chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccines administered 4/17 Visit 4/19 for B/L inferior deltoid (distal to vaccine administration sites) - swelling, erythema some warmth - presumed large /localized reaction. Minimal imp. on benadryl. After 72 hrs persisting symptoms w/ increased induration - cephalexin TID x 5d.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: All of my organs stopped working probably. Both of my arms and hands go numb, tingle with pins and needles all day and night long. My face does the same thing along with my left leg.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Insomnia, Mobility decreased, Nausea
Clinical narrative: severe body pain, unable to move limbs, fingers and toes had difficulty bending, Headache, nausea, sleeplessness due to pain, redness at injection site on upper arm
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: severe body pain, unable to move limbs, fingers and toes had difficulty bending, Headache, nausea, sleeplessness due to pain, redness at injection site on upper arm
Sex: F
Vaccine: HEP
Symptoms: Chills, Fatigue, Wheezing
Clinical narrative: chills, rigor, fatigue, wheezing
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Constipation, Dyspnoea, Joint stiffness, Mobility decreased
Clinical narrative: For three days after receiving the Boostrix shot I experience the following. Muscle Weakness and Muscle aches through out my arms, chest, legs, glutes, hands and feet. Off balance while performing normal activities like standing. Chest pains and shortness of breath.  Bone and joint stiffness, felt like loss of range of motion. Constipation.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Myalgia
Clinical narrative: For three days after receiving the Boostrix shot I experience the following. Muscle Weakness and Muscle aches through out my arms, chest, legs, glutes, hands and feet. Off balance while performing normal activities like standing. Chest pains and shortness of breath.  Bone and joint stiffness, felt like loss of range of motion. Constipation.
Age: 0.5
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLU4, PNC20
Symptoms: Blood potassium increased, Enterovirus test positive, Febrile convulsion, Full blood count normal, Human rhinovirus test positive
Clinical narrative: After routine vaccinations on 3/25 around 4:30 PM patient had a simple febrile seizure on 3/26 at 11:30 AM
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Migraine, Urticaria
Clinical narrative: BY 8pm I had hives on upper body; the next day I had flu like symptoms; third day symptoms gone but developed a migraine (which after taking a migraine otc went away)
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: on 4/16/2024 Patient was in the office and reported that a day after the injection, her arm was very sore.  She had been advised that this could happen so did not think anything of the pain. The following day she reports that the pain was very intense. She reports she could not lift her arm. She reported that she felt the pain was radiating up her neck and down her back. Patient reports she was seen at a local urgent care.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Spikevax was administered 1 month early per CDC guidelines of at least 4 months between last administration.
Age: 16.0
Sex: F
Vaccine: HEP, HPV9, MNQ
Symptoms: Somnambulism, Wrong product administered
Clinical narrative: Hepatitis B was given instead of Meningitis B.  Mom did not call with any adverse events.  However, when she was notified of the error on 4/26/24, mom stated that patient had an episode of sleepwalking the day after receiving vaccines.  Per mom, that has never happened before, and now mom wonders if it was related to the vaccines.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Laboratory test
Clinical narrative: On 05/14/2023, I had a stroke. I went to Hospital. Only at that hospital for a few hours, then I was transferred to Medical Center. I stayed there for 5 weeks, from 05/15/23 - 06/14/23.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Asthenia, Blood culture negative, Fatigue, Full blood count, Nasal congestion
Clinical narrative: Baseline CBC 3/6/24 with mild neutropenia (appx 1000). 4/4/24 CBC obtained immediately prior to immunizations on 4/4/24 showed persistent mild neutropenia (appx 1000 again).  Patient developed rash, possible tactile fever, fatigue, and nose congestion on 4/8/24. Rash was truncal erythematous macules, spread to forehead and shoulders. We repeated CBC on 4/10/24 that showed moderate neutropenia now (ANC appx 600). Discussed with hematology specialist who suspects autoimmune neutropenia. Unclear if immunizations were a factor in drop in ANC or suspected autoimmune neutropenia. Patient has outpatient hematology consultation still pending. Due to possible fever with ANC <1000, we obtained blood culture on 4/10/24 and patient received IM rocephin x 3 doses from 4/10/24 to 4/12/24.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Neutrophil count decreased, Rash, Rash macular
Clinical narrative: Baseline CBC 3/6/24 with mild neutropenia (appx 1000). 4/4/24 CBC obtained immediately prior to immunizations on 4/4/24 showed persistent mild neutropenia (appx 1000 again).  Patient developed rash, possible tactile fever, fatigue, and nose congestion on 4/8/24. Rash was truncal erythematous macules, spread to forehead and shoulders. We repeated CBC on 4/10/24 that showed moderate neutropenia now (ANC appx 600). Discussed with hematology specialist who suspects autoimmune neutropenia. Unclear if immunizations were a factor in drop in ANC or suspected autoimmune neutropenia. Patient has outpatient hematology consultation still pending. Due to possible fever with ANC <1000, we obtained blood culture on 4/10/24 and patient received IM rocephin x 3 doses from 4/10/24 to 4/12/24.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RVX
Symptoms: Body temperature increased, Haematochezia, Mucous stools
Clinical narrative: Patient had a temp of 101F the night of vaccines. He started having mucus in his stool shortly after vaccines and on 4/25/24 the blood in stool started. He had no rashes or vomiting. Seems happy and playful. Also eating and drinking well.
