chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Acupuncture, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Had pneum 23 in left upper arm - immediate pain which lasted through the day. For few days while out of town, she had increased swelling from top of shoulder to her elbow. Along with redness. Had acupuncturist and applied oil to left arm & states shortly there after swelling went away 5/6/19 Back to normal per pt.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Low grade fever - yesterday afternoon. Swelling, redness and hot to the touch. Given Tylenol at home (5/6/19 - 7:00 PM) Given Benadryl 5mL (5/7/19 - in the clinic)
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Influenza virus test, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Day after injection patient had fever to 103, redness /swelling at site & body aches.  Day 4 after injection patient was seen -> only slight pain persists
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Streptococcus test
Clinical narrative: Day after injection patient had fever to 103, redness /swelling at site & body aches.  Day 4 after injection patient was seen -> only slight pain persists
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Dad reports baby started vomiting after getting vaccines today. Advised to hold food and fluids for 1 hour. Start fluids slowly. Will monitor sx.
Age: 0.17
Sex: M
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: The vaccine given was the wrong vaccine. Patient was to receive PCV13 and was given HPV.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Red, painful, and hot at injection site for three days starting the morning of 5/4/2019.  Also, beginning the morning of 5/4/2019 and lasting one day:  extreme fatigue, achy muscles, slight fever, light headedness, headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Red, painful, and hot at injection site for three days starting the morning of 5/4/2019.  Also, beginning the morning of 5/4/2019 and lasting one day:  extreme fatigue, achy muscles, slight fever, light headedness, headache.
Age: 33.0
Sex: M
Vaccine: MMR
Symptoms: Muscle spasms, Seizure, Syncope
Clinical narrative: Patient fainted ~30 seconds after administration of vaccine. Also, the patient appeared to have some sort of muscle spasm/seizures. 911 was called and the paramedics came and took the patient to the hospital.
Age: 0.67
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Hepatitis A immunization was given in error as Hep A is not given until the age of 15 months.   Incident was explained to mom.  She verbalized understanding.  Patient was asked to wait for any signs of adverse reaction.  None were noted.  Mom was asked to call if she has concerns regarding the incident.  Patient left our office in good condition.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Swelling
Clinical narrative: PATIENT CAME BACK ON 5-6-19 AND STATED SHE HAD SEVER SWELLING AND ARTHRITIC PAIN DOWN HER ARM AND RIGHT HAND. SHE SAID IT STARTED ABOUT 3 DAYS AFTER VACCINE AND LASTED 4-5 DAYS. IT WAS HARD FOR HER TO MAKE A FIST. IT HAD RESOLVED ON ITS OWN BEFORE SHE STOPPED BY THE PHARMACY TO REPORT IT
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Muscular weakness, Pain
Clinical narrative: Redness, swelling, and warmth to injection site of left arm, and that the symptoms are nearing her elbow beginning 2/9/18. Client denies fever, and reports she has been taking advil. She saw PCP on 2/11/19, received antibiotics (Augmentin x 10 days) prescribed by PCP, Dr. By 2/12/19  client still felt some weakness in left hand and arm, but warmth, redness, pain, and swelling are improving. Client was supposed to return to our office, at which time we could evaluate her arm. Client did not return, and never responded to final emails to return to the office.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction, Pruritus, Rash erythematous
Clinical narrative: red rash over top third of arm in which the vaccine was administered. started as a small localized reaction right away but spread over course of next few days. has not yet resolved. no pain associated, but some itching. patient will follow up with physician if rash does not resolve in next day or so, she states
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Condition aggravated, Fatigue, Muscle spasms
Clinical narrative: Exhaustion, fever of 102 F. for 3 days, chills and inability to stop shaking, joint pain, muscle spasms, RA flare, rosacea breakout.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rheumatoid arthritis, Rosacea, Tremor
Clinical narrative: Exhaustion, fever of 102 F. for 3 days, chills and inability to stop shaking, joint pain, muscle spasms, RA flare, rosacea breakout.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Paresis, Upper respiratory tract infection
Clinical narrative: URI Symptoms; Extreme muscle weakness/paresis
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Pyelonephritis, Urinary tract infection
Clinical narrative: Chronic diarrhea started after MMR- watery stool 3 times a day for 3 months completed by UTI 2 hour diarrhea with pyelonephritis
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid muscle very tender,  red , swollen. In addition, in am following receiving the vaccine, had headache, left shoulder and neck tenderness and felt sick like coming down with flu--low grade temp. Was very tired and slept for hours. Felt better the second day post vaccing, but deltoid still very red, swollen and tender to touch.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pyrexia, Tenderness
Clinical narrative: Left deltoid muscle very tender,  red , swollen. In addition, in am following receiving the vaccine, had headache, left shoulder and neck tenderness and felt sick like coming down with flu--low grade temp. Was very tired and slept for hours. Felt better the second day post vaccing, but deltoid still very red, swollen and tender to touch.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Impaired work ability, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Left deltoid muscle very tender,  red , swollen. In addition, in am following receiving the vaccine, had headache, left shoulder and neck tenderness and felt sick like coming down with flu--low grade temp. Was very tired and slept for hours. Felt better the second day post vaccing, but deltoid still very red, swollen and tender to touch.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pain, Pyrexia
Clinical narrative: Left deltoid muscle very tender,  red , swollen. In addition, in am following receiving the vaccine, had headache, left shoulder and neck tenderness and felt sick like coming down with flu--low grade temp. Was very tired and slept for hours. Felt better the second day post vaccing, but deltoid still very red, swollen and tender to touch.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered Kinrix and is not within the recommended ages
Age: 16.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Patient came in for a PPD test.  Instead of Tubersol, staff member drew up 0.1ml of IPOL.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain, Pyrexia
Clinical narrative: Began having flu-like symptoms about 4 hours after injection.  Awoke in the night with severe aches and fever, like the worse case of flu I?d ever had.  Much better the second day, but still aches and pains and don?t feel like doing much of anything.  (I was fine with the first dose of Shingrix...just a little arm pain).
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: ARM BECAME RED AND SWOLLEN, PATIENT DEVELOPED HIVES FOLLOWING INJECTION
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Pruritus, Sensory loss
Clinical narrative: About 30 minutes after getting the vaccine patient stated that she felt like her left pinky finger was tingling and started itching.  Pt seen 1 hour and 15 minutes after injection was given and stated that she feels better now, but still some less sensation on left pinky than the rest of her arm and hand.  Pt declined treatment in clinic and stated that she  was going to take Zyrtec.
Sex: M
Vaccine: FLUN4
Symptoms: Acute flaccid myelitis
Clinical narrative: ACUTE FALCCID MYELITIS; A spontaneous report has been received from the regulatory authority concerning a male child of Unknown ethnic origin.    No medical history was reported. No concomitant products were reported.    The patient received Fluenz Tetra (influenza virus vaccine live, intranasal) nasal, on 06-Oct-2018 for routine childhood immunisation.     On 16-Oct-2018, the patient experienced acute falccid myelitis (preferred term: Myelitis).     At the time of reporting, the event of  acute falccid myelitis was ongoing.    The event of  acute falccid myelitis was considered serious (hospitalised) by reporter.; Sender's Comments: This is case report concerning a male child patient with reported myelitis which is not listed in the company core data sheet for Live attenuated influenza vaccine (Q/LAIV). The event occurred 11 days after of administration. Due to limited information on patient's demographics (age), outcome of the event, concurrent diseases, concomitant medication and vaccination profile, relevant medical history, risk factors (such as infections, autoimmune disorders), etiologic and diagnostic workup (magnetic resonance imaging, lumbar puncture, blood test), it is not possible to make conclusive assessment of causal relationship of event with live attenuated influenza vaccine.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; a patient was administered one dose of improperly stored PNEUMOVAX 23; This spontaneous report was received a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions /allergies and concomitant medications was not provided.  On 22-APR-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Lot # R027299, expiration date 09-APR-2022) route of administration and anatomical location were not reported for prophylaxis. No adverse effects were reported.  The time frame was 10 minutes in a temperature above 47 F (70 F), no previous temperature excursion was reported, the call was because data logger. No product quality complaint was involved.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse effect reported; first dose of GARDASIL 4 Valent on 09-AUG-2011 and second dose of GARDASIL 9 on 25-JAN-2019; first dose of GARDASIL 4 Valent on 09-AUG-2011 and second dose of GARDASIL 9 on 25-JAN-2019; first dose of GARDASIL 4 Valent on 09-AUG-2011 and second dose of GARDASIL 9 on 25-JAN-2019; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.  On 09-AUG-2011, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported).  Other suspect therapies included hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 25-JAN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), batch/lot # R025725 and expiration date: 25-MAY-2019, for prophylaxis (strength, dose, unit, route and anatomical location were not reported) (inappropriate schedule of product administration (onset date: 10-AUG-2012), interchange of vaccine products and wrong product administered). No adverse effect was reported. The outcome of inappropriate schedule of product administration, interchange of vaccine products, wrong product administered was unknown. No product quality complaint (PQC) was involved.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast inflammation, Breast pain, Mastitis
Clinical narrative: Patient states she got a breast infection on the side the vaccine was given. She reports symptoms a very sore breast, pain, inflammation in breast. Her doctor did not think it was related to the Shingrix vaccine. She was treated with Penicillin. She still reports soreness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Body temperature increased, Chills, Computerised tomogram abdomen normal, Full blood count
Clinical narrative: Approximately 12 hours after the vaccination, fever and chills started with initial elevated temperature of 101.3F and reaching a maximum of 102.8F and returning to normal by approximately 12 hours from onset.  Approximately 39 hours from vaccination, recurrent vomiting (total of 5 times), abdominal pain, and wide spread, persistent, stinging body pain occurred.  I required intravenous fluids, overall 2 liters.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Pain, Pyrexia, Vomiting
Clinical narrative: Approximately 12 hours after the vaccination, fever and chills started with initial elevated temperature of 101.3F and reaching a maximum of 102.8F and returning to normal by approximately 12 hours from onset.  Approximately 39 hours from vaccination, recurrent vomiting (total of 5 times), abdominal pain, and wide spread, persistent, stinging body pain occurred.  I required intravenous fluids, overall 2 liters.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Breath holding, Crying, Decreased appetite, Fatigue, Hypotonia
Clinical narrative: While getting 4mo shots patient started holding breath after the first vaccine (Hib) was given IM in the RVL (after getting Rotarix orally). Pt. cried when first stuck in RVL but then started holding breath. Pt. continued to hold breath while getting Pediarix and Prevnar in LVL. Pt. held breath after vaccines were finished and I blew in his face. Patient took one deep breath after I blew in his face and then just started blankly looking at me. He became very relaxed in mom's arm and became almost limp but never had LOC. Pt. was silent during the entire episode. Pt. just continued looking at me and mom. I watched patient's eyes and he never had any abnormal movements, he just continued to look straight at me. Never had any twitching or abnormal body movements. I picked patient up out of mom's arm and stood up with him. He pulled his head and chest off of my chest and looked at me and then cuddled his head against my chest for approx. 5 seconds and then pulled head off of my chest and puckered his lips and started to cry. I handed patient back to mom and he stopped crying for a few seconds and then looked back at me and started crying again. Pt. was alert but acted very tired. I went and made the provider aware of situation and she went and examined patient. Provider thought patient may have just had a vagal response. Pt. was alert when provider was in room but looked pale but was smiling appropriately. A couple minutes after provider left the room mom stepped out and said patient was falling asleep. Mom said it was not patient's nap time. Pt. became very sleepy about 5-6 minutes after vaccines were administered and pt. had episode. Provider instructed mom to let patient go to sleep and we would monitor him in clinic for another 10-15 minutes. Provider went back in to check on patient about 10-15 minutes after episode. Patient was still asleep but color was improved but still a little pale per provider. Provider instructed mom to monitor closely this afternoon and to call back if she had trouble getting patient to feed, wake, or any other concerns. I will call to check on patient this afternoon. I called to check on patient at 3:00 p.m.. Mom stated that patient was only eating half of what he normally does, was fussy, and sleeping a lot more than normal. Mom did report that he would smile some when he was awake.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pallor, Somnolence, Staring
Clinical narrative: While getting 4mo shots patient started holding breath after the first vaccine (Hib) was given IM in the RVL (after getting Rotarix orally). Pt. cried when first stuck in RVL but then started holding breath. Pt. continued to hold breath while getting Pediarix and Prevnar in LVL. Pt. held breath after vaccines were finished and I blew in his face. Patient took one deep breath after I blew in his face and then just started blankly looking at me. He became very relaxed in mom's arm and became almost limp but never had LOC. Pt. was silent during the entire episode. Pt. just continued looking at me and mom. I watched patient's eyes and he never had any abnormal movements, he just continued to look straight at me. Never had any twitching or abnormal body movements. I picked patient up out of mom's arm and stood up with him. He pulled his head and chest off of my chest and looked at me and then cuddled his head against my chest for approx. 5 seconds and then pulled head off of my chest and puckered his lips and started to cry. I handed patient back to mom and he stopped crying for a few seconds and then looked back at me and started crying again. Pt. was alert but acted very tired. I went and made the provider aware of situation and she went and examined patient. Provider thought patient may have just had a vagal response. Pt. was alert when provider was in room but looked pale but was smiling appropriately. A couple minutes after provider left the room mom stepped out and said patient was falling asleep. Mom said it was not patient's nap time. Pt. became very sleepy about 5-6 minutes after vaccines were administered and pt. had episode. Provider instructed mom to let patient go to sleep and we would monitor him in clinic for another 10-15 minutes. Provider went back in to check on patient about 10-15 minutes after episode. Patient was still asleep but color was improved but still a little pale per provider. Provider instructed mom to monitor closely this afternoon and to call back if she had trouble getting patient to feed, wake, or any other concerns. I will call to check on patient this afternoon. I called to check on patient at 3:00 p.m.. Mom stated that patient was only eating half of what he normally does, was fussy, and sleeping a lot more than normal. Mom did report that he would smile some when he was awake.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza like illness
Clinical narrative: Reported flu like symptoms managed symptomatically at home
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Mobility decreased, Nausea
Clinical narrative: Very sore about 2 inches below the injection site. The next morning (5/7/2019) a splitting headache, still sore and hard to move my arm, tired (fell asleep for about an hour), slight nausea. Took ibuprofen and it helped.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Very sore about 2 inches below the injection site. The next morning (5/7/2019) a splitting headache, still sore and hard to move my arm, tired (fell asleep for about an hour), slight nausea. Took ibuprofen and it helped.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Acoustic stimulation tests, Deafness bilateral, Tinnitus
Clinical narrative: 48 hours had discrete onset tinnitus and deafness bilaterally
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Insomnia, Pain, Paraesthesia
Clinical narrative: TINGLING AND NUMBNESS IN FINGERS, HAND, AND ARM. SOME PAIN INVOLVED AND COULD NOT SLEEP LAST NIGHT
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Chills, Disorientation, Erythema, Fatigue
Clinical narrative: Awoke at 12:30 a.m. (16 hours after inoculation)  with chills and sensation of skin crawling, muscle pain and leg cramps. Face, torso and arms flushed, red, and hot. Temperature of 102. Anxious and frightened, disoriented. Considered going to ER, but instead took two acetaminophen. 2.5 hours later fever was 100 and other symptoms had lessened. Went back to bed and slept with violent dreams. Awoke at 7:30 a.m. ( 23 hours after the vaccine). Symptoms much reduced, though felt very fatigued.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fear, Flushing, Formication, Muscle spasms, Myalgia
Clinical narrative: Awoke at 12:30 a.m. (16 hours after inoculation)  with chills and sensation of skin crawling, muscle pain and leg cramps. Face, torso and arms flushed, red, and hot. Temperature of 102. Anxious and frightened, disoriented. Considered going to ER, but instead took two acetaminophen. 2.5 hours later fever was 100 and other symptoms had lessened. Went back to bed and slept with violent dreams. Awoke at 7:30 a.m. ( 23 hours after the vaccine). Symptoms much reduced, though felt very fatigued.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nightmare, Pyrexia, Skin warm
Clinical narrative: Awoke at 12:30 a.m. (16 hours after inoculation)  with chills and sensation of skin crawling, muscle pain and leg cramps. Face, torso and arms flushed, red, and hot. Temperature of 102. Anxious and frightened, disoriented. Considered going to ER, but instead took two acetaminophen. 2.5 hours later fever was 100 and other symptoms had lessened. Went back to bed and slept with violent dreams. Awoke at 7:30 a.m. ( 23 hours after the vaccine). Symptoms much reduced, though felt very fatigued.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness and swelling with a lump at injection site
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Carpal tunnel syndrome, Electrocardiogram, Surgery
Clinical narrative: Advancement of minor carpal tunnel symptoms to the point of requiring surgery within tow months
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: For two days:  101 degree fever, bad headache, muscle aches -- severe enough I had to cancel monthly meetings.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash, Rash macular
Clinical narrative: Patient received vaccines yesterday, this afternoon the patient broke out with a red splotchy rash on his arms and legs.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Confusional state, Erythema, Feeling abnormal, Feeling hot, Hypertension
Clinical narrative: Pt received vaccine n clinic, apparently left clinic, went to store, had some popcorn and started feeling poorly.   came back to clinic and was found by an RN in the lobby-"pt was looking confused, very red in skin color and telling me she is not feeling right. I then learned that she had had a MMR vaccine. It appeared that she was having a reaction as she told me her face was feeling hot and lips were swelling".  We administered IM Benadryl and then approx. 24 min later gave IM epinephrine.  911 was called and pt was transported to local ER as was hypertensive and had received epi.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Lip swelling, Vaccination complication
Clinical narrative: Pt received vaccine n clinic, apparently left clinic, went to store, had some popcorn and started feeling poorly.   came back to clinic and was found by an RN in the lobby-"pt was looking confused, very red in skin color and telling me she is not feeling right. I then learned that she had had a MMR vaccine. It appeared that she was having a reaction as she told me her face was feeling hot and lips were swelling".  We administered IM Benadryl and then approx. 24 min later gave IM epinephrine.  911 was called and pt was transported to local ER as was hypertensive and had received epi.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt experienced pain in the deltoid & upper arm that recvd the injection from the day after the immunization, continuing x3months. She had her dr prescribe medication for the arm pain (meloxicam)
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Extremely high fever, 105.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Starting last eve, pt's L upper arm became very sore. Upper arm is now red, swollen and warm to the touch and feels hard from her elbow up to her shoulder.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Feeling hot, Gastrooesophageal reflux disease, Paraesthesia, Pruritus, Sneezing
Clinical narrative: Patient received vaccination and for 10-15 minutes after, no adr reported. Pt went to next door grocery store and there was when pt felt symptoms of itchiness, sneezing, tingling. Later pt developed symptoms of acid reflux and face felt red hot. Pt called pharmacy to alert us of adr and pharmacist on duty recommended taking benadryl to alleviate symptoms. When pt got home, took 50 mg of benadryl (20 ml of benadryl).  About 1 hour later pt called pharmacy and reported symptoms were less severe but still present. Pharmacist on duty recommended to take a dose of benadryl before going to bed and to still monitor any signs and symptoms of difficulty breathing. Previously talking to the pharmacist, pt had talked to a teledoc and teledoc recommended to call the pharmacy to discuss adr. Teledoc didnt prescribe anything despite the pts symptoms that were reported. Warned pt that difficulty breathing is a key symptom indicating that pt will have to go to ER or urgent care as adr are progressing. Pharmacy will follow up with pt following day to see how pt's symptoms are
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Altered state of consciousness, Chills, Fatigue, Hypoaesthesia, Pain
Clinical narrative: Morning of 5/7/2019 developed sudden fatigue and numbness and tingling of both arms, felt like she was going to pass out but laid down and did not have any episode of loss of consciousness. The episode was witnessed. Subsequently developed fatigue, body aches and chills, numbness and tingling is resolving at the time of the report.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Morning of 5/7/2019 developed sudden fatigue and numbness and tingling of both arms, felt like she was going to pass out but laid down and did not have any episode of loss of consciousness. The episode was witnessed. Subsequently developed fatigue, body aches and chills, numbness and tingling is resolving at the time of the report.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: After first day patient had initial inject site reaction, redness and itching. Reaction resolved by day 4 and then returned again on day 7. Rash was a square red patch near injection site, patient reported itching and mild pain. Patient stated had a similar reaction a few years ago when she received zostavax.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: After first day patient had initial inject site reaction, redness and itching. Reaction resolved by day 4 and then returned again on day 7. Rash was a square red patch near injection site, patient reported itching and mild pain. Patient stated had a similar reaction a few years ago when she received zostavax.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site warmth, Muscle tightness, Musculoskeletal pain, Pain in extremity
Clinical narrative: After first day patient had initial inject site reaction, redness and itching. Reaction resolved by day 4 and then returned again on day 7. Rash was a square red patch near injection site, patient reported itching and mild pain. Patient stated had a similar reaction a few years ago when she received zostavax.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: After first day patient had initial inject site reaction, redness and itching. Reaction resolved by day 4 and then returned again on day 7. Rash was a square red patch near injection site, patient reported itching and mild pain. Patient stated had a similar reaction a few years ago when she received zostavax.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Vomiting
Clinical narrative: Large red area and warm to touch on the left thigh.  Also vomited 3 times the day after 1st thing in the morning.  No fever per mom.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Chest pain, Chills, Decreased appetite, Diarrhoea
Clinical narrative: FEVER, CHILLS-SHAKING, SORE ARM, DIARRHEA, ACHING ALL OVER ESPECIALLY CHEST AND HEAD, SHARP PAIN RIGHT EAR AND IN LEFT JAW, LACK OF APPETITE, BED RIDDEN 2 DAYS, LARYNGITIS, WEEPING EYES, DIFFICULTY SLEEPING
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Insomnia, Lacrimation increased, Laryngitis
Clinical narrative: FEVER, CHILLS-SHAKING, SORE ARM, DIARRHEA, ACHING ALL OVER ESPECIALLY CHEST AND HEAD, SHARP PAIN RIGHT EAR AND IN LEFT JAW, LACK OF APPETITE, BED RIDDEN 2 DAYS, LARYNGITIS, WEEPING EYES, DIFFICULTY SLEEPING
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pain in jaw, Pyrexia, Tremor
Clinical narrative: FEVER, CHILLS-SHAKING, SORE ARM, DIARRHEA, ACHING ALL OVER ESPECIALLY CHEST AND HEAD, SHARP PAIN RIGHT EAR AND IN LEFT JAW, LACK OF APPETITE, BED RIDDEN 2 DAYS, LARYNGITIS, WEEPING EYES, DIFFICULTY SLEEPING
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Had a shot in my left arm and developed soreness of arm- not too concerning but also left armpit pain that was very annoying today
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Patient noticed swelling and redness around the injection site. She was counseled by the pharmacist that this type of reaction was a possibility; however, after a couple days of the reaction still existing she went to the doctor's office. The doctor found there was an infection at the injection site. The patient was prescribed Cephalexin 500mg 1 capsule by mouth twice daily for 7 days. When picking up antibiotic prescription the patient reported the adverse effect to the pharmacy on duty.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: rash on left arm, 9 days after injection, at site of varicella injection raised and itchy
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased, Pain, Rash, Skin warm
Clinical narrative: pain, redness, rash, swelling, hot to touch, trouble lifting arm  4x8 inches large
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: pain, redness, rash, swelling, hot to touch, trouble lifting arm  4x8 inches large
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Immunization was to be given orally, it was administered IM injection
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Laboratory test normal, Tremor
Clinical narrative: patient felt cold and shaking. she did Not have a fever. she went to hospital and they ran labs and everything was fine. they gave her IV but it is unknown if medicine in IV.  she was at hospital for 4 hours
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dizziness, Dyspnoea, Feeling hot
Clinical narrative: Pt was lightheaded, hot, coughing, and said she is having a little trouble breathing.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Intense flu-like symptoms (intense headache, fatigue, dizzy, nausea, body aches) for 36 hours.  Tylenol for pain, little benefit. Very sore right arm at injection site.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Intense flu-like symptoms (intense headache, fatigue, dizzy, nausea, body aches) for 36 hours.  Tylenol for pain, little benefit. Very sore right arm at injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: SEVERE SWELLING, PAIN AND REDNESS AT SITE OF INJECTION HEADACHE AND NAUSEA FEVER
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: SEVERE SWELLING, PAIN AND REDNESS AT SITE OF INJECTION HEADACHE AND NAUSEA FEVER
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site bruising, Injection site pain, Injection site swelling, Nausea
Clinical narrative: SEVERE SWELLING, PAIN AND REDNESS AT SITE OF INJECTION HEADACHE AND NAUSEA FEVER
Age: 59.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Administered vaccine in subq space of pt's left arm, but mistakenly used a 1 inch needle instead of 5/8" needle when administering MMR-II which is supposed to be given subq. Pt did not have a reaction to this and this vaccine does not need to be re-administered if inadvertently given IM.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Impaired driving ability, Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: The pt. stated she received SHINGRIX in left arm and PNEUMOVAX in right arm. The next day, she was in a lot of pain (scale 10/10) and could not raise her arm at all. She said the pain radiated up her arm, through her shoulder, and into her neck. I advised her to see her md on 5-6-19 since she was still having trouble driving and still could not raise her arm very much. Her doctor prescribed pain medication. The doctor thought that the injection may have been given into the joint. Also, the pt. said the PNEUMOVAX was in her right arm and SHINGRIX was in her left arm so she thought the PNEUMOVAX was the causative agent. Upon looking at the rx's, it is documented on the screening form and in the dispensing screen that the SHINGRIX was in the right and PNEUMOVAX was in the left. (I marked off that this caused a disability on the next page because she is still having an issue at this time...her md didn't think it is permanent damage though).
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: The pt. stated she received SHINGRIX in left arm and PNEUMOVAX in right arm. The next day, she was in a lot of pain (scale 10/10) and could not raise her arm at all. She said the pain radiated up her arm, through her shoulder, and into her neck. I advised her to see her md on 5-6-19 since she was still having trouble driving and still could not raise her arm very much. Her doctor prescribed pain medication. The doctor thought that the injection may have been given into the joint. Also, the pt. said the PNEUMOVAX was in her right arm and SHINGRIX was in her left arm so she thought the PNEUMOVAX was the causative agent. Upon looking at the rx's, it is documented on the screening form and in the dispensing screen that the SHINGRIX was in the right and PNEUMOVAX was in the left. (I marked off that this caused a disability on the next page because she is still having an issue at this time...her md didn't think it is permanent damage though).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Fatigue, Injection site pain, Pain
Clinical narrative: Not sure of above information, but providing other numbers.  I originally got my first shot over two months ago. I was called in for my second shot.  My arm was still sore from the first shot (right arm).  So, I got the 2nd shot in my left arm. Boy, am I sore and the site very painful,  I have pain radiating across my back.  Then today I was dizzy all day and extremely tired. This is not normal for me and am concerned about further symptoms..
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Blood thyroid stimulating hormone normal, Chest X-ray
Clinical narrative: Patient shared she received meningitis vaccine and two hours later she began having shortness of breath, chills, palpitations, nausea, upper abdominal pain, bilateral knee pain and weakness.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Drug screen negative, Dyspnoea, Electrocardiogram abnormal, Full blood count normal
Clinical narrative: Patient shared she received meningitis vaccine and two hours later she began having shortness of breath, chills, palpitations, nausea, upper abdominal pain, bilateral knee pain and weakness.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Human chorionic gonadotropin normal, Metabolic function test normal, Nausea, Palpitations, Sinus tachycardia
Clinical narrative: Patient shared she received meningitis vaccine and two hours later she began having shortness of breath, chills, palpitations, nausea, upper abdominal pain, bilateral knee pain and weakness.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Troponin I normal, Urine analysis normal
Clinical narrative: Patient shared she received meningitis vaccine and two hours later she began having shortness of breath, chills, palpitations, nausea, upper abdominal pain, bilateral knee pain and weakness.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Red hives @ reaction sites within hours of vaccination, diffuse hives without airway involvement within 24 hr. subsequent intermittent hives w/ possible egg in diet association.
Age: 27.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Pt called on 5/7/19 to report that after having received vaccines in the morning he felt his (R) arm stiffen & by the evening it was swelled from deltoid to below elbow
Sex: M
Vaccine: HPV4
Symptoms: Human papilloma virus test negative, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: the patient was HPV negative; received the shot outside of the indicated age; shot into the shoulder; This spontaneous report as received from currently 81 years old male patient regarding himself. The patient's medical history included papilloma viral infection.   Patient had drug reactions/allergies to cephalexin (KEFLEX). Patient was not on any concomitant medications. On an unknown date (reported as 5 or more years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), 1 dosage form for prevention of hpv (prophylaxis). It was reported that the vaccine was shot into the patient's shoulder (product administered at inappropriate site). It was reported that the patient had quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) shot after he was HPV positive and then got tested again and he was HPV negative (human papilloma virus test negative). The patient also received the shot outside of the indicated age range 5 or more years ago (product administered to patient of inappropriate age). No other side effects were reported. Patient sought medical attention by visiting the doctor. Outcome of the event human papilloma virus test negative was unknown. Causality of the event was not reported.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: AXILLARY MASS; HOT FLUSH; URINE ANALYSIS; ASTHENIA; CHILLS; DIZZINESS; FATIGUE; HEADACHE; Light headed; Weak; This report, as identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 692828) on 17-AUG-2017, refers to an 18-years-old female patient.  There were no medical history or current illnesses reported. Concomitant therapies included ethinyl estradiol, ferrous fumarate, norethindrone acetate (LO LOESTRIN FE). On 28-APR-2017, the patient was vaccinated with dose 2 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular into the left arm, lot # M042853, (frequency and expiration date were not provided), for prophylaxis. On 28-APR-2017, the patient experienced chills, hot flashes, fatigue, headaches, bump under right axillary; she also felt weak and lightheaded. On 28-APR-2017, urine analysis was performed due to possible infection unrelated to immunization.  The outcome of all the events were unknown.  The event of urine analysis was reported as not related to the suspect therapy. The relatedness between other events and the suspect therapy was not reported.  Follow-up information was received on 25-FEB-2019 from the other healthcare professional via FDA. The vaccine administration information were updated, including the vaccine administrator data and vaccine facility data. It was reported, that the patient had no illness at the time of vaccination and the event wasn't previously reported.  Follow up information was received on 06-MAY-2019 from a healthcare professional.   The patient's concomitant medication included meningococcal B rfHbp vaccine (E. coli) (TRUMENBA). Also, the patient experience weak and light headed on 28-APR-2017, the outcome was reported as recovered.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the chills, hot fluses, weak and light headed was reported as probably related.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Hot flush, Swelling, Urine analysis
Clinical narrative: AXILLARY MASS; HOT FLUSH; URINE ANALYSIS; ASTHENIA; CHILLS; DIZZINESS; FATIGUE; HEADACHE; Light headed; Weak; This report, as identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 692828) on 17-AUG-2017, refers to an 18-years-old female patient.  There were no medical history or current illnesses reported. Concomitant therapies included ethinyl estradiol, ferrous fumarate, norethindrone acetate (LO LOESTRIN FE). On 28-APR-2017, the patient was vaccinated with dose 2 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular into the left arm, lot # M042853, (frequency and expiration date were not provided), for prophylaxis. On 28-APR-2017, the patient experienced chills, hot flashes, fatigue, headaches, bump under right axillary; she also felt weak and lightheaded. On 28-APR-2017, urine analysis was performed due to possible infection unrelated to immunization.  The outcome of all the events were unknown.  The event of urine analysis was reported as not related to the suspect therapy. The relatedness between other events and the suspect therapy was not reported.  Follow-up information was received on 25-FEB-2019 from the other healthcare professional via FDA. The vaccine administration information were updated, including the vaccine administrator data and vaccine facility data. It was reported, that the patient had no illness at the time of vaccination and the event wasn't previously reported.  Follow up information was received on 06-MAY-2019 from a healthcare professional.   The patient's concomitant medication included meningococcal B rfHbp vaccine (E. coli) (TRUMENBA). Also, the patient experience weak and light headed on 28-APR-2017, the outcome was reported as recovered.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the chills, hot fluses, weak and light headed was reported as probably related.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Periorbital swelling, Swelling face
Clinical narrative: Eye Swelling/ swelling of both eyes; Swelling of face; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID: 704281) and refers to a 11 year old female patient. The patient's medical history and concurrent conditions were not reported. On 10-NOV-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose not reported) from lot # M032650 with an expiry date of 31-MAR-2019, intramuscularly in the left arm for prophylaxis. Approximately on an unknown date in 2016, the patient experienced mild facial swelling after vaccination with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On 06-JUL-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose not reported) from lot # N000326, intramuscularly in the left arm for prophylaxis. On 06-JUL-2017, one hour after the vaccination the patient developed swelling of face and swelling of both eyes. The swelling decreased the next day, but the patient still had some mild periorbital swelling then. There were no other symptoms reported. The outcome of the events of eye swelling and swelling face was reported as recovered. The causality assessment was not provided.  Follow-up information was obtained on request by the company from the FDA (VAERS ID: 704281) under the Freedom of Information Act on 15-APR-2019. This report was initially reported by a physician and refers to a 11-year-old Asian female patient. The patient does not have allergies to food, medications or other products, chronic or long-standing health conditions, and she did not have any other illness one month prior to vaccination and at the time of vaccination. The patient was not pregnant at the time of vaccination. The patient was not taking over-the-counter medications, dietary supplements, or herbal remedies at the time of vaccination. On 06-JUL-2017 at 10:40, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosing details as previously reported).  On 06-JUL-2017 at 12:00 (also reported as about 1 hour after vaccine), the patient developed swelling of face and swelling of both eyes.  Follow-up information was received from a physician via company representative on 02-MAY-2019. The physician does not have any additional information as she did not file the adverse event and does not know who the patient was.