chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The patient had shingles right then/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (about 30 years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: The patient had shingles right then/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated he/she first got shingles about 30 years ago. The patient had them at the tie of reporting. But after the newest vaccine, no pain. And after the vaccine they went away quickly. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Death
Clinical narrative: Unknown cause of death; Stroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant) and stroke (Verbatim: Stroke) (serious criteria GSK medically significant). The outcome of the stroke was not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The reporter considered the stroke to be related to Shingles vaccine.     It was unknown if the company considered the unknown cause of death to be related to Shingles vaccine. The company considered the stroke to be related to Shingles vaccine.   Additional Information: This case was reported by a reporter via interactive digital media. The reporter stated that you could have the vaccine and have a stroke from it and die like his/her mom did. The patient would rather take chance to have shingles. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: a patient received and expired dose of Pediarix On Feb 19th 2023; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17-FEB-2024) for prophylaxis.   On 19-FEB-2024, the patient received Pediarix. On 19-FEB-2024, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: a patient received and expired dose of Pediarix On Feb 19th 2023). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2024 The reporter called to report that a patient received expired dose of Pediarix, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: ended up getting the flu; Initial information received on 01-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2024SA076777(CLUSTER).  This case involves Elderly and unknown gender patient who ended up getting the flu after receiving Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient had received (dose and units: unknown) suspect Influenza Quadrival A-B High Dose HV Vaccine (lot number, expiration date, formulation, strength, route and administration site not reported) for prophylactic vaccination.  On an unknown date the patient had ended up getting the flu (influenza) (unknown latency) following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  It was reported that even patients who have gotten the flu vaccine have ended up getting the flu also seemed to happen amongst the staff that were vaccinated. Most were using Fluzone Standard and one used the high dose.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (ended up getting the flu).  At time of reporting, the outcome was Unknown for the event ended up getting the flu.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Ipol Max temperature reached: 48.3 DEGREE F, Duration out of labelled range: 1 hour 30 minutes, potentially Administered to a patient with no reported adverse event; Initial information was received on 29-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] max temperature reached: 48.3 degree f, duration out of labelled range: 1 hour 30 minutes, potentially administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Feb-2024, the patient received a dose of suspect IPV (VERO), suspension for injection (dose, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On 26-FEB-2024 the patient recived  ipol max temperature reached: 48.3 degree f, duration out of labelled range: 1 hour 30 minutes, potentially administered to a patient with no reported adverse event (poor quality product administered) (latency same day).  Human error: No   Does extended stability data cover the excursion:No   Administered to a patient: Yes  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle ache Low grade fever
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Reported Symptoms: 10015150:ERYTHEMA; Narrative: Other Relevant HX: Other: ERYTHEMA
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue oedema
Clinical narrative: Reported Symptoms:  10014257:EDEMA TONGUE;   Narrative:  Other Relevant HX: Other: tongue swelling
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC20, RSV, RV1
Symptoms: Diarrhoea, Product administered to patient of inappropriate age, Pyrexia, Wrong product administered
Clinical narrative: The patient was accidentally given Abrysvo (Adult RSV Vaccine) instead of Beyfortus.  The child developed a fever (100.8) and had 3 episodes of water diarrhea.  The on-call physician instructed the child parent to take the child to the local hospital for evaluation.
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No reaction. Asymptomatic. Patient received 3rd Hep A too soon.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received MMRV and Varicella vaccine inadvertently, on same day, resulted in an extra dose of varicella vaccine. At this point no reports of any adverse effects with the patient.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Vaginal ulceration, Vulvovaginal pain, Vulvovaginal swelling
Clinical narrative: Received Tdap as recommended during pregnancy. 36 hours after vaccination had swollen & painful vulva, which later developed into least 2 apthous ulcers on labia minora.  Currently 27 weeks pregnant, EDD 6/1/24.  No issues with baby currently.  This patient has had  2 previous episodes of post-vaccination vulvar ulcerations and previous VAERS reports.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: After administering the vaccine to the client  it was noted that the client may or may not have recieved both components of the Shingles vaccine. Meaning, the client either recieved the adjuvant only or did in fact receive the antigen. Immunization Coordinator was notified. Client was made aware and verbalized understanding. NO adverse reaction occurred. Per instructions from Immunization Coordinator, no further action is needed at this time. Currenlty awaiting for further guidance from Medical Director. Client will be notified of additional actions once received.
