chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This RN did a flu clinic on 10/12/2023 for the nursing faculty. Today, this RN just received the following email from a faculty member that was administered the flu vaccine from this RN:   "Hi reporter,  I got a flu shot on Oct. 12th at flu clinic. Since then, I've had unusual right shoulder pain in the joint area, rating it at 6/10 in intensity. The pain hasn't subsided, and I've taken IBU twice daily for almost two weeks. My healthcare provider suspects a possible shoulder injury from the vaccine (SIRVA). I have an appointment on Thursday, Oct. 26th, at 1:15  and I'll have more information after that evaluation. I've also switched my primary provider and never set up a portal. I request a copy of my flu vaccination record for my work requirements. Thanks for your assistance.   Best regards,  Patient  -- EdD, MSN, RN, AMB-BC"  The vaccine was kept within appropriate temperature before administration, and appropriate needle length of 1" was used for vaccination of this individual. This RN has given hundreds of vaccines over her 6 year career, and always takes care to palpate the Acromion Process, properly sanitize the vaccination site with alcohol, and to vaccinate about an inch below the Acromion Process (depending on patient's anatomy). This RN has never had a complaint like this. This RN encouraged the patient to seek further medical care to determine the cause of his shoulder pain and provided him a copy of his influenza vaccine that he will be able to pick up at the front desk of the clinic per his request.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood urea, Differential white blood cell count, Eczema, Full blood count
Clinical narrative: Rash on groin began one week after receiving vaccine. Rash and hives spread over entire body except neck, face, hands, and feet. No other symptoms (fever, dizziness, or shortness of breath), just a VERY itchy rash on body. After 3rd day, a doctor via telephone appointment stated I had yeast infections in my groin and armpits and eczema on other parts of my body; she prescribed Triamcinolone 0.5% Cream for the eczema. I used the cream for a day or two and did not improve. I saw another doctor in-person two days later, she did not know what it was and just prescribed OTC hydrocortisone cream and referred me to a dermatologist. I saw a dermatologist the next day and she advised that it was a reaction to the Pfzier booster I received the week earlier. She prescribed Hydroxyz Hcl 10 Mg Tab Kvkt and Prednisone 10 Mg Tablet. I am currently on my fifth day of medication and am seeing a slow progress in the rash. I still have hives on my body but they are flat now instead of raised; they are still itchy at times but the topical ointments have helped.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Liver function test, Rash, Rash pruritic, Urticaria
Clinical narrative: Rash on groin began one week after receiving vaccine. Rash and hives spread over entire body except neck, face, hands, and feet. No other symptoms (fever, dizziness, or shortness of breath), just a VERY itchy rash on body. After 3rd day, a doctor via telephone appointment stated I had yeast infections in my groin and armpits and eczema on other parts of my body; she prescribed Triamcinolone 0.5% Cream for the eczema. I used the cream for a day or two and did not improve. I saw another doctor in-person two days later, she did not know what it was and just prescribed OTC hydrocortisone cream and referred me to a dermatologist. I saw a dermatologist the next day and she advised that it was a reaction to the Pfzier booster I received the week earlier. She prescribed Hydroxyz Hcl 10 Mg Tab Kvkt and Prednisone 10 Mg Tablet. I am currently on my fifth day of medication and am seeing a slow progress in the rash. I still have hives on my body but they are flat now instead of raised; they are still itchy at times but the topical ointments have helped.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Vertigo
Clinical narrative: Comirnaty Vaccine Brand Vertigo with some nausea that has now lasted a week. MD prescribed Antivert and Epley maneuver.  Not working
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Hypoaesthesia, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: patient complained after vaccine later that evening she developed swelling in left arm, pain in left arm, swelling to left axilla, slight numbness left hand, "could not wear her wedding ring due to swelling in fingers", reported blurry vision the following day, fatigue and malaise which improved over the course of a few days, however pain in arm persisted and swelling in left axilla for over 5 days
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Vision blurred
