chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: Patient came in to receive Pfizer 2023-2024 COVID 5-11 yr vaccine. After she received her vaccine, she watched her dad receive the Pfizer vaccine. The size of the needle and how the needle was injected to her dad frightened her and resulted in her fainting. She fell down on the floor but was alerted and responsive a few seconds after the fall. Candy, gatorade, ice pack was given to help with recovery. She was kept stable for 20 minutes at the pharmacy before she left.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patients symptoms resolved in less than 15 minutes. No inflammation at injection site
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue, Lethargy
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Other Vaccines:  VaccineTypeBrand: Fluad; Manufacturer: seqirus; LotNumber: 371605; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Head injury, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Within 5 minutes of vaccine, patient fainted at an area away from pharmacy and hit back of head on carpet. Store security checked VITAL SIGNS. Pharmacist assisted patient and recommended that pt hang out in pharmacy for an additional 15 minutes & to get head checked out by dr. Pt stated she has basal vagal syncope episodes since elementary schools which are stress releated. Estimated last episode 2021. pt stated its been awhile since vaccine related syncope / fainting. , Other Vaccines:  VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 944460; Route: IM; BodySite: Upper Left Deltoid; Dose: 00; VaxDate: 09/30/2023
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Within 5 minutes of vaccine, patient fainted at an area away from pharmacy and hit back of head on carpet. Store security checked VITAL SIGNS. Pharmacist assisted patient and recommended that pt hang out in pharmacy for an additional 15 minutes & to get head checked out by dr. Pt stated she has basal vagal syncope episodes since elementary schools which are stress releated. Estimated last episode 2021. pt stated its been awhile since vaccine related syncope / fainting. , Other Vaccines:  VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 944460; Route: IM; BodySite: Upper Left Deltoid; Dose: 00; VaxDate: 09/30/2023
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Nausea, Pyrexia, Syncope
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Severe, Systemic: Nausea-Severe
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Severe, Systemic: Nausea-Severe
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Pt got RSV about a month ago but still has sore arm according to the patient.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: Really bad back spasm, fever up to 103, Other Vaccines:  VaccineTypeBrand: Pfizer 2023-24 syr; Manufacturer: Pfizer; LotNumber: HG4659; Route: IM; BodySite: Left arm; Dose: 1; VaxDate: 09/28/2023
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Muscle spasms, Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: Really bad back spasm, fever up to 103, Other Vaccines:  VaccineTypeBrand: Pfizer 2023-24 syr; Manufacturer: Pfizer; LotNumber: HG4659; Route: IM; BodySite: Left arm; Dose: 1; VaxDate: 09/28/2023
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Biopsy lip, Blood test, Eye pain, Eye swelling
Clinical narrative: Within 24 hours, left eye swelling, pain, vision impairment. Went to urgent care and was given antibiotic ointment, told to make ophthalmologist appointment. Swelling subsided after 2-3 days, returned a week later. Unable to get ophthalmologist appointment until January 2023. Intermittent eye swelling, pain, vision impairment for next 6 months. Appointment with medical facility, referred to specialty facility. Referred from medical facility to specialty facility. Scheduled for orbitotomy of left lacrimal gland for biopsy to rule out lymphoma. Sudden onset of lymphadenopathy & swelling of salivary and parotid glands. referred to Rheumatology.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Flow cytometry, Lymphadenopathy, Orbitotomy, Parotid gland enlargement, Salivary gland enlargement
Clinical narrative: Within 24 hours, left eye swelling, pain, vision impairment. Went to urgent care and was given antibiotic ointment, told to make ophthalmologist appointment. Swelling subsided after 2-3 days, returned a week later. Unable to get ophthalmologist appointment until January 2023. Intermittent eye swelling, pain, vision impairment for next 6 months. Appointment with medical facility, referred to specialty facility. Referred from medical facility to specialty facility. Scheduled for orbitotomy of left lacrimal gland for biopsy to rule out lymphoma. Sudden onset of lymphadenopathy & swelling of salivary and parotid glands. referred to Rheumatology.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Sarcoidosis, Visual field tests, Visual impairment
Clinical narrative: Within 24 hours, left eye swelling, pain, vision impairment. Went to urgent care and was given antibiotic ointment, told to make ophthalmologist appointment. Swelling subsided after 2-3 days, returned a week later. Unable to get ophthalmologist appointment until January 2023. Intermittent eye swelling, pain, vision impairment for next 6 months. Appointment with medical facility, referred to specialty facility. Referred from medical facility to specialty facility. Scheduled for orbitotomy of left lacrimal gland for biopsy to rule out lymphoma. Sudden onset of lymphadenopathy & swelling of salivary and parotid glands. referred to Rheumatology.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Syncope