Age: 4.0
Sex: M
Vaccine: COVID19, FLU4, MMRV, VARCEL
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: incorrect dose administration of covid 19 vaccine- There are 3 doses in each vial and he was only supposed to get 1/3 of the vial but instead got a full vial.  Next day 2/22/24 Noted swelling , redness and left arm soreness. Mom applied a compress
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Patient developed a widespread (throughout entire body) red "spotty" rash, which was not described as itchy or raised. Rash developed approx 4-6 hours following vacctination and resolved with benadryl PO.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT REQUESTED 2023-2024 UPDATED COVID-19 MODERNA VACCINE.  PATIENT DENIED RECENT VACCINATION WITH 2023-2024 UPDATED COVID-19 VACCINE AND  CONSENTED TO RECEIVING VACCINE.  SPIKEVAX 12 YRS & OLDER WAS ADMINISTERED TO PATIENT.  THERE WERE NO SIGNS OR SYMPTOMS OF DISTRESS NOTED FOLLOWING ADMINISTRATION OF VACCINE. UPON REVIEWING CHARTS, IT WAS DISCOVERED THAT THE PATIENT RECEIVED A DOSE OF SPIKEVAX 12YRS & OLDER ON 11/2/23.  THE PATIENT WAS NOTIFIED.  THE PATIENT'S ELECTRONIC HEALTH RECORD AND IMMUNIZATION RECORD WERE UPDATED.  THE PATIENT PROVIDED MULTIPLE COVID VACCINE CARDS.  THE CARDS WERE COMBINDED AND UPDATED TO REFLECT THE PATIENT'S VACCINATION HISTORY.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, PNC20, VARCEL
Symptoms: Rash
Clinical narrative: Started with rash 10 minutes after vaccines was given on forehead and behind right ear.  Monitored for 30 minutes. Rash did not spread was was still present. Did not appear like hives. No respiratory symptoms or lip swelling.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Influenza virus test negative, Injection site erythema, Injection site induration, Injection site warmth, SARS-CoV-2 test negative
Clinical narrative: Left upper extremity with erythema and warmth to touch, hard, area measures 4x5 inches.  Treated with Keflex.  Size of redness has decreased in size.  Not able to tell if hardness has improved.  No longer warm to touch.  On 3/7 child had 20 minutes of violent vomiting.  Mom took to UC and all testing was negative.  No further vomiting after initial episode.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: Left upper extremity with erythema and warmth to touch, hard, area measures 4x5 inches.  Treated with Keflex.  Size of redness has decreased in size.  Not able to tell if hardness has improved.  No longer warm to touch.  On 3/7 child had 20 minutes of violent vomiting.  Mom took to UC and all testing was negative.  No further vomiting after initial episode.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Sensory loss, Tinnitus
Clinical narrative: Pt reports sudden onset of headache 4/10 , tinnitus to right ear and decreased sensation to right arm below the injection site. PNP notified of reaction and assessed pt.  Pt reported decreased headache and tinnitus and regaining sensation to right arm at 1546.