Age: 33.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: pt received hiberix instead of heplisav-b
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Hypersomnia
Clinical narrative: Patient reported his face flushed, he has been tired & sleeping a lot.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site cellulitis
Clinical narrative: Developed cellulitis in right thigh one day after administration.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: CHILD WAS GIVEN A PROQUAD INSTEAD OF AN MMR. HE ALSO OBTAINED A VARICELLA, HIB, HEP A AND PCV 20. ONCE WE REALIZED THE ERROR THE PROVIDER WAS TOLD IMMEDIATELY ALONG WITH MANAGEMENT. HEALTH DEPARTMENT WAS CALLED AS WELL.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Expired 3 days post second 2023-24 Covid-19 vaccine (Pfizer)
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, PNC13
Symptoms: Immune thrombocytopenia
Clinical narrative: thrombocttopenia evaluated by hematolog- diagnosed as ITP_ he thought due to the virus but could not rule out immunizations since 6 month vaccines were given wihin the past 6 weeks. Treated with steroids doing better.
Age: 71.0
Sex: U
Vaccine: UNK
Symptoms: Device issue
Clinical narrative: BD Eclipse Safety Mechanism is breaking off after vaccine given and flipping to guard needle.  This has happened randomly from the reported lot number randomly on different patients.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Drug hypersensitivity
Clinical narrative: The patient reported after their second dose of Pfizer covid vaccine, they had a severe flare up of their ulcerative colitis
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This AE is Medical Error. Once we roomed the patient, his quality measures a few vaccines. The medical assistance apprentice ask if he would like Shingles, TDAP, and Covid Spikevax, and the patient stated yes and that he had not received anything since he moved up here in early 2023. Once she came and reported, I confirm with the patient with the vaccines that he wanted to receive. I gave him the vaccine forms. I went to the pharmacy to pick up the shingrix and pt information forms, as he has no co pay. I walked back to the room to pull out the vaccine consent form, and let him know there was no co pay for shingles. I verified again of the vaccines he was getting and he said yes. I administered the shingles into his right deltoid. He mumbled "that hurt worst than the first time". He then stated that he has had at least in other state. I went to my desk and called the clinic, I asked for his vaccine records, due to us getting records with no vaccines previously. I called the clinic to which I have received the records this morning, in which I noticed the patient had already received a total of 2 shingles vaccines prior to the one we gave him. We requested records 6/13/23 and we never received the vaccine records. I received my first copy of the records on  6/20/23 and they were incomplete. Then we received them again on 6/22/23 and they were also incomplete.  I just received the vaccine records this morning, of the vaccines that he received.  The patient has not reported anything at this time.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine in patients left arm intramuscular, vaccine expired on 4/23/2024 and the vaccine was administered on 04/24/2024.
