chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: her neighbor ended up at the hospital and end up dying.; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, hospitalization, medically significant), outcome "fatal", described as "her neighbor ended up at the hospital and end up dying.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: her neighbor ended up at the hospital and end up dying.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Injection site pain, Pain
Clinical narrative: Vaccine had usual effects of soreness at the site, fatigue, ache. But also set off a really bad chronic pain flare. I am on day 16 of the pain flare today and it doesn?t seem to show any signs of slowing down or stopping.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired drug used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HBV (Engerix B) (batch number 4F472, expiry date 06-NOV-2022) for prophylaxis.   On 07-DEC-2022, the patient received Engerix B. On 07-DEC-2022, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 11-JUN-2024  The clinic manager reported a patient was administered an expired Engerix-B about two years ago, which led to an expired vaccine used. The reporter did not consent to follow-up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2TP74, expiry date 10-JUN-2024) for prophylaxis.   Concomitant products included Proquad.   On 13-JUN-2024, the patient received the 1st dose of Kinrix. On 13-JUN-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used 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: 13-JUN-2024 The nurse explained they accidentally administered an expired dose of Kinrix to a 4 year old patient, which led to expired vaccine used.   Nurse mentioned that on that same day they also administered ProQuad to the patient. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired drug administered in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   On 13-JUN-2024, the patient received Bexsero. On 13-JUN-2024, an unknown time after receiving Bexsero, the patient experienced expired drug administered (Verbatim: patient received an expired dose of Bexsero ). The outcome of the expired drug administered 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: 14-JUN-2024 A pharmacist reported that a patient received an expired dose of Bexsero and asked if the dose should be repeated. Consented to follow up.
Age: 1.25
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: the Engerix-B, that we gave it to a patient on 03Jun2024, and we notice that it was expired,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received HBV (Engerix B) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 03-JUN-2024, the patient received Engerix B. On 03-JUN-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: the Engerix-B, that we gave it to a patient on 03Jun2024, and we notice that it was expired,). The outcome of the expired vaccine used 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: 14-JUN-2024 They had a vaccine , the Engerix-B, that they gave to a patient and they notice that it was expired, and they wanted to see if the vaccine was still okey or valid, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Sex: F
Vaccine: TTOX
Symptoms: Alopecia
Clinical narrative: Patient reported an ER visit due to a bug bite. She received a tetanus shot and she also reports having hair loss. No addt'l information noted. Patient does not consent to be contacted.
Age: 77.0
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Bexsero vaccine administered in left arm. Usual soreness at injection site and fatigue. In addition my arm got so sore I was unable to lift it above my shoulder for over 2 weeks during to soreness. Also I could not sleep or lie on this arm for 3 weeks. I used aspirin and topical Biofreeze to lessen the pain for about a week and a half. This was the first dose. I am a 77 year old female in good heath. I am asplenic due to surgery in 1978. My 2nd dose received today 6/12/2024 in the left hip. We'll see how this goes.
Age: 66.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: I received a third dose of rabies vaccine on June 13. I did not have any reactions to the first two vaccines. About 12 hours later, I felt slightly queasy and I had both sweating and chills along with a slight headache and muscle pain. the next morning I still felt "off". As the day progressed, I felt slightly better but not 100% normal. I have excellent health. I am fairly certain this is due to the rabies vaccine.
