chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurse gave the GARDASIL 9 vaccine to a 12 month old female; No adverse event; This spontaneous report was received from a registered nurse concerning to a 12-month-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and previous drugs reactions were not provided.  On an unknown date, the patient was vaccinated accidentally with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, formulation, dose, route of administration, lot number and expiration date were not reported) (product administered to patient of inappropriate age). No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; HCP called to request information on PROQUAD administration. HCP stated on 5/31/2024, 5-year-old child received PROQUAD IM with an 5/8-inch needle length in the vastus lateralis muscle of anterolateral right thigh.  See additional request case# 02611; This spontaneous report was received from a licensed practical nurse, referring to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 31-MAY-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, administered intramuscularly (IM) with a 5/8-inch needle length in the vastus lateralis muscle of anterolateral right thigh (incorrect route of product administration) (strength and vaccination scheme were not reported; lot number X024913, expiration date reported and validated as 14-APR-2024) as prophylaxis (incorrect route of product administration). No side effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reported PROQUAD was administered to a patient on an unspecified date during a temperature excursion (case 02613440). No additional AE. No PQC.  Names of vaccines involved (including lot/exp) PROQUAD X024655 04/09/2025 Temperature 12°F Time fram; No additional AE; This spontaneous report was received from an medical assistant and refers to a patient of unknown age or gender. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant medication included sterile diluent.  On an unspecified date, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # X024655, expiration date: 09-APR-2025, albumin status stablished as rHA (strength, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion at 12 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion were reported, nor additional adverse events.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain
Clinical narrative: Possible small nerve neuropathy; Constant burning pain in the tops of both feet and intermittently on the tops of my hands; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Possible small nerve neuropathy) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced NEUROPATHY PERIPHERAL (Possible small nerve neuropathy) (seriousness criterion medically significant) and PAIN (Constant burning pain in the tops of both feet and intermittently on the tops of my hands). At the time of the report, NEUROPATHY PERIPHERAL (Possible small nerve neuropathy) and PAIN (Constant burning pain in the tops of both feet and intermittently on the tops of my hands) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were reported. Patient reported constant burning pain in the tops of both feet and intermittently on the tops of her hands starting about 2-4 weeks after her Covid vaccine. This was self-diagnosed. She discussed this with her gynecologist on her annual visit on 12/21/23. Her symptoms continue to this day but were more intermittent. Some days she had mild symptoms and some days her symptoms were more pronounced No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning a 64-year-old female patient with no medical history reported, who experienced the serious (per medically significant) unexpected event of Neuropathy which 2-4 weeks after a dose of mRNA-1273.815 for COVID-19 Vaccination. It was reported that the patient had constant burning pain in the tops of both feet and intermittently on the tops of her hands starting about 2-4 weeks after her Covid vaccine. This was self-diagnosed. She discussed this with her gynecologist on her annual visit on 12/21/23. Her symptoms continue to this day but were more intermittent. Some days she had mild symptoms and some days her symptoms were more pronounced. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-768908 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-768908:Sister Case
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Impaired work ability, Loss of personal independence in daily activities, Muscular weakness, Pain