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Infection, Neutropenia
Clinical narrative: Patient was given FLU VACCINE at 1 year old which caused her to get neutropenia, patient was seen by Hematology/Oncology for one year, patient stable but get sick  (infections) frequently.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Delirium, Floppy infant, Hypotonia, Immunisation reaction
Clinical narrative: From parent: His body went randomly limp - I put him down on our mat to sit up and he couldn?t hold his body at all when normally he sits up very strongly. He also couldn?t hold his head at all, and his full body was floppy. Even when we were holding him he couldn?t hold his head at all, all of the sudden. He had symptoms for about 2 hours but by the time an ER doctor could see us he was back to his normal self. They agree that it?s likely a vaccine reaction to the DTAP since he got it 26 hours before this episode. When he was unwell he also was delirious - he laughed when unprovoked and was otherwise blank so it seemed very neurological. The ER doctor didn?t run any tests and said pt. looked strong (as I said he was mostly back to himself by the time he came in) but he consulted with a pediatrician who agreed it was likely a vaccine reaction.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Malaise
Clinical narrative: From parent: His body went randomly limp - I put him down on our mat to sit up and he couldn?t hold his body at all when normally he sits up very strongly. He also couldn?t hold his head at all, and his full body was floppy. Even when we were holding him he couldn?t hold his head at all, all of the sudden. He had symptoms for about 2 hours but by the time an ER doctor could see us he was back to his normal self. They agree that it?s likely a vaccine reaction to the DTAP since he got it 26 hours before this episode. When he was unwell he also was delirious - he laughed when unprovoked and was otherwise blank so it seemed very neurological. The ER doctor didn?t run any tests and said pt. looked strong (as I said he was mostly back to himself by the time he came in) but he consulted with a pediatrician who agreed it was likely a vaccine reaction.
Age: 2.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site cellulitis, Injection site rash, Injection site warmth
Clinical narrative: Rash, warm to touch at the site of vaccine Dx with celluitis
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product preparation error
Clinical narrative: Diluent only was administered to patient
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse reactions noted.  The covid 19 pfizer  vaccine was being stored in freezer at -25 C.  per manufacture follow up with CDC for validity of vaccine.. Per CDC  if manufacture does not have information on this subject go ahead and revaccinate.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Pt has a history of fainting after receiving immunizations.  Pt is accompanied with her mother.  After receivng her Flu and COVID vaccines, Pt was instructed to stay in the immunization area for 30 minutes for observation. Pt agreed. Pt then fainted in about 5 minutes. Pharmacist rushed and laid pt on the floor and elevated her feet. Pharmacist applie cold pack to patient's forehead. Pt then awoke and asked for water. Pt then was instructed to continually stay lying on the floor until she feels better. Pt laid about 15 minutes on the floor. By then, she was fully awaked. Pt was then monitored for an additional 15 minutes before pt left the pharmacy.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt received Trumenba instead of Menactra. No adverse symptoms
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Trumenba was given instead of Menactra. No adverse symptoms/reaction
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine manufacturer expiration date 4/30/24- vaccine removed from freezer 2/12/24 with BUD 3/13/24. Administered 4/17/24. No adverse event noted after receiving  expired vaccine.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine manufacturer expiration date 4/30/24. Out of freezer BUD expiration date 3/13/24. Vaccine administered 4/25/24-past BUD expiry date. No adverse event
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Covid-19 (MODERNA) mRNA Spikevax ages 12+ was thawed out and became room temperature by clinic staff. After 15 minutes the vaccine was administered by another staff member. After the vaccine was administered it became known that the wrong Covid vaccine was given to the 6-month-old patient. The covid vaccine that was given is intended for children 12+.
Age: 79.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Abdominal discomfort, Balance disorder, Dizziness, Head discomfort, Influenza like illness
Clinical narrative: She got her vaccine, she felt like there was pressure running into her head, like medicine shooting up into her skull.  She told her that she would have flu-like symptoms for a couple of days.  She did have those symptoms, aching, which has now gone, but still has wooziness, balance is still off, and also these are similar to her reaction she had to the COVID vaccine.  She did not call her doctor or take anything for her symptoms.  She is waiting for it to go away, but after 5 days she is still having the wooziness and balance issues.  In the very beginning she had an upset stomach on Monday and then the wooziness kicked in the evening, the upset stomach is gone, the upset stomach is gone, but the others persist.  She still feels pressure in the back of her head, which is usually a reaction she has when her BP drops.   She also got her pneumonia vaccine at that time and was informed that they would not interact.
