chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Patient had a rash on neck and back and described the rash was very itchy and visible lines developed when scratched; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Patient had a rash on neck and back and described the rash was very itchy and visible lines developed when scratched) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Patient had a rash on neck and back and described the rash was very itchy and visible lines developed when scratched). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Itchy rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Patient had a rash on neck and back and described the rash was very itchy and visible lines developed when scratched) had resolved.            No concomitant medications were reported. It was reported that on an unknown date the patient received first booster dose of mRNA-1273 and primary series of unknown product. The Rash was resolved within hours after the over-the-counter (OTC) treatment drug.   This case was linked to MOD-2023-720207 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: her daughter's friend's mother also lost her menstrual period after getting the 2nd dose of the Moderna vaccine but she got it back; This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUATION IRREGULAR (her daughter's friend's mother also lost her menstrual period after getting the 2nd dose of the Moderna vaccine but she got it back) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (her daughter's friend's mother also lost her menstrual period after getting the 2nd dose of the Moderna vaccine but she got it back). At the time of the report, MENSTRUATION IRREGULAR (her daughter's friend's mother also lost her menstrual period after getting the 2nd dose of the Moderna vaccine but she got it back) had resolved.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720346, US-MODERNATX, INC.-MOD-2023-720425 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720346:Reporter case US-MODERNATX, INC.-MOD-2023-720425:daughter's friend's mother
Sex: F
Vaccine: COVID19-2
Symptoms: Immune system disorder
Clinical narrative: Caller says one person was a TV host that said its been a year sine they had the Bivalent and she showed zero immunity; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Caller says one person was a TV host that said its been a year sine they had the Bivalent and she showed zero immunity) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (Caller says one person was a TV host that said its been a year sine they had the Bivalent and she showed zero immunity). At the time of the report, IMMUNE SYSTEM DISORDER (Caller says one person was a TV host that said its been a year sine they had the Bivalent and she showed zero immunity) 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.   Concomitant medication was not provided.   Details regarding AE could not be collected fully. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: Acne, Pharyngeal swelling, Pruritus, Urticaria
Clinical narrative: hives/welts; She also has had lumps on her head like pimples under her hair; Swelling of the throat; severe itching; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives/welts), ACNE (She also has had lumps on her head like pimples under her hair), PHARYNGEAL SWELLING (Swelling of the throat) and PRURITUS (severe itching) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives/welts), ACNE (She also has had lumps on her head like pimples under her hair), PHARYNGEAL SWELLING (Swelling of the throat) and PRURITUS (severe itching). At the time of the report, URTICARIA (hives/welts), ACNE (She also has had lumps on her head like pimples under her hair), PHARYNGEAL SWELLING (Swelling of the throat) and PRURITUS (severe itching) 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.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Patient  got her first dose in September, then another one in December, though unsure which year. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The multiple-Dose Vial with dark pink cap and Label with yellow box for ages 6 months through 5 years was administer as a 1st dose to 3 patients and as a 2nd dose to 1 patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The multiple-Dose Vial with dark pink cap and Label with yellow box for ages 6 months through 5 years was administer as a 1st dose to 3 patients and as a 2nd dose to 1 patient.) and NO ADVERSE EVENT (No adverse event) in an infant 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. 201L22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Rotavirus, Pneumococcal, Pentacel and Hepatitis B. Past adverse reactions to the above products included No adverse event with Hepatitis B, Pentacel, Pneumococcal and Rotavirus.    On 19-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (The multiple-Dose Vial with dark pink cap and Label with yellow box for ages 6 months through 5 years was administer as a 1st dose to 3 patients and as a 2nd dose to 1 patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The multiple-Dose Vial with dark pink cap and Label with yellow box for ages 6 months through 5 years was administer as a 1st dose to 3 patients and as a 2nd dose to 1 patient.) 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 WRONG PRODUCT ADMINISTERED (The multiple-Dose Vial with dark pink cap and Label with yellow box for ages 6 months through 5 years was administer as a 1st dose to 3 patients and as a 2nd dose to 1 patient.).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720355 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720355:Patient 1 out of 4 Patients
