chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) 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 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, the patient experienced WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medication was provided.  It was reported that on 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster.   Treatment medication was not provided by the reporter.  This case contains information about patient-7 out of 26 patients
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Achy arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Achy arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 013A21A and 010M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Synthetic rubber sensitivity (Neoprene) and Allergy to antibiotic (Bacitracin). Concomitant products included APIXABAN (ELIQUIS), FLECAINIDE ACETATE, METOPROLOL SUCCINATE, SIMVASTATIN, FAMOTIDINE and FISH OIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Achy arm). At the time of the report, PAIN IN EXTREMITY (Achy arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications included Centrum Silver (1/day). the patient had never tested positive for COVID-19.  The patient reported that with all the 3 doses she just experienced achy arm.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-658626 (Linked Report). This case was linked to MOD-2022-658776 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658626:Husband case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) 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 immunisation.     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 (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medication was reported. The HCP reported that on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022, 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster were administered. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 26 doses administered to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) 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 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) 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 (26 doses administered to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster).    No relevant concomitant medications were reported.   On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any adverse events after the vaccines were given.   No treatment medication was reported.  This case contains information about 19th patient out of the 26 patients.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) 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 vaccination.  No Medical History information was reported. In October 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, the patient experienced WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine). Concomitant medications were not reported. They were not aware of any adverse event after the vaccines were given. Treatment medications were not reported. This case contains information for the 20th of 26 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event; Administration error 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; Administered vaccine to adult patient from pediatric vials of Moderna COVID-19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to adult patient from pediatric vials of Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to adult patient from pediatric vials of Moderna COVID-19 Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to adult patient from pediatric vials of Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Administration error 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to adult patient from pediatric vials of Moderna COVID-19 Vaccine).    No concomitant medications were reported.  HCP stated that on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022 they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. HCP was not aware of any adverse events after the vaccines were given.  No treatment medications were reported.  Out of 26 patients this case contains details of patient 22.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Hypoaesthesia, Limb discomfort, Muscle spasms
Clinical narrative: muscle cramp that gets worst the higher when raise the arm; Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine; numbness in fingers especially pinky fingers of injected arm; tingling in fingers especially pinky fingers of injected arm; Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side; Under arm was very swollen after the vaccine but the swelling has since went down; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle cramp that gets worst the higher when raise the arm), LIMB DISCOMFORT (Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine), HYPOAESTHESIA (numbness in fingers especially pinky fingers of injected arm), PARAESTHESIA (tingling in fingers especially pinky fingers of injected arm) and AXILLARY PAIN (Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-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 an unknown date, the patient experienced MUSCLE SPASMS (muscle cramp that gets worst the higher when raise the arm), LIMB DISCOMFORT (Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine), HYPOAESTHESIA (numbness in fingers especially pinky fingers of injected arm), PARAESTHESIA (tingling in fingers especially pinky fingers of injected arm), AXILLARY PAIN (Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side) and AXILLARY MASS (Under arm was very swollen after the vaccine but the swelling has since went down). At the time of the report, MUSCLE SPASMS (muscle cramp that gets worst the higher when raise the arm), LIMB DISCOMFORT (Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine) and AXILLARY PAIN (Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side) had not resolved, HYPOAESTHESIA (numbness in fingers especially pinky fingers of injected arm) and PARAESTHESIA (tingling in fingers especially pinky fingers of injected arm) outcome was unknown and AXILLARY MASS (Under arm was very swollen after the vaccine but the swelling has since went down) had resolved.            No concomitant medications were reported.  Patient experienced discomfort since getting the vaccine and it had not gotten any better.  No treatment medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: muscle cramp that gets worst the higher when raise the arm; Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine; numbness in fingers especially pinky fingers of injected arm; tingling in fingers especially pinky fingers of injected arm; Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side; Under arm was very swollen after the vaccine but the swelling has since went down; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle cramp that gets worst the higher when raise the arm), LIMB DISCOMFORT (Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine), HYPOAESTHESIA (numbness in fingers especially pinky fingers of injected arm), PARAESTHESIA (tingling in fingers especially pinky fingers of injected arm) and AXILLARY PAIN (Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-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 an unknown date, the patient experienced MUSCLE SPASMS (muscle cramp that gets worst the higher when raise the arm), LIMB DISCOMFORT (Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine), HYPOAESTHESIA (numbness in fingers especially pinky fingers of injected arm), PARAESTHESIA (tingling in fingers especially pinky fingers of injected arm), AXILLARY PAIN (Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side) and AXILLARY MASS (Under arm was very swollen after the vaccine but the swelling has since went down). At the time of the report, MUSCLE SPASMS (muscle cramp that gets worst the higher when raise the arm), LIMB DISCOMFORT (Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine) and AXILLARY PAIN (Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side) had not resolved, HYPOAESTHESIA (numbness in fingers especially pinky fingers of injected arm) and PARAESTHESIA (tingling in fingers especially pinky fingers of injected arm) outcome was unknown and AXILLARY MASS (Under arm was very swollen after the vaccine but the swelling has since went down) had resolved.            