Clinical narrative: patient complained after vaccine later that evening she developed swelling in left arm, pain in left arm, swelling to left axilla, slight numbness left hand, "could not wear her wedding ring due to swelling in fingers", reported blurry vision the following day, fatigue and malaise which improved over the course of a few days, however pain in arm persisted and swelling in left axilla for over 5 days
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site erythema, Injection site pustule, Injection site vesicles, Injection site warmth
Clinical narrative: 30 minutes after arm pain. Next day arm pain, joint pain, muscle aches. Took Tylenol for pain. On day 8  noticed small blister/pustule  at injection site when I scratched arm, it broke open, Redness, warm to touch, NO fever. Symptom's continued for 10 days. Contacted PCP via patient portal on 10/22/23. Was advised of allergic reaction on 10/23/22. PCP recommended antihistamine. Took Claritin. Joint pain, Muscle aches, arm pain not as severe.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: 30 minutes after arm pain. Next day arm pain, joint pain, muscle aches. Took Tylenol for pain. On day 8  noticed small blister/pustule  at injection site when I scratched arm, it broke open, Redness, warm to touch, NO fever. Symptom's continued for 10 days. Contacted PCP via patient portal on 10/22/23. Was advised of allergic reaction on 10/23/22. PCP recommended antihistamine. Took Claritin. Joint pain, Muscle aches, arm pain not as severe.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus infection, Epstein-Barr virus test positive
Clinical narrative: Epstein-Barr virus.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Seizure like phenomena
Clinical narrative: Chills described as almost like seizures, aching, fever
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Chest X-ray, Computerised tomogram thorax abnormal, Echocardiogram, Haemoptysis
Clinical narrative: BLOOD CLOT IN LEFT LUNG, PATIENT WOKE UP IN HORRIBLE PAIN UNDER LEFT RIB, THURSDAY HE COUGHED UP A "CLOT OF BLOOD" PATIENT WENT BACK TO ER AND WAS THERE FOR 2 DAYS AND STARTED ON BLOOD THINNERS.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pulmonary thrombosis, Sleep disorder
Clinical narrative: BLOOD CLOT IN LEFT LUNG, PATIENT WOKE UP IN HORRIBLE PAIN UNDER LEFT RIB, THURSDAY HE COUGHED UP A "CLOT OF BLOOD" PATIENT WENT BACK TO ER AND WAS THERE FOR 2 DAYS AND STARTED ON BLOOD THINNERS.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain lower, Arthralgia
Clinical narrative: Bilateral hip and lower abdominal pain/discomfort
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Patient inadvertently administered formulation for under 65. Suboptimal dose for age.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Oral Rotateq administered No reaction, no signs or symptoms
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Vaccination error
Clinical narrative: vaccine diluent used was sterile water not 0.9% sodium chloride - vaccine error but no adverse event. Patient re-vaccinated.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: patient got influenza vaccine at 2 months of age due to medical assistant error.
Age: 61.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Tinnitus
Clinical narrative: Tinnitus in right ear
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Poor quality product administered
Clinical narrative: Patient received  suboptimal formulation of flu vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site irritation, Musculoskeletal discomfort, Skin warm
Clinical narrative: 48 hours after time of administration redness, discomfort in shoulder, irritation at site of injection, warm to the touch
Age: 61.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Insomnia, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: PER PT: ARM PAIN, INSOMNIA, SWOLLEN LYMPH NODES,MUSCLE PAIN
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm pain, headache, body aches, chills, fever 101 degrees, fatigue.  This lasted all day from 8am to 8pm when I went to bed.  I woke up the next morning feeling fine again.  I have never had this adverse effect with any of the other Pfizer Covid vaccines.  I literally had to take a "sick day" because I did not get anything done this day.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray normal, Diarrhoea, Dyspnoea, Haematology test normal