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 01-SEP-2022 and administered to patient on 12-JAN-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-SEP-2022 and administered to patient on 12-JAN-2023) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, 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 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-SEP-2022 and administered to patient on 12-JAN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-SEP-2022 and administered to patient on 12-JAN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-SEP-2022 and administered to patient on 12-JAN-2023).    No concomitant medication was reported.  The BUD date was reported as 01-OCT-2022. Date the vial was initially stored in the refrigerator on 01-Sep-2022. The vial did not undergo any temperature excursions.  Dosage text reported as Unknown. No treatment information was reported.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 01-Sep-2022, administration of vaccine on 13-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 01-Sep-2022, administration of vaccine on 13-Oct-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 no. AS7140C) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Nov-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 28-Nov-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 (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 01-Sep-2022, administration of vaccine on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 01-Sep-2022, administration of vaccine on 13-Oct-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 01-Sep-2022, administration of vaccine on 13-Oct-2022).    No concomitant medication were reported.  BUD was 01-Oct-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Fatigue, Rash
Clinical narrative: felt a little tired; however the rash as described after the first Moderna Monovalent vaccine continued; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (felt a little tired) and RASH (however the rash as described after the first Moderna Monovalent vaccine continued) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 59267-0304-02) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No medical history was reported by the reporter.  Concomitant products included ACYCLOVIR [ACICLOVIR], FINASTERIDE, VALSARTAN, ROSUVASTATIN and TADALAFIL for an unknown indication.   On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (felt a little tired) and RASH (however the rash as described after the first Moderna Monovalent vaccine continued). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency; LORATADINE at an unspecified dose and frequency; DIPHENHYDRAMINE at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency. At the time of the report, FATIGUE (felt a little tired) outcome was unknown and RASH (however the rash as described after the first Moderna Monovalent vaccine continued) 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.   Patient's wife reported no chronic medical conditions. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   This case was linked to MOD-2023-720364 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: no adverse event; Patient did not receive her second Moderna Monovalent vaccine greater than 36 days in between doses of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive her second Moderna Monovalent vaccine greater than 36 days in between doses of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 10-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive her second Moderna Monovalent vaccine greater than 36 days in between doses of the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive her second Moderna Monovalent vaccine greater than 36 days in between doses of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive her second Moderna Monovalent vaccine greater than 36 days in between doses of the Moderna Covid-19 vaccine.).    No concomitant medications was reported. No treatment drug details was reported.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 09-Mar-2023; No adverse event; Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, 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 09-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 09-Mar-2023).    No concomitant medications were reported. Vial size was reported as 2.5 mL. Vial was initially stored in the refrigerator on 11-Jan-2023. Vial did not undergo any temperature excursions. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea
Clinical narrative: diarrhea, having trouble keeping foods on her stomach also; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea, having trouble keeping foods on her stomach also) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, lot number 0121204) on 28-Jan-2021, Moderna COVID-19 Vaccine (Dose 2) on 25-Feb-2021, Moderna COVID-19 Vaccine (Dose 4) and Moderna COVID-19 Vaccine (Dose 3). 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 Moderna COVID-19 Vaccine.    On 18-Apr-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced DIARRHOEA (diarrhea, having trouble keeping foods on her stomach also). The patient was treated with AMMONIA ongoing since an unknown date for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea, having trouble keeping foods on her stomach also) 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.   No concomitant medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: 2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.; This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUATION IRREGULAR (2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.). At the time of the report, MENSTRUATION IRREGULAR (2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient went to her primary doctor for the event she was experienced and was told that she was the 2nd person who had similar kind of situation after getting the Moderna vaccine.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720346, US-MODERNATX, INC.-MOD-2023-720348 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720346:Reporter case US-MODERNATX, INC.-MOD-2023-720348:daughter's friend's mother
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 16-Mar-2023; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 16-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Mar-2023, 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 16-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 16-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 16-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 16-Mar-2023).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 11-Jan-2023. The vial did not undergo any temperature excursions. Dosage text reported as unknown. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720388, US-MODERNATX, INC.-MOD-2023-720382, US-MODERNATX, INC.-MOD-2023-720423 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720388:Same reporter US-MODERNATX, INC.-MOD-2023-720382:Same reporter US-MODERNATX, INC.-MOD-2023-720423:Same reporter
