on Dec-2021.  No treatment was provided.   This case was linked to MOD-2022-451952 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizziness) 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 DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment information was reported by the reporter.   This case was linked to MOD-2022-452562 (Patient Link).
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Concerning reactions; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Concerning reactions) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (Concerning reactions). At the time of the report, VACCINATION COMPLICATION (Concerning reactions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment details were provided.    This case was linked to MOD-2022-452812, MOD-2022-452775 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 patients received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 patients received expired vaccine) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 patients received expired vaccine). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 patients received expired vaccine) had resolved. Not Provided. 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. It was reported that the original was kept -15 to -25 and then shipped and kept refrigerate. This lot was shipped 06-Dec-2021 and the new expiration date should have been 05-Jan-2022 due to the refrigeration of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Decreased appetite, Headache, Pain in jaw
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of decreased appetite (lost of appetite), pain in jaw (even the jaw hurt), bone pain (bone ache), chills (severe chills) and headache in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced decreased appetite (lost of appetite), pain in jaw (even the jaw hurt), bone pain (bone ache), chills (severe chills) and headache. At the time of the report, decreased appetite (lost of appetite), pain in jaw (even the jaw hurt), bone pain (bone ache), chills (severe chills) and headache outcome: unknown. No concomitant medication or treatment information provided. The patient developed effects from the booster dose of the vaccine and prefers not to take the vaccine again.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: having headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (having headaches) 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 HEADACHE (having headaches). At the time of the report, HEADACHE (having headaches) 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 reported that after receiving the booster, the patient was having headaches. No treatment information was provided. Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Have aches; Chills; Fever we of 102 F; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Have aches), CHILLS (Chills) and PYREXIA (Fever we of 102 F) 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 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PAIN (Have aches), CHILLS (Chills) and PYREXIA (Fever we of 102 F). At the time of the report, PAIN (Have aches), CHILLS (Chills) and PYREXIA (Fever we of 102 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vial sat out at room temperature unpunctured for greater than 12 hours/ gave dose from this vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vial sat out at room temperature unpunctured for greater than 12 hours/ gave dose from this vial) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vial sat out at room temperature unpunctured for greater than 12 hours/ gave dose from this vial). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna vial sat out at room temperature unpunctured for greater than 12 hours/ gave dose from this vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications includes blood pressure medication. No treatment information was provided.  Reporter stated that the vial was initially stored in refrigerator on 12-Jan-2022 and the vial sat out at room temperature unpunctured for greater than 12 hours. It was first punctured on 13-Jan-2022 at 12:15 PM and on 14-Jan-2022 at 11:54 AM it was administered to the patient.   This case was linked to MOD-2022-452549 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pyrexia
Clinical narrative: extreme dizziness, felt like going down; fever of 102 F; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (extreme dizziness, felt like going down) and PYREXIA (fever of 102 F) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M21A) for COVID-19 vaccination.  The patient's past medical history included Ex-smoker. Concurrent medical conditions included Allergy to antibiotic (severe allergy to amoxicillin 12 months ago). Concomitant products included ASCORBIC ACID (VITAMIN-C) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIZZINESS (extreme dizziness, felt like going down) and PYREXIA (fever of 102 F). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (extreme dizziness, felt like going down) and PYREXIA (fever of 102 F) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102 f (High) 102 F, high.   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.  This case was linked to MOD-2022-452561, MOD-2022-452562 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Same dizzy feeling, but not as bad as the 1st one; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Same dizzy feeling, but not as bad as the 1st one) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M21A) for COVID-19 vaccination.     The patient's past medical history included Cessation of smoking (couple years ago). Concurrent medical conditions included Drug allergy (Allergy to amoxicillin 12 months ago). Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Same dizzy feeling, but not as bad as the 1st one). The patient was treated with IBUPROFEN for Dizzy, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Same dizzy feeling, but not as bad as the 1st one) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient asked whether dizziness was one of an allergic reactions because the patient had allergy to amoxicillin 12 months ago, which she never had before and was wondering if the allergy caused hypersensitivity to the vaccine.   This case was linked to MOD-2022-452546, MOD-2022-452562 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: a sore throat; slight head acce; This spontaneous case was reported by a pharmacist and describes the occurrence of OROPHARYNGEAL PAIN (a sore throat) and HEADACHE (slight head acce) 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 OROPHARYNGEAL PAIN (a sore throat) and HEADACHE (slight head acce). At the time of the report, OROPHARYNGEAL PAIN (a sore throat) and HEADACHE (slight head acce) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Blood pressure went up/high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure went up/high blood pressure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2022, the patient experienced HYPERTENSION (Blood pressure went up/high blood pressure). At the time of the report, HYPERTENSION (Blood pressure went up/high blood pressure) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2022, Blood pressure measurement: high (High) Result Patient reported high blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided. patient was antivaxxer
