chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Chest pain, Exercise tolerance decreased, Full blood count, Inflammatory marker increased
Clinical narrative: Intermittent chest pain/palpitations. Treated with methylprednisolone x2 taper packs (4 mg).  Chest pain mostly resolve except occasional light chest pain with occasional light palpitations. Physical activity stopped.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Palpitations
Clinical narrative: Intermittent chest pain/palpitations. Treated with methylprednisolone x2 taper packs (4 mg).  Chest pain mostly resolve except occasional light chest pain with occasional light palpitations. Physical activity stopped.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05H21A, 016C21A and 020B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Adhesive tape allergy.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2022, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2022, SARS-CoV-2 test: Positive. Patient stated she took regular medications on daily basis but she have not reported the names because they are a lot. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment details was not reported by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: She had progressively worse side effects from those but they happened within two hours of having the shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (She had progressively worse side effects from those but they happened within two hours of having the shots) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She had progressively worse side effects from those but they happened within two hours of having the shots). At the time of the report, IMMUNISATION REACTION (She had progressively worse side effects from those but they happened within two hours of having the shots) outcome was unknown.      Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-662616 (Patient Link).   Reporter did not allow further contact
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Product administered to patient of inappropriate age
Clinical narrative: Difficulty sleeping; Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of INSOMNIA (Difficulty sleeping) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old) in a 2-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old). On an unknown date, the patient experienced INSOMNIA (Difficulty sleeping). At the time of the report, INSOMNIA (Difficulty sleeping) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided.  2 siblings had received a dose of the Moderna COVID-19 vaccne bivalent on 21 Oct 2022 (lot number 017H22A, expiration date 29 May 2023) who were under 6 years old. Both had difficulty sleeping since receiving these doses of the vaccine. No additional doses, medications, or treatments have been administered since this error.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662626 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662626:Patient-2 case
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Product administered to patient of inappropriate age
Clinical narrative: difficulty sleeping; Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of INSOMNIA (difficulty sleeping) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old). On an unknown date, the patient experienced INSOMNIA (difficulty sleeping). At the time of the report, INSOMNIA (difficulty sleeping) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided.  2 siblings had received a dose of the Moderna COVID-19 vaccne bivalent on 21 Oct 2022 with lot number 017H22A and expiration date 29 May 2023 who were under 6 years old. Both had difficulty sleeping since receiving these doses of the vaccine. No additional doses, medications had been administered since that error.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662624 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662624:Patient-1 case
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) monovalent vaccine as booster dose to a 31 year old patient; expiration date 13Feb2022.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) monovalent vaccine as booster dose to a 31 year old patient), EXPIRED PRODUCT ADMINISTERED (expiration date 13Feb2022.) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR4504B, 037C21A and 014C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) monovalent vaccine as booster dose to a 31 year old patient) and EXPIRED PRODUCT ADMINISTERED (expiration date 13Feb2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) monovalent vaccine as booster dose to a 31 year old patient), EXPIRED PRODUCT ADMINISTERED (expiration date 13Feb2022.) 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 (Inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) monovalent vaccine as booster dose to a 31 year old patient) and EXPIRED PRODUCT ADMINISTERED (expiration date 13Feb2022.).    No concomitant medications were reported. Clinic manager reported that they inadvertently gave a pediatric dose of the Moderna Covid-19 vaccine (6-11 years old) as a booster dose to a patient on 24-Oct-2022. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Neighbor had side effects from his last Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Neighbor had side effects from his last Moderna shot) in a male 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 (Neighbor had side effects from his last Moderna shot). At the time of the report, IMMUNISATION REACTION (Neighbor had side effects from his last Moderna shot) outcome was unknown.            No concomitant information provided. It was reported that reporters neighbor had side effects from his last Moderna shot. No treatment information provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Suspected COVID-19
