chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Arthralgia, Exposure during pregnancy, Fatigue, Injection site mass, Injection site pain
Clinical narrative: Pain, swelling/lump at injection site (still present on 11/5), all over joint pain that interrupted sleeping, fatigue, feeling like I was coming down with a cold (sore throat, swollen lymph nodes) symptoms lasted 4+ days after injection. I was aprox. 230lbs and 34 weeks and 6 days pregnant on day of vaccine (due date 11/30/2024
Age: 29.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Injection site swelling, Lymphadenopathy, Nasopharyngitis, Oropharyngeal pain, Sleep disorder
Clinical narrative: Pain, swelling/lump at injection site (still present on 11/5), all over joint pain that interrupted sleeping, fatigue, feeling like I was coming down with a cold (sore throat, swollen lymph nodes) symptoms lasted 4+ days after injection. I was aprox. 230lbs and 34 weeks and 6 days pregnant on day of vaccine (due date 11/30/2024
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Lethargy
Clinical narrative: Large rash around injection location with swelling that lasted 4 days. Felt very lethargic for 2 days. Itching of injection site for a week.
Age: 67.0
Sex: F
Vaccine: PNC21
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: flulike symptoms for 3 days, had red swollen arm at injection site 6 days post vaccination, 4 inch diameter at presentation 11/5, pt was going to take aleve and use cold compress. pt had covid vaccine in same arm the day before the pneumonia vaccine.
Age: 22.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Fall, Loss of consciousness, Vision blurred
Clinical narrative: She received both the Moderna and the Fluzone.  Moderna was administered first, followed by Fluzone. After the Fluzone was administered (approximately 30 seconds after), she stated that she was feeling faint and asked for water. Her friend who was there with her offered water. While trying to drink water, her eyes lost focus, she dropped the water and slid out of her chair.  She woke up approximately 30 seconds after.  She stayed in the vaccination area for another 20 minutes, drank more water, and ate a banana. She stated she's never had a reaction to vaccines before. After 20 minutes, she felt fine and went home
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Headache, Tired to the point where she couldn't get out of bed for at least 3 days, injection site reaction including pain, redness, and hot to the touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 flu shots this season; On 08/13/24 patient was administered the Flucelvax immunization and on 11/03/24 the patient was administered the Fluad immunization; Patient forgot that she received the flu shot (under 65 years) in August before returning to school (teacher) and then when she was here with her daughter to get a flu shot she got a second flu shot (for 65 years and older). Since patient had turned 65 in that time period, she got a different formulation, and it was not caught by the computer system, insurance, or the pharmacist at the time. Patient has been notified of the error and patient reports no adverse effects from having both shots.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came in today and reported an adverse event she had after getting her shots. She said her arm was sore and red and swollen, starting the day after getting her vaccines. She said she waited a couple days to see if it would get better. She said it got worse (swelling), so she went to the hospital and was given a round of antibiotics to treat the (diagnosed by hospital doc) cellulitis, which was effective and her arm got better.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None known at this time; message has been left at father's phone number listed on both (father and son) vaccine intake forms.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received pediatric form instead of 12 plus form, pt has no known adverse reaction at this time
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: 26 y.o. gravid, 37+2 EGA patient presented to Immunization Clinic on Friday, 1 NOV 2024, for routine annual influenza vaccine and TdAP administration. Inadvertently, the patient was given a dose of annual influenza vaccine from an Afluria multidose vial, which is typically not administered to gravid patients out of an abundance of caution, given that the MDV preparations contain trace amounts of thimerosal, a mercury containing compound. It would have been preferable to administer a prefilled syringe dose of the annual flu vaccine to this gravid patient. It was not noted until after administration that the MDV formulation was given.
Age: 43.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Lump, pain, warmth, and itching at injection site continuing at the end of Day 3 still.