Age: 79.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Pain
Clinical narrative: She got her vaccine, she felt like there was pressure running into her head, like medicine shooting up into her skull.  She told her that she would have flu-like symptoms for a couple of days.  She did have those symptoms, aching, which has now gone, but still has wooziness, balance is still off, and also these are similar to her reaction she had to the COVID vaccine.  She did not call her doctor or take anything for her symptoms.  She is waiting for it to go away, but after 5 days she is still having the wooziness and balance issues.  In the very beginning she had an upset stomach on Monday and then the wooziness kicked in the evening, the upset stomach is gone, the upset stomach is gone, but the others persist.  She still feels pressure in the back of her head, which is usually a reaction she has when her BP drops.   She also got her pneumonia vaccine at that time and was informed that they would not interact.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: radiating pain and soreness from injection site immediately following administration
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: Patient is experiencing redness and tenderness spanning 8 inches on her left arm.
Age: 68.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Cardio-respiratory arrest, Catheter placement, Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Resident received Prevnar 20 vaccine at 9:22 PM to left deltoid on 4/25/24 and Moderna COVID-19 vaccine (Spikevax) was received at 9:18 PM to right deltoid, also on 4/25/24.  Around 8:20 AM the morning of 4/26/24, resident found unresponsive in bed by staff.  Code called.  CPR initiated (multiple rounds of chest compressions) with AED application and recurrent directives of "no shock advised", leading to continuation of CPR.  Peripheral IV placed in right antecubital with normal saline IVFs hung and running.  EMS called and arrived to take over the code.  Resident pronounced deceased at 8:46 AM.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Deafness unilateral, Full blood count, Headache, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: Day 8 tinnitus, vertigo, nausea, vomiting. Then day 10 light switch event with total Hearing loss in the left ear, vertigo, severe nausea, headache, and tinnitus. 100% hearing loss in left ear remains along with tinnitus.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Tinnitus, Vertigo, Vomiting
Clinical narrative: Day 8 tinnitus, vertigo, nausea, vomiting. Then day 10 light switch event with total Hearing loss in the left ear, vertigo, severe nausea, headache, and tinnitus. 100% hearing loss in left ear remains along with tinnitus.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Needle issue
Clinical narrative: Dull BD needle on Pediarix syringe. I had to get another pediarix syringe and a new needle to vaccinate child.
Age: 33.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient was accidentally administered a shingles vaccine instead of an MMR II vaccine. The mistake was realized immediately and MMR II vaccine was given as well. Patient was made aware of mistake and information provided to healthcare provider. Will contact patient on Monday 4/29/24 to follow-up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Back pain, Chest X-ray, Chest pain, Dizziness
Clinical narrative: Right arm immediately started severely hurting, then pain in neck, back , chest. Pain when breathing, heart palpitations . Had a hard time sleeping. Woke up the next morning really hurting all over and weak. Went to school late and symptoms worsened over the morning . Tingling in feet and hands. Numbness in hands, headache, severe weakness - felt like she was going to pass out. Horrible chest pains. Went to Emergency Department in early afternoon.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Electrocardiogram, Headache, Hypoaesthesia, Immediate post-injection reaction, Immunisation reaction
Clinical narrative: Right arm immediately started severely hurting, then pain in neck, back , chest. Pain when breathing, heart palpitations . Had a hard time sleeping. Woke up the next morning really hurting all over and weak. Went to school late and symptoms worsened over the morning . Tingling in feet and hands. Numbness in hands, headache, severe weakness - felt like she was going to pass out. Horrible chest pains. Went to Emergency Department in early afternoon.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Insomnia, Neck pain, Pain, Pain in extremity, Painful respiration
Clinical narrative: Right arm immediately started severely hurting, then pain in neck, back , chest. Pain when breathing, heart palpitations . Had a hard time sleeping. Woke up the next morning really hurting all over and weak. Went to school late and symptoms worsened over the morning . Tingling in feet and hands. Numbness in hands, headache, severe weakness - felt like she was going to pass out. Horrible chest pains. Went to Emergency Department in early afternoon.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Palpitations, Paraesthesia, Urine analysis
Clinical narrative: Right arm immediately started severely hurting, then pain in neck, back , chest. Pain when breathing, heart palpitations . Had a hard time sleeping. Woke up the next morning really hurting all over and weak. Went to school late and symptoms worsened over the morning . Tingling in feet and hands. Numbness in hands, headache, severe weakness - felt like she was going to pass out. Horrible chest pains. Went to Emergency Department in early afternoon.
