chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Malaise, Nausea, Parosmia, Pyrexia
Clinical narrative: As usual, I was sick with fever and headache within hours of vaccine. Approximately 24 hours after vaccine I started having serious chest pain. After 5-10 minutes of chest pain I got up to find some relief and was quickly weak, sweaty, felt nauseous and faint on top of the severe chest pain. Sat down and held the wall to keep from toppling over. The worst lasted maybe less than 5 minutes. Felt bad another 10 - 15 minutes, and then it was over. I have had no symptoms since, however I'm not inclined to get another COVID vaccine after that experience. Doctor didn't think enough of it to even suggest what it might have been. First vaccine, no reaction. Each vaccine following was sick for at least 1 day, lingered for 2-3 days. All Pfizer except 4th which was Moderna. Developed phantom smoke smell within 24 hours of 4th vaccine, took over 1/2 year for that to go away. Still notice the smoke smell occasionally but I take COVID tests to make sure it isn't COVID. I've never tested positive for COVID.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative
Clinical narrative: As usual, I was sick with fever and headache within hours of vaccine. Approximately 24 hours after vaccine I started having serious chest pain. After 5-10 minutes of chest pain I got up to find some relief and was quickly weak, sweaty, felt nauseous and faint on top of the severe chest pain. Sat down and held the wall to keep from toppling over. The worst lasted maybe less than 5 minutes. Felt bad another 10 - 15 minutes, and then it was over. I have had no symptoms since, however I'm not inclined to get another COVID vaccine after that experience. Doctor didn't think enough of it to even suggest what it might have been. First vaccine, no reaction. Each vaccine following was sick for at least 1 day, lingered for 2-3 days. All Pfizer except 4th which was Moderna. Developed phantom smoke smell within 24 hours of 4th vaccine, took over 1/2 year for that to go away. Still notice the smoke smell occasionally but I take COVID tests to make sure it isn't COVID. I've never tested positive for COVID.
Age: 58.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Asthma, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: 1) Ongoing moderate  pain, sore arm, swelling at injection site - 1 hour post- injection. 2) Mild  nausea - immediately post- injection,  lasted 5-10 minutes  3) Ongoing fatigue , muscle pain throughout body, headache -  2-3 hours post- injection. 4) Asthma flare - started late evening  post- injection. Ongoing. Used rescue inhaler in am
Age: 58.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea
Clinical narrative: 1) Ongoing moderate  pain, sore arm, swelling at injection site - 1 hour post- injection. 2) Mild  nausea - immediately post- injection,  lasted 5-10 minutes  3) Ongoing fatigue , muscle pain throughout body, headache -  2-3 hours post- injection. 4) Asthma flare - started late evening  post- injection. Ongoing. Used rescue inhaler in am
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Malaise, Oxygen saturation decreased, Pneumonia
Clinical narrative: Pt received Prevnar 20 and Arexvy on 11/17/2023 and became very sick over the weekend and had trouble breathing, and was then admitted to the hospital a couple days later. Pt says her O2 keeps dropping. Pt says she was diagnosed with pneumonia and states that she feels it is from the vaccine. Pt on 11/24 states that she is starting to feel a little bit better
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Patient developed a black and blue circular mark at the vaccine site that hasn't gone away after 2+ weeks.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test normal, Electrocardiogram abnormal, Hypertension, Ventricular extrasystoles
Clinical narrative: 170/90 high blood pressure 85-90 heart beats per minute Serious PVC (Premature ventricular contractions), 1 PVC every 3 heart beats, >20 in a minutes. Weakness in general. Rush to Hospital for Emergency care. Hospitalized for 1 day.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Neuralgia, Pain in extremity, Pelvic pain, Sacral pain
Clinical narrative: Extreme pain nerves sacrum, pelvis, legs, spine
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Spinal pain
Clinical narrative: Extreme pain nerves sacrum, pelvis, legs, spine
Age: 92.0
Sex: M
Vaccine: FLUA4, FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: flu shot given twice to same patient. On 8/29/2023 patient came in asking for a flu shot. he received one. Then on 9/16/2023, patient came in and asked for a flu shot. by mistake he received another one.  The system fast tracked right over the rejection from the insurance. The rph on duty wasn't given the opportunity to see the rejection. Over the last month, we tried to reach the patient so determine the clinical status, left multiple messages to call the pharmacy back. We finally were able to reach the patient on 11/26/2023. Patient states he is fine. No reaction from either vaccine. Thanks us for calling. Patient is now aware he only needs one flu shot per each flu season .
