chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20221252811. This report was associated with product quality complaint: 90000264551.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced neuropathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neuropathy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221252813- neuropathy. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Injection site pain, Off label use
Clinical narrative: SLIGHT SORENESS AT INJECTION SITE; OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had covid or side effects. The patient previously received three doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with three doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patient received fourth dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2). The patient additionally received fifth dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis which was associated with off label dosing frequency (Off label use) and revaccination with different covid-19 vaccine (Dose number in series 3). The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slight soreness at injection site (Dose number in series 3). It was reported that "I got 5 vaccines. Never got covid or side effects beyond slight soreness at injection site". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight soreness at injection site, off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; one dose of Moderna Bivalent vaccine was administered beyond 12 hrs post punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (one dose of Moderna Bivalent vaccine was administered beyond 12 hrs post punctured) 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)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (one dose of Moderna Bivalent vaccine was administered beyond 12 hrs post punctured). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (one dose of Moderna Bivalent vaccine was administered beyond 12 hrs post punctured) 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 EXPIRED PRODUCT ADMINISTERED (one dose of Moderna Bivalent vaccine was administered beyond 12 hrs post punctured).    Concomitant medication not reported. Treatment medication not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22Dec2022.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22Dec2022.) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 1) and flu shot. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and flu shot.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22Dec2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22Dec2022.) 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 (HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22Dec2022.).    Patient had no known conditions. Concomitant product use was not provided by the reporter.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22 Dec 2022. Previous primary series were from Pfizer, but caller did know the dates of administration. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, No adverse event, Product administration interrupted
Clinical narrative: She didn't have a good experience; She never went back for the second; No Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She didn't have a good experience), PRODUCT ADMINISTRATION INTERRUPTED (She never went back for the second) and NO ADVERSE EVENT (No Adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She didn't have a good experience), PRODUCT ADMINISTRATION INTERRUPTED (She never went back for the second) and NO ADVERSE EVENT (No Adverse event). At the time of the report, IMMUNISATION REACTION (She didn't have a good experience), PRODUCT ADMINISTRATION INTERRUPTED (She never went back for the second) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for IMMUNISATION REACTION (She didn't have a good experience) and PRODUCT ADMINISTRATION INTERRUPTED (She never went back for the second).    Concomitant Medication use information was not provided by reporter.  The patient took the first dose of the Moderna vaccine almost two years ago. It was around February 2020.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   Reporter did not allow further contact
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Patient received a dose of the 6-11 years of age monovalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a dose of the 6-11 years of age monovalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 22-Dec-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a dose of the 6-11 years of age monovalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a dose of the 6-11 years of age monovalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a dose of the 6-11 years of age monovalent Moderna COVID-19 vaccine).    Concomitant product use was not provided by the reporter. Patient did not receive other vaccines in the four weeks prior to COVID-19 vaccine. Patient received additional booster dose. Treatment information was not provided.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Erythema, Pain in extremity, Pruritus, Pyrexia, Skin burning sensation
Clinical narrative: Burns on his palms of his hands , elbow, back of the neck,; skin itched / Sometimes the itching is on the patients face, neck; skin itched and was red all over his upper body and comes and goes; swelling of the face, eyelids, the cheeks.; bumps on the back of his neck and shoulder; Sore right arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burns on his palms of his hands , elbow, back of the neck,), PRURITUS (skin itched / Sometimes the itching is on the patients face, neck), ERYTHEMA (skin itched and was red all over his upper body and comes and goes), SWELLING FACE (swelling of the face, eyelids, the cheeks.) and SWELLING (bumps on the back of his neck and shoulder) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Product used for unknown indication: Influenza. Past adverse reactions to the above products included No adverse event with Influenza.   On 06-Dec-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 and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. In December 2022, the patient experienced SKIN BURNING SENSATION (Burns on his palms of his hands , elbow, back of the neck,), PRURITUS (skin itched / Sometimes the itching is on the patients face, neck), ERYTHEMA (skin itched and was red all over his upper body and comes and goes), SWELLING FACE (swelling of the face, eyelids, the cheeks.), SWELLING (bumps on the back of his neck and shoulder), PAIN IN EXTREMITY (Sore right arm ) and PYREXIA (Fever). In December 2022, SKIN BURNING SENSATION (Burns on his palms of his hands , elbow, back of the neck,), PRURITUS (skin itched / Sometimes the itching is on the patients face, neck), ERYTHEMA (skin itched and was red all over his upper body and comes and goes), SWELLING FACE (swelling of the face, eyelids, the cheeks.), PAIN IN EXTREMITY (Sore right arm ) and PYREXIA (Fever) had resolved. At the time of the report, SWELLING (bumps on the back of his neck and shoulder) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  It was reported that the patient didn't had COVID-19 infection previously.  No treatment drug information was provided.   This case was linked to MOD-2022-691350 (Patient Link).