Clinical narrative: Patient experienced syncopal reaction after administration of vaccines.  She experienced nausea, pallor, dizziness and diaphoresis.  Vital signs were monitored and client was given water and crackers.  Felt better within 20 minutes and was dismissed home with parent.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bundle branch block right, Chest pain, Detoxification, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: DEVELOPED CHEST PAIN, PALPITATIONS, HYPERTENSION REQUIRING MULTIPLE MEDICATIONS.  DIAGNOSIS COVID VACCINE INDUCED HYPERTENSION AND SUBCLINICAL MYOPERICARDITIS.  ECG NOTED NEW RBBB.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION, LOSARTAN, AMLODIPINE, NADOLOL, COLCHICINE.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Immunisation reaction, Laboratory test, Myopericarditis, Palpitations
Clinical narrative: DEVELOPED CHEST PAIN, PALPITATIONS, HYPERTENSION REQUIRING MULTIPLE MEDICATIONS.  DIAGNOSIS COVID VACCINE INDUCED HYPERTENSION AND SUBCLINICAL MYOPERICARDITIS.  ECG NOTED NEW RBBB.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION, LOSARTAN, AMLODIPINE, NADOLOL, COLCHICINE.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Syncope, pallor, dizziness.  Patient recovered within about 20 minutes of event and was dismissed home with parent
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose normal, Cold sweat, Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient immediately stated she was dizzy and started to lay back on bed.  She lost consciousness and being to have seizure-like activity that lasted less than 15 seconds.  She regained consciousness and ask "what just happened".  Skin was pale and clammy to touch and site.  Per mother, she has never had a seizure prior to this event, but has passed out after a blood draw.   BP, taken 127/79 Pulse 64 Respiration 20 and O2 99%.  EMS was called. Blood sugar taken and was 97 Temp was 97.6
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pallor, Seizure like phenomena
Clinical narrative: Patient immediately stated she was dizzy and started to lay back on bed.  She lost consciousness and being to have seizure-like activity that lasted less than 15 seconds.  She regained consciousness and ask "what just happened".  Skin was pale and clammy to touch and site.  Per mother, she has never had a seizure prior to this event, but has passed out after a blood draw.   BP, taken 127/79 Pulse 64 Respiration 20 and O2 99%.  EMS was called. Blood sugar taken and was 97 Temp was 97.6
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: At this time no adverse effects noted
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events, patient has no side effects at all.  However, she came into the pharmacy and asked for a Tdap vaccine, which was given to her, and she had just gotten another Tdap vaccine two days prior at her dr office.  She was supposed to come to the pharmacy and ask for a meningitis vaccine, but she was confused as to which one she still needed and couldn't remember what she had already had at the office.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Confusional state, Dyspnoea, Paralysis, Pyrexia
Clinical narrative: High fever, Shortness of breathe, paralysis ( from neck down, couldn't move ) , confusion. Patient woke up husband who confirmed fever. Patient didn't tell husband  about paralysis. Patient felt better in the morning and didn't go to the ER
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dyspnoea, Injection site reaction, Pain
Clinical narrative: chills, fever, body aches, dizziness, labored breathing, site reaction
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: chills, fever, body aches, dizziness, labored breathing, site reaction
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness
Clinical narrative: Patient stated on Imms Questionnaire that she fainted after Covid vaccine; when questioned, patient's mother stated that the patient has "fainted, or felt faint" after injections "ever since she got that Covid shot". Patient asked if she would like a juice drink prior to administration of injections to which the patient stated, "yes" and the patient consumed six ounces of juice drink. Patient history includes receiving one previous injection of MenACWY and Men B for which received second injections today. After receiving one dose each of MenACWY and Men B, the patient stated she "felt faint". Patient assisted to lay down on left recovery side. Ice applied to back of patient's neck and arm pit. Patient alert and oriented x 4; PERRLA. After approximately five minutes, patient stated she, "felt better". Patient assisted to a 45 degree angle; stated she, "felt okay". Patient then assisted to an upright seated position; patient stated she, "still feels okay". Patient given six more ounces of juice drink, and candy of her choosing. After consuming the drink and candy, patient assisted to stand with stand by assist x 1; patient stated, "I feel okay". Patient denies ringing in ears, weakness. Patient walks around room with one assist. Patient leaves with mother. Patient and patient's mother instructed to seek medical attention if patient feels faint again.