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: Increased spread of plaque psoriasis to scalp from prior foot location
Age: 5.75
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discharge, Fatigue, Insomnia, Pain
Clinical narrative: 11/22 Body aches during the night 11/23 Fatigue 11/24 unusual fatigue in evening, difficulty sleeping, fever, chills, congestion during the night 11/24 fever and fatigue all day 11/25 same 11/26 fever but milder. lots of congestion/drainage
Age: 5.75
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: 11/22 Body aches during the night 11/23 Fatigue 11/24 unusual fatigue in evening, difficulty sleeping, fever, chills, congestion during the night 11/24 fever and fatigue all day 11/25 same 11/26 fever but milder. lots of congestion/drainage
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PT IS 60 Y/O AND I ADMIN THE FLUZONE HD. I WAS IN A HURRY, THINKING ABOUT THE RSV VACCINE BEING 60+, NOT THE FLUZONE BEING 65+ AND MADE A MISTAKE. SHE SHOULD HAVE HAD THE REGULAR FLUZONE. SO I CALLED HER WHEN I REALIZED MY MISTAKE, NO REPERCUSSIONS FOR HER AT THAT TIME.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitis
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Magnetic resonance imaging normal, Mobility decreased, Muscular weakness, X-ray normal
Clinical narrative: Patient received the shingrix vaccine on 11/7/2023. At 3 AM the next day, patient got out of bed and her legs gave out. She fell to the ground and could not move her arms. She was on the ground for 35 minutes.
Age: 73.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Blood glucose decreased, Diabetic coma, Thinking abnormal
Clinical narrative: Patient states that she normally keeps a journal where she writes up her normal daily activities. She says that after the vaccine was given, when she got in the taxi to return home, she started writing what she calls "insane" things in her journal, things she described as jibber jabber and random scribbles. She says that during that evening she went into a diabetic coma. Her daughter found her and took her to the hospital. Her blood sugar had gotten as low as 32.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I ADMIN THE SHOT TO HIM AND HE LEFT, I WAS THINKING HE WAS APPROPRIATE BUT I REALIZED IN MY HURRY I HAD BEEN THINKING 60+ WAS OK AND ITS 65+ FOR THE HD.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Culture wound, Debridement, Injection site bruising, Injection site necrosis
Clinical narrative: small bruise at injection site progressed to large bruise, hot and swollen site, progressed to large necrotic tissue area.  The progression took approximately 3-4 weeks.  The area become extremely sore, pain up 8/10 .  Notified PC physician at about 2 weeks at which time I took a 7 day course of Bactrim 800/160MG.  No visible improvement,  continued pain.  Went to ER..  (Dr.).  Prescribed a 7 day course of cephalexin 500 MG,  x-rays taken, blood work done.  ER doctor also prescribed wound care therapy for debridment.  Being seen by Dr at wound care
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Wound treatment, X-ray
Clinical narrative: small bruise at injection site progressed to large bruise, hot and swollen site, progressed to large necrotic tissue area.  The progression took approximately 3-4 weeks.  The area become extremely sore, pain up 8/10 .  Notified PC physician at about 2 weeks at which time I took a 7 day course of Bactrim 800/160MG.  No visible improvement,  continued pain.  Went to ER..  (Dr.).  Prescribed a 7 day course of cephalexin 500 MG,  x-rays taken, blood work done.  ER doctor also prescribed wound care therapy for debridment.  Being seen by Dr at wound care
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Patient had rash, swelling, redness on both legs. Started 48 hours after receiving vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient blacked out and fainted approximately 2 minutes after vaccine was given. Was not told to stay for 10-15 minutes by pharmacist
Age: 37.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: An itchy rash developed on my front torso (lower chest to upper abdomen area). Rash presented as small red dots or hives in a horizontal stripe across the torso. I got the vaccine on a Friday; symptoms began two days afterward (Sunday), and began to subside about 5 days later (next Friday). As of today the rash and itching has mostly cleared up (7 days after the rash appeared, 9 days after the vaccine).