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Swelling, Swelling face
Clinical narrative: Burns on his palms of his hands , elbow, back of the neck,; skin itched / Sometimes the itching is on the patients face, neck; skin itched and was red all over his upper body and comes and goes; swelling of the face, eyelids, the cheeks.; bumps on the back of his neck and shoulder; Sore right arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burns on his palms of his hands , elbow, back of the neck,), PRURITUS (skin itched / Sometimes the itching is on the patients face, neck), ERYTHEMA (skin itched and was red all over his upper body and comes and goes), SWELLING FACE (swelling of the face, eyelids, the cheeks.) and SWELLING (bumps on the back of his neck and shoulder) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Product used for unknown indication: Influenza. Past adverse reactions to the above products included No adverse event with Influenza.   On 06-Dec-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 and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. In December 2022, the patient experienced SKIN BURNING SENSATION (Burns on his palms of his hands , elbow, back of the neck,), PRURITUS (skin itched / Sometimes the itching is on the patients face, neck), ERYTHEMA (skin itched and was red all over his upper body and comes and goes), SWELLING FACE (swelling of the face, eyelids, the cheeks.), SWELLING (bumps on the back of his neck and shoulder), PAIN IN EXTREMITY (Sore right arm ) and PYREXIA (Fever). In December 2022, SKIN BURNING SENSATION (Burns on his palms of his hands , elbow, back of the neck,), PRURITUS (skin itched / Sometimes the itching is on the patients face, neck), ERYTHEMA (skin itched and was red all over his upper body and comes and goes), SWELLING FACE (swelling of the face, eyelids, the cheeks.), PAIN IN EXTREMITY (Sore right arm ) and PYREXIA (Fever) had resolved. At the time of the report, SWELLING (bumps on the back of his neck and shoulder) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  It was reported that the patient didn't had COVID-19 infection previously.  No treatment drug information was provided.   This case was linked to MOD-2022-691350 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received a booster dose today, 22DEC2022,from a vial with a Purple label that states booster only; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a booster dose today, 22DEC2022,from a vial with a Purple label that states booster only) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: FLU (The patient also received a Flu shot today.). Past adverse reactions to the above products included No adverse event with FLU. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 22-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a booster dose today, 22DEC2022,from a vial with a Purple label that states booster only) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a booster dose today, 22DEC2022,from a vial with a Purple label that states booster only) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a booster dose today, 22DEC2022,from a vial with a Purple label that states booster only).    The ID was reported as 80777-275-99.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness / numb fingers to this day; Tingling in hamstrings(GBS like symptoms); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness / numb fingers to this day) and PARAESTHESIA (Tingling in hamstrings(GBS like symptoms)) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness / numb fingers to this day) and PARAESTHESIA (Tingling in hamstrings(GBS like symptoms)). At the time of the report, HYPOAESTHESIA (Numbness / numb fingers to this day) and PARAESTHESIA (Tingling in hamstrings(GBS like symptoms)) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It has been reported that after fifteen days of second Moderna booster patient experienced symptoms. Additionally patient quickly moved to arms and settle in the hands with numb fingers to this day. Patient questioned about 5th mRNA vaccine shot and effectivity of Novavax vaccine against Omicron. Because it had been suggested by neurologists and virologist for Novavax vaccine as booster. Treatment information was not provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; Patient received Bivalent Moderna COVID-19 vaccine instead of first dose Monovalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine instead of first dose Monovalent) and NO ADVERSE EVENT (No Adverse Event) in a 22-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine instead of first dose Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine instead of first dose Monovalent) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine instead of first dose Monovalent).    Concomitant Medication use information was not provided by reporter.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient was not received any other vaccines and did not report any adverse reactions.   Treatment Medication use information was not provided by reporter.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; 1 Patient got a bivalent booster on 07-Oct-2022 and then received other bivalent booster on 20-Dec-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (1 Patient got a bivalent booster on 07-Oct-2022 and then received other bivalent booster on 20-Dec-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 011h22a and 057f22a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-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 20-Dec-2022, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (1 Patient got a bivalent booster on 07-Oct-2022 and then received other bivalent booster on 20-Dec-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (1 Patient got a bivalent booster on 07-Oct-2022 and then received other bivalent booster on 20-Dec-2022) 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 EXTRA DOSE ADMINISTERED (1 Patient got a bivalent booster on 07-Oct-2022 and then received other bivalent booster on 20-Dec-2022).    No concomitant product was reported. Patient received the 1st dose of the Moderna COVID-19 vaccine on 15-Jan-2021 with lot 030l20a, 2nd dose on 12-Feb-2021 with lot 016m20a, 1st booster on 28-Oct-2021 with lot 051f21a and 2nd booster on 12-Apr-2022 with lot 066k21a, bivalent dose on 07-Oct-2022 with lot 057f22a and 2nd bivalent 20-Dec-2022 with lot 011h22a. No treatment information was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent doses administered after the BUD to Patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to Patients) and NO ADVERSE EVENT (No adverse event ) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to Patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to Patients) 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 (Monovalent doses administered after the BUD to Patients).   ID was reported as 7552537. Concomitant medications details were not reported by the reporter.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Total 77 Monovalent doses were administered after the BUD to patients 12 and up. Breakdown of doses was, 37 doses from Lot 059H21, 26 doses from Lot 065K21A and 12 doses from Lot 058A22-2A. Treatment details were not reported by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: Began coughing on 12/7/22 and tested positive for Covid 12/8/22.  Vaccine administered
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Angiogram, Anticoagulant therapy, Atrial fibrillation, COVID-19
Clinical narrative: Hospital Course:  Patient is a 80 y.o. female patient with history of essential hypertension diabetes mellitus coronary artery disease presented with nausea vomiting and diarrhea Discharge Diagnoses: AKI; prerenal Improved Mostly secondary to decreased oral intake and persistent nausea vomiting and diarrhea Avoid nephrotoxic medications Encouraged PO intake     Acute Gastroenteritis Improved Continue supportive care   Covid-19 Virus Infection Date of onset of symptoms: 2 weeks ago and tested positive around thanksgiving period Symptoms present on admission: Nausea vomiting diarrhea Date of covid positive test: Around thanksgiving Vaccination status: vaccinated Imaging: CTA Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: Does not need isolation since patient tested positive more than 2 weeks ago and patient has been afebrile for >24 hrs   Diabetes mellitus Type 2 not long-term insulin use Last A1c 8.310 2622 Continue ISS Likely needs to be taken off Glimepiride due if renal function does not improve.    Anxiety and depression Resume Prozac and Atarax  Chronic HFrEF Stress-induced cardiomyopathy Last echo 10/31/2022 ejection fraction of 45% +/-5 Monitor intake and output with gentle IV hydration Trend troponins Resume GDMT as tolerated   Paroxysmal A. fib on anticoagulation Continue Eliquis and metoprolol
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Diarrhoea, Echocardiogram abnormal, Ejection fraction, Gastroenteritis
Clinical narrative: Hospital Course:  Patient is a 80 y.o. female patient with history of essential hypertension diabetes mellitus coronary artery disease presented with nausea vomiting and diarrhea Discharge Diagnoses: AKI; prerenal Improved Mostly secondary to decreased oral intake and persistent nausea vomiting and diarrhea Avoid nephrotoxic medications Encouraged PO intake     Acute Gastroenteritis Improved Continue supportive care   Covid-19 Virus Infection Date of onset of symptoms: 2 weeks ago and tested positive around thanksgiving period Symptoms present on admission: Nausea vomiting diarrhea Date of covid positive test: Around thanksgiving Vaccination status: vaccinated Imaging: CTA Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: Does not need isolation since patient tested positive more than 2 weeks ago and patient has been afebrile for >24 hrs   Diabetes mellitus Type 2 not long-term insulin use Last A1c 8.310 2622 Continue ISS Likely needs to be taken off Glimepiride due if renal function does not improve.    Anxiety and depression Resume Prozac and Atarax  Chronic HFrEF Stress-induced cardiomyopathy Last echo 10/31/2022 ejection fraction of 45% +/-5 Monitor intake and output with gentle IV hydration Trend troponins Resume GDMT as tolerated   Paroxysmal A. fib on anticoagulation Continue Eliquis and metoprolol
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin increased, Hypophagia, Malaise, Nausea, Renal impairment
Clinical narrative: Hospital Course:  Patient is a 80 y.o. female patient with history of essential hypertension diabetes mellitus coronary artery disease presented with nausea vomiting and diarrhea Discharge Diagnoses: AKI; prerenal Improved Mostly secondary to decreased oral intake and persistent nausea vomiting and diarrhea Avoid nephrotoxic medications Encouraged PO intake     Acute Gastroenteritis Improved Continue supportive care   Covid-19 Virus Infection Date of onset of symptoms: 2 weeks ago and tested positive around thanksgiving period Symptoms present on admission: Nausea vomiting diarrhea Date of covid positive test: Around thanksgiving Vaccination status: vaccinated Imaging: CTA Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: Does not need isolation since patient tested positive more than 2 weeks ago and patient has been afebrile for >24 hrs   Diabetes mellitus Type 2 not long-term insulin use Last A1c 8.310 2622 Continue ISS Likely needs to be taken off Glimepiride due if renal function does not improve.    Anxiety and depression Resume Prozac and Atarax  Chronic HFrEF Stress-induced cardiomyopathy Last echo 10/31/2022 ejection fraction of 45% +/-5 Monitor intake and output with gentle IV hydration Trend troponins Resume GDMT as tolerated   Paroxysmal A. fib on anticoagulation Continue Eliquis and metoprolol
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Stress cardiomyopathy, Troponin, Vomiting
Clinical narrative: Hospital Course:  Patient is a 80 y.o. female patient with history of essential hypertension diabetes mellitus coronary artery disease presented with nausea vomiting and diarrhea Discharge Diagnoses: AKI; prerenal Improved Mostly secondary to decreased oral intake and persistent nausea vomiting and diarrhea Avoid nephrotoxic medications Encouraged PO intake     Acute Gastroenteritis Improved Continue supportive care   Covid-19 Virus Infection Date of onset of symptoms: 2 weeks ago and tested positive around thanksgiving period Symptoms present on admission: Nausea vomiting diarrhea Date of covid positive test: Around thanksgiving Vaccination status: vaccinated Imaging: CTA Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: Does not need isolation since patient tested positive more than 2 weeks ago and patient has been afebrile for >24 hrs   Diabetes mellitus Type 2 not long-term insulin use Last A1c 8.310 2622 Continue ISS Likely needs to be taken off Glimepiride due if renal function does not improve.    Anxiety and depression Resume Prozac and Atarax  Chronic HFrEF Stress-induced cardiomyopathy Last echo 10/31/2022 ejection fraction of 45% +/-5 Monitor intake and output with gentle IV hydration Trend troponins Resume GDMT as tolerated   Paroxysmal A. fib on anticoagulation Continue Eliquis and metoprolol
Age: 29.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: I was sick with a sore throat and runny nose on 12/12/2022. I went to my PCP where they did Strep test which negative. And I also did a COVID-19 home test on 12/12/2022 and 12/13/2022 both days were negative. On 12/21/2022 I had a cough in the afternoon around 03:00PM. I had very mild symptoms so I didn't get care from my doctor. I took over the counter congestions & headaches medication from the pharmacy for 2 days. I still have a mild cough as of 12/27/2022. I am recovering.
Age: 29.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive, Streptococcus test negative
Clinical narrative: I was sick with a sore throat and runny nose on 12/12/2022. I went to my PCP where they did Strep test which negative. And I also did a COVID-19 home test on 12/12/2022 and 12/13/2022 both days were negative. On 12/21/2022 I had a cough in the afternoon around 03:00PM. I had very mild symptoms so I didn't get care from my doctor. I took over the counter congestions & headaches medication from the pharmacy for 2 days. I still have a mild cough as of 12/27/2022. I am recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus right ear.  Started exactly 24 hours after vaccination and is still going on two and a half hours later.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Antimicrobial susceptibility test, Death, Encephalopathy, Endotracheal intubation
Clinical narrative: Hospital Course:  Patient is a 76 y.o. female patient of DO with a history of CAD s/p PCI, paroxysmal atrial fibrillation, HFpEF, Addison's disease on hydrocortisone, chronic pain on suboxone, IDDM2, and OSA/OHS. Presented to hospital 11/18/22 from her ECF with encephalopathy and hypoxia requiring intubation due to acute on chronic hypoxic and hypercapnic respiratory failure with ARDS. Further workup revealed sepsis secondary to polymicrobial pneumonia - RSV, COVID-19, and ESBL E coli; treated with dexamethasone and ertapenem. Ultimately extubated 12/4/22 to heated high flow and BiPAP. Unfortunately could not be weaned from BiPAP. Goals of care discussion with patient and family led to decision to transition care to comfort measures on 12/5/22. Time of death was 12/5/22 at 0200.    Discharge Diagnoses: Acute on chronic hypoxic and hypercapnic respiratory failure with ARDS Combined pneumonia - RSV, COVID-19, and ESBL E coli  Severe sepsis Acute encephalopathy  Tracheomalacia by CT Addison's disease  Paroxysmal atrial fibrillation
