chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Blood urine present, Dizziness, Influenza virus test negative, Lethargy
Clinical narrative: Patient's Daycare called and said patient was lethargic, mild rash, fever of 103.4, seizure, unresponsive, urinated on himself, dizzy, weak, lying on the floor.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Protein urine present, Pyrexia, Rash, Seizure, Specific gravity urine normal
Clinical narrative: Patient's Daycare called and said patient was lethargic, mild rash, fever of 103.4, seizure, unresponsive, urinated on himself, dizzy, weak, lying on the floor.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Streptococcus test negative, Unresponsive to stimuli, Urinary incontinence, Urine ketone body present, Urobilinogen urine increased
Clinical narrative: Patient's Daycare called and said patient was lethargic, mild rash, fever of 103.4, seizure, unresponsive, urinated on himself, dizzy, weak, lying on the floor.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: White blood cells urine negative
Clinical narrative: Patient's Daycare called and said patient was lethargic, mild rash, fever of 103.4, seizure, unresponsive, urinated on himself, dizzy, weak, lying on the floor.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Hypoaesthesia oral, Mouth swelling, Urticaria
Clinical narrative: Patient began experiencing an extreme allergic reaction about 18 hours after the vaccine. He had hives all over his body and 50mg of BENADRYL was not effective. Patient began to have swelling around the mouth and numbness and went to the ER. He received IV BENADRYL and prednisone. Upon returning home he began to react again 24 hours later and had to return to his doctor to get his meds increased.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm hurt 2 months plus later. Don't know which flu shot.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Fatigue, Headache, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: As described by patient: arm pain up through shoulder to neck, severe headache, fever, overall feeling tired. Asked patient about location of vaccine: about 4 inches below the joint. No outcomes reported yet. Advised patient to seek medical treatment if no improvement or if condition worsens.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pyrexia
Clinical narrative: As described by patient: arm pain up through shoulder to neck, severe headache, fever, overall feeling tired. Asked patient about location of vaccine: about 4 inches below the joint. No outcomes reported yet. Advised patient to seek medical treatment if no improvement or if condition worsens.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Injection site 3 inch circular redness, itchy and sore to touch.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Nasal congestion, Skin mass
Clinical narrative: Patient had nasal congestion and redness and swelling at site of injection at the site of injection within a few hours of injection. Knot under the skin. She iced it and had MD look at it at her appointment a few days later. He recommended some Benadryl. and to continue to ice and monitor.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient asked to speak with me about a flu shot that he received on 11/09/2017 given by my colleague  Rph. The patient stated that he had has continuous pain as well as loss of movement in the arm that the shot was given in. This visit took place on 11/18/2017. I was concerned because from what he and his wife stated I thought that the shot may have been given into the shoulder joint above the deltoid muscle. I suggested that pt go to a Dr and speak with the immunizing pharmacist. I spoke with Rph  last week and asked if pt had contacted him. Rph stated that pt had not contacted him. The last information is speculative because I heard it from my pharmacy Tech.  She stated that she had spoke with pt's wife and that pt did go to a Dr. who administered a steroid shot. The Dr told pt that he may have to have surgery if the shot did not help.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Injection site reaction - swelling, rash, injection site pain.
