chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Vision blurred
Clinical narrative: 08/04/2017 Extreme fatigue, severe headache, moments of blurry vision, ocular photosensitivity, sore throat and right inner ear pain, red spot on roof of mouth. Too painful to walk barefoot and awake to swollen finger joint pain, no energy at all. 08/11/2017 behind ear pain and neck pain, pink skin turned into papular rash on right side of neck below right ear, chills, rash was painful rather with moments of itchiness, continued to spread even with benedryl - treated as possible eczema but no history of eczema. Fatigue, headaches and joint pain continuing, maybe a virus? or a flu? 08/20/2017 rash turned vesicular and continued to spread on neck and behind ear, spot on mouth turning white. 08/23/2017 rash spread so far up under jaw and up into scalp behind right ear went to clinic, diagnosed with shingles and started Valtrex 08/27/2017 vesicular rash dried up and almost gone, severe neck and chest pain at night. 08/28/2017 woke up to weeping sore on neck and new red spots on right ear and down by collar bone and chest; went to PCP who cultured fluid and treated as a dermatitis. Rx doxycylcine and steroid cream and off work until 08/31/2017. 08/31/2017 neck rash cleared up but new red spots on chest are growing. Saw different MD in PCP practice - who believed vesicular rash is reaction to MMR, possible allergic reaction or mild form of measles. cultured rash for measles but not very much fluid 09/01/2017 Rash continuing to spread across center of chest between breasts, more fluid in vesicles 09/02/2017 Vesicles scabbing over, redder skin.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt states pain at injection site in right arm (PNEUMOVAX) began yesterday 9/2. This morning she noticed redness and warmth, along with swelling. Pt has taken ibuprofen and is applying ice pack to the red area (approx. 5x6" in the bicep/deltoid area). I did view this reaction.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site rash
Clinical narrative: Headaches,chills, fever, joint aches, shakiness, reddness to area of injection site and rash and heat of left arm with some swelling.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Tremor
Clinical narrative: Headaches,chills, fever, joint aches, shakiness, reddness to area of injection site and rash and heat of left arm with some swelling.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Insomnia, Pain in extremity, Skin warm, Swelling
Clinical narrative: Within hours of administration she began to experience radiating pain down her arm. It was sever enough that it kept her from sleeping and she took ibuprofen to help with the pain. The next day she developed a large red bump located 3/4 down the deltoid and encircled the arm. It was warm to touch the first day. Denied itching or tenderness to area. Denied fever. Pain began resolving after 48 hours. Continuing to watch for resolution of the redness and follow up from primary care physician.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Patient had a knot form at injection site. It was red and swollen and had some "splotches". No systemic issues. I advised her to take ibuprofen or something similar for inflammation. Told patient if it does not resolve within a couple days, or gets worse, to seek medical treatment from PCP or Urgent Care.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Dysphonia, Fluid retention, Migraine, Pyrexia
Clinical narrative: Migraine and hives starting the evening after the vaccinations into the following day. Hives were widespread on arms, legs, back, neck and torso. Migraine was severe. Patient states a low grade fever that broke after more than 24 hours. Some bruises on elbow of left arm. Fluid retention in legs and hoarseness. Patient called pharmacy at 4:37pm on 9/2 with initial migraine and hives and fever being reported. Patient then came into pharmacy on 9/3 to show severity. Patient was advised to seek medical attention the evening of 9/2 when she called the pharmacy.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Migraine and hives starting the evening after the vaccinations into the following day. Hives were widespread on arms, legs, back, neck and torso. Migraine was severe. Patient states a low grade fever that broke after more than 24 hours. Some bruises on elbow of left arm. Fluid retention in legs and hoarseness. Patient called pharmacy at 4:37pm on 9/2 with initial migraine and hives and fever being reported. Patient then came into pharmacy on 9/3 to show severity. Patient was advised to seek medical attention the evening of 9/2 when she called the pharmacy.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling around site of injection.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue
Clinical narrative: Patient did not experience any adverse effect from immunization. When administering immunization at plunger depression, vaccine poured out through space between syringe & needle connection. Needle(EasyPoint) also did not retract, as per its technology. Fault may have been with connection. Obtained a second FLUZONE HD from an alternative Lot# and new EasyPoint syringe from new box, and administered it successfully to patient without incident.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Arthralgia, Axillary pain, Back pain, Chills, Headache
Clinical narrative: Extreme arm and underarm pain to the point that the patient could not lift his arm, lower back and hip pain, fever (101.7), chills, headache; Patient went to visit his primary care doctor. MD thinks patient is experiencing a mild case of the flu. MD recommended that the patient rest for 2 to 5 days, take TYLENOL for the fever and pain, and then check back with MD in 1 week.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Influenza, Pain in extremity, Pyrexia
Clinical narrative: Extreme arm and underarm pain to the point that the patient could not lift his arm, lower back and hip pain, fever (101.7), chills, headache; Patient went to visit his primary care doctor. MD thinks patient is experiencing a mild case of the flu. MD recommended that the patient rest for 2 to 5 days, take TYLENOL for the fever and pain, and then check back with MD in 1 week.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Arthralgia, Back pain, Chills, Hyperhidrosis, Pain in extremity
Clinical narrative: Extreme arm and underarm pain to the point that the patient could not lift his arm, lower back and hip pain, fever (101.7), chills, headache; Patient went to visit his primary care doctor. MD thinks patient is experiencing a mild case of the flu. MD recommended that the patient rest for 2 to 5 days, take TYLENOL for the fever and pain, and then check back with MD in 1 week.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Extreme arm and underarm pain to the point that the patient could not lift his arm, lower back and hip pain, fever (101.7), chills, headache; Patient went to visit his primary care doctor. MD thinks patient is experiencing a mild case of the flu. MD recommended that the patient rest for 2 to 5 days, take TYLENOL for the fever and pain, and then check back with MD in 1 week.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Back pain, Chills, Pain in extremity, Pyrexia
Clinical narrative: Extreme arm and underarm pain to the point that the patient could not lift his arm, lower back and hip pain, fever (101.7), chills, headache; Patient went to visit his primary care doctor. MD thinks patient is experiencing a mild case of the flu. MD recommended that the patient rest for 2 to 5 days, take TYLENOL for the fever and pain, and then check back with MD in 1 week.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient developed a Cellulitis type reaction that her doctor diagnosed as cellulitis. He prescribed Keflex, but I do not have the details of the prescription. Purportedly, the patient improved within 2 days of starting it. She is out of the country as of this time so it's difficult to reach her to get more details. Of note: the patient also received FLUZONE HD at the same time as the Pneumovax, but it was given in the opposite arm, and had no adverse event.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Nodule, Pain, Pain in extremity
Clinical narrative: Large golf ball size painful knot under skin on right arm by injection site. Accute painful inflammation in arm, neck, all over back for over 3 days. Right shoulder felt out of socket after a week, still inflamed. Doctor prescribed Naproxen 500 mg. 2 x day for the pain. Took 3-4 days for inflammation to calm down and another few days before Chiropractor could adjust shoulder back to almost normal. All due to the extreme inflammation from the vaccine and the fact that I had >600 antibodies at the time, which I reported to the nurse practioner before the injection. She said it wouldn't matter at all. I found out different much later.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Pain
Clinical narrative: Very painful after the shot. This is the first time I had the high dose flu shot- never had a problem with the other flu shots that I've had for years. Two days later had a very red rash around where the shot was given- had about a two inch radius. I called the pharmacist who told me to circle the rash and seek medical help if it spreads. It lessened after 3 days but very scary to see.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypoacusis, Loss of consciousness, Visual impairment
Clinical narrative: Pt felt lightheaded, passed out, vision disturbance, hearing disturbance.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Neck pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: On Aug 29, 2017 at 9:33am I injected IM on the left arm and patient said as soon as she's home around noon time she feels so exhausted and slept for 3 & 1/2 hours. Around evening time she said she feels the soreness, swelling and tenderness from the base of the neck to arm. So, on Thursday Aug 31 she decided to pass by the Pharmacy to report and was told to do hot and cold compress alternately to alleviate the pain and tenderness. Yesterday, around 2:30 pm I called her and ask her how was she doing she said she.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: On Aug 29, 2017 at 9:33am I injected IM on the left arm and patient said as soon as she's home around noon time she feels so exhausted and slept for 3 & 1/2 hours. Around evening time she said she feels the soreness, swelling and tenderness from the base of the neck to arm. So, on Thursday Aug 31 she decided to pass by the Pharmacy to report and was told to do hot and cold compress alternately to alleviate the pain and tenderness. Yesterday, around 2:30 pm I called her and ask her how was she doing she said she.
Age: 80.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Rash
Clinical narrative: Patient observed a rash on cheek over the nose and on other cheek and wanted to know if it was related to vaccinations given on 8-28-17.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Immediate post-injection reaction, Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: Gave shot to patient in the left arm and there was immediate swelling and a bump about the size of a nickel formed that was hard. Patient also bled quite a bit. Advised patient to remain sitting down for a few minutes and he immediately became lightheaded. Patient thought he was going to pass out but after sitting for a while and drinking water he was ok. Patient was monitored for about 20 minutes and was told to call pharmacy if he felt that anything was wrong with him.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: She experienced slight soreness on day 1 after vaccination. Then she noticed a red area around injection site a few inches.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: (L) arm swollen from elbow to shoulder; Warm to touch. Acute onset (within 2-3 hours post injection). Resolved in 4 days.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Pruritus
Clinical narrative: Rash around injection site and surrounding areas. Itchiness.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Pruritus
Clinical narrative: Got shot on 8/25 and 3 days later got red/inflamed ring around injection site and itchiness. Recommended ice and acetaminophen, 2hrs later pt reports improvement.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Rash, Skin warm
Clinical narrative: Left arm (PNEUMOVAX) began as 2 quarter size raised rashes developed into large palm size rash that was warm to touch. MD was seen, diagnosed with infection, treatment AUGMENTIN, rash currently improving.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Condition aggravated, Essential tremor, Pyrexia
Clinical narrative: Evening after receiving vaccinations patient ended up in hospital with Pulse 131, increased blood pressure, acute attack of essential tremor, fever 101.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Inflammation
Clinical narrative: Immediate inflammation and bruise.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to the pharmacy on 9/13/17 and proceeded to show myself and intern his left arm. It appeared to be swollen and was red and warm to the touch. It states it was painful when touched. I advised to go to urgent care or ER. I also called the doctor who also stated patient to do the same and go to the ER. I called the patient household and spoke with patient's wife who was also present when patient came to the pharmacy. She verbalized understanding. (I spoke to the answering service with whom Dr left message to go to ER.) At this point, I do not know if patient went to the ER. The swelling was to his elbow.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Chills/fever/body aches. Right arm (no itch) pain elbow to shoulder, hard to lift arm. Bruising at injection site, swollen from elbow to shoulder. Red and hot elbow to shoulder/took Aspirin - getting better. Reported 8/26/17 (Thursday).
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Chills/fever/body aches. Right arm (no itch) pain elbow to shoulder, hard to lift arm. Bruising at injection site, swollen from elbow to shoulder. Red and hot elbow to shoulder/took Aspirin - getting better. Reported 8/26/17 (Thursday).
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: 4" red area swollen around injection site. Used ice.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site haemorrhage, Pain in extremity, Paraesthesia
Clinical narrative: Pt started to bleed from site. Called at 1 PM to say pain in arm is severe, has trouble lifting left arm, has tingling in hand.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Laboratory test, Pain
Clinical narrative: Painful tingling sensation radiating from site of injection to shoulders and neck on left arm.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Injection site paraesthesia, Musculoskeletal pain, Neck pain, Paraesthesia
Clinical narrative: Painful tingling sensation radiating from site of injection to shoulders and neck on left arm.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: Patient reports she received Tdap vaccine 0.5ml on 8/23/17, on 8/24/17 patient noted left deltoid redness, swelling and pain. Patient started taking ibu, ALEVE, and TYLENOL. Patient presented today with left arm pain, and was diagnosed by Dr. with left subdeltoid bursitis. Patient discharged with a prescription of prednisone.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dizziness, Dyspnoea, Headache, Malaise
Clinical narrative: It was a flu shot. I have been sick for 3 days. Heavy coughing, dizziness, headaches runny nose.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: It was a flu shot. I have been sick for 3 days. Heavy coughing, dizziness, headaches runny nose.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Injection site pain
Clinical narrative: 20 minutes after injection metal taste in mouth. Metal taste as lasted 2 and half days. Seems to be lessening. Arm sore at injection site and to elbow. Gone after 2 and half days.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Insomnia
Clinical narrative: Patient had extreme chills, sweating and teeth chattering. Has had vaccine in the past and never had symptoms like this. It last about 36 hours and patient was unable to sleep.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports red, raised, sore and bruised arm.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient described painful arm since having the injection 19 days ago. She said the pain has progressively gotten worse over the weeks until today she was having a hard time putting clothing over it. She said the pain begins towards the shoulder bone area and radiates down the arm when she moves it. She mentioned she thought it was bursitis from doing her own online investigation and described the injection site seeming to be too high on the arm, more toward the shoulder joint instead of the center of the deltoid.
Age: 45.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Insomnia, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient was given Tdap in left arm and FLUARIX QUADRIVALENT in right arm (both IM) on 8-29-17. Patient said both arms were sore as expected for the first two days. On 8-31-17 the patient said the soreness in the left arm was increasing to the point where she could not sleep at night. On 9-3-17 patient returned to pharmacy complaining of shoulder pain and limited range of motion. I told her to contact her primary care physician. I spoke to patient on 9-4-17 and she was told by her physician to take 800mg of Ibuprofen and 1000mg of TYLENOL around the clock for one week.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in to the pharmacy. Injection site is red and swollen. Patient states it is painful itchy and burning and warm. The redness and swelling appears to be radiating almost down to the elbow from the deltoid muscle. Patient states it has been a week and the area feels worse than before. Patient is instructed by pharmacist to go to the ER or primary care as soon as possible. Patient refused ambulance for ER.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Pt states she had a reaction approximately 24 hours after first Hepatits B vaccination. The pt reported developing diffuse hives involving her entire face but no other areas, including the vaccination site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Awoke with chills and fever (101 F) at 11:11 PM accompanied by slight nausea and mild abdominal cramps. The next day fever and headache accompanied by lack of appetite and tiredness persisted until about 2:00 PM. The fever and headache were resolved by Ibuprofen. By 6:00 PM all symptoms had completely resolved.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Awoke with chills and fever (101 F) at 11:11 PM accompanied by slight nausea and mild abdominal cramps. The next day fever and headache accompanied by lack of appetite and tiredness persisted until about 2:00 PM. The fever and headache were resolved by Ibuprofen. By 6:00 PM all symptoms had completely resolved.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Hot flush, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Based on phone call from patient around 1:15pm 9/4/17: Very severe pain in arm at injection site, swelling/inflammation at injection site, jaw on left side was stiff upon awakening this morning after vaccination making it difficult to talk, patient having hot flashes and a lot of anxiety regarding reaction. He wanted to see his PCP to address, but office closed for labor day; the on-call provider recommended he go to the ER. Patient decided to go to ER as he was nervous that the reaction was going to continue to get worse, but wanted the pharmacy to be informed and to be reassured that he received Flu vaccine, as he never had issues in the past.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Joint stiffness, Speech disorder
Clinical narrative: Based on phone call from patient around 1:15pm 9/4/17: Very severe pain in arm at injection site, swelling/inflammation at injection site, jaw on left side was stiff upon awakening this morning after vaccination making it difficult to talk, patient having hot flashes and a lot of anxiety regarding reaction. He wanted to see his PCP to address, but office closed for labor day; the on-call provider recommended he go to the ER. Patient decided to go to ER as he was nervous that the reaction was going to continue to get worse, but wanted the pharmacy to be informed and to be reassured that he received Flu vaccine, as he never had issues in the past.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Pruritus
Clinical narrative: BIG RED SWOLLEN ARM, ITCHING, PATIENT CAN NOT LIFTED UP ARM. DOCTOR PRESCRIBED ANTIBIOTIC, ANTIHISTAMINE, ICE PACK FOR TREATMENTS.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Tinnitus
Clinical narrative: No reaction at site of injection at 3:28pm. After two minutes of the patient talking about her plans of attending nursing school, she suddenly experienced slight flushing and stated she felt ringing in her ears and a little dizzy. I immediately used a smelling salt, gave her bottled water, and kept direct watch of her needs in the IMZ room. After about five minutes, she stated she felt completely better, appreciated the water, denied further medical treatment, said her primary doctor already knows about this effect from getting a shot, and started talking again about her interest in nursing school at various hospitals in the area. She left at 3:50pm. I paged the doctor on call, who stated at 4:14pm, "nothing more to do, she is up and ambulating".
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: It was discovered on 8/30/17 that we had PREVNAR in stock that had expired 5/31/17. We went through all immunizations given in the past year and discovered this one given 8/24/17. We also discovered 1 other patient (separate report completed). We contacted Pfizer, who deferred to the agency's recommendation to have the patient re-vaccinated. We contacted the patient to complete this. We also logged the error via STARS (Strategic Tracking and Reporting System).
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Anxiety, Cardiac murmur, Computerised tomogram, Condition aggravated, Electrocardiogram
Clinical narrative: Since the vaccination ive been to the dr or hospital and they keep telling me I have "anxiety" bla bla bla but ive been diagnosed with heart murmur since then and heart palpatations.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Nuclear magnetic resonance imaging, Palpitations
Clinical narrative: Since the vaccination ive been to the dr or hospital and they keep telling me I have "anxiety" bla bla bla but ive been diagnosed with heart murmur since then and heart palpatations.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: It was discovered on 8/30/17 that we had PREVNAR in stock that had expired 5/31/17.  We also discovered 1 other patient (separate report completed e-report ID 123496). We contacted Pfizer, who deferred to the agency's recommendation to have the patient re-vaccinated. We contacted the patient to complete this. We also logged the error via STARS (Strategic Tracking and Reporting System).
Age: 55.0
Sex: F
Vaccine: TTOX
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Joint range of motion measurement, Pain
Clinical narrative: Typical reaction to tetanus shot the day of and 1st 24 hrs ( tenderness in area).  Unable to move arm actively into extension or able to abduct, internal rotation more painful than external rotation. Only able to move arm into extension and abduction passively. Have been to doctor 3 x's since reaction. to include family practitioner, NP at orthoclinic. Pain is present 24/7 since shot was given. Prednisone does decrease pain but not well tolerated. This adverse reaction is 100 % affecting my job as a personal trainer and coach.
Age: 81.0
Sex: F
Vaccine: TYP
Symptoms: Lethargy, Pyrexia
Clinical narrative: Pt. had initially spoke to her PCP regarding adverse reaction to oral Typhoid after second dose.  She had complained of high fevers (did not take her temperature) and lethargy. Her PCP advised her to stop medication and to call the clinic. The clinic was called to discuss her adverse effects. Patient was advised due to "high" temp and lethargy to go to the emergency room for further evaluation, pt refused.
Age: 33.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Swelling, redness, pain about 1 inch below bottom injection site. Fever.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: RIGHT ARM (PNEUMOVAX ADMINISTERED) IS SWOLLEN. VERY PAINFUL TO TOUCH. NAUSEA AND VOMITING.
Age: 39.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Dyspnoea, Localised oedema, Oedema peripheral, Productive cough, Scrotal oedema
Clinical narrative: After the vaccine patient experience difficult of breathing, said that he cough out a lot of black tar. After a week, the phlegm was clear but patient began experience swollen face and chest. Patient went to see an MD and was advise to rest. On Sept 1st 2017 patient had edema from trunk, scrotum, legs; patient went to urgent care and was hospitalized since.
Age: 39.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Sputum discoloured, Swelling, Swelling face
Clinical narrative: After the vaccine patient experience difficult of breathing, said that he cough out a lot of black tar. After a week, the phlegm was clear but patient began experience swollen face and chest. Patient went to see an MD and was advise to rest. On Sept 1st 2017 patient had edema from trunk, scrotum, legs; patient went to urgent care and was hospitalized since.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Large lump slowly appear at site of injection and approximately 2 inches to the left of injection site. Slight bruise around injection site. Gave 2 BENADRYL. No lightheaded, no trouble breathing. Feeling okay, able to stand/walk normally. No pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Aphasia, Apraxia, Decreased eye contact, Developmental delay, Dyskinesia
Clinical narrative: After receiving his vaccinations patient was extremely fussing, screaming for hours on end and had a high fever. I was told this was normal and to give TYLENOL. With each passing day he seemed to not be himself. Over the course of several months he lost speech and he stopped hitting milestone according to his age (for example social skills, fine motor skills, speech, etc). He also developed severe food aversions as well as many other "sensory issues". We did have patient on a delayed vaccine schedule and so a month after his MMR and Hep A, he did receive two more vaccinations with a similar reaction as described above (DTaP and HIB). I was again told this was all normal and to continue vaccinating. Also on January 12, 2016, he had his second Hep A vaccine and after that round he lost all eye contact, began banging his head and rocking himself. He was evaluated at the autism center at Hospital where he was given the diagnosis of encephalopathy, apraxia, and global developmental delay. Patient is in speech therapy, occupational therapy, and feeding therapy. We did have his measles titers tested and according to the physician they are some of the highest levels she had ever seen and felt like it was indicative of an over reaction to his MMR vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Encephalopathy, Fine motor delay, Food aversion, Head banging, Irritability
Clinical narrative: After receiving his vaccinations patient was extremely fussing, screaming for hours on end and had a high fever. I was told this was normal and to give TYLENOL. With each passing day he seemed to not be himself. Over the course of several months he lost speech and he stopped hitting milestone according to his age (for example social skills, fine motor skills, speech, etc). He also developed severe food aversions as well as many other "sensory issues". We did have patient on a delayed vaccine schedule and so a month after his MMR and Hep A, he did receive two more vaccinations with a similar reaction as described above (DTaP and HIB). I was again told this was all normal and to continue vaccinating. Also on January 12, 2016, he had his second Hep A vaccine and after that round he lost all eye contact, began banging his head and rocking himself. He was evaluated at the autism center at Hospital where he was given the diagnosis of encephalopathy, apraxia, and global developmental delay. Patient is in speech therapy, occupational therapy, and feeding therapy. We did have his measles titers tested and according to the physician they are some of the highest levels she had ever seen and felt like it was indicative of an over reaction to his MMR vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Laboratory test, Measles antibody, Pyrexia, Screaming, Sensory disturbance
Clinical narrative: After receiving his vaccinations patient was extremely fussing, screaming for hours on end and had a high fever. I was told this was normal and to give TYLENOL. With each passing day he seemed to not be himself. Over the course of several months he lost speech and he stopped hitting milestone according to his age (for example social skills, fine motor skills, speech, etc). He also developed severe food aversions as well as many other "sensory issues". We did have patient on a delayed vaccine schedule and so a month after his MMR and Hep A, he did receive two more vaccinations with a similar reaction as described above (DTaP and HIB). I was again told this was all normal and to continue vaccinating. Also on January 12, 2016, he had his second Hep A vaccine and after that round he lost all eye contact, began banging his head and rocking himself. He was evaluated at the autism center at Hospital where he was given the diagnosis of encephalopathy, apraxia, and global developmental delay. Patient is in speech therapy, occupational therapy, and feeding therapy. We did have his measles titers tested and according to the physician they are some of the highest levels she had ever seen and felt like it was indicative of an over reaction to his MMR vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient had swelling of arm at injection site. This happened after patient had already left. Patient called to receive counseling. Counseled patient to take ibuprofen if not allergic and to put ice pack on swelling. If swelling does not subside within 2 days, then go to doctor clinic to be treated.
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Anxiety, Crying, Depression, Hypotonia, Loss of consciousness
Clinical narrative: My daughter's adverse reaction to the DTaP vaccine happened 24 years ago, but needs to be reported. Within a minute of being given her second round of DTaP vaccine, my 3-month old daughter let out a scream that startled both me and the nurse who administered the shot. I had never heard my baby-or any baby for that matter-make such a sound. Then she went unconscious and went completely limp and stayed that way for several seconds. Our family doctor told us not to give her any more vaccines. She cried a lot as an infant and had sleep issues from then until about age 20.  She has struggled with depression and anxiety for several years. At age 12 she was diagnosed with type 1 auto-immune diabetes. She is my only vaccinated child, and my only child with serious health issues.
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Screaming, Sleep disorder
Clinical narrative: My daughter's adverse reaction to the DTaP vaccine happened 24 years ago, but needs to be reported. Within a minute of being given her second round of DTaP vaccine, my 3-month old daughter let out a scream that startled both me and the nurse who administered the shot. I had never heard my baby-or any baby for that matter-make such a sound. Then she went unconscious and went completely limp and stayed that way for several seconds. Our family doctor told us not to give her any more vaccines. She cried a lot as an infant and had sleep issues from then until about age 20.  She has struggled with depression and anxiety for several years. At age 12 she was diagnosed with type 1 auto-immune diabetes. She is my only vaccinated child, and my only child with serious health issues.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: Patient experience localized reaction in left are which consisted of upper left arm swelling above the elbow with redness, warm to the touch, pain that limited range of motion. Patient advised to take TYLENOL and took BENADRYL on her own. Reaction resolved after 4-5 days.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Local reaction
Clinical narrative: Patient experience localized reaction in left are which consisted of upper left arm swelling above the elbow with redness, warm to the touch, pain that limited range of motion. Patient advised to take TYLENOL and took BENADRYL on her own. Reaction resolved after 4-5 days.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Limb discomfort, Myalgia, Swelling
Clinical narrative: Friday afternoon - swelling, heavy (lifting arm), pain in muscle, very war [applied ice]. Saturday morning - emergency room, symptoms continued 6 days.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Patient complained of bruising around injection site, moving to side of left arm, about baseball size blue/purple color. No pain or inflammation.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Patient experienced a localized reaction around the injection site on her right arm after receiving the PNEUMOVAX vaccine. Reaction started in the early evening with soreness that limited range of motion and then progressed on to a red, inflamed, itchy circular area around the injection site about 3-4 inches in diameter. The area was warm to the touch. Resolved 2-3 days.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site warmth, Joint range of motion decreased
Clinical narrative: Patient experienced a localized reaction around the injection site on her right arm after receiving the PNEUMOVAX vaccine. Reaction started in the early evening with soreness that limited range of motion and then progressed on to a red, inflamed, itchy circular area around the injection site about 3-4 inches in diameter. The area was warm to the touch. Resolved 2-3 days.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Adverse reaction, Asthenia, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified race/ethnicity received the 2nd dose of pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration, on an unspecified date in May2016, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received 1st dose of PREVNAR 13 in Mar2016 for immunisation. The patient inadvertently received the 2nd dose of PREVNAR 13 and since then experienced weight loss, congestion, coughing, skin looked dry, feeling unwell, no energy or appetite, listless all on unspecified date with outcome of unknown.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Cough, Decreased appetite, Dry skin, Listless
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified race/ethnicity received the 2nd dose of pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration, on an unspecified date in May2016, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received 1st dose of PREVNAR 13 in Mar2016 for immunisation. The patient inadvertently received the 2nd dose of PREVNAR 13 and since then experienced weight loss, congestion, coughing, skin looked dry, feeling unwell, no energy or appetite, listless all on unspecified date with outcome of unknown.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Malaise, Respiratory tract congestion, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified race/ethnicity received the 2nd dose of pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration, on an unspecified date in May2016, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received 1st dose of PREVNAR 13 in Mar2016 for immunisation. The patient inadvertently received the 2nd dose of PREVNAR 13 and since then experienced weight loss, congestion, coughing, skin looked dry, feeling unwell, no energy or appetite, listless all on unspecified date with outcome of unknown.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, FLUX, HPV9, MENB, MNQ
Symptoms: Decreased appetite, Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer received via a sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml, single (0.5ml injection) for prevent meningococcal disease. The medical history and concomitant medications were not reported. The patient experienced bad rash, fever and pain on an unspecified date with outcome of recovered. The vaccine was administered 2-3 months ago. The side effects lasted 2-3 days and the patient recovered fully. He said that the shot was given on a Friday and by Monday the patient was fine.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, FLUX, HPV9, MENB, MNQ
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer received via a sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml, single (0.5ml injection) for prevent meningococcal disease. The medical history and concomitant medications were not reported. The patient experienced bad rash, fever and pain on an unspecified date with outcome of recovered. The vaccine was administered 2-3 months ago. The side effects lasted 2-3 days and the patient recovered fully. He said that the shot was given on a Friday and by Monday the patient was fine.
Age: 1.75
Sex: M
Vaccine: HEPA, HIBV, HEPA, HIBV
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Mom reports hives starting 8 pm day of shots. Took to physician 2 days later and was given BACTROBAN cream and ORAPRED liquid.
Age: 1.75
Sex: M
Vaccine: HEPA, HIBV, HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: Mom reports hives starting 8 pm day of shots. Took to physician 2 days later and was given BACTROBAN cream and ORAPRED liquid.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abdominal pain upper, Back pain, Dyskinesia, Feeling abnormal, Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64-year-old female patient. The patient had drug reactions/allergies to ondansetron and vancomycin. The patient received unspecified concomitant medications. No information regarding the patient's medical history and concurrent conditions was provided. On 23-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N004564, expiration date: 22-OCT-2017, 1 dose, intramuscularly to prevent pneumonia. On an unknown date in 2017, the patient experienced adverse effects of pain in the back and spine, causing the feeling of paralysis and the patient could not walk. The patient received unspecified treatment for the reported events. The patient sought medical attention at the pharmacy and was given an unknown dose of BENADRYL. The outcome of the events was reported as recovered. The casual relationship between the events and PNEUMOVAX 23 was not reported. Upon internal review the event of feeling of paralysis and could not walk were considered to be medically significant. The pharmacist was requesting a lot check for PNEUMOVAX 23 lot # N004564. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000822.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Immediate post-injection reaction, Ocular hyperaemia, Paraesthesia, Paraesthesia oral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64-year-old female patient. The patient had drug reactions/allergies to ondansetron and vancomycin. The patient received unspecified concomitant medications. No information regarding the patient's medical history and concurrent conditions was provided. On 23-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N004564, expiration date: 22-OCT-2017, 1 dose, intramuscularly to prevent pneumonia. On an unknown date in 2017, the patient experienced adverse effects of pain in the back and spine, causing the feeling of paralysis and the patient could not walk. The patient received unspecified treatment for the reported events. The patient sought medical attention at the pharmacy and was given an unknown dose of BENADRYL. The outcome of the events was reported as recovered. The casual relationship between the events and PNEUMOVAX 23 was not reported. Upon internal review the event of feeling of paralysis and could not walk were considered to be medically significant. The pharmacist was requesting a lot check for PNEUMOVAX 23 lot # N004564. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000822.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abasia, Back pain, Paralysis, Spinal pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64-year-old female patient. The patient had drug reactions/allergies to ondansetron and vancomycin. The patient received unspecified concomitant medications. No information regarding the patient's medical history and concurrent conditions was provided. On 23-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N004564, expiration date: 22-OCT-2017, 1 dose, intramuscularly to prevent pneumonia. On an unknown date in 2017, the patient experienced adverse effects of pain in the back and spine, causing the feeling of paralysis and the patient could not walk. The patient received unspecified treatment for the reported events. The patient sought medical attention at the pharmacy and was given an unknown dose of BENADRYL. The outcome of the events was reported as recovered. The casual relationship between the events and PNEUMOVAX 23 was not reported. Upon internal review the event of feeling of paralysis and could not walk were considered to be medically significant. The pharmacist was requesting a lot check for PNEUMOVAX 23 lot # N004564. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000822.
Age: 62.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Back pain, Contusion, Insomnia, Paraesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist on 23-Aug-2017. This case involves a 62-year-old male patient, who was vaccinated ADACEL via intramuscular route (batch number: U5654AA, expiry date: 27-Apr-2019, dose and dose in series not reported) on 14-Aug-2017 in right deltoid. Patient had allergies to penicillin, hypothyroidism, Osteopenia and GERD (gastro esophagus reflux disease). Concomitant medications or any other vaccinations within 4 weeks of vaccinations was reported as none. On 14-Aug-2017, same day following the vaccination, the patient experienced elbow and knee joint pain and then back pain and intermittent, generalized "tingling" like "pins and needles" that was still continuing till 23-Aug-2017. Lab test not reported. Patient received TYLENOL as corrective treatment. It was reported that joint pain and back pain improved (recovering) but did not resolved with treatment. Patient did not recovered from "tingling like pins and needles". Documents held by sender: none.
Age: 62.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Back pain, Paraesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist on 23-Aug-2017. This case involves a 62-year-old male patient, who was vaccinated ADACEL via intramuscular route (batch number: U5654AA, expiry date: 27-Apr-2019, dose and dose in series not reported) on 14-Aug-2017 in right deltoid. Patient had allergies to penicillin, hypothyroidism, Osteopenia and GERD (gastro esophagus reflux disease). Concomitant medications or any other vaccinations within 4 weeks of vaccinations was reported as none. On 14-Aug-2017, same day following the vaccination, the patient experienced elbow and knee joint pain and then back pain and intermittent, generalized "tingling" like "pins and needles" that was still continuing till 23-Aug-2017. Lab test not reported. Patient received TYLENOL as corrective treatment. It was reported that joint pain and back pain improved (recovering) but did not resolved with treatment. Patient did not recovered from "tingling like pins and needles". Documents held by sender: none.