Clinical narrative: Pain started upon waking morning after administration and has worsened since. Pain tends to increase in morning and evening and is affecting all work and ADLs. Symptoms are as follows: Sharp L sided posterolateral shoulder pain. Positive special tests: empty can, Hawkins-kennedy, full can.  Pain with AROM and PROM flexion, abduction, external rotation. Weakness in external rotation, abduction, flexion. Injection site notably superior to deltoid muscle belly.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Product administered at inappropriate site
Clinical narrative: Pain started upon waking morning after administration and has worsened since. Pain tends to increase in morning and evening and is affecting all work and ADLs. Symptoms are as follows: Sharp L sided posterolateral shoulder pain. Positive special tests: empty can, Hawkins-kennedy, full can.  Pain with AROM and PROM flexion, abduction, external rotation. Weakness in external rotation, abduction, flexion. Injection site notably superior to deltoid muscle belly.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Hypoaesthesia, Limb mass, Nausea
Clinical narrative: Chills, nausea,  dizziness,  lumpy arm.  Numbness in arm from shoulder to all 5 fingertips.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pt was given wrong dosage/was given pediatric instead of adult.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in 57-year-old-male 7-days after first inoculation with J&J EUA medical countermeasure. DOSE1 date 04/12/21 LOT#206A21A. DOD 04/19/2021. Adverse event does not appear to be entered in the VAERS system.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: On 3/12/2024, I received my first dose of Shingrix vaccine (Shingrix 50 MCG/0.5ML INJ GLAX, NDC 58160-823-11) and experienced no problems. On 5/17/2024, I received my second dose of the Shingrix vaccine. On the day of my immunization, the pharmacist, apologized to (redacted) and I for our long wait time, stating that it took longer than normal to blend/compound the Shingrix suspension (or similar wordage). That statement may, or may not, have been relevant to my medical situation. By 5/20/2024, I broke out in itchy hives all over my body (torso, face, neck, arms & legs). I have never experienved an adverse reaction to any type of vaccine before (except Swine flu), not have I ever had any allergic reactions to any food or drug. On 05/26/2024, I contacted my family physicain, Dr via email, asking for medical advise on how to treat my hives outbreak. On 5/28/2024, Dr advsed that I continue to take an OTC antihistmine. On 6/4/2024. I submitted a vaccine SIDE EFFECT report to www.fda.gove/medwatch. I am still getting new hives in different places on my body, but they are not as mumerous as initially (5/20/2024). The same HIVES side effect happened to my wife, after her second dose of the Shingrix vaccine. She had the same vaccines Dose#1 & #2 date & time, pharmacy & pharmacist, etc as me.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: On 3/12/2024,  I received my first dose of the Shingrix vaccine (Shingrix 50 MCG/0.5ML INJ GLAX, NDC 58160-0823-11) and experienced no problems. On 5/17/2024, I received my second dose of the Shingrix vaccine. On the day of my immunization, the pharmacist apologized to  us for our long wait time, stating that it took longer than normal to blend/compound the Shingrix suspension (or similar wordage). That statement may, or may not, have been relevant to my medical situation. By 5/22/2024, I broke out in itchy hives all over my body (torso, face, neck, arms, & legs). I have never experienced an adverse reaction to any type of vaccine before, nor have I ever had an allergic reactions to any food or drug (except for getting a skin rash once, from a topical Sulpha RX, taken 50 years ago). On 5/26/2024, I contacted my family physician, via email, asking for medical advise on how to treat my hives outbreak. On 05/28/2024, Dr advised that I continue to take an OTC antihistamine (but stop using Cortizone-10 oOn 6/4/2024. I submitted a vaccine SIDE EFFECTS report to www.fda.gov/medwatch. I am still getting new hives in different places on my body, but they are not as numerous as initially (5/22/2024). The same HIVES side effect happened to my husband, after his second dose of the Shingrix vaccine. He had the same vaccine Dose#1 & #2 date & time, pharmacy & pharmacist, etc as me.
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Drug ineffective, Erythema, Furuncle, Herpes simplex test positive
