chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: pt states she initially had some itching but then a red welp developed at the injection site that is warm to the touch. It is 2 inches wide and 3 inches long.  She had chills. She contacted her doctors office and was told to apply cortisone cream to it and to come in if she continued to have any other symptoms. Today the redness is some better but it continues to be itchy and irritated so she is still using the cortisone cream.
Age: 74.0
Sex: F
Vaccine: PNC21
Symptoms: Blood test normal, CSF test normal, Chills, Magnetic resonance imaging normal, Malaise
Clinical narrative: Patient states she began feeling  "very sick" about 4 hours after administration.  She suddenly developed fever, chills, and body aches.  Fever spiked to over 103 F.  She went to local emergency department for evaluation.  She was then transported to another higher level facility to for neurology evaluation.  Had MRI, blood draw and lumbar puncture.  Pt states she was negative for guillain-barre syndrome.  Today, she is feeling better and has recovered.  She was hospitalized for 2 days.
Age: 74.0
Sex: F
Vaccine: PNC21
Symptoms: Pain, Pyrexia
Clinical narrative: Patient states she began feeling  "very sick" about 4 hours after administration.  She suddenly developed fever, chills, and body aches.  Fever spiked to over 103 F.  She went to local emergency department for evaluation.  She was then transported to another higher level facility to for neurology evaluation.  Had MRI, blood draw and lumbar puncture.  Pt states she was negative for guillain-barre syndrome.  Today, she is feeling better and has recovered.  She was hospitalized for 2 days.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Unrelated I suspect. I've barely toileted for months. And the drugs I've been taking for days don't seem to have had much affect at all so I will go to urgent care.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Pyrexia, Respiratory pathogen panel
Clinical narrative: Cough, shortness of breath, fever
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Blood test normal, Eye swelling, Headache, Joint swelling
Clinical narrative: Vaccine received on Monday evening.  On Tuesday afternoon, noticed swelling of ankles, feet, and hands.  On Wednesday morning, swelling had increased to face/eyes and increased swelling in ankles, feet, hands, and sharp headache.  Visited Urgent Care for BP check.  BP was elevated to 160/90.  Was advised to proceed to ER where I was admitted.  Received intravenous Lasix to reduce swelling and bring down BP.  Discharged from ER.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Vaccine received on Monday evening.  On Tuesday afternoon, noticed swelling of ankles, feet, and hands.  On Wednesday morning, swelling had increased to face/eyes and increased swelling in ankles, feet, hands, and sharp headache.  Visited Urgent Care for BP check.  BP was elevated to 160/90.  Was advised to proceed to ER where I was admitted.  Received intravenous Lasix to reduce swelling and bring down BP.  Discharged from ER.
Sex: M
Vaccine: FLU3
Symptoms: Cardiac arrest, Death, Fatigue, Resuscitation, Somnolence
Clinical narrative: Emergency room report received from hospital.  Pt last seen well at 4PM, mother stated baby had flu vaccine in the afternoon and was fatigued, sleeping since.  When mother checked on baby, he was unresponsive, and she called EMS.  Arrived to ED at 10:32PM.  Baby was in asystole on arrival to ED and remained throughout multiple attempts to resuscitate.  Time of death 10:55 PM
Sex: M
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: Emergency room report received from hospital.  Pt last seen well at 4PM, mother stated baby had flu vaccine in the afternoon and was fatigued, sleeping since.  When mother checked on baby, he was unresponsive, and she called EMS.  Arrived to ED at 10:32PM.  Baby was in asystole on arrival to ED and remained throughout multiple attempts to resuscitate.  Time of death 10:55 PM
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Pruritus, Urticaria
Clinical narrative: I work in the Adult Behavioral Health Unit at Hospital, where my coworker had given me the flu vaccine in my left arm at roughly 11:15 am. I went to lunch shortly after, an when I returned around noon I had noticed that I had broken out into hives on my neck, chest, and arms. Affected areas were itchy as well as my back and under my breasts. My vitals were taken right on my floor, then I was instructed to be taken downstairs to the ER where I received medication through an IV in my right arm, which cleared the affected areas. Blood was also drawn out of my right arm to be sent to the lab. I was discharged around 2:00 pm. I was prescribed prednisone for the next five days which I picked up at my pharmacy, and I am experiencing no further complications.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: None reported.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: No adverse event occurred as a result of vaccine being given. However, we acknowledge that this was an "off label" use of vaccine due to recommendation for ProQuad to only be used in children ages 12 months-12 years.