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Blood test, Bone pain, Electrocardiogram, Fall
Clinical narrative: The evening of 22nd started feeling bad. Went to bed and woke up at 3:00 am in excruciating pain. All joints, bones including jaws. Had to drag myself to the bathroom and fell getting on the toilet. Went to the emergency room on 5/23 @ 5:00pm. Exp 6/30/2025 Time 1:44 PM
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Feeling abnormal, Pain, Urine analysis, X-ray abnormal
Clinical narrative: The evening of 22nd started feeling bad. Went to bed and woke up at 3:00 am in excruciating pain. All joints, bones including jaws. Had to drag myself to the bathroom and fell getting on the toilet. Went to the emergency room on 5/23 @ 5:00pm. Exp 6/30/2025 Time 1:44 PM
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Eye movement disorder, Hyperventilation, Syncope, Tremor
Clinical narrative: PATIENT FAINTED,HYPERVENTILATING.EYES ROLLED BACK AND BRIEFLY HAD HEAD SHAKING.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Imaging procedure, Influenza virus test negative, Respiratory syncytial virus test negative, Retching, SARS-CoV-2 test
Clinical narrative: Infant received vaccines at 9 am, no adverse reaction in office. Later that afternoon at 5:30 pm infant had episode of vomiting X 4. At 8:15 same evening had another episode of vomiting 4-5 times. Mother took to ER as baby continued to have dry heaving.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Infant received vaccines at 9 am, no adverse reaction in office. Later that afternoon at 5:30 pm infant had episode of vomiting X 4. At 8:15 same evening had another episode of vomiting 4-5 times. Mother took to ER as baby continued to have dry heaving.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects noted
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash papular
Clinical narrative: erythematous fine papular rash starting at lower back and spreading diffusely following injection, patient treated with benadryl and dexamethasone
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Loss of consciousness
Clinical narrative: DONOR CAME INTO THE CENTER AND DISCLOSED WITH SCREENERS ABOUT HAVING A POSSIBLITY OF SEZUIRES WITH AN LOC LOSS LESS THAN 60 SECS AFTER DONATION/IMMUNIZATION. DONOR STATED HE DIDN'T EAT THAT DAY, OR THE NIGHT BEFORE. DONOR WAS VACCINATED ON 05/30/2024 AND REPORTED REACTION ON 06/17/2024. DONOR IS AWARE OF POLICY ON REPORT DAEs AND CALLING THE FACILITY TO REPORT ANY ISSUES.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Blood pressure decreased, Heart rate increased, Loss of consciousness, Oxygen saturation decreased
Clinical narrative: Patient passed out approximately 1-2 minutes after receiving vaccine.  Heart rate was elevated with decreased BP and O2 sat.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site inflammation, Injection site pain, Pain
Clinical narrative: Patient received second dose of Shingrix on 05/29/2024 and presented to clinic today, 06/20/2024. Pt reports severe left shoulder pain rated 10/10 that radiates to upper arm, began after receiving vaccine and has worsened. Pt states the pain keeps her from sleeping at night. Dr. noted slight redness and inflammation noted around injection site. Patient received  Ketorolac injection 30mg IM today, 06/20/2024. Pt  tolerated injection well and reports improved pain, rated 7/10.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Patient received second dose of Shingrix on 05/29/2024 and presented to clinic today, 06/20/2024. Pt reports severe left shoulder pain rated 10/10 that radiates to upper arm, began after receiving vaccine and has worsened. Pt states the pain keeps her from sleeping at night. Dr. noted slight redness and inflammation noted around injection site. Patient received  Ketorolac injection 30mg IM today, 06/20/2024. Pt  tolerated injection well and reports improved pain, rated 7/10.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: LUE weakness
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: After giving injection, when I was going to document the vaccine, I realized it was the incorrect one. I called the patient parent who was willing to come back and get the intended dose. Patient was fine and had no symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema multiforme, Rash
Clinical narrative: Started 6/19/2024  with rash on his legs, bottom and back. Mom given Benadryl. Patient came in today and seen provider and given famotidine. Patient diagnosis is erythema multiforme, unspecified. No other issues.