Age: 38.0
Sex: F
Vaccine: TYP
Symptoms: Exposure via skin contact, Eye irrigation, Syringe issue
Clinical narrative: Patient was administering 0.5 ml of Typhoid vaccine to a patient and the needle came off the syringe during the push. The vaccine sprayed back onto patient's face. She washed her face, flushed her eyes and consulted with her physician.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash, Sleep disorder, Swelling
Clinical narrative: She had a rash down her arm, pain (couldn't sleep on that arm for a week) and swelling.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Hypertension
Clinical narrative: She has controlled hypertension, after receiving the vaccine she said that her blood pressure was high and out of control for 2 weeks. She even visited her doctor's office because she felt so horrible. She has had controlled HTN for a long time.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Acupuncture, Facial paralysis
Clinical narrative: 11/8 diagnosed Paralysis of Right side of face - Bell's Palsy, dx prednisone and acyclovir 800mg. Acupuncture.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site mass, Injection site pain
Clinical narrative: After receiving the vaccine at about 5 pm, later in the evening she first noticed a rash on the arm lower than the site of the shot - the following symptoms were all over the arm radiating towards the elbow and inner left arm - it was very hot, red and inflamed, felt hard and looked like a tennis ball like hard lump, she also noticed a red streak like a red line towards the elbow. Today 12/02/17 - two days after receiving the shot - it is still sore and tender to touch, still hot, some rash, red horizontal line right above crease of the elbow, 2.5 inches long. Not as hard as it was before.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site streaking, Injection site warmth
Clinical narrative: After receiving the vaccine at about 5 pm, later in the evening she first noticed a rash on the arm lower than the site of the shot - the following symptoms were all over the arm radiating towards the elbow and inner left arm - it was very hot, red and inflamed, felt hard and looked like a tennis ball like hard lump, she also noticed a red streak like a red line towards the elbow. Today 12/02/17 - two days after receiving the shot - it is still sore and tender to touch, still hot, some rash, red horizontal line right above crease of the elbow, 2.5 inches long. Not as hard as it was before.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Gait disturbance
Clinical narrative: Felt for about a week after the shot had gait problems, and felt very unsteady walking. Had to have a friend hold him up couple times. Had trouble staying balanced when moving.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Cough, Hyperhidrosis, Pneumonia, Vaccination site pain
Clinical narrative: The day after both vaccines were given in the same arm over 2 inches apart the patient developed rigors, sweats and the vaccine site was hot, swollen and sore. He went thru multiple days of these symptoms then developed a severe cough. He went to the Urgent Care Center and was diagnosed on 11/28 with pneumonia and had just over 80% oxygen saturation. He has been to the doctor at least five times so far for the symptoms that he experienced.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: The day after both vaccines were given in the same arm over 2 inches apart the patient developed rigors, sweats and the vaccine site was hot, swollen and sore. He went thru multiple days of these symptoms then developed a severe cough. He went to the Urgent Care Center and was diagnosed on 11/28 with pneumonia and had just over 80% oxygen saturation. He has been to the doctor at least five times so far for the symptoms that he experienced.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Blotches and rash on arms and upper chest. Triamcinolone cream applied twice daily. Blotches and rash have gotten slightly better and treatment has to stop this Sunday night. Going to see PCP 12/5/2017.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Gait inability
Clinical narrative: When pt woke up on 11/30/17, 21 hours after having the flu vaccine, he was unable to walk. It was his right leg that was giving him the issue. This went on for 1 hour 45 minutes. Patient was then able to walk but with a very noticeable limp and his right foot turned slightly outward. Patient did not seem to be in pain but was very distress because he was unable to walk. When he could walk he was still in distress because he could not walk without the limp. Patient went to urgent care at 8:15 on 11/30/17 but was told by the doctor that the symptoms could possible be caused by rheumatoid arthritis and that I, the patients mother, was to keep a log of when symptoms happen so that if continued, testing could be performed. The limp continued throughout the day and evening. Patient saw chiropractor at 6:00pm 11/29/17 for an adjustment. On 12/1/17 patient woke up with slight limp again. Patient was given 1 teaspoon ibuprofen in hopes to calm any inflammation. Slight limp continued and patient was given 1 teaspoon ibuprofen before bed at 8pm. Patient woke up on 12/2/17 less of a limp than previous day and was given 1 teaspoon ibuprofen for any additional inflammation. That takes us to right now where patient still isn't waking like normal but is much better than day prior.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Pt has developed a non bumpy but extremely red, itchy rash from the neck down to her groin. She states this is the same reaction she had to a pneumonia vaccine, but she is unsure of which pnuemonia vaccine it was.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had an adverse reaction (swelling, redness, feeling of heat and pain near and on the arm in which she received the vaccine) for several days after receiving ZOSTAVAX immunization on 11/28/17. I spoke with the patient originally on Friday, 12/1/17, about the reaction and made the recommendation to seek medical advice if her reaction got worse. On Saturday, 12/2/17, she went to the local ER and confirmed that she had a reaction to the vaccine. She was prescribed both a steroid and antibiotic to address the reaction. She was advised to report the incident to the manufacture in addition to the pharmacy she received it at. I then again spoke to her when she reported the incident to us on 12/2/17. She was not upset with us, and appreciated my support and help. She did confirm that she would be notifying the manufacture personally in which I provided her the contact information.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Throat tightness
Clinical narrative: Patient states feeling itchiness and throat started to feel tight about 15 minutes after getting TDAP vaccine.
