chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; patient received 0.25 instead of 0.5 of the Moderna Bivalent vaccine/accidental under dose of the Moderna Bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 of the Moderna Bivalent vaccine/accidental under dose of the Moderna Bivalent booster) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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 (patient received 0.25 instead of 0.5 of the Moderna Bivalent vaccine/accidental under dose of the Moderna Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 of the Moderna Bivalent vaccine/accidental under dose of the Moderna 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 (patient received 0.25 instead of 0.5 of the Moderna Bivalent vaccine/accidental under dose of the Moderna Bivalent booster).    No concomitant medication details was reported.  It was reported that the patient received 0.25 instead of 0.5 in the beginning of the month or last month. Patient was over 18 years old and should have received the 0.5 dose.  No treatment medication details was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 74-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 treatment: Ginger (To fight COVID) in 2020 and Zinc (To fight COVID) in 2020. Past adverse reactions to the above products included No adverse event with Ginger and Zinc.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not provided.  It was reported that in 2020 before there was a treatment for COVID patient had used zinc and ginger to fight COVID and it worked and kept it away. Then he had took the Moderna COVID vaccine. Now he could not find a way to get rid of it. It grewand kept replicating. He thought he was okay after vaccine but maybe it was still there.  Treatment medications were not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus
Clinical narrative: itching in her lower arms; Shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching in her lower arms) and DYSPNOEA (Shortness of breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 609F21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (sulfa antibiotics), Allergy to antibiotic (Z-pak), Asthma (since early 20s Recent change in status: stable with medications except for asthma attack after 2nd dose using Albuterol, Pulmicort.) and Blood pressure high (2 years ago Recent change in status: stable) since 2020. Concomitant products included ALBUTEROL [SALBUTAMOL] and BUDESONIDE (PULMICORT) for Asthma, DILTIAZEM, THIORIDAZINE, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), IBUPROFEN (ADVIL [IBUPROFEN]), IRON, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and CALCIUM CITRATE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced PRURITUS (itching in her lower arms) and DYSPNOEA (Shortness of breath). On 07-Jan-2021, PRURITUS (itching in her lower arms) and DYSPNOEA (Shortness of breath) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient had no history of COVID-19 infection and no history of Myocarditis or pericarditis. Patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  After 1st dose patient experienced itching in her lower arms and shortness of breath during 1 hour. After 1st booster she experienced again itching and shortness of breath during 10 or 15 minutes.. Patient called her pulmonologist to seek medical care for Adverse events. Cardiac related signs and symptoms: Patient experienced the symptom shortness of breath on 7Jan2021, 4Feb2021, and 3Dec2021 and related with 1st, 2nd and 1st booster dose and resolved. No timeline of symptoms, including Cardiac Lab values cause determined. No history of Myocarditis/pericarditis.   This case was linked to MOD-2022-661757 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Pyrexia, Somnolence
Clinical narrative: Sleepy; loss of appetite; slight fever; chills; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Sleepy), DECREASED APPETITE (loss of appetite), PYREXIA (slight fever) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 031L20A and 039F21A) for COVID-19 prophylaxis.     The patient's past medical history included Acid reflux (esophageal) (Severe). Concurrent medical conditions included Asthma and Blood pressure high. Concomitant products included AMLODIPINE, LOSARTAN, EXEMESTANE, OMEPRAZOLE and ATORVASTATIN for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced SOMNOLENCE (Sleepy), DECREASED APPETITE (loss of appetite), PYREXIA (slight fever) and CHILLS (chills). At the time of the report, SOMNOLENCE (Sleepy), DECREASED APPETITE (loss of appetite), PYREXIA (slight fever) and CHILLS (chills) outcome was unknown.            On 09 Feb 2021, the patient had experienced the events of slight fever, sleepy, loss of appetite, and chills after Dose 1 of Moderna COVID-19 vaccine. On 09 Mar 2021, the patient had experienced the events of slight fever, sleepy, loss of appetite, and chills after Dose 2 of Moderna COVID-19 vaccine. On 04 Nov 2021, the patient had experienced the events of slight fever, sleepy, loss of appetite, and chills after first booster dose of Moderna COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to MOD-2022-661435 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She got sick from COVID-19 vaccine (Moderna); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She got sick from COVID-19 vaccine (Moderna)) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She got sick from COVID-19 vaccine (Moderna)). At the time of the report, ILLNESS (She got sick from COVID-19 vaccine (Moderna)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling hot, Pyrexia, Somnolence
Clinical narrative: Got very hot; sleepy; loss of appetite; she was burning up with a high fever/slight fever; chills; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Got very hot), SOMNOLENCE (sleepy), DECREASED APPETITE (loss of appetite), PYREXIA (she was burning up with a high fever/slight fever) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 039F21A, 031L20A and 030M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma, Blood pressure high and Acid reflux (esophageal) (Severe). Concomitant products included AMLODIPINE, LOSARTAN, EXEMESTANE, OMEPRAZOLE and ATORVASTATIN for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced SOMNOLENCE (sleepy), DECREASED APPETITE (loss of appetite), PYREXIA (she was burning up with a high fever/slight fever) and CHILLS (chills). On 14-May-2022 at 5:00 AM, the patient experienced FEELING HOT (Got very hot). At the time of the report, FEELING HOT (Got very hot), SOMNOLENCE (sleepy), DECREASED APPETITE (loss of appetite), PYREXIA (she was burning up with a high fever/slight fever) and CHILLS (chills) outcome was unknown.            The patient had received Omeprazole DR. On 04-Nov-2021, the patient received the 1st Booster dose of Moderna COVID-19 Vaccine. On 05-May-2022, the patient received the 2nd Booster dose of Moderna COVID-19 Vaccine. Patient reported that she got very hot at 5AM on 14-May-2022. She felt like she was burning up with a high fever. a slight fever, sleepy, loss of appetite, and chills. No treatment medications were reported.   This case was linked to MOD-2022-661406 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: injection site arm is itchy; injection site arm is red; injection site arm is hard; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (injection site arm is itchy), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE INDURATION (injection site arm is hard) 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 18-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced VACCINATION SITE PRURITUS (injection site arm is itchy), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE INDURATION (injection site arm is hard). At the time of the report, VACCINATION SITE PRURITUS (injection site arm is itchy), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE INDURATION (injection site arm is hard) outcome was unknown.            Concomitant medications details were not reported by the reporter.  The patient received first Moderna Covid 19 vaccine primary series on 4-FEB-2021. The patient received second Moderna Covid 19 vaccine primary series on 2-MAR-2021. The patient received first Moderna Covid 19 vaccine booster dose on 5-NOV-2021. Patient reported no Adverse reactions after first booster. The patient received second Moderna Covid 19 vaccine booster dose on 29-APR-2022.   Treatment details was not reported by the reporter.   This case was linked to MOD-2022-661563, MOD-2022-661585, MOD-2022-661589 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: My friend mentioned that she had a fever after her Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (My friend mentioned that she had a fever after her Moderna booster) 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 PYREXIA (My friend mentioned that she had a fever after her Moderna booster). At the time of the report, PYREXIA (My friend mentioned that she had a fever after her Moderna booster) outcome was unknown.     No concomitant medications were reported. No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Pruritus
Clinical narrative: shortness of breath; asthma attack; itching in lower arms; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), ASTHMA (asthma attack) and PRURITUS (itching in lower arms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Allergy to antibiotic, Drug allergy (Z-pak), Asthma (since early 20s, was stable with medications except for asthma attack after 2nd dose) and Blood pressure high (2 years ago, stable). Concomitant products included DILTIAZEM, ALBUTEROL [SALBUTAMOL], BUDESONIDE (PULMICORT), THIORIDAZINE, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), IBUPROFEN (ADVIL [IBUPROFEN]), IRON, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and CALCIUM CITRATE for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPNOEA (shortness of breath), ASTHMA (asthma attack) and PRURITUS (itching in lower arms). On 04-Feb-2021, DYSPNOEA (shortness of breath), ASTHMA (asthma attack) and PRURITUS (itching in lower arms) had resolved.            Patient had no history of COVID-19 infection and no history of Myocarditis or pericarditis. Patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Patient had asthma attacks before. Patient experienced itching in lower arms and shortness of breath during 15 minutes and 10 minutes later patient experienced an asthma attack. Patient used inhaler Albuterol and Pulmicort for asthma attack.   This case was linked to MOD-2022-661394 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14OCT2022 and 15OCT2022; No adverse event; Moderna COVID-19 vaccines were given as first doses after the 30 day refrigeration mark; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given as first doses after the 30 day refrigeration mark), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14OCT2022 and 15OCT2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In October 2022,  after starting mRNA-1273 (Spikevax), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given as first doses after the 30 day refrigeration mark). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14OCT2022 and 15OCT2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given as first doses after the 30 day refrigeration mark), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14OCT2022 and 15OCT2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccines were given as first doses after the 30 day refrigeration mark) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14OCT2022 and 15OCT2022).    No concomitant medication was reported.  The doses were administered on 14-OCT-2022 and 15-OCT-2022 for 2 different patient.  The vial did not undergo any temperature excursions.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-661762 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661762:MOD-2022-661762 (patient case)
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; monovalent dose ages 6-11 administered instead of bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose).    No concomitant drug information was provided.  It was reported that patient was supposed to receive the bivalent booster dose but instead they were given the monovalent vaccine ages 6-11.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-659987, US-MODERNATX, INC.-MOD-2022-661797, US-MODERNATX, INC.-MOD-2022-661798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659987:same reporter US-MODERNATX, INC.-MOD-2022-661797:Same reporter US-MODERNATX, INC.-MOD-2022-661798:Same reporter
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; monovalent dose ages 6-11 administered instead of bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose).    No concomitant medication was provided.  It was reported that 4 patients were supposed to receive the bivalent booster dose instead they were given the monovalent vaccine ages 6-11.  Treatment medication was not provided by the reporter.  This case contains information of 3rd patient out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-661790, US-MODERNATX, INC.-MOD-2022-659987 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661790:Same reporter
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; monovalent dose ages 6-11 administered instead of bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose).    No concomitant medication was provided.  It was reported that 4 patients were supposed to receive the bivalent booster dose instead they were given the monovalent vaccine ages 6-11.  Treatment medication was not provided by the reporter.  This case contains information of 4th patient out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-659987, US-MODERNATX, INC.-MOD-2022-661797, US-MODERNATX, INC.-MOD-2022-661790, US-MODERNATX, INC.-MOD-2022-661797 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659987:Same reporter (1st of 4 patients) US-MODERNATX, INC.-MOD-2022-661797:Same reporter (3rd of 4 patients) US-MODERNATX, INC.-MOD-2022-661790:Same reporter (2nd of 4 patients) US-MODERNATX, INC.-MOD-2022-661797:Same reporter
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: right arm was itchy for two days after receiving the bivalent Covid-19 vaccine; Swollen right arm; Arm was hurting from her wrist to her the neck; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (right arm was itchy for two days after receiving the bivalent Covid-19 vaccine), PERIPHERAL SWELLING (Swollen right arm) and PAIN IN EXTREMITY (Arm was hurting from her wrist to her the neck) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050P224) for COVID-19 prophylaxis.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 17-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced PAIN IN EXTREMITY (Arm was hurting from her wrist to her the neck). On 18-Oct-2022, the patient experienced PRURITUS (right arm was itchy for two days after receiving the bivalent Covid-19 vaccine) and PERIPHERAL SWELLING (Swollen right arm). On 19-Oct-2022, PRURITUS (right arm was itchy for two days after receiving the bivalent Covid-19 vaccine) and PERIPHERAL SWELLING (Swollen right arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was hurting from her wrist to her the neck) outcome was unknown.            Patient received first Moderna Covid 19 vaccine primary series on 16-Jan-2021 Lot number 041620A expiration date is not known Left arm of administration. The patient received second Moderna Covid 19 vaccine primary series on 13-Feb-2021 Lot number 016M20A expiration date is not known left arm of administration. The patient received first Moderna Covid 19 vaccine booster dose on 19-Aug-2021 Lot number 041B21A expiration date is not known left arm of administration. The patient received second Moderna Covid 19 vaccine booster dose on 27-Apr-2022 Lot number 041L21A expiration date is not known left arm of administration. The patient received her bivalent booster dose on Monday 17-Oct-2022. Her arm was swollen and itchy on Tuesday 18-Oct-2022 and Wednesday 19-Oct-2022. The patient's right arm was itchy for two days after receiving the bivalent Covid-19 vaccine. She had a swollen right arm.  Arm was hurting from her wrist to her the neck.  Treatment details were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662126 (E2B Linked Report). This case was linked to MOD-2022-661808 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662126:Same reporter
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slightly sore arm/slight arm soreness/sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (slightly sore arm/slight arm soreness/sore left arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L21A, 041B21A, 016M20A and 041620A) for COVID-19 prophylaxis.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (slightly sore arm/slight arm soreness/sore left arm). At the time of the report, VACCINATION SITE PAIN (slightly sore arm/slight arm soreness/sore left arm) outcome was unknown.            The patient experienced slightly sore arm/slight arm soreness/sore left arm after 1st dose (16/Jan/2021), 2nd dose (13/Feb/2021), first booster (19/Aug/2021) and second booster (27/Apr/2022).  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662126 (E2B Linked Report). This case was linked to MOD-2022-661802 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662126:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: she does not feel that she got a full dose. After administering the vaccine, she had a small drop of vaccine that came out of her arm; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (she does not feel that she got a full dose. After administering the vaccine, she had a small drop of vaccine that came out of her arm) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (she does not feel that she got a full dose. After administering the vaccine, she had a small drop of vaccine that came out of her arm) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (she does not feel that she got a full dose. After administering the vaccine, she had a small drop of vaccine that came out of her arm) 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 ACCIDENTAL UNDERDOSE (she does not feel that she got a full dose. After administering the vaccine, she had a small drop of vaccine that came out of her arm).    No concomitant medication were reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered with expired monovalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired monovalent vaccine) 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 EXPIRED PRODUCT ADMINISTERED (Administered with expired monovalent vaccine).    No concomitant medication reported.  Patient was inadvertently administered with the monovalent vaccine which was past beyond the manufacturer expiration date.   The vial size was 5.5 ml. The vial did not undergo any temperature excursions. The vial was removed from the freezer to the refrigerator on 02-Sep-2022.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-661787 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2022: Live follow-up received and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661787:Bivalent Dose Case
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; an adult received 0.25 ml of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (an adult received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-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) .25 milliliter. On 20-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (an adult received 0.25 ml of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (an adult received 0.25 ml of the bivalent vaccine) 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 (an adult received 0.25 ml of the bivalent vaccine).    Concomitant medication was not provided.  Patient received two primary doses and one booster dose.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired Moderna vaccine given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine given) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 17-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine given). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine given) 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 EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine given).    No concomitant medications were provided. The nurse practitioner stated that expired Moderna vaccine was given.  The dose on the vial was 100 mcg/0.5 ml, but the vial volume was unknown.  The patient information was unknown, but it was the second dose for the patient. The nurse practitioner did not have the date of initial thaw.  The date of vial which was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. No treatment medication was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: trouble walking; her head felt really hot; her hands felt really cold; her upper arm sore; headache; her temperature was not very high; Sweats; she really did not feel good; chills; aching in her joints; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Sweats), MALAISE (she really did not feel good), GAIT DISTURBANCE (trouble walking), FEELING HOT (her head felt really hot) and PERIPHERAL COLDNESS (her hands felt really cold) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053022A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer COVID-19 vaccine (1st dose, lot number: ER8727) on 18-Mar-2021, Pfizer COVID-19 vaccine (2nd dose, lot number: ER8729) on 08-Apr-2021, Pfizer COVID-19 vaccine (1st booster dose and lot number: FU162C) on 16-Mar-2022. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Concomitant products included LISINOPRIL and METFORMIN for an unknown indication.    On 19-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 19-Oct-2022, the patient experienced HYPERHIDROSIS (Sweats), MALAISE (she really did not feel good), CHILLS (chills) and ARTHRALGIA (aching in her joints). On 20-Oct-2022, the patient experienced GAIT DISTURBANCE (trouble walking), FEELING HOT (her head felt really hot), PERIPHERAL COLDNESS (her hands felt really cold) and HEADACHE (headache). 20-Oct-2022, the patient experienced PAIN IN EXTREMITY (her upper arm sore) and PYREXIA (her temperature was not very high). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweats), MALAISE (she really did not feel good), GAIT DISTURBANCE (trouble walking), FEELING HOT (her head felt really hot), PERIPHERAL COLDNESS (her hands felt really cold), PAIN IN EXTREMITY (her upper arm sore), CHILLS (chills), ARTHRALGIA (aching in her joints), HEADACHE (headache) and PYREXIA (her temperature was not very high) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     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.   The patient had no allergies and no acute and chronic illnesses at the time of vaccination. The patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient had never had COVID + test or diagnosis.  On 19-Oct-2022, the patient received the booster dose of Moderna COVID-19 vaccine, Bivalent. The patient took 5 Baby Aspirins.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slightly sore left arm/sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slightly sore left arm/sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 012M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Slightly sore left arm/sore left arm). At the time of the report, VACCINATION SITE PAIN (Slightly sore left arm/sore left arm) outcome was unknown.            No concomitant product was reported.  The patient experienced sore left arm on 23-Aug-2021, after first Moderna COVID-19 vaccine booster.  The patient received second Moderna COVID-19 vaccine booster dose on 27-Apr-2022 in left arm. Patient had no adverse reactions.  The patient received first Moderna COVID-19 bivalent vaccine booster dose on 17-Oct-2022 (Batch number- 050D22A) in left arm. Patient had no adverse reactions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-661802 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661802:Same reporter
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: sore arm; the vaccine was administered undiluted to a 3 year old female patient; the vaccine was administered undiluted to a 3 year old female patient; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 3-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2022 as dose 3 (maroon cap; booster), single (Lot number: FT9142) at the age of 3 years for covid-19 immunisation. The patient's relevant medical history included: "antibiotic" (unspecified if ongoing). Concomitant medication(s) included: BACTRIM PAEDIATRIC taken for antibiotic therapy, start date: 08Aug2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 29Jul2022, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 19Aug2022, for Covid-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 14Oct2022, outcome "unknown" and all described as "the vaccine was administered undiluted to a 3 year old female patient"; PAIN IN EXTREMITY (non-serious) with onset 15Oct2022, outcome "recovered" (16Oct2022), described as "sore arm".  Additional information: A non-diluted covid vaccine was administered to a 3-year-old patient. Forgot to dilute in sodium chloride. The reporter was asking for advice on what to inform patient and what to do next. It was clarified that the type of medication error was overdose. The stage of medication error was preparation and administration. It was reported that pharmacy student comes once a week and was very busy and made the mistake. The overdose event was for the 3rd dose of the vaccine. The reporter called the patient 4-5 times since the overdose incident to check on them. Friday, 14Oct2022, the day of the overdose, the patient was fine and did not need any medical evaluation or treatment. Saturday (15Oct2022) she called the patient at 10:00 and the mom said the patient had a sore arm. Sunday (16Oct2022) she called the patient at 9:30 and the mom said the arm was arm still a little sore, but by 17:00 on Sunday no more sore arm. She called the patient on Monday (17Oct2022) and the patient was fine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (18Oct2022): This is a spontaneous follow-up report received from a contactable Pharmacist. This pharmacist reported in response to HCP telephonic follow-up activity. Updated information included: Historical vaccines (dose 1 and dose 2 added), medical history (antibiotic therapy added), Suspected vaccine (lot number FT9142, vaccination date, Dosage regimen, Vaccination facility details for dose 3), concomitant (Bactrim paediatric added), event data (Pain in arm added, onset date for vaccine overdose and product concentrate not diluted added) and additional information updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pharyngeal swelling, Urticaria
Clinical narrative: noticed slight swelling of throat; hives on right arm; Day of vaccination and day after headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 12Oct2022 at 09:00, outcome "recovering", described as "Day of vaccination and day after headaches"; URTICARIA (non-serious) with onset 14Oct2022, outcome "recovering", described as "hives on right arm"; PHARYNGEAL SWELLING (non-serious) with onset 14Oct2022, outcome "recovering", described as "noticed slight swelling of throat". Therapeutic measures were taken as a result of headache, pharyngeal swelling, urticaria.  Additional information: The patient had no known allergies. The patient did not receive other vaccine in four weeks or other medications in two weeks. Day of vaccination and day after headaches. 14Oct noticed hives on right arm and noticed slight swelling of throat. The patient took Benadryl-antihistamine which mitigated symptoms such as itching. The patient took OTC antihistamines which helped. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.