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes are swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (lymph nodes are swollen) 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 LYMPHADENOPATHY (lymph nodes are swollen). At the time of the report, LYMPHADENOPATHY (lymph nodes are swollen) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient got the booster on Thursday evening. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Sleep disorder, Tinnitus
Clinical narrative: real high blood pressure,my heart rate was elevated real high; severe ringing in ears. It was super loud and freaked me out; still waking up two or three times a night with severe ringing in my ear; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE MEASUREMENT (real high blood pressure,my heart rate was elevated real high), TINNITUS (severe ringing in ears. It was super loud and freaked me out) and SLEEP DISORDER (still waking up two or three times a night with severe ringing in my ear) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 045A21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE MEASUREMENT (real high blood pressure,my heart rate was elevated real high), TINNITUS (severe ringing in ears. It was super loud and freaked me out) and SLEEP DISORDER (still waking up two or three times a night with severe ringing in my ear). At the time of the report, BLOOD PRESSURE MEASUREMENT (real high blood pressure,my heart rate was elevated real high), TINNITUS (severe ringing in ears. It was super loud and freaked me out) and SLEEP DISORDER (still waking up two or three times a night with severe ringing in my ear) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had heart monitor test and adrenal test. Two days later same thing (ringing etc) happened again and again. From JAN until today patient had blood pressure thing which not got so high. Cardiac lab values(ECG,cardiac test,cardiac enzymes)reported and they did base one twice and wore heart monitor two days and don't had results. They increased blood pressure medication. concomitant medications include blood pressure medication  Treatment medication was not provided.   This case was linked to MOD-2022-452826 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Bronchitis, Illness, Upper respiratory tract infection
Clinical narrative: Upper Respiratory Infection; bronchitis; sick a lot; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), BRONCHITIS (bronchitis) and ILLNESS (sick a lot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (high anxiety).    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), BRONCHITIS (bronchitis) and ILLNESS (sick a lot). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), BRONCHITIS (bronchitis) and ILLNESS (sick a lot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not provided.  Reported that patient couldn't get flu shot because of sickness.   This case was linked to MOD-2022-452729 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (a vaccine given two days after the expiration date) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19  immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (a vaccine given two days after the expiration date). At the time of the report, administered expired product (a vaccine given two days after the expiration date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination site bruising, Vaccination site erythema, Vaccination site haemorrhage
Clinical narrative: Nowit is like a bleed; fingers were tingling and this was also very painful; fingers were tingling; now it is more like a bigger bruise; a red circle on the lower inside part of the arm of the injection; it is painful/hurts so bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Nowit is like a bleed), PAIN IN EXTREMITY (fingers were tingling and this was also very painful), PARAESTHESIA (fingers were tingling), VACCINATION SITE BRUISING (now it is more like a bigger bruise) and VACCINATION SITE ERYTHEMA (a red circle on the lower inside part of the arm of the injection) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.    On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION SITE HAEMORRHAGE (Nowit is like a bleed), PAIN IN EXTREMITY (fingers were tingling and this was also very painful), PARAESTHESIA (fingers were tingling), VACCINATION SITE BRUISING (now it is more like a bigger bruise), VACCINATION SITE ERYTHEMA (a red circle on the lower inside part of the arm of the injection) and VACCINATION SITE PAIN (it is painful/hurts so bad). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE HAEMORRHAGE (Nowit is like a bleed), PAIN IN EXTREMITY (fingers were tingling and this was also very painful), PARAESTHESIA (fingers were tingling), VACCINATION SITE BRUISING (now it is more like a bigger bruise), VACCINATION SITE ERYTHEMA (a red circle on the lower inside part of the arm of the injection) and VACCINATION SITE PAIN (it is painful/hurts so bad) outcome was unknown.            Other concomitant medications included birth control medication and unknown another medicine. The patient  got the booster from Moderna last Friday and a few hours later developed a red circle on the lower inside part of the arm of the injection, Now it was more like a bigger bruise, like a bleed and it was painful and hurts so bad the patient was crying last night. Also state the patient's fingers were tingling and this was also very painful. It was reported that the first and second doses might had been administered at the patient's place of work early on, might be last winter since the patient is a nursing aid. Reporter was concerned that it might be a blood clot.   This case was linked to MOD-2022-452965 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Nowit is like a bleed; fingers were tingling and this was also very painful; fingers were tingling; now it is more like a bigger bruise; a red circle on the lower inside part of the arm of the injection; it is painful/hurts so bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Nowit is like a bleed), PAIN IN EXTREMITY (fingers were tingling and this was also very painful), PARAESTHESIA (fingers were tingling), VACCINATION SITE BRUISING (now it is more like a bigger bruise) and VACCINATION SITE ERYTHEMA (a red circle on the lower inside part of the arm of the injection) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.    On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION SITE HAEMORRHAGE (Nowit is like a bleed), PAIN IN EXTREMITY (fingers were tingling and this was also very painful), PARAESTHESIA (fingers were tingling), VACCINATION SITE BRUISING (now it is more like a bigger bruise), VACCINATION SITE ERYTHEMA (a red circle on the lower inside part of the arm of the injection) and VACCINATION SITE PAIN (it is painful/hurts so bad). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE HAEMORRHAGE (Nowit is like a bleed), PAIN IN EXTREMITY (fingers were tingling and this was also very painful), PARAESTHESIA (fingers were tingling), VACCINATION SITE BRUISING (now it is more like a bigger bruise), VACCINATION SITE ERYTHEMA (a red circle on the lower inside part of the arm of the injection) and VACCINATION SITE PAIN (it is painful/hurts so bad) outcome was unknown.            Other concomitant medications included birth control medication and unknown another medicine. The patient  got the booster from Moderna last Friday and a few hours later developed a red circle on the lower inside part of the arm of the injection, Now it was more like a bigger bruise, like a bleed and it was painful and hurts so bad the patient was crying last night. Also state the patient's fingers were tingling and this was also very painful. It was reported that the first and second doses might had been administered at the patient's place of work early on, might be last winter since the patient is a nursing aid. Reporter was concerned that it might be a blood clot.   This case was linked to MOD-2022-452965 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Bronchitis, Illness, Upper respiratory tract infection
Clinical narrative: sick; Upper Respiratory Infection; bronchitis; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), BRONCHITIS (bronchitis) and ANXIETY (Anxiety) 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.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (sick), UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), BRONCHITIS (bronchitis) and ANXIETY (Anxiety). At the time of the report, ILLNESS (sick), UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), BRONCHITIS (bronchitis) and ANXIETY (Anxiety) outcome was unknown.            No concomitant medications were reported by reporter.  No treatment information provided.   This case was linked to MOD-2022-452712 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives/patient started to experience hives on his legs and knees; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/patient started to experience hives on his legs and knees) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045j21a) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.   On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (Hives/patient started to experience hives on his legs and knees). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) for Adverse event, at a dose of 1 dosage form; HYDROCORTISONE for Adverse event, at a dose of 1 dosage form; MICONAZOLE NITRATE (LOTRIMIN AF ANTIFUNGAL) for Adverse event, at a dose of 1 dosage form and UNDECYLENIC ACID (WALGREENS ANTI FUNGAL) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives/patient started to experience hives on his legs and knees) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient was  treated  adverse event  with over-the-counter medicines and was not recovered
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patients under 18 years of age got a booster dose from Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patients under 18 years of age got a booster dose from Moderna) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine and Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patients under 18 years of age got a booster dose from Moderna). On 08-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patients under 18 years of age got a booster dose from Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Had an issue with my toe nails on 6 of my 10 nails,I had the moderna booster anw my toenails are clearing up; This spontaneous case was reported by an other health care professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Had an issue with my toe nails on 6 of my 10 nails,I had the moderna booster anw my toenails are clearing up) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nail discomfort.    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 THERAPEUTIC RESPONSE UNEXPECTED (Had an issue with my toe nails on 6 of my 10 nails,I had the moderna booster anw my toenails are clearing up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Had an issue with my toe nails on 6 of my 10 nails,I had the moderna booster anw my toenails are clearing up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment details were provided.  Patient had an issue with her toe nails, on 6 of 10 nails and tried everything without any luck. Patient reported that her toenails are clearing up after having booster dose.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 patients under 18 years of age got a booster dose from Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 patients under 18 years of age got a booster dose from Moderna) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (DOSE-2) and PFIZER BIONTECH COVID-19 VACCINE (DOSE-1). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 patients under 18 years of age got a booster dose from Moderna). On 08-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 patients under 18 years of age got a booster dose from Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients had previously received the 2 doses of the Pfizer vaccine and moderna as booster dose No concomitant and treatment information were reported by the reporter
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Product administered to patient of inappropriate age
Clinical narrative: mild sore arm (after 1st dose); Patient received vaccine at the age of 14; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (mild sore arm (after 1st dose)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received vaccine at the age of 14) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 54615) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included DEXMETHYLPHENIDATE HYDROCHLORIDE (FOCALIN XR ER) for ADHD, GUAIFENESIN and MELATONIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced MYALGIA (mild sore arm (after 1st dose)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received vaccine at the age of 14). On 15-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received vaccine at the age of 14) had resolved. At the time of the report, MYALGIA (mild sore arm (after 1st dose)) 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 medication details were reported.   This case was linked to MOD-2022-452812, MOD-2022-452102 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: low grade fever on and off for over a week; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (low grade fever on and off for over a week) and HEADACHE (headache) 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 PYREXIA (low grade fever on and off for over a week) and HEADACHE (headache). At the time of the report, PYREXIA (low grade fever on and off for over a week) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.