No concomitant medications were reported.  Patient experienced discomfort since getting the vaccine and it had not gotten any better.  No treatment medications were reported.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Pediatric patient received a 2nd booster dose from a vial with dark blue cap and a label with a purple border- Monovalent; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received a 2nd booster dose from a vial with dark blue cap and a label with a purple border- Monovalent) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received a 2nd booster dose from a vial with dark blue cap and a label with a purple border- Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received a 2nd booster dose from a vial with dark blue cap and a label with a purple border- Monovalent) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received a 2nd booster dose from a vial with dark blue cap and a label with a purple border- Monovalent).    Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: received booster on Monday and would like to report some side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (received booster on Monday and would like to report some side effects) 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 10-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 an unknown date, the patient experienced IMMUNISATION REACTION (received booster on Monday and would like to report some side effects). At the time of the report, IMMUNISATION REACTION (received booster on Monday and would like to report some side effects) outcome was unknown.        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.   No concomitant medication information was reported. No treatment information was reported.   This case was linked to MOD-2021-393473 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Immunisation reaction, Menstrual disorder
Clinical narrative: trouble with the Moderna vaccine because it's the worst of all for the side effects; affections in blood pressure and menstrual cycle; affections in blood pressure and menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (trouble with the Moderna vaccine because it's the worst of all for the side effects), BLOOD PRESSURE ABNORMAL (affections in blood pressure and menstrual cycle) and MENSTRUAL DISORDER (affections in blood pressure and menstrual cycle) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (trouble with the Moderna vaccine because it's the worst of all for the side effects), BLOOD PRESSURE ABNORMAL (affections in blood pressure and menstrual cycle) and MENSTRUAL DISORDER (affections in blood pressure and menstrual cycle). At the time of the report, IMMUNISATION REACTION (trouble with the Moderna vaccine because it's the worst of all for the side effects), BLOOD PRESSURE ABNORMAL (affections in blood pressure and menstrual cycle) and MENSTRUAL DISORDER (affections in blood pressure and menstrual cycle) outcome was unknown.        mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Patient had some trouble with the Moderna vaccine because it was the worst of all for the side effects. Patient mentioned there were affections in blood pressure and menstrual cycle, these injections should be studied more. Patient would not be getting any more injections and just use the COVID-19 pills. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1 was administered on 21-JAN-2021 and Dose 2 was administered on  26-FEB-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 21-JAN-2021 and Dose 2 was administered on  26-FEB-2021) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 prophylaxis.  Concurrent medical conditions included Dry eyes (Just dry eyes for which I take Xiidra). Concomitant products included LIFITEGRAST (XIIDRA) for Dry eyes, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 21-JAN-2021 and Dose 2 was administered on  26-FEB-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 21-JAN-2021 and Dose 2 was administered on  26-FEB-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Patient had third dose of Moderna on left arm (Lot number 011F21A)  on 29 Oct 2021. Patient had fourth dose of Pfizer on left arm (Lot FM7553) on 16 Jun 2022. On 12 Oct 2022, patient had started sneezing a lot, itchy nose, slight runny nose, body aches and had no fever and symptoms very mild and were recovering. That was first day after testing positive as a rebound after taking Paxlovid. Patient had COVID-19 treatment started on 26-SEP-2022 and last dose was administered on 1-OCT-2022. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. The Device Date was reported as 12Oct2022.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower
Clinical narrative: Severe left lower quadrant abdominal pain/his pain is worse; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN LOWER (Severe left lower quadrant abdominal pain/his pain is worse) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. UJ901AB) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced ABDOMINAL PAIN LOWER (Severe left lower quadrant abdominal pain/his pain is worse). The patient was treated with ACETAMINOPHEN for Lower abdominal pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN LOWER (Severe left lower quadrant abdominal pain/his pain is worse) had not resolved.            No concomitant medications were provided.  It was reported that patient had received 4 doses of the Moderna COVID-19 vaccines by intramuscular injection on 20-FEB-2021 (lot number unknown, expiration date unknown), 19-MAR-2021 (lot number unknown,expiration date unknown), 26-NOV-2021 (lot number 012H21B, expiration date unknown).  The lot number of dose 4 was reported as 061F22A.  It was reported that patient had taken 2 acetaminophen and was able to sleep through the night.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had COVID Disease 3 months after 2nd Monovalent Booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had COVID Disease 3 months after 2nd Monovalent Booster) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2022, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (Had COVID Disease 3 months after 2nd Monovalent Booster). The patient was treated with MONOCLONAL ANTIBODY 17-1A for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Had COVID Disease 3 months after 2nd Monovalent Booster) outcome was unknown.     No Concomitant medication was reported. Patient had had COVID and received Monoclonal antibody 3 months ago. Reporter did not allow further contact