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2023 and was administered on 15-Mar-2023; No adverse event; Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2023 and was administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, 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 15-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2023 and was administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2023 and was administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2023 and was administered on 15-Mar-2023).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. The 2.5ml individual vial did not underwent any temperature excursions No treatment information was provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720395:Same reporter
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 11-Jan-2023/vial was administered to the patient on 06-Apr-2023; No adverse event; HCP Pharmacist reporting that Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP Pharmacist reporting that Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Jan-2023/vial was administered to the patient on 06-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, 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 06-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP Pharmacist reporting that Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Jan-2023/vial was administered to the patient on 06-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP Pharmacist reporting that Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Jan-2023/vial was administered to the patient on 06-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP Pharmacist reporting that Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Jan-2023/vial was administered to the patient on 06-Apr-2023).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial was initially stored in the refrigerator on 11-Jan-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Cough, Dysstasia, Fatigue, Feeling abnormal
Clinical narrative: Started with sinus drainage continued for a day or so, fatigue and mild achiness and sensitive skin. Then I started to feel tired. It felt like a cold and mild flu. I coughed because of the drainage, I had some chest congestion, but it was not bad. For the most part it stayed upper respiratory, more so. After 4 or 5 days, I felt fine and then it bounced back the drainage, not the achiness and tiredness. After testing negative, the drainage lingered afterwards, a few days slowly decreasing after 15 days. I tested negative with multiple tests. My son and wife got it a little behind me. None of us were terribly sick. The drainage took a long time to go away. Middle of my back bunch up, knotted up, to stand up straight work with physical therapist. I felt like roaming, stiff neck, stiff shoulders, pain and unstable hips, getting knotted up. It lasted for 4 or 5 days.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Gait disturbance, Influenza like illness, Joint instability, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Started with sinus drainage continued for a day or so, fatigue and mild achiness and sensitive skin. Then I started to feel tired. It felt like a cold and mild flu. I coughed because of the drainage, I had some chest congestion, but it was not bad. For the most part it stayed upper respiratory, more so. After 4 or 5 days, I felt fine and then it bounced back the drainage, not the achiness and tiredness. After testing negative, the drainage lingered afterwards, a few days slowly decreasing after 15 days. I tested negative with multiple tests. My son and wife got it a little behind me. None of us were terribly sick. The drainage took a long time to go away. Middle of my back bunch up, knotted up, to stand up straight work with physical therapist. I felt like roaming, stiff neck, stiff shoulders, pain and unstable hips, getting knotted up. It lasted for 4 or 5 days.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nasopharyngitis, Pain, Paranasal sinus hypersecretion, Respiratory tract congestion, Sensitive skin
Clinical narrative: Started with sinus drainage continued for a day or so, fatigue and mild achiness and sensitive skin. Then I started to feel tired. It felt like a cold and mild flu. I coughed because of the drainage, I had some chest congestion, but it was not bad. For the most part it stayed upper respiratory, more so. After 4 or 5 days, I felt fine and then it bounced back the drainage, not the achiness and tiredness. After testing negative, the drainage lingered afterwards, a few days slowly decreasing after 15 days. I tested negative with multiple tests. My son and wife got it a little behind me. None of us were terribly sick. The drainage took a long time to go away. Middle of my back bunch up, knotted up, to stand up straight work with physical therapist. I felt like roaming, stiff neck, stiff shoulders, pain and unstable hips, getting knotted up. It lasted for 4 or 5 days.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm, Ischaemic stroke, Lacunar stroke
Clinical narrative: ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 1/28/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 1/27/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Feeling cold, Pain, Pyrexia
Clinical narrative: I was on a shopping trip with my granddaughter on 2/17/2023, and I was suddenly seized by chills, and I was shaking all over and felt cold. I then went out to the car and turned on the heated seat. While I was in the car waiting on my granddaughter, I fell asleep at one point. I was the driver, but when my granddaughter saw me, she insisted on driving me home. At this point, I felt pretty sure that I had COVID-19. When I got home,though, I took a home antigen test and got a negative result. I then took some Tylenol and went to bed. The following morning on 2/18/2023, I took another home antigen test and got another negative result. I had a fever of 100 and intermittent chills. I called the 24-hour number for the medical group that runs the practice where my PCP works. They told me that I needed to go to the ER or a walk-in clinic. I then called the on-call doctor at the practice and spoke to her personally. I had previously gone to the clinic and had a urinalysis done earlier in the week, and the on-call physician informed me that I had a urinary tract infection. The on-call doctor was concerned on account of my chills and fever. I remembered that when I had had a kidney infection many years before, I had had chills and fever. The doctor was unsure whether I