Age: 2.0
Sex: M
Vaccine: COVID19, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: incorrect dose administration-There are 3 doses in each vial and he was only supposed to get 1/3 of the vial but instead got a full vial
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Proteinuria
Clinical narrative: masses near axilla bilaterally found 3/5/2024
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 89.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Patient presented to the pharmacy on 3/7/2024  (20 days after vaccine administration) and 3 days after noticing the dark violet and swollen area on her right arm. Pharmacist observed a dark purple area on right arm above the elbow, 6 inches below injection site deltoid, about 8-9 inches length & 6 inches wide, wrapped around right arm. Mild swelling and normal body temp. Patient denies experiencing any other symptoms i.e. headache, fatigue, muscle aches, fever, nor injection site pain/redness post vaccination and date of assessment.  Patient was advised to self-treat with antihistamine to see if swelling and redness would go down, and referred to Urgent Care and/or ER for assessment to rule out a blood clot.  Called patient twice post pharmacy visit at 6pm 3/7/2024 and 9am 3/8/2024 to obtain details of medical history and follow up with self-care and result of Urgent Care/ER visit but calls went to voicemail. Left message for patient to call pharmacy for update on outcome/result of adverse event which is unknown at time of this documentation.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriogram carotid, Balance disorder, Erythema, Magnetic resonance imaging head abnormal, Pain in extremity
Clinical narrative: Arm was just red and a little sore, but about 2 weeks after 2nd shot I vomited violently, then went to bed and fell asleep.  I woke up the next morning feeling unbalanced.   I did not think to much of it.  When I saw my Dr. the middle of November and told him how I was feeling he immediately ordered an MRI of my brain and a carotid artery scan.  When the results came in they showed I had had 2 mini strokes, one in my cerebellum and the other in the right caudate nucleus.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Vomiting
Clinical narrative: Arm was just red and a little sore, but about 2 weeks after 2nd shot I vomited violently, then went to bed and fell asleep.  I woke up the next morning feeling unbalanced.   I did not think to much of it.  When I saw my Dr. the middle of November and told him how I was feeling he immediately ordered an MRI of my brain and a carotid artery scan.  When the results came in they showed I had had 2 mini strokes, one in my cerebellum and the other in the right caudate nucleus.
Age: 66.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Employee received expired vaccine. Thought expiration was 2024JUN07, but was actually 2024JAN07
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Rash maculo-papular
Clinical narrative: maculopapular rash
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Adverse reaction, Rash, Skin warm, Swelling, Tenderness
Clinical narrative: Swelled up and became bumpy and hot to the touch sore to the touch adverse reaction continues to grow in size
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Aphasia, Deafness, Dizziness, Dyskinesia, Electrocardiogram normal
Clinical narrative: I called my uber, while I was in the uber, I was on my way to work, I started feeling drowsy and getting sleepy, so I took a quick nap. Then once I closed my eyes, i felt like I blanked. Next thing I know, paramedics was waking me up and putting me into the ambulance. While I was in the ambulance, they started t explained t me that the uber driver called them due to me shaking. So they did an ekg, and they told her everything came back normal. But it seemed as though I had a seizure cause the right side of my tongue was swollen. The paramedics told me I was having a seizure when they arrived. The second one happened a couple weeks later in my bed room. I was talking on the phone and I felt it coming. Everything started getting black around me and I felt I was passing out. I couldn't move my mouth, and I caught the seziure before it actually occurred, I still bit my tongue. The third time was in January, the end of that month, I was at work walking with a co worker and and everything around me started getting dark again. I was trying to grab someone but couldn't talk. I fell in the hallway. The senators that was present called the paramedics to let them know I was having a seizure. The paramedics stated that I did not have a grand mal seziure due to me not urinating on myself. They transported me to Hospital located in. After that, they kept me for a few hours. They did an ekg, and mri, and for me to see an neurologist. They told me that they're not sure what could be causing the seziure. They're telling me it's an non epilepsy seizure, so what is it? The last seziure occured last night. I came back in from the state of the union. I was standing my my dining room table, then everything became dim and I couldnt say anything. My hearing left, and I try to hurry up and make it to the couch. Apparently I did, but I woke up on the couch and it's like I just blanked. The whole left side of my tongue is swollen, and I broke two nails.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Magnetic resonance imaging, Onychoclasis, Seizure, Somnolence