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose; Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose), COVID-19 IMMUNISATION (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 21-Aug-2022. Past adverse reactions to the above products included No adverse event with Pfizer. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose), COVID-19 IMMUNISATION (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose), COVID-19 IMMUNISATION (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose) 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 assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose) and COVID-19 IMMUNISATION (Child received a first primary dose from Pfizer on 21Aug2022 and HCP gave her Moderna Covid 19 vaccine as a second primary dose). HCP was calling on behalf of a mother. No concomitant drug was reported. No treatment drug was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got COVID with minimal symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got COVID with minimal symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In June 2022, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, the patient experienced COVID-19 (got COVID with minimal symptoms). At the time of the report, COVID-19 (got COVID with minimal symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Negative) tested negative on the 23 or 24. No concomitant medication was provided by the reporter. It was reported that patient was senior and got COVID around 13-Jul-2022 with minimal symptoms. Patient tested negative on the 23rd or 24th. Patient had to wait 3 months to get the newest vaccine. Patient had had two regular shots and then the two boosters. No treatment medication was provided by the reporter. Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Myalgia
Clinical narrative: Had considerable body aches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Had considerable body aches) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Patient had never tested COVID-19 positive.  Previously administered products included for Product used for unknown indication: Shingles vaccine (With 2nd dose of vaccine) and Shingles vaccine (With 2nd dose of vaccine). Past adverse reactions to the above products included Myalgia with Shingles vaccine; and Shivering with Shingles vaccine. Concurrent medical conditions included Drug allergy (Sudafed allergic, cause Tachycardia). Concomitant products included NADOLOL for an unknown indication.   On 07-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) .5 milliliter and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. In September 2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced MYALGIA (Had considerable body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (Had considerable body aches) had resolved.            Patient received 0.5 mL of first dose of Moderna COVID-19 vaccine on 25-Mar-2021, Lot Number 002B21A. Patient received 0.5 mL of second dose of Moderna COVID-19 vaccine on 27-Apr-2021, Lot Number 009C21A. Patient received 0.25 mL of third dose of Moderna COVID-19 vaccine on 05-Nov-2021, Lot number 033F21A.  Patient received 0.25 mL of fourth dose of Moderna COVID-19 vaccine on 11-Apr-2022, Lot number 005M21A.  It was reported that the Body aches persisted for 18-24 hours.   This case was linked to US-MODERNATX, INC.-MOD-2022-658071, US-MODERNATX, INC.-MOD-2022-658065, US-MODERNATX, INC.-MOD-2022-658064, US-MODERNATX, INC.-MOD-2022-658061 (E2B Linked Report). This case was linked to MOD-2022-658188, MOD-2022-658148 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658071:Husband Dose 5 US-MODERNATX, INC.-MOD-2022-658065:Husband Dose 4 US-MODERNATX, INC.-MOD-2022-658064:Husband Dose 2-3 US-MODERNATX, INC.-MOD-2022-658061:Husband Dose 1
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea, Vaccination site pain
Clinical narrative: Arm was sore; Runny nose; Running a temperature; arm is sore/site is sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), RHINORRHOEA (Runny nose), PYREXIA (Running a temperature) and VACCINATION SITE PAIN (arm is sore/site is sore) in a 59-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.     The patient's past medical history included COVID-19 in May 2022. Previously administered products included for Drug use for unknown indication: Pfizer on 12-Mar-2021, Pfizer on 09-Apr-2021 and Pfizer on 26-Oct-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer, Pfizer and Pfizer.    On 12-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced PAIN IN EXTREMITY (Arm was sore), RHINORRHOEA (Runny nose), PYREXIA (Running a temperature) and VACCINATION SITE PAIN (arm is sore/site is sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore), RHINORRHOEA (Runny nose), PYREXIA (Running a temperature) and VACCINATION SITE PAIN (arm is sore/site is sore) outcome was unknown. No concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Expired Monovalent booster after 30-day Use By Date; Received Monovalent instead of Bivalent Booster by mistake/Received Monovalent booster from a Pediatric Vial (6Y-11Y)  by mistake; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake/Received Monovalent booster from a Pediatric Vial (6Y-11Y)  by mistake) 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. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date) and WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake/Received Monovalent booster from a Pediatric Vial (6Y-11Y)  by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake/Received Monovalent booster from a Pediatric Vial (6Y-11Y)  by mistake) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date) and WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake/Received Monovalent booster from a Pediatric Vial (6Y-11Y)  by mistake).    No concomitant medication information provided. It was reported that an adult patient received an expired booster dose from a Moderna COVID-19 vaccine from the vial intended for 6Y-11Y patient group.  The 30 Day beyond use date was 30-Sep-2022 and it was administered on 13-Oct-2022. They intended to give Bivalent but by mistake, they picked the Monovalent 6Y-11Y vial  that was also expired (Lot#  AR4504B & Exp. Date: 13Nov2022). The vial did not undergo any temperature excursions. No treatment information provided. This case considered of 1st adult patient of the three adult patients.   Reporter did not allow further contact.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nerve injury, Neuropathy peripheral
Clinical narrative: "Got my flu shot on 10/03/22, felt pain after the shot, thought it was normal. Pain didn't go away, spoke to physician at clinic who said it was probably a vaccine injury."  Was sent to a physician on 10/12/2022 and was prescribed Lidocaine patch, gabapentin and Tylenol, physical therapy, shoulder ultrasound, b-complex vitamins and light stretching. Treatment is ongoing at this time.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Ultrasound Doppler
Clinical narrative: "Got my flu shot on 10/03/22, felt pain after the shot, thought it was normal. Pain didn't go away, spoke to physician at clinic who said it was probably a vaccine injury."  Was sent to a physician on 10/12/2022 and was prescribed Lidocaine patch, gabapentin and Tylenol, physical therapy, shoulder ultrasound, b-complex vitamins and light stretching. Treatment is ongoing at this time.
Age: 24.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Arthralgia, Dizziness, Dysstasia, Heart rate increased, Hypertension
Clinical narrative: 10/16/2022 08:50 pm: Sudden throat tightness, dizziness, lightheadedness, followed by fainting briefly. Nausea, dizziness and lightheadedness lasted for a couple hours after. 10/17/2022 09:15 am: Dizziness and lightheadedness, worsening until I could not stand or sit up around 9:30 am. High heart rate and blood pressure, subsided by 10:00 am. Continued dizziness, lightheadedness, nausea, headaches, joint aches, and chills on and off throughout the rest of the day.
Age: 24.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Nausea, Syncope, Throat tightness
Clinical narrative: 10/16/2022 08:50 pm: Sudden throat tightness, dizziness, lightheadedness, followed by fainting briefly. Nausea, dizziness and lightheadedness lasted for a couple hours after. 10/17/2022 09:15 am: Dizziness and lightheadedness, worsening until I could not stand or sit up around 9:30 am. High heart rate and blood pressure, subsided by 10:00 am. Continued dizziness, lightheadedness, nausea, headaches, joint aches, and chills on and off throughout the rest of the day.
Age: 39.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered a 0.3 mL dose of monovalent Pfizer vaccine instead of intended 0.3 mL bivalent Pfizer vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Blister, Cutaneous vasculitis, Henoch-Schonlein purpura, Macule
Clinical narrative: * Rash - on the lower legs , ankles , and feet present for 10 days . Initially itchy . Painful when he touches . No new medications . No fever , chills , joint pain . Unsure if he had chicken pox in the past .   Exam shows erythematous macules with some necrotic centers . Some pustules and some surrounding erythema . Tend to be non - blanching lesions . 1 bulla on the ankle . Oral mucous , tongue , lips , and conjunctiva all clear .
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Necrosis, Pustule, Rash, Rash erythematous, Rash pruritic
Clinical narrative: * Rash - on the lower legs , ankles , and feet present for 10 days . Initially itchy . Painful when he touches . No new medications . No fever , chills , joint pain . Unsure if he had chicken pox in the past .   Exam shows erythematous macules with some necrotic centers . Some pustules and some surrounding erythema . Tend to be non - blanching lesions . 1 bulla on the ankle . Oral mucous , tongue , lips , and conjunctiva all clear .
Age: 70.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Wrong product administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer vaccine instead of intended 0.3 mL bivalent Pfizer booster.
Age: 47.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer booster.
Age: 46.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered
Clinical narrative: patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer booster
Age: 33.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Wrong product administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer booster.
Age: 32.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered
Clinical narrative: patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer booster.
Age: 38.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered
Clinical narrative: patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer booster.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Red circle rash at injection site. Painful and itchy to touch. About 3 inches wide. Painful, extemely hard, and inflamed.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site rash
Clinical narrative: Red circle rash at injection site. Painful and itchy to touch. About 3 inches wide. Painful, extemely hard, and inflamed.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 103.9 all day Sunday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 17:30 as dose 4 (booster), single (Lot number: GJ6665) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMICTAL; CLONIDINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 09Oct2022 at 00:30, outcome "not recovered", described as "Fever of 103.9 all day Sunday". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia. Additional information: Fever of 103.9 all day Sunday, did respond to Tylenol and Advil but spiked again 4-6 hours later. No covid prior vaccination. Not covid tested post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.