Age: 1.08
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Body temperature increased, Rash, Seizure, Urinary tract infection, Urine analysis abnormal
Clinical narrative: On 11/1/2024 rash, 11/2/2024 rash worse spread all over body. In the evening of 11/2/24 mom says temperature 101F, gave Motrin and within a minute started having a seizure 911 was called and arrived. 5 minutes later temperature was 105F (mom checked time on clock)
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse event. Patient is 11 years old. He was administered Spivax Covid 12+.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Condition aggravated, Impaired work ability, Pain
Clinical narrative: Flare up of arthralgia causing severe pain. 2.5 days of sick time take. Rheumatologist contnacted with prescription fo Prednisone 20-40 mg daily for one week started today   Covid (Pfizer) and Flu (Flucelvax) vaccine received 10/27/2022 - Pain in joints started within 1 week of vaccines and became so bad that visit to primary care provider on 11/18/24. Started to see Rheumatologist on 11/18/2022.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Headache, Heart rate increased, Palpitations
Clinical narrative: By noon, 10.10.24 stilling to notice elevated BP/Heart rate, headache.  took BP at home 153/92; usual BP at 135/85. Unknown heart rate. "quivering inside" 1330 10.10.24 medical appt with Dr they too commented elevated BP/HR, and headache, quivering had stopped. Patient does not known BP/HR at Dr's officer. 10.11.24 headache continued, BP/HR resolved, unknown numbers. 11.5.2 reported symptoms to Occupation Health, RN
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: An RSV vaccine was processed and had gone through insurance. After administrating vaccine patient then informed us that they had the RSV vaccine in 2023. Therefore, patient was double vaccinated with a vaccine that is a one time vaccine.
Age: 22.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Chills, Hot flush, Hypersensitivity, Injection site erythema, Injection site nodule
Clinical narrative: Patient was seen at urgent care on 09/19/2024 with throat "tingling" and was given steroids due to an allergic reaction.; Given steroids due to an allergic reaction; She woke up with hot flashes and chills; She woke up with hot flashes and chills; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; KNOT AT THE INJECTION SITE; This spontaneous case, initially received on 10-Oct-2024 (with additional information received on 17-Oct-2024), was reported by a health professional by a health authority via Vaccine Adverse Event Reporting System (VAERS ID 1033113) and concerns an adult female patient.  Administration of company suspect drug(s): On 17-Sep-2024 02:00, the patient received Flucelvax (TIV) for an indication Not reported., Dose regimen: 1 Route of administration: Intramuscular, Injection site: Left Arm Lot number: AW3225B.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 17-Sep-2024, the patient experienced KNOT AT THE INJECTION SITE (outcome: Not Reported). On 18-Sep-2024, the patient experienced She woke up with hot flashes and chills (outcome: Not Reported), She woke up with hot flashes and chills (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported). On 19-Sep-2024, the patient experienced Patient was seen at urgent care on 09/19/2024 with throat "tingling" and was given steroids due to an allergic reaction. (outcome: Not Reported), Given steroids due to an allergic reaction (outcome: Not Reported).   Patient noticed a knot at the injection site on 17-Sep-2024. On 18-Sep-2024 she woke up with hot flashes and chills, and noticed the injection site was warm, red, swollen and sore to the touch. She advised that she noticed the redness and swelling was continuing despite taking benadryl. Patient was seen at urgent care on 19-Sep-2024 with throat tingling and was given steroids due to an allergic reaction. Patient advised she has not previously had any sort of allergic reaction to an immunization.     Flucelvax (TIV) action taken: Not Applicable  Treatment medication: Benadryl and steroids (Not specified)  Reporter's assessment:  The reporter did not provide causality assessment (HA cases). In addition, the events were considered as non-serious; Reporter's Comments: All the events are considered related to Flucelvax (TIV) administration.
Age: 22.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pharyngeal paraesthesia
Clinical narrative: Patient was seen at urgent care on 09/19/2024 with throat "tingling" and was given steroids due to an allergic reaction.; Given steroids due to an allergic reaction; She woke up with hot flashes and chills; She woke up with hot flashes and chills; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; KNOT AT THE INJECTION SITE; This spontaneous case, initially received on 10-Oct-2024 (with additional information received on 17-Oct-2024), was reported by a health professional by a health authority via Vaccine Adverse Event Reporting System (VAERS ID 1033113) and concerns an adult female patient.  Administration of company suspect drug(s): On 17-Sep-2024 02:00, the patient received Flucelvax (TIV) for an indication Not reported., Dose regimen: 1 Route of administration: Intramuscular, Injection site: Left Arm Lot number: AW3225B.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 17-Sep-2024, the patient experienced KNOT AT THE INJECTION SITE (outcome: Not Reported). On 18-Sep-2024, the patient experienced She woke up with hot flashes and chills (outcome: Not Reported), She woke up with hot flashes and chills (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported). On 19-Sep-2024, the patient experienced Patient was seen at urgent care on 09/19/2024 with throat "tingling" and was given steroids due to an allergic reaction. (outcome: Not Reported), Given steroids due to an allergic reaction (outcome: Not Reported).   Patient noticed a knot at the injection site on 17-Sep-2024. On 18-Sep-2024 she woke up with hot flashes and chills, and noticed the injection site was warm, red, swollen and sore to the touch. She advised that she noticed the redness and swelling was continuing despite taking benadryl. Patient was seen at urgent care on 19-Sep-2024 with throat tingling and was given steroids due to an allergic reaction. Patient advised she has not previously had any sort of allergic reaction to an immunization.     Flucelvax (TIV) action taken: Not Applicable  Treatment medication: Benadryl and steroids (Not specified)  Reporter's assessment:  The reporter did not provide causality assessment (HA cases). In addition, the events were considered as non-serious; Reporter's Comments: All the events are considered related to Flucelvax (TIV) administration.