Clinical narrative: no adverse event related to the vaccine, but patient was admitted to the Adult Care Unit for COVID-related issues on 10/15/2023.   Presented to the ED the same day for chief complaints of nausea, vomiting, diarrhea that began the night before.  From ED physician note:  This is a 62-year-old female with a history of borderline diabetes and obesity who is presenting with nausea, vomiting and diarrhea starting last night, as well as shortness of breath which she states is actually more of a chronic issue.  She was found to be hypoxic to the mid 80s on room air, COVID-positive.  X-ray shows no evidence of lobar pneumonia.  She does not appear to be systemically ill or toxic.  She has a completely benign abdominal examination with no major metabolic or hematologic abnormalities.  I do not suspect an acute intra-abdominal process that would warrant a CT scan at this time.  Likewise I do not suspect an alternative acute cardiac or pulmonary process.  As mentioned above she was placed on 2 L nasal cannula, with oxygen saturations now in the mid 90s.  Given her COVID?19 and hypoxia she will need to be admitted to the hospital for further care.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoxia, Metabolic function test normal, Nausea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: no adverse event related to the vaccine, but patient was admitted to the Adult Care Unit for COVID-related issues on 10/15/2023.   Presented to the ED the same day for chief complaints of nausea, vomiting, diarrhea that began the night before.  From ED physician note:  This is a 62-year-old female with a history of borderline diabetes and obesity who is presenting with nausea, vomiting and diarrhea starting last night, as well as shortness of breath which she states is actually more of a chronic issue.  She was found to be hypoxic to the mid 80s on room air, COVID-positive.  X-ray shows no evidence of lobar pneumonia.  She does not appear to be systemically ill or toxic.  She has a completely benign abdominal examination with no major metabolic or hematologic abnormalities.  I do not suspect an acute intra-abdominal process that would warrant a CT scan at this time.  Likewise I do not suspect an alternative acute cardiac or pulmonary process.  As mentioned above she was placed on 2 L nasal cannula, with oxygen saturations now in the mid 90s.  Given her COVID?19 and hypoxia she will need to be admitted to the hospital for further care.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Mass, Pain, Skin warm
Clinical narrative: Patient reports a lump that started the night after vaccine. The lump is painful and is hot to the touch.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: patient states his right arm is ache. pt states he was dizzy after the vaccine but that resolved the next day. patient states he has difficulty walking but upon further questionning to get more details patient stated that he always has difficulty walking due to age. I advised patient to seek care form his provider
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac monitoring abnormal, Electrocardiogram abnormal, Palpitations, Ventricular extrasystoles
Clinical narrative: Heart palpitations- frequent PVCs.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Dysphagia, Paraesthesia oral, Throat irritation, Throat tightness
Clinical narrative: Patient stated that after two hours of administration, she felt that her tongue and lips were tingling. Her throat felt tight and scratchy. She felt that she was having a tough time swallowing. We gave her 10ml of Benadryl liquid 12.5mg/5ml. She left the pharmacy against the pharmacist's recommendation. She was advised to come back, but she said she will be fine, so she stayed home. Informed patient to call EMS if symptoms worsen or have trouble breathing.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse sequelae. Patient received suboptimal formulation for age.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Albumin globulin ratio, Anion gap, Aspartate aminotransferase normal, Basophil count, Basophil percentage
Clinical narrative: Single episode seizure (no prior history of seizures), witnessed by wife. Seizure consisted of thrashing around with foaming at mouth middle of night.  EMS found postictal with gradual clearing of senses. No residual symptoms after time in emergency department. Discharged by afternoon of the same day with levetiracetam 750mg BID (500mg tabs 1.5 tabs BID).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood creatinine normal
Clinical narrative: Single episode seizure (no prior history of seizures), witnessed by wife. Seizure consisted of thrashing around with foaming at mouth middle of night.  EMS found postictal with gradual clearing of senses. No residual symptoms after time in emergency department. Discharged by afternoon of the same day with levetiracetam 750mg BID (500mg tabs 1.5 tabs BID).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal
Clinical narrative: Single episode seizure (no prior history of seizures), witnessed by wife. Seizure consisted of thrashing around with foaming at mouth middle of night.  EMS found postictal with gradual clearing of senses. No residual symptoms after time in emergency department. Discharged by afternoon of the same day with levetiracetam 750mg BID (500mg tabs 1.5 tabs BID).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Carbon dioxide, Drug screen negative, Electrocardiogram abnormal, Eosinophil count normal, Foaming at mouth
Clinical narrative: Single episode seizure (no prior history of seizures), witnessed by wife. Seizure consisted of thrashing around with foaming at mouth middle of night.  EMS found postictal with gradual clearing of senses. No residual symptoms after time in emergency department. Discharged by afternoon of the same day with levetiracetam 750mg BID (500mg tabs 1.5 tabs BID).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Globulin, Glomerular filtration rate, Haemoglobin decreased, Immature granulocyte count, Lymphocyte count
Clinical narrative: Single episode seizure (no prior history of seizures), witnessed by wife. Seizure consisted of thrashing around with foaming at mouth middle of night.  EMS found postictal with gradual clearing of senses. No residual symptoms after time in emergency department. Discharged by afternoon of the same day with levetiracetam 750mg BID (500mg tabs 1.5 tabs BID).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphocyte percentage, Magnetic resonance imaging normal, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: Single episode seizure (no prior history of seizures), witnessed by wife. Seizure consisted of thrashing around with foaming at mouth middle of night.  EMS found postictal with gradual clearing of senses. No residual symptoms after time in emergency department. Discharged by afternoon of the same day with levetiracetam 750mg BID (500mg tabs 1.5 tabs BID).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Mean platelet volume, Monocyte count, Monocyte percentage, Neutrophil count, Neutrophil percentage
Clinical narrative: Single episode seizure (no prior history of seizures), witnessed by wife. Seizure consisted of thrashing around with foaming at mouth middle of night.  EMS found postictal with gradual clearing of senses. No residual symptoms after time in emergency department. Discharged by afternoon of the same day with levetiracetam 750mg BID (500mg tabs 1.5 tabs BID).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Platelet count decreased, Postictal state, Protein total normal, Red blood cell count decreased, Red cell distribution width normal
Clinical narrative: Single episode seizure (no prior history of seizures), witnessed by wife. Seizure consisted of thrashing around with foaming at mouth middle of night.  EMS found postictal with gradual clearing of senses. No residual symptoms after time in emergency department. Discharged by afternoon of the same day with levetiracetam 750mg BID (500mg tabs 1.5 tabs BID).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure, Sinus rhythm, White blood cell count
Clinical narrative: Single episode seizure (no prior history of seizures), witnessed by wife. Seizure consisted of thrashing around with foaming at mouth middle of night.  EMS found postictal with gradual clearing of senses. No residual symptoms after time in emergency department. Discharged by afternoon of the same day with levetiracetam 750mg BID (500mg tabs 1.5 tabs BID).
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Poor quality product administered
Clinical narrative: Patient administered suboptimal dose for age. No adverse sequelae.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac operation, Condition aggravated, Electrocardiogram ambulatory abnormal, Palpitations
Clinical narrative: My son had had heart palpitations 3 times over a period of one year. I expressed my reluctance to get his COVID vaccine because of this and had consulted with a doctor and his school and was told that it was mandatory for him to be able to attend school. Within two days of his first shot he had another heart episode and from there he started having them weekly. As his heart rate was over 200bpm his doctor recommended that he have heart surgery and he finally had surgery on 4/8/22. I have a very long list of his regular heart episodes with some print outs of when we managed to capture it on a monitor. Happy to provide the documentation. I bought a kardia heart monitor so that I could monitor what was happening for his doctor.
Age: 59.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose of Shingrix prior to the 60 day mark.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Nausea, Pallor, Rash erythematous
Clinical narrative: 30 min after vaccine, noted to appear pale, nauseated, abd pain and faint pink rash on body., lasted about 20 min.
