chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Nausea, Neck pain, Pain
Clinical narrative: Nausea; Injection site soreness; Uncomfortable; Back Pain/body, neck and back aches; Neck Pain/body, neck and back aches; Body aches/body, neck and back aches; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 929PN, expiry date 29-MAR-2025) for prophylaxis.   On 20-DEC-2023 10:40, the patient received Arexvy (left arm). In DEC-2023, an unknown time after receiving Arexvy, the patient experienced discomfort (Verbatim: Uncomfortable), back pain (Verbatim: Back Pain/body, neck and back aches), neck pain (Verbatim: Neck Pain/body, neck and back aches), general body pain (Verbatim: Body aches/body, neck and back aches) and chills (Verbatim: Chills). On 20-DEC-2023, the patient experienced injection site pain (Verbatim: Injection site soreness). On 21-DEC-2023 02:00, the patient experienced nausea (Verbatim: Nausea). The patient was treated with paracetamol (Tylenol). The outcome of the injection site pain, discomfort, back pain, neck pain, general body pain and chills were not resolved and the outcome of the nausea was resolved.   It was unknown if the reporter considered the injection site pain, nausea, discomfort, back pain, neck pain, general body pain and chills to be related to Arexvy.     It was unknown if the company considered the injection site pain, nausea, discomfort, back pain, neck pain, general body pain and chills to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-DEC-2023 The patient self-reported this case. The patient reported that the injection site got sore as the evening progressed and was still sore today (on reporting day). The patient also reported that she had chills last night from reporting starting around midnight, where she was so cold, she had to drink a warm drink to warm up, and was still cold on reporting day. The patient also reported she had body, neck and back aches that started around midnight last night from reporting, and she still had these aches on reporting day. The patient was very uncomfortable and having to use heat on her back. The patient also reported that she had nausea that started around 2:30 to 2 AM (15 hours 20 minutes after vaccination) on reporting day morning, but it was now gone. The patient reported that she took 1-Tylenol Rapid Release 500 mg tablet around 1 to 2 AM reporting day morning; and the patient took 2 more Tylenol Rapid Release 500 mg tablets reporting day morning (no specific time provided). The reporter consented to follow up.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Pregnant patient received Arexvy; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-DEC-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnant patient received Arexvy). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 21-Dec-2023 The patient was self-reported this case. The patient reported that she received wrong vaccine during pregnancy at pharmacy. The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Incorrect route of product administration
Clinical narrative: female patient received a dose of Pediarix via subcutaneous route on 19Dec2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis.   On 19-DEC-2023, the patient received Pediarix (subcutaneous). On 19-DEC-2023, an unknown time after receiving Pediarix, the patient experienced intramuscular formulation administered by other route (Verbatim: female patient received a dose of Pediarix via subcutaneous route on 19Dec2023). The outcome of the intramuscular formulation administered by other route 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: 21-DEC-2023 A nurse reported that a patient received a dose of Pediarix via subcutaneous route, which led to intramuscular formulation administered by other route.  No symptoms reported. The reporter consented to follow up via email.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: she inadvertently administered a pediatric dose of Engerix-B to 39 year old female patient; she inadvertently administered a pediatric dose of Engerix-B to 39 year old female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 39-year-old female patient who received HBV (Engerix B pediatric) (batch number F5L5E, expiry date 11-APR-2025) for prophylaxis.   On 14-DEC-2023, the patient received the 2nd dose of Engerix B pediatric. On 14-DEC-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: she inadvertently administered a pediatric dose of Engerix-B to 39 year old female patient) and adult use of a child product (Verbatim: she inadvertently administered a pediatric dose of Engerix-B to 39 year old female patient). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-DEC-2023 The reporter was pharmacy intern calling on behalf of a nurse who reported that she inadvertently administered a pediatric dose of Engerix-B to patient, which led to accidental underdose and adult use of a child product. No further dosing had been administered as of time of call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: possible inappropriate reconstitution; administered 1 vaccine that was just diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 37d4f, expiry date 20-MAR-2025) for prophylaxis.   