Age: 22.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Chills, Hot flush, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was seen at urgent care on 09/19/2024 with throat "tingling" and was given steroids due to an allergic reaction.; Given steroids due to an allergic reaction; She woke up with hot flashes and chills; She woke up with hot flashes and chills; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; KNOT AT THE INJECTION SITE; This spontaneous case, initially received on 10-Oct-2024 (with additional information received on 17-Oct-2024), was reported by a health professional by a health authority via Vaccine Adverse Event Reporting System (VAERS ID 1033113) and concerns an adult female patient.  Administration of company suspect drug(s): On 17-Sep-2024 02:00, the patient received Flucelvax (TIV) for an indication Not reported., Dose regimen: 1 Route of administration: Intramuscular, Injection site: Left Arm Lot number: AW3225B.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 17-Sep-2024, the patient experienced KNOT AT THE INJECTION SITE (outcome: Not Reported). On 18-Sep-2024, the patient experienced She woke up with hot flashes and chills (outcome: Not Reported), She woke up with hot flashes and chills (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported). On 19-Sep-2024, the patient experienced Patient was seen at urgent care on 09/19/2024 with throat "tingling" and was given steroids due to an allergic reaction. (outcome: Not Reported), Given steroids due to an allergic reaction (outcome: Not Reported).   Patient noticed a knot at the injection site on 17-Sep-2024. On 18-Sep-2024 she woke up with hot flashes and chills, and noticed the injection site was warm, red, swollen and sore to the touch. She advised that she noticed the redness and swelling was continuing despite taking benadryl. Patient was seen at urgent care on 19-Sep-2024 with throat tingling and was given steroids due to an allergic reaction. Patient advised she has not previously had any sort of allergic reaction to an immunization.     Flucelvax (TIV) action taken: Not Applicable  Treatment medication: Benadryl and steroids (Not specified)  Reporter's assessment:  The reporter did not provide causality assessment (HA cases). In addition, the events were considered as non-serious; Reporter's Comments: All the events are considered related to Flucelvax (TIV) administration.
Age: 22.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Injection site warmth, Pharyngeal paraesthesia
Clinical narrative: Patient was seen at urgent care on 09/19/2024 with throat "tingling" and was given steroids due to an allergic reaction.; Given steroids due to an allergic reaction; She woke up with hot flashes and chills; She woke up with hot flashes and chills; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH; KNOT AT THE INJECTION SITE; This spontaneous case, initially received on 10-Oct-2024 (with additional information received on 17-Oct-2024), was reported by a health professional by a health authority via Vaccine Adverse Event Reporting System (VAERS ID 1033113) and concerns an adult female patient.  Administration of company suspect drug(s): On 17-Sep-2024 02:00, the patient received Flucelvax (TIV) for an indication Not reported., Dose regimen: 1 Route of administration: Intramuscular, Injection site: Left Arm Lot number: AW3225B.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 17-Sep-2024, the patient experienced KNOT AT THE INJECTION SITE (outcome: Not Reported). On 18-Sep-2024, the patient experienced She woke up with hot flashes and chills (outcome: Not Reported), She woke up with hot flashes and chills (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported), INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE TO THE TOUCH (outcome: Not Reported). On 19-Sep-2024, the patient experienced Patient was seen at urgent care on 09/19/2024 with throat "tingling" and was given steroids due to an allergic reaction. (outcome: Not Reported), Given steroids due to an allergic reaction (outcome: Not Reported).   Patient noticed a knot at the injection site on 17-Sep-2024. On 18-Sep-2024 she woke up with hot flashes and chills, and noticed the injection site was warm, red, swollen and sore to the touch. She advised that she noticed the redness and swelling was continuing despite taking benadryl. Patient was seen at urgent care on 19-Sep-2024 with throat tingling and was given steroids due to an allergic reaction. Patient advised she has not previously had any sort of allergic reaction to an immunization.     Flucelvax (TIV) action taken: Not Applicable  Treatment medication: Benadryl and steroids (Not specified)  Reporter's assessment:  The reporter did not provide causality assessment (HA cases). In addition, the events were considered as non-serious; Reporter's Comments: All the events are considered related to Flucelvax (TIV) administration.