Clinical narrative: I called my uber, while I was in the uber, I was on my way to work, I started feeling drowsy and getting sleepy, so I took a quick nap. Then once I closed my eyes, i felt like I blanked. Next thing I know, paramedics was waking me up and putting me into the ambulance. While I was in the ambulance, they started t explained t me that the uber driver called them due to me shaking. So they did an ekg, and they told her everything came back normal. But it seemed as though I had a seizure cause the right side of my tongue was swollen. The paramedics told me I was having a seizure when they arrived. The second one happened a couple weeks later in my bed room. I was talking on the phone and I felt it coming. Everything started getting black around me and I felt I was passing out. I couldn't move my mouth, and I caught the seziure before it actually occurred, I still bit my tongue. The third time was in January, the end of that month, I was at work walking with a co worker and and everything around me started getting dark again. I was trying to grab someone but couldn't talk. I fell in the hallway. The senators that was present called the paramedics to let them know I was having a seizure. The paramedics stated that I did not have a grand mal seziure due to me not urinating on myself. They transported me to Hospital located in. After that, they kept me for a few hours. They did an ekg, and mri, and for me to see an neurologist. They told me that they're not sure what could be causing the seziure. They're telling me it's an non epilepsy seizure, so what is it? The last seziure occured last night. I came back in from the state of the union. I was standing my my dining room table, then everything became dim and I couldnt say anything. My hearing left, and I try to hurry up and make it to the couch. Apparently I did, but I woke up on the couch and it's like I just blanked. The whole left side of my tongue is swollen, and I broke two nails.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Swollen tongue, Tongue biting, Tremor, Visual impairment
Clinical narrative: I called my uber, while I was in the uber, I was on my way to work, I started feeling drowsy and getting sleepy, so I took a quick nap. Then once I closed my eyes, i felt like I blanked. Next thing I know, paramedics was waking me up and putting me into the ambulance. While I was in the ambulance, they started t explained t me that the uber driver called them due to me shaking. So they did an ekg, and they told her everything came back normal. But it seemed as though I had a seizure cause the right side of my tongue was swollen. The paramedics told me I was having a seizure when they arrived. The second one happened a couple weeks later in my bed room. I was talking on the phone and I felt it coming. Everything started getting black around me and I felt I was passing out. I couldn't move my mouth, and I caught the seziure before it actually occurred, I still bit my tongue. The third time was in January, the end of that month, I was at work walking with a co worker and and everything around me started getting dark again. I was trying to grab someone but couldn't talk. I fell in the hallway. The senators that was present called the paramedics to let them know I was having a seizure. The paramedics stated that I did not have a grand mal seziure due to me not urinating on myself. They transported me to Hospital located in. After that, they kept me for a few hours. They did an ekg, and mri, and for me to see an neurologist. They told me that they're not sure what could be causing the seziure. They're telling me it's an non epilepsy seizure, so what is it? The last seziure occured last night. I came back in from the state of the union. I was standing my my dining room table, then everything became dim and I couldnt say anything. My hearing left, and I try to hurry up and make it to the couch. Apparently I did, but I woke up on the couch and it's like I just blanked. The whole left side of my tongue is swollen, and I broke two nails.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Arthralgia, Back pain, Blood pressure increased, Bursitis
Clinical narrative: On January 30, 2024, I received my influenza vaccination during my annual well visit. According to the notes, I received the influenza vaccine, QUADRIVALENT (IIV4) (Fluarix, FluLaval, Fluzone) (Z23).  The shot was administered into the back of my upper left arm.  I do not recall the nurse washing her hands or using gloves. I do not recall if she used latex free supplies or bandage. (I am allergic to latex.) I have never received a shot in the back of my tricep before this.  The shot was extremely painful. My previous vaccines have not hurt like this.  Immediately after, I walked to the Lab area in my doctor?s office.  By the time I got there, I was already in pain all the way down to my wrist, my shoulder, my neck, and my upper back.  When I got to the car, I called my husband who is a physician to report what I was experiencing, and he thought it was unusual.  He said to take some Ibuprofen when I got home. By the time I got home, I had an excruciating headache, full body aches down to my ankles, my neck hurt very badly, and my legs felt so heavy that I had difficulty getting up the stairs to lay in my bed. I spent the rest of the day in bed as much as possible.  By the time my husband arrived home from work, there was a rash on my upper left arm, shoulder and upper back.  Over the next few days, the skin on the upper left quadrant of my back was a different color from the rest of my skin. I took ibuprofen and Tylenol for the pain in my arm, shoulder, back, neck and head.  I began experiencing intermittent chest pain, especially when lying down.  I began having frequent diarrhea and lost weight.  