Clinical narrative: Condition after medical visit caused an infection pertained to be shingles. Have had Shingres shots 3 years past and start again November 2023. Swab at Facility Taking Antiviral VALTREX causing Heart Racing..05/26/2024 not healing, back to facility. Another swab positive HSV-1. New treatment FAMCICLORIS anti viral Having Shingles after Shingres shots. Again Heart racing, in and out AFIB. Heart rate at rest 100-110. Finished FAMCICLORIS on Sunday 06/02/2024, MONDAY JUNE 03- June 05, this report, heart rate back to 68. No heart arrhythmia. I've had this occur prior in 2007 with TEKTURNA OCCUR in 2012 with Flomax. TEKTURNA put me in hospital in 2007 for 6 days with AFIB. Shingrix shots were ineffective in Shingle Prevention, but usage previous years Shingres ended a neural itch in both wrist and hands after several years of the Neural itching. THE ARM BREAKOUT OCCURRED 24 hours after a BP CUFF WAS USED AT PAIN CLINIC. RAISED LIKE A HUGE PIMBLE, FEW DAY LOOKED LIKE A BOIL. LEFT ALONE, THE BOIL TUNRED INTO SKIN INFECTION AND WENT FROMHALF CENTIMETER TO FIVE SQUARE CENTIMETER AREA. IS CLEARING, HAVE A SCAR PINK AREA CURRENTLY 06/06/2024
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired healing, Neuropathic pruritus, Palpitations, Rash
Clinical narrative: Condition after medical visit caused an infection pertained to be shingles. Have had Shingres shots 3 years past and start again November 2023. Swab at Facility Taking Antiviral VALTREX causing Heart Racing..05/26/2024 not healing, back to facility. Another swab positive HSV-1. New treatment FAMCICLORIS anti viral Having Shingles after Shingres shots. Again Heart racing, in and out AFIB. Heart rate at rest 100-110. Finished FAMCICLORIS on Sunday 06/02/2024, MONDAY JUNE 03- June 05, this report, heart rate back to 68. No heart arrhythmia. I've had this occur prior in 2007 with TEKTURNA OCCUR in 2012 with Flomax. TEKTURNA put me in hospital in 2007 for 6 days with AFIB. Shingrix shots were ineffective in Shingle Prevention, but usage previous years Shingres ended a neural itch in both wrist and hands after several years of the Neural itching. THE ARM BREAKOUT OCCURRED 24 hours after a BP CUFF WAS USED AT PAIN CLINIC. RAISED LIKE A HUGE PIMBLE, FEW DAY LOOKED LIKE A BOIL. LEFT ALONE, THE BOIL TUNRED INTO SKIN INFECTION AND WENT FROMHALF CENTIMETER TO FIVE SQUARE CENTIMETER AREA. IS CLEARING, HAVE A SCAR PINK AREA CURRENTLY 06/06/2024
Sex: M
Vaccine: VARZOS
Symptoms: Scar, Skin infection, Therapeutic response unexpected
Clinical narrative: Condition after medical visit caused an infection pertained to be shingles. Have had Shingres shots 3 years past and start again November 2023. Swab at Facility Taking Antiviral VALTREX causing Heart Racing..05/26/2024 not healing, back to facility. Another swab positive HSV-1. New treatment FAMCICLORIS anti viral Having Shingles after Shingres shots. Again Heart racing, in and out AFIB. Heart rate at rest 100-110. Finished FAMCICLORIS on Sunday 06/02/2024, MONDAY JUNE 03- June 05, this report, heart rate back to 68. No heart arrhythmia. I've had this occur prior in 2007 with TEKTURNA OCCUR in 2012 with Flomax. TEKTURNA put me in hospital in 2007 for 6 days with AFIB. Shingrix shots were ineffective in Shingle Prevention, but usage previous years Shingres ended a neural itch in both wrist and hands after several years of the Neural itching. THE ARM BREAKOUT OCCURRED 24 hours after a BP CUFF WAS USED AT PAIN CLINIC. RAISED LIKE A HUGE PIMBLE, FEW DAY LOOKED LIKE A BOIL. LEFT ALONE, THE BOIL TUNRED INTO SKIN INFECTION AND WENT FROMHALF CENTIMETER TO FIVE SQUARE CENTIMETER AREA. IS CLEARING, HAVE A SCAR PINK AREA CURRENTLY 06/06/2024
Age: 1.0
Sex: M
Vaccine: MMRV, PNC20
Symptoms: Injection site bruising, Pyrexia
Clinical narrative: Patient spiked fever overnight and was ebrile this morning. Tylenol given x 2. 101.2 this morning. has dime sized bruised appearance to R thigh, otherwise pinpoint marks. Per vaccine record, got prevnar and proquad at that site.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Nodule and tenderness and itching 4x2.5cm on R arm at vaccine site
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Localized cellulitis
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough, fatigue, fever