Age: 84.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: PATIENT PRESENTS TO CLINIC TODAY STATING HER LEFT ARM STARTED GETTING SORE, RED  AND SWOLLEN ABOUT A DAY AGO. OBSERVED LEFT ARM IN CLINIC AND UPPER ARM IS  SWOLLEN AND RED AROUND INJECTION SITE. REDNESS DESCENDS ON UPPER LEFT ARM BUT  DOES NOT REACH ELBOW.  CONSULTED WITH DR. DR. OBSERVED LEFT UPPER ARM AND INSTRUCTED PATIENT  TO APPLY HYDROCORTISONE 1% CREAM TO ARM, TAKE AN ANTIHISTAMINE, SUCH AS ZYRTEC  OR ALLEGRA, IN THE MORNING AND TAKE A BENADRYL AT NIGHT. PATIENT VU. PATIENT  WILL F/U IF REACTION DOES NOT IMPROVE OR WORSENS. LATE ENTRY FOR 06/14/2024: CONTACTED PATIENT. PATIENT STATES SHE HAS BEEN FOLLOWING PROVIDER'S  RECOMMENDATIONS AND HER ARM IS NOT SWOLLEN ANYMORE, THERE IS ONLY A LITTLE  REDNESS REMAINING.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia
Clinical narrative: About a week and a half after receiving the vaccine, client states that she lost her sense of taste. It has not returned. Denies any illnesses or medication changes.
Age: 25.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The second dose of IPV was given too soon, less than 4 weeks from the first dose. No adverse effects noted 45 minutes after IPV vaccine was given in clinic.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Dysstasia, Fatigue, Lethargy, Muscular weakness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Patient reported "lockjaw" about 3 hours after vaccination which lasted until the following day. Patietn said she was unable to swallow or move her jaw and at one point her legs gave out and she had to sit down/unable to stand for an hour-Severe, Additional Details: Patient reported over phone "lockjaw" about 3 hours after vaccination which lasted until the following day. Patietn said she was unable to swallow or move her jaw and at one point her legs gave out and she had to sit down/unable to stand for an hour. I advised patient over the phone to go to ER or urgent care for evaluation but as far as I know patient ignored that advice and did not seek medical care. All symptoms resolved on their own within 24 hours., Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness, Trismus
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Patient reported "lockjaw" about 3 hours after vaccination which lasted until the following day. Patietn said she was unable to swallow or move her jaw and at one point her legs gave out and she had to sit down/unable to stand for an hour-Severe, Additional Details: Patient reported over phone "lockjaw" about 3 hours after vaccination which lasted until the following day. Patietn said she was unable to swallow or move her jaw and at one point her legs gave out and she had to sit down/unable to stand for an hour. I advised patient over the phone to go to ER or urgent care for evaluation but as far as I know patient ignored that advice and did not seek medical care. All symptoms resolved on their own within 24 hours., Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: day after injection was given patient noticed full rash on torso from waist climbing up to armpits, took benadryl, awaiting results, was advised to go to emergency if worsens or if throat is involved at all
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Dyspnoea, Pulmonary thrombosis
Clinical narrative: Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Patient experienced difficulty breathing two days after receiving vaccine. Patient scheduled a doctor visit with PCP where a blood clot in the lungs was confirmed. No hospitalization was required. Patient has been treated and recovered.
