chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Headache, Mobility decreased, Nausea
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (can't lift arm, can't put pressure on it), VACCINATION SITE PAIN (extreme left arm pain), PAIN IN EXTREMITY (can bend it but it hurts when bent, body aches on the feet), VOMITING (threw up water) and NAUSEA (nauseous) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5714B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Fruit allergy (Allergic to mango), Reaction to monosodium glutamate and Allergy to plants (Allergic to sage). On 15-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced MOBILITY DECREASED (can't lift arm, can't put pressure on it), VACCINATION SITE PAIN (extreme left arm pain), PAIN IN EXTREMITY (can bend it but it hurts when bent, body aches on the feet), VOMITING (threw up water), NAUSEA (nauseous), HEADACHE (extreme pain at the back of the head and this is not the regular headache), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (body aches on the hip). At the time of the report, MOBILITY DECREASED (can't lift arm, can't put pressure on it), VACCINATION SITE PAIN (extreme left arm pain), PAIN IN EXTREMITY (can bend it but it hurts when bent, body aches on the feet), VOMITING (threw up water), NAUSEA (nauseous), HEADACHE (extreme pain at the back of the head and this is not the regular headache), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (body aches on the hip) had not resolved. No relevant concomitant medications were reported. On 29-JAN-2021, patient received first dose of Moderna vaccine, lot number 007M20A. On 25-FEB-2021, patient received second dose of Moderna vaccine, lot number 010A21A. On 17-DEC-2021, patient received third dose (first booster dose) of Moderna vaccine, lot number 013F21A. It was reported that AE dose not cause patient to seek medical care and patient does not experienced a similar event in the past. Treatment medication was not provided by the reporter. Reporter did not allow further contact.
Sex: U
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (can't lift arm, can't put pressure on it), VACCINATION SITE PAIN (extreme left arm pain), PAIN IN EXTREMITY (can bend it but it hurts when bent, body aches on the feet), VOMITING (threw up water) and NAUSEA (nauseous) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5714B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Fruit allergy (Allergic to mango), Reaction to monosodium glutamate and Allergy to plants (Allergic to sage). On 15-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced MOBILITY DECREASED (can't lift arm, can't put pressure on it), VACCINATION SITE PAIN (extreme left arm pain), PAIN IN EXTREMITY (can bend it but it hurts when bent, body aches on the feet), VOMITING (threw up water), NAUSEA (nauseous), HEADACHE (extreme pain at the back of the head and this is not the regular headache), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (body aches on the hip). At the time of the report, MOBILITY DECREASED (can't lift arm, can't put pressure on it), VACCINATION SITE PAIN (extreme left arm pain), PAIN IN EXTREMITY (can bend it but it hurts when bent, body aches on the feet), VOMITING (threw up water), NAUSEA (nauseous), HEADACHE (extreme pain at the back of the head and this is not the regular headache), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (body aches on the hip) had not resolved. No relevant concomitant medications were reported. On 29-JAN-2021, patient received first dose of Moderna vaccine, lot number 007M20A. On 25-FEB-2021, patient received second dose of Moderna vaccine, lot number 010A21A. On 17-DEC-2021, patient received third dose (first booster dose) of Moderna vaccine, lot number 013F21A. It was reported that AE dose not cause patient to seek medical care and patient does not experienced a similar event in the past. Treatment medication was not provided by the reporter. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: pressure on her chest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST DISCOMFORT (pressure on her chest) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (pressure on her chest). At the time of the report, CHEST DISCOMFORT (pressure on her chest) outcome was unknown.            Concomitant medication details were not reported by the reporter.  The reporter stated her mother got something similar. The patient felt it in a dream that had pressure on the chest and was trying to get the pressure off.  Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles) in an  male patient who received mRNA-1273 (MODERNA COVID-19 VACCINE,  for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Sep-2022, the patient received dose of mRNA-1273(MODERNA COVID-19 VACCINE, (ORIGINAL AND  (unknown route) .5 milliliter. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.      For mRNA-1273 (MODERNA COVID-19 VACCINE, (Unknown), the reporter did not provide any causality assessments.   The patient's age was given as approximate 70 years.  No concomitant medications was reported.  No treatment drug details was reported.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, COVID-19 immunisation, Eye pruritus, Fatigue, Headache