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: 18 y.o. old w/mom for men B #2 (private) Patient presents for Immunization(s). with mother Left deltoid IM   VIS given.  Immunization administered.  Within a minute of receiving vaccine patient c/o she felt sweaty , lightheaded and pale. Assisted to lie down and feet elevated  Initial vs BP 90/60 P 64 lying down Given water, 1 pack of saltines, gingerale, box of  pack of graham crackers  Patient was  brought slowly to sitting position after no longer c/o light headed or dizzy , no longer sweaty Ice pack applied forehead/back of neck Sitting vs initially 80/50 - 2 more packs of saltines, and apple juice given.  Sitting BP came up to 90/60 P 93 Patient no longer lightheaded or sweaty, color returned to face (pale complexion at baseline) Slowly brought to standing position stood for several minutes vs 92/60 p 91   Last vs on record from last physical 11/06/2023 BP 96/62 P-84   Patient was alert, talking, no longer feeling lightheaded, sweaty and ready for discharge home at 1045am -given glass of water for the ride home FYI to pcp  will do a status check on patient this afternoon
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient received dose of MMR-V and Varicella.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Concussion, Contusion, Dizziness, Electrocardiogram normal
Clinical narrative: Began to feel lightheaded while at work around 7:00pm on 05/28/2024. Fainted around 8:10pm and fell backwards and hit head on tile floor. Went to ER at Hospital and was diagnosed with a concussion and had 6 staples inserted in wounds. Had one episode of vomiting after staples were put in, around 1:30am. Was discharged around 2:15am on 05/29/2024.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury, Mucosal hypertrophy, Pregnancy test urine negative, Scalp haematoma
Clinical narrative: Began to feel lightheaded while at work around 7:00pm on 05/28/2024. Fainted around 8:10pm and fell backwards and hit head on tile floor. Went to ER at Hospital and was diagnosed with a concussion and had 6 staples inserted in wounds. Had one episode of vomiting after staples were put in, around 1:30am. Was discharged around 2:15am on 05/29/2024.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Subcutaneous emphysema, Subdural haematoma, Suture insertion, Syncope, Vomiting
Clinical narrative: Began to feel lightheaded while at work around 7:00pm on 05/28/2024. Fainted around 8:10pm and fell backwards and hit head on tile floor. Went to ER at Hospital and was diagnosed with a concussion and had 6 staples inserted in wounds. Had one episode of vomiting after staples were put in, around 1:30am. Was discharged around 2:15am on 05/29/2024.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: Began to feel lightheaded while at work around 7:00pm on 05/28/2024. Fainted around 8:10pm and fell backwards and hit head on tile floor. Went to ER at Hospital and was diagnosed with a concussion and had 6 staples inserted in wounds. Had one episode of vomiting after staples were put in, around 1:30am. Was discharged around 2:15am on 05/29/2024.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Bell's palsy
Clinical narrative: No adverse local reaction or pain or fever but patient went to the ER on the same day with  symptoms of left Bells Palsy. History of follow up for brain tumor as mention above. Mother says she has left sided Bells Palsy when she was pregnant  with this patient before he was born.
Age: 26.0
Sex: M
Vaccine: COVID19-2, HEP, HPV9, MMR
Symptoms: Blindness, Dizziness, Dyskinesia, Fatigue, Hyperhidrosis
Clinical narrative: Patient made an involuntary movement of fainting right at the moment last vaccine was administered. He was dizzy, sweaty, loss vision and very fatigue. He was monitored for over 30 minutes for symptoms improvement.
Age: 26.0
Sex: M
Vaccine: COVID19-2, HEP, HPV9, MMR
Symptoms: Syncope
Clinical narrative: Patient made an involuntary movement of fainting right at the moment last vaccine was administered. He was dizzy, sweaty, loss vision and very fatigue. He was monitored for over 30 minutes for symptoms improvement.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Adult 12+ vaccine given instead of Pedi dose. Patient/Responsible Party did not report adverse reaction to this clinic. Report filed d/t ImmTrac2 notification of inappropriate age vaccine given. Patient has returned to clinic since being vaccinated with COVID to receive other vaccines.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Urticaria
Clinical narrative: Patient developed hives within 10 minutes of receiving vaccines.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC20, RV5
Symptoms: Emotional distress, Haematochezia
Clinical narrative: mild hematochezia (parent observation) after Rotateq dose 1 and 2 (first dose 3/12/24 0953 lot #1579978).  had two one hour episodes inconsolability  6/3/24 that resolved without intervention.  anal fissure noted after first dose.  hematochezia did not recur on trial maternal dairy-free diet.  unrestricted maternal diet was resumed before second dose.
Age: 19.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abdominal discomfort, Chest discomfort, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Patient reports that he felt like he had a reaction to his MMR vaccine that he had in APR. Reports that it was hard to describe the way he felt, but he remembers feeling warm all over. He states that he was checked out by provider who told him that it was a normal reaction. Could not find documentation in his chart of incident, so told him that we would give him his second dose, along with his VAR, but that we would watch him in clinic for 30 minutes post administration. Gave him instructions on alerting us if he felt any S/SX of reaction. Vaccines were administered at 0920. At 0930 he reports feeling very similar to reaction last time and reports feeling hot, feeling nauseas/GI distress, heavy chest. He was diaphoretic, pale, and very restless. VS were taken 110/60, 36.6, 80, 16. SA02 100%. Providers, additional staff were called per protocol and  EPI 0.3 was given to him in his R quad at 0940. His SX improved after receiving EPI. He continued to be monitored by provider and nursing staff until EMS arrived.
Age: 19.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pallor, Restlessness
Clinical narrative: Patient reports that he felt like he had a reaction to his MMR vaccine that he had in APR. Reports that it was hard to describe the way he felt, but he remembers feeling warm all over. He states that he was checked out by provider who told him that it was a normal reaction. Could not find documentation in his chart of incident, so told him that we would give him his second dose, along with his VAR, but that we would watch him in clinic for 30 minutes post administration. Gave him instructions on alerting us if he felt any S/SX of reaction. Vaccines were administered at 0920. At 0930 he reports feeling very similar to reaction last time and reports feeling hot, feeling nauseas/GI distress, heavy chest. He was diaphoretic, pale, and very restless. VS were taken 110/60, 36.6, 80, 16. SA02 100%. Providers, additional staff were called per protocol and  EPI 0.3 was given to him in his R quad at 0940. His SX improved after receiving EPI. He continued to be monitored by provider and nursing staff until EMS arrived.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Condition aggravated, Haematochezia
Clinical narrative: pt has a history of blood in stool mother states increased blood in stool after Rota  Tech given
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given 1 dose of Pneumovax 23 which is not intended for anyone under the age of 2 years of age.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient was given an additional dose of shingrix.  he  was originally vaccinated 2021 and 2022
Age: 17.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient was given a Dtap vaccine instead of Tdap for a vaccine catch-up.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Patient today reports full body rash lasting 6 weeks, appearing about a week after last covid 19 vaccine.   no reaction to previous vaccines.
Age: 23.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was erroneously administered 1ml of MMR instead of the recommended dose of 0.5ml.   Patient experienced no adverse events.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site induration, Injection site pain
Clinical narrative: severe pain and induration  with swelling at the injections site and beyond.  Chills, fever, transient headache that came back twice, severe lethargy.  For the first 24 hours I felt almost like I had the flu minus the muscle ache.  Fever lasted about 18 hours running between 100 and 100.5.  72 hours later symptoms have resolved except my arm is still very sore to the touch with less induration and swelling.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Pyrexia
Clinical narrative: severe pain and induration  with swelling at the injections site and beyond.  Chills, fever, transient headache that came back twice, severe lethargy.  For the first 24 hours I felt almost like I had the flu minus the muscle ache.  Fever lasted about 18 hours running between 100 and 100.5.  72 hours later symptoms have resolved except my arm is still very sore to the touch with less induration and swelling.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: mmrv  was administered on 5/06/2024 to patient  was an invalid dose. The MMRV administered is only valid when given to patients 12 years and younger. patient is 16 years old.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Injection site abscess, Injection site cellulitis, Injection site induration, Injection site nodule
Clinical narrative: Patient reports that approximately one week post-vaccination she developed an abscess at the site.  Pt reports a hard knot at the site and was dx with cellulitis.