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Pregnant patient requested RSV vaccine, Arexvy given in error. Medical Asst unaware of the difference between Arexvy & Abrysvo. She became aware when attempting to document vaccine given in the EMR.  PCP did inform patient of error & discussed that the baby will need to receive the RSV monoclonal antibody Nirsevimab shortly before/during the first RSV season for RSV prevention (per CDC FAQ).
Age: 38.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: 33 weeks pregnant patient request RSV vaccine.  Medical assistant unaware of the difference between Arexvy & Abrysvo.  Primary care physician did speak with patient about the error & discussed that the baby will need to receive the RSV monoclonal antibody Nirsevimab shortly before/during the first RSV season for RSV precautions as recommended in CDC FAQ. Patient had no known side effects from the vaccine.
Age: 38.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: 33 weeks pregnant patient request RSV vaccine.  Medical assistant unaware of the difference between Arexvy & Abrysvo.  Primary care physician did speak with patient about the error & discussed that the baby will need to receive the RSV monoclonal antibody Nirsevimab shortly before/during the first RSV season for RSV precautions as recommended in CDC FAQ. Patient had no known side effects from the vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: PT REPORTED EXTREME FATIGUE AND HEADACHE. WAS CONCERENED ABOUT MYCARDITIS. PT WAS ADVICED TO CONTACT HIS DOCTOR TO REPORT ADVERSE REACTION. PT WAS ADVISED TO STAY HYDRATED, USE COLD COMPRESS ON THE FORHEAD, TAKE PAIN RELIEVER OTC AND NOTIFY MD IF SYMPTOMS DO NOT IMPROVE WITHIN 24 HOURS.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: PT REPORTED EXTREME FATIGUE AND HEADACHE. WAS CONCERENED ABOUT MYCARDITIS. PT WAS ADVICED TO CONTACT HIS DOCTOR TO REPORT ADVERSE REACTION. PT WAS ADVISED TO STAY HYDRATED, USE COLD COMPRESS ON THE FORHEAD, TAKE PAIN RELIEVER OTC AND NOTIFY MD IF SYMPTOMS DO NOT IMPROVE WITHIN 24 HOURS.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse calling to report that an expired dose of PNEUMOVAX 23 was administered on 10/09/2024.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-OCT-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, valid lot #W029533, expiration date reported and confirmed as 07-OCT-2024, administered for prophylaxis by a health care professional (strength, dose, route of administration, and anatomical location were not provided) (expired product administered). No additional adverse event reported (no adverse event). Conferenced caller with and ''MTM'' for information on viability and possible revaccination was reported.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE; Nurse calling to report that an expired dose of PNEUMOVAX 23 was administered on 10/09/2024.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-OCT-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, valid lot #W029533, expiration date reported and confirmed as 07-OCT-2024, administered for prophylaxis by a health care professional (strength, dose, route of administration, and anatomical location were not provided) (expired product administered). No additional adverse event reported (no adverse event). Conferenced caller with and ''MTM'' for information on viability and possible revaccination was reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; A nurse called to report an AE. The caller reported that a pregnant patient, who is approximately 30 weeks pregnant, received a dose of GARDASIL 9; This spontaneous report was received from a nurse regarding a female pregnant patient of unknown age.   The patient's medical, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 31-OCT-2024, while the patient was approximately 30 weeks pregnant, she was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, once, administered for prophylaxis (route of administration and anatomical site of injection were not provided; lot number reported as Y00002D6 is an invalid number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) [GARDASIL 9], expiration date 23-SEP-2026) (Exposure during pregnancy). The reported stated that no symptoms or side effects were noted, and no additional information was provided to further clarify the details. Pregnancy outcome was pending and fetal outcome was unknown.   No additional adverse event was reported for the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Near death experience, Toxic shock syndrome