Age: 43.0
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Pharmacist called to report that a patient has arrived to the clinic requesting to receive his second dose of GARDASIL 9. Pharmacist reports that that first dose of GARDASIL 9 was administered on 29-JUL-20239, 2023, and that the patient did not retur; No further AE details available. No PQC; This spontaneous report was received from a pharmacist and refers to a 44-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 29-JUL-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The patient did not return for the second dose until 04-JUN-2024 (reported as today) (inappropriate schedule of product administration). No additional adverse events were reported.
Age: 77.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Flushing, Hyperhidrosis, Seizure, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient received all three vaccinations in sequence (comirnaty, flucelvax then heplisav-b), after administration of third vaccine patient was unresponsive for about 10-15 seconds before convulsing for 5-10 seconds. Patient became alert and was oriented x 3, BP was 137/76, HR 97. EMT arrived within 5 minutes and checked vitals. Patient chose to stay, rather than go with EMT. Patient remained in store and continued to feel better. Patient left store within 20 minutes to go home., Other Vaccines:  VaccineTypeBrand: flucelvax; Manufacturer: seqirus; LotNumber: 370655; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 10/01/2023, VaccineTypeBrand: comirnaty; Manufacturer: pfizer; LotNumber: hh7595; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 77.0
Sex: M
Vaccine: HEP
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient received all three vaccinations in sequence (comirnaty, flucelvax then heplisav-b), after administration of third vaccine patient was unresponsive for about 10-15 seconds before convulsing for 5-10 seconds. Patient became alert and was oriented x 3, BP was 137/76, HR 97. EMT arrived within 5 minutes and checked vitals. Patient chose to stay, rather than go with EMT. Patient remained in store and continued to feel better. Patient left store within 20 minutes to go home., Other Vaccines:  VaccineTypeBrand: flucelvax; Manufacturer: seqirus; LotNumber: 370655; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 10/01/2023, VaccineTypeBrand: comirnaty; Manufacturer: pfizer; LotNumber: hh7595; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Nausea-Medium
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Nausea-Medium
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis
Clinical narrative: Systemic: Flushed / Sweating-Mild, Additional Details: pt recovered after lying supine with feet elevated for about 20 mins. BP stable and pt able to sit, walk and stand without problem
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: fluad; Manufacturer: sequris; LotNumber: 371612; Route: im; BodySite: right arm; Dose: 1; VaxDate: 09/28/2023
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: gsk; LotNumber: 29gb3; Route: intramuscular; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Redness around injection site with redness and burning sensation, radius about 5 inches , Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: Glaxo; LotNumber: 5777F; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: patient received fluzone quad 2023-2024 and prevnar 20 on 9/29/23. On 9/30/23 a small red spot was noticed at the injection site. On 10/1/23 the red spot was larger and warm to the touch. On 10/2/23, the red spot was a little larger, warm to the touch, slightly raised and slighty itchy and a bit sore. Patient took ibuprofen and zyrtec. Patient counseled to try benadryl, keep an eye on the rash and notify md if symptoms persist or worsen., Other Vaccines:  VaccineTypeBrand: prevnar 20; Manufacturer: pfizer; LotNumber: gw7964; Route: im; BodySite: left arm; Dose: 2; VaxDate: 09/29/2023
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: patient received fluzone quad 2023-2024 and prevnar 20 on 9/29/23. On 9/30/23 a small red spot was noticed at the injection site. On 10/1/23 the red spot was larger and warm to the touch. On 10/2/23, the red spot was a little larger, warm to the touch, slightly raised and slighty itchy and a bit sore. Patient took ibuprofen and zyrtec. Patient counseled to try benadryl, keep an eye on the rash and notify md if symptoms persist or worsen., Other Vaccines:  VaccineTypeBrand: prevnar 20; Manufacturer: pfizer; LotNumber: gw7964; Route: im; BodySite: left arm; Dose: 2; VaxDate: 09/29/2023
Age: 57.0
Sex: U