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Extubation, Hypoxia, Pneumonia, Positive airway pressure therapy, Respiratory failure
Clinical narrative: Hospital Course:  Patient is a 76 y.o. female patient of DO with a history of CAD s/p PCI, paroxysmal atrial fibrillation, HFpEF, Addison's disease on hydrocortisone, chronic pain on suboxone, IDDM2, and OSA/OHS. Presented to hospital 11/18/22 from her ECF with encephalopathy and hypoxia requiring intubation due to acute on chronic hypoxic and hypercapnic respiratory failure with ARDS. Further workup revealed sepsis secondary to polymicrobial pneumonia - RSV, COVID-19, and ESBL E coli; treated with dexamethasone and ertapenem. Ultimately extubated 12/4/22 to heated high flow and BiPAP. Unfortunately could not be weaned from BiPAP. Goals of care discussion with patient and family led to decision to transition care to comfort measures on 12/5/22. Time of death was 12/5/22 at 0200.    Discharge Diagnoses: Acute on chronic hypoxic and hypercapnic respiratory failure with ARDS Combined pneumonia - RSV, COVID-19, and ESBL E coli  Severe sepsis Acute encephalopathy  Tracheomalacia by CT Addison's disease  Paroxysmal atrial fibrillation
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test, SARS-CoV-2 test, Sepsis, Tracheomalacia, Weaning failure
Clinical narrative: Hospital Course:  Patient is a 76 y.o. female patient of DO with a history of CAD s/p PCI, paroxysmal atrial fibrillation, HFpEF, Addison's disease on hydrocortisone, chronic pain on suboxone, IDDM2, and OSA/OHS. Presented to hospital 11/18/22 from her ECF with encephalopathy and hypoxia requiring intubation due to acute on chronic hypoxic and hypercapnic respiratory failure with ARDS. Further workup revealed sepsis secondary to polymicrobial pneumonia - RSV, COVID-19, and ESBL E coli; treated with dexamethasone and ertapenem. Ultimately extubated 12/4/22 to heated high flow and BiPAP. Unfortunately could not be weaned from BiPAP. Goals of care discussion with patient and family led to decision to transition care to comfort measures on 12/5/22. Time of death was 12/5/22 at 0200.    Discharge Diagnoses: Acute on chronic hypoxic and hypercapnic respiratory failure with ARDS Combined pneumonia - RSV, COVID-19, and ESBL E coli  Severe sepsis Acute encephalopathy  Tracheomalacia by CT Addison's disease  Paroxysmal atrial fibrillation
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Confusional state, Electroencephalogram normal, Feeling abnormal, Foreign travel
Clinical narrative: Exactly 4 to 5 days after my vaccination I was waking up with headache, brain fog and confusion and memory issues, I thought I was experiencing COVID-19 symptoms. I went to the ER and was tested and sent home. I was told to follow-up with my Neurologist. When I did, he found not issues with my symptoms and sent me home with no answers. I was diagnosed with new onset of seizures for not any reasons. It is listed as unknown. I started having seizures in my sleep 4 to 5 days after receiving vaccines. I have bilateral temporal seizures now. I am now taking LAMICTAL. I have been missed diagnosed three times from the ER and my Neurologist. I had awakened up to the symptoms again on 11/27/2022. I went to the ER, and they performed the same test and sent me back to my Neurologist and he gave me no results or answers. He said he believed I had sleep apnea and recommended a sleep study test. Instead of the test I went to visit my daughter. There I had awaken in my rental with no visual memory of how the building I was staying in looked or where the rooms where. I was confused and had no idea of how to get to the place. This lasted about 4 hours. I contacted my cousin who is neurologist and had me carry an ambulatory EEG machine to record my brain patterns. I was diagnosed with having seizures in my sleep. I have never had this issue before; I was being misdiagnosed.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Memory impairment, SARS-CoV-2 test, Seizure
Clinical narrative: Exactly 4 to 5 days after my vaccination I was waking up with headache, brain fog and confusion and memory issues, I thought I was experiencing COVID-19 symptoms. I went to the ER and was tested and sent home. I was told to follow-up with my Neurologist. When I did, he found not issues with my symptoms and sent me home with no answers. I was diagnosed with new onset of seizures for not any reasons. It is listed as unknown. I started having seizures in my sleep 4 to 5 days after receiving vaccines. I have bilateral temporal seizures now. I am now taking LAMICTAL. I have been missed diagnosed three times from the ER and my Neurologist. I had awakened up to the symptoms again on 11/27/2022. I went to the ER, and they performed the same test and sent me back to my Neurologist and he gave me no results or answers. He said he believed I had sleep apnea and recommended a sleep study test. Instead of the test I went to visit my daughter. There I had awaken in my rental with no visual memory of how the building I was staying in looked or where the rooms where. I was confused and had no idea of how to get to the place. This lasted about 4 hours. I contacted my cousin who is neurologist and had me carry an ambulatory EEG machine to record my brain patterns. I was diagnosed with having seizures in my sleep. I have never had this issue before; I was being misdiagnosed.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome, Temporal lobe epilepsy