Age: 79.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Cardioversion
Clinical narrative: patient says he ended up in the hospital and had to have a cardioversion on the26th of october and that he had no previous history of heart related problems.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient has developed shingles rash on her body as per her doctor.
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope and patient regained consciousness within a minute
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ocular hyperaemia
Clinical narrative: very bloodshot eye.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Eye disorder
Clinical narrative: very bloodshot eye.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ocular hyperaemia
Clinical narrative: eye related side effect patient is also encouraged to report
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Eye disorder
Clinical narrative: eye related side effect patient is also encouraged to report
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: The patient was administered one whole, undiluted vial of Pfizer COVID-19 for individuals 6 months to 4 years of age on 11/26/2023 at around 11:45am. The parents were contacted after a few hours and did not report any adverse events.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Cough, Fatigue, Feeling hot, Headache
Clinical narrative: Symptoms started 12 hours post injections on Thursday 11/24:  headaches, aching muscles, chills, fatigue, hot spells, runny nose and cough.  Coughing, runny nose and feeling fatigued continue. Reporting on day 4 and symptoms continue.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Myalgia, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: Symptoms started 12 hours post injections on Thursday 11/24:  headaches, aching muscles, chills, fatigue, hot spells, runny nose and cough.  Coughing, runny nose and feeling fatigued continue. Reporting on day 4 and symptoms continue.
Age: 85.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: After getting her Fluad shot on 11/22/2023, patient developed cellulitis with redness starting at the injection site. The redness continued to move down her arm and patient went to seek medical attention on Friday. Patient was diagnose with cellulitis and prescribed an antibiotic.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Chalazion, Cough, Dysphonia, Laryngitis
Clinical narrative: Chalazion on right eyelid Laryngitis and deep, hoarse cough - unproductive
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Dyskinesia, Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Jerking of entire body on the night of the vaccine. Sore swollen arm hot to touch for about 5 days. Still sore to touch as of 11/25/2023 when event was reported.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Peripheral swelling, Ultrasound scan normal
Clinical narrative: My right leg became mildly swollen and this lasted for about a week.  Primary care doctor had me seen by her nurse practitioner and she referred me to have an ultrasound to see if there was a blood clot.  This was taken about a week after symptoms started and no clot was found.  The leg returned to normal about 10 days after onset of symptoms. I self prescribed a regular aspirin every 12 hours in case a clot was present. Please note that the pharmacist noted the incorrect injection site.  It was right arm, not left.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eye irritation, Eye pain, Feeling abnormal, Headache
Clinical narrative: I?ve had all my current Pfizer Covid-19 shots and I never experienced nothing I was always fine but When I got the new fall 2023 Pfizer BioNTech shot on November 8th 2023 as soon as the nurse shot me in my left arm about 15 minutes later my mom told me my eyes were very red as if I had been crying but I didn?t know I couldn?t feel anything. But once I got home after 30mins later my eyes started to burn and I Started to feel this burning sensation from my shoulders up to my head and I started to not feel right. From there on I started itching all over and my eyes started hurting and feeling like something was in both eyes. Day 2 I woke up with all those symptoms plus my eyes were blurry and I started to feel a bad headache so I went to my primary doctor he prescribed me some eye drops and steroids but he forgot to put my medicine in to my pharmacist so I had to go the entire weekend without anything and the symptoms kept getting worse I believe I was having a allergic reaction to the Pfizer Covid 19 shot because I was perfectly fine prior to getting it. I ended up going to my eye doctor they said my eyes were fine. But i was still having symptoms so I went to the ER and they gave me Motrin and steroids to take for 6 days to see if that will help with allergic reaction and now I feel better than I did so I think the steroids helped me I hope I continue to get back completely normal.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pruritus, Vision blurred
Clinical narrative: I?ve had all my current Pfizer Covid-19 shots and I never experienced nothing I was always fine but When I got the new fall 2023 Pfizer BioNTech shot on November 8th 2023 as soon as the nurse shot me in my left arm about 15 minutes later my mom told me my eyes were very red as if I had been crying but I didn?t know I couldn?t feel anything. But once I got home after 30mins later my eyes started to burn and I Started to feel this burning sensation from my shoulders up to my head and I started to not feel right. From there on I started itching all over and my eyes started hurting and feeling like something was in both eyes. Day 2 I woke up with all those symptoms plus my eyes were blurry and I started to feel a bad headache so I went to my primary doctor he prescribed me some eye drops and steroids but he forgot to put my medicine in to my pharmacist so I had to go the entire weekend without anything and the symptoms kept getting worse I believe I was having a allergic reaction to the Pfizer Covid 19 shot because I was perfectly fine prior to getting it. I ended up going to my eye doctor they said my eyes were fine. But i was still having symptoms so I went to the ER and they gave me Motrin and steroids to take for 6 days to see if that will help with allergic reaction and now I feel better than I did so I think the steroids helped me I hope I continue to get back completely normal.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: Positional Vertigo.  Standing when tilting head up or down.  Laying on back when tilting head to the side.  Vertigo ceases shortly after correcting position of head.  Positional Vertigo remained for 6 months before no longer present.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: Positional Vertigo.  Standing when tilting head up or down.  Laying on back when tilting head to the side.  Vertigo ceases shortly after correcting position of head.  Positional Vertigo remained for 6 months before no longer present.
