chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Incorrect route of product administration, Pyrexia
Clinical narrative: Fever, chills; Fever, chills; right arm, subcutaneous; Fever, chills; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of the first episode of PYREXIA (Fever, chills), CHILLS (chills), the second episode of PYREXIA (Fever, chills), CHILLS (Fever, chills) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (right arm, subcutaneous) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A, 042B21A and Unknown) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. In September 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced the first episode of PYREXIA (Fever, chills) and CHILLS (chills). On 01-May-2021, the patient experienced the second episode of PYREXIA (Fever, chills), CHILLS (Fever, chills) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (right arm, subcutaneous). On 06-Apr-2021, CHILLS (chills) had resolved. On 03-May-2021, last episode of PYREXIA (Fever, chills) and CHILLS (Fever, chills) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (right arm, subcutaneous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       No treatment medications were reported. No concomitant medications were reported.  Vaccine 1 (orignal series) received April 3, 2021 from Vaccine event in right arm: experienced fever and chills, bed rest, recovered without medical attention in 3 days.  Vaccine 2 (original series) received May 1, 2021 in right arm, subcutaneous: patient experienced fever and chills, recovered without medical attention in 1.5 days.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27-Feb-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis. No Medical History information was reported.    On 27-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27-Feb-2023) 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 EXPIRED PRODUCT ADMINISTERED (HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27-Feb-2023).    No concomitant medications were provided. The patient in this report did not experience any side effects from the invalid dose that was administered. No treatment medication was provided.  No concomitant medications details were reported.  Moderna was not authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Details of inquiry was there any stability data on Moderna primary series 6 to 11 year old vaccine given within a week of the expiration date passing also, what was the recommendation on revaccination if expired product was given. The Moderna lot number 064A22A expired on 24-Feb-2023. The patient in this report did not experience any side effects from the invalid dose that was administered.  No treatment medications details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713718, US-MODERNATX, INC.-MOD-2023-713858, US-MODERNATX, INC.-MOD-2023-713723 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2023: Follow-up received includes non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713718:Same reporter US-MODERNATX, INC.-MOD-2023-713858:Same reporter US-MODERNATX, INC.-MOD-2023-713723:Same reporter
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram pulmonary normal, Chest X-ray normal, Dyspnoea, Echocardiogram normal, Laboratory test normal
Clinical narrative: Tinnitus in both ears, shortness of breath
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Scan with contrast, Stress echocardiogram normal, Tinnitus
Clinical narrative: Tinnitus in both ears, shortness of breath
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023; No adverse event; Patients administered doses after the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-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 23-Feb-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 (Patients administered doses after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) 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 (Patients administered doses after the BUD) and PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023).    No concomitant drug information was provided.  It was reported that the 6 patients had received the vaccine beyond BUD.  No treatment medication information was provided.  The case belongs to the first out of 6 patients who had received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713881, US-MODERNATX, INC.-MOD-2023-713883, US-MODERNATX, INC.-MOD-2023-713884, US-MODERNATX, INC.-MOD-2023-713885, US-MODERNATX, INC.-MOD-2023-713888 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2023: Follow-up received, updated suspect drug batch number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713881:(pt 2 of 6) US-MODERNATX, INC.-MOD-2023-713885:(pt 3 of 6) US-MODERNATX, INC.-MOD-2023-713883:(pt 4 of 6) US-MODERNATX, INC.-MOD-2023-713888:(pt 5 of 6) US-MODERNATX, INC.-MOD-2023-713884:(pt 6 of 6)