Clinical narrative: toxic shock; almost died; This serious case was reported by a consumer via interactive digital media and described the occurrence of shock in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shock (Verbatim: toxic shock) (serious criteria GSK medically significant) and near death experience (Verbatim: almost died) (serious criteria GSK medically significant). The outcome of the shock and near death experience were not reported.   It was unknown if the reporter considered the shock and near death experience to be related to Shingles vaccine.     The company considered the shock and near death experience to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-OCT-2024 This case was reported by a patient via interactive digital media. The patient received the shingles vaccine last year and went into toxic shock and almost died. The patient stated that he/she was grateful to be alive and will not do it again.; Sender's Comments: Shock and Near death experience are unlisted events which are considered unrelated to GSK Shingles vaccine.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Fatigue, Nausea
Clinical narrative: Nausea within 30 minutes of taking the vaccine.  6 hours later I experienced sever discomfort and a burning sensation in my upper chest.  It lasted about an hour.  Once it subsided my only reaction was slight fatigue the following day.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Pruritus, Pyrexia, Tremor
Clinical narrative: On the night after receiving the vaccine, patients reported these symptoms: severe chill/shake, itchiness on face and neck, migraine headache, and low grade fever. Patient took some benadryl and the itchiness became better on the 2nd day.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Device connection issue
Clinical narrative: A defective needle was used to administer influenza vaccine to this patient at a mass vaccination event. Although the needle was secured well by twisting it onto the pre-filled syringe dose of flu vaccine, when the administrator injected the fluid inside the pre-filled syringe seeped out of the juncture between the hypodermic needle and syringe. Due to this supposed defect that was undetectable prior to attempt at vaccine administration, the patient had to be given a new, separate pre-filled syringe dose of flu vaccine.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Device connection issue
Clinical narrative: A defective needle was used to administer influenza vaccine to this patient at a mass vaccination event. Although the needle was secured well by twisting it onto the pre-filled syringe dose of flu vaccine, when the administrator injected the fluid inside the pre-filled syringe seeped out of the juncture between the hypodermic needle and syringe. Due to this supposed defect that was undetectable prior to attempt at vaccine administration, the patient had to be given a new, separate pre-filled syringe dose of flu vaccine. Disposed of vaccine connected to defective needle, and used new vaccine PFS with new needle. Documented brand and lot number of defective needle used. Brand: COVIDIEN Magellan, 22 G x 1.5", LOT # 23M380.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong technique in product usage process
Clinical narrative: Patient had to be 'stuck' twice, as the first vaccine dose that was attempted did not enter the tissue and leaked out down arm. Patient was administered an additional dose after first dose failed to enter arm.
Age: 35.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: I was administered the wrong RSV vaccine Arexvy which is not approved for use in pregnant women due to a slight increased risk of preterm labor. I should have received the RSV vaccine Abrysvo. This was an error on behalf of the nurse who administered the vaccine as she did not apparently have anyone double check that she was administering the correct vaccine according to the pharmacist I spoke with. I am 32 weeks pregnant and my estimated date of delivery is 12/27/24.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Syncope, Tunnel vision
Clinical narrative: Brief syncopal event sustained in response to vaccination, which has apparently occurred on numerous other occasions per MOP. LOC lasted 3-5 seconds, and patient was clammy and felt light headed and reported tunnel vision prior to event. Felt better after lying supine and being monitored for 20 minutes, and after eating a sugary donut and drinking lemon lime soda. Instructed MOP to return to hospital via ER if her son demonstrated worsening after returning home. Released from mass vaccination event after vital signs were assured as stable. All of MOP's and patient's questions answered to their apparent satisfaction and understanding.
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AE; inadvertent administration of PNEUMOVAX 23 to a 2.5-month-old infant; This spontaneous report was received from the healthcare professional and referred to a 2-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 18-JUL-2024, the patient was inadvertent received pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No adverse event was reported (No adverse event).