Age: 6.0
Sex: M
Vaccine: FLU4, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted, the pfizer  covid vaccine given at the time was being stored  in freezer at -25 C. per manufacturer it is non viable.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Client did not disclose pregnancy until after vaccinations given. Client received Menveo & HPV vaccines which writer would have recommended delaying until after pregnancy. Client is currently 14 weeks and 6 days pregnant.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Client did not disclose pregnancy until after vaccinations given. Client received Menveo & HPV vaccines which writer would have recommended delaying until after pregnancy. Client is currently 14 weeks and 6 days pregnant.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Abdominal pain upper, Asthenia, Blood glucose normal, Dizziness, Haemoglobin normal
Clinical narrative: 04:40 pm: Pt receives HPV vaccine along with 2 other vaccines, at  04:45 while pt is in lobby he starts complaining of feeling dizzy and begins to mildly sweat and complaints of stomach pain and presents  syncope episode, at 4:46 a CODE BLUE is activated and MD begins assessment with pt weak but alert and able to answer questions with 9-1-1 activated, MD orders glucose, pt proceeds to have 2 squirts of Glucagon. Pt is in w/c with feet elevated and Vital Signs being monitored, pt is able to keep eyes open. Second set of Vital signs reveal pt's blood pressure has slightly improved, but is still verbalizing weakness. Paramedics arrive, take over the scene and proceed to assess and transport pt via gurney to a nearby hospital.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: 04:40 pm: Pt receives HPV vaccine along with 2 other vaccines, at  04:45 while pt is in lobby he starts complaining of feeling dizzy and begins to mildly sweat and complaints of stomach pain and presents  syncope episode, at 4:46 a CODE BLUE is activated and MD begins assessment with pt weak but alert and able to answer questions with 9-1-1 activated, MD orders glucose, pt proceeds to have 2 squirts of Glucagon. Pt is in w/c with feet elevated and Vital Signs being monitored, pt is able to keep eyes open. Second set of Vital signs reveal pt's blood pressure has slightly improved, but is still verbalizing weakness. Paramedics arrive, take over the scene and proceed to assess and transport pt via gurney to a nearby hospital.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Patient has pain in left arm around the vaccination site. The muscle in left arm hurts all the time when moving it. It hurts after swimming and when he massages it. The pain has increased so has to take pain killers everyday. The level of pain when sleeping is a 5 and during the day it 2-3 level pain when he moves arm.  Patient plans to seek medical help. Probably got to an orthopedic doctor and see about getting an MRI.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Nerve injury, Pain
Clinical narrative: Patient has pain in left arm around the vaccination site. The muscle in left arm hurts all the time when moving it. It hurts after swimming and when he massages it. The pain has increased so has to take pain killers everyday. The level of pain when sleeping is a 5 and during the day it 2-3 level pain when he moves arm.  Patient plans to seek medical help. Probably got to an orthopedic doctor and see about getting an MRI.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Joint range of motion decreased, Myalgia, Nerve injury
Clinical narrative: Patient has pain in left arm around the vaccination site. The muscle in left arm hurts all the time when moving it. It hurts after swimming and when he massages it. The pain has increased so has to take pain killers everyday. The level of pain when sleeping is a 5 and during the day it 2-3 level pain when he moves arm.  Patient plans to seek medical help. Probably got to an orthopedic doctor and see about getting an MRI.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: Patient has pain in left arm around the vaccination site. The muscle in left arm hurts all the time when moving it. It hurts after swimming and when he massages it. The pain has increased so has to take pain killers everyday. The level of pain when sleeping is a 5 and during the day it 2-3 level pain when he moves arm.  Patient plans to seek medical help. Probably got to an orthopedic doctor and see about getting an MRI.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram normal, Balance disorder, Brain fog, Dizziness, Electrocardiogram normal