Age: 63.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Dizziness, Sensory disturbance
Clinical narrative: AFTER RECEIVING THE LAST VACCINE, PATIENT STATED THAT SHE MAY LOOSE CONSCIOUSNESS AND THAT HER FACE AND RIGHT HAND FELT LIKE THEY WERE LOCKED. I STAYED WITH THE PATIENT AND FANNED HER FACE AND NECK TO MAKE AIR MOVING. SHE STAYED AWAKE AND MAYBE 5-7 MINUTES LATER STARTED FEELING BETTER AND WAS ABLE TO  WALK. I GAVE PATIENT SOME WATER AND ASKED HER TO REMAIN IN THE WAITING ROOM FOR ANOTHER 30 MINUTES. I CALLED PATIENT AT 8:25 PM AND SHE STATED SHE DID NOT HAVE ANY ISSUES AND WAS FEELING FINE.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Electrocardiogram, Gait inability, Incontinence
Clinical narrative: HIS LEGS AND ARMS HAD NO STREGTH. HE COULD NOT WALK OR PUSH HIMSELF OUT OF A CHAIR. WE HAD TO CALL MEDICS SINCE WE COULD NOT EVEN GET HIM UP OR TO THE BATHROOM. HE HAD AN ACCIDENT IN HIS CHAIR BUT DOESN'T REMEMBER IT AT ALL.  IN ER AROUND 10PM HE WAS ABLE TO LIFT HIS LEGS ON COMMAND. BEFORE THAT IT WAS LIKE HIS BRAIN WAS NOT ABLE TO COMMUNICATE WITH HIS LEGS OR ARMS.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Mobility decreased, Prothrombin time, Urine analysis
Clinical narrative: HIS LEGS AND ARMS HAD NO STREGTH. HE COULD NOT WALK OR PUSH HIMSELF OUT OF A CHAIR. WE HAD TO CALL MEDICS SINCE WE COULD NOT EVEN GET HIM UP OR TO THE BATHROOM. HE HAD AN ACCIDENT IN HIS CHAIR BUT DOESN'T REMEMBER IT AT ALL.  IN ER AROUND 10PM HE WAS ABLE TO LIFT HIS LEGS ON COMMAND. BEFORE THAT IT WAS LIKE HIS BRAIN WAS NOT ABLE TO COMMUNICATE WITH HIS LEGS OR ARMS.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Malaise, Pruritus, Pyrexia
Clinical narrative: PATIENT STATES THAT ALMOST IMMEDIATELY SHE DEVELOPED A FEVER AND CHILLS BUT IT DID NOT SUBSIDE AND THEN SHE BEGAN TO HAVE CHEST PAIN AND ITCHING - STILL NOT WELL AT TIME OF REPORT
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Gait disturbance, Headache, Malaise, Tendon pain
Clinical narrative: First off, I've been an avid runner / workout (9-10x week), former elite triathlete and take care of my body very well and know injury maintenance /massage for the last 18 years.  The Moderna vaccine on 10/10/23 put me down the next day pretty good, I did not workout on 10/11/23 due to the headache / not feeling well.  Around lunchtime I noticed my left achilles was sore when I stood up and went out to run some errands.   This pain felt like it was on the verge of pulling/tearing achilles.  So I rested with no workout the rest of the week and the pain rescinded with continuous calf massage with a massage stick, making sure not to get anywhere close to my Achilles to aggravate it.   I decided to go for a small run on 10/16/23 for 1 mile (very easy) but felt my left Achilles was tight so did not run anymore.   (I've ran 15-35 miles a week for 15 years).   On 10/21 I went out for a 3 mile run (easy) and right after the run (1-2 hours) my lower right calf is tight as it's ever been, and as I noted, it was an easy run.   Now I have a left Achilles that is tight and a right lower calf that is very tight.   I can barely walk due to the soreness.     Furthermore, I've had persistent tinnitus after the vaccine as well.      Feel free to reach out to me as this information should be made public as I see some Achilles tears in some papers however they still do not associate it to the vaccine it seems.   I can 100% tell you this was due to the vaccine.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: First off, I've been an avid runner / workout (9-10x week), former elite triathlete and take care of my body very well and know injury maintenance /massage for the last 18 years.  The Moderna vaccine on 10/10/23 put me down the next day pretty good, I did not workout on 10/11/23 due to the headache / not feeling well.  Around lunchtime I noticed my left achilles was sore when I stood up and went out to run some errands.   This pain felt like it was on the verge of pulling/tearing achilles.  So I rested with no workout the rest of the week and the pain rescinded with continuous calf massage with a massage stick, making sure not to get anywhere close to my Achilles to aggravate it.   I decided to go for a small run on 10/16/23 for 1 mile (very easy) but felt my left Achilles was tight so did not run anymore.   (I've ran 15-35 miles a week for 15 years).   On 10/21 I went out for a 3 mile run (easy) and right after the run (1-2 hours) my lower right calf is tight as it's ever been, and as I noted, it was an easy run.   Now I have a left Achilles that is tight and a right lower calf that is very tight.   I can barely walk due to the soreness.     Furthermore, I've had persistent tinnitus after the vaccine as well.      Feel free to reach out to me as this information should be made public as I see some Achilles tears in some papers however they still do not associate it to the vaccine it seems.   I can 100% tell you this was due to the vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU4, HPV9
Symptoms: Hypotension, Loss of consciousness, Nausea, Seizure
Clinical narrative: Patient was fine after the covid and flu shot; however, after the gardasil shot she proceeded to have a small seizure lasting less than 1 minute where she did loose consciousness. Upon regaining consciousness, she was extremely nauseous. EMS was called and she was directed to the hospital especially since she had extreme hypotension