Age: 91.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered 2 flu vaccines at the same visit. No adverse effects reported/observed. patient was to get covid and flu but received 2 high dose flu vaccines
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient did not have an adverse response. Patient was to get a flu immunization and received a tdap
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Product preparation issue
Clinical narrative: syringe administered without prior mixing of vial with powder
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate increased, Intensive care, Pneumonia, Pyrexia
Clinical narrative: In 24 hours the resident developed a high fever, high heart rate and respiratory symptoms. Resident was transferred to the ED and later on admitted in the ICU with new onset AFIB and pneumonia
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory symptom
Clinical narrative: In 24 hours the resident developed a high fever, high heart rate and respiratory symptoms. Resident was transferred to the ED and later on admitted in the ICU with new onset AFIB and pneumonia
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain, decreased range of motion
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Electrocardiogram, Hypotonia, Posture abnormal, Unresponsive to stimuli
Clinical narrative: After about 15 seconds of giving him the shot, he dropped his cane, his head went back, his eyes and mouth opened and started falling to the side.  EMS was called and the paramedics arrived.  He did still had a pulse but was unresponsive.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: bruise around injection site
Age: 0.75
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product preparation issue
Clinical narrative: MA ADMINISTERED COVID BABY VACCINE WITHOUT DILUTING AND ADMINISTERED ALL 3 DOSES.  NO TREATMENT WAS REQUIRED. CLINICIAN NOTIFIED FAMILY. CHILD WAS DOING OKAY.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Coronary angioplasty, Coronary arterial stent insertion, Coronary artery occlusion, Coronary artery thrombosis, Myocardial infarction
Clinical narrative: I started to suffer blood clots in arteries and suffered heart attack so they did an angioplasty where stents were placed. However, the condition got worse and now all three arteries are severely obstructed. CURRENTLY awaiting heart bypass surgery
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: The following has happened every time I received the COVID vaccine:   Upon awakening the day after vaccine, I find I am completely unable to move my legs.  Ability to move them returns  early to mid afternoon.   I failed to report this to my doctor until recently.  Once reported, I was advised not to take the vaccine again due to concerns I my contract Epstein-Barre.   NOTE:   I had been hospitalized in March of 2020 with severe COVID infection.
Age: 1.83
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Broke out in hives all over body
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient came in requesting a flu shot and got a 2 second shot 3 months apart. He forgot the shot he had received in August 17.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Wrong patient
Clinical narrative: Patient was brought down to be vaccinated by school nurse but he was the patients brother. No adverse effects with patient.
Age: 3.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a dose of Hep B Adult vaccine. Patient's guardian was informed and advised to wait in clinic while we consulted with the medical provider on site. Provider went in to check on patient and speak to patient's guardian.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Patient calling for chronic RIGHT arm pain, limited movement, and RIGHT arm weakness. Was seen in office on 10/28/24 and continuing to have symptoms (got prednisone for concomitant respiratory infection and thus improved). Got worse after prednisone discontinued. Worse than has ever been. Pain is #8 aching, stabbing, burning, pressure. Can't do most things with RIGHT arm, needs to use LEFT arm to move RIGHT arm, cannot freely move RIGHT arrm. Is able to grasp with RIGHT hand and ROM of RIGHT lower arm is normal. Can feel the pain when using RIGHT hand, but pain is only above elbow -- not collarbone, not rotator cuff (already has issues with rotator cuff) but somewhat into shoulder.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received Covid vaccine 10/11/24 as well as 11/14/24. No s/s following administration.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body aches, headache, fatigue, chills and fever lasting 5 days
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: Swelling of foot, face and tongue throat
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, MMRV
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EFFECT
Age: 67.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blood urine present, Computerised tomogram, Urine analysis
Clinical narrative: The afternoon following vax I had bright red blood for the first 2 seconds of urination, then returned to normal. No additional occurrences.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Atrial fibrillation, Bacterial infection, Blood culture positive, Blood test abnormal