should go to the ER. I didn't really want to go to the ER, so the doctor ordered an antibiotic whose name I don't recall. She then instructed me that if I didn't feel better the following day, I should go to the ER. I took two doses of the antibiotic, and the following morning, I didn't feel better, so I went to the ER on 2/19/2023. They did a COVID-19 test, other bloodwork, and a urinalysis. They also started an IV. They gave me something for pain, because I hurt all over, and I felt like I had flank pain. A few hours later, I was told that I had tested positive for COVID-19. Interestingly, though, I tested negative for a urinary tract infection when the urinalysis was done. I was then discharged, but before I left, I asked for Paxlovid. However, they refused to prescribe it to me because of the medications I was taking. I ended up calling my PCP's practice and then getting the Paxlovid prescription. I was given low-dose Paxlovid. The doctor told me to stop taking atorvastatin while I was on the Paxlovid and to watch my blood pressure and blood sugar. I took the Paxlovid for five days, and I started feeling better by 2/21/2023. I isolated for five days from the time I was diagnosed. During my illness, I had no cough or other respiratory symptoms. After 2/21/2023, I steadily got better.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Tremor, Urinary tract infection, Urine analysis abnormal
Clinical narrative: I was on a shopping trip with my granddaughter on 2/17/2023, and I was suddenly seized by chills, and I was shaking all over and felt cold. I then went out to the car and turned on the heated seat. While I was in the car waiting on my granddaughter, I fell asleep at one point. I was the driver, but when my granddaughter saw me, she insisted on driving me home. At this point, I felt pretty sure that I had COVID-19. When I got home,though, I took a home antigen test and got a negative result. I then took some Tylenol and went to bed. The following morning on 2/18/2023, I took another home antigen test and got another negative result. I had a fever of 100 and intermittent chills. I called the 24-hour number for the medical group that runs the practice where my PCP works. They told me that I needed to go to the ER or a walk-in clinic. I then called the on-call doctor at the practice and spoke to her personally. I had previously gone to the clinic and had a urinalysis done earlier in the week, and the on-call physician informed me that I had a urinary tract infection. The on-call doctor was concerned on account of my chills and fever. I remembered that when I had had a kidney infection many years before, I had had chills and fever. The doctor was unsure whether I should go to the ER. I didn't really want to go to the ER, so the doctor ordered an antibiotic whose name I don't recall. She then instructed me that if I didn't feel better the following day, I should go to the ER. I took two doses of the antibiotic, and the following morning, I didn't feel better, so I went to the ER on 2/19/2023. They did a COVID-19 test, other bloodwork, and a urinalysis. They also started an IV. They gave me something for pain, because I hurt all over, and I felt like I had flank pain. A few hours later, I was told that I had tested positive for COVID-19. Interestingly, though, I tested negative for a urinary tract infection when the urinalysis was done. I was then discharged, but before I left, I asked for Paxlovid. However, they refused to prescribe it to me because of the medications I was taking. I ended up calling my PCP's practice and then getting the Paxlovid prescription. I was given low-dose Paxlovid. The doctor told me to stop taking atorvastatin while I was on the Paxlovid and to watch my blood pressure and blood sugar. I took the Paxlovid for five days, and I started feeling better by 2/21/2023. I isolated for five days from the time I was diagnosed. During my illness, I had no cough or other respiratory symptoms. After 2/21/2023, I steadily got better.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Unknown, reporting administering vaccine after BUD.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Chest discomfort, Cold sweat, Dyspnoea, Electrocardiogram normal
Clinical narrative: Within 15 minutes of vaccination, patient reported feeling sweaty, hands were clammy, and chest tightness and discomfort. She stated that her "heart felt inflamed." Patient was watched for 15 more minutes, at which point she was sweating more and having some labored breathing, but no difficulty speaking. EMS was called and she was found to be highly tachycardic and hypertensive.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Hypertension, Tachycardia
Clinical narrative: Within 15 minutes of vaccination, patient reported feeling sweaty, hands were clammy, and chest tightness and discomfort. She stated that her "heart felt inflamed." Patient was watched for 15 more minutes, at which point she was sweating more and having some labored breathing, but no difficulty speaking. EMS was called and she was found to be highly tachycardic and hypertensive.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cataract operation, Metamorphopsia, Neovascular age-related macular degeneration, Retinal function test abnormal
Clinical narrative: In 12/2022, I had distorted vision. I went to an eye doctor. They did cataract surgery and then they realized it was more than that. Then they sent me to a specialist. The specialist doctor had me come back and ran more test and diagnosed me with Wet Macular Degeneration in my left eye on 03/22/2023. The doctor said I needed shots in my eye. I had 2 now, they were a month apart.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neoplasm, Ultrasound scan abnormal, Uterine leiomyoma, Vaginal haemorrhage
Clinical narrative: I had some light spotting on or about 2/16/2023. This lasted for about five days. I called my doctor, and I underwent an ultrasound a few days later. I then went in for a consultation on the findings of the ultrasound. It found that my fibroid tumors had grown. I now have eight of them that are more than an inch. My doctor recommended that I undergo a hysterectomy and an endometrial biopsy. At the time of this writing, I am in the process of seeking a second opinion, because I feel that this is a big decision to make on account of what seems to be a minor event. I currently have no symptoms.