Clinical narrative: revaccination with different covid-19 vaccine; interchange of vaccine products; back pain; sore arm; fatigue; headache; muscle ache; itchy eyes/right eye was itchy/both eyes are itching; eyelid is swollen; This spontaneous case was reported by a patient and describes the occurrence of EYE PRURITUS (itchy eyes/right eye was itchy/both eyes are itching), SWELLING OF EYELID (eyelid is swollen), COVID-19 IMMUNISATION (revaccination with different covid-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and BACK PAIN (back pain) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7149B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had not event COVID + test or diagnosis. The patient had not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: pfizer (1st dose (She had very mild side effects with Pfizer doses. She might have had fatigue and headache)), pfizer (booster dose (no side effects from the booster dose)) and pfizer (2nd dose (She had very mild side effects with Pfizer doses. She might have had fatigue and headache)). Past adverse reactions to the above products included Adverse event with pfizer and pfizer; and No adverse event with pfizer. Concurrent medical conditions included Allergy to antibiotic (Allergies: trimethoprim).    On 13-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Sep-2022, the patient experienced BACK PAIN (back pain), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle ache). In September 2022, the patient experienced EYE PRURITUS (itchy eyes/right eye was itchy/both eyes are itching) and SWELLING OF EYELID (eyelid is swollen). On an unknown date, the patient experienced COVID-19 IMMUNISATION (revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). On 13-Sep-2022, BACK PAIN (back pain), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle ache) had resolved. At the time of the report, EYE PRURITUS (itchy eyes/right eye was itchy/both eyes are itching) and SWELLING OF EYELID (eyelid is swollen) had not resolved and COVID-19 IMMUNISATION (revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.            No concomitant medications were reported.  The patient had not experienced a similar event in the past.  It was reported that the patient called eye doctor, who said it's probably a reaction to the vaccine. That's why the patient looked online and read that it was not recommended to take Benadryl, but hoped Benadryl will help with the itching eyes.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration, Needle issue
Clinical narrative: needle broke up and patient had half the dose; Vaccine was administered after 36 days from first vaccination; needle broke up and patient had half the dose; This spontaneous case was reported by a medical assistant and describes the occurrence of NEEDLE ISSUE (needle broke up and patient had half the dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered after 36 days from first vaccination) and ACCIDENTAL UNDERDOSE (needle broke up and patient had half the dose) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 061B22A and 927B21A) for COVID-19 vaccination.     It was reported that patient had no allergies, not had COVID  test or diagnosis, no acute and chronic illnesses at the time of vaccination.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 15-Sep-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .25 milliliter. On 15-Sep-2022, the patient experienced NEEDLE ISSUE (needle broke up and patient had half the dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered after 36 days from first vaccination) and ACCIDENTAL UNDERDOSE (needle broke up and patient had half the dose). At the time of the report, NEEDLE ISSUE (needle broke up and patient had half the dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered after 36 days from first vaccination) and ACCIDENTAL UNDERDOSE (needle broke up and patient had half the dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was reported that patient administered 0.5ml (Intramuscular) dose of Moderna Pfizer Johnson and Johnson. No treatment medication were provided.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sleep disorder, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: having a Hard time sleeping.; Patient can hardly move her arm; left arm is very sore and painful after her first bivalent booster dose/Pain is 8 or 9 out of 10; This spontaneous case was reported by a patient and describes the occurrence of SLEEP DISORDER (having a hard time sleeping.), VACCINATION SITE MOVEMENT IMPAIRMENT (Patient can hardly move her arm) and VACCINATION SITE PAIN (left arm is very sore and painful after her first bivalent booster dose/Pain is 8 or 9 out of 10) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Sep-2022, the patient experienced SLEEP DISORDER (having a Hard of a time sleeping.), VACCINATION SITE MOVEMENT IMPAIRMENT (Patient can hardly move her arm) and VACCINATION SITE PAIN (left arm is very sore and painful after her first bivalent booster dose/Pain is 8 or 9 out of 10). At the time of the report, SLEEP DISORDER (having a Hard of a time sleeping.), VACCINATION SITE MOVEMENT IMPAIRMENT (Patient can hardly move her arm) and VACCINATION SITE PAIN (left arm is very sore and painful after her first bivalent booster dose/Pain is 8 or 9 out of 10) outcome was unknown.            