Clinical narrative: Lightheadedness,  feeling off balance, fatigue and brain fog. Lasting for almost 6 months. Have seen all the specialists and they can't find anything. Nephrologist, cardiologist, primary care doctor, ENT and a neurologist. I've been tested for Vertigo, had a tilt table test. I've had a brain MRI and there appears to be no reason for the lightheadedness. I've also had an EkG, and an Angiogram.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Magnetic resonance imaging head normal, Tilt table test normal
Clinical narrative: Lightheadedness,  feeling off balance, fatigue and brain fog. Lasting for almost 6 months. Have seen all the specialists and they can't find anything. Nephrologist, cardiologist, primary care doctor, ENT and a neurologist. I've been tested for Vertigo, had a tilt table test. I've had a brain MRI and there appears to be no reason for the lightheadedness. I've also had an EkG, and an Angiogram.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Aphonia, Dark circles under eyes, Erythema, Induration, Pruritus
Clinical narrative: Approximately 24 hours after her her immunization, while she was at school, she began itching on her head and the back of her neck and arms.  When she got off the bus after school, Mom said under her eyes was very dark, she had no voice, and her left arm from just above the elbow to the top of her shoulder was red, hot and hard and the skin was raised like a hive.  Mom took her to an urgent care clinic right away and the doctor there gave her steroids and sent her home with oral and topical steroids.  The doctor told mom to delay getting the next shot (Scheduled 5/7/24- on catch-up schedule) till later and to talk to the health department about getting an exemption for shots for school.  Mom states child has PCP and will follow up with that doctor for the exemption.  Mom also states child's father had a severe rash when he was a baby after receiving polio vaccine and had an exemption for any further polio vaccinations.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Skin swelling, Skin warm, Urticaria
Clinical narrative: Approximately 24 hours after her her immunization, while she was at school, she began itching on her head and the back of her neck and arms.  When she got off the bus after school, Mom said under her eyes was very dark, she had no voice, and her left arm from just above the elbow to the top of her shoulder was red, hot and hard and the skin was raised like a hive.  Mom took her to an urgent care clinic right away and the doctor there gave her steroids and sent her home with oral and topical steroids.  The doctor told mom to delay getting the next shot (Scheduled 5/7/24- on catch-up schedule) till later and to talk to the health department about getting an exemption for shots for school.  Mom states child has PCP and will follow up with that doctor for the exemption.  Mom also states child's father had a severe rash when he was a baby after receiving polio vaccine and had an exemption for any further polio vaccinations.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 10.0
Sex: F
Vaccine: FLU4, HEPA, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions.  Pfizer Covid vaccine that was given was being kept in freezer at -25 C. per manufacturer vaccine is non viable.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received Boostrix 3/11/22. Received dose on 4/23/24 instead of after 10 years.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, IPV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions.  Pfizer Covid vaccine that was given was being kept in freezer at -25 C. per manufacturer vaccine is non viable.
Age: 36.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Injection site pain
Clinical narrative: Pt called today saying her #2HPV shot hurt for months, 3/10 muscle pain to left deltoid, and she is wondering is she should get the 3rd dose, which is due.  She says the  injection felt normal going in and the next day it was painful, and remained so for months.  She said the first one lasted a week.  She denies reddness or swelling at the site. She did not use any medications or comfort measures to remedy the pain.