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Rash on arm
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: 3-day headache, fever, chills, body aches for 2 days, swelling pain and rash extending from injection site in a band around my arm toward lymph node only fading on Sunday following jab on Tuesday, tired and feeling wrung out. Arm is still slightly sore today, 7 days after. Tylenol only to treat. This is my 4th Moderna vaccine (1 Pfizer). Side effects worsen with each dose. Possibly I'm developing an allergy to some component of this vaccine. My next one will be Pfizer.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: 3-day headache, fever, chills, body aches for 2 days, swelling pain and rash extending from injection site in a band around my arm toward lymph node only fading on Sunday following jab on Tuesday, tired and feeling wrung out. Arm is still slightly sore today, 7 days after. Tylenol only to treat. This is my 4th Moderna vaccine (1 Pfizer). Side effects worsen with each dose. Possibly I'm developing an allergy to some component of this vaccine. My next one will be Pfizer.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Injection site become inflamed, swollen and bump appears right away. I called patient after few hours and patient said that he is fine with no inflammation or swelling .
Age: 10.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product dispensing error
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient presented for a COVID and influenza vaccine on 10/27/2023.  Upon entering the Moderna Spikevax vaccination into the state immunization registry it was discovered that she had received Comirnaty on 9/27/23 at another vaccination site.
Age: 79.0
Sex: U
Vaccine: COVID19, FLU4, RSV
Symptoms: Body temperature increased, Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: Got the three vaccines in left arm and that night had pain and redness and had temperature of 102F.  Woke up with pain in arm and rash going down to elbow. Rash has continued down arm and felt itching up until today.
Age: 79.0
Sex: U
Vaccine: COVID19, FLU4, RSV
Symptoms: Rash
Clinical narrative: Got the three vaccines in left arm and that night had pain and redness and had temperature of 102F.  Woke up with pain in arm and rash going down to elbow. Rash has continued down arm and felt itching up until today.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Consciousness fluctuating, General physical condition abnormal, Malaise, Posture abnormal, Respiration abnormal
Clinical narrative: I was conducting a vaccine clinic at a local school. The patient was unhappy and apprehensive about getting the vaccine when she arrived. Patient finally agreed to get the vaccine and after I administered the vaccine she said she did not feel well and slumped over slightly. Her mother was by her side supporting her and talking her through it. She then put her head back and  was breathing heavily. She seemed to go in and out of consciousness initially. After a few seconds, she appeared a little dazed but alert within approximately 40 to 60 seconds. My technician got her a drink of water and  I offered to call 911 but patient's mother did not think it was necessary. Patient went back to her mother's office instead of going back to the classroom. We checked on the patient at the end of the clinic and she had gone home to rest. The clinic coordinator was asked to notify us if there was any additional concerns.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Mass, Pain in extremity, Peripheral swelling
Clinical narrative: The left arm started to itch, I scratched on top of the bandaid. The arm began to swell slightly. Itch started to spread deeper into the arm flesh. There was pain but not too bad. By Morning 5am Sunday the arm had a 3"x3" round oval red inflamed lump the size of a large egg. it is hot to the touch. It is spongy. It fells like a 2nd degree chemical burn. or sun burn. I tried witch-hazel. no difference. no change. I tried neosporin antibiotic clear cream. no change. I tried benedryl  oral 25mg. no change. I tried motrin 400mg and icing it. no change. I tried calamine lotion pink lotion dabbed on with cotton ball. slight change . it took the sting out slightly. and swelling down slightly. I will see the doctor on Tuesday 102423. I will most likely continue with calamine lotion.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin warm
Clinical narrative: The left arm started to itch, I scratched on top of the bandaid. The arm began to swell slightly. Itch started to spread deeper into the arm flesh. There was pain but not too bad. By Morning 5am Sunday the arm had a 3"x3" round oval red inflamed lump the size of a large egg. it is hot to the touch. It is spongy. It fells like a 2nd degree chemical burn. or sun burn. I tried witch-hazel. no difference. no change. I tried neosporin antibiotic clear cream. no change. I tried benedryl  oral 25mg. no change. I tried motrin 400mg and icing it. no change. I tried calamine lotion pink lotion dabbed on with cotton ball. slight change . it took the sting out slightly. and swelling down slightly. I will see the doctor on Tuesday 102423. I will most likely continue with calamine lotion.