Patient received 1st dose on 23-Jan-2021 with lot number 005C21A. Patient received 2nd dose on 20-Feb-2021 with lot number 007M20A. Patient received 1st booster on 26-Oct-2021 with lot number 939903. Patient received 2nd booster on 01-Apr-2022 with lot number 048L21A. The patient received all of the doses in the left arm. Concomitant medication list was not provided. Treatment information was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2022: Live follow up received: added batch lot number.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: No adverse event; potentially given the wrong type of vaccine; potentially given the wrong type of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (potentially given the wrong type of vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (potentially given the wrong type of vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (potentially given the wrong type of vaccine). On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (potentially given the wrong type of vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (potentially given the wrong type of vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (potentially given the wrong type of vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that, the vaccine provider stated that they were given the vaccine for the 12 years and up.  Treatment information was not provided.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: aches and pain; fever; lingering headache; lingering nausea; This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches and pain), PYREXIA (fever), HEADACHE (lingering headache) and NAUSEA (lingering nausea) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Asplenia (15 years ago), Idiopathic thrombocytopenic purpura and Immunocompromised.    On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced PAIN (aches and pain), PYREXIA (fever), HEADACHE (lingering headache) and NAUSEA (lingering nausea). On 13-Sep-2022, PAIN (aches and pain) and PYREXIA (fever) had resolved. At the time of the report, HEADACHE (lingering headache) and NAUSEA (lingering nausea) had not resolved.            Concomitant products were not reported.  It was reported that patient did not have any allergies to medications, food and other products.  Patient received Moderna 1st dose on 06-Jan-2021, lot number - 012L20, 2nd dose on 02-Feb-2021, lot number - 010M20A, 1st booster dose on 19-Aug-2021, lot number - 049E21A, 2nd booster dose on 28-Mar-2022, lot number - 066K21A. The event did not cause the patient to seek medical care. The symptoms are still lingering.  Treatment medications were not reported.   This case was linked to MOD-2022-647031 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Inappropriate schedule of product administration
Clinical narrative: atrial fibrillation; First dose taken on 30Jan2021 and second dose taken on 22Feb2021; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007MC08) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoporosis.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 30Jan2021 and second dose taken on 22Feb2021). In March 2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Atrial fibrillation, at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 30Jan2021 and second dose taken on 22Feb2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The patient was wearing a heart monitor.  Company comment- This spontaneous case concerns a 75-year-old female patient with no relevant medical history, who experienced unexpected, serious (medically significant) AESI Atrial fibrillation, which occurred a few weeks after vaccination of a second dose of mRNA-1273. The interval between the first and second dose is 23 days, hence Inappropriate schedule of product administration was also captured as an event. The patient reported that she is currently taking Eliquis (Apixaban) and has a heart monitor. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-647013.; Sender's Comments: This spontaneous case concerns a 75-year-old female patient with no relevant medical history, who experienced unexpected, serious (medically significant) AESI Atrial fibrillation, which occurred a few weeks after vaccination of a second dose of mRNA-1273. The interval between the first and second dose is 23 days, hence Inappropriate schedule of product administration was also captured as an event. The patient reported that she is currently taking Eliquis (Apixaban) and has a heart monitor. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Immunocompromised patient received first booster after second dose; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (Immunocompromised patient received first booster after second dose) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 010M20A and 012L20A) for COVID-19 vaccination.     Patient did not had allergies to medications, food and other products.  Previously administered products included for Product used for unknown indication: Flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Asplenia (15 years ago), Idiopathic thrombocytopenic purpura and Immunocompromised.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Immunocompromised patient received first booster after second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Immunocompromised patient received first booster after second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to MOD-2022-647028 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Eye pruritus, Fatigue, Headache, Myalgia