On 21-DEC-2023, the patient received Arexvy. On 21-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: possible inappropriate reconstitution) and inappropriate dose of vaccine administered (Verbatim: administered 1 vaccine that was just diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-DEC-2023 The reporter reported that they had a medication error on the day of reporting where a couple (patients) came in for their RSV Arexvy vaccines and they administered 1 vaccine that was just diluent and 1 that was correctly prepared. They were trying to find a course of action here because they did not know which patient got the vaccine and was protected who just got diluent, so they were wondering what recommendation was. Reporter wanted to know, could they revaccinate both patients, knowing that one person (patient) would be getting a double dose. The reporter consented to follow-up. The reporter reported that they administered only diluent of Arexvy vaccine to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with the case US2023178723, reported by same reporter.; Sender's Comments:  US-GSK-US2023178723:Same reporter
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: administered 1 vaccine that was just diluent; administered 1 vaccine that was just diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 37d4f, expiry date 20-MAR-2025) for prophylaxis.   On 21-DEC-2023, the patient received Arexvy. On 21-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered 1 vaccine that was just diluent) and inappropriate dose of vaccine administered (Verbatim: administered 1 vaccine that was just diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-DEC-2023 The reporter reported that they had a medication error on reporting day where a couple came in for their RSV Arexvy vaccines and they administered 1 vaccine that was just diluent and 1 that was correctly prepared. They were trying to find a course of action here because they did not know which patient got the vaccine and was protected who just got diluent so they were wondering what was recommendation. Reporter asked question that could they revaccinate both of them, knowing that one patient would be getting a double dose. The vaccine administration facility was the same as primary reporter The reporter consented to follow-up. The reporter reported that they administered Arexvy vaccine only diluent to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with the case US2023178722, reported by same reporter.; Sender's Comments:  US-GSK-US2023178722:Same reporter
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: pregnant female was administered AREXVY (Wrong Vaccine Administered) instead of ABRYSVO; pregnant female was administered AREXVY (Wrong Vaccine Administered) instead of ABRYSVO.; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-DEC-2023, the patient received Arexvy. On 19-DEC-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: pregnant female was administered AREXVY (Wrong Vaccine Administered) instead of ABRYSVO.) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant female was administered AREXVY (Wrong Vaccine Administered) instead of ABRYSVO). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-DEC-2023 The reporter called to report that a pregnant patient was administered Arexvy (Wrong Vaccine Administered) instead of Abrysvo, which led to vaccine exposure during pregnancy and wrong vaccine administered. The patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration. No further information was known.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site hypersensitivity, Pain in extremity
Clinical narrative: little sore; Patient had local sensitivity for a day or two after the previous doses.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (little sore) and INJECTION SITE HYPERSENSITIVITY (Patient had local sensitivity for a day or two after the previous doses.) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     The patient's past medical history included Leg discomfort.    On 28-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced PAIN IN EXTREMITY (little sore) and INJECTION SITE HYPERSENSITIVITY (Patient had local sensitivity for a day or two after the previous doses.). At the time of the report, PAIN IN EXTREMITY (little sore) outcome was unknown and INJECTION SITE HYPERSENSITIVITY (Patient had local sensitivity for a day or two after the previous doses.) had resolved.            The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to MOD-2023-754417 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Inappropriate schedule of product administration, Lethargy
Clinical narrative: She was very lethargic; patient ended up in bed for a couple of days and thought she had COVID-19; Patient took 1st dose on Feb 2021 and took 2nd dose on Oct 2021; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (She was very lethargic), BEDRIDDEN (patient ended up in bed for a couple of days and thought she had COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on Feb 2021 and took 2nd dose on Oct 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (She was very lethargic), BEDRIDDEN (patient ended up in bed for a couple of days and thought she had COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on Feb 2021 and took 2nd dose on Oct 2021). At the time of the report, LETHARGY (She was very lethargic), BEDRIDDEN (patient ended up in bed for a couple of days and thought she had COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on Feb 2021 and took 2nd dose on Oct 2021) outcome was unknown.            Patient year of birth was reported.  Concomitant product use was not provided by the reporter.  It was reported the patient had a bad reaction from the second dose of the Moderna vaccine, clarified as the patient ended up in bed for a couple of days and thought she had COVID-19. She was very lethargic. The patient had a booster dose of Pfizer BioNTech COVID-19 vaccine in NOV-2022 and did not have any reaction.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Post vaccination syndrome