Age: 1.92
Sex: M
Vaccine: FLU4, HEPA, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions.  Pfizer Covid vaccine that was given was being kept in freezer at -25 C. per manufacturer vaccine is non viable.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: PATIENT HAS A CIRCULAR RED AREA ON HER LOWER LEFT ARM NEAR THE ELBOW. IT WAS WARM TO THE TOUCH AND PER PATIENT IT WAS CAUSING HER A LOT OF PAIN
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Wrong product administered
Clinical narrative: The Doctor ordered Bexsero, however, a third dose of Gardasil 9 was administered.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Joint swelling, Peripheral swelling, Pyrexia
Clinical narrative: Patient developed a rash on 4/23 that was consistent with urticaria.  She then developed low grade fever, swelling and pain in her knees and refusal to bear weight.  Her knee symptoms improved but then she developed swelling in her feet.  Her rash spread to her whole body and some lesions became purple/dusky in center.  She was diagnosed with serum sickness like reaction.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Serum sickness-like reaction, Skin discolouration, Skin lesion, Urticaria
Clinical narrative: Patient developed a rash on 4/23 that was consistent with urticaria.  She then developed low grade fever, swelling and pain in her knees and refusal to bear weight.  Her knee symptoms improved but then she developed swelling in her feet.  Her rash spread to her whole body and some lesions became purple/dusky in center.  She was diagnosed with serum sickness like reaction.
Age: 8.0
Sex: M
Vaccine: FLU4, HEPA, IPV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions.  Pfizer Covid vaccine that was given was being kept in freezer at -25 C. per manufacturer vaccine is non viable.
Age: 95.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already completed the two-dose Shingrix series at another pharmacy in 2019.  She received a third dose in error at our pharmacy on 3/25/24.  The patient stated that she did not experience any adverse effects due to receiving an extra dose of Shingrix.
Age: 19.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Caller stated her son has not had any symptoms; Caller stated her 19 year old son received an extra dose of the "current HPV vaccine."; This spontaneous report was received from a consumer referring to a 19-year-old male patient. The patient's medical history and concomitant therapies were not reported. The reporter stated her son was fully vaccinated for human papilloma virus (HPV) in 2016.  Recently the patient went to a new doctor who didn't have his vaccination records. The reporter stated she was not at the appointment with her son and her son didn't know if he had been vaccinated so the doctor gave him an extra dose of the "current HPV vaccine." on 25-MAR-2024 (hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, administered for prophylaxis [strength, dose, lot #, expiry date, and route of administration were not provided]; or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 1 dose, administered for prophylaxis [strength, dose, lot #, expiry date, and route of administration were not provided]) (the Company unidentified HPV vaccine administered [name and lot number not provided]) (Extra dose administered). The reporter believed it was hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) but was unable to confirm the brand name. The reporter stated her son had not had any symptoms (No adverse event).  Lot # is being requested and will be submitted if received.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; A HCP called to report a dose of PEDVAX HIB (Lot: X009000 Expiration: 11/21/2025) that was exposed to multiple temperature excursions was inadvertently administered to a patient on 03/27/2024.; This spontaneous report was received from a physician referring to a 16-month-old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapies were not reported.  A dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was exposed to multiple temperature excursions at 31.6 fahrenheit scale (F) for 15 minutes on 12-FEB-2024 and at 48.9 F for 15 minutes on 25-MAR-2024.  On 27-MAR-2024 (onset date was also reported as 24-MAR-2024, conflicting information), the patient inadvertently administered to improperly stored vaccine with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, once, Lot#X009000 has been verified to be a valid lot number, expiration date reported as 21-NOV-2025, administered for prophylaxis (strength, and anatomical location were not provided) (product storage error).The patient did not experience any adverse issues or side effects from the administration. No additional adverse (AE) (no adverse event). No product quality concern (PQC).
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Arthritis
Clinical narrative: HCP reported a patient developed joint pain and inflammation approximately 1-2 weeks after receiving her first dose of GARDASIL 9.  Location of the inflammation is unknown by reported.; HCP reported a patient developed joint pain and inflammation approximately 1-2 weeks after receiving her first dose of GARDASIL 9.  Location of the inflammation is unknown by reported.; This spontaneous report was received from a physician referring to a 2-decade-old female patient (reported as 20's). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 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) injection, administered for human papilloma virus (HPV) immunisation (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in March 2024 (reported as approximately 1-2 weeks after receiving her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)), the patient developed joint pain and inflammation. Location of the inflammation was unknown by reported. The patient sought medical attention (unspecified). At the time of reporting, the outcome of the events was unknown. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), joint pain and inflammation was not reported.  Lot # is being requested and will be submitted if received.