I was unable to sleep from the pain in my body. Within the next few weeks, I developed terrible pain in my lower back, had muscle spasms in my thighs, and my left arm continued to hurt with any use. By the first week in March, I was feeling completely exhausted from the pain and lack of sleep. I felt like I was in a constant state of panic, overwhelmed, and not formulating thoughts properly. Everything was very upsetting to me, and I felt emotional and paranoid.  I felt like I was dying. I was very scared and decided that the ibuprofen was not sufficient. I called my doctor on March 6th and was seen that day.    He assessed me with left shoulder pain, likely a reaction to flu shot- local and perhaps systemic.  Left trapezius pain and neck pain due to guarding of upper left arm (pain due to bursitis +/- tendinitis).  Poor sleep/anxiety due to not feeling well- which compounds other symptoms. He referred me to physical therapy for my shoulder, prescribed Celecoxib for inflammation and Trazadone for sleep. He discussed possibly using steroids in the future if necessary.  He advised me to follow up as needed.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Diarrhoea, Emotional distress, Fatigue, Fear
Clinical narrative: On January 30, 2024, I received my influenza vaccination during my annual well visit. According to the notes, I received the influenza vaccine, QUADRIVALENT (IIV4) (Fluarix, FluLaval, Fluzone) (Z23).  The shot was administered into the back of my upper left arm.  I do not recall the nurse washing her hands or using gloves. I do not recall if she used latex free supplies or bandage. (I am allergic to latex.) I have never received a shot in the back of my tricep before this.  The shot was extremely painful. My previous vaccines have not hurt like this.  Immediately after, I walked to the Lab area in my doctor?s office.  By the time I got there, I was already in pain all the way down to my wrist, my shoulder, my neck, and my upper back.  When I got to the car, I called my husband who is a physician to report what I was experiencing, and he thought it was unusual.  He said to take some Ibuprofen when I got home. By the time I got home, I had an excruciating headache, full body aches down to my ankles, my neck hurt very badly, and my legs felt so heavy that I had difficulty getting up the stairs to lay in my bed. I spent the rest of the day in bed as much as possible.  By the time my husband arrived home from work, there was a rash on my upper left arm, shoulder and upper back.  Over the next few days, the skin on the upper left quadrant of my back was a different color from the rest of my skin. I took ibuprofen and Tylenol for the pain in my arm, shoulder, back, neck and head.  I began experiencing intermittent chest pain, especially when lying down.  I began having frequent diarrhea and lost weight.  I was unable to sleep from the pain in my body. Within the next few weeks, I developed terrible pain in my lower back, had muscle spasms in my thighs, and my left arm continued to hurt with any use. By the first week in March, I was feeling completely exhausted from the pain and lack of sleep. I felt like I was in a constant state of panic, overwhelmed, and not formulating thoughts properly. Everything was very upsetting to me, and I felt emotional and paranoid.  I felt like I was dying. I was very scared and decided that the ibuprofen was not sufficient. I called my doctor on March 6th and was seen that day.    He assessed me with left shoulder pain, likely a reaction to flu shot- local and perhaps systemic.  Left trapezius pain and neck pain due to guarding of upper left arm (pain due to bursitis +/- tendinitis).  Poor sleep/anxiety due to not feeling well- which compounds other symptoms. He referred me to physical therapy for my shoulder, prescribed Celecoxib for inflammation and Trazadone for sleep. He discussed possibly using steroids in the future if necessary.  He advised me to follow up as needed.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Frequent bowel movements, Gait disturbance, Headache, Inflammation, Injection site pain
Clinical narrative: On January 30, 2024, I received my influenza vaccination during my annual well visit. According to the notes, I received the influenza vaccine, QUADRIVALENT (IIV4) (Fluarix, FluLaval, Fluzone) (Z23).  The shot was administered into the back of my upper left arm.  I do not recall the nurse washing her hands or using gloves. I do not recall if she used latex free supplies or bandage. (I am allergic to latex.) I have never received a shot in the back of my tricep before this.  The shot was extremely painful. My previous vaccines have not hurt like this.  Immediately after, I walked to the Lab area in my doctor?s office.  By the time I got there, I was already in pain all the way down to my wrist, my shoulder, my neck, and my upper back.  When I got to the car, I called my husband who is a physician to report what I was experiencing, and he thought it was unusual.  He said to take some Ibuprofen when I got home. By the time I got home, I had an excruciating headache, full body aches down to my ankles, my neck hurt very badly, and my legs felt so heavy that I had difficulty getting up the stairs to lay in my bed. I spent the rest of the day in bed as much as possible.  By the time my husband arrived home from work, there was a rash on my upper left arm, shoulder and upper back.  Over the next few days, the skin on the upper left quadrant of my back was a different color from the rest of my skin. I took ibuprofen and Tylenol for the pain in my arm, shoulder, back, neck and head.  I began experiencing intermittent chest pain, especially when lying down.  