Clinical narrative: Less than 48 hours after injection, a rash appeared on the face and body. Applied cream (have had rashes before from allergies), rash would clear up and break out somewhere else. Rash became worse in the next day or two, Tues Oct 29, started with fever, nauseous and weakness. Had to go to bed with extreme headache. Wednesday and Thursday felt better but rash was spreading quickly. Thursday night, fever, weakness and headache hit again and went to bed. Friday, Nov 1 felt the same symptoms all day. Was not sleeping. Saturday woke up with face inflamed. Went to walk in clinic. Low grade fever and was told allergies and sent homand could not eat or drink with nauseous symptoms. Was swabbed for covid and many other viruses Could not find the cause of the severe rash that was now in some areas, peeling and bleeding. Given fluids for dehydration and sent home with powder for rashes. Infection was brought up but not pursued. Tuesday night Nov 5, high fever weak, couldn't walk without assistance, dizzy and nauseous and unfortunately, after 6 years clear, went into AFIB. Went back to ER. Had xrays, urine samples, blood work, blood cultures and was determined to have a severe bacterial infection/sepsis.Was admitted to hospital. No cause was ever found for this infection. I was fine and healthy before having vaccine and several doctors were going to investigate this Novavax as they had never heard of it.e with cream for rash. No relief on Sunday. Monday Nov 4, went to ER as was feeling weaker
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Condition aggravated, Decreased appetite, Dehydration, Dizziness, Gait disturbance
Clinical narrative: Less than 48 hours after injection, a rash appeared on the face and body. Applied cream (have had rashes before from allergies), rash would clear up and break out somewhere else. Rash became worse in the next day or two, Tues Oct 29, started with fever, nauseous and weakness. Had to go to bed with extreme headache. Wednesday and Thursday felt better but rash was spreading quickly. Thursday night, fever, weakness and headache hit again and went to bed. Friday, Nov 1 felt the same symptoms all day. Was not sleeping. Saturday woke up with face inflamed. Went to walk in clinic. Low grade fever and was told allergies and sent homand could not eat or drink with nauseous symptoms. Was swabbed for covid and many other viruses Could not find the cause of the severe rash that was now in some areas, peeling and bleeding. Given fluids for dehydration and sent home with powder for rashes. Infection was brought up but not pursued. Tuesday night Nov 5, high fever weak, couldn't walk without assistance, dizzy and nauseous and unfortunately, after 6 years clear, went into AFIB. Went back to ER. Had xrays, urine samples, blood work, blood cultures and was determined to have a severe bacterial infection/sepsis.Was admitted to hospital. No cause was ever found for this infection. I was fine and healthy before having vaccine and several doctors were going to investigate this Novavax as they had never heard of it.e with cream for rash. No relief on Sunday. Monday Nov 4, went to ER as was feeling weaker
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Hypersensitivity, Inflammation, Insomnia, Nausea
Clinical narrative: Less than 48 hours after injection, a rash appeared on the face and body. Applied cream (have had rashes before from allergies), rash would clear up and break out somewhere else. Rash became worse in the next day or two, Tues Oct 29, started with fever, nauseous and weakness. Had to go to bed with extreme headache. Wednesday and Thursday felt better but rash was spreading quickly. Thursday night, fever, weakness and headache hit again and went to bed. Friday, Nov 1 felt the same symptoms all day. Was not sleeping. Saturday woke up with face inflamed. Went to walk in clinic. Low grade fever and was told allergies and sent homand could not eat or drink with nauseous symptoms. Was swabbed for covid and many other viruses Could not find the cause of the severe rash that was now in some areas, peeling and bleeding. Given fluids for dehydration and sent home with powder for rashes. Infection was brought up but not pursued. Tuesday night Nov 5, high fever weak, couldn't walk without assistance, dizzy and nauseous and unfortunately, after 6 years clear, went into AFIB. Went back to ER. Had xrays, urine samples, blood work, blood cultures and was determined to have a severe bacterial infection/sepsis.Was admitted to hospital. No cause was ever found for this infection. I was fine and healthy before having vaccine and several doctors were going to investigate this Novavax as they had never heard of it.e with cream for rash. No relief on Sunday. Monday Nov 4, went to ER as was feeling weaker
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pyrexia, Rash, SARS-CoV-2 test negative, Sepsis, Skin exfoliation