Age: 47.0
Sex: M
Vaccine: PNC13
Symptoms: Facial paresis, Guillain-Barre syndrome
Clinical narrative: Patient developed bilateral face weakness with laboratory testing consistent with a subtype of Guillain-Barre Syndrome and is receiving treatment for this diagnosis currently in the hospital.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pt. came to the pharmacy on 12/2/2017 stating  that her arm still hurts from the vaccination. She said it hurts to lift arm.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: Patient's husband called and said patient had swelling in her left arm with red rash. He said the swelling was lower than the previous day after receiving the vaccination. Pt did not have any discharge in the arm.
Age: 18.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Laboratory test, Urticaria
Clinical narrative: Hives, relieved by Benadryl. Pt undergoing allg testing.
Age: 18.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Dyspepsia, Headache, Lip swelling, Swelling face, Urticaria
Clinical narrative: Hives, relieved by Benadryl. Pt undergoing allg testing.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: PATIENT DEVELOPED CHILLS AND FEVER. WAS LATER DIAGNOSED WITH CELLULITIS IN LEFT ARM PER DAUGHTER'S REPORT. PRESCRIBED ANTIBIOTICS.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis
Clinical narrative: PATIENT DEVELOPED CHILLS AND FEVER. WAS LATER DIAGNOSED WITH CELLULITIS IN LEFT ARM PER DAUGHTER'S REPORT. PRESCRIBED ANTIBIOTICS.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Red, swelling, sore arm. Started the night of the injection.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain, Paraesthesia
Clinical narrative: ~2/3 days after receiving shot on 11/4/17, I thought I injured my shoulder somehow but hadn't fallen or strained it or anything. Ground Zero of the pain was right where the shot was given but I didn't put it together at first and went to chiropractor with no relief. Certain motions caused extreme pain and  range of mobility was limited. Difficult to put on or take off shirts, shampoo or dry hair etc. It did not get better, only worsened to tingling in arm and hand/fingers, so went to family Dr. on Nov. 30. He diagnosed reaction to flu shot and prescribed Methylprednisolone 4mg DSPK, Gabapentin 300 mg and physical therapy.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Vaccination complication
Clinical narrative: ~2/3 days after receiving shot on 11/4/17, I thought I injured my shoulder somehow but hadn't fallen or strained it or anything. Ground Zero of the pain was right where the shot was given but I didn't put it together at first and went to chiropractor with no relief. Certain motions caused extreme pain and  range of mobility was limited. Difficult to put on or take off shirts, shampoo or dry hair etc. It did not get better, only worsened to tingling in arm and hand/fingers, so went to family Dr. on Nov. 30. He diagnosed reaction to flu shot and prescribed Methylprednisolone 4mg DSPK, Gabapentin 300 mg and physical therapy.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient stated injection site was swollen and warm to the touch for around 5 days, area cleared up without any treatment.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient called and complained of her arm being red for over a quarter of the arm and complained of soreness.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: I had a flu shot in my right arm. I did notice that it was higher up then when I got them in the past. The next day is when I started getting sharp pain in the shoulder and down my arm. This happened on October 31st and I've been suffering ever since. My primary care Dr referred me to an orthopedic Dr  on Nov. 13th. He didn't do any tests since he was convinced it was due to the flu shot. He told me to take 4 Ibuprofons a day, get therapy and come back on December 4th. (Two days from now) I never took pain pills due to a history of stomach sensitivity but I had to this time due to the terrible pain. I've had to use my left hand to do  things like wiping off a table etc.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain in extremity
Clinical narrative: Patient said her back started hurting before she left the store. Eventually her arms and legs had severe pain. She called her doctor. She has always taken the regular flu shot without any problems she said.  This was her first time receiving the High Dose. Her pain lasted two days.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscle spasms, Musculoskeletal discomfort, Walking aid user
Clinical narrative: Pt received 2 vaccinations in right arm greater than 1 inch apart due to her request on 11/30, pt contacted the pharmacy on 12/2/17 to inquire if there could be a interaction with her Meloxicam that she has been taking for her chronic knee issues. Pt stated that she has had to rely on her cane more since the vaccination and has experienced " Charlie Horse" discomfort in her right hip/muscle after taking 2-3 steps. Advised the pt to follow up with Dr if the issue continues.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Swelling at injection site, heat and pain at the site, very red skin. Skin very tight and swollen on arm. Pt treated with ZYRTEC 10mg, MOTRIN 800mg, and Hydrocortisone cream 1%.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Decreased appetite, Diarrhoea, Dizziness, Dyspepsia
Clinical narrative: 7-16-17-Went to PM pediatrics due to neck pain. Was jumping on trampoline day before. 7-19-17 seen here due to neck pain, nausea, loose stool, sore throat, dizziness. 7-21-17 seen by orthopedics due to neck pain. 8-7-17 seen due to sore throat, nausea, anxiety. 8-8-17 seen by gastroenterology due to poor appetite, nausea, heartburn-endoscopy done subsequently. 8-25-17 seen due to rash. 12-2-17 seen for headaches and nausea and referred to neurology.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Endoscopy, Nausea, Neck pain, Oropharyngeal pain, Rash
Clinical narrative: 7-16-17-Went to PM pediatrics due to neck pain. Was jumping on trampoline day before. 7-19-17 seen here due to neck pain, nausea, loose stool, sore throat, dizziness. 7-21-17 seen by orthopedics due to neck pain. 8-7-17 seen due to sore throat, nausea, anxiety. 8-8-17 seen by gastroenterology due to poor appetite, nausea, heartburn-endoscopy done subsequently. 8-25-17 seen due to rash. 12-2-17 seen for headaches and nausea and referred to neurology.
Age: 69.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Swelling face
Clinical narrative: The patient stated she woke up the next morning after her immunizations and her face was very swollen. She took BENADRYL and the swelling improved. Patient consulted her primary doctor.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Thigh redness, painful, itchiness.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Muscle tightness
Clinical narrative: Flu shot in left shoulder. Soreness/tightness in shoulder muscle area in the injection area. Movement is not limited, but soreness/pain is lingering from September to December. Received the Influenza, Injectable, Quadrivalent, Preservative Free shot.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: I received the vaccine about an inch below the acromion process. I immediately felt burning and I mentioned to the Pharmacist that it has an unusual burn this year. I had increased soreness for the next three days and caught myself guarding the shoulder. By the next week, the soreness decrease but I started having right joint pain and difficulty with range of motion. I sought care with my PCM, on 11/30/2017, who referred me for an MRI. As of today, as still have pain at rest and with movement and I am waiting for the referral's processing in order to schedule the MRI.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: Joint pain in both knees, ankles and wrists. Began midday and worsened as day progressed.
Age: 10.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Anger, Anxiety, Blood test, Depression, Obsessive-compulsive disorder
Clinical narrative: In October of 2014, depression suiciadal talk, OCD, severe anxiety, unprovoked anger. Lasted daily through March 2015 when I researched and learned to detox through diet and added holistic neurotransmitter supplements.
Age: 10.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Suicidal ideation
Clinical narrative: In October of 2014, depression suiciadal talk, OCD, severe anxiety, unprovoked anger. Lasted daily through March 2015 when I researched and learned to detox through diet and added holistic neurotransmitter supplements.
Age: 51.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Breast tenderness, Burning sensation, Herpes zoster, Pruritus, Rash
Clinical narrative: Diagnosed with Herpes Zoster (Shingles) by Dr. (a self described Infectious disease expert!) on 12/02/2017 at Urgent Care. Dr. prescribed VALTREX. Received the 1st stick of TWINRIX on 11/15/2017 at Primary Care by PA. The first symptom of burning/itching noticed on upper right back sometime on or about 11/20/2017.  Few days later noticed tenderness in right breast. Rash appeared on or about 11/28/17 on upper right back and chest.
Age: 51.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Breast pain, Breast tenderness, Burning sensation, Herpes zoster, Pruritus
Clinical narrative: Diagnosed with Herpes Zoster (Shingles) by Dr. (a self described Infectious disease expert!) on 12/02/2017 at Urgent Care. Dr. prescribed VALTREX. Received the 1st stick of TWINRIX on 11/15/2017 at Primary Care by PA. The first symptom of burning/itching noticed on upper right back sometime on or about 11/20/2017.  Few days later noticed tenderness in right breast. Rash appeared on or about 11/28/17 on upper right back and chest.
Age: 51.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Rash
Clinical narrative: Diagnosed with Herpes Zoster (Shingles) by Dr. (a self described Infectious disease expert!) on 12/02/2017 at Urgent Care. Dr. prescribed VALTREX. Received the 1st stick of TWINRIX on 11/15/2017 at Primary Care by PA. The first symptom of burning/itching noticed on upper right back sometime on or about 11/20/2017.  Few days later noticed tenderness in right breast. Rash appeared on or about 11/28/17 on upper right back and chest.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Swelling
Clinical narrative: Patient had mild swelling to the bicep and bruising at the injection site. The swelling went down and the there was still a little brusing at the injection site as of 12/4/2017.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Sleep apnoea syndrome
Clinical narrative: The night of vaccinations, patient had a spell of apnea lasting greater than 30 seconds, but less than 1 minute while asleep, which caused his monitor to alarm. Monitor was purchased over the counter for peace of mind, not for a medical device. Monitor alarmed that night at which time I, his mother, blew in his face and rubbed his chest to get him to respond and take a breath. The following night the alarm went off again (Nov 16th) on the night of November 17th the alarm sounded three times. Twice were vibrating alerts after 15 seconds of no breathing detected, which stimulated him to breathe and the third being a 30 second or greater alarm. The night of the 18th there was one instance of apnea and the night of the 19th there was one instance of apnea. At the time of this report, there have been no further instances. Prior to this event, he had one apnic episode where I had to flip him on his stomach and rub his back vigorously to respond, which was following his immunizations he received at 3 months (Hib and PCV13) this instance was reported after he now had a second similar reaction due to correlation. It was previously thought prior to this referenced reaction by his pediatrician and myself, that the first instance could have been unrelated to his immunizations. Now as his mother I believe there is a correlation. He wears what is called a Levana Oma, bought by Snuza, which clips to his diaper and monitors belly movement to detect respiration. The monitor has been worn since birth and also with my daughter for >6 months with no false alarms other than once, when my daughter kicked it off into her footie pajamas. The monitor is meant to vibrate after 15 seconds of no breaths detected and then if no response after another 15 second time span, it will alarm loudly. The monitor shows different colors as well in the am, in case a vibration was not heard by the parent.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Flushing, Headache, Pain in extremity
Clinical narrative: Severe headache, flushed hot face, pain in arms and legs, weakness for 36 hours.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient presented to clinic the next day roughly 26 hours after injection with redness around injection site that was warm to the touch, pain 4/10. Patient was seen by the provider here at the clinic and was prescribed an antibiotic.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Inflammation, Pain, Pyrexia, Rash
Clinical narrative: Patient said he had a rash spreading from his arm to elbow for weeks after receiving vaccination. It occurred within 2h hours after vaccination but do no remember exact time. He also acknowledges that the area was painful and inflamed with chills and fever.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Allergy test negative, Asthma, Influenza like illness, Lung hyperinflation, Nasal congestion
Clinical narrative: Severe cold and flu like symptoms including high fevers for the first 10 days. Continued severe and flu like symptoms with low grade fevers for additional 6 wks. Chronic stuffy nose and postnasal drip every day from 21 April 2016 to present with various cold and flu like symptoms and low grade fevers. While seeking medical assistance with two Clinics, patient was informed that she now has asthma.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Nasopharyngitis, Pyrexia, Upper-airway cough syndrome
Clinical narrative: Severe cold and flu like symptoms including high fevers for the first 10 days. Continued severe and flu like symptoms with low grade fevers for additional 6 wks. Chronic stuffy nose and postnasal drip every day from 21 April 2016 to present with various cold and flu like symptoms and low grade fevers. While seeking medical assistance with two Clinics, patient was informed that she now has asthma.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient came in to pharmacy on 12/3/17 complaining of redness on inside of left arm. Area was sore, hot to touch, and swollen. There was no redness where injection site was on outside of arm. Patient did not use any ice, advil, etc to alleviate symptoms but said she thought it was getting better today. I advised patient to ice the area since she did not want to take any pills to help the swelling. I told her to go to her doctor if it does not get any better or it gets worse and to contact us.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Later that same day injection site area became painful and red rash developed 4x6 inches, in the following days pain increased and black and blue mark developed at injection site a little larger than a half dollar. Red rash went away in 3 to 4 days. Six days later still has some pain and tenderness and black and blue mark still there.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Patient states that after recieving the vaccine, he devoloped muscle soreness which he thought was normal. This soreness went away but was replaced with a sharp stabbing pain (when moving his arm).  Patient states that this is intermitent and only occurs when moving.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Patient had redness, and skin was warm to touch and appeared a day later.
Age: 53.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient report feeling pain in all body, headache and minor fever. Also pain in arms. Patient took 2 TYLENOL and next day feeling better. Pharmacist gave counseling to patient.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Swelling
Clinical narrative: Patient contacted the pharmacy and let us know that he got a huge (size of an egg) knot on his right under arm, where the shot was given. Patient did no notice the knot until 12/03/17. He got the shot on 12/01/17. Patient did mention that he does not have any other problem beside the swelling on the area of the shot. The pharmacist on duty had mention the patient to put some ice pack over it and if any thing  else occur, he will need to go to the doctor.