Clinical narrative: post vaccination syndrome; This spontaneous case was reported by a consumer and describes the occurrence of POST VACCINATION SYNDROME (post vaccination syndrome) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Moderna COVID-19 vaccine (Dose 2) and Moderna COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On an unknown date, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST VACCINATION SYNDROME (post vaccination syndrome). At the time of the report, POST VACCINATION SYNDROME (post vaccination syndrome) outcome was unknown.            Concomitant and treatment medications were not reported.  Reported that patient received Moderna COVID-19 vaccine dose 1 and dose 2, and then a booster shot (dose 3) 1 year later for COVID-19 vaccination. It was reported the patient was diagnosed with post vaccination syndrome by their doctor.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral coldness
Clinical narrative: the patient's fingertips on both hands are numb, hurt, and stay cold all the time; the patient's  fingertips on both hands are numb, hurt, and stay cold all the time; the patient's  fingertips on both hands are numb, hurt, and stay cold all the time; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (the patient's fingertips on both hands are numb, hurt, and stay cold all the time), PAIN IN EXTREMITY (the patient's  fingertips on both hands are numb, hurt, and stay cold all the time) and HYPOAESTHESIA (the patient's  fingertips on both hands are numb, hurt, and stay cold all the time) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (the patient's fingertips on both hands are numb, hurt, and stay cold all the time), PAIN IN EXTREMITY (the patient's  fingertips on both hands are numb, hurt, and stay cold all the time) and HYPOAESTHESIA (the patient's  fingertips on both hands are numb, hurt, and stay cold all the time). At the time of the report, PERIPHERAL COLDNESS (the patient's fingertips on both hands are numb, hurt, and stay cold all the time), PAIN IN EXTREMITY (the patient's  fingertips on both hands are numb, hurt, and stay cold all the time) and HYPOAESTHESIA (the patient's  fingertips on both hands are numb, hurt, and stay cold all the time) outcome was unknown.            No concomitant medication was reported.  It was reported that after their last Moderna booster, Patient experienced events.  No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (Covid). At the time of the report, COVID-19 (Covid) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       This case contains information for the 1st patient out of 2 patients described by the reporter.  No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-754679 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-754679:Same reporter (2nd Patient)
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Erythema, Feeling hot, Gastroenteritis, Rash, Weight
Clinical narrative: Stomach flu/stomach bug; Warm to the touch (localised feeling of warmth); Redness; Rash on the right side of her abdomen that spread; This spontaneous case was reported by a patient and describes the occurrence of GASTROENTERITIS (Stomach flu/stomach bug), FEELING HOT (Warm to the touch (localised feeling of warmth)), ERYTHEMA (Redness) and RASH (Rash on the right side of her abdomen that spread) in a 56-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for Immunisation.    Co-suspect product included non-company product INFLUENZA VACCINE for Immunisation.    Previously administered products included for Drug use for unknown indication: Remodulin. Past adverse reactions to the above products included No adverse event with Remodulin. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included BIFIDOBACTERIUM LACTIS, CURCUMA LONGA, PREDNISONE, LEVOTHYROXINE SODIUM (UNITHROID), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), TADALAFIL, CARVEDILOL, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), METFORMIN, RABEPRAZOLE, IRON, OXYGEN, VALSARTAN, CALCIUM, MAGNESIUM, VITAMIN C [ASCORBIC ACID], ALBUTEROL [SALBUTAMOL], FUROSEMIDE (LASIX [FUROSEMIDE]), MONTELUKAST, CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC-D), GUAIFENESIN (MUCINEX), ROSUVASTATIN CALCIUM (CRESTOR), AMBRISENTAN, HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE), VITAMIN D2, VITAMIN B NOS, EMPAGLIFLOZIN (JARDIANCE) and MAGNESIUM SULFATE (EPSOM SALT) for an unknown indication.   