chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Aphasia
Clinical narrative: 3 patients were unable to speak; Initial information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 3 patients of an unknown demographics who were unable to speak (aphasia), while they received vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient's received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient's were unable to speak (aphasia) unknown latency following the administration of INFLUENZA VACCINE.   Other relevant tests were not reported.  Final diagnosis was aphasia.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for aphasia.   Information on the batch number was requested.  List of document held by sender: none.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Headache, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: After influenza vaccine, patient was able to cut wood for a few hours.  Later in the day, went to meet friends and began to feel "as stiff as a board", had headache, felt weak and his legs ached at approximately 6:30pm, came home and temp was 101. Took some ibuprofen, slept in recliner over night.  This morning, fever and headache were gone and the weakness improved but legs remain a little sore and achy. Patient did not phone medical provider.  Writer updated MD today.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: On 10/9/19 @ 1610, the healthcare worker presented to Employee Health Services with reports of generalized itching, hives and  raised blotchy rash to back, under bilateral breasts and right anti-cubital area of arm.  Reports onset of itching  on 10/3/19 approx. 1 to 2 hrs after receiving flu vaccine.  Noticed hives and rash at approx 8 pm  on 10/3/19 upon disrobing at home.   Admits to taking Benadryl PRN and saw her PCP on 10/5/19 who advised  her symptoms may be related to the flu vaccine.   Further assessment revealed  No c/o  chest pain or  SOB, No breathing difficulty, No fever/Chills.  Large tattoo present at injection site; however,  no underlying redness  or swelling  was seen.  Denies pain or tenderness to touch at the injection site .   No rash noted to left arm- distal to injection site.    The health care worker  advised EHN her PCP 's  office called and would like for her to be re-evaluated.  She was referred back to her PCP.   Denies use of new foods, soaps or fragrances .
Age: 49.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received vaccines on 10-14-19. On 10-15-19, patient had some redness. On 10-16-19, patient's upper arm was very swollen down to elbow, red, painful, and hard to move. He was seen by his PCP. Received shot to stop reaction and an antibiotic.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product quality issue
Clinical narrative: vaccine quarantined and should have been discarded on 09/30/19.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Asthenia, Blood glucose increased, Fatigue, Pollakiuria, Thirst
Clinical narrative: The symptoms started immediately as drinking a lot of water and going to bathroom and we went to her doctor after she was tired and losing her energy; so when diagnosed her ; found her blood sugar more than 500 and she asked us to send our daughter to emergency to correct her blood sugar and to know how to deal with her condition, now she is living on insulin shots and this very horrible addition to her autistic condition...
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Type 1 diabetes mellitus
Clinical narrative: The symptoms started immediately as drinking a lot of water and going to bathroom and we went to her doctor after she was tired and losing her energy; so when diagnosed her ; found her blood sugar more than 500 and she asked us to send our daughter to emergency to correct her blood sugar and to know how to deal with her condition, now she is living on insulin shots and this very horrible addition to her autistic condition...
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Significant muscle pain, soreness and redness  at the  injection area for 5 days Chills, fever for 1 day, beginning the day after dosing  Abdominal pain for 2-3 days
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Mobility decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: pain on shoulder, radiating to neck, arm soreness, couldn't move arm, dizziness. symptoms x 3 days now
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: pain on shoulder, radiating to neck, arm soreness, couldn't move arm, dizziness. symptoms x 3 days now
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: I received my 2nd dose (shot) of Shingrix vaccine since it was recommended by my gastro MD given I am on immunosuppressant drugs for my colitis.  The first dose received about 2 months ago yielded a lot of soreness and red block near site (1-2 inches) for 4-5 days.  2nd dose yielded significant flu like symptoms (full body aches, soreness, headache, tiredness) the following morning on 10/14.  These symptoms are now almost gone 3 days later.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Limb discomfort
Clinical narrative: Pt presents with arm discomfort and redness after receiving the flu vaccine. Unsure of exact vaccine. Pt reports high dose.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: progressive swelling from injection site down L arm to forearm. warm, swollen, red. mildly tender at injection site, improving. no fever. no drainage from injection site. normal strength.  she had a milder reaction to the flu vaccine last year- more localized.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 2. Men B vaccine:  Today, discussed. After receiving the vaccine left deltoid, the MA took the needle off and set it down and the site swelled up --instantaneously, I walked in to the room right after pt arm had a 5 cm swelling at the injection site mildly firm, as I was massaging the child mentioned she is feeling dizzy, made her lie down and massaged the injection site, POX 98, HR 52, BP 110/70, after 3-4 minutes of lying down the child started feeling better, rested for 15 minutes, CTAB, S1S2, RRR, no hives , swelling in the arm went down to 2cm, pt was sitting up for 5 minutes without any return of symptoms, POX 100, HR 66, BP 104/70, remained symptom free some pain in the injection site started, was given motrin and reassessed, CTAB, S1S2 RRR, no hives, comfortable,  d/c home 45 minutes after the vaccine and pt walked normal and stable at d/c.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt developed rash, red itchy bumps, to lower extremities and buttock a few hours after flu shot . MOP administer benardryl at home and was seen by provider then next day.   Labs were sent for food allergy profile and follow up appointment made for 5 days.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial test positive, Blood creatine phosphokinase decreased, Blood culture negative, Chills, Culture urine positive
Clinical narrative: Day after vaccination with both PSV 23 and unknown flu vaccine, pt developed fever, whole body pain, chills, rigors, leukocytosis, along with extreme pain at the injection site.  Site had no bruising.  Patient was admitted to the hospital the next day, blood cultures are negative, pt was started on antibiotics for continued fever and leukocytosis.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Escherichia test positive, Injection site pain, Leukocytosis, Pain, Procalcitonin increased
Clinical narrative: Day after vaccination with both PSV 23 and unknown flu vaccine, pt developed fever, whole body pain, chills, rigors, leukocytosis, along with extreme pain at the injection site.  Site had no bruising.  Patient was admitted to the hospital the next day, blood cultures are negative, pt was started on antibiotics for continued fever and leukocytosis.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Urinary sediment present, White blood cell count increased, White blood cells urine positive
Clinical narrative: Day after vaccination with both PSV 23 and unknown flu vaccine, pt developed fever, whole body pain, chills, rigors, leukocytosis, along with extreme pain at the injection site.  Site had no bruising.  Patient was admitted to the hospital the next day, blood cultures are negative, pt was started on antibiotics for continued fever and leukocytosis.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Hypertension, Migraine with aura, Paraesthesia, Tremor
Clinical narrative: About 15 minutes after the vaccine, I experienced tingling down both my arms into my hand and fingers. It then felt like needles were pricking my fingers. My hands started to shake, too. The nurse checked my blood pressure. It was high, but she said it could have been anxiety, although I didn't really feel anxious. The symptoms were very similar to food allergy symptoms I have experienced before. It did not progress into anaphylaxis, though. The symptoms abated after about an hour. But then I experienced a ocular migraine that lasted about 30 minutes.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site cellulitis, Injection site rash, Injection site swelling
Clinical narrative: Cellulitis on right thigh, rash of lower right extremity. swelling to lower right extremity.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Crying, Erythema, Screaming, Swelling
Clinical narrative: redness about 5"x5", mild swelling, with small 2mm bumps, screaming/crying for several minutes after vaccine, lungs clear, no difficulty breathing.  Redness and swelling went down within 20-30min after shot with ice pack - redness was <1" diameter and swelling was gone.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: vomit
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: patient complaining of sharp stabbing pain in left arm that spreads to his neck.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Rash erythematous
Clinical narrative: square red band with bumps, slight itch
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Fluzone was injected, and pt returned in a couple minutes complaining of lightheadedness. He put his head down and fainted. He regained consciousness, and kept his head down for a few more minutes. he was sweating profusely, pale, and his pulse was very weak and rapid. Epinephrine was injected, and his symptoms resolved rapidly. He was transported to the hospital and observed for the possible need of a second epinephrine injection. No further injection was given and the patient was released
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Pulse abnormal, Syncope
Clinical narrative: Fluzone was injected, and pt returned in a couple minutes complaining of lightheadedness. He put his head down and fainted. He regained consciousness, and kept his head down for a few more minutes. he was sweating profusely, pale, and his pulse was very weak and rapid. Epinephrine was injected, and his symptoms resolved rapidly. He was transported to the hospital and observed for the possible need of a second epinephrine injection. No further injection was given and the patient was released
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Flu vaccination.  Developed hives at about 5 sites on body: Abdomen, buttocks, left thigh, near left and right armpits. Treated with over the counter cortisone cream. Symptoms abated after a few days.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: At time of injetion, the patient stated it hurt, but left stating she felt fine and was just sore. Today, 10/16/19 (injection given yesterday) a caretaker came in and showed me pictures of her arm with redness on the exterior portion of her arm (injection site) and it went downward a few inches below the injection site. She also showed me pictures of brusing on the inside portion of her arm. She stated she could move it fine but that it was just very sore and she was concernced about the redness and bruising. I stated the redness was most likely an injection site reaction, but the bruising was probably secondary to her fall eariler in the week; however its not 100% certain.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash, Skin warm
Clinical narrative: 6 inch diameter rash, hot to the touch, painful
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea, Pruritus, Rash erythematous
Clinical narrative: dizziness, nausea, red spots, itch
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient was leaving store and passed out and hit her head on a chair while passing out.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, No adverse event, Product preparation issue
Clinical narrative: RPh gave shot, but only gave Adjuvant.  After shot given, peeling labels off vials, it was discovered that only adjuvant was given, and the vaccine was still in its vial, in powder form.  Had to use a second Adjuvant, to mix the powder, to give shot.  Pt rec'd  "2 doses" of adjuvant.    Outcome was no adverse effects.  MD was notified immediately of RPh's error.  Pt reported no ill effects and no ill effects 5months later.   Pt did report local tenderness, to both arms.  (Left arm rec'd adjuvant only) (Right arm rec'd vaccine+adjuvant).
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site inflammation, Injection site reaction, Rash erythematous
Clinical narrative: Patient presented with red rash and inflammation under the injection site
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging normal, Mobility decreased, Musculoskeletal pain, Pain in extremity, Vomiting
Clinical narrative: Started feeling pain within an hour or 2 of the vaccination but thought it was  a slight reaction to the shot.  Over the next several days my right should became extremely painful.  I can not lift my arm and the pain is excruciating.  There is a constant pain, along with sharp pain radiating the length of my arm.  I have to keep my arm completely tight against my stomach.  When I vomited from the pain after catching myself from a fall, I made an appointment with Dr.  He prescribed 800 milligrams of Ibuprofen and sent me for a MRI.  I returned after completing the MRI and could not believe  that my rotator cuff was not torn completely.  After the appointment I thought back to what could have triggered my extreme pain, as it was not a tear.  I realized that the pain started almost immediately after my shot.  I did not know there could be a correlation between the vaccine and my shoulder pain until I googled my symptoms.  I have an appointment with an Orthopedist on 10/25/19
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Chills, Erythema, Pain in extremity, Pruritus
Clinical narrative: PATIENT GOT FLUZONE HD AND PNEUMOVAX 23 ON RIGHT ARM ON 10/14, THAT AFTERNOON PATIENT STATED SHE HAD UPPER ARM SWELLING AND IT HURT, HAD CHILLS ON THAT MONDAY AND TUESDAY, AND ON TUESDAY AREA WAS PURPLE/RED, CURRENTLY SOME ITCHINESS IN THE AREA, AND STATED THAT AREA THAT HURT EXTENDED INTO HER CHEST FROM THAT RIGHT ARM BUT THAT SHE WAS DOING BETTER ON THE WEDNESDAY.  SINCE PATIENT STATED SYMPTOMS WERE GETTING BETTER ADVISED PATIENT TO MONITOR, AND CONTACT PHARMACY. AND/OR MD, TAKE TYLENOL, BENADRYL  AND APPLY COLD PACK IF NECESSARY.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin discolouration, Swelling
Clinical narrative: PATIENT GOT FLUZONE HD AND PNEUMOVAX 23 ON RIGHT ARM ON 10/14, THAT AFTERNOON PATIENT STATED SHE HAD UPPER ARM SWELLING AND IT HURT, HAD CHILLS ON THAT MONDAY AND TUESDAY, AND ON TUESDAY AREA WAS PURPLE/RED, CURRENTLY SOME ITCHINESS IN THE AREA, AND STATED THAT AREA THAT HURT EXTENDED INTO HER CHEST FROM THAT RIGHT ARM BUT THAT SHE WAS DOING BETTER ON THE WEDNESDAY.  SINCE PATIENT STATED SYMPTOMS WERE GETTING BETTER ADVISED PATIENT TO MONITOR, AND CONTACT PHARMACY. AND/OR MD, TAKE TYLENOL, BENADRYL  AND APPLY COLD PACK IF NECESSARY.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Irritability, Oral herpes, Pyrexia
Clinical narrative: Fatigue, fever, cold sores, weakness, crankiness.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Arthralgia, Cold sweat, Decreased appetite, Depression
Clinical narrative: aches and pains in all muscles and joints, cold sweats, tiredness, anxiety, depression, fever, lack of appetite.  Ibuprofen for pain.  Valium for anxiety and depression.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: aches and pains in all muscles and joints, cold sweats, tiredness, anxiety, depression, fever, lack of appetite.  Ibuprofen for pain.  Valium for anxiety and depression.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest pain, Depressed level of consciousness, Dyspnoea, Erythema