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 47-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) 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 10-Feb-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) 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 medicine were reported. No treatment medicine were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     It was Unknown if Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) 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 (Dose administered after manufacturer date of expiry).    No concomitant medications were reported. It was reported that the expired dose of vaccine was given on 28-Feb-2023, they had been receiving monovalent that had been expiring early, like a week and a half. Dose was administered after manufacturer date of expiry. Product was Monovalent vaccine. The vial did not undergo any temperature excursions  No treatment details were reported.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue
Clinical narrative: little fatigued; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (little fatigued) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    In September 2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced FATIGUE (little fatigued). At the time of the report, FATIGUE (little fatigued) had 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 drugs were not reported.  It was reported that patient received dose 1 of Moderna intramuscularly on 16-Jan-2021 with lot number 011J20A on left arm, dose 2 of Moderna on 13-Feb-2021 with lot number 031M20A on left arm, dose 3 as first booster of Moderna on 20-Aug-2021 with lot number 052E11A on left arm and dose 4 as second booster of Moderna on 21-Mar-2022 with lot number as 046L21A on right arm.  Treatment medications were not provided.   This case was linked to MOD-2023-713924 (Patient Link).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: PATIENT IS IMMUNOCOMPROMISED AND IS ON METHOTREXATE FOR RA AN D HAS COVID AND SHINGLES IN DECEMBER 2022, PT WANTED SHINGRIX 1ST DOSE AND AFTER SHE GOT SHE SAID SHE HAD A RASH AROUND SITE OF INJECTION AND RASH THAT LOOKS LIKE SHINGLES SHE WAS CHECKED BY MD AND HE SAID IT IS FLARE UP DUE TO HER DECEMEBER CASE BUT SHE IS FEELING BETTER AND NO FURTHER ACTION NEEDED
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 4.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Expired product administered
Clinical narrative: expired shot of DTAP given 3/1/23. Given on 3/6/23
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Mother of child said "No Reaction." Already received another Booster dose.   To whom it may concern: In November 2022 our Vaccine program did our every-other-year audits in both of our offices. It was discovered at that time, that some Covid Vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received.) The Program directed us to fill out VAERS forms and send them to you. They also counselled us that it was our providers and parents joint decision as to whether to re-vaccinate pts or not.  We only use Pfizer vaccines for Covid - and the listed lot #'s given outside the expiration date are listed below.  Location #1 FM0698 (orange top) FM0698 (purple top) FL8095 (orange top) FL8094 (orange top) FM7553 (purple)  Location #2 FM0698 (purple) FP4554 (purple) FL8094 (orange) FL8095 (orange) FT1551 (orange)  Please see the attached VAERS forms, and feel free to contact the office for further questions or concerns.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bacterial test positive, Blood albumin normal, Blood chloride increased, Blood creatinine increased
Clinical narrative: Patient presented to the ED and was admitted on 2/21/2023. Patient had been experiencing symptoms of back pain on her right side, feeling lethargic, on and off fevers, and fatigue since 2/19/2023. When presented to the ED, patient was afebrile. Urine culture positive for E. coli infection, UTI. Urine color was amber. Patient was treated with IV Rocephin. Leukocytosis-elevated at 12.77. Hypokalemia-low at 3.2. Hyperglycemia noted, likely in reaction to infection. Ultrasound of her kidneys was obtained and did demonstrate bilateral cysts on her native kidneys, normal transplant kidney, no evidence of pyelonephritis, no evidence of stranding, no evidence of hydronephrosis. Patient believed she heard a renal cyst pop, and reported she usually gets a UTI. Patient reported a history of cysts on her native kidneys and have had cysts rupture in the past. Patient reported the main concern of her admission was due to a rupture of a cyst on one of her native kidneys. She has been completely afebrile for the duration of her admission. Patient was given Keflex for treatment when discharged. During the course of her admission, patient had an outbreak of Herpes Labialis and was given acyclovir orally to treat for 10 days. Patient received the Janssen Ad26.CoV2.S vaccine on 9/7/2022. Patient is approximately 180 days post-vaccination at time of the report. Per research study PI, this adverse event is not related to the Janssen Ad26.CoV2.S vaccination on 9/7/2022.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood phosphorus decreased, Blood potassium decreased, Blood sodium normal, Blood urea decreased, Blood urine present