Clinical narrative: Eyes lids are swollen; Eyes are itching; Back pain; Fatigue; Headache; Muscle ache; Sore arm at the injection site; This spontaneous case was reported by a patient and describes the occurrence of SWELLING OF EYELID (Eyes lids are swollen), EYE PRURITUS (Eyes are itching), BACK PAIN (Back pain), FATIGUE (Fatigue) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Patient had 3 doses of Pfizer previously.). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING OF EYELID (Eyes lids are swollen), EYE PRURITUS (Eyes are itching), BACK PAIN (Back pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, SWELLING OF EYELID (Eyes lids are swollen), EYE PRURITUS (Eyes are itching), BACK PAIN (Back pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.            Concomitant medication details were not reported by the reporter. Reporter wanted to know if patient could take Benadryl or was there anything else Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Vaccination site pain
Clinical narrative: Eyes lids are swollen; Eyes are itching; Back pain; Fatigue; Headache; Muscle ache; Sore arm at the injection site; This spontaneous case was reported by a patient and describes the occurrence of SWELLING OF EYELID (Eyes lids are swollen), EYE PRURITUS (Eyes are itching), BACK PAIN (Back pain), FATIGUE (Fatigue) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Patient had 3 doses of Pfizer previously.). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING OF EYELID (Eyes lids are swollen), EYE PRURITUS (Eyes are itching), BACK PAIN (Back pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, SWELLING OF EYELID (Eyes lids are swollen), EYE PRURITUS (Eyes are itching), BACK PAIN (Back pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.            Concomitant medication details were not reported by the reporter. Reporter wanted to know if patient could take Benadryl or was there anything else Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Nausea, Pyrexia, Vaccination site bruising
Clinical narrative: arm appeared to be more red; fever of 101.5F; Nauseated; started to become foggy; my arm appeared swollen; my arm appeared bruised; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (my arm appeared bruised), FEELING ABNORMAL (started to become foggy), VACCINATION SITE SWELLING (my arm appeared swollen), VACCINATION SITE ERYTHEMA (arm appeared to be more red) and PYREXIA (fever of 101.5F) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7410C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced VACCINATION SITE BRUISING (my arm appeared bruised) and VACCINATION SITE SWELLING (my arm appeared swollen). On 15-Sep-2022 at 4:00 PM, the patient experienced FEELING ABNORMAL (started to become foggy) and NAUSEA (Nauseated). On 15-Sep-2022 at 7:00 PM, the patient experienced PYREXIA (fever of 101.5F). On 16-Sep-2022, the patient experienced VACCINATION SITE ERYTHEMA (arm appeared to be more red). The patient was treated with ACETAMINOPHEN on 15-Sep-2022 at a dose of 500 milligram twice a day. At the time of the report, VACCINATION SITE BRUISING (my arm appeared bruised) and VACCINATION SITE SWELLING (my arm appeared swollen) had not resolved and FEELING ABNORMAL (started to become foggy), VACCINATION SITE ERYTHEMA (arm appeared to be more red), PYREXIA (fever of 101.5F) and NAUSEA (Nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2022, Body temperature: 101.5 fever of 101.5F, At 19:00. On 16-Sep-2022, Body temperature: 101 In morning, fever of 101F.         No concomitant medication were reported.  It was reported that the patient did not experience any adverse event within 15 min of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2022: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: arm appeared to be more red; fever of 101.5F; Nauseated; started to become foggy; my arm appeared swollen; my arm appeared bruised; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (my arm appeared bruised), FEELING ABNORMAL (started to become foggy), VACCINATION SITE SWELLING (my arm appeared swollen), VACCINATION SITE ERYTHEMA (arm appeared to be more red) and PYREXIA (fever of 101.5F) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7410C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced VACCINATION SITE BRUISING (my arm appeared bruised) and VACCINATION SITE SWELLING (my arm appeared swollen). On 15-Sep-2022 at 4:00 PM, the patient experienced FEELING ABNORMAL (started to become foggy) and NAUSEA (Nauseated). On 15-Sep-2022 at 7:00 PM, the patient experienced PYREXIA (fever of 101.5F). On 16-Sep-2022, the patient experienced VACCINATION SITE ERYTHEMA (arm appeared to be more red). The patient was treated with ACETAMINOPHEN on 15-Sep-2022 at a dose of 500 milligram twice a day. At the time of the report, VACCINATION SITE BRUISING (my arm appeared bruised) and VACCINATION SITE SWELLING (my arm appeared swollen) had not resolved and FEELING ABNORMAL (started to become foggy), VACCINATION SITE ERYTHEMA (arm appeared to be more red), PYREXIA (fever of 101.5F) and NAUSEA (Nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2022, Body temperature: 101.5 fever of 101.5F, At 19:00. On 16-Sep-2022, Body temperature: 101 In morning, fever of 101F.         