Age: 62.0
Sex: F
Vaccine: PNC20, RSV, UNK
Symptoms: Asthenia, Bone pain, Decreased appetite, Diarrhoea, Facial paralysis
Clinical narrative: Náusea vomitting diarrhea weakened loss of appetite face numb dropping bone pain x2 weeks
Age: 62.0
Sex: F
Vaccine: PNC20, RSV, UNK
Symptoms: Hypoaesthesia, Nausea, Vomiting
Clinical narrative: Náusea vomitting diarrhea weakened loss of appetite face numb dropping bone pain x2 weeks
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was seen on 6/6/24 for vaccines with Dr. Provider ordered MMRV and Dtap/IPV. RN saw order for ProQuad and Kinrix and went into immunization tab where she saw MMR and Varicella highlighted separately. This confusion resulted in patient getting a ProQuad and a Varicella instead of just ProQuad. RN did not realize until later in the day where she immediately called Nurse Manager to inform of incident. Nurse Manager Spoke to Site Medical Director who advised that from a medical standpoint no harm done. Informed staff. Call parent of patients to inform. Nurse Manager discussed incident with RN and informed to pick up orders from Progress Notes or under view orders. Advise RN to double check orders and avoid distractions. TE sent to Dr. to inform of incident. There will be a written warning completed for RN involved in incident.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pruritus, Urticaria
Clinical narrative: Glaxo Smith Kline Manufacture.   Patient came back to clinic about 30 minutes after experiencing hives and itchiness, after receiving Dose #2 of Bexsero.  Gave a dose of Benadryl to help with symptoms and monitored.  Improved in a couple of hours, called parent for update- doing well
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Had MMR (lateral thight) and DTaP/IPV (anterior thigh) vaccines on 6/5 on right leg. Later that day pt developed red, hot area on anterior right thigh. Pt was not complaining of pain initially but then once parents noted the reaction she started to c/o some pain. Area has increased in size since 6/5- approximately 8-9cm today (06/07/24). Applied topical Benadryl for itching. No limping. No fever.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was given expired vaccine. 12 weeks out of ultra cold temp was May 6, 2024.  Vaccine received May 9, 2024
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood glucose normal, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: PATIENT EXPERIENCED ACUTE FAINTING EPISODE IMMEDIATELY AFTER RECIEVING VACCINATIONS. REGAINED CONCIOUSNESS WITHIN SECONDS. VITALS ALL WITHIN NORMAL RANGE. EMS CHECKED OUT APPROXIMATELY 20 MINUTES AFTER ADVERSE REACTION
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Eye irritation, Headache, Herpes zoster, Lymphadenopathy
Clinical narrative: Herpes zoster rash occured day after vaccine on right chest and back. Stinging,  burning, itching on chest, headache, burning eyes, swollen lymph nodes in neck.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash vesicular
Clinical narrative: Herpes zoster rash occured day after vaccine on right chest and back. Stinging,  burning, itching on chest, headache, burning eyes, swollen lymph nodes in neck.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Emotional distress, Needle issue, Product preparation error, Syringe issue, Underdose
Clinical narrative: was upset; loose tip cap from sterile diluent prefilled syringe used to reconstitute MMRII vaccine/top of syringe came of; Poor quality device used; vaccine came out of side of syringe; Treatment delayed; This non-valid spontaneous report was received from a physician and refers to an unspecified patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) that was reconstituted with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, lot #1950631, expiration date: 09-JAN-2026 which had a loose tip cap (device connection issue; poor quality device used). No adverse event was reported.  The product was available for retrieval and caller would send the photos. The reporter stated he had 3 unopened boxes with similar lot number and expiration date however no additional event occurred.  Follow-up information was received by the physician regarding the 3-year-old male patient on 30-MAY-2024. It was stated that the patient had no illness at the time he received the vaccine on 05-MAR-2024, at the private physician's office, when a medical assistant administered the patient with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, administered for prophylaxis  in his thigh (unspecified) (strength, lot #, expiry date, and route of administration were not provided) that was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (also reported as drawn into syringe dose of sterile diluent) (conflicting information also reported as measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [M-M-R II]), however the top part of the syringe came off while the vaccine was being administered (also reported as while the needle was in the patient's thigh) causing the vaccine to come out of the middle of the syringe, as  according to the reporter, the sterile diluent (BAXTER STERILE DILUENT) single dose syringe was defective. Due to this, the patient was upset, but he was given a new varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as the first one was wasted, as the defect caused delayed treatment and non-administration of the specific syringe (which was disposed or discarded on sharps [conflicting information, also reported as available for evaluation]) (Mood altered, Device leakage; treatment delayed). At the time of reporting the outcome of  mood altered had not been provided. The causal relationship between all the suspect products was not provided.   No additional information or clarification was provided.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported; HCP called to report MMR II that was given to a patient after expiration. Expired on 5/10/2024, administered 5/13/2024.; This spontaneous report was received from a medical assistant and referred to a 12-month-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 13-MAY-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W034593, expiration date: 10-MAY-2024, administered for prophylaxis (strength, dose, route of administration and anatomical site of administration were not provided). No adverse side effects were reported (no adverse event, expired product administered).
