chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Bad case of COVID Disease and was sick for 10 days after 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Bad case of COVID Disease and was sick for 10 days after 2nd primary shot) and VACCINATION FAILURE (Vaccination failure) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019871A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hemochromatosis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Bad case of COVID Disease and was sick for 10 days after 2nd primary shot). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure). In August 2021, COVID-19 (Bad case of COVID Disease and was sick for 10 days after 2nd primary shot) had resolved. At the time of the report, VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  4 Months after 2nd shot patient had a bad case of COVID Disease and was sick for 10 days. He had a Positive PCR test at a testing center. He stayed at home and did not see a doctor. No treatment information was provided.  Company comment: This is a spontaneous case regarding a 63-year-old male patient, with concurrent medical condition of Hemochromatosis, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 approximately 4 months after the second dose. According to the patient, he had a bad case of COVID disease and was sick for 10 days. He had a Positive PCR test at a testing center. He stayed at home and did not see a doctor. An additional event of vaccination failure was also considered. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-644303 (Patient Link).; Sender's Comments: This is a spontaneous case regarding a 63-year-old male patient, with concurrent medical condition of Hemochromatosis, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 approximately 4 months after the second dose. According to the patient, he had a bad case of COVID disease and was sick for 10 days. He had a Positive PCR test at a testing center. He stayed at home and did not see a doctor. An additional event of vaccination failure was also considered. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Vaccination failure; Bad case of COVID Disease and was sick for 10 days after 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Bad case of COVID Disease and was sick for 10 days after 2nd primary shot) and VACCINATION FAILURE (Vaccination failure) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019871A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hemochromatosis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Bad case of COVID Disease and was sick for 10 days after 2nd primary shot). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure). In August 2021, COVID-19 (Bad case of COVID Disease and was sick for 10 days after 2nd primary shot) had resolved. At the time of the report, VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  4 Months after 2nd shot patient had a bad case of COVID Disease and was sick for 10 days. He had a Positive PCR test at a testing center. He stayed at home and did not see a doctor. No treatment information was provided.  Company comment: This is a spontaneous case regarding a 63-year-old male patient, with concurrent medical condition of Hemochromatosis, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 approximately 4 months after the second dose. According to the patient, he had a bad case of COVID disease and was sick for 10 days. He had a Positive PCR test at a testing center. He stayed at home and did not see a doctor. An additional event of vaccination failure was also considered. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-644303 (Patient Link).; Sender's Comments: This is a spontaneous case regarding a 63-year-old male patient, with concurrent medical condition of Hemochromatosis, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 approximately 4 months after the second dose. According to the patient, he had a bad case of COVID disease and was sick for 10 days. He had a Positive PCR test at a testing center. He stayed at home and did not see a doctor. An additional event of vaccination failure was also considered. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; Patient has received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of eachother; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient has received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of eachother) and NO ADVERSE EVENT (no adverse event) in an elderly female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 12-Sep-2022, received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 12-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient has received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of eachother). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient has received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of eachother) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient has received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of eachother).    The concomitant medication was not reported by reporter. The patient had received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of each other. Patient was being held for observation currently. This patient was over 65 and had not yet experienced any symptoms. The treatment medication was not reported by reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Pain, Peripheral swelling
Clinical narrative: Between the joints are swollen/ 1 ankle is swollen; 2-3 hours her digits were swollen/ both hands, 2 middle fingers; It hurts to bend/ take Aleve or something due to pain; 1 ankle is swollen, but later mentioned painful; This spontaneous case was reported by a physician and describes the occurrence of JOINT SWELLING (Between the joints are swollen/ 1 ankle is swollen), PERIPHERAL SWELLING (2-3 hours her digits were swollen/ both hands, 2 middle fingers), PAIN (It hurts to bend/  take Aleve or something due to pain) and ARTHRALGIA (1 ankle is swollen, but later mentioned painful) in a 40-year-old female patient who received mRNA-1273  (MODERNA COVID-19 VACCINE for COVID-19 vaccination.     Concurrent medical conditions included Allergic to dogs (has taken allergy shots) and Allergic to cats (has taken allergy shots).    On 10-Sep-2022, the patient received fourth dose of mRNA-1273 MODERNA COVID-19 VACCINE, (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Sep-2022, the patient experienced JOINT SWELLING (Between the joints are swollen/ 1 ankle is swollen), PERIPHERAL SWELLING (2-3 hours her digits were swollen/ both hands, 2 middle fingers), PAIN (It hurts to bend/ She can take Aleve or something due to pain) and ARTHRALGIA (1 ankle is swollen, but later mentioned painful). At the time of the report, JOINT SWELLING (Between the joints are swollen/ 1 ankle is swollen), PERIPHERAL SWELLING (2-3 hours her digits were swollen/ both hands, 2 middle fingers), PAIN (It hurts to bend/ She can take Aleve or something due to pain) and ARTHRALGIA (1 ankle is swollen, but later mentioned painful) outcome was unknown.        For mRNA-1273 MODERNA COVID-19 VACCINE(Intramuscular), the reporter did not provide any causality assessments.   Patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were provided. On an unknown date, patient received primary series as well as 1 booster dose of Moderna vaccine. No treatment medications were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received the bivalent booster instead of completing the primary series(For the 2nd dose patient received the new Moderna bivalent booster); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster instead of completing the primary series(For the 2nd dose patient received the new Moderna bivalent booster)) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     It was unknown, if the patient was ever had tested or diagnosed with COVID. It was unknown if the history was related to mentioned event and both Acute and Chronic illnesses at the time of vaccination. It was unknown whether other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose).     On 10-Sep-2022, the patient received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster instead of completing the primary series(For the 2nd dose patient received the new Moderna bivalent booster)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster instead of completing the primary series(For the 2nd dose patient received the new Moderna bivalent booster)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster instead of completing the primary series(For the 2nd dose patient received the new Moderna bivalent booster)).    It was reported that patient took 1st moderna dose 0.5 ml on 09Jan2022, Intramuscular (left arm) with lot number 066H21A with indication of COVID-19 vaccine. Patient received 1st booster Bivalent as 2nd dose. Reporter does not know if patient was taking other medication.  No concomitant medication was reported. No treatment medication was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patients received 0.25 ml of the bivalent vaccine; No Adverese event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No Adverese event) in a 79-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No Adverese event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No Adverese event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverese event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine).    Concomitant product use was not provided by the reporter.  Patient was administered with Booster dose. Pharmacist stated she did not realize the vaccine dosage for the booster has been change from 0.5 ml to 0.25 ml.  The patient did not experienced any side effect. She wanted to know if the other half need to be re-administered and what will be the dosage window. Pharmacist does not know if the patient were taking other medication. HCP was not aware of incident.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-644400 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644400:Patient - Husband case
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema
Clinical narrative: small round red areas under my skin; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (small round red areas under my skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1773 and 11320A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-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 ERYTHEMA (small round red areas under my skin). At the time of the report, ERYTHEMA (small round red areas under my skin) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  It was reported that patient had the Covid shot the only medication that has changed with regular medication. Patient started on Prolia, however, that was after patient noticed the skin issue. Patient had been to dermatologist and Internal medicine doctor that do not know what was causing this under the skin. The Internal Medicine doctor has ordered a complete autoimmune blood work up ,however , the results will take 5 weeks to be completed.  The patient has iced the area and tried homeopathic therapies. Patient also used Arnica, some lotion, Vaseline, and tea tree oil.   This case was linked to MOD-2022-644598, MOD-2022-644265 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2022: Follow up received contains significant information, reporters, suspect product information and dosing regimens were updated
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: small round red areas under my skin; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (small round red areas under my skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1773 and 11320A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-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 ERYTHEMA (small round red areas under my skin). At the time of the report, ERYTHEMA (small round red areas under my skin) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  It was reported that patient had the Covid shot the only medication that has changed with regular medication. Patient started on Prolia, however, that was after patient noticed the skin issue. Patient had been to dermatologist and Internal medicine doctor that do not know what was causing this under the skin. The Internal Medicine doctor has ordered a complete autoimmune blood work up ,however , the results will take 5 weeks to be completed.  The patient has iced the area and tried homeopathic therapies. Patient also used Arnica, some lotion, Vaseline, and tea tree oil.   This case was linked to MOD-2022-644598, MOD-2022-644265 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2022: Follow up received contains significant information, reporters, suspect product information and dosing regimens were updated