No concomitant medication were reported.  It was reported that the patient did not experience any adverse event within 15 min of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2022: Follow up received contains no new information.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I had a fever; A sore arm near the injection site; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (I had a fever) and PAIN IN EXTREMITY (A sore arm near the injection site) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 14-Sep-2022 at 5:15 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 15-Sep-2022 at 12:00 PM, the patient experienced PYREXIA (I had a fever) and PAIN IN EXTREMITY (A sore arm near the injection site). The patient was treated with ACETAMINOPHEN for Fever and Vaccination site pain, at an unspecified dose and frequency. In September 2022, PYREXIA (I had a fever) and PAIN IN EXTREMITY (A sore arm near the injection site) had resolved.            Patient received booster dose.  No concomitant medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient had a bad reaction after getting first shot of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient had a bad reaction after getting first shot of the Moderna COVID-19 Vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had a bad reaction after getting first shot of the Moderna COVID-19 Vaccine). At the time of the report, IMMUNISATION REACTION (Patient had a bad reaction after getting first shot of the Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever/child experienced similar symptoms during last COVID-19 Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever/child experienced similar symptoms during last COVID-19 Moderna vaccine) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     Patient had no acute illnesses at the time of vaccination and up to one month before. Patient had no prescriptions, over the counter medications, dietary supplements, or herbal remedies  which was being taken at time of vaccination and/ or at the time of the adverse event.  The patient's past medical history included COVID-19 on 13-Jan-2022 and Premature baby 26 to 32 weeks (Premature infant of 29 week gestation).    On 15-Jul-2022 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In 2022, the patient experienced PYREXIA (Fever/child experienced similar symptoms during last COVID-19 Moderna vaccine). At the time of the report, PYREXIA (Fever/child experienced similar symptoms during last COVID-19 Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     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.   Patient race was reported. No concomitant medication was reported. It was reported that patient parents shared that he experienced fever the evening after the vaccine was administered. Fever resolved by the next day after given Tylenol. Patient mom mentioned the child experienced similar symptoms during last COVID-19 Moderna vaccine.  No treatment medication was reported in first dose case of the patient.   This case was linked to MOD-2022-628903 (Patient Link).
Age: 1.42
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) in a 17-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis. Patient was never been diagnosed with or tested positive for COVID-19. Patient did not had any acute illness at the time of vaccination and up to one month before. Patient did not had any chronic or long-standing health conditions. On 08-Jul-2022 at 2:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In 2022, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. 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. Patient race was reported as "Private". No concomitant medications were reported. The site of administration was reported as RVL. No treatment information was reported. This case was linked to MOD-2022-628906 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Eye swelling, Periorbital swelling, Pruritus
Clinical narrative: Eyes swollen; Eyes puffy; Her arm got itchy after vaccination; This spontaneous case was reported by a patient and describes the occurrence of EYE SWELLING (Eyes swollen), PERIORBITAL SWELLING (Eyes puffy) and PRURITUS (Her arm got itchy after vaccination) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Patient had no allergies.     On 18-Sep-2022 at 12:45 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Sep-2022, the patient experienced EYE SWELLING (Eyes swollen), PERIORBITAL SWELLING (Eyes puffy) and PRURITUS (Her arm got itchy after vaccination). At the time of the report, EYE SWELLING (Eyes swollen), PERIORBITAL SWELLING (Eyes puffy) and PRURITUS (Her arm got itchy after vaccination) outcome was unknown.            No concomitant medication was provided.  On 18-Sep-2022, night after vaccination one of patient eyes swollen and it was puffy. On 19-Sep-2022, morning the same thing happened for both of her eyes. Treatment medication was not provided by the reporter. Reporter did not allow further contact.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: achiness; Chills; Fever; Patient also experienced pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Patient also experienced pain at the injection site) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that patient had history of reaction to other prior vaccines.   