Age: 1.17
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Rhinorrhoea, Seizure
Clinical narrative: Patient received the vaccines on 11/06/2017 and started having reactions such as a fever, runny nose, and on 12/03/2017 she woke up at 4am with a seizure. Her fever has not gotten down past 101 all day.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Contusion, Dry skin, Injection site dryness, Injection site erythema, Injection site pruritus
Clinical narrative: Patient developed a bruise shortly after administration, then developed a rash on left upper arm that started around 11/26/17-11/27/17 (2-3 days after administration). The rash is characterized as dry, itchy, bumpy, and red. The rash has spread from the patient's arm to her abdomen. It has not resolved as of 12/3/17.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient developed a bruise shortly after administration, then developed a rash on left upper arm that started around 11/26/17-11/27/17 (2-3 days after administration). The rash is characterized as dry, itchy, bumpy, and red. The rash has spread from the patient's arm to her abdomen. It has not resolved as of 12/3/17.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT RETURNED TO PHARMACY CONCERNED WITH REDNESS, WARMTH, SORENESS, AND SWELLING AT THE INJECTION SITE AND SURROUNDING AREA WHICH SHE HAS NEVER PREVIOUSLY EXPERIENCED AFTER A VACCINATION.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Insomnia, Myalgia
Clinical narrative: Patient stated that within a week of receiving the vaccines, his right arm developed muscular pain that worsens at night if he sleeps on that arm. This has continued for the last 3 months with no improvement and he is unable to sleep with his weight on that side anymore.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash to abdomen at this time.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Patient discovered erythema and 3 cm x 3 cm indurated area at injection site and reported localized reaction to this RN who notified the physician on call to requesting the MD to assess at the bedside. Area was measured and traced to assess for improvement or worsening. Patient is 27 3/7 gestational age and Estimated date of delivery is 03/01/2018. Patient has a OB history of x2 spontaneous vaginal deliveries (1 preterm @ 30 weeks; and x1 fetal demise @ 35 weeks).
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Patient is feeling pain from shoulder down to fingertips. Feels like joint pain and muscle pain.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Gastrointestinal tube insertion, Hypothermia, Intensive care, Lethargy, Skin discolouration
Clinical narrative: Hypothermia, lethargy, unresponsive, change in skin color, sleep apnea. 1 week NICU stay, antibiotics, NG tube, oxygen.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Sleep apnoea syndrome, Unresponsive to stimuli
Clinical narrative: Hypothermia, lethargy, unresponsive, change in skin color, sleep apnea. 1 week NICU stay, antibiotics, NG tube, oxygen.
Age: 16.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Haematochezia
Clinical narrative: This serious initial spontaneous case was received on 23-Nov-2017 from a Pharmacist, concerns a 16-year-old, female patient. The patient did not have medical history. Concomitant medication included Doxycycline for an unknown indication. On 09-Nov-2017, the patient was administered with influenza vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, trade name, manufacturer and expiry date: not reported). On 10-Nov-2017, one day after vaccination, the patient experienced bloody stools and her stomach hurt for 2 days. The patient did not take any treatment measure for the events. On 12-Nov-2017, the patient recovered from the events. Case  Comment:  Based  on  the  available  information,  the  company  assesses  the  events  as  related  to  vaccine  considering  the  close  temporal  relationship.  The  event  bloody  stools  can  be  due  to  any  other  medical  condition  or  infection,  but  considering  the  close  temporal  relationship  the  role  of  vaccine  cannot  be  ruled  out.  The  events  will  be  reassessed  upon  receipt  of  further  details.  The  event  haematochezia  was  considered  medically  significant.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Paraesthesia, Ultrasound scan normal
Clinical narrative: Left arm-elbow to shoulder sore for 4 days. No swelling. Arm "thick". Went to Dr for U/S and X-ray. After 2 months still achy and tingling down to hand while at rest. Cannot lift arm above head. No heat, no swelling. No redness. Went to Ortho MD 1 wk ago. No treatment for dull, ache. Told patient to give it 6 months to get better, and to call him if it gets worse. Difficulty lifting arm. Dull ache.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: X-ray normal
Clinical narrative: Left arm-elbow to shoulder sore for 4 days. No swelling. Arm "thick". Went to Dr for U/S and X-ray. After 2 months still achy and tingling down to hand while at rest. Cannot lift arm above head. No heat, no swelling. No redness. Went to Ortho MD 1 wk ago. No treatment for dull, ache. Told patient to give it 6 months to get better, and to call him if it gets worse. Difficulty lifting arm. Dull ache.
Sex: F
Vaccine: HEPA, YF
Symptoms: Herpes simplex test negative, Injection site erythema, Injection site vesicles
Clinical narrative: Initial unsolicited report received from the literature on 23-Oct-2017. This case is linked with cases 2017SA205665, 2017SA207244, 2017SA207251, 2017SA207248, 2017SA207263, 2017SA207271, 2017SA207273, 2017SA207275, 2017SA207277, 2017SA207279, 2017SA207282, 2017SA207280. (same literature). Abstract: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. Keywords: yellow fever vaccine; adverse reaction; blisters; rash; hyperpigmentation. This case involves a 23-year-old female patient who was vaccinated with a first dose of YF-VAX (batch number: UF716AA, expiry date and dose were not reported) subcutaneously in right arm and also vaccinated with first dose of HAVRIX (manufacturer: GLAXOSMITHKLINE BIOLOGICALS for HAVRIX) (batch number: AHAVB375AA, expiry date and dose were not reported) intramuscularly in left arm on 04-Jun-2010. Patient's preexisting conditions includes Hashimoto's Thyroiditis, she had no current illness and allergies were not reported. Patient's concomitant medication includes 25 mcg dose of SYNTHROID. On 06-Jun-2010, two days after the vaccination, the patient experienced redness with blisters on right arm at site of yellow fever vaccine, multiple vesicles occurring at the yellow fever inoculation site, however no skin pigment changes developed or were reported. On an unknown date, HSV (herpes simplex virus) culture of blisters was performed and it was found to be negative. The events were not life threatening and the patient was not hospitalized. The patient required emergency room (ER) visit. Patient's other laboratory test and corrective treatment were not reported. The outcome of all the events was reported as not recovered. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 70 year old female patient. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On 10-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N019983; expiry date 03-MAR-2019, intramuscularly (dose was not reported). On 10-NOV-2017, the patient experienced soreness in left deltoid at area of injection. The outcome of the event was unknown. The causality assessment was not provided.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 70 year old female patient. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On 10-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N019983; expiry date 03-MAR-2019, intramuscularly (dose was not reported). On 10-NOV-2017, the patient experienced soreness in left deltoid at area of injection. The outcome of the event was unknown. The causality assessment was not provided.
Age: 81.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient complained of injection site reactions 1-2 days after given the PREVNAR 13. He showed me the area and it was red, raised and swollen. He complained that it was itchy and very painful, especially on 11/25/17. I advised to put an ice pack and take some TYLENOL.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site mass, Limb injury, Musculoskeletal pain, Vaccination complication
Clinical narrative: Following the vaccine, I was unable to move my right arm to a 90 degree angle or higher. I had pain in my right arm. I was unable to lift items. I thought it would get better with time, but it didn't. After about 5 weeks, I asked a medical doctor who thought they had hit a vein. Symptoms worsened and I saw a DC. He checked online for my symptoms and a flu shot and told me it was probably Sirva.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Limb injury, Pain in extremity, Vaccination complication
Clinical narrative: Following the vaccine, I was unable to move my right arm to a 90 degree angle or higher. I had pain in my right arm. I was unable to lift items. I thought it would get better with time, but it didn't. After about 5 weeks, I asked a medical doctor who thought they had hit a vein. Symptoms worsened and I saw a DC. He checked online for my symptoms and a flu shot and told me it was probably Sirva.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: Patient reported cellulitis 2 days following vaccine, treated with antibiotics.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis
Clinical narrative: Patient reported cellulitis 2 days following vaccine, treated with antibiotics.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site cyst, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: The reaction began the day after the vaccine with a fever (under 100.1) and a nickel sized raised, warm injection site. It was very itchy to my son. The injection site continued to grow in size until it was the size of an adult hand approximately 7 inches. It was warm, raised and itchy over the next two days. It took one week to fully subside and left a cyst within my son's leg for a month (30 days). No TYLENOL was given and no other medications were given during this time, we brought my son back to the doctor after the reaction continued to get worse. We were told to monitor it as it was a reaction to the vaccine. The reaction subsided within a week.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Vaccination complication