Clinical narrative: Patient presented to the ED and was admitted on 2/21/2023. Patient had been experiencing symptoms of back pain on her right side, feeling lethargic, on and off fevers, and fatigue since 2/19/2023. When presented to the ED, patient was afebrile. Urine culture positive for E. coli infection, UTI. Urine color was amber. Patient was treated with IV Rocephin. Leukocytosis-elevated at 12.77. Hypokalemia-low at 3.2. Hyperglycemia noted, likely in reaction to infection. Ultrasound of her kidneys was obtained and did demonstrate bilateral cysts on her native kidneys, normal transplant kidney, no evidence of pyelonephritis, no evidence of stranding, no evidence of hydronephrosis. Patient believed she heard a renal cyst pop, and reported she usually gets a UTI. Patient reported a history of cysts on her native kidneys and have had cysts rupture in the past. Patient reported the main concern of her admission was due to a rupture of a cyst on one of her native kidneys. She has been completely afebrile for the duration of her admission. Patient was given Keflex for treatment when discharged. During the course of her admission, patient had an outbreak of Herpes Labialis and was given acyclovir orally to treat for 10 days. Patient received the Janssen Ad26.CoV2.S vaccine on 9/7/2022. Patient is approximately 180 days post-vaccination at time of the report. Per research study PI, this adverse event is not related to the Janssen Ad26.CoV2.S vaccination on 9/7/2022.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide normal, Chromaturia, Condition aggravated, Culture urine positive, Escherichia test positive
Clinical narrative: Patient presented to the ED and was admitted on 2/21/2023. Patient had been experiencing symptoms of back pain on her right side, feeling lethargic, on and off fevers, and fatigue since 2/19/2023. When presented to the ED, patient was afebrile. Urine culture positive for E. coli infection, UTI. Urine color was amber. Patient was treated with IV Rocephin. Leukocytosis-elevated at 12.77. Hypokalemia-low at 3.2. Hyperglycemia noted, likely in reaction to infection. Ultrasound of her kidneys was obtained and did demonstrate bilateral cysts on her native kidneys, normal transplant kidney, no evidence of pyelonephritis, no evidence of stranding, no evidence of hydronephrosis. Patient believed she heard a renal cyst pop, and reported she usually gets a UTI. Patient reported a history of cysts on her native kidneys and have had cysts rupture in the past. Patient reported the main concern of her admission was due to a rupture of a cyst on one of her native kidneys. She has been completely afebrile for the duration of her admission. Patient was given Keflex for treatment when discharged. During the course of her admission, patient had an outbreak of Herpes Labialis and was given acyclovir orally to treat for 10 days. Patient received the Janssen Ad26.CoV2.S vaccine on 9/7/2022. Patient is approximately 180 days post-vaccination at time of the report. Per research study PI, this adverse event is not related to the Janssen Ad26.CoV2.S vaccination on 9/7/2022.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Escherichia urinary tract infection, Fatigue, Glomerular filtration rate decreased, Hyperglycaemia, Hypokalaemia
Clinical narrative: Patient presented to the ED and was admitted on 2/21/2023. Patient had been experiencing symptoms of back pain on her right side, feeling lethargic, on and off fevers, and fatigue since 2/19/2023. When presented to the ED, patient was afebrile. Urine culture positive for E. coli infection, UTI. Urine color was amber. Patient was treated with IV Rocephin. Leukocytosis-elevated at 12.77. Hypokalemia-low at 3.2. Hyperglycemia noted, likely in reaction to infection. Ultrasound of her kidneys was obtained and did demonstrate bilateral cysts on her native kidneys, normal transplant kidney, no evidence of pyelonephritis, no evidence of stranding, no evidence of hydronephrosis. Patient believed she heard a renal cyst pop, and reported she usually gets a UTI. Patient reported a history of cysts on her native kidneys and have had cysts rupture in the past. Patient reported the main concern of her admission was due to a rupture of a cyst on one of her native kidneys. She has been completely afebrile for the duration of her admission. Patient was given Keflex for treatment when discharged. During the course of her admission, patient had an outbreak of Herpes Labialis and was given acyclovir orally to treat for 10 days. Patient received the Janssen Ad26.CoV2.S vaccine on 9/7/2022. Patient is approximately 180 days post-vaccination at time of the report. Per research study PI, this adverse event is not related to the Janssen Ad26.CoV2.S vaccination on 9/7/2022.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Leukocytosis, Oral herpes, Protein urine, Pyrexia