Clinical narrative: thought they had Covid; arm is sore; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (thought they had Covid) and PAIN IN EXTREMITY (arm is sore) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-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 SUSPECTED COVID-19 (thought they had Covid) and PAIN IN EXTREMITY (arm is sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of after about 9 hours later. At the time of the report, SUSPECTED COVID-19 (thought they had Covid) and PAIN IN EXTREMITY (arm is sore) outcome was unknown.      Concomitant medications details were not reported by the reporter.  Patient received first dose on 31-Jan-2021 (Batch number: 010M20A), second dose on 28-Feb-2021 (Batch number: 013A21A) and first booster dose on 22-Oct-2021 (Batch number: 012F21A) of moderna shots. Reportedly, Patient had other Moderna shots and had headaches.  Patient received Advil as an treatment medication after about 9 hours later and headache lasted until yesterday.   This case was linked to MOD-2022-663899 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2022: Follow-up document contains updated patient demographics, events added and narrative updated accordingly.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Erythema, Joint swelling, Peripheral swelling, Rash
Clinical narrative: pain in all joints; Joint, hand and feet, swelling; Joint, hand and feet, swelling; hands and feet- redness/redness in knees; Rash around body; This case was reported by a nurse via call center representative and described the occurrence of generalized joint pain in a 27-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 9722R, expiry date 20th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th October 2022, 2 days after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced generalized joint pain, peripheral swelling, swollen joints, erythema of extremities and generalized rash. On 17th October 2022, the outcome of the generalized rash was recovered/resolved. On an unknown date, the outcome of the generalized joint pain was unknown and the outcome of the peripheral swelling, swollen joints and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the generalized joint pain, peripheral swelling, swollen joints, erythema of extremities and generalized rash to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-OCT-2022 Reporter's comment: The nurse had reported that the patient was administered with Flulaval on 13 October, 2022 and by 15 October, 2022 had pain in all joints, especially hands and feet- redness and swelling. The patient had experienced swelling and redness in knees, which had gone down but was still present on 17 October, 2022.  The patient had experienced a rash around body, which had resolved. The reporter had consented to follow-up.
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero administered instead of Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a male patient who received Men B NVS (Bexsero) (batch number 9R42C, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: The nurse practitioner reported that Menveo was ordered for the patient but Bexsero was administered in error. The health care professional did not have expiration date at time of the reporting, forgot to ask about follow up but telephone number and email were present in the HCP details. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received a dose Bexsero instead of Menveo, which led to wrong vaccine administered.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Received second dose more than 36 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose).    No concomitant medications were reported.  On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine), batch no. 028A21A.  Patient was not sure if he got a monovalent or a bivalent vaccine. There was concern that it could have been a bivalent vaccine.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Product administration error
Clinical narrative: No adverse event; Bivalent was not properly administered and slipped down the patient's arm; Accidental underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Bivalent was not properly administered and slipped down the patient's arm), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) in a male 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. 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-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 24-Oct-2022, the patient experienced PRODUCT ADMINISTRATION ERROR (Bivalent was not properly administered and slipped down the patient's arm) and ACCIDENTAL UNDERDOSE (Accidental underdose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (Bivalent was not properly administered and slipped down the patient's arm), ACCIDENTAL UNDERDOSE (Accidental underdose) 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 PRODUCT ADMINISTRATION ERROR (Bivalent was not properly administered and slipped down the patient's arm) and ACCIDENTAL UNDERDOSE (Accidental underdose).    No concomitant medication information was provided.