Clinical narrative: Immediately hurt worse than any flu shot I have had in the past. About one minute later when trying to leave the store I felt like I was going to pass out, face turns bright red, nauseous, weak, trouble breathing, chest pain, heart racing. Made it back to the pharmacist where she had me sit for about 10 minutes until I felt well enough to walk and drive home. About one hour later my lips turned numb, another 20-30 minutes later my left hand turned numb and a fever spiked. I felt extreme fatigue and just slept the rest of the day. Woke up the next day and my hand and lips were still numb. It comes a goes. Fever spiked again 24 hours after the vaccine and got a headache.  Now I?m about 28 hours after the vaccine and lips are numb but hand is not. Fever controlled with Tylenol. If the numbness persists over a week I will go to a doctor.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Hypersomnia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Immediately hurt worse than any flu shot I have had in the past. About one minute later when trying to leave the store I felt like I was going to pass out, face turns bright red, nauseous, weak, trouble breathing, chest pain, heart racing. Made it back to the pharmacist where she had me sit for about 10 minutes until I felt well enough to walk and drive home. About one hour later my lips turned numb, another 20-30 minutes later my left hand turned numb and a fever spiked. I felt extreme fatigue and just slept the rest of the day. Woke up the next day and my hand and lips were still numb. It comes a goes. Fever spiked again 24 hours after the vaccine and got a headache.  Now I?m about 28 hours after the vaccine and lips are numb but hand is not. Fever controlled with Tylenol. If the numbness persists over a week I will go to a doctor.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Nausea, Palpitations, Pyrexia
Clinical narrative: Immediately hurt worse than any flu shot I have had in the past. About one minute later when trying to leave the store I felt like I was going to pass out, face turns bright red, nauseous, weak, trouble breathing, chest pain, heart racing. Made it back to the pharmacist where she had me sit for about 10 minutes until I felt well enough to walk and drive home. About one hour later my lips turned numb, another 20-30 minutes later my left hand turned numb and a fever spiked. I felt extreme fatigue and just slept the rest of the day. Woke up the next day and my hand and lips were still numb. It comes a goes. Fever spiked again 24 hours after the vaccine and got a headache.  Now I?m about 28 hours after the vaccine and lips are numb but hand is not. Fever controlled with Tylenol. If the numbness persists over a week I will go to a doctor.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Vasculitis
Clinical narrative: Dull Headache , vasculitis, upset stomach, diarrhea, and fatigue
Age: 59.0
Sex: F
Vaccine: FLUR4, TDAP
Symptoms: Blood test, Cardiomegaly, Chest X-ray, Chills, Computerised tomogram
Clinical narrative: All per patient - Approximately 24 hours the symptoms started very quickly. Presented with "raspy non-productive cough". She described feeling cold and chills. She went to the ER within a few hours due to the symptoms on 10/13/19.  They did the tests below and then sent her home after about 6-7 hours. Clinic called back the next morning and told her to go back to the ER or they would call her an ambulance due to labs being high and likely/probable clot and likely an enlarged heart. At that visit she sat in the waiting room for several hours before getting to be seen. They did further blood work and a CT Scan. Patient unclear if she had pneumonia or bronchitis, enlarged heart, and fluid around her lungs and heart.
Age: 59.0
Sex: F
Vaccine: FLUR4, TDAP
Symptoms: Cough, Electrocardiogram, Feeling cold, Laboratory test abnormal, Thrombosis
Clinical narrative: All per patient - Approximately 24 hours the symptoms started very quickly. Presented with "raspy non-productive cough". She described feeling cold and chills. She went to the ER within a few hours due to the symptoms on 10/13/19.  They did the tests below and then sent her home after about 6-7 hours. Clinic called back the next morning and told her to go back to the ER or they would call her an ambulance due to labs being high and likely/probable clot and likely an enlarged heart. At that visit she sat in the waiting room for several hours before getting to be seen. They did further blood work and a CT Scan. Patient unclear if she had pneumonia or bronchitis, enlarged heart, and fluid around her lungs and heart.
Age: 16.0
Sex: M
Vaccine: DTAP, IPV, MNQ
Symptoms: Diarrhoea, Eye pain, Headache, Vomiting
Clinical narrative: Four days after receiving these three vaccines patient started to experience diarrhea every day with an accompanying headache behind his eyes.  On the seventh day he vomited once. He has continued to have diarrhea currently three weeks and two days after the injections. He reported that his headache went away yesterday, although it was unresponsive to increased hydration and over the counter pain relievers during the last three weeks. He has an appointment scheduled to see his primary care Dr on October 23rd
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Patient was fine when he received the vaccines around 11 am.  Patient went home and wife called stating that he vomited a couple times and had 1 round of diarrhea at about 1 pm.  Stated that he had zero other negative effects.  They called PCP and they were just told to get him seen at ER or call for their advice.  They chose not to get him seen and are just keeping him hydrated and at home.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Fatigue, Influenza like illness, Malaise, Nausea, Pain
Clinical narrative: Early morning the day after receiving the shot, the patient awakened with extreme flu-like symptoms of aches, nausea, and malaise. Patient reported no fever but extreme feeling of fatigue and nausea that lasted greater than 24 hours. No emesis occurred.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Flushing, Pruritus
Clinical narrative: flushing and redness of face, itching of arms & legs, a couple of hours after vaccine, family member gave her benadryl. He returned to pharmacy the next day to inform of the reaction.  He said she did not need to see her MD.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Excessive eye blinking, Eye movement disorder, Injection site haemorrhage, Muscle rigidity, Posture abnormal
Clinical narrative: Pt expressed nervousness prior to shot being administered. She had a small amount of blood at injection site. When she looked at blood she became rigid, her eyes rolled back and fluttered, and her head fell back. She was not responsive for about 1 minute.  I helped her to the floor and made sure her airway was clear. I called her mother into the room and continued to monitor the patient. She regained consciousness. Mother stated this had not happened previously and that pt had not hx of seizures or fainting. I had the patient remain lying on floor for another couple of minutes and had her raise her knees.  Mother and pt declined further medical assistance.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt expressed nervousness prior to shot being administered. She had a small amount of blood at injection site. When she looked at blood she became rigid, her eyes rolled back and fluttered, and her head fell back. She was not responsive for about 1 minute.  I helped her to the floor and made sure her airway was clear. I called her mother into the room and continued to monitor the patient. She regained consciousness. Mother stated this had not happened previously and that pt had not hx of seizures or fainting. I had the patient remain lying on floor for another couple of minutes and had her raise her knees.  Mother and pt declined further medical assistance.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: itchy red skin on throat and ears, patient self administered Epipen that she owned. Once she was home she took Benadryl and Zyrtec and symptoms went away that evening
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing
Clinical narrative: pt reported unknown flushing on 10/16/2019 -- she had no other symptoms but noticed around 1 pm on 10/16/2019 flushing --- she did not report any other symptoms at this time and had no other changes to routine other than receiving flu vaccine on 10/11/2019
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Extreme arm and shoulder pain for more than 24 hours.  Fever for more than 24 hours.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Electrocardiogram, Hyperhidrosis, Presyncope, Vision blurred
Clinical narrative: AFTER BOTH SHOTS, IN 2-3 MINTUES, PT EXPERIENCED FAINTING SENSATION AND SWEATING, BLURRED VISION AND ALMOST COLLAPSED, IMMEDIATLY CALLED 911 AND CREW ARRIVED IN  LESS TAHN 3 MINUTES, DURING THAT TIME, PT RECOVERED VISION AND FEELING BETTER
Age: 96.0
Sex: F
Vaccine: FLUA3
Symptoms: Pancreatitis
Clinical narrative: Pancreatitis, patient went into the hospital one day after vaccination, was there Tuesday until Sunday. Her symptoms resolved.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Chills, Decreased interest, Dysphagia, Eye burns
Clinical narrative: 4.5 hours after shot received: Agitation  Mild headache Flushing of face Loss of interest in activities Hard to swallow/ painful in throat Sensitivity to light, noise, and smell Fever 100.2 Chills Involuntary shaking/ teeth chattering Eyes burning, tearing Respiratory difficulty Swollen tongue Anxiety
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Flushing, Headache, Lacrimation increased, Oropharyngeal pain, Oversensing
Clinical narrative: 4.5 hours after shot received: Agitation  Mild headache Flushing of face Loss of interest in activities Hard to swallow/ painful in throat Sensitivity to light, noise, and smell Fever 100.2 Chills Involuntary shaking/ teeth chattering Eyes burning, tearing Respiratory difficulty Swollen tongue Anxiety
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Parosmia, Photophobia, Pyrexia, Swollen tongue, Tremor
Clinical narrative: 4.5 hours after shot received: Agitation  Mild headache Flushing of face Loss of interest in activities Hard to swallow/ painful in throat Sensitivity to light, noise, and smell Fever 100.2 Chills Involuntary shaking/ teeth chattering Eyes burning, tearing Respiratory difficulty Swollen tongue Anxiety
Age: 35.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Hyperhidrosis, Palpitations
Clinical narrative: SWEATING, PALPITATIONS, DIZZINESS
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Side effects lasted 36 hours. Side effects started 5 hours after vaccine. Headache Severe joint pain Severe muscle pain Fever Chills Nausea/ threw up
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Side effects lasted 36 hours. Side effects started 5 hours after vaccine. Headache Severe joint pain Severe muscle pain Fever Chills Nausea/ threw up
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Back pain, Discomfort, Erythema, Headache, Injection site erythema
Clinical narrative: large red and inflammed circle around injection site, red patches on face and stomach, painful skin, headache, nausea, lower back (kidney) pain, lethargy, generalized pain and discomfort
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site inflammation, Lethargy, Nausea, Pain, Pain of skin
Clinical narrative: large red and inflammed circle around injection site, red patches on face and stomach, painful skin, headache, nausea, lower back (kidney) pain, lethargy, generalized pain and discomfort
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Renal pain, Skin reaction
Clinical narrative: large red and inflammed circle around injection site, red patches on face and stomach, painful skin, headache, nausea, lower back (kidney) pain, lethargy, generalized pain and discomfort
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient came to the pharmacy on 10/16/2019 to explain that her left arm was very swollen and painful after receiving the vaccine. She stated it is less swollen and much less painful today.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Facial pain
Clinical narrative: Moderate Facial Pain at R inner eye to R nose, following line across cheek; lessening toward R ear.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness, Syncope
Clinical narrative: patient passed out 2 minutes after vaccine ,called 911 and the er doctor said it was syncope
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Paraesthesia oral, Pruritus, Skin warm, Urticaria
Clinical narrative: 37 minutes after getting the Flu Vaccine in the (L) deltoid, I began to get hives on the (L) arm, (L) rib region, (L) side of face and (L) thigh. My lips became tingly and itching to head & ears. (L) ear was red & warmth to the touch. I took oral Benadryl, used my inhaler (proair) took singulair and followed up with Dr. (allergist) prescribed prednisone.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: Local reaction at the injection site
Age: 63.0
Sex: U
Vaccine: FLUX
Symptoms: Dizziness, Documented hypersensitivity to administered product, Memory impairment, Nystagmus, Opticokinetic nystagmus tests abnormal
Clinical narrative: Was administered vaccine of thimersol against my written and oral instructions. Two and half months of Dizziness sore left arm motion memory (which is stored in the hippocampus) was faulty.
Age: 63.0
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Was administered vaccine of thimersol against my written and oral instructions. Two and half months of Dizziness sore left arm motion memory (which is stored in the hippocampus) was faulty.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction, at the injection site
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Lymphadenitis, Phlebitis, Ultrasound Doppler normal
Clinical narrative: Lymphadenitis, superficial phlebitis (R) axilla and erythema (R) ant chest, began 4d after vaccine. 1st OV 9/23/19 - Rx with Keflex 500mg bid x 10d & warm compresses Last OV 10/15/19 - some residual small cords in Rt. Axilla - still some axillary pain
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Night sweats, Pain, Pyrexia, Skin warm
Clinical narrative: States has had multiple years of swelling at injection site. 2019 injection site at 1 hour baseball size swelling had fever/night sweats, body aches. Site swelling dimishes each day. Warm touch. 4 years has experience cumulative reaction.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Palpitations, Paraesthesia oral
Clinical narrative: Swelling + redness at injection site tingling lips racing heart Prior to shot I advised pharmacist of my alpha gel allergy, assured not an issue. I called pharmacy, next day, due to reaction, again assured not and issue. Called Dr. -allergist's office -RN returned call, advised I take Benadryl. called Seqiris- they said no gelatin in vaccine, allergy should not be an issue. I took 2nd dose of Benadryl 8pm, fine the next day Called Seqiris again days later, after reviewing package insert that mentioned DNA products in vaccine. So, I am not certain that the canine DNA in the shot caused the reaction. I have never had a reaction to the flu shot, have had a flu shot yearly for over 10 years. I thought I should let you know about reaction for possible adverse allergy reaction. [I have had alpha gel allergy since Oct 2018] Thank you.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Immediate post-injection reaction, Pain
Clinical narrative: Patient received flu vaccine on 10/2/2019 during a school flu clinic event sponsored by Health Department with participation of Nursing. Client mention that when she received the vaccine she got discomfort right away but thinking it was just a regular effect from the shot but that discomfort extend the next day became moderate pain on 10/3/2019 till 10/8/2019 and from 10/9/2019 till 10/11/2019 pain decrease to low pain but became intensify from 10/12/19 till 10/14/2019 that opt her to seek medical help and see her PCP. As per patient PCP diagnosed that the shot was given to high and not in the muscle. Patient verbalized that during the course of events she did not experience any fever, no chills, no redness on the site, no discharges on the site but only tender to touch. Patient told Public health nurse that she will need to seek physical therapist help as per PCP advise because she had limited range of motion on that site. Public Health Nurse took this telephone report on 10/15/2019 through a call from the school nurse where client works as one of the staff.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: -Itching and hives on left arm. no SOB. Prednisone & monitor. Started 8 hours or after administration. Mom reports similar reaction last year to flu shot but only 1 red mark.
Age: 0.9
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Patient was given flu vaccine (R) vastus lateralis and patient waited 15m because no hx eggs. After 15 min RN assessed thigh had 2 1/2 inch x 1 1/4 inch red, raised welt where shot was given. Benadryl 15mg/5ml given orally @155pm after Dr assessed child. No respiratory symptoms. Patient discharged home with mom
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complains of swollen, redness, and pain of injection site, bruise.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Was was inadvertently given a dose of Shingrix during a presumed acute outbreak of Zoster lesions. Pt seems to have not been adversely affected.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain
Clinical narrative: On 10/9/19 Pt. reported continued shoulder soreness without swelling, redness or increased warmth.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Blood creatine phosphokinase, C-reactive protein, Epstein-Barr virus antibody, Full blood count
Clinical narrative: Patient states about 10 days ago started with bilateral lower extremity pain.  Severity of pain can be 6 out of 10.  This morning the pain was left anterior thigh pain up by the hip.  The pain starts after she gets up and walks.  Pain has been below right as well as left knee area shooting down the to ankle.  Patient experience sudden pain lasting hours.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states about 10 days ago started with bilateral lower extremity pain.  Severity of pain can be 6 out of 10.  This morning the pain was left anterior thigh pain up by the hip.  The pain starts after she gets up and walks.  Pain has been below right as well as left knee area shooting down the to ankle.  Patient experience sudden pain lasting hours.
Sex: U
Vaccine: FLUA3, VARZOS
Symptoms: Pain
Clinical narrative: Pt claims she started to experience pain around October 10/2/2019. Pt received vaccine 8/17/2019 right arm.
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Rash
Clinical narrative: Rash over entire body; This case was reported by a nurse via call center representative and described the occurrence of rash in a 73-year-old female patient who received Hepatitis B vaccine for prophylaxis.   The patient's past medical history included heart transplant and herpes zoster. Concurrent medical conditions included immunocompromised (Compromised immune system diagnosed in 2003), diabetes and joint pain.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   The reporter considered the rash to be related to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported by the Retired Nurse Practitioner. The age at vaccination was not reported. The nurse stated that she has a heart transplant, and a compromised immune system. Many years ago she got a Hepatitis B vaccine (brand unknown) and it caused a rash over her entire body.
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Arthralgia, Condition aggravated, Erythema, Eye discharge, Feeling abnormal
Clinical narrative: Rash over entire body; This case was reported by a nurse via call center representative and described the occurrence of rash in a 73-year-old female patient who received Hepatitis B vaccine for prophylaxis.   The patient's past medical history included heart transplant and herpes zoster. Concurrent medical conditions included immunocompromised (Compromised immune system diagnosed in 2003), diabetes and joint pain.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   The reporter considered the rash to be related to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported by the Retired Nurse Practitioner. The age at vaccination was not reported. The nurse stated that she has a heart transplant, and a compromised immune system. Many years ago she got a Hepatitis B vaccine (brand unknown) and it caused a rash over her entire body.
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Nasal congestion
Clinical narrative: Rash over entire body; This case was reported by a nurse via call center representative and described the occurrence of rash in a 73-year-old female patient who received Hepatitis B vaccine for prophylaxis.   The patient's past medical history included heart transplant and herpes zoster. Concurrent medical conditions included immunocompromised (Compromised immune system diagnosed in 2003), diabetes and joint pain.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   The reporter considered the rash to be related to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported by the Retired Nurse Practitioner. The age at vaccination was not reported. The nurse stated that she has a heart transplant, and a compromised immune system. Many years ago she got a Hepatitis B vaccine (brand unknown) and it caused a rash over her entire body.
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Nasopharyngitis, Oropharyngeal discomfort, Pain in extremity, Pruritus, Skin mass
Clinical narrative: Rash over entire body; This case was reported by a nurse via call center representative and described the occurrence of rash in a 73-year-old female patient who received Hepatitis B vaccine for prophylaxis.   The patient's past medical history included heart transplant and herpes zoster. Concurrent medical conditions included immunocompromised (Compromised immune system diagnosed in 2003), diabetes and joint pain.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   The reporter considered the rash to be related to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported by the Retired Nurse Practitioner. The age at vaccination was not reported. The nurse stated that she has a heart transplant, and a compromised immune system. Many years ago she got a Hepatitis B vaccine (brand unknown) and it caused a rash over her entire body.
Age: 30.0
Sex: M
Vaccine: JEV1
Symptoms: Burning sensation, Myalgia
Clinical narrative: Muscle pain (burning sensation in forearms and lower legs, comes and goes); The following information was received from a healthcare professional on 09 July 2018.  A vaccinee (no identifiers available) received a first dose of IXIARO (Japanese encephalitis vaccine, batch number unknown) on an unknown date.   Seven hours after vaccination muscle pain, described as 'burning that comes and goes', occurred. Outcome was not reported.   ---  Follow up 1 received from a physician via distributor on 11 July 2018.  The 30 year old male received his first dose of IXIARO on 02 July 2018.   The burning sensation, location specified as in forearms and lower legs, had not resolved by time of this report ('coming and going').   He had experienced similar reactions after receiving minocycline years ago.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Cardiac disorder, Dizziness, Electrocardiogram, Headache, Loss of personal independence in daily activities
Clinical narrative: Electrocardiogram; Tilt table test positive; Ultrasound scan; Nausea; Dizziness; Headache; Loss of personal independence in daily activities; Pain; Postural orthostatic tachycardia syndrome; Cardiac disorder; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 797712) and refers to a 13-year-old female patient. The patient's medical history was unknown. There were no current illness for the patient. The patient's other medication included multivitamin. On 18-AUG-2014, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 2) (lot number: K001631) (needle and syringe (not specified further)) (dose, frequency and expiration date was unknown) on arm (unspecified) for prophylaxis.  On 26-OCT-2014, the patient had a lot of pain after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) shot. On that day she started to get headaches and dizzy spells causing the patient to miss a lot of school (loss of personal independence in daily activities). On 29-OCT-2014, the patient was taken to see doctor, because she had been dizzy and nauseous for 3 days. The doctor referred the patient to an ear, nose, and throat (ENT) doctor.The ENT did a tilt table test and determined the patient's dizziness to be a cardiac issue (cardiac problem). On 31-OCT-2014, the doctor performed a thorough evaluation of the patient's heart and symptoms. The following tests were performed: electrocardiogram (EKG), ultrasound, tilt table test and thorough history for heart rate and blood pressure. On that day, the patient was diagnosed with Postural orthostatic tachycardia syndrome (POTS) by a pediatric cardiologist. The patient did not have problems like this before. She was an elite soccer player. The outcome of all the events was reported as not recovered at the reporting time. The causality assessment of the events to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. The agency considered the events to be serious as it caused disability.  Lot number (K001631) is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  Follow-up information was received on 03-JUL-2019 from a consumer via the FDA under the Freedom of Information Act (VAERS # 797712) . The patient's details were updated. The patient's concurrent conditions included penicillin allergy. She had not any adverse events following any previous vaccines. Her concomitant therapies included vitamins (unspecified) (reported as multivitamin; previously reported as an other medication). She was not pregnant at the time of the vaccination.  Follow-up information was received from the registered nurse on 10-OCT-2019. The reporter was unable to assist. There were no patient identifiers on the original form. They were redacted. Additional information has been requested.