Clinical narrative: Patient presented to the ED and was admitted on 2/21/2023. Patient had been experiencing symptoms of back pain on her right side, feeling lethargic, on and off fevers, and fatigue since 2/19/2023. When presented to the ED, patient was afebrile. Urine culture positive for E. coli infection, UTI. Urine color was amber. Patient was treated with IV Rocephin. Leukocytosis-elevated at 12.77. Hypokalemia-low at 3.2. Hyperglycemia noted, likely in reaction to infection. Ultrasound of her kidneys was obtained and did demonstrate bilateral cysts on her native kidneys, normal transplant kidney, no evidence of pyelonephritis, no evidence of stranding, no evidence of hydronephrosis. Patient believed she heard a renal cyst pop, and reported she usually gets a UTI. Patient reported a history of cysts on her native kidneys and have had cysts rupture in the past. Patient reported the main concern of her admission was due to a rupture of a cyst on one of her native kidneys. She has been completely afebrile for the duration of her admission. Patient was given Keflex for treatment when discharged. During the course of her admission, patient had an outbreak of Herpes Labialis and was given acyclovir orally to treat for 10 days. Patient received the Janssen Ad26.CoV2.S vaccine on 9/7/2022. Patient is approximately 180 days post-vaccination at time of the report. Per research study PI, this adverse event is not related to the Janssen Ad26.CoV2.S vaccination on 9/7/2022.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Renal cyst, Ultrasound kidney abnormal, Urine analysis abnormal, Urine ketone body present, Urine leukocyte esterase positive
Clinical narrative: Patient presented to the ED and was admitted on 2/21/2023. Patient had been experiencing symptoms of back pain on her right side, feeling lethargic, on and off fevers, and fatigue since 2/19/2023. When presented to the ED, patient was afebrile. Urine culture positive for E. coli infection, UTI. Urine color was amber. Patient was treated with IV Rocephin. Leukocytosis-elevated at 12.77. Hypokalemia-low at 3.2. Hyperglycemia noted, likely in reaction to infection. Ultrasound of her kidneys was obtained and did demonstrate bilateral cysts on her native kidneys, normal transplant kidney, no evidence of pyelonephritis, no evidence of stranding, no evidence of hydronephrosis. Patient believed she heard a renal cyst pop, and reported she usually gets a UTI. Patient reported a history of cysts on her native kidneys and have had cysts rupture in the past. Patient reported the main concern of her admission was due to a rupture of a cyst on one of her native kidneys. She has been completely afebrile for the duration of her admission. Patient was given Keflex for treatment when discharged. During the course of her admission, patient had an outbreak of Herpes Labialis and was given acyclovir orally to treat for 10 days. Patient received the Janssen Ad26.CoV2.S vaccine on 9/7/2022. Patient is approximately 180 days post-vaccination at time of the report. Per research study PI, this adverse event is not related to the Janssen Ad26.CoV2.S vaccination on 9/7/2022.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased, White blood cells urine positive
Clinical narrative: Patient presented to the ED and was admitted on 2/21/2023. Patient had been experiencing symptoms of back pain on her right side, feeling lethargic, on and off fevers, and fatigue since 2/19/2023. When presented to the ED, patient was afebrile. Urine culture positive for E. coli infection, UTI. Urine color was amber. Patient was treated with IV Rocephin. Leukocytosis-elevated at 12.77. Hypokalemia-low at 3.2. Hyperglycemia noted, likely in reaction to infection. Ultrasound of her kidneys was obtained and did demonstrate bilateral cysts on her native kidneys, normal transplant kidney, no evidence of pyelonephritis, no evidence of stranding, no evidence of hydronephrosis. Patient believed she heard a renal cyst pop, and reported she usually gets a UTI. Patient reported a history of cysts on her native kidneys and have had cysts rupture in the past. Patient reported the main concern of her admission was due to a rupture of a cyst on one of her native kidneys. She has been completely afebrile for the duration of her admission. Patient was given Keflex for treatment when discharged. During the course of her admission, patient had an outbreak of Herpes Labialis and was given acyclovir orally to treat for 10 days. Patient received the Janssen Ad26.CoV2.S vaccine on 9/7/2022. Patient is approximately 180 days post-vaccination at time of the report. Per research study PI, this adverse event is not related to the Janssen Ad26.CoV2.S vaccination on 9/7/2022.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: After receiving the new 2023 pneumococcal vaccine on 2/13/23 I did not have any noticeable side effects. However, about 8 days later, my arm began swelling at the injection site and was very sore and painful. The swollen area grew in diameter by over an inch for 3-4 days. I experienced severe headaches, joint and body aches, and chills.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: After receiving the new 2023 pneumococcal vaccine on 2/13/23 I did not have any noticeable side effects. However, about 8 days later, my arm began swelling at the injection site and was very sore and painful. The swollen area grew in diameter by over an inch for 3-4 days. I experienced severe headaches, joint and body aches, and chills.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pustular psoriasis, Skin exfoliation, Skin haemorrhage
Clinical narrative: Acitretin (Soriatane), 25 mg. daily, was prescribed and used for several months and then discontinued. The Rx was for pustular psoriasis developed from the Pfizer COVID-19 vaccine. The use Acitretin caused loss of skin layers and bleeding on arms, chest, and legs. The skin has yet to recover even though the use of Acitretin has been discontinued.
Sex: M
Vaccine: COVID19
Symptoms: Injection site injury
Clinical narrative: This appears to be a problem with delayed injection site injury from Novel Coronavirus Vaccine. I received treatment in November and December 2022 in the form of a cortisone injection and physical therapy. That treatment was in my opinion 95% effective. However a couple of months later it seems to have returned.
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Hypoaesthesia
Clinical narrative: Systemic: pt had numbness in the elbow no pain a little redness for a few days but pt is still having numbness in arm in elbow area-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: pt had no pain but numbness in elbow area. he confirmed there was no issue with movement of the arm or restriction and placement of the vaccine was correct not too high in shoulder or too low to affect the radial nerve pt just wanted to report to the vaers to and see if any issues with lot i told him also to go to dr if it gets worse or does not resolve. pt been having the numbness when he touches the arm
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Confusional state, Dyspnoea, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild
Age: 78.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Got COVID-was vaccinated
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary normal, Atrial fibrillation, Cast application, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Patient arrives with chief complaint of shortness of breath from her rehab center.  Patient is there for bilateral broken legs.  Patient does have problems with shortness of breath and is on home O2 at 7 L.  Patient says her shortness of breath got markedly worse today but she did not have chest pain.  Patient has an increase in her cough but she is not able to cough anything up.  Patient denies having a runny nose sore throat or ear pain or fevers.  Both patient's legs are in cast making it difficult to ascertain her fluid status.  Patient denies any history of MI cardiac stent or CABG.  Patient denies diabetes.  Patient has past medical history of hypertension and dyslipidemia.  Patient has A-fib but she is not on any blood thinners due to bloody noses. Patient past surgical history is positive for left wrist Patient is a former smoker that rarely drinks alcohol Associated Symptoms: cough, shortness of breath, wheezing
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Electrocardiogram T wave inversion, Electrocardiogram abnormal, Fibrin D dimer increased
Clinical narrative: Patient arrives with chief complaint of shortness of breath from her rehab center.  Patient is there for bilateral broken legs.  Patient does have problems with shortness of breath and is on home O2 at 7 L.  Patient says her shortness of breath got markedly worse today but she did not have chest pain.  Patient has an increase in her cough but she is not able to cough anything up.  Patient denies having a runny nose sore throat or ear pain or fevers.  Both patient's legs are in cast making it difficult to ascertain her fluid status.  Patient denies any history of MI cardiac stent or CABG.  Patient denies diabetes.  Patient has past medical history of hypertension and dyslipidemia.  Patient has A-fib but she is not on any blood thinners due to bloody noses. Patient past surgical history is positive for left wrist Patient is a former smoker that rarely drinks alcohol Associated Symptoms: cough, shortness of breath, wheezing
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lower limb fracture, Sputum retention, Troponin normal, Wheezing
Clinical narrative: Patient arrives with chief complaint of shortness of breath from her rehab center.  Patient is there for bilateral broken legs.  Patient does have problems with shortness of breath and is on home O2 at 7 L.  Patient says her shortness of breath got markedly worse today but she did not have chest pain.  Patient has an increase in her cough but she is not able to cough anything up.  Patient denies having a runny nose sore throat or ear pain or fevers.  Both patient's legs are in cast making it difficult to ascertain her fluid status.  Patient denies any history of MI cardiac stent or CABG.  Patient denies diabetes.  Patient has past medical history of hypertension and dyslipidemia.  Patient has A-fib but she is not on any blood thinners due to bloody noses. Patient past surgical history is positive for left wrist Patient is a former smoker that rarely drinks alcohol Associated Symptoms: cough, shortness of breath, wheezing
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram thorax abnormal, Dysphonia, Lung opacity, Respiratory tract congestion
Clinical narrative: In August 2021 I started experiencing a nasal sounding voice and around October 2021 I started wheezing. My mother was in hospice at this time and I may have contracted COVID while staying there but I was never diagnosed and did not have any other symptoms. I started seeing a pulmonologist and had a CT scan that showed ground glass in my lungs, like white dots on my lungs, and was told it was typical in people who have had COVID. I started on a medication that has helped my wheezing, but I still sound like I am congested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Wheezing
Clinical narrative: In August 2021 I started experiencing a nasal sounding voice and around October 2021 I started wheezing. My mother was in hospice at this time and I may have contracted COVID while staying there but I was never diagnosed and did not have any other symptoms. I started seeing a pulmonologist and had a CT scan that showed ground glass in my lungs, like white dots on my lungs, and was told it was typical in people who have had COVID. I started on a medication that has helped my wheezing, but I still sound like I am congested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram abdomen, Diabetes mellitus, Thirst, Urine output increased
Clinical narrative: My issue was I developed increased in thirst and in urination that would not stop. I was losing weight. Went to the doctor & they did some testing & it came back I am now a diabetic.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: My issue was I developed increased in thirst and in urination that would not stop. I was losing weight. Went to the doctor & they did some testing & it came back I am now a diabetic.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: I experienced heavy menstrual bleeding
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient was given the orange top Covid 19 Pfizer 5-11 years 0.3 ml undiluted solution . No adverse reaction reported at this time.  Pt was due for Covid 19 Pfizer gray top 12 plus years vaccine, monovalent 2nd dose
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Oral mucosal eruption
Clinical narrative: Mother appears at the vaccination center on Monday, march 6 at 10:28am to notify that the patient got rash in the area of the mouth on Saturday, march 4 at 9:00pm indicates that he will take it to his pediatrician, Dr.
Age: 32.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Started Tuesday night 17JAN2023 with chills aches fatigue just really a runny nose but on Thursday 19JAN2023 diarrhea and in the evening a headache and I had until Friday 20JAN2023 and the headache was persistent so I went into urgent care and was told to take plenty of fluids and EXCEDRIN. I was feeling better by the end of the weekend 22JAN2023 had mostly recovered.
Age: 32.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Rhinorrhoea
Clinical narrative: Started Tuesday night 17JAN2023 with chills aches fatigue just really a runny nose but on Thursday 19JAN2023 diarrhea and in the evening a headache and I had until Friday 20JAN2023 and the headache was persistent so I went into urgent care and was told to take plenty of fluids and EXCEDRIN. I was feeling better by the end of the weekend 22JAN2023 had mostly recovered.
Age: 18.0
Sex: F
Vaccine: HEPA, MMRV, MNQ, TDAP, VARCEL
Symptoms: Wrong product administered
Clinical narrative: MMRV Vaccine given in error when MMR vaccine should have been given.  Patient received Varicella vaccine in the other arm at the same time.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Gave vaccine to pt and realized after I was going to chart it that it was expired. 2/26/2023 was the expiration date.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent Pfizer COVID vaccine instead of Bivalent booster. Patient will be offered bivalent vaccine in 2 months.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: red raised rash located around injection site, not warm or painful per mom
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: red raised rash located around injection site, not warm or painful per mom
Age: 0.67
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received a rotavirus vaccine after the age of 8 months
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase normal, Pain in extremity, Red blood cell sedimentation rate normal, Sleep disorder
Clinical narrative: Patient was given her 10 year booster update for Tdap on day of her physical exam.  Later that night she began to have severe bilateral leg pain that woke her up from sleep.  She continued to have this pain mainly at night when she lied down for the next few days and her itraconazole and statin medications were stopped to see if they were contributing.  As of 3/7/23 she continues to have bilateral severe leg pain at night despite stopping these medications and with no other  symptoms.  Her creatinine kinase and ESR are both normal.  She was just started on gabapentin last night with some relief.  Lumbar spine x-rays are pending.  Due the acute onset of the pain on the night of her exam with no other precipitating events or injuries, and the severity of symptoms I thought it should be reported.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram head, Hypoacusis, Migraine, Speech disorder, Transient ischaemic attack
Clinical narrative: Onset of Migraine headache followed by a TIA and 3 rounds of vomiting . Patient had difficulty hearing and speaking .  Symptoms resolved the next day.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Onset of Migraine headache followed by a TIA and 3 rounds of vomiting . Patient had difficulty hearing and speaking .  Symptoms resolved the next day.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Bronchitis, COVID-19, Cough, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I started have a sore throat and developed crazy coughing. I made an appointment with my doctor and had a telehealth appointment we discussed my symptoms by then I was wheezing. I was given a prescription for antibiotics. It took me about 8 to 10 days to get over the bronchitis. Once I got COVID-19 in February, I emailed the doctor and was prescribed, molnupiravir. I started taking it immediately I was still coughing five days later so I had a telehealth appointment and the doctor called in antibiotics to help me to finish get rid of the cough.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Wheezing
Clinical narrative: I started have a sore throat and developed crazy coughing. I made an appointment with my doctor and had a telehealth appointment we discussed my symptoms by then I was wheezing. I was given a prescription for antibiotics. It took me about 8 to 10 days to get over the bronchitis. Once I got COVID-19 in February, I emailed the doctor and was prescribed, molnupiravir. I started taking it immediately I was still coughing five days later so I had a telehealth appointment and the doctor called in antibiotics to help me to finish get rid of the cough.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was administered Hep B on 2/23/23 with pediatric vaccine instead of adult vaccine. no adverse events were observed.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was administered Hep B on 2/23/23 with pediatric vaccine instead of adult vaccine. no adverse events were observed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Patient received 2nd dose of primary series of COVID vaccine 8 days after her 1st primary dose (per pharmacy instruction). Reports s/s started ~15 mins after receiving vaccination; redness, swelling at the site. Reports rash from shoulder to elbow. Describes swelling as moderate to severe and states "it looked like fluid under the skin." Patient with GI s/s x3 weeks (nausea, vomiting). Fever x3-4 days, highest temp was 103*F. Patient treated s/s using Tylenol, Ibuprofen, Zofran, Dayquil/Nyquil. S/s resolved after ~3 weeks of treating.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vomiting
