chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: headache; fever; body aches; chills; nausea; This case was reported by a physician via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Hepatitis A vaccine, Typhoid vaccine and JAPANESE ENCEPHALITIS VACCINE.   On 25th October 2019, the patient received the 2nd dose of Shingrix. On 25th October 2019, less than a day after receiving Shingrix, the patient experienced headache, low grade fever, general body pain, chills and nausea. On an unknown date, the outcome of the headache and low grade fever were recovering/resolving and the outcome of the general body pain, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the headache, low grade fever, general body pain, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that within 12 to 24 hours after the 2nd dose of Shingrix patient developed headache, low grade fever, body aches, chills and nausea. The reporter stated that the symptoms have improved in some ways, but the patient continues to have headache and low grade fever intermittently. The reporter stated that the 15 days prior to receiving Shingrix the patient received Japanese encephalitis, the first dose of Hepatitis A and Typhoid vaccine.
Age: 78.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Chest pain
Clinical narrative: After receiving the Fluzone + Pneumovax 23 vaccinations the patient complained of chest + back pain. EMS was called + patient transported to the ER.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adverse drug reaction, Injected limb mobility decreased, Joint noise, Pain, Pain in extremity
Clinical narrative: I was taking antibiotics (Levaquin) for Diverticulitis and had both The flu and Pneumonia vaccines. The right arm which had the Pneumovax was swollen with a rash The next day. (Fri). By Sat. I could barely move it. It stayed swollen and painful for 2 weeks in spite of ice, heat, & Aleve. It is still sore with movement. My doctor said it was probably a reaction with the Levaquin I was taking for the diverticulitis. Apparently one of the side effects of Levaquin is tendinitis and tendon rupture. I did have popping in my upper arm when the pain was at it's worst. I am worried because it is still sore  and online it says sometimes damage is permanent.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: I was taking antibiotics (Levaquin) for Diverticulitis and had both The flu and Pneumonia vaccines. The right arm which had the Pneumovax was swollen with a rash The next day. (Fri). By Sat. I could barely move it. It stayed swollen and painful for 2 weeks in spite of ice, heat, & Aleve. It is still sore with movement. My doctor said it was probably a reaction with the Levaquin I was taking for the diverticulitis. Apparently one of the side effects of Levaquin is tendinitis and tendon rupture. I did have popping in my upper arm when the pain was at it's worst. I am worried because it is still sore  and online it says sometimes damage is permanent.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain
Clinical narrative: Patient reported arm pain that occurred during administration and lasted for a week before they decided to seek medical care from the ER on two occasions concerning this pain. The patient reported that the ER diagnosed it as bursitis. The patient also went to their PCP Dr. to seek treatment for the adverse event. According to the patient, he referred the patient to a neurologist and orthopedic specialists to rule out potential causes of the pain.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient developed full body hives within two hours of vaccination
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: FACIAL BUMPS, RASH ITCHY, SCALP, EARS, A FEW BUMPS ON SHOULDERS
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Seizure
Clinical narrative: Chills, convulsions, strong injection site pain, and strong body aches which were mild for about 1/2 day, then were very strong over the next day and 1/2.  By Day 3 the symptoms subsided, except the strong pain at injection site remained.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Feeling nauseous and very tired.  Went to bed, vomited once, 20 hours later was feeling well enough to get up but very weak.  Had the same reaction last year (2018).