Clinical narrative: Less than 48 hours after injection, a rash appeared on the face and body. Applied cream (have had rashes before from allergies), rash would clear up and break out somewhere else. Rash became worse in the next day or two, Tues Oct 29, started with fever, nauseous and weakness. Had to go to bed with extreme headache. Wednesday and Thursday felt better but rash was spreading quickly. Thursday night, fever, weakness and headache hit again and went to bed. Friday, Nov 1 felt the same symptoms all day. Was not sleeping. Saturday woke up with face inflamed. Went to walk in clinic. Low grade fever and was told allergies and sent homand could not eat or drink with nauseous symptoms. Was swabbed for covid and many other viruses Could not find the cause of the severe rash that was now in some areas, peeling and bleeding. Given fluids for dehydration and sent home with powder for rashes. Infection was brought up but not pursued. Tuesday night Nov 5, high fever weak, couldn't walk without assistance, dizzy and nauseous and unfortunately, after 6 years clear, went into AFIB. Went back to ER. Had xrays, urine samples, blood work, blood cultures and was determined to have a severe bacterial infection/sepsis.Was admitted to hospital. No cause was ever found for this infection. I was fine and healthy before having vaccine and several doctors were going to investigate this Novavax as they had never heard of it.e with cream for rash. No relief on Sunday. Monday Nov 4, went to ER as was feeling weaker
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Skin haemorrhage, Urine analysis abnormal, Viral test negative, X-ray
Clinical narrative: Less than 48 hours after injection, a rash appeared on the face and body. Applied cream (have had rashes before from allergies), rash would clear up and break out somewhere else. Rash became worse in the next day or two, Tues Oct 29, started with fever, nauseous and weakness. Had to go to bed with extreme headache. Wednesday and Thursday felt better but rash was spreading quickly. Thursday night, fever, weakness and headache hit again and went to bed. Friday, Nov 1 felt the same symptoms all day. Was not sleeping. Saturday woke up with face inflamed. Went to walk in clinic. Low grade fever and was told allergies and sent homand could not eat or drink with nauseous symptoms. Was swabbed for covid and many other viruses Could not find the cause of the severe rash that was now in some areas, peeling and bleeding. Given fluids for dehydration and sent home with powder for rashes. Infection was brought up but not pursued. Tuesday night Nov 5, high fever weak, couldn't walk without assistance, dizzy and nauseous and unfortunately, after 6 years clear, went into AFIB. Went back to ER. Had xrays, urine samples, blood work, blood cultures and was determined to have a severe bacterial infection/sepsis.Was admitted to hospital. No cause was ever found for this infection. I was fine and healthy before having vaccine and several doctors were going to investigate this Novavax as they had never heard of it.e with cream for rash. No relief on Sunday. Monday Nov 4, went to ER as was feeling weaker
Age: 81.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received a dose of Twinrix after already completing a Hepatitis B series in 2020.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Full body rash outset 1 week and one day from injection
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Echocardiogram, Electrocardiogram QRS complex shortened, Laboratory test, Myopericarditis
Clinical narrative: PFIZER #1 7/23/2021 PFIZER #2 8/13/2021 DEVELOPED SUBCLINICAL VACCINE MYOPERICARDITIS AND SINUS PAUSES WITH NARROW QRS.  ONE SYMPTOMATIC SIX SECOND PAUSE WITHOUT SYNCOPE RECORDED.   BEING CONSIDERED FOR PACEMAKER.  TREATED WITH COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus arrest
Clinical narrative: PFIZER #1 7/23/2021 PFIZER #2 8/13/2021 DEVELOPED SUBCLINICAL VACCINE MYOPERICARDITIS AND SINUS PAUSES WITH NARROW QRS.  ONE SYMPTOMATIC SIX SECOND PAUSE WITHOUT SYNCOPE RECORDED.   BEING CONSIDERED FOR PACEMAKER.  TREATED WITH COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 1.58
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt was given another dose of flu vaccine a month from initial dose for this season. Upon further review, pt already had a 2 series flu vaccine last season.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, VARCEL, COVID19, FLU3, VARCEL, COVID19, FLUX, VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: patient was given Varicella vaccine instead of the adult Shringrix. Patient has no reaction at this time.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, VARCEL, COVID19, FLU3, VARCEL, COVID19, FLUX, VARCEL
Symptoms: Wrong product administered
Clinical narrative: patient was given Varicella vaccine instead of the adult Shringrix. Patient has no reaction at this time.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, VARCEL, COVID19, FLU3, VARCEL, COVID19, FLUX, VARCEL
Symptoms: Ill-defined disorder, Pain, Wrong product administered
Clinical narrative: patient was given Varicella vaccine instead of the adult Shringrix. Patient has no reaction at this time.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Gastrointestinal disorder, Mast cell activation syndrome, Rash, Urticaria
Clinical narrative: Few days post vaccine, full body welts/ rashes that required E.R visit in order to reduce symptoms. Visited allergist and was placed on full cycle of allergy medicines, continues to be unresolved. Unable to discontinue allergy meds due to mast cell disruption from vaccine continues to affect bowel and welts of body.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: New onset seizures
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness, warmth, tender, soreness to raise left arm around injection site
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose of Hepatitis B vaccine given to adult who should have received adult dose of Hepatitis B vaccine.