I began having frequent diarrhea and lost weight.  I was unable to sleep from the pain in my body. Within the next few weeks, I developed terrible pain in my lower back, had muscle spasms in my thighs, and my left arm continued to hurt with any use. By the first week in March, I was feeling completely exhausted from the pain and lack of sleep. I felt like I was in a constant state of panic, overwhelmed, and not formulating thoughts properly. Everything was very upsetting to me, and I felt emotional and paranoid.  I felt like I was dying. I was very scared and decided that the ibuprofen was not sufficient. I called my doctor on March 6th and was seen that day.    He assessed me with left shoulder pain, likely a reaction to flu shot- local and perhaps systemic.  Left trapezius pain and neck pain due to guarding of upper left arm (pain due to bursitis +/- tendinitis).  Poor sleep/anxiety due to not feeling well- which compounds other symptoms. He referred me to physical therapy for my shoulder, prescribed Celecoxib for inflammation and Trazadone for sleep. He discussed possibly using steroids in the future if necessary.  He advised me to follow up as needed.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Insomnia, Limb discomfort, Mental impairment, Muscle spasms
Clinical narrative: On January 30, 2024, I received my influenza vaccination during my annual well visit. According to the notes, I received the influenza vaccine, QUADRIVALENT (IIV4) (Fluarix, FluLaval, Fluzone) (Z23).  The shot was administered into the back of my upper left arm.  I do not recall the nurse washing her hands or using gloves. I do not recall if she used latex free supplies or bandage. (I am allergic to latex.) I have never received a shot in the back of my tricep before this.  The shot was extremely painful. My previous vaccines have not hurt like this.  Immediately after, I walked to the Lab area in my doctor?s office.  By the time I got there, I was already in pain all the way down to my wrist, my shoulder, my neck, and my upper back.  When I got to the car, I called my husband who is a physician to report what I was experiencing, and he thought it was unusual.  He said to take some Ibuprofen when I got home. By the time I got home, I had an excruciating headache, full body aches down to my ankles, my neck hurt very badly, and my legs felt so heavy that I had difficulty getting up the stairs to lay in my bed. I spent the rest of the day in bed as much as possible.  By the time my husband arrived home from work, there was a rash on my upper left arm, shoulder and upper back.  Over the next few days, the skin on the upper left quadrant of my back was a different color from the rest of my skin. I took ibuprofen and Tylenol for the pain in my arm, shoulder, back, neck and head.  I began experiencing intermittent chest pain, especially when lying down.  I began having frequent diarrhea and lost weight.  I was unable to sleep from the pain in my body. Within the next few weeks, I developed terrible pain in my lower back, had muscle spasms in my thighs, and my left arm continued to hurt with any use. By the first week in March, I was feeling completely exhausted from the pain and lack of sleep. I felt like I was in a constant state of panic, overwhelmed, and not formulating thoughts properly. Everything was very upsetting to me, and I felt emotional and paranoid.  I felt like I was dying. I was very scared and decided that the ibuprofen was not sufficient. I called my doctor on March 6th and was seen that day.    He assessed me with left shoulder pain, likely a reaction to flu shot- local and perhaps systemic.  Left trapezius pain and neck pain due to guarding of upper left arm (pain due to bursitis +/- tendinitis).  Poor sleep/anxiety due to not feeling well- which compounds other symptoms. He referred me to physical therapy for my shoulder, prescribed Celecoxib for inflammation and Trazadone for sleep. He discussed possibly using steroids in the future if necessary.  He advised me to follow up as needed.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain, Pain in extremity, Panic reaction, Paranoia
Clinical narrative: On January 30, 2024, I received my influenza vaccination during my annual well visit. According to the notes, I received the influenza vaccine, QUADRIVALENT (IIV4) (Fluarix, FluLaval, Fluzone) (Z23).  The shot was administered into the back of my upper left arm.  I do not recall the nurse washing her hands or using gloves. I do not recall if she used latex free supplies or bandage. (I am allergic to latex.) I have never received a shot in the back of my tricep before this.  The shot was extremely painful. My previous vaccines have not hurt like this.  Immediately after, I walked to the Lab area in my doctor?s office.  By the time I got there, I was already in pain all the way down to my wrist, my shoulder, my neck, and my upper back.  When I got to the car, I called my husband who is a physician to report what I was experiencing, and he thought it was unusual.  He said to take some Ibuprofen when I got home. By the time I got home, I had an excruciating headache, full body aches down to my ankles, my neck hurt very badly, and my legs felt so heavy that I had difficulty getting up the stairs to lay in my bed. I spent the rest of the day in bed as much as possible.  By the time my husband arrived home from work, there was a rash on my upper left arm, shoulder and upper back.  Over the next few days, the skin on the upper left quadrant of my back was a different color from the rest of my skin. I took ibuprofen and Tylenol for the pain in my arm, shoulder, back, neck and head.  