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Neck pain, Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Neck pain occured 1 hour after injection, tingling in fingertips, feet and face occured that same night at 11pm. As on 1:30pm following day, patient says symptoms have mildly improved.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Headache-Mild, Additional Details: Patient visited urgent care and was diagnosed with injection site reaction.  She was put on keflex 500mg x 7 days for diagnosed cellulitus., Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GSK; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Headache-Mild, Additional Details: Patient visited urgent care and was diagnosed with injection site reaction.  She was put on keflex 500mg x 7 days for diagnosed cellulitus., Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GSK; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: Fluad Quad; Manufacturer: Seqirus,inc; LotNumber: 371603; Route: IM; BodySite: Right Arm; Dose: 1; VaxDate: 09/26/2023
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Foreign body sensation in eyes, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: L.EYE SENSATION, R/L NOSE BUMP, INFLAMMATION-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: NO FEVER, ARM WARM & SORE, HAD L.EYE SENSATION OF SOMETHING IN IT, L NOSE BUMP SWELLING OCCURRED, THEN SAME BUMP SMALLER ON R.SIDE NOSE. WAS CONCERNED SHE WAS GETTING SHINGLES OUTBREAK FROM VACCINE. I RECOMMENDED HER TO CALL PCP AND OPTOMITRIST/OPHTHAMOLOGIST FOR FURTHER FOLLOWUP. STATED THAT I WOULD SEND THIS NOTE TO VAERS
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Swelling face, Visual impairment
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: L.EYE SENSATION, R/L NOSE BUMP, INFLAMMATION-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: NO FEVER, ARM WARM & SORE, HAD L.EYE SENSATION OF SOMETHING IN IT, L NOSE BUMP SWELLING OCCURRED, THEN SAME BUMP SMALLER ON R.SIDE NOSE. WAS CONCERNED SHE WAS GETTING SHINGLES OUTBREAK FROM VACCINE. I RECOMMENDED HER TO CALL PCP AND OPTOMITRIST/OPHTHAMOLOGIST FOR FURTHER FOLLOWUP. STATED THAT I WOULD SEND THIS NOTE TO VAERS
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Back pain, Injection site pain, Neck pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: sharp pain radiating from upper arm towards the back and neck-Medium, Additional Details: Patient is experiencing sharp pain radiating from the upper arm (where injection site was) towards the back and lower neck
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Agitation, Anxiety, Confusional state, Feeling abnormal, Flushing
Clinical narrative: Systemic: Confusion-Mild, Systemic: anxiety, agitation-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild, Additional Details: After administering both the flu and COVID vaccines in the left arm, the patient reported feeling "funny" and yelled out for help. Patient reported use of recreational drugs. Patient's blood pressure was normal at 125/81 and pulse of 79. Patient reported ringing in the ears that went away after 10 minutes, sweating, and was visually anxious and agitated. Paramedics were called, but patient refused paramedic help so the call to paramedics was then cancelled. Wife picked him up when he felt better, Other Vaccines:  VaccineTypeBrand: Comirnaty; Manufacturer: Pfizer; LotNumber: HG4677; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 10/02/2023
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Screaming, Tinnitus
Clinical narrative: Systemic: Confusion-Mild, Systemic: anxiety, agitation-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild, Additional Details: After administering both the flu and COVID vaccines in the left arm, the patient reported feeling "funny" and yelled out for help. Patient reported use of recreational drugs. Patient's blood pressure was normal at 125/81 and pulse of 79. Patient reported ringing in the ears that went away after 10 minutes, sweating, and was visually anxious and agitated. Paramedics were called, but patient refused paramedic help so the call to paramedics was then cancelled. Wife picked him up when he felt better, Other Vaccines:  VaccineTypeBrand: Comirnaty; Manufacturer: Pfizer; LotNumber: HG4677; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 10/02/2023
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Other Vaccines:  VaccineTypeBrand: fluzone High dose; Manufacturer: sanofi; LotNumber: u8130aa; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 09/27/2023
