chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: REBOUND OF COVID; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 01 total administered at left arm on 02-APR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of non-company suspect vaccine Spikevax Moderna Covid-19 Vaccine (Elasomeran) (Dose number in series 2) (batch number: 019F21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered at left arm on 05-OCT-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with booster dose of Spikevax Moderna Covid-19 Vaccine (Elasomeran) (Dose number in series 2). The patient additionally received booster dose of non-company suspect vaccine Pfizer Biontech Covid-19 Vaccine (Tozinameran) (form of admin, route of admin, and batch number were not reported, expiry unknown) dose was not reported, administered at left arm administered on 15-APR-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). No concomitant medications were reported. On an unspecified date in 2022, the patient had COVID-19 infection for which patient took paxlovid (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered from 23-SEP-2022 to 27-SEP-2022 for covid-19 treatment. On 03-OCT-2022, the patient experienced rebound of covid (suspected covid-19 infection) (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, tozinameran was not applicable and with paxlovid was treatment discontinued. The patient was recovering from rebound of covid, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 19-OCT-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). On an unspecified date, the patient received non-company suspect vaccine elasomeran (Moderna covid-19 vaccine) (Dose number in series 2) (form of admin, route of admin, and batch number and expiry were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced covid rebound started with coughing, sneezing, runny nose and symptoms were fever, chills, significant joint pain, and fatigue. The rebound is diarrhea, upper and lower colds (confirmed covid-19 infection) (Dose number in series 2) and had revaccination with different covid-19 vaccine (Dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the confirmed covid-19 infection and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000255909.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, COVID-19 immunisation, Fatigue, Injection site warmth, Pyrexia
Clinical narrative: ALMOST KILLED/A LONG LIST OF SIDE EFFECT; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; LITTLE HEAT AT THE SITE OF INJECTION; LOW GRADE FEVER; FATIGUE REOCCURENCE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic fatigue syndrome, non-alcohol user, non-smoker, fibromyalgia, panic and anxiety disorder (genetic), heart burn (occasional), not sleep good, and drug allergy (Azithromycin), and other pre-existing medical conditions included: The patient had no COVID infections after vaccination. The patient experienced fatigue and little heat at the site of injection when treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total administered on 19-MAR-2021 to left arm for covid-19 prophylaxis. On an unspecified date in 2021, the patient experienced low grade fever for 2-3 days, little heat at the site of injection, and fatigue reoccurence (Dose number in series 1). Patient reported that adverse events were minor with no diarrhea and no vomiting. The patient additionally received non-company suspect vaccine Moderna covid-19 vaccine (Spikevax) (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 29-OCT-2021 for covid-19 prophylaxis which was revaccination with different COVID-19 vaccine (Dose number in series 2). Concomitant medications included alprazolam, and naproxen.  On an unspecified date, the patient experienced a long list of side effect following her Moderna covid-19 vaccine (Spikevax) which almost killed her that means patient had lot of adverse events. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from low grade fever on 2021, and the outcome of little heat at the site of injection, fatigue reoccurence, almost killed/a long list of side effect and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid-19. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced MYALGIA (Muscle pain). On 21-Jan-2021, MYALGIA (Muscle pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-023445, MOD-2022-662026 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Blood pressure measurement, Dizziness, Hypotension, Vaccination site erythema
Clinical narrative: Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced MYALGIA (Muscle pain). On 21-Jan-2021, MYALGIA (Muscle pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-023445, MOD-2022-662026 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced MYALGIA (Muscle pain). On 21-Jan-2021, MYALGIA (Muscle pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-023445, MOD-2022-662026 (Patient Link).   Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; monovalent dose ages 6-11 administered instead of bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose).    No concomitant medication was provided by the reporter.  The patient was supposed to receive the Bivalent Booster dose but instead patient was given the Monovalent vaccine ages 6-11.  No treatment medication was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-661790 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2022: Added patient demographics. Report type and I narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661790:same reporter
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: right arm soreness; right arm redness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (right arm soreness) and ERYTHEMA (right arm redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 015M20A and 030L20AH) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-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 09-Nov-2021, the patient experienced PAIN IN EXTREMITY (right arm soreness) and ERYTHEMA (right arm redness). At the time of the report, PAIN IN EXTREMITY (right arm soreness) and ERYTHEMA (right arm redness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2022-660549, MOD-2022-660555, MOD-2022-660560, MOD-2022-660563 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of Bivalent booster vial; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of Bivalent booster vial) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of Bivalent booster vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of Bivalent booster vial) 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 (Received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of Bivalent booster vial).    This case contains information on 1st of 6th adult patients as described by the reporter.   No concomitant medications were reported.  It was reported that 6 Adult patients were received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y-11Y) instead of Bivalent booster vial.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660860, US-MODERNATX, INC.-MOD-2022-661292, US-MODERNATX, INC.-MOD-2022-661298, US-MODERNATX, INC.-MOD-2022-661299, US-MODERNATX, INC.-MOD-2022-661300 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Additional follow-up received : Narrative updated and IRD of initial version was captured to 17-Oct-2022. On 17-Oct-2022: Additional follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660860:Adult patient 2 US-MODERNATX, INC.-MOD-2022-661292:Adult patient 3 US-MODERNATX, INC.-MOD-2022-661298:Adult patient 4 US-MODERNATX, INC.-MOD-2022-661299:Adult patient 5 US-MODERNATX, INC.-MOD-2022-661300:Adult patient 6
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she traveled to 2 other places. She came down with mild COVID Disease with Positive PCR test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she traveled to 2 other places. She came down with mild COVID Disease with Positive PCR test) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     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)) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced COVID-19 (she traveled to 2 other places. She came down with mild COVID Disease with Positive PCR test). At the time of the report, COVID-19 (she traveled to 2 other places. She came down with mild COVID Disease with Positive PCR test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2022, SARS-CoV-2 test: Positive.         No concomitant information provided  On 08-Mar-2021, The patient received first dose of moderna COVID-19 vaccine (Lot: 036A21A).  On 05-Apr-2021, The patient received second dose of moderna COVID-19 vaccine (Lot: 025B21A).  On 01-Nov-2021, The patient received 1st booster of moderna COVID-19 vaccine (Lot: 004 F21A).  On 02-May-2022, The patient received 2nd booster of moderna COVID-19 vaccine (Lot: 002M21A).  It was reported that she traveled to 2 other places and came down with mild COVID disease with positive PCR test on 06-Oct-2022, less than a month after bivalent Booster.  No treatment information provided
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 019B21A, 032F21A and 002M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.            No concomitant medication were reported.  Patient experienced  of sore left arm on 6-APR-2021 and on 12-APR-2022. Patient had no adverse reactions reported with third dose.                No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: No adverse event; fluid had dripped down her arm from the hub of the syringe; fluid had dripped down her arm from the hub of the syringe; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (fluid had dripped down her arm from the hub of the syringe), UNDERDOSE (fluid had dripped down her arm from the hub of the syringe) and NO ADVERSE EVENT (No adverse event) 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 28-Sep-2022 at 8:00 AM, 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 28-Sep-2022 at 8:00 AM, the patient experienced DEVICE CONNECTION ISSUE (fluid had dripped down her arm from the hub of the syringe) and UNDERDOSE (fluid had dripped down her arm from the hub of the syringe). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (fluid had dripped down her arm from the hub of the syringe), UNDERDOSE (fluid had dripped down her arm from the hub of the syringe) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 assessments were provided for DEVICE CONNECTION ISSUE (fluid had dripped down her arm from the hub of the syringe) and UNDERDOSE (fluid had dripped down her arm from the hub of the syringe).    No Concomitant medication was reported.  The patient reported that she felt, there was an initial trickle of cool liquid running down her arm during the injection and when she looked over while the nurse was injecting it, she saw the liquid leaking down her arm to the point where it needed to be wiped. The Patient reports it looks like the liquid was leaking out from the area where the needle screws into the syringe. The reporter reports that it was not much that leaked out, only a drop that rolled all the way down her arm. Patient noticed there was more fluid that had dripped down of her arm in two other places. For all 3 spots, in all she thinks it was at least 2 microliters of fluid. Patient was concerned that she did not receive the full dose.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of bivalent booster vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of bivalent booster vial) 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. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of bivalent booster vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of bivalent booster vial) 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 booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of bivalent booster vial).    This case contains information for the sixth patient out of the 6 adult patients as described by reporter.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660841, US-MODERNATX, INC.-MOD-2022-660860, US-MODERNATX, INC.-MOD-2022-661292, US-MODERNATX, INC.-MOD-2022-661298, US-MODERNATX, INC.-MOD-2022-661299 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow up contains significant information that included updated IRD of initial version to 17-OCT-2022 as per narrative. On 17-Oct-2022: Live follow up contains non-significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660841:same reporter US-MODERNATX, INC.-MOD-2022-660860:same reporter US-MODERNATX, INC.-MOD-2022-661292:same reporter US-MODERNATX, INC.-MOD-2022-661298:same reporter US-MODERNATX, INC.-MOD-2022-661299:same reporter
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; May have received original vaccine instead of the Bivalent/may have received an incorrect vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (May have received original vaccine instead of the Bivalent/may have received an incorrect vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (May have received original vaccine instead of the Bivalent/may have received an incorrect vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (May have received original vaccine instead of the Bivalent/may have received an incorrect vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant product use was reported.  Husband wanted confirmation on the vaccine code, AS7764B if it was Bivalent or original vaccine.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Left arm where the injection was given was still swollen but better; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Left arm where the injection was given was still swollen but better) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027#22A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Taking unspecified medication for high blood pressure) and Penicillin allergy.    On 17-Oct-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 17-Oct-2022, the patient experienced VACCINATION SITE SWELLING (Left arm where the injection was given was still swollen but better). At the time of the report, VACCINATION SITE SWELLING (Left arm where the injection was given was still swollen but better) was resolving.            Concomitant product included unspecified high blood pressure medication. On 15-Feb-2021, the patient received first dose of Moderna vaccine with lot number 015M20A. On 15-Mar-2021, the patient received second dose of Moderna vaccine with lot number 002B21A. On 15-Nov-2021, the patient received first booster dose with lot number 033L21A. On 11-Apr-2022, the patient received second booster dose with lot number 005M21A. On 17-Oct-2022, the patient received third booster dose with lot number 027#22A. The patient never had covid positive test or diagnosis. The patient received booster dose and experienced arm was swollen. It was swollen and puffy. This was currently going in to the third day. The patient put an ice pack on it. The patient was able to move arm. She felt great as far as health wise. Her arms felt lumpy at the time of report. At the time of the report, patient's left arm where the injection was given was swollen but better.    Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2022: Live follow-up information received included reporter details, patient details, events and narrative updated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, Somnolence
Clinical narrative: I felt like a polar bear just sleeping all day; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (I felt like a polar bear just sleeping all day) and FATIGUE (Fatigue) in a 44-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.     Patient had no known drug allergies. Patient had no acute and chronic illnesses at the time of vaccination.  The patient's past medical history included COVID-19 (Patient had COVID positive test or diagnosis and no hospitalizations.) in January 2022. Previously administered products included for Product used for unknown indication: Pfizer (Patient's previous doses were all Pfizer doses and route intramuscular.). Past adverse reactions to the above products included No adverse event with Pfizer. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 15-Oct-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 16-Oct-2022, the patient experienced SOMNOLENCE (I felt like a polar bear just sleeping all day) and FATIGUE (Fatigue). At the time of the report, SOMNOLENCE (I felt like a polar bear just sleeping all day) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that the adverse event did not cause the patient to seek medical care and the patient had not experienced a similar event in the past.  Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Post-acute COVID-19 syndrome, Skin reaction, Tinnitus
Clinical narrative: Severe tinnitus; Continued hair loss; severe muscle aches / fatigue symptoms associated with long Covid; Severe skin reaction; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Severe tinnitus), ALOPECIA (Continued hair loss), POST-ACUTE COVID-19 SYNDROME (severe muscle aches / fatigue symptoms associated with long Covid) and SKIN REACTION (Severe skin reaction) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Severe tinnitus), ALOPECIA (Continued hair loss), POST-ACUTE COVID-19 SYNDROME (severe muscle aches / fatigue symptoms associated with long Covid) and SKIN REACTION (Severe skin reaction). At the time of the report, TINNITUS (Severe tinnitus), ALOPECIA (Continued hair loss), POST-ACUTE COVID-19 SYNDROME (severe muscle aches / fatigue symptoms associated with long Covid) and SKIN REACTION (Severe skin reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant product reported by reporter.  Suspect drug reported with unknown batch number and expiration date. Patient had severe muscle aches and fatigue as symptoms associated with long COVID.  No treatment medication reported by reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Tinnitus
Clinical narrative: After 4th dose, the ringing in her ears lasted for about 4 months and it was very loud/With the first 4 doses, the ringing was only in one ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (After 4th dose, the ringing in her ears lasted for about 4 months and it was very loud/With the first 4 doses, the ringing was only in one ear) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cholesterol, Macular degeneration (status such as improvement or worsening was reported as Stable.) since 2019, Drug allergy (allergy to Meloxicam) and Fruit allergy (allergy to Blueberries). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, BEVACIZUMAB for Macular degeneration, LEVOTHYROXINE SODIUM (SYNTHROID) and TRETINOIN for an unknown indication.    On 11-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (After 4th dose, the ringing in her ears lasted for about 4 months and it was very loud/With the first 4 doses, the ringing was only in one ear). At the time of the report, TINNITUS (After 4th dose, the ringing in her ears lasted for about 4 months and it was very loud/With the first 4 doses, the ringing was only in one ear) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure was normal at 118/75.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received five doses of the Moderna COVID-19 vaccine and it included Moderna COVID-19 bivalent booster. After each shot Patient experienced ringing in ear. With the first 4 doses Patient experienced the event of ringing in ear, and it was only in one ear. Patient read that dehydration could be a cause of ear ringing. However, the Patient consumed a lot drinking water. Hence Patient concluded that dehydration was not cause. Also, Patient has normal blood pressure hence Patient ruled out that it was also not cause for ringing in ear. As patient read online that ringing in ear could be caused due to high blood pressure  Patient did not experience a similar event in the past. Patient went to hearing doctor for the symptoms.  Symptoms improved over time between each shot for patient and it came back whenever Patient had another Moderna shot.  Patient never had COVID-19 or Patient never test or diagnosis with COVID-19.  No treatment medication was reported.   This case was linked to MOD-2022-661330, MOD-2022-661339 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Tinnitus
Clinical narrative: She says that after each shot she has experienced ringing in her ears,  the ringing was only in one ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (She says that after each shot she has experienced ringing in her ears,  the ringing was only in one ear) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 010M20A and 013A21A) for COVID-19 prophylaxis.     It was reported that patient did not have COVID + test or diagnosis.  Concurrent medical conditions included Drug allergy (allergy to Meloxicam), Fruit allergy (allergy to Blueberries), Cholesterol and Macular degeneration (status such as improvement or worsening was reported as Stable.) since 2019. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, BEVACIZUMAB for Macular degeneration, LEVOTHYROXINE SODIUM (SYNTHROID) and TRETINOIN for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Oct-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 TINNITUS (She says that after each shot she has experienced ringing in her ears,  the ringing was only in one ear). At the time of the report, TINNITUS (She says that after each shot she has experienced ringing in her ears,  the ringing was only in one ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure was normal at 118/75..         Patient stated that she has received 5 doses of the Moderna COVID-19 vaccine so far, included the most recent Moderna COVID-19 bivalent booster. She stated that after each shot, she had experienced ringing in her ears, which she never had before. When the vaccine started to wear off, the ringing in her ears stop. With the first 4 doses, the ringing was only in one ear. But with the most recent bivalent booster, she had ringing in both ears. She read online that ringing could be caused due to high blood pressure but her most recent blood pressure was normal at 118/75. She also read that dehydration could be a cause, but she stated that she drank a lot of water so it could not be that.  Patient did not experience a similar event in the past. Flu shot was given 2 weeks before Moderna bivalent  Patient had been to the "hearing" doctor for her symptoms. Patient hearing had been reduced.  The symptoms improved over time between each shot but came back whenever she had another Moderna shot. No treatment medication was reported.    This case was linked to MOD-2022-661330, MOD-2022-661336 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Getting out of breath; COVID-19 Vaccine Booster - Tested Positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Getting out of breath) and COVID-19 (COVID-19 Vaccine Booster - Tested Positive for COVID) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056AZZA, 041C21A, 016M20A and 011L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma (Asthma Diagnosed 40 years ago) and Blood pressure high. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from an unknown date to 16-Oct-2022 for Asthma, AMLODIPINE from 01-Oct-2022 to an unknown date for Blood pressure high.   On 26-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 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Getting out of breath) and COVID-19 (COVID-19 Vaccine Booster - Tested Positive for COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) ongoing from 15-Oct-2022 for COVID-19, at an unspecified dose and frequency; NIRMATRELVIR on 15-Oct-2022 at a dose of 300 milligram, 2 Nirmatrelvir at a time and RITONAVIR on 15-Oct-2022 at a dose of 100 milligram,1 Ritonavir at a time. At the time of the report, DYSPNOEA (Getting out of breath) and COVID-19 (COVID-19 Vaccine Booster - Tested Positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Patient was getting out of breath: started before Paxlovid. Doesn't happen unless patient had an asthma attack. She must had omicron variant.