Clinical narrative: Patient received 2nd dose of primary series of COVID vaccine 8 days after her 1st primary dose (per pharmacy instruction). Reports s/s started ~15 mins after receiving vaccination; redness, swelling at the site. Reports rash from shoulder to elbow. Describes swelling as moderate to severe and states "it looked like fluid under the skin." Patient with GI s/s x3 weeks (nausea, vomiting). Fever x3-4 days, highest temp was 103*F. Patient treated s/s using Tylenol, Ibuprofen, Zofran, Dayquil/Nyquil. S/s resolved after ~3 weeks of treating.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Diarrhoea, Dizziness, Nausea, SARS-CoV-2 test positive
Clinical narrative: 02/18/23 presents to ED for "dizziness, nausea and diarrhea". PMHx of "right eye blindness, partial vision loss of left eye, CHI, CKD stage 2, T2DM, GERD, HTN, HLD, CAD, PVD, OSA, Pulmonary hypertension, anemia of chronic disease"
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Nausea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: 02/18/23 presents to ED for "nausea, vomiting" "no significant past medical history"
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received 6 month - 4 year Pfizer monovalent for a third dose instead of 6 month - 4 year Pfizer Bivalent in error. Patient will return to office to receive correct dose
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Muscular weakness, Musculoskeletal stiffness, Myalgia, Tendon disorder
Clinical narrative: "Pain and weakness" in left bicept which gets better with movement; "weakness and stiffness" to both leg/calf muscles; "clicking" feeling to tendon/muscles in left leg and achilles tendons are tender.   Symptoms are intermittent and he reports that they are all improving over the last 4 months. It should be noted that he had an inlfuenza vaccine that same day.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given a second dose of her primary series of Moderna one week earlier than the minimum interval of 28 days. No adverse effects were noted. Patient will be notified to come back in 28 days to receive a valid second dose.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Dysuria, Fall, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 02/19/23 presents to ED for "falls" "difficulty urinating, fevers". PMHx of "CAD, HTN, hypothyroidism, DM type 2"
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: client passed out after vaccines completed, smelling salts adm and client awakened without incident, monitored for 15 minutes and then mother took her home to rest.  this has happened in the past and mother did not make staff aware of this prior to incident or administration of vaccines.  PPD was also administered in the left arm prior to vaccinations
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Epistaxis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: 4 days of red, swollen, hard, itchy upper left arm about 5 inches in length by 3 inches. Basically his entire upper arm.  On day 4 we are seeing some improvement.   Also presented with unusual nose bleeding during that same time.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Pain
Clinical narrative: On 01/27/2023 I started experiencing a slight cough as my symptoms progressed I had severe body aches, fever, chills, rash and diarrhea. I tested positive on 01/28/2023. I had a telehealth visit and treated my symptoms with OTC TYLENOL and antidiarrheal medication. I tested negative on 02/10/2023. I have recovered at this time.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Rash, SARS-CoV-2 test positive
Clinical narrative: On 01/27/2023 I started experiencing a slight cough as my symptoms progressed I had severe body aches, fever, chills, rash and diarrhea. I tested positive on 01/28/2023. I had a telehealth visit and treated my symptoms with OTC TYLENOL and antidiarrheal medication. I tested negative on 02/10/2023. I have recovered at this time.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: 02/19/23 presents to ED for "fever, chills, myalgias, headache". PMHx of "Lambert Eaton syndrome on rituximab and prednisone, asthma"
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 02/19/23 presents to ED for "fever, chills, myalgias, headache". PMHx of "Lambert Eaton syndrome on rituximab and prednisone, asthma"
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Apnoea, Auscultation, Cardiac arrest, Death, Mechanical ventilation
Clinical narrative: Patient continues to have increased seizure activity and worsening respiratory status.  I have discussed the patients decline with Dr.   The family is now at the bedside and we have discussed the patients decline, they wish to withdrawal care at this time.  Will order comfort medications and discontinue current medications and the ventilator.   I was notified by the patients nurse that the patient had become asystolic and apneic shortly after withdrawal of care.  At my assessment the patient is asystolic and there is no palpable pulse.  No spontaneous respirations or breath sounds/heart sounds with 2 minutes of auscultation.  She is nonresponsive, corneal reflexes are absent.  Time of death is 1210pm.  The family is at the bedside.  I will notify the attending physician.  RN to notify Agency and funeral home.