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Received First Dose in 2023, and Have Not Received Second Dose; Initial report received on 25-Sep-2024.  A pharmacist reported that a 47-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose yet.  Medical history and concomitant medications were not reported.   On 29-Jun-2023, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, and NDC # 43528-002-01, route and site not reported)]. At the time of reporting, the patient has not received the second dose of HEPLISAV-B yet.  No adverse reactions were reported from the patient.  No other information was available from the reporter.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these Fluarix were given after the temperature excursion which led to incorrect product storage error. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128774:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128750:same reporter/different patient US-GSK-US2024128747:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128740:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128716:same reporter/different patient
Sex: F
Vaccine: UNK
Symptoms: Syringe issue, Underdose
Clinical narrative: incorrect dose volume; We were administering the vaccine and it came down on the patient's arm; This spontaneous case, initially received on 09-Oct-2024, with additional information on 17-Oct-2024, was reported by a health professional and concerns a female patient.  Administration of company suspect drug(s): On 09-Oct-2024, the patient received Flucelvax Quadrivalent for Flu immunization, Dose regimen: .5 ml, Route of administration: not reported, Anatomical location: not reported. Lot number: 391637.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 09-Oct-2024, the patient experienced incorrect dose volume (outcome: Unknown), We were administering the vaccine and it came down on the patient's arm (outcome: Unknown).  Administering the vaccine and it came down on the patient's arm, reporter was wondering what the patient needs to do, there was a leak in the syringe. When it was being administered could see that some of the juice ran it out, so not all of the dose has been administered. Health care professional (HCP) informed the patient was herself and it was administered by a colleague. Partial dose administered and revaccination. The colleague discovered the defect, whilst administering the dose. The plunger was depressed, the needle shield was not in place, no sigs of damage on the syringe. The needle used was EasyPoint 25 Gauge 1 Inch.  Flucelvax Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter considered the event as non-serious and causality was not reported.; Reporter's Comments: All events were considered not related.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood creatine phosphokinase, Injection site pain
Clinical narrative: Injected BEXSERO in right upper arm with persistent pain at site. No swelling or erythema. Recommended heat + ibuprofen (MOTRIN).
Age: 4.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product preparation issue
Clinical narrative: Toddler COVID vaccine, which requires dilution with NaCl, was not diluted prior to administration.
Age: 0.42
Sex: M
Vaccine: PNC20
Symptoms: Urticaria
Clinical narrative: hives
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC15, RV5
Symptoms: Rash, Rash erythematous
Clinical narrative: Approximately 10 minutes post vaccines had a erythematous rash come up to cheeks + forehead. Rash faded quickly after, but went ahead + gave 1.5 ml of Childrens Benadryl. Watched for several more minute before patient was allowed to leave. Rash completely resolved before they left.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Admitted to hospital 11/5 with shortness of breath
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis infective, Back pain, Bursitis, COVID-19
Clinical narrative: BRIEF OVERVIEW: Admission Date: 10/24/2024 Discharge Date: Nov 4, 2024 Discharge Disposition:  inpatient rehab facility  #Acute metabolic encephalopathy likely due to COVID infectio, resolved #COVID infection - CT head negative for intracranial pathology - CXR 10/29/24 No radiographic evidence of cardiopulmonary process - RVP positive for COVID - pt remains on room air DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Left arm cellulitis [L03.114] Olecranon bursitis of left elbow [M70.22] Infection of left elbow (HCC) [M00.9]  HOSPITAL COURSE: 81-year-old male presents via EMS with initial complaint back, BL Leg pain and Left elbow pain. Patient was admitted for L arm cellulitis, which improved on Unasyn IV. Wound culture positive for MSSA.   Admission was complicated by COVID infection, and acute on chronic HFpEF with fluid overload. He was diuresed. TTE notable for reduced ejection fraction and generalized WMA. Cardiology was consulted, recommending outpatient follow up once optimized. He is to continue with GDMT as BP permits.   Patient was able to participate meaningfully with PT/OT. PMR recommending IPR. Patient was medically optimized and hemodynamically stable at time of discharge.  Discharged to Inpatient Rehab Facility.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure acute, Cellulitis, Chest X-ray normal, Computerised tomogram head normal, Echocardiogram abnormal