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site indentation, Muscle atrophy, Pain in extremity
Clinical narrative: Consumer stated that her left arm formed an "indentation" where the shot was given and gradually "got really deep"; her "arm is sunk in half an inch and is disfiguring." Consumer stated her physician told her that her muscle is deteriorating; Consumer stated that she received PNEUMOVAX 23 on 16SEP2022 in her left arm and afterwards experienced a sore left arm for 3 weeks.; This spontaneous report was received from patient referring to herself as 74-year-old female. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On 16-SEP-2022 at age of 73, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered in her left arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  The patient stated that afterwards experienced a sore left arm for 3 weeks (vaccination site pain). In addition, the patient's arm formed an indentation where the shot was given and gradually got really deep (injection site indentation) and her arm was sunk in half an inch and was disfiguring. The physician told the patient that her deltoid muscle was deteriorating (injection site atrophy). The patient received an unspecified pain cream as treatment for the events. At the reporting time the patient was not recovered for the events.   The causal relationship between adverse events and  pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.   Lot number is being requested and will be submitted if received.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, High risk pregnancy
Clinical narrative: was given GARDASIL 9 and she is currently 27 weeks pregnant.; high risk pregnancy; This spontaneous report was received from a consumer and referred to a 32-year-old female patient.  The patient's concurrent conditions included blood pressure high and penicillin allergy. Historical drugs included penicillin. The patient's medical history was not reported.  The patient's last menstrual period (LMP) was 16-NOV-2023 and estimated due date (EDD) of 22-AUG-2024. The pregnancy outcome was outcome pending. The fetal outcome was unknown.  On an unknown date, the patient went to a pharmacy to get the O-Negative shot (unspecified, reported as concomitant therapy) per her HCP request and the pharmacist suggested she get the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination since she had not had it. On 22-MAY-2024, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (route of administration was reported as arm Injection, strength, dose, lot #, expiry date, and were not provided) (Exposure during pregnancy).  On 22-MAY-2024, the patient experienced high-risk pregnancy. It was also reported labs completed monthly (unspecified). The outcome of the event was reported as recovered (date not reported).  The causal relationship between high-risk pregnancy and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Lot # is being requested and will be submitted if received.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored VARIVAX.; This spontaneous report was received from a medical assistant concerning a 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 17-MAY-2024, the patient was vaccinated with single dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# X026789, confirmed as a valid lot number, expiration date: 14-NOV-2025) administered for prophylaxis (strength, dose, unit, route of administration, and anatomical location were not provided).   The vaccine was improperly stored at a temperature of 19.8 degrees Fahrenheit (F) for a time frame of 20 hours and 15 minutes (PT: Product storage error). There was no previous temperature excursion (TE). No adverse effects reported (no adverse event).   This is one of several cases from the same reporter (34 associated cases).; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007924: US-009507513-2405USA007700: US-009507513-2405USA007912: US-009507513-2405USA007488: US-009507513-2405USA007692: US-009507513-2405USA007720: US-009507513-2405USA007905: US-009507513-2405USA007916: US-009507513-2405USA007722: US-009507513-2405USA007713: US-009507513-2405USA007454: US-009507513-2405USA007588: US-009507513-2405USA007771: US-009507513-2405USA007935:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received inappropriately stored VARIVAX; This spontaneous report was received from a medical assistant and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-MAY-2024, the patient was vaccinated with an inappropriately stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, lot #X026789, expiration date: 14-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion of 19.8 degrees Fahrenheit for 20 hours and 15 minutes was reported. No previous temperature excursion.   No adverse effects reported (No adverse event).  This is one of 34 reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007924:2405USA007905 US-009507513-2405USA007454: US-009507513-2405USA007916: US-009507513-2405USA007912: US-009507513-2405USA007488: US-009507513-2405USA007588: US-009507513-2405USA007573: US-009507513-2405USA007578: US-009507513-2405USA007617: US-009507513-2405USA007648: US-009507513-2405USA007667: US-009507513-2405USA007684: US-009507513-2405USA007692: US-009507513-2405USA007713: US-009507513-2405USA007720: US-009507513-2405USA007722: US-009507513-2405USA007724: US-009507513-2405USA007727: US-009507513-2405USA007728: US-009507513-2405USA007731: US-009507513-2405USA007761: US-009507513-2405USA007763: US-009507513-2405USA007771: US-009507513-2405USA007791: US-009507513-2405USA007833: US-009507513-2405USA007841: US-009507513-2405USA007901: US-009507513-2405USA007909: US-009507513-2405USA007911: US-009507513-2405USA007912: US-009507513-2405USA007935: US-009507513-2405USA008015: US-009507513-2405USA007700: US-009507513-2405USA007771:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report PROQUAD administered to patient following a TE. See TE case 02607915. No additional AE/No PQC.; No additional AE/No PQC.; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender.  