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any adverse issues or side effects; A dose of GARDASIL 9 affected by the unknown temperature conditions was then inadvertently administered to a patient on 04/19/2024.; This spontaneous report was received from a nurse regarding to a 16-year-old patient of unspecified gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  The reporter called to report that his data logger in his vaccine refrigerator quit working on 08-MAR-2024, but was not realized and reset (until 31-MAY-2024), which resulted in unknown temperature condition exposure to the vaccines.   On 19-APR-2024, a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, affected by the unknown temperature conditions, was inadvertently administered to the patient (product storage error), lot number W028349 (lot # W028349 had been verified to be valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine [yeast] [GARDASIL 9]), expiration date reported and confirmed as 07-JUN-2025 (strength, dose, route and site of administration and anatomical injection site were not provided) for prophylaxis by a health care professional. Ni oprior excursions reported.  The patient did not experience any adverse issues or side effects (no adverse event) from the administered dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No other information was able to be provided during the call.  This is one of the several reports received form the same reporter. ; Sender's Comments:  US-009507513-2406USA001816: US-009507513-2406USA001829: US-009507513-2406USA001684: US-009507513-2406USA001795: US-009507513-2406USA001818: US-009507513-2406USA001844: US-009507513-2406USA001849: US-009507513-2406USA001893: US-009507513-2406USA001974: US-009507513-2406USA001983: US-009507513-2406USA001987: US-009507513-2406USA002012: US-009507513-2406USA002143:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Additional Details: AS OF TODAY, 10/02/23, CUSTOMER STILL HAS ON GOING HEADACHE, FEVER, AND NAUSEA., Other Vaccines:  VaccineTypeBrand: FLUAD QUAD 2023-2024; Manufacturer: SEQIRUS; LotNumber: 371624; Route: INTRAMUSCULAR; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Additional Details: patientstarted to develop mid hives given benadryl and was gointo follow up with urgent care if needed has a number of alllergies but has had pfizer vaccine number of times and no issues
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: pain and swelling in right leg-Medium
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Other Vaccines:  VaccineTypeBrand: Fluzone Quadrivalent; Manufacturer: Sanofi; LotNumber: U8041AA; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Other Vaccines:  VaccineTypeBrand: Fluzone Quadrivalent; Manufacturer: Sanofi; LotNumber: U8041AA; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 85.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: bruise and some swelling
Age: 92.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient reported loss of motility of the right arm, muscle weakness and difficulty to perform daily tasks. Patient was observed flexing and using her right hand on 10/3/2023
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt received her shot on 9/27/23. On 10/2/23, she developed severe pain in the bicep/shoulder area.  She is unable to lift her arm to put her hair in a ponytail.  The pain has also radiated down to her knuckles and included tingling and numbness. She is not having redness, swelling, or fever. Pt stated that she is dropping things and her arm/hand isn't working like normal.  She will be going to the ER to have her arm checked if she is not better.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt received her shot on 9/27/23. On 10/2/23, she developed severe pain in the bicep/shoulder area.  She is unable to lift her arm to put her hair in a ponytail.  The pain has also radiated down to her knuckles and included tingling and numbness. She is not having redness, swelling, or fever. Pt stated that she is dropping things and her arm/hand isn't working like normal.  She will be going to the ER to have her arm checked if she is not better.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: customer was given shingrix and fluzone in left arm on 9/30/23. customer called on 10/1/23 experiencing what was thought to be injection site reaction. customer was told to use ice and if no better within 48 hours seek medical attention. Customer calls on 10/3/23 after being seen by PCP and was diagnosed with cellulitis and was given antibotics. She states her left arm swelled to double the size within 12 hours. She was vomiting, had fever, and site was warm and painful. , Other Vaccines:  VaccineTypeBrand: fluzone (flu); Manufacturer: sanofi pasteur; LotNumber: ut8069ja; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: customer was given shingrix and fluzone in left arm on 9/30/23. customer called on 10/1/23 experiencing what was thought to be injection site reaction. customer was told to use ice and if no better within 48 hours seek medical attention. Customer calls on 10/3/23 after being seen by PCP and was diagnosed with cellulitis and was given antibotics. She states her left arm swelled to double the size within 12 hours. She was vomiting, had fever, and site was warm and painful. , Other Vaccines:  VaccineTypeBrand: fluzone (flu); Manufacturer: sanofi pasteur; LotNumber: ut8069ja; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Joint Pain-Severe, Additional Details: Patient also has Sjogren's syndrome and is on MTX but hasn't had any issue with moderna covid vaccination until this new booster shot. Pt's symptoms are still ongoing but is more tolerable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Joint Pain-Severe, Additional Details: Patient also has Sjogren's syndrome and is on MTX but hasn't had any issue with moderna covid vaccination until this new booster shot. Pt's symptoms are still ongoing but is more tolerable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Pt developed hives all over her body and face. Benadryl helped reduced hives after initial doses.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Hyperhidrosis, Lip discolouration, Syncope, Tremor
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Additional Details: HER LIPS TURNED ASHY
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Additional Details: HER LIPS TURNED ASHY
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was fainting for about 30 seconds after receiving moderna and fluzone vaccines. pt responded well after 30 seconds. Called EMS to check on patient. Patient rested, felt well and went home after the EMS made sure he was ok to go home, Other Vaccines:  VaccineTypeBrand: fluzone; Manufacturer: sanofi-pasteur; LotNumber: U8192DA; Route: im; BodySite: right deltoid; Dose: ; VaxDate: 10/03/2023
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Pt complaining about redness and swelling below and above injection site, have a small rash at the injection site also.  More pain at the injection site and feels different than other vaccine he has had in the past.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Dyspnoea, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: extreme back pain-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Severe, Other Vaccines:  VaccineTypeBrand: pneumovax 23; Manufacturer: merck; LotNumber: x018273; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 10/03/2023
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypertension, Hyperventilation
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: extreme back pain-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Severe, Other Vaccines:  VaccineTypeBrand: pneumovax 23; Manufacturer: merck; LotNumber: x018273; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 10/03/2023
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: just arm pain
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Hypersensitivity, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Other Vaccines:  VaccineTypeBrand: covid booster spikevax; Manufacturer: moderna; LotNumber: AU3832M; Route: im; BodySite: keft deltoid; Dose: ; VaxDate: UNKNOWN
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pain, Pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Other Vaccines:  VaccineTypeBrand: covid booster spikevax; Manufacturer: moderna; LotNumber: AU3832M; Route: im; BodySite: keft deltoid; Dose: ; VaxDate: UNKNOWN
Sex: F
Vaccine: HPV4
Symptoms: Fall, Injury, Loss of consciousness
Clinical narrative: Caller is a retired HCP who states a patient reported she passed out,; fell to the floor and injured herself; fell to the floor and injured herself; This spontaneous report was received from physician and refers to a female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2004, the was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2004 (also reported as aproximately 20 years ago), the patient passed out, fell to the floor and injured herself. At the time of reporting, the outcome of the events was not known.  The causal relationship between all adverse event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.  Upon internal review, the event of passed out, was determined to be medically significant.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: pt received new pfizer comirnaty vaccine; option not available when selecting vaccine type NDC: 00069-2392-10; LOT: HG4628; EXP: 11/30/2023
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Other Vaccines:  VaccineTypeBrand: varicella; Manufacturer: ; LotNumber: x007372; Route: SQ; BodySite: left arm; Dose: n/a; VaxDate: 10/02/2023
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Epistaxis, Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: bloody nose for 3 days-Medium, Additional Details: Bloody nose
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Joint injury, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Other Vaccines:  VaccineTypeBrand: Fluzone; Manufacturer: Sanofi-Pasteur; LotNumber: ut8155ja; Route: IM; BodySite: Deltoid; Dose: 1; VaxDate: 10/01/2023
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild