chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: When I got my first Shringrix vaccine, I was in bed with fever and chills for 3 days and under the weather for 3 more. I took the second one because the pharmacist said it would not be as bad. Still spiking fever up to 102 and haven't gotten out of bed for 2 days. I am dizzy, weak and have severe body aches.  I am healthy, rarely get sick and have never had any kind of adverse reaction to a vaccine. Don't know how much longer I will be sick this time. I missed 3 days of work the first time and we'll see how many this time. Do not know how long I will be sick. The pharmacist told me he has heard many stories like mine and I am angry and also worry of elderly that are getting these shots.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Peripheral swelling, Skin warm
Clinical narrative: Patient noted that her left arm started to get red and hot last night, but really noticed it this morning. Outside of left arm is red, hot, and swollen. NOT accompanied by fever, and the surface of the skin does not look puckered.  Patient has used ice pack to arm with some relief and just took aspirin ~1 hour ago to assist with inflammation. Patient noted this reaction was DIFFERENT than her reaction to the tetanus vaccine, she repeats NO BREATHING ISSUES with this flu shot. Patient informed VAERS would be submitted and PCP immediately notified.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial test, C-reactive protein, Differential white blood cell count, Erythema, Full blood count
Clinical narrative: Left arm redness and warmth, 9cm length  by 5cm width
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Red blood cell sedimentation rate, Skin warm, Ultrasound scan
Clinical narrative: Left arm redness and warmth, 9cm length  by 5cm width
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema
Clinical narrative: Edema presented shortly after vaccine was administered. Cold compress on site applied for about 30 minutes and patient was monitored for about an hour. No systemic symptoms noted.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Right shoulder pain started promptly after she received flu vaccine. She thought the placement seemed "abnormally high". Right after that, she started having R shoulder pain, tender to palpation at site and mild decrease in range of motion cross body abduction and overhead movements. Evaluated by MD 11/21/19 and referred to ortho for evaluation and possible steroid injection.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Wrong product administered
Clinical narrative: Did not authorize Pedarix signed for just DTap. Incorrect vaccine given without consent to a four month old
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site rash, Pruritus
Clinical narrative: Patient developed a rash around the injection site. Itchiness, currently taking Benadryl as prescribed. No other symptoms or fever reported.
Age: 25.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site pain, Injection site paraesthesia, Pain in extremity
Clinical narrative: Noticed slight burning and tingling in arm during vaccine administration.  Approximately 30 minutes later burning had subsided but had tingling L elbow, pain fingers L hand (esp. little finger), and pain if clenching fist (these symptoms did not subside).  Seen same day @ 1530 by MD at same office immunization given. Advised to return if symptoms worsen or do not resolve.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: about 2 weeks after this vaccine she received a second influenza vaccine from an urgent care clinic as well. 3 weeks ago she started having an itchy rash on her face and upper chest, sparing the eyes, mouth. there was an erythematous, bumpy appearance. treated with 7 days of prednisone 40mg per day with resolution but returning within 48h off of prednisone.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: PATIENT STATES HAS HAD A SORE ARM FOR 3 WEEKS WILL BE SEEING DR IN A COUPLE WEEKS WILL DISCUSS WITH HIM IF STILL HURTING
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT COMPLAINED OF REDNESS/SORENESS, SILVER DOLLAR AT INJECTION SITE, WARM UNDERNEATH ON 11/21/19 AT 9:30AM.  THE PHARMACIST ON DUTY AT THE TIME ADVISED THE PATIENT TO CONTACT HER DOCTOR.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: red,swollen area across entire left arm
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: The patient called the pharmacy after receiving the flu vaccine stating there was a lump and swelling at the inject site (no redness or fever reported). The patient applied an ice pack for the swelling. The patient was told to take Tylenol if any pain occurs and to call the pharmacy if fever or any other side effect arise. The patient refused to take Tylenol or any other over-the-counter pain medications.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Contusion, Injected limb mobility decreased
Clinical narrative: as per patient she was unable to lift both the arms for 3 days, and she had bruise in right arm for 3 weeks and her left arm is fine now but not the right arm. she is starting physical therapy from 11/22/2019 as advised by her doctor
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Ecchymosis, Immunoglobulin therapy, Platelet count decreased, Purpura, Splenectomy
Clinical narrative: Thrombocytopenia Purpura developed 48 hours after influenza vaccine.  Ecchymosis developed in mouth, purpura on legs. Platelets initially found to be 2.  Initial moderate response to corticosteroids, but short lived duration.  Platelets dropped back to 1-2 for 10 days and did not improve with IVIG.   Patient elected for splenectomy and platelets have increased to 135 post operatively (still on Prednisone and NPlate)
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Thrombocytopenic purpura
Clinical narrative: Thrombocytopenia Purpura developed 48 hours after influenza vaccine.  Ecchymosis developed in mouth, purpura on legs. Platelets initially found to be 2.  Initial moderate response to corticosteroids, but short lived duration.  Platelets dropped back to 1-2 for 10 days and did not improve with IVIG.   Patient elected for splenectomy and platelets have increased to 135 post operatively (still on Prednisone and NPlate)
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: PATIENT STATES THAT THE EVENING DAY AFTER THE VACCINE SHE WAS WEAK, DIZZY AND HAD NAUSEA. THE NEXT DAY, 24 HOURS AFTER THE VACCINE HER SYMPTOMS GOT  WORSE . SHE HAD FEVER OF 102 DEGREES  AFTER ABOUTH 28 HOURS OF THE VACCINE. ON THE THIRD DAY SHE STATES SHE WAS VERY ACHY ALL OVER AND HAS BEEN TAKING TYLENOL AROUND THE CLOCK.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient states that 1 week after getting Shingrix, she developed a rash on her trunk. The doctor told her it was Shingles.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Injection site pain, Pain in extremity
Clinical narrative: Patient came in with her husband on 11/18/19 for shots. He had fluad she had fluad and pneumovax 23. I recommended she get it in separate arms but she wanted it in one.   She presented today said that she was really sore the next day, and her arm got red and is now sore when she touches the injection site. She already visited her doctor and she says he cleared her and is fine. She is taking benadryl. Her husband who had the fluad is fine .
Age: 81.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Erythema
Clinical narrative: Significant red on arm that patient noticed this morning. She asked for the event to be reported.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site rash, Pain in extremity
Clinical narrative: LEFT ARM FROM SITE OF INJECTION DOWN TO HAND IS VERY RED; 3 BUMPS AROUND SITE OF INJECTION; PATIENT DESCRIBED FEELING AS HOT AND CLAIMS ARM IS VERY SORE
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Muscular weakness, Nausea, Tremor, Vomiting
Clinical narrative: Patient representative stated after receiving the vaccination, he experienced shakiness, feeling cold, nausea / vomiting for 2 days, legs and arms were feeling week.  Patient went to his doctor and told him how he was feeling after the vaccination, and they stated it could have been a side effect of the pneumonia vaccine.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient reported to the pharmacy one month after injection stating that his arm is still sore. He has not gotten medical care for it.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: pain, soreness and redness at the injection site immediately, soreness and redness lasted for 2 days  low grade fever, achy muscles, chills started a few hours later and lasted for 3 days
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pain, soreness and redness at the injection site immediately, soreness and redness lasted for 2 days  low grade fever, achy muscles, chills started a few hours later and lasted for 3 days
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: After Prevnar 13 was given, patient had pain in the injection site. Area became swollen and patinet reports of pain that started the night after vaccination was given. Patient took Tylenol 500mg The day after, the patient noticed hives and pain persists. She took Advil the whole day. On 11/20/2019, she started having itchiness on injection site and she took Benadryl. Rash started to decrease.  On 11/21/2019, She went to After Hours Clinic.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Insomnia, Musculoskeletal discomfort, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: After receiving the flu Vaccine(not sure which exact one) my shoulder was sore which was to be expected, but a week later it still had not improved. Heat and ibuprofen has helped a little, over the head movements pushing or pulling things using my upper arm muscle is very painful. To be able to sleep at night I half to sit up since laying down in any position is to painful to sleep. While sweeping and mopping I felt a crunching sensation in my shoulder similar to clicking and poping but no sound. It is now FIVE WEEKS LATER and my shoulder has not improved.suden movements of my arm or my shoulder flexing is very painful, and there is generally a constant ache. I went to an orthopedic walk in clinic and the doctor said the main pain is in my deltoid muscle but doesn't know why. He has refered me to a physical therapist to learn some at home stretches and exercises to hopefully help my arm heal.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large raised red painful injection site. Ice to the area, Tylenol or ibuprofen prn