Clinical narrative: BRIEF OVERVIEW: Admission Date: 10/24/2024 Discharge Date: Nov 4, 2024 Discharge Disposition:  inpatient rehab facility  #Acute metabolic encephalopathy likely due to COVID infectio, resolved #COVID infection - CT head negative for intracranial pathology - CXR 10/29/24 No radiographic evidence of cardiopulmonary process - RVP positive for COVID - pt remains on room air DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Left arm cellulitis [L03.114] Olecranon bursitis of left elbow [M70.22] Infection of left elbow (HCC) [M00.9]  HOSPITAL COURSE: 81-year-old male presents via EMS with initial complaint back, BL Leg pain and Left elbow pain. Patient was admitted for L arm cellulitis, which improved on Unasyn IV. Wound culture positive for MSSA.   Admission was complicated by COVID infection, and acute on chronic HFpEF with fluid overload. He was diuresed. TTE notable for reduced ejection fraction and generalized WMA. Cardiology was consulted, recommending outpatient follow up once optimized. He is to continue with GDMT as BP permits.   Patient was able to participate meaningfully with PT/OT. PMR recommending IPR. Patient was medically optimized and hemodynamically stable at time of discharge.  Discharged to Inpatient Rehab Facility.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Heart failure with reduced ejection fraction, Hypervolaemia, Metabolic encephalopathy, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: BRIEF OVERVIEW: Admission Date: 10/24/2024 Discharge Date: Nov 4, 2024 Discharge Disposition:  inpatient rehab facility  #Acute metabolic encephalopathy likely due to COVID infectio, resolved #COVID infection - CT head negative for intracranial pathology - CXR 10/29/24 No radiographic evidence of cardiopulmonary process - RVP positive for COVID - pt remains on room air DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Left arm cellulitis [L03.114] Olecranon bursitis of left elbow [M70.22] Infection of left elbow (HCC) [M00.9]  HOSPITAL COURSE: 81-year-old male presents via EMS with initial complaint back, BL Leg pain and Left elbow pain. Patient was admitted for L arm cellulitis, which improved on Unasyn IV. Wound culture positive for MSSA.   Admission was complicated by COVID infection, and acute on chronic HFpEF with fluid overload. He was diuresed. TTE notable for reduced ejection fraction and generalized WMA. Cardiology was consulted, recommending outpatient follow up once optimized. He is to continue with GDMT as BP permits.   Patient was able to participate meaningfully with PT/OT. PMR recommending IPR. Patient was medically optimized and hemodynamically stable at time of discharge.  Discharged to Inpatient Rehab Facility.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Staphylococcus test positive
Clinical narrative: BRIEF OVERVIEW: Admission Date: 10/24/2024 Discharge Date: Nov 4, 2024 Discharge Disposition:  inpatient rehab facility  #Acute metabolic encephalopathy likely due to COVID infectio, resolved #COVID infection - CT head negative for intracranial pathology - CXR 10/29/24 No radiographic evidence of cardiopulmonary process - RVP positive for COVID - pt remains on room air DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Left arm cellulitis [L03.114] Olecranon bursitis of left elbow [M70.22] Infection of left elbow (HCC) [M00.9]  HOSPITAL COURSE: 81-year-old male presents via EMS with initial complaint back, BL Leg pain and Left elbow pain. Patient was admitted for L arm cellulitis, which improved on Unasyn IV. Wound culture positive for MSSA.   Admission was complicated by COVID infection, and acute on chronic HFpEF with fluid overload. He was diuresed. TTE notable for reduced ejection fraction and generalized WMA. Cardiology was consulted, recommending outpatient follow up once optimized. He is to continue with GDMT as BP permits.   Patient was able to participate meaningfully with PT/OT. PMR recommending IPR. Patient was medically optimized and hemodynamically stable at time of discharge.  Discharged to Inpatient Rehab Facility.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Depression, Impaired quality of life, Injection site bruising, Injection site induration, Injection site mass
Clinical narrative: Patient reports a large hard lump and bruise forming days after vaccination near injection site, followed by pain on both arms, and muscle weakness. She had multiple ER and doctor visits in the months following immunization.  Patient reports this has greatly affected her quality of life resulting in depression and suicidal ideations because of the pain. Doctors determined that she developed brachial neuritis as a result of the vaccination.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Magnetic resonance imaging, Muscular weakness, Pain in extremity, Radiculitis brachial, Suicidal ideation
Clinical narrative: Patient reports a large hard lump and bruise forming days after vaccination near injection site, followed by pain on both arms, and muscle weakness. She had multiple ER and doctor visits in the months following immunization.  Patient reports this has greatly affected her quality of life resulting in depression and suicidal ideations because of the pain. Doctors determined that she developed brachial neuritis as a result of the vaccination.