Age: 23.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: A few minutes following vaccination patient temporarily lost consciousness and collapsed. He regained consciousness quickly but when he attempted to stand again after a few more minutes it happened again. Vitals in normal range but EMS was called. After initial evaluation from paramedics, he tried to stand again and had a repeat episode and was brought to hospital for evaluation and continued monitoring.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP, HIBV, HIBV, PNC20, PNC20
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Child was found non responsive 0400 and EMS was Called and transported to Hospital. He passed and was pronounced dead on 1114/2024 @  0522.  It is undertimed at this time  what the cause of death is. The Child recieved the vaccines on the day befoe At 3:15pm  11/13/2024
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Shingrex vaccine given. 3-4 hours after vaccine patient noticed localized swelling, erythema. Then developed hives, present for 6 days at time of first encounter
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Balance disorder, Burning sensation, Chest pain, Chills
Clinical narrative: panic attacks started the very next day, extreme fatigue, tingling and burning sensation in feet, legs, chest, and right ear. Upper back hurting, chills, balance is off, extremely high blood pressure despite being on medication for blood pressure. I constantly feel like my insides are shaking. This has been occuring for 3 1/2 weeks. I've lost 1 1/2 pounds.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Ear discomfort, Fatigue, Hypertension, Nervousness, Paraesthesia
Clinical narrative: panic attacks started the very next day, extreme fatigue, tingling and burning sensation in feet, legs, chest, and right ear. Upper back hurting, chills, balance is off, extremely high blood pressure despite being on medication for blood pressure. I constantly feel like my insides are shaking. This has been occuring for 3 1/2 weeks. I've lost 1 1/2 pounds.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Weight decreased
Clinical narrative: panic attacks started the very next day, extreme fatigue, tingling and burning sensation in feet, legs, chest, and right ear. Upper back hurting, chills, balance is off, extremely high blood pressure despite being on medication for blood pressure. I constantly feel like my insides are shaking. This has been occuring for 3 1/2 weeks. I've lost 1 1/2 pounds.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site paraesthesia, Injection site reaction, Skin disorder
Clinical narrative: Injection site , skin broken, patient complainng to pain at site and tingling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness around injection site, itch on arm, most severe during the night improving the next day
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain
Clinical narrative: Injection site got very sore one week after receiving the shot and then my entire arm turned very black and blue, the bruising took over one month to heal.  My prior Covid shots were Pfizer, and this was Moderna.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Tachycardia
Clinical narrative: Patient experienced diaphoresis and tachycardia within 5 minutes of vaccination, resolved within 15 minutes with rest and ice packs.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Impaired driving ability, Injection site haemorrhage, Mobility decreased, Myalgia
Clinical narrative: Patient reports ongoing muscle soreness, joint pain in the shoulder with limited range of motion.  She states it is difficult to move her arm up and down.  Driving long distance fatigues her arm which was not a problem prior to getting vaccination.  She claims she bled quite a bit after the vaccination and that had "never happened before." She talked to her provider but patient states the MD did not do anything about her concerns.  Encouraged patient to reach out again.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3, UNK
Symptoms: Arthralgia, Arthritis, C-reactive protein increased, Myalgia
Clinical narrative: Developed painful, inflamed joints & muscles 2-3 days after vaccination
Age: 36.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain in extremity, Paraesthesia
Clinical narrative: 11/08/24-pt reported immediate pain and numbness in left arm right after flu shot to relief pharmacist. pharmacist reported to pharmacy manager later of the day. multiple calls to patient for follow up but was unsuccessful of the day. 11/13/24, pt came back and complained the radiating pain and numbness was still there in the left arm along with coldness. The injection site seemed to be close to the shoulder, and more inward (toward center of the body) than on the side of the arm. 11/14/24, pharmacy manager spoke to patient and confirmed pain was still there in lower part of the arm and tingling feelings in fourth and fith fingers. no fever or other systemic symptoms