I began experiencing intermittent chest pain, especially when lying down.  I began having frequent diarrhea and lost weight.  I was unable to sleep from the pain in my body. Within the next few weeks, I developed terrible pain in my lower back, had muscle spasms in my thighs, and my left arm continued to hurt with any use. By the first week in March, I was feeling completely exhausted from the pain and lack of sleep. I felt like I was in a constant state of panic, overwhelmed, and not formulating thoughts properly. Everything was very upsetting to me, and I felt emotional and paranoid.  I felt like I was dying. I was very scared and decided that the ibuprofen was not sufficient. I called my doctor on March 6th and was seen that day.    He assessed me with left shoulder pain, likely a reaction to flu shot- local and perhaps systemic.  Left trapezius pain and neck pain due to guarding of upper left arm (pain due to bursitis +/- tendinitis).  Poor sleep/anxiety due to not feeling well- which compounds other symptoms. He referred me to physical therapy for my shoulder, prescribed Celecoxib for inflammation and Trazadone for sleep. He discussed possibly using steroids in the future if necessary.  He advised me to follow up as needed.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site, Rash, Rotator cuff syndrome, Skin discolouration, Sleep disorder
Clinical narrative: On January 30, 2024, I received my influenza vaccination during my annual well visit. According to the notes, I received the influenza vaccine, QUADRIVALENT (IIV4) (Fluarix, FluLaval, Fluzone) (Z23).  The shot was administered into the back of my upper left arm.  I do not recall the nurse washing her hands or using gloves. I do not recall if she used latex free supplies or bandage. (I am allergic to latex.) I have never received a shot in the back of my tricep before this.  The shot was extremely painful. My previous vaccines have not hurt like this.  Immediately after, I walked to the Lab area in my doctor?s office.  By the time I got there, I was already in pain all the way down to my wrist, my shoulder, my neck, and my upper back.  When I got to the car, I called my husband who is a physician to report what I was experiencing, and he thought it was unusual.  He said to take some Ibuprofen when I got home. By the time I got home, I had an excruciating headache, full body aches down to my ankles, my neck hurt very badly, and my legs felt so heavy that I had difficulty getting up the stairs to lay in my bed. I spent the rest of the day in bed as much as possible.  By the time my husband arrived home from work, there was a rash on my upper left arm, shoulder and upper back.  Over the next few days, the skin on the upper left quadrant of my back was a different color from the rest of my skin. I took ibuprofen and Tylenol for the pain in my arm, shoulder, back, neck and head.  I began experiencing intermittent chest pain, especially when lying down.  I began having frequent diarrhea and lost weight.  I was unable to sleep from the pain in my body. Within the next few weeks, I developed terrible pain in my lower back, had muscle spasms in my thighs, and my left arm continued to hurt with any use. By the first week in March, I was feeling completely exhausted from the pain and lack of sleep. I felt like I was in a constant state of panic, overwhelmed, and not formulating thoughts properly. Everything was very upsetting to me, and I felt emotional and paranoid.  I felt like I was dying. I was very scared and decided that the ibuprofen was not sufficient. I called my doctor on March 6th and was seen that day.    He assessed me with left shoulder pain, likely a reaction to flu shot- local and perhaps systemic.  Left trapezius pain and neck pain due to guarding of upper left arm (pain due to bursitis +/- tendinitis).  Poor sleep/anxiety due to not feeling well- which compounds other symptoms. He referred me to physical therapy for my shoulder, prescribed Celecoxib for inflammation and Trazadone for sleep. He discussed possibly using steroids in the future if necessary.  He advised me to follow up as needed.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Headache, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: fever, vomiting, severe headache, back pain, and paresthesias in lower extremity
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Headache, Hypertension
Clinical narrative: Employee states she felt very dizzy, and had a headache after receiving second Hep A vaccine. Denied having any reaction to first Hep A vaccine she received or any other vaccines "except for COVID 19". ( this was not disclosed to RN until she returned to office). Employee was found to have very high blood pressure (on meds) 174/110, 196/105. Vaccine given at 8:51 AM and employee notified employee health staff at 11:18 AM
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Erythema multiforme, Eye swelling, Rash, Urticaria
Clinical narrative: initially developed swollen eyes, then rash consistent with hives and erythema multiforme
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blindness unilateral, Optic ischaemic neuropathy
Clinical narrative: Sudden vision loss in right eye. Eye stroke that resulted in permanent partial vision loss in right eye. No preexisting conditions related to final diagnosis of NAION.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction, 11 year old patient received 12 and up covid vaccine.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE WAS ADMINISTERED. GUARDIAN NOTIFIED. VACCINATION RE-ADMINISTERED AS SOON AS POSSIBLE.