Age: 24.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller stated that expired VAQTA was administered today, 04/12/2024; This spontaneous report was received from a nurse and refers to a 24-year-old male patient. The patient's concurrent conditions (reported as: illness at time of vaccination) included chronic hepatitis b. The patient's medical history, concomitant therapies, drug reactions and allergies were not reported.  On 12-APR-2024, the patient was vaccinated in a private doctor's office/hospital with an expired dose of a hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W038118, expiration date: 06-APR-2024, (strength, exact dose, dose#, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (expired product administered). The suspect vaccine was prescribed by medical doctor (MD). The suspect vaccine did not experience a temperature excursion. There was no problem with device. The vaccine was not available for return/evaluation. The vaccine was used according to the instruction leaflet. Operator of vaccine was a healthcare professional, and they was trained. No additional adverse event (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE, no PQC.; Pharmacist called to report multiple temperature excursion for PROQUAD and VARIVAX. Caller was unsure but thinks the products were likely administered to about 3 patients.; This spontaneous report has been received from a pharmacist, regarding 3 patients of unknown age and gender. The patients' pertinent medical history, previous drug reactions or allergies were not reported.  On unspecified dates, the patients were vaccinated with improperly storage doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, both as prophylaxis (strengths, doses, schemes, routes and anatomical locations of administration were not reported, lot numbers and expiration dates were not reported).  The administered doses underwent unspecified temperature excursions during unspecified amount of time.  Reporter was unsure but thinks the products were likely administered to about 3 patients.  No additional adverse event was reported.  This case was determined to be non-valid due to the lack of the 3 patients' identifiers.  Follow-up information was received from the pharmacist on 23-APR-2024:  Pharmacist stated she was able to confirm that 2 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were administered and 1 dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered after being involved in temperature excursion. Pharmacist provided patient initials and administration dates for the 3 patients.  The patient identifiers were provided.  On 11-APR-2024, the patient was vaccinated with improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # X018583, expiration date: 05-JAN-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.   Administered dose of vaccine was exposed to the temperature excursion of -8 degrees Celsius for 105 hours. Cumulative excursion time provided. Caller stated that the products were involved in multiple excursions starting sometime in March 2024, but her data logger did not break down the excursions any further (Product storage error). Caller stated that no patient symptoms have been reported, no additional adverse event reportd (No adverse event).
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptomatic adverse events were reported; temperature excursions that occurred for GARDASIL-9.; This spontaneous report was received from a nurse referring to a 12-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 02-AUG-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W010663, expiration date: 11-MAR-2024, administered for prophylaxis (strength, dose and route of administration were not provided). This vaccine was exposed to temperature excursion of 33 degree Fahrenheit for 3 hours, 60 degree Fahrenheit for 4 hours 30 minutes, 34.10 degree Fahrenheit for 240 hours, 52 degree Fahrenheit for 5 hours 45 minutes, 51.78 degree Fahrenheit for 192 hours (Incorrect product storage). There was no symptomatic adverse event reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored ROTATEQ was administered to 2 patients on 4/22/2024; No additional AE; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #2003148, expiration date: 31-MAY-2025, administered orally for prophylaxis (strength was not provided). The suspect vaccine was improperly stored, temperature: 57.5 F, time frame: 1 hour 45 minutes 0 seconds (Product storage error). No previous temperature excursion. No additional adverse events.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2404USA010253:Merck
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; Information has been received regarding a case in litigation from a lawyer and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On or about 10-JUL-2017, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced multiple outbreaks of herpes zoster and was treated for the injury. The outcome of the event was not provided. The event was considered as related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Rash vesicular
Clinical narrative: Patient developed a case of Shingles 3 days after the vaccination at the pharmacy; the site of the shingles rash; This serious case was reported by a physician via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: Patient developed a case of Shingles 3 days after the vaccination at the pharmacy) (serious criteria other: serious as per reporter) and vesicular rash (Verbatim: the site of the shingles rash) (serious criteria other: serious as per reporter). The outcome of the shingles and vesicular rash were resolved.   The reporter considered the shingles and vesicular rash to be related to Shingrix.   The company considered the shingles and vesicular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2024 The patient developed shingles 3 days after the vaccination at the pharmacy. The doctor had to treat the virus for the patient. It was her upper left arm that was affected and that was also the site of the shingles rash.