Age: 34.0
Sex: U
Vaccine: COVID19-2
Symptoms: Antibody test positive, Blood test, COVID-19, Cardiovascular disorder, Erythema
Clinical narrative: Inflammation after months in my arm  Miss diagnoses with autoimmune conditions  High white cell blood count  High antibodies  High hsv 2 reaction
Age: 34.0
Sex: U
Vaccine: COVID19-2
Symptoms: Herpes simplex test positive, Hypertension, Inflammation, Injection site inflammation, Malaise
Clinical narrative: Inflammation after months in my arm  Miss diagnoses with autoimmune conditions  High white cell blood count  High antibodies  High hsv 2 reaction
Age: 34.0
Sex: U
Vaccine: COVID19-2
Symptoms: Pain in extremity, Palpitations, White blood cell count increased
Clinical narrative: Inflammation after months in my arm  Miss diagnoses with autoimmune conditions  High white cell blood count  High antibodies  High hsv 2 reaction
Age: 1.75
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: ADMINISTERED THE Dark pink cap; yellow label border INSTEAD of Dark blue cap; gray label border as indicated by the CDC
Age: 61.0
Sex: M
Vaccine: FLUR4
Symptoms: Thrombosis
Clinical narrative: PATIENT STATED THAT FLU SHOT CAUSED HIS CLOTS
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness ,swelling at injection site
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Cough, Dry mouth, Dyspnoea
Clinical narrative: Couldn't breathe,  entire body was in pain. Runny nose, cough,cold sweats, chills, blurred vision, evacuation,  sore throat, dry mouth, gasping for air,
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Oropharyngeal pain, Pain, Rhinorrhoea, Vision blurred
Clinical narrative: Couldn't breathe,  entire body was in pain. Runny nose, cough,cold sweats, chills, blurred vision, evacuation,  sore throat, dry mouth, gasping for air,
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac failure congestive, Cardiac function test, Echocardiogram, Laboratory test
Clinical narrative: I was diag7with CHF 11 months after getting the shot, was healthy up to the point when I was hospitalized
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Headache, No adverse event, Oropharyngeal pain
Clinical narrative: I did not have an adverse reaction to the Covid vaccine.  On April 1, 2023, I woke with a severe sore throat, headache, and general aches and weakness, and then tested positive for Covid.  After a telemedicine visit with my doctor's office, I started taking a 5 day course of Paxlovid on April 2, 2023.  My Covid symptoms abated quickly.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the Covid vaccine.  On April 1, 2023, I woke with a severe sore throat, headache, and general aches and weakness, and then tested positive for Covid.  After a telemedicine visit with my doctor's office, I started taking a 5 day course of Paxlovid on April 2, 2023.  My Covid symptoms abated quickly.
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: I accidently administered Pentacel that had expired two days prior to administration. It expired 04-02-2023. I administered it on 04-04-2023. No adverse events or reactions noted.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonia, Unresponsive to stimuli
Clinical narrative: On 4/13/2023 child had Immunizations (Pentacel, Prevnar, Rotateq) after 7 to 10 minutes that Immunizations were given child became limp, not responding (parent already in the car with infant on carseat) episode lasted 5-10 minutes child's color was good, breathing, during episode
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Breath holding, Eye movement disorder, Hypotonia
Clinical narrative: Pt received DTaP & Hib then eyes rolled back, held breath, went limp for a few seconds then woke & acted normally.