Age: 52.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Back pain, C-reactive protein normal, Loss of personal independence in daily activities, Red blood cell sedimentation rate normal, Sacral pain
Clinical narrative: SpikeVax and Flucelvax  Sudden onset of severe Back/Sacro-Iliac joint pain.  The pain was 7-8/10 (behind giving birth without anesthesia) I am a very active person/Pediatrician and in 2 days I was unable to tie my shoes or put on socks.  On day 3-4 I went to my PCP and got a 5 day course of steroids.  I am now almost completely back to my normal functioning 1 week later with just a small amount of back pain remaining. I am not sure if this is due to the vaccine. However, the strange thing is my husband and I , experienced the exact same sudden onset of severe back pain 1 week apart and we got the vaccines on the same day.  He is currently having difficulty walking due to pain that came on suddenly 2 days ago (only his shingles pain last year was worse)
Age: 51.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Back pain, Gait disturbance, Loss of personal independence in daily activities, Urine analysis normal
Clinical narrative: SpikeVax and Flucelvax given the same day.  Not sure if symptoms are due to the vaccine. Sudden onset of low back pain getting progressively worse over 4 days.  Now difficulty walking due to pain but not having weakness.  Seems to be in the L4/L5 distribution.  No known strain or injury.  Function now completely different from baseline. Wife had exact same symptoms 1 week prior in the S1 area with completely different from baseline (eg could not tie shoes or walk or sit without pain but no weakness).  She got a 5 day course of steroids and is now back to normal 1 week later.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Erythema, Mechanical urticaria, Pruritus
Clinical narrative: 2 weeks after receiving the Moderna Spivax booster I developed severe redness, burning and itching in the palms of both hands. A few days layer, my entire body erupted with Dermatographia and has never gone away. I visited my primary care and then an allergist. Ive been taking 180 mg of Allegra daily. It helped at first but is no longer helping , 2 months later.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Meniere's disease, Vertigo
Clinical narrative: Meniers flair. Severe vertigo and dizziness for 8 hours.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blood glucose normal, Eye movement disorder, Feeling abnormal, Loss of consciousness, Syncope
Clinical narrative: Patient stood to let her brother sit for his vaccines, as he was being prepared, she reached out to me, said she didn't feel right, and promptly fainted, luckily bottom first and I caught her arms so she didn't hit her head. She came to in a short time. Once she was feeling better and had been able to sit up for awhile, I assisted her to a nearby chair. She sat and pretty quickly her eyes rolled back and she lost consciousness again. We moved her to a side lying position and she came to. We gave her something to drink and called for an ambulance. By the time the EMTs arrived, she was starting to act like herself. While they checked her out she moved herself back into the chair, drank some more, and her BP, O2 and blood sugar all measured in the normal range for her age and gender.