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema
Clinical narrative: The patient's first dose (lot 11320A) of Moderna was on 04Jan2021 and second dose (lot 1773) on 28Jan2021; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose (lot 11320A) of Moderna was on 04Jan2021 and second dose (lot 1773) on 28Jan2021) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1773 and 11320A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose (lot 11320A) of Moderna was on 04Jan2021 and second dose (lot 1773) on 28Jan2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose (lot 11320A) of Moderna was on 04Jan2021 and second dose (lot 1773) on 28Jan2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication information was provided.  No treatment medication was provided.   This case was linked to MOD-2022-644257, MOD-2022-644265 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient's first dose (lot 11320A) of Moderna was on 04Jan2021 and second dose (lot 1773) on 28Jan2021; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose (lot 11320A) of Moderna was on 04Jan2021 and second dose (lot 1773) on 28Jan2021) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1773 and 11320A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose (lot 11320A) of Moderna was on 04Jan2021 and second dose (lot 1773) on 28Jan2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose (lot 11320A) of Moderna was on 04Jan2021 and second dose (lot 1773) on 28Jan2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication information was provided.  No treatment medication was provided.   This case was linked to MOD-2022-644257, MOD-2022-644265 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: 6 weeks to 2 months after receiving her first dose of the vaccine she also experienced sciatica; This spontaneous case was reported by a patient and describes the occurrence of SCIATICA (6 weeks to 2 months after receiving her first dose of the vaccine she also experienced sciatica) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 037F21A and 005M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-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 SCIATICA (6 weeks to 2 months after receiving her first dose of the vaccine she also experienced sciatica). At the time of the report, SCIATICA (6 weeks to 2 months after receiving her first dose of the vaccine she also experienced sciatica) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-024267 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid/tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (diagnosed with Covid/tested positive) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 016C21A and 040B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (diagnosed with Covid/tested positive). At the time of the report, COVID-19 (diagnosed with Covid/tested positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2022, SARS-CoV-2 test: (Positive) positive. On 09-Sep-2022, SARS-CoV-2 test: (Positive) positive. On 10-Sep-2022, SARS-CoV-2 test: (Positive) positive. In September 2022, Pyrexia: 97.5 degree Celsius.         No concomitant medications was reported.  The patient tested positive this past Thursday and then had a fever these last two days and then dropped back down to 97.5 degrees. The patient was slightly congested.  No treatment medications was reported.  Company Comment: This is a spontaneous case concerning a 38-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately 10 months after receiving the third dose of mRNA-1273 vaccine. The patient reported to have fever and slightly congested. Clinical course and treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 38-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately 10 months after receiving the third dose of mRNA-1273 vaccine. The patient reported to have fever and slightly congested. Clinical course and treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Skin haemorrhage
Clinical narrative: Bleeding under the skin/unsightly bruising or bleeding/she started getting what looks like bleedskin. Its on both of her shins down to her ankle; This spontaneous case was reported by a patient and describes the occurrence of SKIN HAEMORRHAGE (Bleeding under the skin/unsightly bruising or bleeding/she started getting what looks like bleedskin. Its on both of her shins down to her ankle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04AL21A, 088D2119, 1773 and 11320A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN HAEMORRHAGE (Bleeding under the skin/unsightly bruising or bleeding/she started getting what looks like bleedskin. Its on both of her shins down to her ankle). The patient was treated with DENOSUMAB (PROLIA) for Skin disorder, at an unspecified dose and frequency and PARAFFIN (VASELINE [PARAFFIN]) for Skin disorder, at an unspecified dose and frequency. At the time of the report, SKIN HAEMORRHAGE (Bleeding under the skin/unsightly bruising or bleeding/she started getting what looks like bleedskin. Its on both of her shins down to her ankle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. It was reported that the small round areas were diagnosed as bleeding under the skin by the dermatologist. It started off as little tiny bumps. Then the bumps became bigger and more profound. From March, patient had both of the shins with 4 inch area from knee to ankle with unsightly bruising or bleeding. It was further cleared by the reporter that there was no trauma, pain, itching or swelling to that area just bruising under the skin. The COVID shot was the only medication that had changed with the patient's regular medication.  Patient went to the dermatologist and internal medicine doctor who ordered for a complete autoimmune blood work-up, and results will take 5 weeks to complete.  Patient also reported that she was unable to go to the community pool due to the reported event. The patient had iced the area and tried homeopathic therapies. Also used Arnica, some lotion  and tea tree oil.   This case was linked to MOD-2022-644598, MOD-2022-644257 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2022: Additional follow-up received, suspect drug information and I-narrative was updated.