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got COVID even though had all shots; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (got COVID even though had all shots) 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 COVID-19 (got COVID even though had all shots). At the time of the report, COVID-19 (got COVID even though had all shots) outcome was unknown. Concomitant drugs were not reported. It was reported that patient had all the shots and then got COVID-19. Treatment medications were not provided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: feel a little bit logy, draggy; sore arm; body aches; running a fever of 99.8; arm was a little bit swollen; kind of pink; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (arm was a little bit swollen), SKIN DISCOLOURATION (kind of pink), FEELING ABNORMAL (feel a little bit logy, draggy), PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061FZZA) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 20-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. In October 2022, the patient experienced PERIPHERAL SWELLING (arm was a little bit swollen), SKIN DISCOLOURATION (kind of pink), MYALGIA (body aches) and PYREXIA (running a fever of 99.8). On an unknown date, the patient experienced FEELING ABNORMAL (feel a little bit logy, draggy) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In October 2022, SKIN DISCOLOURATION (kind of pink) had resolved. At the time of the report, PERIPHERAL SWELLING (arm was a little bit swollen), FEELING ABNORMAL (feel a little bit logy, draggy), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and PYREXIA (running a fever of 99.8) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, Body temperature: fever of 99.8.         Patient previously received Moderna OCVID-19 vaccine First dose on 20-Jan-2021, Second dose on 17-Feb-2021, First booster on 26-Oct-2021 and Second booster on 26-Apr-2022.  Patient had the Bivalent shot and it's their 5th Moderna shot since the vaccine became available. She had Covid the first week in June and waited 4 months before getting the new booster shot. Within 24 hours after having the Bivalent caller was running a fever of 99.8, body aches, draggy, arm was a little bit swollen and kind of pink which lasted 3 or 4 days. Patient took a Tylenol and it did relieve the symptoms.   This case was linked to MOD-2022-662883 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin discolouration
Clinical narrative: feel a little bit logy, draggy; sore arm; body aches; running a fever of 99.8; arm was a little bit swollen; kind of pink; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (arm was a little bit swollen), SKIN DISCOLOURATION (kind of pink), FEELING ABNORMAL (feel a little bit logy, draggy), PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061FZZA) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 20-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. In October 2022, the patient experienced PERIPHERAL SWELLING (arm was a little bit swollen), SKIN DISCOLOURATION (kind of pink), MYALGIA (body aches) and PYREXIA (running a fever of 99.8). On an unknown date, the patient experienced FEELING ABNORMAL (feel a little bit logy, draggy) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In October 2022, SKIN DISCOLOURATION (kind of pink) had resolved. At the time of the report, PERIPHERAL SWELLING (arm was a little bit swollen), FEELING ABNORMAL (feel a little bit logy, draggy), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and PYREXIA (running a fever of 99.8) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, Body temperature: fever of 99.8.         Patient previously received Moderna OCVID-19 vaccine First dose on 20-Jan-2021, Second dose on 17-Feb-2021, First booster on 26-Oct-2021 and Second booster on 26-Apr-2022.  Patient had the Bivalent shot and it's their 5th Moderna shot since the vaccine became available. She had Covid the first week in June and waited 4 months before getting the new booster shot. Within 24 hours after having the Bivalent caller was running a fever of 99.8, body aches, draggy, arm was a little bit swollen and kind of pink which lasted 3 or 4 days. Patient took a Tylenol and it did relieve the symptoms.   This case was linked to MOD-2022-662883 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.   In 2022, the patient received doseof mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant medication was not provided.  Pharmacist reported that 20 adult patients  received 0.25 ml instead of 0.5 ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.  Treatment information was not provided.  This case contains information for the 1st patient of twenty adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-662881:Patient14 US-MODERNATX, INC.-MOD-2022-663014: US-MODERNATX, INC.-MOD-2022-663016:Patient 1
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Achy; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Achy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achy). At the time of the report, MYALGIA (Achy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medication was not reported by reporter. Patient got the first 2 Moderna and got booster and each time patient got achy. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662819 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662819:(same reporter).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported. Pharmacist reported that 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022 No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-662875:Patient 11