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza like illness, Urticaria
Clinical narrative: Head to toe hives, flu like symptoms
Age: 13.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9
Symptoms: Contusion, Dyskinesia, Erythema, Fall, Posture abnormal
Clinical narrative: After pt. received vaccines and was waiting on his mom to get her vaccine he was standing and leaning back on the exam table when he mumbled something. When we turned towards him he was on the floor and proceeded to have some bodily jerking with his head thrown back. This lasted approximately 30 seconds. Mom very concerned that he had a seizure. Pt. slowly positioned from laying, to sitting, to a chair, to standing over about 30-40 minutes. Right cheek was red from fall. I called his mom the following day to check on him. She said he was doing OK and was at school. Right cheek was bruised.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Rash 2 inches x 2 inches, red spots, itchy, relieved by cold
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events or symptoms reported. Patient received a 6th dose in error
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Weight bearing difficulty
Clinical narrative: Pt Reports trouble walking and trouble weight bearing. States she was on bed rest the entire weekend. Symptoms are now resolved.
Age: 2.67
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse events or symptoms reported. Patient received the 4th dose too soon
Age: 65.0
Sex: M
Vaccine: HEPAB, HIBV, IPV, TDAP, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: after administration of Boostrix, immediate swelling occurred at site of injection. No significant bleeding occurred, patient did report stinging sensation.  Patient stayed in pharmacy for about 10 min for completion of other vaccinations and did not report and worsening or dizziness or difficulties breathing. Patient's doctor was notified of reaction. Swelling was about the size of a quarter and raised about 1/4-1/2 inch.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Headache, Malaise, Pain
Clinical narrative: headache, body ache/melasie + CGF since yesterday after receiving vaccine
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Incisional drainage, Injection site abscess, Injection site cellulitis, Pyrexia
Clinical narrative: Cellulitis (L) shoulder with Abscess.  fever of 102.6 - hospital admit for I & d with drainage.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Diarrhoea, Flatulence
Clinical narrative: Prolonged diarrhea, gas, abdominal pain lasting 8 months. Symptoms began to subside after 3 months, but continued intermittantly for another 6 months and stopped at 8 months. No treatment available. This was the first time I had been given the quadrivalent flu vaccine. All past flue vaccines I received had been the trivalent vaccine (approx. the last 6 years). At my annual physical in September, 2019, my PCPs office offered to give me a flu shot at that time. I explained what happened in 2018, they advised the quadrivalent vaccine was too strong for me and instructed to get the trivalent vaccine going forward. Unable to get it this year as it's only available to those ever 65 years of age.
Age: 89.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Chills, Peripheral coldness, Tremor
Clinical narrative: Generalized trouble with sensation of cold hand & feet shaking chills - normal temp.  Increased in BP to 190/90 (normal BP 120/60) lasted about 1 1/2 hr. + gradually subsided no residual
Age: 83.0
Sex: F
Vaccine: FLUA3
Symptoms: Aspiration joint, Blood test, Bursitis, Computerised tomogram, Inflammation
Clinical narrative: Shot was given in upper right at,. Returned to store twice. I was told to take Advil for inflammation. On the second trip, I was told to use ice. As the pain continued, 9/27/2019, I went to the ER, where they took X-rays. Dr told me that if my arm swells and gets red, return to the ER, which I did on 9/28/2019. They took a CT scan, blood and fluid from my swollen joint. I was given 4 prescriptions and they fitted me with a shoulder sling. Other instruction was to see Dr, orthopedic to be re-checked. On 10/01/2019, had an appointment Dr. He stated that I have Bursitis and gave me a steroid shot. He recommended that I take Tylenol or Aleve for pain and continue with ice as needed. After 2 days, the pain was gone and I am feeling better.
Age: 83.0
Sex: F
Vaccine: FLUA3
Symptoms: Joint swelling, Pain, X-ray
Clinical narrative: Shot was given in upper right at,. Returned to store twice. I was told to take Advil for inflammation. On the second trip, I was told to use ice. As the pain continued, 9/27/2019, I went to the ER, where they took X-rays. Dr told me that if my arm swells and gets red, return to the ER, which I did on 9/28/2019. They took a CT scan, blood and fluid from my swollen joint. I was given 4 prescriptions and they fitted me with a shoulder sling. Other instruction was to see Dr, orthopedic to be re-checked. On 10/01/2019, had an appointment Dr. He stated that I have Bursitis and gave me a steroid shot. He recommended that I take Tylenol or Aleve for pain and continue with ice as needed. After 2 days, the pain was gone and I am feeling better.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Soreness, bump showed up, spreading from arm to shoulder, numb, tingles at times. Lasting for several weeks.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Erythema, Pruritus
Clinical narrative: flushing,itching,anxiety,rash,difficulty breathing
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anxiety, Dyspnoea, Flushing, Pruritus, Rash
Clinical narrative: flushing,itching,anxiety,rash,difficulty breathing
Age: 68.0
Sex: M
Vaccine: FLU4, VARZOS, FLU4, VARZOS
Symptoms: Hiccups
Clinical narrative: & 6 consecutive days of hiccups
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Paraesthesia, Urticaria
Clinical narrative: Hives, High BP, Numbness/Tingling in legs and feet, cool sensation in lower extremities, muscle twitches and weakness.
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Hypoaesthesia, Muscle twitching, Muscular weakness, Paraesthesia, Peripheral coldness
Clinical narrative: Hives, High BP, Numbness/Tingling in legs and feet, cool sensation in lower extremities, muscle twitches and weakness.
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: Hives, High BP, Numbness/Tingling in legs and feet, cool sensation in lower extremities, muscle twitches and weakness.
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Feeling cold, Hypertension, Hyperventilation, Hypoaesthesia, Hyporeflexia
Clinical narrative: Hives, High BP, Numbness/Tingling in legs and feet, cool sensation in lower extremities, muscle twitches and weakness.
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Inflammatory marker test, Muscle twitching, Paraesthesia, Primitive reflex test, Protein total normal
Clinical narrative: Hives, High BP, Numbness/Tingling in legs and feet, cool sensation in lower extremities, muscle twitches and weakness.
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Swelling of eyelid, Urticaria
Clinical narrative: Hives, High BP, Numbness/Tingling in legs and feet, cool sensation in lower extremities, muscle twitches and weakness.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Severe allergy , hives over all my body . Itching everywhere .
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: about 2 hours after getting flu shot, he started getting red all over and itching and developed hives. This lasted about 1.5 weeks. He self treated with benadryl
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acoustic stimulation tests abnormal, Balance disorder, Deafness unilateral, Magnetic resonance imaging brain normal, Magnetic resonance imaging normal
Clinical narrative: 3 days later, lost hearing in right ear, began losing balance, by next morning, severe vertigo, vomiting, full right ear hearing loss.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Vertigo, Viral infection, Vomiting
Clinical narrative: 3 days later, lost hearing in right ear, began losing balance, by next morning, severe vertigo, vomiting, full right ear hearing loss.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Deafness unilateral, Influenza like illness
Clinical narrative: 3 days later, lost hearing in right ear, began losing balance, by next morning, severe vertigo, vomiting, full right ear hearing loss.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Skin irritation
Clinical narrative: Patient woke up with skin irritation left arm pit, left chest, and both sides of neck. He states he took Benadryl and used cold compresses.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site pain, Nausea
Clinical narrative: Fever, chills, headache, blurred vision, night sweats,queasy stomach, over all body aches and pains, weakness, very sore arm at injection site. Ibuprofen, Excedrin, acetaminophen, Benadryl . So far this is day three of these events and I am trying everything to get these things done with. Heating pad helps somewhat.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Pain, Pyrexia, Vision blurred
Clinical narrative: Fever, chills, headache, blurred vision, night sweats,queasy stomach, over all body aches and pains, weakness, very sore arm at injection site. Ibuprofen, Excedrin, acetaminophen, Benadryl . So far this is day three of these events and I am trying everything to get these things done with. Heating pad helps somewhat.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Magnetic resonance imaging abnormal, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain radiating from top of hand down arm to elbow then up to shoulder and back between shoulder blades.  Consult doctor for results of MRI.  Dr suggested potential onset of Arthritis based on MRI.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient received unspecified HPV vaccine on 12/27/2013 and 5/3/2016/ the patient inadvertently received 2 doses of GARDASIL 9 on 7/10/2019 and 9/25/2019; no adverse effect; a patient received unspecified HPV vaccine on 12/27/2013 and 5/3/2016/ the patient inadvertently received 2 doses of GARDASIL 9 on 7/10/2019 and 9/25/2019; a patient received unspecified HPV vaccine on 12/27/2013 and 5/3/2016/ the patient inadvertently received 2 doses of GARDASIL 9 on 7/10/2019 and 9/25/2019; a patient received unspecified HPV vaccine on 12/27/2013 and 5/3/2016; a patient received unspecified HPV vaccine on 12/27/2013 and 5/3/2016; Information has been received from a nurse practitioner, referring to a patient of unknown age and gender. The patients concurrent condition, historical condition and concomitant medication were not provided.  On 27-DEC-2013 and 03-MAY-2016, the patient received with unspecified HPV vaccine (route, dose, frequency, lot number and expiration date unknown) for prophylaxis (product origin unknown, Inappropriate schedule of product administration). On 10-JUL-2019 and 25-SEP-2019, the patient was inadvertently received 2 doses of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number reported as R027577 and expiration date reported as 23-JUN-2021 for both two doses; route unknown) for prophylaxis (Interchange of vaccine products, Inappropriate schedule of product administration, Incorrect dose administered). There was no adverse effect as reported for the patient.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine.; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not provided.  On 30-SEP-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, lot number S004251, expiration date 22-SEP-2020, orally for prophylaxis (Product storage error). The storage temperature was 1.4 degrees Celsius for a time frame of 20 minutes. Previous temperature excursion was 10.5 degrees Celsius for 56 minutes. The call was because of a data logger.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; a patient received an expired dose of VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On 18-OCT-2019, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # N021720, expiration date 10-AUG-2019 (strength, dose and route of administration were not provided) for prophylaxis. There were no adverse effects.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient received the PNEUMOV AX 23 (Lot#Unknown/Exp:Unknown) vaccine five times; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On unspecified dates, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot # and expiration date were not reported) five times for prophylaxis (reported as prevent pneumonia) (inappropriate schedule of product administration). The pharmacist reported that the patient "engages in polyphannacy and polyphysicians". The patient's present status was fine.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient; a vaccine following a temperature excursion; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was unknown.   On 29-OCT-2019, the patient was vaccinated with one dose of hepatitis a vaccine, inactivated (VAQTA) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis following a temperature excursion.   Temperature excursion was reported as below 36 Fahrenheit (F)/2 Celsius degrees (C) (35F) for 430 minutes. There was no previous temperature excursion. No digital data logger was involved.   No adverse effects were reported in the patient.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: progressive rash development/slightly below the injection site/ near her armpit/ the rash was red and itchy; progressive rash development/slightly below the injection site/ near her armpit/ the rash was red and itchy; she had 2 quarter size areas (injection site and slightly below the injection site) and a third area near her armpit which was a bit smaller than the other two; Information has been received from a nurse referring to a 66 years old female patient. The patient's current condition included breast cancer, ischemic heart disease, malignant melanoma of skin and seasonal allergies. The patient was allergic to penicillin and hydrocodone. The patient's concomitant therapies included anastrozole(ARIMIDEX) and unknown nasal medication for allergies. The patient's historical vaccine included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).     On 28-OCT-2019, the patient was vaccinated with her first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot#S025133, expiration date 01-SEP-2020, intramuscular in the left deltoid) for prophylaxis (reported as age related vaccines). Throughout the day of 30-OCT-2019, the patient reported progressive rash development. By the time the patient spoke with the office, she had 2 quarter size areas (injection site and slightly below the injection site) and a third area near her armpit which was a bit smaller than the other two. The rash was red and itchy. The patient denied fever, breathing problems and arthralgia. The physician prescribed use of diphenhydramine hydrochloride (BENADRYL) on 30-OCT-2019 and cold packs with a follow up if there was no resolution. No lab diagnostics or studies was performed. The outcome of all the events was reported as not recovered. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient was administered an improperly stored dose of Varivax; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S015460 and expiration date 20-MAY-2021 (exact dose and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. No adverse effect were reported. The temperature was from 6°F to 14°F (7.4F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; administered a dose of PNEUMO VAX 23 which was improperly stored; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 31-OCT-2019, the patient was administered a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (lot # S026366 has been verified to be a valid lot number, expiration date 17-SEP-2020) (exact dose and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature excursion of 1.1 Celsius degree for 10 hours. Digital Data Logger was involved. No previous temperature excursion was reported. No adverse effects were reported. The outcome was reported as supported (unspecified).
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: the patient's arm was painful and warm to touch; the patient's arm was painful and warm to touch; the patient's arm, where she vaccinated with Pneumovax 23, swelled up at the injection site and further down her arm; the patient's arm, where she vaccinated with Pneumovax 23, swelled up at the injection site and further down her arm; This spontaneous report as received from a medical assistant refers to a 71-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included amlodipine, hydrocodone, clotrimazole cream, triamcinolone cream and albuterol (VENTOLIN) inhalation as needed. On 25-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly (lot # S018405, expiration date reported as 28-MAR-2021, but upon internal validation established as 23-MAR-2021) (exact dose and route of administration were not reported) for prophylaxis. On 25-OCT-2019, the patient's arm, where she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), swelled up at the injection site and further down her arm. Additionally, the patient's arm was painful and warm to touch. The patient sought medical attention by visiting the office and received dexamethasone injection as a treatment. The outcome of injection site swelling, skin warm, pain in extremity and peripheral swelling was unknown. No causality assessment was provided by the reporter.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Colposcopy, Smear cervix abnormal, Vaccination complication
Clinical narrative: My pap was bad within a month of the last injection; I had a horrible reaction to it; This spontaneous report was received from a consumer, from a media report, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On an unknown date, when she was 26 years old, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis. After vaccination, the patient had a horrible reaction to it  and went through 2 years of colposcopies every 3 months because of this vaccine (vaccination complication). Additionally, her pap was bad within a month of the last injection (smear cervix abnormal ).  At the reporting time, the outcome of smear cervix abnormal and vaccination complication was unknown. The reporter did not give the causality assessment between events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; on 11/02/2019 improperly stored doses of PROQUAD were administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 02-NOV-2019, improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S007074, expiration date 06-SEP-2020) (lot # S017245, expiration date 01-DEC-2020) (strength, dose, frequency and route were not reported) for prophylaxis (improper storage of product in use) were administered.  Temperature excursion was -6.6 Centigrade for 1 hour 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported.  This is a non-valid case due to lack of patient's identifier and number.
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: allergy; This spontaneous report has been received from a consumer through other company (Novartis) regarding to himself, a 55-year-old male patient. The patient's concurrent conditions, medical history or concomitant therapies were not provided.    On an unknown date, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, dose, frequency, route of administration and anatomical location of vaccine were not provided) for prophylaxis.   On an unknown date, the patient experienced allergy. At the reporting time, the outcome for the event was unknown.   The causality assessment between allergy and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; a patient was administered improperly stored dose of Varivax; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 20-NOV-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S002736, expiry date : 28-JAN-2021) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of -0.2 degrees Celsius for 2 hours and 40 minutes (product storage error). There was previous temperature excursion of 4.25 degrees Celsius for 2 hours and 40 minutes. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered; This spontaneous report was received from other health professional (nurse) refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies, concurrent conditions and concomitant medications were not reported. On 19-NOV-2019, the patient was vaccinated with improperly stored dose of  hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dosage,  route, indication were not reported, lot # R021372 has been verified to be a valid lot number for (hepatitis b vaccine (recombinant)), expiration date reported as 25-MAY-2021) for prophylaxis (product storage error).   No product quality complaint was reported. The vaccine underwent temperature excursion and time frame 25 fahrenheit (F) for 6 hours 28 minutes and 55 fahrenheit for 7 hours. There was no previous temperature excursion. There was involvement of data logger. The outcome of product storage error was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored dose of VARIVAX; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 19-NOV-2019 (also reported as 20-NOV-2019), the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S002736, expiry date : 28-JAN-2021) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of -0.2 degrees Celsius for 2 hours and 40 minutes (product storage error). There was previous temperature excursion of 4.25 degrees Celsius for 2 hours and 40 minutes. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Loss of personal independence in daily activities, Middle insomnia, Musculoskeletal disorder, Pain
Clinical narrative: Patient expressed severe pain immediately following the flu shot and is experiencing persisting pain. The pain has caused a lot of pain and wakes her up in the middle of the night. She is not able to have full use of her arm and has not been able to exercise.
Age: 67.0
Sex: F
Vaccine: FLUR4
Symptoms: Eye pruritus, Oral pruritus, Pruritus, Rash
Clinical narrative: Full body rash & itching;  facial swelling; itching of mouth, itching of eyes.  All symptoms lasted three (3) days.  Treated at home with Allegra as patient is allergic to benedryl and prednisone.  Resolved without lingering adverse effect.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: pt returned to clinic 3 days later and has a local reaction on the arm.  area slightly raised and warm and pink to the touch.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MNQ, HPV9, MNQ
Symptoms: Injection site swelling, Pain, Swelling
Clinical narrative: Initially after vaccines were given she had approx 2-3 days of soreness, slight swelling. All symptoms went away within 3 days. 8 days after immunization she woke up with a swollen left deltoid. No pain, redness, numbness, tingling, weakness, SOB, or any other symptoms. Nothing can contribute to the swelling- no recent illness, activity, medications, injury.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MNQ, HPV9, MNQ
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Initially after vaccines were given she had approx 2-3 days of soreness, slight swelling. All symptoms went away within 3 days. 8 days after immunization she woke up with a swollen left deltoid. No pain, redness, numbness, tingling, weakness, SOB, or any other symptoms. Nothing can contribute to the swelling- no recent illness, activity, medications, injury.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MNQ, HPV9, MNQ
Symptoms: Injection site swelling
Clinical narrative: Initially after vaccines were given she had approx 2-3 days of soreness, slight swelling. All symptoms went away within 3 days. 8 days after immunization she woke up with a swollen left deltoid. No pain, redness, numbness, tingling, weakness, SOB, or any other symptoms. Nothing can contribute to the swelling- no recent illness, activity, medications, injury.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: 9x9 cm area of redness at site of injection
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: For about 3 days, moderate soreness in area of injection, redness and slight swelling in area of injection For a few hours on evening of second day (11/20), fatigue and mild chills  No treatment - I probably should have taken ibuprofen, but it wasn't that bad
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Erythema, Headache, Rash macular
Clinical narrative: Patient states that she turned red, blochy from the chest up to her head and developed a headache. BP was 16/90. Patient went to the ED and was given Benadryl, Tylenol and Ibuprofen. Patient states that her symptoms resolved by the time she left the ED.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-SEP-2019, the patient received improperly stored hepatitis a vaccine, inactivated (VAQTA) 1 dose intramuscularly, in left thigh (lot # S007770, expiry date 24-JUL-2020) for prophylaxis. Previously, the patient was administered one dose of hepatitis a vaccine, inactivated (VAQTA). Storage temperature was 1.4 Celsius degree during the time frame of 20 minutes. Previous temperature excursion was 10.5 Celsius degrees for 56 minutes. The digital data logger was involved. The outcome of product storage error was unknown.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; administered his first dose of properly stored PNEUMOV AX 23 (lot N019348 & expiration date 2/8/2019); This spontaneous report was received from a pharmacist referring to a 31 years old male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.   On 17-OCT-2019, the patient was administered his first dose of properly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # N019348, expiration date was 08-FEB-2019)(exact dose and strength were not reported) intramuscularly for disease condition to receive vaccine(expired product administered). No adverse effect reported.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 4 month old was vaccinated with PNEUMOVAX 23 instead of PREVNAR 13; 4 month old was vaccinated with PNEUMOVAX 23; No adverse symptoms reported; This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.  On an unknown date, the 4-month-old patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (exact dose, route, site of administration, lot# and expiration date were not provided) instead of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (exact dose, route, site of administration, lot# and expiration date not provided) for prophylaxis. No adverse symptoms reported.