Age: 0.83
Sex: M
Vaccine: PNC13, UNK, UNK, UNK, UNK
Symptoms: Lethargy, Mobility decreased
Clinical narrative: Borderline lethargic, limited movement of arms and face, not moving legs or body for 16 hours. This extremely active 10 month old was acting like he did at 2 months old. After 16 hours he finally started crawling slowly and it wasn't until the day after that that he was back to normal activity, movement, climbing, crawling, assisted walking, sitting up, etc.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Left arm rash/ redness, swelling of injection site with redness, warm to the touch within 24 hours. Subjects temperature low grade fever (98.9-99.6). Day two itchy skin at site with similar redness/rash and swelling.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Left arm rash/ redness, swelling of injection site with redness, warm to the touch within 24 hours. Subjects temperature low grade fever (98.9-99.6). Day two itchy skin at site with similar redness/rash and swelling.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough
Clinical narrative: Harsh cough
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Sore throat, cough, runny nose, fever
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Ultrasound scan
Clinical narrative: Small for Dates Baby; Foetal exposure during pregnancy; This spontaneous report was received from an other health professional referring to a female new baby whose mother a 41-year-old female patient. The patient's concurrent condition, medical history, and concomitant medications were not reported.   On 13-JUL-2023, the mother was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, administered intramuscularly for prophylaxis (strength, dose, lot #, and expiry date were not provided) (foetal exposure during pregnancy). The mother was expecting to deliver on 17-AUG-2023 (date of last menstrual period (LMP) was 10-NOV-2022) (The mother's details were captured in # 2307USA009014). On 38.2 weeks of gestation age, the patient was born by vaginal birth after cesarean (VBAC). The birth weight was 5 lbs 6.1 oz (2440.894 g) (small for dates baby). The Apgar score was 9 at 1 min, 9 at 5 min. There were no neonatal problems or congenital anomalies. The baby was normal. At the reporting time, the outcome of small for dates baby was not reported. the action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable.  The causality between small for dates baby and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.; Sender's Comments:  US-009507513-2307USA009014:mother case
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Small for dates baby
Clinical narrative: Small for Dates Baby; Foetal exposure during pregnancy; This spontaneous report was received from an other health professional referring to a female new baby whose mother a 41-year-old female patient. The patient's concurrent condition, medical history, and concomitant medications were not reported.   On 13-JUL-2023, the mother was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, administered intramuscularly for prophylaxis (strength, dose, lot #, and expiry date were not provided) (foetal exposure during pregnancy). The mother was expecting to deliver on 17-AUG-2023 (date of last menstrual period (LMP) was 10-NOV-2022) (The mother's details were captured in # 2307USA009014). On 38.2 weeks of gestation age, the patient was born by vaginal birth after cesarean (VBAC). The birth weight was 5 lbs 6.1 oz (2440.894 g) (small for dates baby). The Apgar score was 9 at 1 min, 9 at 5 min. There were no neonatal problems or congenital anomalies. The baby was normal. At the reporting time, the outcome of small for dates baby was not reported. the action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable.  The causality between small for dates baby and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.; Sender's Comments:  US-009507513-2307USA009014:mother case
Age: 61.0
Sex: F
Vaccine: FLU4, RSV, RSV
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: pt started having extensive rash on 11/4 but was covering her entire body (90%PSA) on 11/5/23. she was not febrile but could not sleep and it had a burning feel, not pruritic
Age: 61.0
Sex: F
Vaccine: FLU4, RSV, RSV
Symptoms: Burning sensation, Crystal urine present, Metabolic function test normal, Neutrophil count increased, Rash
Clinical narrative: pt started having extensive rash on 11/4 but was covering her entire body (90%PSA) on 11/5/23. she was not febrile but could not sleep and it had a burning feel, not pruritic
Age: 61.0
Sex: F
Vaccine: FLU4, RSV, RSV
Symptoms: Sleep disorder, White blood cell count increased, White blood cells urine positive
Clinical narrative: pt started having extensive rash on 11/4 but was covering her entire body (90%PSA) on 11/5/23. she was not febrile but could not sleep and it had a burning feel, not pruritic
Age: 0.5
Sex: F
Vaccine: MNQ, MMR, MNQ, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction to date, Menveo dose was the incorrect formulation for age. Patient was given Menveo (pink cap) formulation ages 10yr-55yrs. Contacted the Manufacturer (no resolution given);  therefore, contacted the CDC, informed after medical review, valid dose, no repeating of dose needed.