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Accidental underdose, No adverse event, Wrong technique in device usage process
Clinical narrative: No adverse event; not receive the dose of the bivalent booster as it was not properly injected in the arm and instead sprayed in the air and in the arm; Dose was sprayed in the air and in the arm; This spontaneous case was reported by a patient and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not receive the dose of the bivalent booster as it was not properly injected in the arm and instead sprayed in the air and in the arm), ACCIDENTAL UNDERDOSE (Dose was sprayed in the air and in the arm) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 017hzza) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-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 19-Oct-2022, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not receive the dose of the bivalent booster as it was not properly injected in the arm and instead sprayed in the air and in the arm) and ACCIDENTAL UNDERDOSE (Dose was sprayed in the air and in the arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not receive the dose of the bivalent booster as it was not properly injected in the arm and instead sprayed in the air and in the arm), ACCIDENTAL UNDERDOSE (Dose was sprayed in the air and in the arm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported.   Caller received 4 doses of the Moderna COVID19 vaccine in the past   Caller did not receive the dose of the bivalent booster as it was not properly injected in the arm and instead sprayed in the air and in the arm  No treatment information was reported
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Injection site discharge, Underdose
Clinical narrative: No adverse event; not receive the dose of the bivalent booster as it was not properly injected in the arm and instead sprayed in the air and in the arm; Dose was sprayed in the air and in the arm; This spontaneous case was reported by a patient and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not receive the dose of the bivalent booster as it was not properly injected in the arm and instead sprayed in the air and in the arm), ACCIDENTAL UNDERDOSE (Dose was sprayed in the air and in the arm) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 017hzza) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-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 19-Oct-2022, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not receive the dose of the bivalent booster as it was not properly injected in the arm and instead sprayed in the air and in the arm) and ACCIDENTAL UNDERDOSE (Dose was sprayed in the air and in the arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not receive the dose of the bivalent booster as it was not properly injected in the arm and instead sprayed in the air and in the arm), ACCIDENTAL UNDERDOSE (Dose was sprayed in the air and in the arm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported.   Caller received 4 doses of the Moderna COVID19 vaccine in the past   Caller did not receive the dose of the bivalent booster as it was not properly injected in the arm and instead sprayed in the air and in the arm  No treatment information was reported
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Myalgia
Clinical narrative: She still ended up with Covid / getting horrible month-long sick with covid; Body aches and it hurts from inside your bones; Body ache and it hurts from inside your bones out; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (She still ended up with Covid / getting horrible month-long sick with covid), BONE PAIN (Body aches and it hurts from inside your bones) and MYALGIA (Body ache and it hurts from inside your bones out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (Dose 1) on 08-Apr-2021 and Johnson and Johnson vaccine (Dose 1) on 08-Apr-2021. Past adverse reactions to the above products included Bone pain with Johnson and Johnson vaccine; and Myalgia with Johnson and Johnson vaccine.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (She still ended up with Covid / getting horrible month-long sick with covid), BONE PAIN (Body aches and it hurts from inside your bones) and MYALGIA (Body ache and it hurts from inside your bones out). At the time of the report, COVID-19 (She still ended up with Covid / getting horrible month-long sick with covid), BONE PAIN (Body aches and it hurts from inside your bones) and MYALGIA (Body ache and it hurts from inside your bones out) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient had first dose of Johnson and Johnson vaccine and received booster dose/second shot from Moderna Covid vaccine on 19-Nov-2021. Patient still ended up with Covid. It was almost going on a year now where patient was getting horrible month-long sick with covid and suffering all the effects and not sure if wanted to get another vaccination.  It was reported that both Johnson and Johnson COVID vaccine and Moderna vaccine had done a number of side effects as she had body aches and it hurts from inside your bones out.   No treatment medications were provided by the reporter.  Patient had signed herself up for the Pfizer booster but thought she should look into it further before getting it. Patient had called in March of this past year when symptoms were horrific and was not going away and reported that appointment was not until March of 2023.