Age: 58.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Joint swelling, Mobility decreased, Paraesthesia
Clinical narrative: After flu shot was given on Thursday afternoon experienced tingling of the left arm all the way down to his hand. Pt. went to bed and woke up the following day with pain and swelling around the elbow area. Pain continued to increase throughout the weekend and the pain and affected his ability to extend and flex his arm. Monday morning pt. took ibuprofen for pain and swelling and had some relief. Pt. came to clinic to be evaluated.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Blindness, Headache, Muscular weakness, Paraesthesia
Clinical narrative: Patient reported unable to see because everything was dark, weakness in limb so had to be carried, tingling all over body, headache. Patient placed in supine position and attempted Trendelenburg position on exam table and Emergency response activated. SPO2 97% entire time.  Patient  reported all symptoms dissipated at the time paramedics/ emergency personnel arrived.  5 mins from start of symptom to recovery. Parent (father) opted to go home with patients. Emergency team reports v/s in stable condition. Patient stated he is fine and all symptoms gone.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Fatigue, Headache, Vertigo
Clinical narrative: Vertigo, intense headache, chest heaviness, profound fatigue with body and joint aches.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dyspnoea, Erythema, Feeling hot, Heart rate increased, Palpitations
Clinical narrative: Patient stated that her heart was pounding, and she felt hot about 1 minute after injections. Patient's face, neck, and chest became red. Heart rate was elevated to 101. Patient grabbed throat and stated she felt like she was having difficulty breathing.  O2 saturation 95%. at this time and maintained. Patient was given a cold towel for the back of her neck and was encouraged to slow her breathing.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pain, Pallor, Presyncope
Clinical narrative: Immediately after HPV administration patient began to feel dizzy and went pale. Was assisted to laying position and Pulse Ox applied. Patient remained alert and oriented X3. No LOC. Was given apple juice, vitals taken, and monitored for 30 minutes post administration. Called mom at 0852 and notified her of vasovagal episode and that patient was awake, A&Ox3, and resting. Patient was assisted to sitting position, monitored for 5 minutes, and then to standing position. Patient denied any further dizziness, no numbness or tingling in body, steady on his feet while walking, reports some soreness to his arms at site of administration: ice pack given for comfort. NP walked patient back to class without incident.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Pruritus, Rash
Clinical narrative: Patient reports developing a rash in her arms and back after being vaccinated. She has used OTC anti-itch medications, like hydrocortisone and Benadryl in cream, but none have helped with the itching or rash. By 11/06/2024 patient still has the rash.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: accidentally gave this baby a hepatitis B vaccination when she has scanned and meant to give it to another patient. Nursery was hectic with lots of babies and nurse had a lot going on. She immediately notified the provider and her unit directors. The parents will be notified as soon as they return to unit. Per MD, no harm was done to infant since it already obtained the hepatitis B vaccine. The correct infant did receive the hepatitis B vaccine as well
Age: 26.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Dizziness, Dysstasia, Hypopnoea, Nausea
Clinical narrative: nearly 12 hours after both vaccines in upper left arm got super dizzy, shallow breathing, nausea, body weakness. Went to bathroom to take 400mg advil. Super nauseaus so layed down on bathroom floor for 30 minutes, unable to stand or refill water bottle in sink. Crawled back to bed. Woke up 3 hours later (around 3am) and symptoms were gone. Only arm and body pain/weakness remains. Had similar reaction 2 years ago when had covid and flu shot.
Age: 26.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: nearly 12 hours after both vaccines in upper left arm got super dizzy, shallow breathing, nausea, body weakness. Went to bathroom to take 400mg advil. Super nauseaus so layed down on bathroom floor for 30 minutes, unable to stand or refill water bottle in sink. Crawled back to bed. Woke up 3 hours later (around 3am) and symptoms were gone. Only arm and body pain/weakness remains. Had similar reaction 2 years ago when had covid and flu shot.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Food refusal, Lethargy, Oxygen saturation decreased
Clinical narrative: 11/1/24:  oxygen saturation dropped to 88% and had to be placed on oxygen, he refused to eat .  11/5/24: shortness of breath, lethargy, labored breathing, 101.1 fever.    11/6/24: expired