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: significant erythema, edema, pain right upper extremity
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Pyrexia
Clinical narrative: Severe diarrhea, fever, chills, stomach ache, weakness, vomiting, beginning 7 Mar 2024, approximately 18 hrs after injection.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe diarrhea, fever, chills, stomach ache, weakness, vomiting, beginning 7 Mar 2024, approximately 18 hrs after injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Influenza like illness, Injection site bruising, Injection site erythema
Clinical narrative: Pain at injection site first night, tested with ice. Upper arm soreness next morning, with flu-like symptoms developing by 1:30 (upset stomach, body aches, chills, slight fever). Treated with rest and fluids. Flu symptoms gone by morning of March 8, but have bruising, redness and hard, sore spots around injection site today (March 8).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Pain, Pyrexia
Clinical narrative: Pain at injection site first night, tested with ice. Upper arm soreness next morning, with flu-like symptoms developing by 1:30 (upset stomach, body aches, chills, slight fever). Treated with rest and fluids. Flu symptoms gone by morning of March 8, but have bruising, redness and hard, sore spots around injection site today (March 8).
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: Pruritic rash on anterior chest and posterior neck
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Headache, Injection site swelling, Pyrexia
Clinical narrative: patient had sever swelling at sit of injection in left arm and went down to the elbow; patient also had some shortness of breath and headache with fever
Age: 23.0
Sex: F
Vaccine: HEP, HPV9, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Client denied pregnancy verbally in office to RN. Client called office 1.5 hours later to tell RN that she was pregnant. Client given information per CDC about Vaccines and pregnancy. Submitted to Merck per CDC protocol.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Female, 17 y/o that came to the office whith her mother for HPV vaccine (order placed by Dr), checked in 4.34 pm. Order verified, consent obtained. Right after injection patient feels dizzy, pale, and diaphoretic. Patient was placed in trendelemburg position, offer to breath alcohol pads for around 5 minutes. BP: 80/52mmHg - HR: 52min - Sat O2: 90%. After 10 minutes of observation verbalize feeling better with vital signs BP: 100/68 HR: 84bpm Sat O2: 98%. Evaluated by Dr during this event. Patient left the procedure room in stable condition with his mother.
Age: 82.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Death
Clinical narrative: Patient daughter states patient  recieved Spikevax(Covid) vaccine and Fluzone HD(Flu shot) and 4 days later her father died
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site induration, Injection site rash, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt. states arms started hurting  and were sore the day after immunizations, pain in rt. arm stopped, but left arm  got worse,  Pt. also developed rash & hardness  around shot site which improved but rash was back today on exam.   had a raised slightly warm irregular patch that was 10.3cm vertical on arm and 7 cm horizontal , was not totally around the arm, no blisters. no axillary lymph node enlargement.  Patient was given oral steroids for 5 days, instructed to use over the counter benadryl and ibuprofen for pain and swelling. Informed Father to monitor for increased redness or swelling, if the rash goes completely around the arm will need to be re-seen.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received #2 doses of the vaccine within 30 minutes of each other. No adverse reaction was noted.