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired booster as per lot # on vaccination Card; Patient received an expired booster as per lot # on vaccination Card; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster as per lot # on vaccination Card) and NO ADVERSE EVENT (Patient received an expired booster as per lot # on vaccination Card) in a 24-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 015F21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster as per lot # on vaccination Card) and NO ADVERSE EVENT (Patient received an expired booster as per lot # on vaccination Card). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster as per lot # on vaccination Card) and NO ADVERSE EVENT (Patient received an expired booster as per lot # on vaccination Card) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (Patient received an expired booster as per lot # on vaccination Card) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster as per lot # on vaccination Card).    Concomitant medications were not reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Stem cell transplant
Clinical narrative: stem cell transplant; This spontaneous case was reported by a patient and describes the occurrence of STEM CELL TRANSPLANT (stem cell transplant) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient's past medical history included Multiple myeloma in September 2021. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (First booster) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Immunocompromised.   On 23-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2022, the patient experienced STEM CELL TRANSPLANT (stem cell transplant). At the time of the report, STEM CELL TRANSPLANT (stem cell transplant) outcome was unknown.      Concomitant medications were not reported. He had to have a stem cell transplant on 17Jun2022, and doctor said he had to have 3 months. It was reported that, patient had to have a stem cell transplant on 17Jun2022, and physician said he had to have 3 months. His physician stated that he needs to restart his covid vaccinations, so can the Bivalent vaccines be used as his primary series, since they provide better protection. No treatment information was provided by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Accidental underdose, Feeling abnormal, Pyrexia
Clinical narrative: like something was working in my body; felt somewhat feverish/it wasn't measurable; lower than authorized dose of Moderna bivalent administered to patient/.25 dose for bivalent; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (like something was working in my body), PYREXIA (felt somewhat feverish/it wasn't measurable) and ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent administered to patient/.25 dose for bivalent) in a 68-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included PRAVASTATIN for Blood cholesterol abnormal.   On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 08-Sep-2022, the patient experienced FEELING ABNORMAL (like something was working in my body), PYREXIA (felt somewhat feverish/it wasn't measurable) and ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent administered to patient/.25 dose for bivalent). On 09-Sep-2022, FEELING ABNORMAL (like something was working in my body) and PYREXIA (felt somewhat feverish/it wasn't measurable) had resolved. At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent administered to patient/.25 dose for bivalent) outcome was unknown.        The action taken with mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       It was reported that, the patient received the bivalent vaccine 0.25 mL dosage instead of 0.5 mL. A couple days after receiving the bivalent vaccine, the vaccine provider called the patient and told about the error and wanted the patient to come in to get an additional 0.25 mL dosage of the bivalent vaccine. Patient also had received his flu shot along with his Moderna bivalent vaccine on the same day. Later, the patient felt somewhat feverish for 24 hours but was not sure if it was caused due to the flu shot or the bivalent vaccine. Patient reported that, it was not a measurable temperature rise and did not feel sick, but felt like something was working in body.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2022: Significant follow up received contains additional event information. On 12-Sep-2022: Follow-up document received includes no new information.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: neck was stiff on one side; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck was stiff on one side) in a male patient of an unknown age who received mRNA-1273 BIVALENT (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 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (neck was stiff on one side). At the time of the report, MUSCULOSKELETAL STIFFNESS (neck was stiff on one side) outcome was unknown.            No Concomitant medications were provided. Patient received moderna shot on Thursday. The patient had 5 shots of the Moderna vaccine at this time. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-644025 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644025:Wife case (MOD22-023160)
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse event; Received two Bivalent vaccine doses on the same day; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Received two Bivalent vaccine doses on the same day) and NO ADVERSE EVENT (No Adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (Received two Bivalent vaccine doses on the same day). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Received two Bivalent vaccine doses on the same day) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.            No concomitant medications were reported. Patient received accidentally two doses of the new Bivalent booster on 12Sep2022. He was expected to receive one Bivalent Booster and one Flu shot but instead, nurse applied 2 Covid-19 shots one in his left arm and one in his right arm. He realized that happened because nurse said oh my god had put two of them in each arm. Patient asked if he was in danger or what he should do. He was not comfortable with Agent's accent and asked several times to be transferred to a United States Agent. He asked if he should go to the Emergency room. No treatment  medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: sore arm; some chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and CHILLS (some chills) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Full blood count decreased (history of lowblood cell count and wanted to be protected). Concurrent medical conditions included Muscle weakness (Since 20 years( issue with muscles in the lower back, and was had trouble walking and moving)).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and CHILLS (some chills). At the time of the report, PAIN IN EXTREMITY (sore arm) and CHILLS (some chills) outcome was unknown.            No concomitant medications were reported. After receiving the previous Moderna vaccines the patient had a sore arm and some chills. When the patient took newbivalent booster vaccine on 07-Sep-2022 and states the vaccine was great and it was the first dose that did not cause patient any reaction. After receiving new bivalent booster the next day patient visited the doctor because of issues with the muscles in his lower back, he was having trouble walking and moving. The patient mentioned that these were not related to the vaccine, as patient had historical weak muscle problems (for 20 years). On 09-Sep-2022 the doctor gave the patient a 7 day treatment of prednisone and a shot of Toradol. The patient was wondering if these medications interfere with the vaccine and he was very concerned, he mentioned that he had history of low blood cell count and wanted to be protected. No treatment medication were provided for the events pain in extremity and chills.   This case was linked to US-MODERNATX, INC.-MOD-2022-644268 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644268:(Case for Friends)
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort
Clinical narrative: arm was not usable/could not pick anything up/couldn't pick up milk in her fridge/couldn't pick up one pound; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (arm was not usable/could not pick anything up/couldn't pick up milk in her fridge/couldn't pick up one pound) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Patient had no allergies and patient not had COVID positive test or diagnosis. Patient not had any medical history. No any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced LIMB DISCOMFORT (arm was not usable/could not pick anything up/couldn't pick up milk in her fridge/couldn't pick up one pound). The patient was treated with Physical therapy for Limb discomfort. At the time of the report, LIMB DISCOMFORT (arm was not usable/could not pick anything up/couldn't pick up milk in her fridge/couldn't pick up one pound) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported that after the first vaccination arm was not usable and could not pick up anything. Prior to the first moderna vaccine patient was able to pick up 130 pounds in terms of pressing weight and patient hobby was weight lifting. After the vaccine patient could not pick up anything for close to 6 months. Patient stated that the vaccine was on bicep on left arm, patient works out and was very fit. Patient had Electromyogram(EMG). As a treatment patient was taking acupuncture and aquatic therapy. It was reported that there was some residual effects and the symptoms was improved but not 100 percent. Patient had not experienced similar events in past.   This case was linked to MOD-2022-644427 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Mobility decreased
Clinical narrative: arm was not usable/could not pick anything up/couldn't pick up milk in her fridge/couldn't pick up one pound; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (arm was not usable/could not pick anything up/couldn't pick up milk in her fridge/couldn't pick up one pound) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Patient had no allergies and patient not had COVID positive test or diagnosis. Patient not had any medical history. No any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced LIMB DISCOMFORT (arm was not usable/could not pick anything up/couldn't pick up milk in her fridge/couldn't pick up one pound). The patient was treated with Physical therapy for Limb discomfort. At the time of the report, LIMB DISCOMFORT (arm was not usable/could not pick anything up/couldn't pick up milk in her fridge/couldn't pick up one pound) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported that after the first vaccination arm was not usable and could not pick up anything. Prior to the first moderna vaccine patient was able to pick up 130 pounds in terms of pressing weight and patient hobby was weight lifting. After the vaccine patient could not pick up anything for close to 6 months. Patient stated that the vaccine was on bicep on left arm, patient works out and was very fit. Patient had Electromyogram(EMG). As a treatment patient was taking acupuncture and aquatic therapy. It was reported that there was some residual effects and the symptoms was improved but not 100 percent. Patient had not experienced similar events in past.   This case was linked to MOD-2022-644427 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort
Clinical narrative: I can only manage about 15 pounds; first dose >35 days from second dose; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (I can only manage about 15 pounds) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose >35 days from second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01C21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose >35 days from second dose). On an unknown date, the patient experienced MOBILITY DECREASED (I can only manage about 15 pounds). At the time of the report, MOBILITY DECREASED (I can only manage about 15 pounds) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose >35 days from second dose) outcome was unknown.            No concomitant medications were reported. Prior to the first moderna vaccine patient was able to pick up 130 pounds in terms of pressing weight and patient hobby was weight lifting. After the vaccine patient could not pick up anything for close to 6 months. Patient states that the vaccine was on bicep on left arm, patient works out and was very fit. Patient had Electromyogram(EMG): Unknown result It was reported that there was some residual effects and the symptoms was improved but not 100 percent. Patient had not experienced similar events in past. As a treatment patient was taking acupuncture and aquatic therapy.   This case was linked to MOD-2022-644399 (Patient Link).