Clinical narrative: The reaction began the day after the vaccine with a fever (under 100.1) and a nickel sized raised, warm injection site. It was very itchy to my son. The injection site continued to grow in size until it was the size of an adult hand approximately 7 inches. It was warm, raised and itchy over the next two days. It took one week to fully subside and left a cyst within my son's leg for a month (30 days). No TYLENOL was given and no other medications were given during this time, we brought my son back to the doctor after the reaction continued to get worse. We were told to monitor it as it was a reaction to the vaccine. The reaction subsided within a week.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Swollen arm, mild fever from 11-29 thru 12-1 followed by vomiting, diarrhea,  severe headache, and fever of 99 to 103.7.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Employee got a flu shot and had swollen lymph nodes on the side the shot was given.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Oral disorder, Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a registered nurse, via company representative, concerning a 6 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2017 the patient was vaccinated with a booster dose of VARIVAX lot # N007930 and expiration date 08-MAR-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. On 22-OCT-2017, the patient broke out in lesions on the mouth, feet and most of his extremities (varicella post vaccine). The patient visited an unknown physician's office on 25-OCT-2017, and was treated for Varicella. At the time of this report, the outcome of varicella post vaccine was reported as recovered on an unknown date in 2017. The reporting nurse did not asses the causal relationship between the Varicella post vaccine and the vaccination with VARIVAX. There was no PQC involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist and refers a currently 63-year-old female patient with diabetes. The patient's medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, for prophylaxis (lot#, expiration date, exact dose and route of administration were not reported). Concomitant therapies included metformin. On an unknown date, after vaccination with ZOSTAVAX, the patient developed shingles. According to the reporter, the patient went to see a pharmacist, when seeking a medical attention. The outcome of shingles was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 02-NOV-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX injection (lot # N019921 with expiration date on 05-JUL-2018; dose, route of administration were not reported) for prophylaxis. Concomitant therapy included sterile diluent (STERILE DILUENT). The doses of vaccine experienced a temperature excursion of 15 to 46 degrees Fahrenheit for 720 hours. No previous temperature excursion was reported. Data logger was not involved in recording the excursion details. No adverse effect was reported.
Sex: F
Vaccine: FLUX, PPV, TTOX
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Urticaria, Vaccination complication
Clinical narrative: This spontaneous report was received from a patient's friend and refers to a 41-year-old non pregnant female patient. The patient had no pertinent medical history, drug reactions or allergies. On approximately 27-OCT-2017 (reported as "about 6 days ago"), the patient was vaccinated with PNEUMOVAX 23 injection, in the right arm (dose, route of administration, lot # and expiration date were not reported) for prevention of pneumococcal disease. Concomitant therapies included influenza virus vaccine and tetanus toxoid vaccine in her left arm. In approximately 2017, the patient experienced swelling, pain, and whelps around the injection and all over her right arm. The reporter stated that the patient saw her primary physician, who confirmed she was having a reaction to PNEUMOVAX 23, and recommended her to take BENADRYL as a treatment. No laboratory diagnostic studies were performed. The reporter stated that on unspecified date in 2017, reported as "6 days later", the patient was "still experiencing the same symptoms" from the PNEUMOVAX 23 injection. The outcome of the events was reported as not recovered. The reporter considered the events to be related to the PNEUMOVAX 23.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64-year-old female patient. The patient did not have any pertinent medical history or drug allergies. On 31-OCT-2017, the patient was vaccinated with ZOSTAVAX subcutaneous, lot number N003697, expiration date 13-MAR-2018 (also reported as 01-MAR-2018) (dose and injection site were not provided) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) lot number N015478, expiration date 28-SEP-2019.  On 01-NOV-2017, the patient experienced a red and itchy rash at the injection site. On 03-NOV-2017, the patient reported that the rash was travelling down to her elbow. The patient did not receive any treatment. The outcome of the events was reported as not recovered. The relatedness between ZOSTAVAX and the events was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a office manager and refers to a 75-year-old male patient. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date in September 2015, the patient was first time vaccinated with ZOSTAVAX, subcutaneously, for prophylaxis (lot #, expiration date, dosage were unknown).  On an unknown date in October 2017, the patient was second time vaccinated with the ZOSTAVAX, subcutaneously, for prophylaxis (lot #, expiration date, dosage were unknown).
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 21-year-old male patient. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date in February 2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot number, expiration date, route of administration were not reported). On 03-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9, lot # M009378, expiration date 20-APR-2018, for prophylaxis (route of administration was not reported). No adverse effect was reported. Product quality complaint (PQC) was involved.