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mom phoned day after immunizations reporting patient woke up with pain, swelling, heat, and redness at injection sites.  He was brought to the office that day.  He had no fever.  Left deltoid area had redness measuring 7.5 by 6cm, warm and tender.  He was dx with vaccine reaction/cellulitis and placed on cephalexin for 10 days.  Reaction completely resolved 11/2/19, 2 days later.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Vaccination complication
Clinical narrative: Mom phoned day after immunizations reporting patient woke up with pain, swelling, heat, and redness at injection sites.  He was brought to the office that day.  He had no fever.  Left deltoid area had redness measuring 7.5 by 6cm, warm and tender.  He was dx with vaccine reaction/cellulitis and placed on cephalexin for 10 days.  Reaction completely resolved 11/2/19, 2 days later.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood albumin abnormal, Blood electrolytes, Culture stool, Dehydration, Diarrhoea
Clinical narrative: Pt developed vomiting and diarrhea the day after the shots.  diarrhea persisted, and pt became dehydrated, needing hospitalization for hypoalbuminemia; pt needed TPN for a few days
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Full blood count, Hypoalbuminaemia, Parenteral nutrition, Platelet count increased, Stool analysis normal
Clinical narrative: Pt developed vomiting and diarrhea the day after the shots.  diarrhea persisted, and pt became dehydrated, needing hospitalization for hypoalbuminemia; pt needed TPN for a few days
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Transaminases increased, Vomiting, White blood cell count increased
Clinical narrative: Pt developed vomiting and diarrhea the day after the shots.  diarrhea persisted, and pt became dehydrated, needing hospitalization for hypoalbuminemia; pt needed TPN for a few days
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site scab
Clinical narrative: Muscle aches, Headache, Malaise, Sore at injection site x5 days,  nausea and vomiting at day 2.  Injection site still has not completely healed, itched,  scabbed over and then bled repeatedly.  Scabbed over currently, but not healed and gone.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Myalgia, Nausea, Vomiting
Clinical narrative: Muscle aches, Headache, Malaise, Sore at injection site x5 days,  nausea and vomiting at day 2.  Injection site still has not completely healed, itched,  scabbed over and then bled repeatedly.  Scabbed over currently, but not healed and gone.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Dyspnoea, Gait disturbance, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Breathing, leg pain, stomach pain, walking, talking, etc. Diagnosed with Guillain-Barre Syndrome
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Magnetic resonance imaging, Pain in extremity, Speech disorder
Clinical narrative: Breathing, leg pain, stomach pain, walking, talking, etc. Diagnosed with Guillain-Barre Syndrome
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: Pain at injection site initially, Later same evening redness, soreness, headache, muscle aches shivering, fatigue
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Pain at injection site initially, Later same evening redness, soreness, headache, muscle aches shivering, fatigue
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Lymph node pain, Lymphadenopathy, Paraesthesia
Clinical narrative: Pt stated that she experienced lymph node swelling in her left armpit a few days after she was given the shingrix vaccine (she received the flu vaccine on her right deltoid on the same day). She stated that her lymph node swelling is gone and the bruising she developed later is significantly better so is the lymph node pain. Pt denies pain, numbness, tingling in her left arm/fingers and anywhere else in her body. Pt declined to come back in the clinic because she states she is feeling better and will return after February 2020 for her second Shingles shot.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Chest X-ray normal, Discomfort, Dizziness, Electrocardiogram normal
Clinical narrative: Four hours after receiving Prevnar 13, I all of a sudden felt a sudden heavy weight descending on me and then dizzy. I was alone so immediately called 911, unlocked front door and went to a chair. Next thing I knew a voice was talking to me on my phone - I had fainted. I was then aware of extreme pain in my left arm at the vaccine site, aching all over, and nausea. Ambulance took me to ER, admitted for heart tests, and ultrasound for possible blood clot. All was normal - appeared to be reaction to Prevnar 13.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain, Syncope, Ultrasound scan normal, Vaccination complication
Clinical narrative: Four hours after receiving Prevnar 13, I all of a sudden felt a sudden heavy weight descending on me and then dizzy. I was alone so immediately called 911, unlocked front door and went to a chair. Next thing I knew a voice was talking to me on my phone - I had fainted. I was then aware of extreme pain in my left arm at the vaccine site, aching all over, and nausea. Ambulance took me to ER, admitted for heart tests, and ultrasound for possible blood clot. All was normal - appeared to be reaction to Prevnar 13.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site pain