On 15-Oct-2023, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced GASTROENTERITIS (Stomach flu/stomach bug), FEELING HOT (Warm to the touch (localised feeling of warmth)), ERYTHEMA (Redness) and RASH (Rash on the right side of her abdomen that spread). At the time of the report, GASTROENTERITIS (Stomach flu/stomach bug), FEELING HOT (Warm to the touch (localised feeling of warmth)), ERYTHEMA (Redness) and RASH (Rash on the right side of her abdomen that spread) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2023, Weight: 182.6 lbs. In October 2023, Weight: 183 lbs.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I wanted to report my symptoms; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (I wanted to report my symptoms) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I wanted to report my symptoms). At the time of the report, IMMUNISATION REACTION (I wanted to report my symptoms) outcome was unknown.            No Concomitant medications provided by the reporter.  No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had COVID) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (had COVID). At the time of the report, COVID-19 (had COVID) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-754645 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-754645:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Pain in extremity
Clinical narrative: it it last only one day with a previous dose where it was a little sore.; I had local sensitivity for a day or two after the shot in my left shoulder upper arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (it it last only one day with a previous dose where it was a little sore.) and INJECTION SITE HYPERSENSITIVITY (I had local sensitivity for a day or two after the shot in my left shoulder upper arm) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 prophylaxis.     The patient's past medical history included Peripheral arterial disease (blockage in legs.).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (it it last only one day with a previous dose where it was a little sore.) and INJECTION SITE HYPERSENSITIVITY (I had local sensitivity for a day or two after the shot in my left shoulder upper arm). In 2021, PAIN IN EXTREMITY (it it last only one day with a previous dose where it was a little sore.) and INJECTION SITE HYPERSENSITIVITY (I had local sensitivity for a day or two after the shot in my left shoulder upper arm) had resolved.            No concomitant medication was reported. The batch number for dose1 was reported as 0302275A- (not legible) and dose 3 as KGF12A (not legible).  It was reported that the first ones were a little stuff; but a few days later, maybe 2-3 days later the patient had local sensitivity for a day or two after the shot in the left shoulder upper arm. Patient explained that this was longer then what the patient felt with the first ones and that the last only one day with a previous dose where it was a little sore.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-754417 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-754417:Same Patient (New Variant 2023-24 dose)
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fatigue, Myalgia, Retching
Clinical narrative: covid 19; dry heaves; felt faint; Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel body aches and fatigue,; Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel fatigue,; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19), RETCHING (dry heaves), DIZZINESS (felt faint), MYALGIA (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel body aches and fatigue,) and FATIGUE (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel fatigue,) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (Dose 1, Batch-038A21A) on 22-Mar-2021, Moderna COVID-19 Vaccine (Dose 2, Batch-036B219) on 19-Apr-2021, Moderna COVID-19 Vaccine (Dose 3, Batch-034F21A) on 13-Nov-2021 and Pneumonia vaccine Prevnar (Pneumonia vaccine Prevnar). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Pneumonia vaccine Prevnar.    On 18-Dec-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Dec-2023, the patient experienced MYALGIA (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel body aches and fatigue,) and FATIGUE (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel fatigue,). On 21-Dec-2023, the patient experienced COVID-19 (covid 19), RETCHING (dry heaves) and DIZZINESS (felt faint). At the time of the report, COVID-19 (covid 19), RETCHING (dry heaves) and DIZZINESS (felt faint) had not resolved and MYALGIA (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel body aches and fatigue,) and FATIGUE (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel fatigue,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient stated she has no fever, and no shortness of breath, no drainage, just fatigue. It was reported that patient saw HCP yesterday, 21-Dec-2023, and told since she has no symptoms, to take Tylenol. The treatment medication was not reported by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: covid 19; dry heaves; felt faint; Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel body aches and fatigue,; Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel fatigue,; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19), RETCHING (dry heaves), DIZZINESS (felt faint), MYALGIA (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel body aches and fatigue,) and FATIGUE (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel fatigue,) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (Dose 1, Batch-038A21A) on 22-Mar-2021, Moderna COVID-19 Vaccine (Dose 2, Batch-036B219) on 19-Apr-2021, Moderna COVID-19 Vaccine (Dose 3, Batch-034F21A) on 13-Nov-2021 and Pneumonia vaccine Prevnar (Pneumonia vaccine Prevnar). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Pneumonia vaccine Prevnar.    On 18-Dec-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Dec-2023, the patient experienced MYALGIA (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel body aches and fatigue,) and FATIGUE (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel fatigue,). On 21-Dec-2023, the patient experienced COVID-19 (covid 19), RETCHING (dry heaves) and DIZZINESS (felt faint). At the time of the report, COVID-19 (covid 19), RETCHING (dry heaves) and DIZZINESS (felt faint) had not resolved and MYALGIA (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel body aches and fatigue,) and FATIGUE (Patient received the vaccine, Spikevax on Monday, 18Dec2023 and I expected to feel fatigue,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient stated she has no fever, and no shortness of breath, no drainage, just fatigue. It was reported that patient saw HCP yesterday, 21-Dec-2023, and told since she has no symptoms, to take Tylenol. The treatment medication was not reported by reporter.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: HCP called to report that 1 dose of VAXELIS and 1 dose of ROTATEQ were given on 9/21/2023 to the same patient, after the products had been through a TE..Vaccines involved VAXERLIS and ROTATEQ.Temp:48F, Time frame:40min; This spontaneous non-serious safety report, with reference number 02477148, was received by a partner on 21-SEP-2023 and forwarded to Company on 22-SEP-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP called to report that 1 dose of VAXELIS and 1 dose of ROTATEQ were given on 9/21/2023 to the same patient, after the products had been through a TE. Vaccines involved VAXERLIS and ROTATEQ.Temp:48F, Time frame:40min" was assessed as not applicable due to the nature of the event.  Further information is expected.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Experienced dizziness, headache and nausea. Seen in ED on 12/26/23 and discharged home in stable condition.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Blood pressure increased, Contusion, Impaired work ability, Joint swelling
Clinical narrative: joint (Knee, ankle, toes, fingers, wrist, elbow, shoulders, neck) pain and swollen, hard to bend, blood pressure went up so high up to 158 and 110.  The swollen area has turned into dark color bruise.  Pain disrupted sleep and daily living which affected financially.  The pain was extremely bad and couldn't work for 8 weeks.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: joint (Knee, ankle, toes, fingers, wrist, elbow, shoulders, neck) pain and swollen, hard to bend, blood pressure went up so high up to 158 and 110.  The swollen area has turned into dark color bruise.  Pain disrupted sleep and daily living which affected financially.  The pain was extremely bad and couldn't work for 8 weeks.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Sleep disorder, Swelling
Clinical narrative: joint (Knee, ankle, toes, fingers, wrist, elbow, shoulders, neck) pain and swollen, hard to bend, blood pressure went up so high up to 158 and 110.  The swollen area has turned into dark color bruise.  Pain disrupted sleep and daily living which affected financially.  The pain was extremely bad and couldn't work for 8 weeks.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Nephrolithiasis
Clinical narrative: The patient developed kidney stones 8 days after vaccination. He reports having no prior history of renal issues or kidney stones. At first he thought it was a flair of his Crohn's Disease. After his symptoms worsened and he sought treatment he was diagnosed with kidney stones. He presented to the pharmacy to ask if we were seeing these develop in patients who had been given both vaccines on the same day.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: patient received the vaccine and waited in the waiting area. i checked on her after 10 minutes, and she said she felt dizzy, which started after receiving the vaccine. i checked on her every 10 minutes a couple more times, and she said the symptoms had not improved. i asked if there were any other symptoms experienced and she said no. patient did state that she had not eaten anything since breakfast this morning and possibly she was hungry. i offered to get her something to eat and drink, and she asked for water and pretzels. after having some pretzels, she said the feeling of dizziness did subside. i asked if she needed to use a wheelchair, but she declined. she stayed for about 50 minutes after receiving the vacci  vaccine before leaving
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: prolonged stiffness,pain, weakness at site of reaction and down left arm.  Pain when doing normal everyday tasks such as driving, putting on clothing.  Patient was seen at urgent care and treated with meloxicam and and medrol dosepak.  The symptoms are still persisting.  Patient also followed up with family doctor and has used physical therapy on left arm.
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions
Age: 36.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: patient doesn't have full rotation of arm, its achy all the time.  vaccine seemed higher than normal on the arm
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Acupuncture, Injected limb mobility decreased, Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: At our hospital's yearly Flu vaccine clinic, I received a flu vaccine which was injected into my R shoulder. Unlike previous vaccines, the injection was very painful, like a sharp, metalic stabbing kind of a pain sensation. The pain did not subside over the next few weeks. I started to use Voltaren Gel with no significant change. I then started weekly Acupuncture sessions which lessened the pain. But instead of resolving the injury over time I noticed a significant limitation in ROM and stabbing pains when I want to reach with my r arm. I finally filed a injury report at my work and a case was opened.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Red rash at injection site with swelling and itching. Worsening each day. Day 6 showed to pharmacist who advised reporting and to take benedryl.  Saw my doctor same day ( my cardiologist) who advised taking Pepcid( h-2 blocker)  plus benedryl 25mg for 3 days.  If not better or worsens to call my internist dr .
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Implantable defibrillator insertion, Myocardial fibrosis, Ventricular tachycardia
Clinical narrative: Scar on lateral wall of heart leading to ventricle tachycardia and defibrillator implant.
Age: 14.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Syncope
Clinical narrative: PATIENT RECEIVED BOTH VACCINES THEN LEFT THE PHARMACY WITH HER FAMILY. THE PATIENT FAINTED AT THE CHECK OUT SECTION OF THE STORE. MEDICS WERE CALLED.  NO APPARENT HARM WERE IDENTIFIED, PATIENT WAS ABLE TO LEAVE ON HER OWN.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Lowgrade fever, chills, muscle pain in back of neck and shoulders
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: vomiting, nausea, chills and fever
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received high dose flu shot when they should have received  regular strength. Besides sore arm, patient states that no other symptoms were experienced.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Administration of MMRV instead of MMR. Patient also received separate Varicella vaccine on Same date 12/21/23.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC15
Symptoms: Expired product administered
Clinical narrative: was given Hep A with date of exp. 12-07-2023 and the patient grandmother was notified and the dr was notified as well.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Echocardiogram normal, Electrocardiogram normal, Electromyogram normal
Clinical narrative: Anxiety panic, fast heart rate.  3 days later tingling tongue that has now spread body wide.  Chest pain that sent me to er on Dec 21 2021.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Panic reaction, Paraesthesia, Paraesthesia oral
Clinical narrative: Anxiety panic, fast heart rate.  3 days later tingling tongue that has now spread body wide.  Chest pain that sent me to er on Dec 21 2021.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cold symptoms
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Pyrexia, Rash
Clinical narrative: Father reported that pt developed fever of 103 -104 deg F 3 hours after injection.Four days later, father reported that they called pt's PCP regarding fever, and provider  advised to take pt to ER; Presented with generalized rash all over face and body.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2653188-1. The original narrative from the sender is the following:  "Father reported that pt developed fever of 103 -104 deg F 3 hours after injection. Father denied giving pt medication at home. Four days later, father reported that they called pt's PCP regarding fever, and provider advised to take pt to ER. Pt was taken to ER on 7/1/23, and pt was given prescription for Motrin and father was told fever should resolve in 2-3 days. Pt arrived to clinic on 7/5/23, pt with no fever (temp 98.8 tympanic) and in no apparent distress but presented with generalized rash all over face and body. Father denied taking pt back to ER for rash when it developed. Father reports that rash started after ER visit but does not know what day exactly. Advised father to take pt back to ER to get evaluated for rash, get blood tests, and treated for rash".  The reporter assessed the casual relationship between Vaxelis and the events " Father reported that pt developed fever of 103 -104 deg F 3 hours after injection. Four days later, father reported that they called pt's PCP regarding fever", and "provider advised to take pt to ER and Presented with generalized rash all over face and body" as related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, RV5, DTPPVHBHPB, RV5
Symptoms: Hyporesponsive to stimuli, Hypotonia, Oxygen saturation decreased, Pallor
Clinical narrative: Oxygen saturation dropped to 60; pale in color; less responsive within 5 minutes of vaccine administration; patient became hypotonic; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2653718-1. The original narrative from the sender is the following:  "Patient became hypotonic, pale in color, and less responsive within 5 minutes of vaccine administration. Oxygen saturation dropped to 60. Patient resumed normal color and oxygen saturation about 5 minutes following".  The reporter did not provide an assessment of causal relationship between Vaxelis and the events " Oxygen saturation dropped to 60"," pale in color", " less responsive within 5 minutes of vaccine administration" and "patient became hypotonic."  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, RV5, DTPPVHBHPB, RV5
Symptoms: Hyperresponsive to stimuli, Hypotonic-hyporesponsive episode, Oxygen saturation decreased, Pallor
Clinical narrative: Oxygen saturation dropped to 60; pale in color; less responsive within 5 minutes of vaccine administration; patient became hypotonic; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2653718-1. The original narrative from the sender is the following:  "Patient became hypotonic, pale in color, and less responsive within 5 minutes of vaccine administration. Oxygen saturation dropped to 60. Patient resumed normal color and oxygen saturation about 5 minutes following".  The reporter did not provide an assessment of causal relationship between Vaxelis and the events " Oxygen saturation dropped to 60"," pale in color", " less responsive within 5 minutes of vaccine administration" and "patient became hypotonic."  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Diet refusal, Erythema, Infant irritability, Injection site urticaria, Poor feeding infant
Clinical narrative: Patient refused to nurse following vaccine administration; Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back.; Patient was very warm to the touch and red.; Patient was very warm to the touch and red.; Very irritable; Poor feeding infant; Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2655914-1. The original narrative from the sender is the following:  "Patient refused to nurse following vaccine administration. Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back. Patient was very warm to the touch and red. Very irritable. 9mg of Benadryl were given when this occurred. Patient began to improve around 15 min later".  The reporter assessed the casual relationship between Vaxelis and the events " Patient refused to nurse following vaccine administration"," Patient refused to nurse following vaccine administration"," Patient was very warm to the touch and red.", "Very irritable ", " Poor feeding infant" and" Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back" as related.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Skin warm, Urticaria
Clinical narrative: Patient refused to nurse following vaccine administration; Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back.; Patient was very warm to the touch and red.; Patient was very warm to the touch and red.; Very irritable; Poor feeding infant; Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2655914-1. The original narrative from the sender is the following:  "Patient refused to nurse following vaccine administration. Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back. Patient was very warm to the touch and red. Very irritable. 9mg of Benadryl were given when this occurred. Patient began to improve around 15 min later".  The reporter assessed the casual relationship between Vaxelis and the events " Patient refused to nurse following vaccine administration"," Patient refused to nurse following vaccine administration"," Patient was very warm to the touch and red.", "Very irritable ", " Poor feeding infant" and" Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back" as related.  No further information is expected.