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Blindness unilateral, Blood test normal, Computerised tomogram normal, Facial paralysis, Hyperventilation
Clinical narrative: 9 days after the flu mist, neurological problems, blurred vision, blindness in one eye, paralysis on right side of face neck and arm, vomiting, hyperventilating, migraine.  He tested positive for Mono and Strep Throat.    One month after flu mist, same exact issues happened.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Laboratory test, Magnetic resonance imaging normal, Migraine, Mononucleosis heterophile test positive, Monoplegia
Clinical narrative: 9 days after the flu mist, neurological problems, blurred vision, blindness in one eye, paralysis on right side of face neck and arm, vomiting, hyperventilating, migraine.  He tested positive for Mono and Strep Throat.    One month after flu mist, same exact issues happened.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Nervous system disorder, Paralysis, Streptococcus test positive, Vision blurred, Vomiting
Clinical narrative: 9 days after the flu mist, neurological problems, blurred vision, blindness in one eye, paralysis on right side of face neck and arm, vomiting, hyperventilating, migraine.  He tested positive for Mono and Strep Throat.    One month after flu mist, same exact issues happened.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 1-2 days after vaccine administered, patient noticed a non painful, non pruritic rash: small scattered flesh colored papules on bilateral upper arms, left flank, and posterior shoulders.  It is slowly resolving and there are no new lesions.
Age: 41.0
Sex: F
Vaccine: COVID19, FLU3, TDAP
Symptoms: Chest pain, Computerised tomogram thorax normal, Echocardiogram normal, Lymphocyte percentage decreased, Neutrophil percentage increased
Clinical narrative: On 10/9 I began having dull chest pain. I went to the ER on 10/13 as it was persisting and increasing in severity. I was diagnosed with pericarditis, and have been in treatment for that since.
Age: 41.0
Sex: F
Vaccine: COVID19, FLU3, TDAP
Symptoms: Pericarditis, Scan with contrast normal
Clinical narrative: On 10/9 I began having dull chest pain. I went to the ER on 10/13 as it was persisting and increasing in severity. I was diagnosed with pericarditis, and have been in treatment for that since.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: NO ADVERSE REACTIONS REPORTED BUT PATIENT RECIEVED AN UNDILUTED DOSE OF THE ENTIRE VIAL CONTENT PFIZER VACCINE AGE  3-4
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: NO ADVERSE REACTIONS NOTED BUT PATIENT RECIEVED AN UNDILUTED DOSE OF THE ENTIRE VIAL CONTENT PFIZER VACCINE AGE  3-4
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: arm pain, decreased ROM since vaccine. Has seen PMD, and ortho.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Flushing, Nausea, Skin burning sensation
Clinical narrative: Patient presented to pharmacy for first shingrix immunization. Shortly after the immunization, patient reported feeling flushed and stated that her face felt "like it was on fire". Patient also reported nausea and dizziness but denied any difficulty breathing or swelling. Pharmacist checked blood pressure in store at 167/87 -- patient admits to taking high blood pressure medication but her reading was 'normal' at her doctor's appointment earlier today. Patient has not had any reactions to any other vaccines in the past. Patient's symptoms progressed to itching in the arms so she agreed to a dose of Benadryl. Patient failed to improve so EMS was called for further evaluation. Blood pressure taken by EMS was 180 / 86 and they transported patient away from pharmacy for further care. Patient only  uses this pharmacy for acute needs so her full medication list and medical history is not immediately available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient presented to pharmacy for first shingrix immunization. Shortly after the immunization, patient reported feeling flushed and stated that her face felt "like it was on fire". Patient also reported nausea and dizziness but denied any difficulty breathing or swelling. Pharmacist checked blood pressure in store at 167/87 -- patient admits to taking high blood pressure medication but her reading was 'normal' at her doctor's appointment earlier today. Patient has not had any reactions to any other vaccines in the past. Patient's symptoms progressed to itching in the arms so she agreed to a dose of Benadryl. Patient failed to improve so EMS was called for further evaluation. Blood pressure taken by EMS was 180 / 86 and they transported patient away from pharmacy for further care. Patient only  uses this pharmacy for acute needs so her full medication list and medical history is not immediately available.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Formication