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: cramps; Tingling on head, face, arms and legs; Initial information received on 14-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp (patient).  This case involves a 45 years old female patient who experienced tingling on head, face, arms and legs (Paraesthesia) and cramps (muscle spasms), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The medical history, medical treatments, vaccinations and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date in Sep-2018, the patient developed a serious tingling on head, face, arms and legs (paraesthesia) (Unknown latency) and cramps (muscle spasms) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized for this event 1 week after vaccination.   Other relevant tests included No lab data.  Final diagnosis was tingling on head, face, arms and legs, cramps.   A patient has been treated by a neurologist.  The outcome of the events was Unknown for tingling on head, face, arms and legs, cramps.  Information on the batch number was requested.; Sender's Comments: This case concerns 45 years old female patient who experienced Paraesthesia and Muscle spasms after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Pt had severe headache, severe myalgia, nausea diarrhea or 3 days
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Agitation, Cold sweat, Discomfort, Disturbance in attention, Dyskinesia
Clinical narrative: The night of 11/20/19, patient received his first flu vaccine. After flu clinic, patient was hyperactive, seemed to have difficulty with focusing, with rapid eye movements; seemed almost manic to the parents and agitated. He seemed unable to get comfortable when held but was not crying as if in pain. His tongue was protruding as if it was numb and seemed limp. His grip was weak; he was unable to hold onto his toys or hold his pacifier to his mouth or keep it in his mouth. He was inconsolable for more than four hours with rapid respirations. He was thrashing in his sleep, sweaty and clammy; he barely slept, only about two hours total overnight. He had decreased oral intake; refused a bottle from 2100 to 0500 -- which is unusual for him. Parents gave him Tylenol and ibuprofen but neither seemed to help. He was returning to baseline the following day; simply seemed like he didn't feel well. Mother reports that patient bumped his head four days prior, but seemed normal afterward. Grandmother wondered about possibility of concussion symptoms being delayed.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Emotional distress, Eye movement disorder, Grip strength decreased, Head injury, Hyperhidrosis
Clinical narrative: The night of 11/20/19, patient received his first flu vaccine. After flu clinic, patient was hyperactive, seemed to have difficulty with focusing, with rapid eye movements; seemed almost manic to the parents and agitated. He seemed unable to get comfortable when held but was not crying as if in pain. His tongue was protruding as if it was numb and seemed limp. His grip was weak; he was unable to hold onto his toys or hold his pacifier to his mouth or keep it in his mouth. He was inconsolable for more than four hours with rapid respirations. He was thrashing in his sleep, sweaty and clammy; he barely slept, only about two hours total overnight. He had decreased oral intake; refused a bottle from 2100 to 0500 -- which is unusual for him. Parents gave him Tylenol and ibuprofen but neither seemed to help. He was returning to baseline the following day; simply seemed like he didn't feel well. Mother reports that patient bumped his head four days prior, but seemed normal afterward. Grandmother wondered about possibility of concussion symptoms being delayed.