Clinical narrative: Exactly 4 to 5 days after my vaccination I was waking up with headache, brain fog and confusion and memory issues, I thought I was experiencing COVID-19 symptoms. I went to the ER and was tested and sent home. I was told to follow-up with my Neurologist. When I did, he found not issues with my symptoms and sent me home with no answers. I was diagnosed with new onset of seizures for not any reasons. It is listed as unknown. I started having seizures in my sleep 4 to 5 days after receiving vaccines. I have bilateral temporal seizures now. I am now taking LAMICTAL. I have been missed diagnosed three times from the ER and my Neurologist. I had awakened up to the symptoms again on 11/27/2022. I went to the ER, and they performed the same test and sent me back to my Neurologist and he gave me no results or answers. He said he believed I had sleep apnea and recommended a sleep study test. Instead of the test I went to visit my daughter. There I had awaken in my rental with no visual memory of how the building I was staying in looked or where the rooms where. I was confused and had no idea of how to get to the place. This lasted about 4 hours. I contacted my cousin who is neurologist and had me carry an ambulatory EEG machine to record my brain patterns. I was diagnosed with having seizures in my sleep. I have never had this issue before; I was being misdiagnosed.
Age: 36.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Cardiac stress test, Dizziness, Malaise
Clinical narrative: I was having a little lightheadedness for about a week and a half probably started about December 8th or 9th, 2022. I have a blood pressure cuff at home and took it since I wasn't feeling well. It was 160/104. I made an appointment with doctor. I spoke with my doctor December 20th, 2022 who prescribed me a NORVASC. I took the first day and then on December 22nd, 2022.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Agitation, Feeling abnormal, Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received the pfizer pediatric booster vaccine, but it was undiluted. When I called the parent to inform them, they stated the kids are already feeling agitated and out of it.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Agitation, Feeling abnormal, Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received the pfizer pediatric booster vaccine, but it was undiluted. When I called the parent to inform them, they stated the kids are already feeling agitated and out of it.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Gait disturbance, Headache, Loss of consciousness, Nausea
Clinical narrative: Patient received vaccine and several minutes later, while shopping in store, had ringing in ears and had trouble walking. The mother caught her as she passed out, she did not hit her head. She regained consciousness a couple seconds later and felt very dizzy, nauseous and still had ringing in the ears. She also stated that the light was very bright and that she had a headache. Emergency Services was called and paramedics checked her vitals after escorting  her off the premises.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Photophobia, Tinnitus
Clinical narrative: Patient received vaccine and several minutes later, while shopping in store, had ringing in ears and had trouble walking. The mother caught her as she passed out, she did not hit her head. She regained consciousness a couple seconds later and felt very dizzy, nauseous and still had ringing in the ears. She also stated that the light was very bright and that she had a headache. Emergency Services was called and paramedics checked her vitals after escorting  her off the premises.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Cough, Fatigue, Hypersomnia, Influenza A virus test positive
Clinical narrative: I was feeling sick after the end of November and then about a week later I was feeling like I was over the sickness and better, but it came back. I was having a fever; body aches and chills along with a cough that is still linger today. I was also so tired and exhausted during all of this and slept a lot more than I normally do. I was on a trip and the hotel had an urgent care, so I went there, and they tested me for COVID-19 and Influenza. I was negative for COVID but positive for Influenza A. Even though I was past the time frame for TAMIFLU, but the provider did set me a prescription for that. I do not think that the medication helped but it gave me peace of mind to try it. I started feeling better on about the 8 or 9th which was right before I flew home from my trip.