Clinical narrative: Feeling of spider web on the right side of my face. I keep swiping at it because it feels like something is there. Also, my balance is off.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Rash macular, Urticaria, Wheezing
Clinical narrative: Red splotchy rash on arm, upper chest and right knee with some hives noted, later developed new wheezing
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY WITH REDNESS AND SWELLING ON HER LEFT ARM WHERE SHE GOT HER FLU SHOT. THE AREA WAS HOT TO THE TOUCH. THE AREA WAS SMALL (PALM SIZE). SHE WAS ADVISED TO CONTINUE IBUPROFEN TO HELP WITH THE SWELLING. ALSO TO ICE THE AREA AND TAKE A NON DROSWY CLARITIN IN THE DAY TIME. SHE WAS NOT SEEN BY A PROVIDER OR HOSPTIAL AT THIS TIME. SHE WAS TOLD TO MONITOR THE AREA AND ADVISED TO BE SEEN BY A DOCTOR IF RASH WORSENS.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report as received from a medical assistant refers to a 69-year-old male patient.  Pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies included influenza vaccine (INFLUENZA TRIVALENT VACCINE).  On 18-OCT-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (lot # W029533, expiration date: 07-OCT-2024; dose and route of administration not provided) (expired product administered). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD was administered following TE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-OCT-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #Y009348, expiration date reported as and upon internal review confirmed to be: 11-NOV-2025, administered for prophylaxis (dose, route and vaccination site of administration were not provided). A temperature excursion (TE) was noted and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered following TE (improper storage of product in use). No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).; Sender's Comments:  US-009507513-2411USA001696:MSD
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injury associated with device, No adverse event, Syringe issue
Clinical narrative: No additional AE; HCP calling to report that during administration of VARIVAX vaccine, the STERILE DILUENT PFS leaked out around the luer lock.  Per HCP, no cracks or other defects noted with STERILE DILUENT PFS so she is not sure why the product leaked out.  Patient; HCP calling to report that during administration of VARIVAX vaccine, the STERILE DILUENT PFS leaked out around the luer lock.  Per HCP, no cracks or other defects noted with STERILE DILUENT PFS so she is not sure why the product leaked out.  Patient; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-OCT-2024, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, single dose, lot #1973285, expiration date: 15-OCT-2026, administered for prophylaxis (strength, and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). During administration of varicella virus vaccine live (oka/merck) (VARIVAX) vaccine, the sterile diluent (BAXTER STERILE DILUENT) leaked out around the luer lock. No cracks or other defects noted with sterile diluent (BAXTER STERILE DILUENT) so the reporter was not sure why the product leaked out (syringe issue, poor quality device used). The patient did not get first dose due to leak, so reporter drew up a second dose and administered without issue on second attempt. The patient received unnecessary needle stick due to leakage. No adverse effects reported (no adverse event). The size and gauge of the needle was reported as 25g 5/8 in.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event was reported; Medical Assistant calling to report adverse event regarding improperly stored and administered VAQTA.  Medical Assistant stated that the supply of VAQTA at their facility was exposed to temperature excursions beginning in May 2024 and the product was; This spontaneous report was received from administrator and refers to patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-SEP-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #Y007585, expiration date: 31-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion from May 2024 (Product storage error). No additionad adverse event was reported.
Age: 23.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional adverse event was reported; HCP calling to get information on PROQUAD;  HCP stated a male, adult patient inadvertently received  PROQUAD instead of MMR II today on 11/11/2024. No other information was provided or known by HCP.  No side effects reported.  No additional AE report; This spontaneous report was received from registered nurse and refers to a 23-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-NOV-2024, the patient was inadvertently vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, one dose, 1st dose, lot #Y011210, expiration date: 18-DEC-2025, administered for prophylaxis (strength, and route of administration were not provided); instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Wrong product administered). No additional adverse event was reported.
Age: 39.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event.; Pharmacist called to report a male patient, 39 years old, received first dose of GARDASIL 9 on 4/19/2024, and now received second dose on 10/14/2024. Pharmacist inquiring about recommendations to continue with series after an interrupted schedule.; This spontaneous report has been received from a Pharmacist regarding a 39-year-old male patient.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 19-APR-2024, 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) and on 14-OCT-2024, he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), both injection, prefilled syringe, 0.5 ml/2 doses of 3 doses, administered for prophylaxis (lot number X024650 has been verified to be a valid number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) [GARDASIL 9], expiration date 31-MAY-2026, (anatomical site of injection and route of administration were not provided for any of the vaccines) (Inappropriate schedule of product administration).   No additional adverse event was reported for the patient.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally given instead of Varicella vaccine; 30 years old patient received Shingrix; This non-serious case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 30-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Varicella zoster vaccine (Varicella vaccine) for prophylaxis.   On 17-OCT-2024, the patient received the 1st dose of Shingrix (unknown deltoid). On an unknown date, the patient did not receive Varicella vaccine. On 17-OCT-2024, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: accidentally given instead of Varicella vaccine) and inappropriate age at vaccine administration (Verbatim: 30 years old patient received Shingrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 17-OCT-2024 The reporter reported that the patient received the first dose of shingrix vaccine accidentally given instead of Varicella vaccine and had no adverse event other than wrong vaccine given, which led to wrong vaccine administered. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: RVX, RVX, RVX
Symptoms: Extra dose administered, Mobility decreased, Pain in extremity, X-ray
Clinical narrative: patient can not lift arm; arm hurt; got the three vaccines of RSV; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis and RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of RSV vaccine, the 2nd dose of RSV vaccine and the 1st dose of RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, RSV vaccine and RSV vaccine, the patient experienced mobility decreased (Verbatim: patient can not lift arm), pain in arm (Verbatim: arm hurt) and extra dose administered (Verbatim: got the three vaccines of RSV). The outcome of the mobility decreased and pain in arm were not reported and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the mobility decreased and pain in arm to be related to RSV vaccine, RSV vaccine and RSV vaccine.     It was unknown if the company considered the mobility decreased and pain in arm to be related to RSV vaccine, RSV vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 15-OCT-2024 The case was received from the patient via interactive digital media. The patient was reporter. The patient got the three vaccines and left arm  is very bad, patient also can not lift arm, it hurts too much. The reported that the patient received extra doses of RSV vaccine, which led to extra dose administered. The reported that the patient had already been two kisses.  At the hospital they did an X-ray and they stated that patient have nothing but they can not lift arm and a person told to patient that it was the vaccines.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: rash was located from hips to forehead, chest and back.; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash trunk in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-OCT-2024, the patient received the 1st dose of Shingrix (right arm) .5 ml. In OCT-2024, less than a month after receiving Shingrix, the patient experienced rash trunk (Verbatim: rash was located from hips to forehead, chest and back.). On an unknown date, the patient experienced shingles (Verbatim: patient stated that she was positive it was Shingrix). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the rash trunk was resolved (duration 48 hrs) and the outcome of the shingles was unknown.   It was unknown if the reporter considered the rash trunk and shingles to be related to Shingrix.     It was unknown if the company considered the rash trunk and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-OCT-2024 Reporter was the patient who received the dose of Shingrix and reported a rash on her upper body for 24 hours after receiving suspect vaccine.  The reporter stated that rash was located from hips to forehead, chest and back.  The patient took Benadryl for the rash, and it resolved in 48 hours.  The reporter stated that she had this rash before from an allergic reaction and her doctor thought she might be allergic to something in the vaccine.  Patient stated that her doctor had recommended that she did not get the second dose of the vaccine series.  However, patient stated that she was positive it was Shingrix.
Sex: F
Vaccine: FLU4
Symptoms: Hyperacusis, Tinnitus
Clinical narrative: she began experiencing tinnitus and noted that loud sounds were heightened.; This non-serious case was reported by a consumer via call center representative and described the occurrence of tinnitus in a adult female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2024-2025 season) for prophylaxis.   On 09-OCT-2024, the patient received Fluarix Quadrivalent 2024-2025 season. On 09-OCT-2024, 2 hrs after receiving Fluarix Quadrivalent 2024-2025 season, the patient experienced tinnitus (Verbatim: she began experiencing tinnitus and noted that loud sounds were heightened.). On 10-OCT-2024, the outcome of the tinnitus was resolved (duration 1 day).   It was unknown if the reporter considered the tinnitus to be related to Fluarix Quadrivalent 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the tinnitus to be related to Fluarix Quadrivalent 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.   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: 15-OCT-2024 The patient was the reporter. The reporter reported that she received the 2024-2025 Fluarix vaccine (the product search did not offer this option) and began experiencing tinnitus and noted that loud sounds were heightened. The reporter did not consent to follow-up.