Age: 0.42
Sex: M
Vaccine: DTPPVHBHPB, HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: none noted - no obvious signs/symptoms Gardasil not indicated for 5 mo. baby, inadvertently given in place of Prevnar.
Age: 49.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Atrial fibrillation, Condition aggravated, Electrocardiogram ambulatory abnormal
Clinical narrative: Possibly triggered my Afib. Only rarely have it. It went away with medication. Note: unsure of brand of flu vaccine. May be incorrect.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: CSF virus identified, Confusional state, Dizziness, Headache, Hypoacusis
Clinical narrative: Patient received Moderna updated Covid-19 vaccine on 9/21/2023. Patient developed Flu like symptoms on 9/26/2023. Patient developed progressive headache, dizziness, tinnitus, decreased hearing, confusion, was admitted on 10/14/2023 . Patient was diagnosed with Varicella Zoster Meningitis.  Patient developed Non sustained Ventricular Tachycardia on 10/19/23.  Patient was started on Acyclovir 800 mg IV every 8 hour on 10/15/2023 and is planned until 11/06/2023.  Patient received Solu-Medrol 1 g IV QD x 3 days. Neurology considered IVIG but was not ordered.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Tinnitus, Varicella meningitis, Ventricular tachycardia
Clinical narrative: Patient received Moderna updated Covid-19 vaccine on 9/21/2023. Patient developed Flu like symptoms on 9/26/2023. Patient developed progressive headache, dizziness, tinnitus, decreased hearing, confusion, was admitted on 10/14/2023 . Patient was diagnosed with Varicella Zoster Meningitis.  Patient developed Non sustained Ventricular Tachycardia on 10/19/23.  Patient was started on Acyclovir 800 mg IV every 8 hour on 10/15/2023 and is planned until 11/06/2023.  Patient received Solu-Medrol 1 g IV QD x 3 days. Neurology considered IVIG but was not ordered.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Death, Life support, Withdrawal of life support
Clinical narrative: The inoculations occurred on 02/27/21 and 03/27/21.  The Lot number for Dose1 was 001A21A.  The Lot number for Dose2 was 025A21A.  A mutual friend of the decendent is/was an employee of hospital.  The deceased was a high BMI, male with a prior history having a stroke that resulted in comatose about ten years ago prior to inoculation with two doses of Moderna.  During a martial arts training session the victim had a stroke.  He was transported to hospital.  He was placed on life support.  A few days later life support was withdrawn.  At his funeral his jiujitsu instructor stated he had a heart attack prior to the stroke event.  I am not aware if the heart attack occurred before or after inoc
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tendon disorder
Clinical narrative: 2 days after injection in left arm the tendon going across the top of my left hand going out to my left  thumb started feeling kind of weird like I had pulled a muscle or something. And the tendons on the  backside of my left leg from the knee joint all the way down to my foot started feeling unusually tired all  the time. its been over two weeks now and both the hand and the leg haven't got any better
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against and then tested positive for COVID-19
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt came to pharmacy on 5/24/23 for her first shingles vaccine. She filled out the consent form verbally with pharmacist. Pharmacist dropped the vaccine batch at 1:45PM. Batch was verified at 1:46PM. Pharmacist mixed the vaccine at 1:47PM, administration of vaccine was between 1:48-1:51PM. Pharmacist has no recollection of the interaction, nothing remarkable occurred. Pharmacist is diligent in his vaccination administration and follow a steady routine of palpating the deltoid muscle as he moves for injection squeezing the deltoid off the humorous being to ensure proper vaccine technique within the center of the deltoid.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Pt came to pharmacy on 5/24/23 for her first shingles vaccine. She filled out the consent form verbally with pharmacist. Pharmacist dropped the vaccine batch at 1:45PM. Batch was verified at 1:46PM. Pharmacist mixed the vaccine at 1:47PM, administration of vaccine was between 1:48-1:51PM. Pharmacist has no recollection of the interaction, nothing remarkable occurred. Pharmacist is diligent in his vaccination administration and follow a steady routine of palpating the deltoid muscle as he moves for injection squeezing the deltoid off the humorous being to ensure proper vaccine technique within the center of the deltoid.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Death
Clinical narrative: Patient went to bed in his normal state of health the night he received his vaccine and was found deceased upon family waking the following morning; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2671468-1. The original narrative from the sender is the following:  Patient went to bed in his normal state of health the night he received his vaccine and was found deceased upon family waking the following morning.  Treatment medication included nystatin oral solution prescribed on 07-AUG-2023, but unsure if started.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "Patient went to bed in his normal state of health the night he received his vaccine and was found deceased upon family waking the following morning".  No further information is expected.  COMPANY COMMENT: The event Death is assessed as serious due to the event being fatal.  Death is unlisted as per the Safety Information.  Considering that the event occurred within 2 days after the vaccination and despite the co-suspect vaccines as a confounding factor and the lack of information (Medical history, autopsy report not provided), the causal relationship between Vaxelis and Death cannot be fully excluded and is assessed as related. However, due to background incidence in the pediatric population, an independent event needs to be taken into consideration.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: The event Death is assessed as serious due to the event being fatal.  Death is unlisted as per the Safety Information.  Considering that the event occurred within 2 days after the vaccination and despite the co-suspect vaccines as a confounding factor and the lack of information (Medical history, autopsy report not provided), the causal relationship between Vaxelis and Death cannot be fully excluded and is assessed as related. However, due to background incidence in the pediatric population, an independent event needs to be taken into consideration.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Reported Cause(s) of Death: Death
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated, Diarrhoea, Feeling of body temperature change
Clinical narrative: Severely arthritic in my knees (both); Constant pain; Don't feel like walking.; Impacting my daily activity level to the point; Arm pain; Swelling arm; Rash on arm; Fever; GI issues; Flu-like symptoms; This non-serious case was reported by a consumer via sales rep and described the occurrence of knee arthritis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had bad case in 2022).   On 25-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced knee arthritis (Verbatim: Severely arthritic in my knees (both)), pain (Verbatim: Constant pain), walking difficulty (Verbatim: Don't feel like walking.), activities of daily living impaired (Verbatim: Impacting my daily activity level to the point), pain in arm (Verbatim: Arm pain), swelling arm (Verbatim: Swelling arm), rash (Verbatim: Rash on arm), fever (Verbatim: Fever), gastrointestinal disorder (Verbatim: GI issues) and influenza-like symptoms (Verbatim: Flu-like symptoms). The outcome of the knee arthritis was not resolved and the outcome of the pain, walking difficulty and activities of daily living impaired were resolved and the outcome of the pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms were not reported.   It was unknown if the reporter considered the knee arthritis, pain, walking difficulty, activities of daily living impaired, pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the knee arthritis, pain, walking difficulty, activities of daily living impaired, pain in arm, swelling arm, rash, fever, gastrointestinal disorder and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2023, 16-OCT-2023 and 17-OCT-2023 The patient was self-reported this case. The patient reported that she received Shingrix vaccine at the recommendation of her physician and since then experienced severely arthritic in her both knees. The patient experienced constant pain all day long.  The patient was an active person so she was very concerned and it was impacting her daily activity level to the point where she do not felt like walking. The patient was reached out to her physician for follow up.  The patient stated that all other issues had resolved except for the arthritis.  She was afraid. The patient experienced arm pain, swelling arm, rash on arm, fever, GI issues and flu-like symptoms. The patient stated that she will not be getting her second dose of Shingrix because of this reaction.