The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 17-MAY-2024, the patient started was vaccinated with a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) injection, lot #Y003116, expiration date: 27-JUL-2025, administered as prophylaxis (strength, anatomical location, and route of administration were not provided) following a temperature excursion (TE) (Improper storage of product in use). However, there were no additional adverse events or product quality complaints.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; inadvertent administration of VAQTA to a 2-month-old patient; This spontaneous report was received from an Other Health Professional and referred to a 2-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 31-MAY-2024, the patient was inadvertent vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X025163, expiration date: 12-MAY-2025, administered for prophylaxis (strength, dose and route of administration were not provided) (Product administered to patient of inappropriate age). No additional AE.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: HCP called to report that a patient developed a rash after receiving an initial dose of VARIVAX.  30 year old female.  Administered in February 2024. No other information was available, including the patient information, exact date of administration,; This spontaneous report was received from a nurse and refers to a 30-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On FEB-2024 the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X010531 and expiration date 11-APR-2025, 0.5 milliliter for prophylaxis (route and site of administration were not reported).  On FEB-2024 the patient experienced rash. The outcome of rash was unknown. Action taken with varicella virus vaccine live (oka/merck) (VARIVAX) regarding the event was not applicable.  The causality between varicella virus vaccine live (oka/merck) (VARIVAX) and the event was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This literature marketed report has been received from the authors in a published literature article, entitled as stated below and referred to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, dose, anatomical Location, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced anaphylaxis. At the time of reporting, the outcome of the event anaphylaxis was unknown. The action taken with zoster vaccine live (ZOSTAVAX)regarding anaphylaxis was as not Applicable.   The causality between anaphylaxis and zoster vaccine live (ZOSTAVAX) was assessed as related.   Upon internal review, the event anaphylaxis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Lot number is being requested and will be submitted if received.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any adverse issues or side effects from the administered dose of GARDASIL 9; A HCP called to report that his data logger in his vaccine refrigerator quit working on 03/08/2024, but was not realized and reset until 05/31/2024, which resulted in unknown temperature condition exposure to the vaccines.  A dose of GARDASIL 9 affec; This spontaneous report was received from nurse and refers to an 11-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-MAY-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, lot #W028349, expiration date: 07-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). It was reported that data logger in vaccine refrigerator quit working on 08-MAR-2024, but it was not realized until 31-MAR-2024, which resulted in unknown temperature excursion to the vaccine. On 13-MAY-2024, the vaccine which underwent temperature excursion was inadventely administered to a patient (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HBP calling. VAXELIS and ROTATEQ were administered following a TE. See TE case. No additional AE/No PQC.; This spontaneous report was received from Other and referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and drug allergies/reactions were not reported.  On 04-JUN-2024, the patient was vaccinated with improperly stored of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7536AA, expiration date: 30-SEP-2025, (strength, dose, and route of administration were not provided); and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1965643, expiration date: 05-OCT-2024, administered orally (strength and dose not provided) (product storage error); both vaccines administered for prophylaxis by health professional. These vaccines were exposed to temperature excursion (TE) on an unknown date. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure / got the shingles; Got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure / got the shingles) (serious criteria GSK medically significant) and shingles (Verbatim: 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. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAY-2024 This case was reported by a patient via interactive digital media. The patient reported that he/she had the same thing but the patient thought it would have been worse without it. 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 a listed event which is considered related to GSK vaccine Shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-MAY-2024 The reporter needed a guidance for a patient who received a third dose of Shingrix, which led to extra dose administered. The patient already completed the two dose series. The reporter consented to follow up.