Age: 0.5
Sex: F
Vaccine: MNQ, MMR, MNQ, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse reaction to date, Menveo dose was the incorrect formulation for age. Patient was given Menveo (pink cap) formulation ages 10yr-55yrs. Contacted the Manufacturer (no resolution given);  therefore, contacted the CDC, informed after medical review, valid dose, no repeating of dose needed.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP reported VARIVAX was administered post expiration date. Confirmed product has been stored appropriately. No additional AE/no PQC.; HCP reported VARIVAX was administered post expiration date. Confirmed product has been stored appropriately. No additional AE/no PQC.; Information has been received from a Medical Assistant referred to a patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On 27-OCT-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX), 1 dose, (strength, dose number, route, anatomical location, and frequency were not reported), lot # U025789, expiration date 19-AUG-2023, as prophylaxis (expired product administered). No adverse event was reported. It was confirmed product had been stored appropriately.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event, Vaccination failure, Wrong product administered
Clinical narrative: Rcvd Second Dose Titers Pulled and Levels Still 3.1; First dose was HEPLISAV-B, second dose was Recombivax; Initial Report Received on 05-Jul-2023, 06-Jul-2023, and 11-Jul-2023  This spontaneous report was received from a Medical Assistant who reported that a 47-year-old female patient (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) as the first dose for hepatitis B immunization and had a second dose with RECOMBIVAX (hepatitis B vaccine, recombinant), had titers pulled a month later, and the levels did not change from 3.1.  No relevant medical history was reported.    Relevant concomitant medications were reported as unknown.    On 14-Apr-2023, a titer was drawn.  On 19-Apr-2023, the patient received the first dose of HEPLISAV-B (Lot # 941582, expiration date: 24-Jan-2025 and NDC # 43528-002-01) intramuscularly in the right glute from a medical assistant.   On 01-Jun-2023, the patient received a dose of RECOMBIVAX (Lot # w011618, expiration date 10-Apr-2024 and NDC # not reported) by mistake as the second dose for hepatitis B immunization in the left deltoid (route of administration not reported) from a medical assistant.   On 03-Jul-2023, a titer was drawn.  It was reported that the levels did not change from 3.1.  The patient did not report any adverse events.    No additional information was reported.   Company Comment: The company assessed the event as non-serious and non-immunologically confirmed for vaccine failure due to wrong vaccine administed as second dose, and limited information on serological marker.; Sender's Comments: The company assessed the event as non-serious and non-immunologically confirmed for vaccine failure due to wrong vaccine administed as second dose, and limited information on serological marker.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Pregnancy; Initial Report Received on 17-Jul-2023  A pregnant female patient reported to the Health Authority  that she (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications were reported.   The last menstrual period date, pregnancy history, and pregnancy risk factors were not reported. The patient's estimated date of delivery is 28-Oct-2023.  On 03-Jul-2023, the pregnant patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported) in error by the Pharmacy. The patient declined to participate in the Pregnancy Registry and did not provide permission for Dynavax to follow up. Therefore, no additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Pain in extremity
Clinical narrative: I have had arm pain for over a month. I think that it caused chest pain that resulted in a. Emergency room visit.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH, ANTH
Symptoms: Blister, Injection site erythema, Injection site swelling, Lip blister, Paraesthesia oral
Clinical narrative: swollen and red injection site. eczema-like blisters appeared on right hand between the fingers, 3 days later after third dose in series. tingling and small blisters appeared at lip region within 30 days of injection of third dose in series.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Incorrect route of product administration, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: -INJECTION AREA WAS SWOLLEN TO A RAISED MASS 3 INCHES IN DIAMETER THAT WAS TIGHT AND HOT TO THE TOUCH.  -VISIT EMERGENCY ROOM AS DIRECTED AND INFORMED THEM THAT I BELIEVED THE SHOT DIDN'T GO DEEP ENOUGH AND THAT THE NEEDLE WAS PULLED OOUT PREMATURELY.  -HCP AND NURSE TOLD ME THAT I RECEIVED A BAD SHOT BECAUSE THEY BELIEVED IT WAS GIVEN INCORRECTLY.  THEY BELIEVED IT SHOULD HAVE BEEN GIVEN INTRAMUSCULAR AND DID NOT GO DEEP ENOUGH INTO THE MUSCLE AND THAT THE NURSE THAT GAVE THE SHOT PROBABLY USED A NEEDLE THAT WAS TOO SMALL.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; The medical assistant is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX  (w032370  4/19/2025) Temperature: 37.2F; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 12-OCT-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose and route of administration not reported) lot number w032370, expiration date 10-OCT-2024 for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 37.2 degrees Fahrenheit for 18 hours. No previous excursion was reported.