On 16-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced PAIN (achiness), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Patient also experienced pain at the injection site). In September 2022, PAIN (achiness), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Patient also experienced pain at the injection site) had resolved.            No concomitant medication information was provided. It was reported that patient recovered without visiting a healthcare professional. No treatment medication were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: she had chills after second booster; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (she had chills after second booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 939904, 016B21A and 012A21A) for COVID-19 vaccination.     Patient had no history of Pericarditis or myocarditis Patient not diagnosed with COVID positive test  .  Concurrent medical conditions included Penicillin allergy and Sarcoidosis. Concomitant products included ROSUVASTATIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (she had chills after second booster). At the time of the report, CHILLS (she had chills after second booster) had resolved.            The patient had not received other vaccine within 1 month prior to Moderna COVID-19 vaccine.  It was reported that, the patient had chills which went away the next day.   No treatment medications were reported.   This case was linked to MOD-2022-647514, MOD-2022-647505 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: The 1st 2 shot and booster she had a slight headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (The 1st 2 shot and booster she had a slight headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 016B21A and 012A21A) for COVID-19 vaccination.     Patient never had COVID+ test or diagnosis. Patient did not have a history of Pericarditis or myocarditis.  Concurrent medical conditions included Penicillin allergy and Sarcoidosis. Concomitant products included ROSUVASTATIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-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 HEADACHE (The 1st 2 shot and booster she had a slight headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (The 1st 2 shot and booster she had a slight headache) outcome was unknown.            Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient was taking other medication.   This case was linked to MOD-2022-647505, MOD-2022-647512 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Head discomfort, Tinnitus
Clinical narrative: Brain disorder; loud noises from inside the brain; Started getting tinnitus, which was pretty bad; This spontaneous case was reported by a patient and describes the occurrence of CEREBRAL DISORDER (Brain disorder), HEAD DISCOMFORT (loud noises from inside the brain) and TINNITUS (Started getting tinnitus, which was pretty bad) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041A21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced TINNITUS (Started getting tinnitus, which was pretty bad). On 18-Sep-2022, the patient experienced CEREBRAL DISORDER (Brain disorder) and HEAD DISCOMFORT (loud noises from inside the brain). At the time of the report, CEREBRAL DISORDER (Brain disorder) and HEAD DISCOMFORT (loud noises from inside the brain) outcome was unknown and TINNITUS (Started getting tinnitus, which was pretty bad) had not resolved.            Patient's height was reported as 5'6. Patient had never tested COVID-19 positive. No other vaccines were given 1 month prior to Moderna Vaccine. No concomitant medications was reported.  It was reported that the patient did not wanted to get anymore booster doses as the patient had side effects after the second vaccination. Patient started getting Tinnitus almost exactly 2 weeks after vaccination, it was bad. In the day time, patient had to play the TV loudly to cover the sounds inside head. It was an electronic, static-y type of sound. The patient had to sleep with loud music, it was awful. The patient went to nurses and doctors. It was like a hypochondriac, had never been one. The event came and go, it started getting back in last three weeks with different intensity. On 18-Sep-2022 night, It was in left ear only, Patient reported it as brain disorder, It had loud noises form inside the brain. Patient did not seek any medical care for events.  No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received monovalent booster instead of bivalent booster of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received monovalent booster instead of bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received monovalent booster instead of bivalent booster of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received monovalent booster instead of bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received monovalent booster instead of bivalent booster of Moderna COVID-19 vaccine).    No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  This case contains information for the 1st of four adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-647563, US-MODERNATX, INC.-MOD-2022-647564, US-MODERNATX, INC.-MOD-2022-647562 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647563:Patient-3 US-MODERNATX, INC.-MOD-2022-647564:Patient-4 US-MODERNATX, INC.-MOD-2022-647562:Patient-2