Clinical narrative: Four hours after receiving Prevnar 13, I all of a sudden felt a sudden heavy weight descending on me and then dizzy. I was alone so immediately called 911, unlocked front door and went to a chair. Next thing I knew a voice was talking to me on my phone - I had fainted. I was then aware of extreme pain in my left arm at the vaccine site, aching all over, and nausea. Ambulance took me to ER, admitted for heart tests, and ultrasound for possible blood clot. All was normal - appeared to be reaction to Prevnar 13.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Contusion, Crying, Headache, Insomnia, Kawasaki's disease
Clinical narrative: He started to run a fever on 10/24/19 of 100.9 at 4pm. He did not eat and went to bed a few hours later with a temp of 101.5. He woke up at 4am not able to sleep still running a fever of 102.2. He complained his feet hurt. I took him to abovementioned Dr's Office on 10/25/19. They did an exam and stated it was just a virus. Took him home, alternating Tylenol and Motrin every 4 hours and his temp was not responding to the fever reducer. He continued to have a 102.9 temperature. He woke up at 4am on 10/26/19 screaming and crying saying his head hurt and his feet hurt. We noticed his lip was swollen 3x's the normal size. His lips where bright red and chapped. Both feet were swollen and with red blotches and even bruising on both ankles and toes. I took him to the abovementioned Dr's office Urgent care on 10/26/19 the practicing Dr examed him and diagnosed with Kawasaki's Disease. He called Dr. who was at Medical Center and he agreed his sypmtoms were consistent with Kawasaki's Disease. He also had a strawberry tongue, his hands and wrist were swollen and bruised looking, as well as swollen lymph nodes. He sent us immediately to Hospital to be admitted to PEdiatric ICU for Kawasaki's Disease. He had a treamtment of IVIG for 14hrs and his temperature broke that evening at 1am.  They kept us for 48hrs and on Monday 10/28/19 at 5pm he spiked another temperature of 102.2. They gave another dose of the IVIG treatment. He did not have another fever after the treatment on 10/29/19. He was discharged on 10/31/19. We spent 5 nights/ 6 days in the Hospital.  He continues to be fatigue quickly and not normal, as well as complaines his feet can still hurt at times. He will follow up with a cardiologist on 11/14 for hit 3 echocardigram and then will continue to have follow up appointments with a cardiologist.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Laboratory test, Lip erythema, Lip swelling, Lymphadenopathy, Peripheral swelling
Clinical narrative: He started to run a fever on 10/24/19 of 100.9 at 4pm. He did not eat and went to bed a few hours later with a temp of 101.5. He woke up at 4am not able to sleep still running a fever of 102.2. He complained his feet hurt. I took him to abovementioned Dr's Office on 10/25/19. They did an exam and stated it was just a virus. Took him home, alternating Tylenol and Motrin every 4 hours and his temp was not responding to the fever reducer. He continued to have a 102.9 temperature. He woke up at 4am on 10/26/19 screaming and crying saying his head hurt and his feet hurt. We noticed his lip was swollen 3x's the normal size. His lips where bright red and chapped. Both feet were swollen and with red blotches and even bruising on both ankles and toes. I took him to the abovementioned Dr's office Urgent care on 10/26/19 the practicing Dr examed him and diagnosed with Kawasaki's Disease. He called Dr. who was at Medical Center and he agreed his sypmtoms were consistent with Kawasaki's Disease. He also had a strawberry tongue, his hands and wrist were swollen and bruised looking, as well as swollen lymph nodes. He sent us immediately to Hospital to be admitted to PEdiatric ICU for Kawasaki's Disease. He had a treamtment of IVIG for 14hrs and his temperature broke that evening at 1am.  They kept us for 48hrs and on Monday 10/28/19 at 5pm he spiked another temperature of 102.2. They gave another dose of the IVIG treatment. He did not have another fever after the treatment on 10/29/19. He was discharged on 10/31/19. We spent 5 nights/ 6 days in the Hospital.  He continues to be fatigue quickly and not normal, as well as complaines his feet can still hurt at times. He will follow up with a cardiologist on 11/14 for hit 3 echocardigram and then will continue to have follow up appointments with a cardiologist.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Screaming, Strawberry tongue
Clinical narrative: He started to run a fever on 10/24/19 of 100.9 at 4pm. He did not eat and went to bed a few hours later with a temp of 101.5. He woke up at 4am not able to sleep still running a fever of 102.2. He complained his feet hurt. I took him to abovementioned Dr's Office on 10/25/19. They did an exam and stated it was just a virus. Took him home, alternating Tylenol and Motrin every 4 hours and his temp was not responding to the fever reducer. He continued to have a 102.9 temperature. He woke up at 4am on 10/26/19 screaming and crying saying his head hurt and his feet hurt. We noticed his lip was swollen 3x's the normal size. His lips where bright red and chapped. Both feet were swollen and with red blotches and even bruising on both ankles and toes. I took him to the abovementioned Dr's office Urgent care on 10/26/19 the practicing Dr examed him and diagnosed with Kawasaki's Disease. He called Dr. who was at Medical Center and he agreed his sypmtoms were consistent with Kawasaki's Disease. He also had a strawberry tongue, his hands and wrist were swollen and bruised looking, as well as swollen lymph nodes. He sent us immediately to Hospital to be admitted to PEdiatric ICU for Kawasaki's Disease. He had a treamtment of IVIG for 14hrs and his temperature broke that evening at 1am.  They kept us for 48hrs and on Monday 10/28/19 at 5pm he spiked another temperature of 102.2. They gave another dose of the IVIG treatment. He did not have another fever after the treatment on 10/29/19. He was discharged on 10/31/19. We spent 5 nights/ 6 days in the Hospital.  He continues to be fatigue quickly and not normal, as well as complaines his feet can still hurt at times. He will follow up with a cardiologist on 11/14 for hit 3 echocardigram and then will continue to have follow up appointments with a cardiologist.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Facial paralysis, Headache, Neuralgia, Rash
Clinical narrative: Skin rash,head and nerve pain back of head severe, bells palsey 3 days later
Age: 33.0
Sex: F
Vaccine: FLUR4
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Patient is experiencing pain in her left arm after receiving a flu shot 10/1/19.  Rates pain 6/10, dull, constant and is aggravated with movements such as putting on a jacket and reaching across her body.  She is also experiencing joint stiffening in her (L) shoulder, most noticeable in the mornings.  Has applied hot/cold compresses, lidocaine patches, muscle relaxers and has taken ibuprofen heat without relief.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Five minutes at receiving Flu vaccine, employee c/o " L arm itching from deltoid to wrist." Given 25 mg of Benadryl and sent to the Emergency department.
Age: 74.0
Sex: M
Vaccine: FLUR4
Symptoms: Pain
Clinical narrative: patient reported pain ( > 10 on scale of 1-10) at time of injection and that the pain subsided over the next few days, similar to past flu shots; called back today said that still was having some pain when moving the arm ( 5 on scale of 1-10); patient asked what he should do, pharmacist that spoke to patient recommended that patient call PCP for evaluation.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Injection site nodule, Injection site pain, Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: Patient came in today with a severe rash and whelp on her right arm where the vaccine was given a week and a half ago. She has been seeking help from her doctor who has been monitoring the spread of the rash down her arm. It was warm to touch and felt like a knot. She said it was very painful, so much so that she can't sleep on that arm. She noticed the reaction the day after her vaccine was given and it seems to be getting worse.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Sleep disorder
Clinical narrative: Patient came in today with a severe rash and whelp on her right arm where the vaccine was given a week and a half ago. She has been seeking help from her doctor who has been monitoring the spread of the rash down her arm. It was warm to touch and felt like a knot. She said it was very painful, so much so that she can't sleep on that arm. She noticed the reaction the day after her vaccine was given and it seems to be getting worse.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: pain in shoulder and difficulty moving arm, concern for injection to bursa
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Blood thyroid stimulating hormone, Diplopia, Full blood count, Magnetic resonance imaging brain, Malaise
Clinical narrative: Malaise, double vision and muscle weakness
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test, Muscular weakness
Clinical narrative: Malaise, double vision and muscle weakness
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS AROUND INJECTION SITE, SWELLING AND WARMTH STARTED WITHINT 24 HOURS AFTER INJECTION, NOTICED BY MOM 24 HOURS LATER.  MOM CALLED ME THE FOLLOWING DAY, SYMPTOMS NOT WORSENING AND NO SIGNS OF FEVER OR RESPIRATORY INVOLVEMENT.  CONSERVATIVE-COMPRESSES, ORAL PAIN CONTROL MEDICATION AS NEEDED OR BENADRYL.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: extreme prolonged arm pain. no redness, swelling or immobility
Age: 48.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash, Rash pruritic
Clinical narrative: Developed rash over torso and limbs, itchy but not raised  36-48 hours after receiving vaccine. Self treated with antihistamines - employee is a physician.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient can't move right arm, has sharp throbbing pain in right arm, pain is terrible and is radiating between shoulder down to elbow.
Age: 1.17
Sex: F
Vaccine: DTAP, FLU4, HIBV, VARCEL
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: ITP- platelet count down to 5
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Deafness
Clinical narrative: ON 11.5.19, PT'S HUSBAND CALLED THE PHARMACY AND STATED THE PT HAS A "LOSS OF HEARING".  SINCE 10.21.19 INJECTION DAY.  HE SAID SHE HAS TAKEN BENADRYL AND IT HAS NOT HELPED.  HER PROVIDER'S OFFICE, WAS CALLED ON THAT DAY.  RPh, THE INJECTING PHARMACIST, CALLED AND SPOKE WITH STAFF.  SHE WAS CHECKING TO SEE IF THEY HAVE COMPLTEED A VAERS REPORT.  NO RETURN CALL HAD BEEN MADE, SO I (RPh, PIC) COMPLETED THIS REPORT.  PT WAS CALLED BY RPh ON 11.6.19 TO DETERMINE HER CONDITION BUT LEFT A MESSAGE.  PT HAS NOT CALLED BACK.
Sex: F
Vaccine: PPV
Symptoms: Blood test, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: severe local site reaction; severe local site reaction, itching and swelling; severe local site reaction, itching and swelling; This spontaneous report was received from a 77-year-old female patient referring to herself. The patient's pertinent medical history included severe site reaction that never needed medical attention. The patient's drug reactions and allergies included allergy to bee stings. Concomitant therapies included unspecified asthma inhaler, unspecified sleep aid, unknown antidepressant and vitamin d. On 14-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) one vaccination in the deltoid in the right arm (exact dose, route of administration, lot # and expiration date were not reported) as pneumonia booster. On the same day, the patient experienced severe local site reaction, itching and swelling. The patient sought medical attention and contacted clinic. She received prednisone as a treatment. The unspecified blood work was done but no results were provided. The outcome of events was reported as not recovered/not resolved. There was no causality assessment provided by the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; administered dose one ofGARDASlL 9 in 2/2019 and will be in the ofT1ce today, 11/5/2019 to receive the second dose; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On an unknown date in February 2019, patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose (dose, frequency, route, lot# and expiry date were not reported) for prophylaxis. On 05-NOV-2019, patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose (dose, frequency, route, lot# and expiry date were not reported) for prophylaxis. On 05-NOV-2019, longer than recommended interval between dose one and two (inappropriate schedule of product administration). No adverse event was reported. No additional information was reported. No product quality complaint (PQC) was reported.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient has a large red area on upper arm 6 inches above and below injection site that has been increasing in size. The area itches and is painful. She saw her physician in the hospital on 11/7/19 where the doctor determined she has cellulitis in the upper arm. She was given Bactrim DS taking 1 tab twice daily for 10 days.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia, Pyrexia
Clinical narrative: 36 HOURS OF HIGH TEMP -102 3 DAYS OF SORE MUSCLES
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Contusion, Product administered at inappropriate site, Swelling
Clinical narrative: the patient received Pediarix and Prevnar 13  in left thigh. The vaccine was not placed in the correct area which caused swelling with black and blue bruising. The patient did not have any other symptoms. The provider was able to touch the area. The parent were informed if the area does not improve to return to the office.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever of 101, redness, tenderness, and hot to touch at injection site for three days. Alternating Tylenol and ibuprofen, icing to the injection site. Will continue to monitor and call PCP is symptoms worsen or persist.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: pts arm was red hot and swollen from shoulder to mid arm. recommended motrin, benadryl and an ice pack
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Guillain-Barre syndrome, Lumbar puncture abnormal, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Started with my legs giving out on me & pain in legs 7 Back.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve conduction studies, Pain in extremity
Clinical narrative: Started with my legs giving out on me & pain in legs 7 Back.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Dreamy state, Loss of consciousness, Musculoskeletal stiffness, Neurological examination, Seizure
Clinical narrative: Approx. 2 min after vaccine patient showed signs of seizure activity.  She became stiff from head to toe with no shaking, she became unconscious and urinated herself.  This lasted about 60seconds.  I held the patient until she came out of the spell.  She stated she felt like she was dreaming.    Patient was given fruit juice and was given a neurological exam.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Urinary incontinence
Clinical narrative: Approx. 2 min after vaccine patient showed signs of seizure activity.  She became stiff from head to toe with no shaking, she became unconscious and urinated herself.  This lasted about 60seconds.  I held the patient until she came out of the spell.  She stated she felt like she was dreaming.    Patient was given fruit juice and was given a neurological exam.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Neuropathy peripheral, Peroneal nerve palsy
Clinical narrative: Peroneal nerve neuropathy with foot drop, this is now resolving but not completely gone.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Headache, Injection site nodule, Pain
Clinical narrative: 101 temp., headache, left side of body achy with chills and knot @ injection site. Has been taking Tylenol every 4hours for fever.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Streptococcus test positive
Clinical narrative: 101 temp., headache, left side of body achy with chills and knot @ injection site. Has been taking Tylenol every 4hours for fever.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Patient complains of sore arm lasting longer than she has ever experienced with flu shot in the past. Seen by MD with continued soreness on 11/7/19. Outcome unknown
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Lethargy, Pain in extremity, Peripheral swelling
Clinical narrative: swollen, sore arm. Hot and reddened within 24 hours with 3 inch diameter of redness.  Headache and lethargic for 28 hours.  Lethargy better after 68 hours, yet arm still painful, swollen and red.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: swollen, sore arm. Hot and reddened within 24 hours with 3 inch diameter of redness.  Headache and lethargic for 28 hours.  Lethargy better after 68 hours, yet arm still painful, swollen and red.
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Magnetic resonance imaging, Mobility decreased, Myalgia
Clinical narrative: Severe deltoid muscle pain and could barely raise arm.  Still cannot left arm above head or behind back without pain level 8 to 10. Anti-inflammatory products do not take away pain
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Influenza like illness, Myalgia
Clinical narrative: At 12 hrs muscle ache and joint pain. At 24 hrs. symptoms continue  with increasing muscle,joints and back pain. Increasing fatigue and virus type(flu like) symptoms resulting in bed confinement.
Sex: F
Vaccine: ADEN_4_7
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 23.0
Sex: M
Vaccine: FLU4, MNQ, TYP, YF
Symptoms: Abdominal mass, Cough, Limb mass, Mouth swelling
Clinical narrative: Pt called clinic at 13:45 stating he developed a cough around 11:40 after leaving clinic, then began to notice slight swelling on the left side of his mouth. Pt denied any difficulty breathing. He stated he also began to notice a small 1/2 of a penny-sized lump on his left lower anterior forearm as well as the same lump on his anterior abdomen. He denies any itching at the sites. He stated the swelling, lumps, and cough were seeming to ''go away'' at time of call to clinic. I advised pt to go to nearest ER/ contact nurse triage line (provided pt w/ number)
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient is having an extremely sore arm that has lasted for 7 days and counting. Patient states it is getting better slowly and was instructed to call back or see doctor if her arm does not continue to improve.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives on 11/7/2019, histamine blockers, otc anti itch medication
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, UNK, UNK
Symptoms: Malaise, Pyrexia, Rash morbilliform
Clinical narrative: Patient had a rash resembling measles for two days. She also had a low grade fever with this rash and was feeling generally unwell. We did not seek treatment.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Menactra was just administered to a patient, no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a patient (with unknown demographics) who received expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported, Exp. Date 09-Oct-2019) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: diarrhea; nausea; Vomiting; fever of 100.2 F; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68 years old female patient who experienced diarrhea (diarrhoea), Nausea (Nausea), vomiting (vomiting) and fever of 100.2 degree F (pyrexia) , while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included LOPERAMIDE HYDROCHLORIDE (IMODIUM AD).  On 17-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ284AB, via intramuscular route in the left arm. The patient was taking steroids for the condition of periodermangrinosa  On an unknown date, the patient developed a non-serious diarrhea (diarrhoea), Nausea, vomiting and fever of 100.2 f (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported  Final diagnosis was diarrhea, vomiting, nausea and fever.  The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) and to stay hydrated.  The event outcome is reported as Recovering for diarrhea, as Not Recovered for nausea, vomiting and as Unknown for fever of 100.2 degree F.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel administered to patient / no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old patient who received 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5307AA via (Expiry date 23-Oct-2019) intramuscular route in the left thigh.  The patient's medical history and concomitant medications were not reported.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB); and HEPATITIS A VACCINE INACT (VAQTA).  It was an actual medication error case due to Expired vaccine used.  At a time of reporting No adverse reaction reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel adminisetred to patient / no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 years old male patient who received 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5281AA (Expiry date 05-Oct-2019) via intramuscular route in the left thigh on 24-Oct-2019.  The patient's medical history and concomitant medications were not reported.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) ; and HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error case due to Expired vaccine used.  At a time of reporting No adverse reaction reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 16 years old received Flublok Quadrivalent/ no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to cases 2019SA304486 and 2019SA304487 (same reporter).  This case involves a 16 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not have any concomitant therapy.   On 10-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left deltoid.  It was of actual medication error case due to inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Wrong product administered
Clinical narrative: the child was given FluLaval and not Fluzone Quadrivalent/no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who was administered with vaccine INFLUENZA VACCINE INACT SPLIT VIRION 3V [FLULAVAL] instead of QUADRIVALENT INFLUENZA VACCINE[FLUZONE QUADRIVALENT]   On an unknown date, the patient received a 0.5 ml dose of suspect VACCINE INACT SPLIT VIRION 3V [FLULAVAL] lot unknown, expiration date: unknown, via unknown route of administration.  It was a case of actual medication error due to Wrong vaccine administered.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9 years old patient received Flublok Quadrivalent/no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to cases 2019SA304486 and 2019SA304462 (same reporter).  This case involves a 9 years old male patient who received vaccine  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] ].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not have any concomitant therapy.   On 12-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left deltoid.  It was of actual medication error case due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced ornot.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 16 month old was given Adacel instead of Daptacel/No AE; 16 month old patient was given a dose of Adacel/No AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old male patient who received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 10-Oct-2019, the patient received a fourth 0.5mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5566AA, expiry date- 13-02-2021 via intramuscular route in the left thigh.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: injected with Daptacel on 25Oct2019 that expired on 23Oct2019/no ae; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves 9 month old male patient who received  vaccine  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 25-Oct-2019 that expired on 23-Oct-2019.  Concomitant medications included HAEMOPHILUS TYPE B (HIB) VACCINE (Act-HIB) for Immunisation; and QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) for Immunisation.  On 25-Oct-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via intramuscular route in the left thigh.  It was a case of actual medication error due to expired vaccine used.  It was confirmed no adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  Information on the batch number was requested.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: Fluzone squirted all over the patient, no AE; vaccine was leaking at the base of the needle hub to the tip of the syringe, no AE; vaccine was leaking at the base of the needle hub to the tip of the syringe where the needle would be attached, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe) lot UT6686NA, expiry date: 30-Jun-2020 via intramuscular route in the left arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 31-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6686NA via intramuscular route in the left arm.  It was a case of vaccine underdose.  Also a case of Exposure via skin contact and syringe leakage. It was reported that Pharmacist administered Fluzone Quad for a patient and it was leaking at the base of the needle hub to the tip of the syringe where the needle would be attached and it squirted all over the patient.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Somnolence
Clinical narrative: Redness and swelling at injection sight, severe fatigue and somnolence days following vaccination.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: arm significantly swollen warm red and painful from vaccination
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Dizziness, Gait inability, Loss of consciousness
Clinical narrative: Patient states that he woke up about midnight after his flu and pneumonia shots on 10/30/19 and felt like he had a "whoosh" rushing feeling into his head, followed by weakness and inability to walk. He states that he felt this way for two days and that at one point he passed out. He did not go in to the ER or to be evaluated.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Chills, Computerised tomogram abdomen, Computerised tomogram head, Fatigue
Clinical narrative: Night of what I can only describe as head to toe nerve pain making it impossible to sleep in any position. Followed by a general sense of fatigue to the point where walking was the max exercise I could do 3 days after the injection. Woke up during the night on day 4 with flu-like symptoms.  Went to work and came home mid afternoon and slept for two hours. Later that evening started to shiver.  Shivering  accompanied by fever of 103 continued.  Advil brought fever down to almost normal but shivering and flu-like symptoms persisted.  Tested negative for flu and mono.  Went to the ER on  10/31 and diagnosed with viral meningitis.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Influenza virus test negative, Insomnia, Lumbar puncture, Magnetic resonance imaging brain
Clinical narrative: Night of what I can only describe as head to toe nerve pain making it impossible to sleep in any position. Followed by a general sense of fatigue to the point where walking was the max exercise I could do 3 days after the injection. Woke up during the night on day 4 with flu-like symptoms.  Went to work and came home mid afternoon and slept for two hours. Later that evening started to shiver.  Shivering  accompanied by fever of 103 continued.  Advil brought fever down to almost normal but shivering and flu-like symptoms persisted.  Tested negative for flu and mono.  Went to the ER on  10/31 and diagnosed with viral meningitis.