Age: 25.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired administration of GARDASIL 9.  Pharmacist stated that the GARDASIL 9 dose administered had a labeled expiration date of 4/28/2023 and the dose was administered on 10/30/2023.; This spontaneous report was received from a pharmacist referring to a 25-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-OCT-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 mL (two or three dose series), lot #U006800, expiration date: 28-APR-2023, administered for prophylaxis (strength, and route of administration were not provided) in which this was to be the first dose in the series (reported as their). It was reported that the vaccine dose administered on that day was expired (Expired product administered). Pharmacist confirmed they had not received any reports of the patient involved having any medical concerns or symptoms related to the administration of the expired dose of the vaccine. No additional information provided regarding this adverse event. No additional adverse event (No adverse event).
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: extra dose administered (fourth dose of HIB vaccine administered); inappropriate age at vaccine administration (third dose administred to less than 12-month old patient); This spontaneous report has been received from a physician, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (# 2309USA001668), concerning a 6-month-old female patient.  Her medical history and concurrent conditions were not provided. Concomitant vaccines included unspecified diphtheria vaccine toxoid (+) pertussis vaccine (+) tetanus vaccine toxoid (DTP), unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) vaccine or unspecified diphtheria vaccine toxoid (+) tetanus vaccine toxoid (DT), unspecified polio vaccine (POLIO) and unspecified hepatitis b vaccine (recombinant.  On 14-JAN-2000, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, administered for prophylaxis (exact dose, anatomical location, lot #, expiry date, and route of administration were not provided). On 20-MAR-2000, she the received second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, administered for prophylaxis (exact dose, anatomical location, lot #, expiry date and route of administration were not provided). On 24-MAY-2000, the patient received the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown)  intramuscular injection, administered for prophylaxis (exact dose, anatomical location, lot #, expiry date and route of administration were not provided) (product administered to patient of inappropriate age). On 01-JUN-2001, the patient received the fourth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown)  intramuscular injection, administered for prophylaxis (exact dose, anatomical location, lot #, expiry date and route of administration were not provided) (extra dose administered).    This is one of several reports regarding the same patient.; Sender's Comments:  US-009507513-2309USA001668:original case
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of GARDASIL 9 was administered.; This spontaneous report as received from a pharmacist, referring to 12-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 17-NOV-2023, the patient was vaccinated with expired second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 mL, intramuscularly, lot #U019413 was valid for formulation pre-filled syringe, expiration date 01-NOV-2023, anatomical location was not provided) for prophylaxis (Expired vaccine used). No other information provided. No additional adverse events (AEs) or product quality complaint (PQC) reported (No adverse event).
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired GARDASIL 9 was administered; This spontaneous report as received from employee, referring to 21-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 21-NOV-2023, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #U008316 was valid for formulation pre-filled syringe, expiration date 15-AUG-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No other information provided. No additional adverse events (AEs) or product quality complaint (PQC) reported (No adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided. No additional AE reported.; Caller is a medical assistant who reports ROTATEQ that experienced temperature excursion was administered. Excursion occurred 11/2/2023 and was administered 11/16/2023.  ?    Names of vaccines involved (including lot/exp) ROTATEQ  1965569  9/18/202; This spontaneous report eas received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 16-NOV-2023 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1965569 and expiration date for prophylaxis (exact dose, dose number and route of administration were not provided). The temperature excursion lasted for 6 minutes in temperature above 9 Celsius degrees (°C) (product storage error and no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; ROTATEQ that experienced temperature excursion was administered.; This spontaneous report has been received from a medical assistant, regarding to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, past drug reactions or allergies and concomitant therapies were not provided.  On 13-NOV-2023, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), oral liquid, orally, lot number 1965569 has been verified to be valid for Rotavirus Vaccine, Live, Oral, Pentavalent, expiration date reported and confirmed as 18-SEP-2024 (strength, exact dose, route and site of administration were not provided), for prophylaxis. The administered vaccine had suffered a temperature excursion on 02-NOV-2023, the temperature was above 9 Celsius degrees (°C) and last for 0 hours 6 minutes and 0 seconds. It was reported that the vaccine had not suffered previous temperature excursion (product storage error). No additional adverse events were reported.  This is one of several reports from same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events were reported; ROTATEQ that experienced temperature excursion was administered.; This spontaneous report has been received from a medical assistant, regarding to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, past drug reactions or allergies and concomitant therapies were not provided.  On 06-NOV-2023, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), oral liquid, orally, lot number 1965569 has been verified to be valid for Rotavirus Vaccine, Live, Oral, Pentavalent, expiration date reported and confirmed as 18-SEP-2024 (strength, exact dose, route and site of administration were not provided), for prophylaxis. The administered vaccine had suffered a temperature excursion on 02-NOV-2023, the temperature was above 9 Celsius degrees (°C) and last for 0 hours 6 minutes and 0 seconds. It was reported that the vaccine had not suffered previous temperature excursion (product storage error). No additional adverse events were reported.  This is one of several reports from same reporter.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Received Second Dose, Titers Pulled and Levels Still 3.1; Initial Report Received on 05-Jul-2023  This spontaneous report was received from a Medical Assistant who reported that a patient (race, gender, and ethnicity not provided) received a second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, had titers pulled a month later, and the levels did not change from 3.1.  No relevant medical history was reported.    Relevant concomitant medications were reported as unknown.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot # andexpiration date not reported,, NDC # 43528-002-01, route and site of administration not reported).   No additional information was reported.   Company Comment: The company assessed the event as non-serious and non-immunologically confirmed for vaccine failure due to limited information on dosing schedule and serological marker.; Sender's Comments: The company assessed the event as non-serious and non-immunologically confirmed for vaccine failure due to limited information on dosing schedule and serological marker.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 Year Old Patient Received First Dose of Heplisav-B; Initial report received on 09-Aug-2023  A phlebotomist reported that a 16-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose.  No relevant medical history or concomitant medications at the time of vaccination were reported. The patient had no known allergies or reactions.  On 12-Jul-2023, the 16-year-old patient received the first dose of HEPLISAV-B (Lot # 943241, expiration date 07 Sep 2025; NDC # and route not reported) in the right deltoid. No adverse reactions were reported.  No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: First Dose in April, Second Dose in July; Initial report received on 18-Aug-2023  A consumer reported that she, a 34-year-old female patient (race and ethnicity not provided), received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Apr-2023, did not know to go back, and got the second dose in Jul-2023.  No relevant medical history, allergies, or concomitant medications at the time of vaccination were reported.   On 20-Apr-2023, the patient received the first dose of HEPLISAV-B (Lot # 940487, expiration date unknown, and NDC # not reported) intramuscularly in the left arm. The patient reported that she did not know to go back and got the second dose in July.  On 07-Jul-2023, 79 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 940487, expiration date unknown, and NDC # not reported) intramuscularly in the left arm. The patient reported no issues related to receiving the vaccine.  No additional information was provided.  Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Head discomfort, Neck pain, Tenderness
Clinical narrative: inability to turn head; Extreme upper back and neck pain and soreness; Extreme upper back and neck pain and soreness; Extreme upper back and neck pain and soreness; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Extreme upper back and neck pain and soreness), HEAD DISCOMFORT (inability to turn head), BACK PAIN (Extreme upper back and neck pain and soreness) and TENDERNESS (Extreme upper back and neck pain and soreness) in a 38-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 18-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced NECK PAIN (Extreme upper back and neck pain and soreness). On an unknown date, the patient experienced HEAD DISCOMFORT (inability to turn head), BACK PAIN (Extreme upper back and neck pain and soreness) and TENDERNESS (Extreme upper back and neck pain and soreness). At the time of the report, NECK PAIN (Extreme upper back and neck pain and soreness) and BACK PAIN (Extreme upper back and neck pain and soreness) had not resolved and HEAD DISCOMFORT (inability to turn head) and TENDERNESS (Extreme upper back and neck pain and soreness) outcome was unknown.            Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not reported.