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6 days old newborn error of receiving the 2,4,6 months vaccines of Rota, Pentacel, and Prevnar 20. At the time of injection and 1 hour of monitoring in the office no adverse symptoms occured.  All 3 manufactures were called for reporting.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient presented to pharmacy on 6/16/24 and states that her right arm has some swelling and hardness at injection site. Also states that the area of injection site is warm to touch. , Other Vaccines:  VaccineTypeBrand: moderna 2023-24; Manufacturer: ; LotNumber: 203j23a; Route: intramuscular; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: The patient recieved the MMRV vaccination instead of the MMR vaccination. There were no adverse reactions while the patient was under our care.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB reconstituted with diluent sterile water, rather than diluent sterile saline associated with ActHIB.  No adverse outcomes.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This vaccine is approved for ages 4 to 6
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy one month after vaccine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Chest discomfort, Pain, Pain in extremity
Clinical narrative: Patient reported on 6/19/24 that she went to the emergency room in the evening of 6/18/24 with chest discomfort and pain. It was attributed to the Arexvy vaccination. She was given Tylenol and sent home. She reported that she felt fine on 6/19/24 except for a sore arm.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Hypotonia, Pallor, Posture abnormal
Clinical narrative: pt became pale, head fell back and body went limp, lasted about 7-10 seconds, was in office hr 50 o2 sat 100 he had pedialyte pop, water and saltine crackers held in office for 15 minute until color returned and pt stabalized. pt left with mom advised to remain indoors and push fluids and rest today
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: intussusception hospitalized 06/16/24 for observation and discharged 06/17/2024
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Electroencephalogram normal, Full blood count normal, Magnetic resonance imaging normal, Seizure
Clinical narrative: Seizure - origin unknown (clear MRI, CT Scan, EEG)
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: right upper arm red,,swollen, painful,,lumpy at injection sites started within several hours, resolving, not yet completely resolved.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 6/19/24
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Wrong technique in product usage process
Clinical narrative: Patient's mother reported that the wrong needle size was utilized for the Vaxelis vaccine that was given.
Age: 54.0
Sex: M
Vaccine: MMR
Symptoms: Dysgeusia, Erythema, Flushing, Pruritus
Clinical narrative: Recipient complained of facial flushing and metallic taste thirty minutes post injection. Vital signs within normal limits. Recipient assessed by ARNP and gave Allegra 60mg tablet PO and Depo Medrol 40mg IM for itchiness and redness to his back. Recipient monitored for additional 30 minutes until recipient stated he was feeling better. Per ARNP recipient can leave accompanied by spouse.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Rash, Rash erythematous
Clinical narrative: Within minutes of administration patient had a rash (redness) on face.  Dr. was made aware and did re-examine patient and patient was monitored. Rash had improved by the time patient left facility.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Before Pt's immunization appointment, I looked in the vaccine record to see what immunizations were needed.  At the time, it showed that she needed her kindergarten shots and she had only received one dose of MMR and Varicella.  Her record was complete and up to date and so I gave her a dose of Kinrix, MMR and Varicella.  Later that day, mom produced another immunization record that showed Patient had received a dose of MMR and Varicella on 5/6/2020 at pediatric clinic.  I then added those doses to her vaccine record.  Therefore I gave her an extra dose of MMR and Varicella.  I contacted mom and explained the error.   I called mom today and she said that other than a fever of 101 last night, Pt is doing well.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Detoxification, Echocardiogram, Electrocardiogram
Clinical narrative: PFIZER #1 3/6/2021 PFIZER #2 2/28/2021 HAD VACCINE FAILURE AND COVID-19 DEVELOPED VACCINE SUBCLINICAL MYOPERICARDITIS.   HTN WORSENED WITH RECENT LOW BACK SURGERY.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION AND COLCHICINE.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Laboratory test, Myopericarditis, Spinal operation, Vaccination failure
Clinical narrative: PFIZER #1 3/6/2021 PFIZER #2 2/28/2021 HAD VACCINE FAILURE AND COVID-19 DEVELOPED VACCINE SUBCLINICAL MYOPERICARDITIS.   HTN WORSENED WITH RECENT LOW BACK SURGERY.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION AND COLCHICINE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: PATIENT BEGAN TO HAVE REDNESS TO LEFT THIGH WHERE DTAP/IPV GIVEN. MOTHER ADVISED TO GIVE BENADRYL AND MOTRIN FOR AGE AND WEIGHT EVERY SIX HOURS AND APPLY COLD COMPRESS AS TOLERATED. TODAY 6/20/24 MOM NOTED HEAT AT SITE, REDNESS FROM GROIN TO KNEE ON LEFT LEG, AND HARDNESS OF SITE.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Death
Clinical narrative: Patient is deceased
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Acute respiratory failure, Ascending flaccid paralysis, Cardiac arrest, Endotracheal intubation, Gastrostomy
Clinical narrative: 60 y.o. male with PMH of amphetamine and cocaine abuse now in remission on suboxone since 2022, and MDD/ADHD. Admitted on 05/15 for ascending paralysis due to GBS in the setting of recent RSV vaccination. Course c/b acute respiratory failure s/p intubation (05/17). S/p 5-day course of IVIG (EOT 05/20) with poor response ; not a candidate for PLEX. Course further c/b PEA arrest s/p brief CPR with ROSC (05/23). With chronic vent dependence s/p trach/PEG  (06/07). Remains admitted as of 6/20/2024 with minimal recovery
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation, Pulseless electrical activity, Resuscitation
Clinical narrative: 60 y.o. male with PMH of amphetamine and cocaine abuse now in remission on suboxone since 2022, and MDD/ADHD. Admitted on 05/15 for ascending paralysis due to GBS in the setting of recent RSV vaccination. Course c/b acute respiratory failure s/p intubation (05/17). S/p 5-day course of IVIG (EOT 05/20) with poor response ; not a candidate for PLEX. Course further c/b PEA arrest s/p brief CPR with ROSC (05/23). With chronic vent dependence s/p trach/PEG  (06/07). Remains admitted as of 6/20/2024 with minimal recovery
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Tracheostomy
Clinical narrative: 60 y.o. male with PMH of amphetamine and cocaine abuse now in remission on suboxone since 2022, and MDD/ADHD. Admitted on 05/15 for ascending paralysis due to GBS in the setting of recent RSV vaccination. Course c/b acute respiratory failure s/p intubation (05/17). S/p 5-day course of IVIG (EOT 05/20) with poor response ; not a candidate for PLEX. Course further c/b PEA arrest s/p brief CPR with ROSC (05/23). With chronic vent dependence s/p trach/PEG  (06/07). Remains admitted as of 6/20/2024 with minimal recovery
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: THE FIRST DAY BEGAN WITH A WELT, SIMILAR TO A MOSQUITO BITE ON THE ADMINISTRATOR'S ARM. THEN SEVERAL HIVES APPEAR ON DIFFERENT PARTS OF THE BODY. SOME WELTS LOOKED LIKE BITES AND OTHERS LOOKED LIKE SCRATCHES, WHICH THE PATIENT'S MOTHER INDICATES COME AND GO.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Appendix disorder, Colectomy, Enema administration, Gastrointestinal necrosis, Haematochezia
Clinical narrative: Patient presented to Hospital on May 30 for evaluation of bloody stool. She was found to have intussusception on ultrasound. Intussusception was unable to be reduced by air/contrast enema so she required open surgery to reduce it. The terminal ileum, cecum and appendix were necrotic and she required right hemicolectomy.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Intestinal operation, Intussusception, Necrosis, Procedural failure, Ultrasound abdomen abnormal
Clinical narrative: Patient presented to Hospital on May 30 for evaluation of bloody stool. She was found to have intussusception on ultrasound. Intussusception was unable to be reduced by air/contrast enema so she required open surgery to reduce it. The terminal ileum, cecum and appendix were necrotic and she required right hemicolectomy.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Paraesthesia, Sensory disturbance
Clinical narrative: My arm swelled at injection site June 19.  Arm tingling, and dead-arm feeling.
Age: 1.25
Sex: M
Vaccine: DTPPVHBHPB, HEPA, PNC15
Symptoms: Blood lactic acid, Cellulitis, Influenza A virus test negative, Influenza B virus test negative, Injection site inflammation
Clinical narrative: injection site inflamed, fever within 24 hours after injection. Was taken to ED. Treated for Cellulitis with antibioitcs. Possible underlying URI and mild dehydration also stated in ED paperwork.  Mom reports white count was elevated. No fever for child after 06/19/24.
Age: 1.25
Sex: M
Vaccine: DTPPVHBHPB, HEPA, PNC15
Symptoms: Metabolic function test, Pyrexia, Respiratory syncytial virus test negative, White blood cell count increased
Clinical narrative: injection site inflamed, fever within 24 hours after injection. Was taken to ED. Treated for Cellulitis with antibioitcs. Possible underlying URI and mild dehydration also stated in ED paperwork.  Mom reports white count was elevated. No fever for child after 06/19/24.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Injection site nodule
Clinical narrative: 7mm nodule noted. suggested use of warm compresses to site. Site not specified.  Stated baby had nodules from injection given on 03/07/2024 and that they went away with massaging. Did receive additional immunizations.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Dad called asking if headaches are normal after receiving the menquadfi vaccine. On Wednesday 06/19/2024. I explained that it is a normal side affect but if he has any other concerns do not hesitate to come back in. Dad called again today asking if vomittiing, stomach pain and severe headaches are also normal I then let dad know he should bring pt back in to be seen by a doctor. Sent to call center to make the appointment.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaqta was given on 5/24/2024 and it was too early to give pt and needs another Vaqta six months from 05/24/2024. This will be given after the date of 11/24/2024.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Nodule
Clinical narrative: Twin sister had vaccinations the same day and had similar reactions from 3/7 vaccination. Site not specified. State nodules developed and did go away with massaging.  No reactions for either baby from 05/06/2024 vaccinations.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Vitiligo
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Unevaluable event
Clinical narrative: no known symptoms, needs revaccination
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: 2/20/24 vaccination  parent reports pea to dime size nodule developed on L thigh.  from 4/22/24 vaccination child 3-4 cm redness and associated nodule to left thigh where 2nd dose of PCV15 was given. was seen for reaction from 04/22 vaccination. red, hot rash, was given rocephin injection, steroids and oral antibiotics.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: PATIENT INFORMED US TODAY THAT SHE HAS SWELLING.REDDNESS AND ITCHING. PATIENT DOES NOT HAVE A FEVER AND THE REDDNESS HAS NOT PROGRESSED. PATIENT STARTED TAKING BENADRYL . WE EILL FOLLOW UP WITH HER
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong patient
Clinical narrative: Patient received the wrong vaccine. Patient was here with siblings who were due for a Menquadfi. Patient was supposed to get an HPV9, but instead got one of the siblings Menquadfi's. Patient was feeling fine in office after receiving the Menquadfi all the way through check out and leaving the office.
Age: 60.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient said her left arm which was the shingrix was red and swollen and warm to the touch.  She said she was taking motrin and using ice pack, along with rubbing her arm
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Peripheral swelling, Pruritus, Rash, Rash erythematous
Clinical narrative: Same day: Red, itchy bumps appeared on my chest under my breast (left); symptoms lessened over the next 24 hours, but have come and gone since then, and have spread across to my right side; 16 days after vaccine (yesterday): Hypothenar eminence of right palm suddenly became very itchy, swollen, and turned bright white color for 10-20 minutes. The white discoloration faded rapidly but the swelling persisted. 17 days after vaccine (today): Pinky finger of right palm suddenly became itchy and bright white for 5 minutes or less and then returned to normal. Swelling of hypothenar eminence of right palm has persisted since yesterday.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Same day: Red, itchy bumps appeared on my chest under my breast (left); symptoms lessened over the next 24 hours, but have come and gone since then, and have spread across to my right side; 16 days after vaccine (yesterday): Hypothenar eminence of right palm suddenly became very itchy, swollen, and turned bright white color for 10-20 minutes. The white discoloration faded rapidly but the swelling persisted. 17 days after vaccine (today): Pinky finger of right palm suddenly became itchy and bright white for 5 minutes or less and then returned to normal. Swelling of hypothenar eminence of right palm has persisted since yesterday.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: The provider who saw him, started/treated him with Rocephin injection, IM systemic Steroid and oral Augmentin, which he is still taking.  They were also told to use benadryl as needed.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Muscle swelling, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Developed right arm erythema, swelling, pain, redness, and fever, as well as vomiting in the first 24 hours after vaccination. The vomiting subsided, but the right arm erythema progressed for 72 hours after immunization, as did the muscle swelling and pain. The area of erythema was 4 inches by 5 inches, and the muscle swelling was 1.5 inches by 2.5 inches.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Developed right arm erythema, swelling, pain, redness, and fever, as well as vomiting in the first 24 hours after vaccination. The vomiting subsided, but the right arm erythema progressed for 72 hours after immunization, as did the muscle swelling and pain. The area of erythema was 4 inches by 5 inches, and the muscle swelling was 1.5 inches by 2.5 inches.
Age: 52.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site streaking, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT DESCRIBED HAVING A RED, BLOTCHY, STREAKING RED LINES DOWN FROM THE INJECTION SITE. THE ARM WAS SWOLLEN AND PAINFUL. PATIENT CALLED ON 05/24/24 AND ASKED WHAT TO DO. PHARMACY TOLD HER TO TAKE TYLENOL AND TO MOVE HER ARM TO HELP BREAK UP THE INFLAMMATION.
Age: 52.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Rash macular
Clinical narrative: PATIENT DESCRIBED HAVING A RED, BLOTCHY, STREAKING RED LINES DOWN FROM THE INJECTION SITE. THE ARM WAS SWOLLEN AND PAINFUL. PATIENT CALLED ON 05/24/24 AND ASKED WHAT TO DO. PHARMACY TOLD HER TO TAKE TYLENOL AND TO MOVE HER ARM TO HELP BREAK UP THE INFLAMMATION.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received their first Vaqta dose at 1year and 1 month and received their second dose at 1 year and 7 months which was pointed out that the second dose was given too early and was supposed to be 6 months apart and needs to be repeated after 11/28/2024.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: same evening, started with fever, aches, chills, headache, slight dizziness. symptoms have improved.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Diplegia, Incontinence, Neck pain
Clinical narrative: Sharp stabbing pains in back, shoulders and neck. emergency hospitalization for diagnosis, Plasma transfusions, steroid treatment, antiviral medication, gabapentin and more.  Symptoms became waist down parallelization and incontinence.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Transfusion
Clinical narrative: Sharp stabbing pains in back, shoulders and neck. emergency hospitalization for diagnosis, Plasma transfusions, steroid treatment, antiviral medication, gabapentin and more.  Symptoms became waist down parallelization and incontinence.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: No adverse event noted at office visit.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Client rec'd Men A in Right Deltoid 6/17/24 at 1 pm.  According to parent client started experiencing redness and bump approx 1 hour after injection.  Parent provided Tylenol and Benadryl.  By the end of the evening redness had progressed almost to Right elbow and bump grew larger.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Mobility decreased, Muscle spasms, Pain
Clinical narrative: numbness in right arm, soreness, achey arm, difficult to move arm, muscle spasms, burning
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: numbness in right arm, soreness, achey arm, difficult to move arm, muscle spasms, burning
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: wrong age group vaccine given to pt
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red rash over right triceps area. Onset sometime after injection. Associated with pruritus, warmth, and tenderness. Contacted doctor office 6/18. Reported taking Benadryl Allergy Liquid and applying anti-itch cream, with only minimal relief. Symptoms subsided 6/19 and by in-person appointment on 6/20 symptoms had resolved.
Age: 1.83
Sex: F
Vaccine: COVID19, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events to reported. The vaccine was given on 6/17/2024 and the vaccine was expired on 6/15/2024.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Chest pain, Detoxification, Echocardiogram, Electrocardiogram
Clinical narrative: MODERNA #1 01/02/2021  DEVELOPED RIGHT EYE MONOCULAR MIGRAINES AND TRANSIENT BLINDNESS, CHEST PAIN, PALPITATIONS, FATIGUE, DIAGNOSES WITH COVID VACCINE MYOPERICARDITIS. TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION AND COLCHICINE. Clinical Approach to Post-acute Sequelae After COVID-19 Infection and Vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test, Migraine, Palpitations
Clinical narrative: MODERNA #1 01/02/2021  DEVELOPED RIGHT EYE MONOCULAR MIGRAINES AND TRANSIENT BLINDNESS, CHEST PAIN, PALPITATIONS, FATIGUE, DIAGNOSES WITH COVID VACCINE MYOPERICARDITIS. TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION AND COLCHICINE. Clinical Approach to Post-acute Sequelae After COVID-19 Infection and Vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: I woke up at 3:00 am feeling very hot. My temperature was 38.3 degrees celsius. I felt nauseated and had a bad headache. Also sore throat and stomach ache. And I felt very dizzy as well.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: I woke up at 3:00 am feeling very hot. My temperature was 38.3 degrees celsius. I felt nauseated and had a bad headache. Also sore throat and stomach ache. And I felt very dizzy as well.
Age: 1.83
Sex: M
Vaccine: COVID19, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events to reported. Vaccine was given on 06/17/2024 and the expiration date for the vaccine was 06/15/2024.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm red and swollen.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 12Jun2024 to 16Jun2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: MMRV
Symptoms: Abdominal pain upper, Cough, Erythema, Immune system disorder, Nausea
Clinical narrative: coughing and requesting water/felt nauseous, more intense coughing/stomach ache and felt like he might throw up/His sons eyes were turning red, his ears tur. red/  this was apparent that it was an immediate immune reaction to the PROQUAD; This spontaneous report was received from a patient father and refers to a 4-year-old male patient. The patient's had eggs allergy. The patient's medical history, concomitant therapies, and drug reactions were not reported.  On 13-JUN-2024, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, (strength, dose, dose#, lot #, expiry date, anatomical site of vaccination and route of administration were not provided) for prophylaxis (reported as prevention).  On the same day, the patient experienced reaction: it was reported that within 3-5 minutes after getting the suspect vaccine the patient started coughing and requesting water. Healthcare professional (HCP) advised, he wait in the waiting room. About 10 minutes later his son felt nauseous, more intense coughing, stomach ache and felt like he might throw up. His sons eyes were turning red, his ears and cheeks were also turning red. His son was also having an increase in mucus production and started to feel sleepy after about 15 minutes from the injection. The patient's father stated this was apparent that it was an immediate immune reaction to the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). He also stated that his son had no symptoms or infections prior to getting the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) that would cause these reactions. Due to the event, HCP administered liquid oral rupatadine in the office and his symptoms cleared up after about 25 minutes after having the antihistamine. His son has had vaccines in the past both Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) and "never had this issue". The patient's father was going to follow up with an allergist and HCP. On the same day, the patient had recovered from the event of immediate immune reaction (reported as his symptoms cleared up after about 25 minutes after having the antihistamine).  The reporter considered the event of immediate immune reaction to be related to measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  Upon internal review, the event of immediate immune reaction was determined to be medically significant.  Lot number is being requested and will be submitted if received.
Sex: M
Vaccine: MMRV
Symptoms: Ocular hyperaemia, Secretion discharge, Somnolence
Clinical narrative: coughing and requesting water/felt nauseous, more intense coughing/stomach ache and felt like he might throw up/His sons eyes were turning red, his ears tur. red/  this was apparent that it was an immediate immune reaction to the PROQUAD; This spontaneous report was received from a patient father and refers to a 4-year-old male patient. The patient's had eggs allergy. The patient's medical history, concomitant therapies, and drug reactions were not reported.  On 13-JUN-2024, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, (strength, dose, dose#, lot #, expiry date, anatomical site of vaccination and route of administration were not provided) for prophylaxis (reported as prevention).  On the same day, the patient experienced reaction: it was reported that within 3-5 minutes after getting the suspect vaccine the patient started coughing and requesting water. Healthcare professional (HCP) advised, he wait in the waiting room. About 10 minutes later his son felt nauseous, more intense coughing, stomach ache and felt like he might throw up. His sons eyes were turning red, his ears and cheeks were also turning red. His son was also having an increase in mucus production and started to feel sleepy after about 15 minutes from the injection. The patient's father stated this was apparent that it was an immediate immune reaction to the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). He also stated that his son had no symptoms or infections prior to getting the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) that would cause these reactions. Due to the event, HCP administered liquid oral rupatadine in the office and his symptoms cleared up after about 25 minutes after having the antihistamine. His son has had vaccines in the past both Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) and "never had this issue". The patient's father was going to follow up with an allergist and HCP. On the same day, the patient had recovered from the event of immediate immune reaction (reported as his symptoms cleared up after about 25 minutes after having the antihistamine).  The reporter considered the event of immediate immune reaction to be related to measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  Upon internal review, the event of immediate immune reaction was determined to be medically significant.  Lot number is being requested and will be submitted if received.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Extra dose administered; Inappropriate schedule of vaccine administered; This spontaneous report has been received from a lawyer, via an immunization record from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (MARRS #2405USA003892), concerning a 4-month-old female patient.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 18-NOV-2003, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacture unknown) intramuscular injection. On 16-JAN-2004, the patient was vaccinated with thesecond dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacture unknown) (Inappropriate schedule of product administration). On 12-MAR-2004, she received the third dose(Extra dose administered). On 20-JUN-2005, she received the fourth dose(Inappropriate schedule of product administration). All: administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  This is one of several reports for the same patient.; Sender's Comments:  US-009507513-2405USA003892: US-009507513-2406USA005486:
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/PQC.; first dose of GARDASIL-9 16-AUG-2018 when he was 18 years old.  Patient is now in the pharmacy looking to get the second dose of the GARDASIL-9 series; This spontaneous report was received from a pharmacist and refers to an approximately 24-year-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2018, 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) injection, at a dose of 0.5 milliliter, once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and at time of reporting, patient was in the pharmacy looking to get the second dose of t hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series. Pharmacist confirmed there were no symptomatic adverse events related to the vaccine and patient delayed the second dose due to probably having "forgotten". No additional information at this time.  Lot # was being requested and will be submitted if received.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; she received an expired live vaccine dose; This spontaneous report was received from an other health professional via voicemail and referred to a female patient with unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-JUN-2024 (also reported as today), the patient was given a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #U039723, expiration date: 15-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The reporter wondering how should proceed to get the patient a valid not an unexpired dose and requested call back. It was confirmed the dose of varicella virus vaccine live (oka/merck) (VARIVAX) had never been involved in a temperature excursion. No additional information at this time. No additional adverse event (AE) reported (No adverse event).
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE.; A HCP called to report a TE for VARIVAX in which one lot number experienced a prior TE and was also inadvertently administered to a patient on 06/15/2024.  The HCP was unable to provide the date of the current excursion or any details for the prior e; This spontaneous report was received from a medical assistant and refers to a 3-year-old patient. No information on patient's medical history and current conditions. Concomitant therapies included sterile diluent (STERILE DILUENT).  On 15-JUN-2024 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X028612 and expiration date 13-DEC-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided). The reporter was unable to provide the date of the current excursion or any details for the prior excursion and would call back with the details when available. The excursion lasted 1 hour 30 minutes in temperature of 11.1 degrees Fahrenheit (F). The patient did not report any adverse issues or side effects from the administration (product storage error and no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Know a few who have had the vaccination and still got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Know a few who have had the vaccination and still got the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   The company considered the vaccination failure to be related to Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2024 This case was reported via (social media) interactive digital media. The reporter knows a few who had the vaccination and still got the shingles and said nothing was 100 percent. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Sender's Comments: Vaccination failure is listed events which are considered related to GSK vaccine Shingles vaccine.  Herpes zoster is an unlisted events which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of extra dose administered in a patient who received HBV (Engerix B) for prophylaxis.   On 10-JUN-2024, the patient received Engerix B. On 10-JUN-2024, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2024. The reporter calling to confirm that he/she had to submit a report since Monday one of his/her patients got an extra vaccine which led to extra dose administered and reporter was not sure if he/she calling the correct number. No additional information was provided.  Reporter did not provide permission to be contacted further regarding the event.