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported.  It was reported that 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.   No treatment medications were reported.  This case contains information for the 3rd of 20 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662859, US-MODERNATX, INC.-MOD-2022-662863, US-MODERNATX, INC.-MOD-2022-662865, US-MODERNATX, INC.-MOD-2022-662866, US-MODERNATX, INC.-MOD-2022-662869, US-MODERNATX, INC.-MOD-2022-662873, US-MODERNATX, INC.-MOD-2022-662876, US-MODERNATX, INC.-MOD-2022-662879, US-MODERNATX, INC.-MOD-2022-662958, US-MODERNATX, INC.-MOD-2022-662995, US-MODERNATX, INC.-MOD-2022-663011, US-MODERNATX, INC.-MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871: US-MODERNATX, INC.-MOD-2022-662849: US-MODERNATX, INC.-MOD-2022-662859: US-MODERNATX, INC.-MOD-2022-662863: US-MODERNATX, INC.-MOD-2022-662865: US-MODERNATX, INC.-MOD-2022-662866: US-MODERNATX, INC.-MOD-2022-662869: US-MODERNATX, INC.-MOD-2022-662873: US-MODERNATX, INC.-MOD-2022-662876: US-MODERNATX, INC.-MOD-2022-662879: US-MODERNATX, INC.-MOD-2022-662958: US-MODERNATX, INC.-MOD-2022-662995: US-MODERNATX, INC.-MOD-2022-663011: US-MODERNATX, INC.-MOD-2022-662875: US-MODERNATX, INC.-MOD-2022-662881:Patient 3 US-MODERNATX, INC.-MOD-2022-663016:Patient 3
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 assessment was provided for UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant product use was not provided by the reporter.  Total of 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.  Treatment information was not provided.  This case contains information for the 4th of twenty adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662859, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662863, US-MODERNATX, INC.-MOD-2022-662865, US-MODERNATX, INC.-MOD-2022-662866, US-MODERNATX, INC.-MOD-2022-662869, US-MODERNATX, INC.-MOD-2022-662873, US-MODERNATX, INC.-MOD-2022-662876, US-MODERNATX, INC.-MOD-2022-662879, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-662958, US-MODERNATX, INC.-MOD-2022-662995, US-MODERNATX, INC.-MOD-2022-663010, US-MODERNATX, INC.-MOD-2022-663011, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-662875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662849: US-MODERNATX, INC.-MOD-2022-662859: US-MODERNATX, INC.-MOD-2022-662860: US-MODERNATX, INC.-MOD-2022-662863: US-MODERNATX, INC.-MOD-2022-662865: US-MODERNATX, INC.-MOD-2022-662866: US-MODERNATX, INC.-MOD-2022-662869: US-MODERNATX, INC.-MOD-2022-662873: US-MODERNATX, INC.-MOD-2022-662876: US-MODERNATX, INC.-MOD-2022-662879: US-MODERNATX, INC.-MOD-2022-662881: US-MODERNATX, INC.-MOD-2022-662958: US-MODERNATX, INC.-MOD-2022-662995: US-MODERNATX, INC.-MOD-2022-663010: US-MODERNATX, INC.-MOD-2022-663011: US-MODERNATX, INC.-MOD-2022-663014: US-MODERNATX, INC.-MOD-2022-663016: US-MODERNATX, INC.-MOD-2022-662875:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 assessment was provided for UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant drugs were not reported. It was reported that 20 adult patients received Bivalent booster from end of August to middle of October 2022. Treatment medications were not provided. The case was reported for Adult patient 5.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-662866, US-MODERNATX, INC.-MOD-2022-662861, US-MODERNATX, INC.-MOD-2022-662875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663016:Patient 5 US-MODERNATX, INC.-MOD-2022-662881:Patient 5 US-MODERNATX, INC.-MOD-2022-662860: US-MODERNATX, INC.-MOD-2022-662866:Patient 5 US-MODERNATX, INC.-MOD-2022-662871:Patient 5 US-MODERNATX, INC.-MOD-2022-663014: US-MODERNATX, INC.-MOD-2022-662861: US-MODERNATX, INC.-MOD-2022-662875:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster) 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 assessment was provided for UNDERDOSE (Patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster).    No concomitant medications were reported. 20 patients received 0.25mL instead of 0.5mL of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022. No treatment information was provided.  This case contains information for the 6th of twenty adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:Patient  US-MODERNATX, INC.-MOD-2022-662860:Patient
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported.  It was reported that 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.   No treatment medications were reported.  This case contains information for the 8 of twenty adult patients as described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-662871, MODERNATX, INC.-MOD-2022-662860, MODERNATX, INC.-MOD-2022-662881, MODERNATX, INC.-MOD-2022-663016, MODERNATX, INC.-MOD-2022-663014, MODERNATX, INC.-MOD-2022-662866, MODERNATX, INC.-MOD-2022-662861, MODERNATX, INC.-MOD-2022-662875, MODERNATX, INC.-MOD-2022-662995 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-662871:Patient 9 MODERNATX, INC.-MOD-2022-662860:Patient 3 MODERNATX, INC.-MOD-2022-662866:Patient 7 MODERNATX, INC.-MOD-2022-663014:Patient 19 MODERNATX, INC.-MOD-2022-662861:Patient 4 MODERNATX, INC.-MOD-2022-662875:Patient 11 MODERNATX, INC.-MOD-2022-663016:Patient 20 MODERNATX, INC.-MOD-2022-662881:Patient 14 MODERNATX, INC.-MOD-2022-662995:patient 16
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant medication was not provided.  Pharmacist reported that 20 adult patients received 0.25 ml instead of 0.5 ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.  Treatment information was not provided.  This case contains information for the 10th patient of twenty adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-662866 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663016:Patient 1 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-663014:Patient 19 US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662875:Patient 11 US-MODERNATX, INC.-MOD-2022-662881:Patient 2 US-MODERNATX, INC.-MOD-2022-662866:Patient 10 US-MODERNATX, INC.-MOD-2022-662861: