chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Pt. developed a large bump; looked like a small hive around the injection site. After 5 minutes the swelling went down (normalized). Pt. was not worried; was given diphenhydramine 25mg with water. Pt normalized.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Pain, Pyrexia
Clinical narrative: Trouble swallowing - body aches - fever and chills - however didn't take temperature.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood glucose increased, Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Patient began to develop pain 2 hours after vaccine administration. Approximately 4 hours after administration was unable to move arm due to pain. Injection area and down elbow of vaccinated arm was swollen and red and hot to touch. Follow up with patient and stated arm no longer swollen and was without pain and completely normal by 9/27. Patient was later admitted to the hospital for elevated glucose but vaccine arm was OK.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Itching, redness, swelling, pain and tingling to left arm, extending to arm, fingers and neck. Prescribed ABx by MD. Took TYLENOL and applied ice pack.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Neck pain, Pain in extremity
Clinical narrative: Rec'd influenza vaccine to (L) deltoid at 1030am. Within 5 min, pain to (L) wrist. Within 15 min, radiating pain in forearm to fingertips. Pain in collar bone, (L) side of neck. Pain continues as of note, 3 hours after vaccination.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, swelling, pain to injection site.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site nodule in a 37-year-old female patient who received FLULAVAL quadrivalent (batch number 93T79, expiry date 30th June 2016). On 23rd September 2015, the patient received FLULAVAL quadrivalent .5 ml. On 23rd September 2015, 3 hrs 30 min after receiving FLULAVAL quadrivalent, the patient experienced injection site nodule. On an unknown date, the outcome of the injection site nodule was recovered/resolved. It was unknown if the reporter considered the injection site nodule to be related to FLULAVAL quadrivalent. Additional detail were provided as follows: On 23rd September 2015, at 11.30, the patient received FLULAVAL QIV vaccine. On the same day, at 3.00, 3 hours and 30 minutes after receiving the vaccine, the patient experienced knot at the injection site (right deltoid). The patient came back to clinic at 3.30 to complain of a knot at the injection site (injection site nodule).
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of lip swelling in a adult female patient who received FLUARIX. Co-suspect products included FLUARIX. In 2009, the patient received FLUARIX. In 2012, the patient received seasonal Influenza vaccine. On an unknown date, an unknown time after receiving seasonal Influenza vaccine and not applicable after receiving seasonal Influenza vaccine, the patient experienced lip swelling. On an unknown date, the outcome of the lip swelling was recovered/resolved and the outcome of the lip swelling was unknown. It was unknown if the reporter considered the lip swelling to be related to seasonal Influenza vaccine. It was unknown if the reporter considered the lip swelling to be related to seasonal Influenza vaccine. Additional details were received as follows: The reporter stated that, each time after receiving Flu vaccine the patient experienced lip swelling. In 2009, the patient received unspecified brand Flu vaccine. In 2010, the patient received Flu nasal mist (unknown brand). In 2012, the patient received unspecified bran Flu vaccine. The patient experienced lip swelling each time after receiving Flu vaccine and Flu nasal mist. The reporter did not know if patient was treated for the lip swelling. The brand names and batch numbers of the vaccines were not available.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of urticaria in a 50-year-oldf female patient who received FLUARIX quadrivalent (batch number 9X7LY, expiry date 29th June 2016). Previously administered products included Flu vaccine (no history of problems with previous Flu vaccinations). On 25th September 2015 12:00, the patient received FLUARIX quadrivalent .5 ml. On 25th September 2015 20:30, 8 hrs 30 min after receiving FLUARIX quadrivalent, the patient experienced urticaria and throat tightness. On an unknown date, the outcome of the urticaria and throat tightness were recovering/resolving. The reporter considered the urticaria and throat tightness to be possibly related to FLUARIX quadrivalent. Additional details were received as follows: On 28th September 2015, the patient was evaluated at the physician's office and they noted that urticaria and throat tightness were resolving. The reporter forgot to ask if vaccination was given subcutaneously, but the patient gave him no reason to think otherwise. The patient visited the emergency room.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection 2 days after vaccination - arm red, swollen, warm. Treated with KEFLEX 500mg once po TID x7d.
Age: 72.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Chills, Rash erythematous, Rash macular
Clinical narrative: Red blotchy rash on arms, stomach, buttocks and legs. Patient experienced chills but no fever.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Rash
Clinical narrative: Pt. received PREVNAR 13 (RA) and FLUZONE HD vaccines (LA). Developed a rash in right arm near injection site. Rash has spread down arm. Called on 10-4-15 -> got hydrocortisone cr and BENADRYL.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Pt. received PREVNAR 13 (RA) and FLUZONE HD vaccines (LA). Developed a rash in right arm near injection site. Rash has spread down arm. Called on 10-4-15 -> got hydrocortisone cr and BENADRYL.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Rash
Clinical narrative: Patient got a rash that spread from injection site to wrist (right deltoid).
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Patient got a rash that spread from injection site to wrist (right deltoid).
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Cardiac monitoring, Depressed level of consciousness, Heart rate increased
Clinical narrative: My daughter was given the first GARDASIL shot on Sept. 22, 2015 and one week later on Sept. 29, 2015 became sick. She was at school and had to have someone pick her up because she was very weak and felt like blacking out. We took her to the emergency room where she was put on IV meds to help control her heart rate that went over 150 3 or more times. She now has on a heart monitor and the Drs are leaning toward POTS. My child was healthy and active before I had her take this shot! I should have looked at all the warnings people have posted about GARDASIL.....I cannot believe the government can be so reckless with our children. I honestly felt that if the government allowed it and the Drs were encouraging it then everything should be fine. I took my "perfect" child and exposed her to possible HELL! I just pray she comes out of it.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Postural orthostatic tachycardia syndrome
Clinical narrative: My daughter was given the first GARDASIL shot on Sept. 22, 2015 and one week later on Sept. 29, 2015 became sick. She was at school and had to have someone pick her up because she was very weak and felt like blacking out. We took her to the emergency room where she was put on IV meds to help control her heart rate that went over 150 3 or more times. She now has on a heart monitor and the Drs are leaning toward POTS. My child was healthy and active before I had her take this shot! I should have looked at all the warnings people have posted about GARDASIL.....I cannot believe the government can be so reckless with our children. I honestly felt that if the government allowed it and the Drs were encouraging it then everything should be fine. I took my "perfect" child and exposed her to possible HELL! I just pray she comes out of it.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Injection site discolouration, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: PREVNAR 13 injection on Tuesday, September 29. The injection itself hurt like heck. A few hours after the injection I developed a very sore throat and felt awful. It is now Sunday, October 4th and I still have a sore throat and feel like crap. I do not believe I have a fever. The injection site is still swollen, black and blue, hard and painful to the touch.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain
Clinical narrative: PREVNAR 13 injection on Tuesday, September 29. The injection itself hurt like heck. A few hours after the injection I developed a very sore throat and felt awful. It is now Sunday, October 4th and I still have a sore throat and feel like crap. I do not believe I have a fever. The injection site is still swollen, black and blue, hard and painful to the touch.
Age: 62.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Asthma, Immediate post-injection reaction, Urticaria
Clinical narrative: Given Thurs. 10/1/15 8am. Fri at 2:30am had been fine broke out in hives dime size immediately after that she had an asthma attack immed. went to ER.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Neuralgic amyotrophy, Pain, Paraesthesia
Clinical narrative: Numbness, tingling, pain. Dx: brachial plexus neuritis.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Discomfort, Emotional distress, Hypoaesthesia, Injection site pain
Clinical narrative: Numbness, tingling, pain. Dx: brachial plexus neuritis.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Neuralgic amyotrophy, Neurological examination, Pain in extremity, Paraesthesia
Clinical narrative: Numbness, tingling, pain. Dx: brachial plexus neuritis.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Neuralgic amyotrophy, Pain, Paraesthesia
Clinical narrative: I received the quadrivalent influenza vaccine on 10/03/15 in the left deltoid. I subsequently experienced numbness, tingling, heaviness, weakness, and extreme pain in my left shoulder/arm/hand. I have been evaluated by my primary care provider and a neurologist and diagnosed with brachial plexus neuritis secondary to receiving the influenza vaccine. There has been minimal improvement and this injury has caused significant distress and functional impairment.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Discomfort, Emotional distress, Hypoaesthesia, Injection site pain
Clinical narrative: I received the quadrivalent influenza vaccine on 10/03/15 in the left deltoid. I subsequently experienced numbness, tingling, heaviness, weakness, and extreme pain in my left shoulder/arm/hand. I have been evaluated by my primary care provider and a neurologist and diagnosed with brachial plexus neuritis secondary to receiving the influenza vaccine. There has been minimal improvement and this injury has caused significant distress and functional impairment.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Neuralgic amyotrophy, Neurological examination, Pain in extremity, Paraesthesia
Clinical narrative: I received the quadrivalent influenza vaccine on 10/03/15 in the left deltoid. I subsequently experienced numbness, tingling, heaviness, weakness, and extreme pain in my left shoulder/arm/hand. I have been evaluated by my primary care provider and a neurologist and diagnosed with brachial plexus neuritis secondary to receiving the influenza vaccine. There has been minimal improvement and this injury has caused significant distress and functional impairment.
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Lethargy
Clinical narrative: Guest received FLUMIST on Oct 1 2015 nad experience a slight cough and extreme lethargy.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Flushing, Headache, Hyperhidrosis
Clinical narrative: Patient complained of feeling hot, sweaty, flushed, dizzy, headache within 5 minutes of receiving flu shot. Epinephrine 0.3ml SQ given as instructed per Dr. Symptoms resolved.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Wrong drug administered
Clinical narrative: Pt had requested HD vaccine. Nurse gave the regular quadrivalent vaccine by mistake. After consulting with the nursing supervisor, she administered the HD vaccine.  2 flu shots were given.  No immediate adverse effects occurred.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain
Clinical narrative: Chest pain.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash
Clinical narrative: Patient came to office on 10/06/2015 complaining of rash on right deltoid.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain, Skin warm
Clinical narrative: Area of left arm became erythematous and hot to touch about 1 hour after injection given. Area involved included left shoulder up to neck area. Pt thought she was having an MI based on the symptoms. Redness and swelling improving but still very sore.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Basophil count decreased, Basophil count normal, Basophil percentage, Basophil percentage increased, CSF protein normal
Clinical narrative: Patient developed a fever up to 105.0 over the course of 48 hours.  Had severe diarrhea, and became listless, not eating well, crying inconsolably.  She was hospitalized for several days, developed a UTI due to E. coli, and was placed on antibiotics and IV fluids. She has a follow up with a specialist to make sure her kidneys were not damaged.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Diarrhoea, Differential white blood cell count normal, Eosinophil count decreased, Eosinophil count normal
Clinical narrative: Patient developed a fever up to 105.0 over the course of 48 hours.  Had severe diarrhea, and became listless, not eating well, crying inconsolably.  She was hospitalized for several days, developed a UTI due to E. coli, and was placed on antibiotics and IV fluids. She has a follow up with a specialist to make sure her kidneys were not damaged.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eosinophil percentage increased, Escherichia test positive, Feeding disorder of infancy or early childhood, Full blood count, Haematocrit decreased
Clinical narrative: Patient developed a fever up to 105.0 over the course of 48 hours.  Had severe diarrhea, and became listless, not eating well, crying inconsolably.  She was hospitalized for several days, developed a UTI due to E. coli, and was placed on antibiotics and IV fluids. She has a follow up with a specialist to make sure her kidneys were not damaged.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haemoglobin decreased, Listless, Lymphocyte count increased, Lymphocyte percentage increased, Mean cell haemoglobin concentration decreased
Clinical narrative: Patient developed a fever up to 105.0 over the course of 48 hours.  Had severe diarrhea, and became listless, not eating well, crying inconsolably.  She was hospitalized for several days, developed a UTI due to E. coli, and was placed on antibiotics and IV fluids. She has a follow up with a specialist to make sure her kidneys were not damaged.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Mean cell haemoglobin decreased, Mean cell volume normal, Mean platelet volume normal, Monocyte count increased, Monocyte percentage increased
Clinical narrative: Patient developed a fever up to 105.0 over the course of 48 hours.  Had severe diarrhea, and became listless, not eating well, crying inconsolably.  She was hospitalized for several days, developed a UTI due to E. coli, and was placed on antibiotics and IV fluids. She has a follow up with a specialist to make sure her kidneys were not damaged.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutrophil count decreased, Neutrophil percentage decreased, Neutrophil toxic granulation present, Platelet count normal, Platelet morphology abnormal
Clinical narrative: Patient developed a fever up to 105.0 over the course of 48 hours.  Had severe diarrhea, and became listless, not eating well, crying inconsolably.  She was hospitalized for several days, developed a UTI due to E. coli, and was placed on antibiotics and IV fluids. She has a follow up with a specialist to make sure her kidneys were not damaged.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Red blood cell count decreased, Red blood cell nucleated morphology present, Red blood cell schistocytes present, Red cell distribution width normal
Clinical narrative: Patient developed a fever up to 105.0 over the course of 48 hours.  Had severe diarrhea, and became listless, not eating well, crying inconsolably.  She was hospitalized for several days, developed a UTI due to E. coli, and was placed on antibiotics and IV fluids. She has a follow up with a specialist to make sure her kidneys were not damaged.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urinary tract infection, White blood cell count normal
Clinical narrative: Patient developed a fever up to 105.0 over the course of 48 hours.  Had severe diarrhea, and became listless, not eating well, crying inconsolably.  She was hospitalized for several days, developed a UTI due to E. coli, and was placed on antibiotics and IV fluids. She has a follow up with a specialist to make sure her kidneys were not damaged.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule
Clinical narrative: Nodule (round) lateral neck same side of vaccine. Didn't notice it before receiving the vaccine.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Joint dislocation, Myalgia
Clinical narrative: Began as muscle soreness in right upper arm, limited mobility, constant sharp pain in upper shoulder, feels like shoulder is dislocated.
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Chest X-ray, Chest pain, Dizziness, Electrocardiogram, Laboratory test
Clinical narrative: Dizziness/lightheadedness; chest pain; tingling of throat and tongue.
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Dizziness/lightheadedness; chest pain; tingling of throat and tongue.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient states arm was red and warm to touch at injection site. Per pharmacist's advice she took 25 mg Benadryl 2 hours after presenting to pharmacy. Benadryl helped the redness temporarily but arm was increasingly warm, itchy, and was developing a firm lump the next morning. Denies any systemic symptoms (fever, facial swelling, dyspnea). I advised her at that time to see her PCP, as she likely has a mild case of cellulitis. Advised patient to follow up with us so we know her status.
Age: 83.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: PT SAYS ARM ITCH AND RED AND SWOLLEN.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain to back of left upper arm where varicella vaccine was given 10/5/15. She finished classes and got home around 12:30 and noted in mirror area to back of left upper arm was warm, red (tennis ball size) and swollen. No other symptoms.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Dyspnoea, Electrocardiogram, Hypertension, Hypoaesthesia
Clinical narrative: Numbness of left arm and left side of face, shortness of breath, tachycardia, hypertensive. Patient presented to EC at 1300. Meds given include ASA, NTG, Ativan. Patient discharged from EC at 1625.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Tachycardia
Clinical narrative: Numbness of left arm and left side of face, shortness of breath, tachycardia, hypertensive. Patient presented to EC at 1300. Meds given include ASA, NTG, Ativan. Patient discharged from EC at 1625.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Metallic taste within 30 minutes of receiving flu vaccine which resolved approximately 12 hours after onset.  No treatment required.
Age: 20.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Erythema, Pruritus, Rash pruritic, Swelling
Clinical narrative: Erythema, pruritis above injection site and swelling.
Age: 1.03
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Child developed hives about 3 hours after receiving the Flu vaccine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Tenderness
Clinical narrative: Right underarm felt swollen and tender.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Myalgia, Neck pain, Pain in jaw
Clinical narrative: Severe headache. Jaw pain. Neck pain muscles in head pain all right right vision.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Grip strength decreased, Hypoaesthesia, Paraesthesia, Skin swelling
Clinical narrative: Approximately 25 min after receiving the vaccine in the Right Deltoid, numbness and tingling to the right hand. Unable to grip to hold onto a glass of water.  Feels as if the skin is swollen.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Glossodynia, Pruritus, Rash, Rash macular, Swollen tongue
Clinical narrative: 3:00 PM Rash and blotchiness on chest with itchiness. Patient tongue feeling hot. 3:15 PM Patient tongue started swelling - 25 mg diphenhydramine given IM and sent to ER. Received 0.3 mg epinephrine IM in ER.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Headache, Hyperhidrosis, Injection site erythema, Injection site rash
Clinical narrative: Redness and blotchy spots at site of injection. Hives, and blotchy spots on the neck area. Looking flushed, and sweaty. Complaint of intense itching. Headache.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: Redness and blotchy spots at site of injection. Hives, and blotchy spots on the neck area. Looking flushed, and sweaty. Complaint of intense itching. Headache.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Impaired work ability, Injection site induration, Injection site mass
Clinical narrative: Patient reported of chills, Headaches, sorethroat, pain on left deltoid, swollen with harden lump; no redness, no throbbing. Patient stated to call in sick, missed 1 day of work.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Oropharyngeal pain
Clinical narrative: Patient reported of chills, Headaches, sorethroat, pain on left deltoid, swollen with harden lump; no redness, no throbbing. Patient stated to call in sick, missed 1 day of work.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Musculoskeletal pain
Clinical narrative: Shoulder pain with rotation becoming more severe as the night goes on.  Discussed with Ortho: recommends NSAIDS and ice.  Next day started Medrol dose pack to minimize shoulder inflammation and further injury.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Fatigue, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms: chills, fever, aches, fatigue, nausea, loss of appetite.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Flu like symptoms: chills, fever, aches, fatigue, nausea, loss of appetite.
Age: 45.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Feeling abnormal, Malaise, Vertigo
Clinical narrative: Dizziness, vertigo, and foggy head.  I was grocery shopping when I felt dizzy looking for items in the store.  I felt sick and had to return to the car and drive home. The symptoms continue days later.
Age: 1.8
Sex: M
Vaccine: FLU3
Symptoms: Breath holding, Crying, Cyanosis, Oxygen saturation normal
Clinical narrative: Upon giving FLUZONE vacc pt. began holding his breath, mom and myself tried triggering him to breathe. Pt began breathing and crying, then performed finger stick to check HgB, pt began holding breath again. Pt began turning blue, called out for help for either Dr or nurse practitioner, 911 was called, and pt was taken from office to ER via ambulance at 12:30pm.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Groin pain, Headache, Pain in extremity
Clinical narrative: Patient called stating after vaccination her arm hurt, right leg around knee hurts too. She stated a can was needed to get around. Furthermore, head, groin, lower back also hurts. No swelling at injection site.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Injection site of ZOSTAVAX given in the back of the left arm SQ is very red, warm and there is a hard lump (feels 100% fine other than her arm).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pain, Pain in extremity, Palpitations
Clinical narrative: Heart racing; body aches/chills; nauseated; sore arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperaesthesia, Pain
Clinical narrative: Soreness/sensitivity overnight after receiving vaccine.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Cellulitis like reaction around the injection site, fever.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Peripheral swelling, Pyrexia
Clinical narrative: Pt's thigh swelled up after flu shot (tennis ball). Site was warm, red, tender x24 hours. Ice and topical antihistamine were applied. Low grade fever x24 hours. Resolved.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Dizzy and headache immediately after immunization. Lasted for several hours.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Electrocardiogram, Heart rate decreased, Hyperhidrosis, Hypotension
Clinical narrative: Patient came in for 4 month f/u appt. Pt given flu vaccine at 09:30am during this appt. Pt kept in exam room for 15 min following vaccination to monitor for possible reaction. Pt went back to lab for bloodwork and started c/o red bumps on both lower forearms. Dr. observed and prescribed 125mg SOLU-MEDROL and 25mg BENADRYL. Immediately given in left deltoid. Pt became pale and diaphoretic. Blood sugar taken, was normal. Pt taken to exam room. Vitals and EKG obtained. 2L O2 administered via nasal cannula. BP and pulse low. 1mg epinephrine given. IV started with normal saline. EMS called. Pt's BP and pulse still no improvement. Another 1mg of epinephrine given. EMS arrived and patient transported to hospital.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pallor, Rash, Rash erythematous
Clinical narrative: Patient came in for 4 month f/u appt. Pt given flu vaccine at 09:30am during this appt. Pt kept in exam room for 15 min following vaccination to monitor for possible reaction. Pt went back to lab for bloodwork and started c/o red bumps on both lower forearms. Dr. observed and prescribed 125mg SOLU-MEDROL and 25mg BENADRYL. Immediately given in left deltoid. Pt became pale and diaphoretic. Blood sugar taken, was normal. Pt taken to exam room. Vitals and EKG obtained. 2L O2 administered via nasal cannula. BP and pulse low. 1mg epinephrine given. IV started with normal saline. EMS called. Pt's BP and pulse still no improvement. Another 1mg of epinephrine given. EMS arrived and patient transported to hospital.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Blood pressure decreased, Electrocardiogram, Heart rate decreased, Hyperhidrosis
Clinical narrative: Patient came in for 4 month f/u appt. Pt given flu vaccine at 09:30am during this appt. Pt kept in exam room for 15 min following vaccination to monitor for possible reaction. Pt went back to lab for bloodwork and started c/o red bumps on both lower forearms. Dr. observed and prescribed 125mg SOLU-MEDROL and 25mg BENADRYL. Immediately given in left deltoid. Pt became pale and diaphoretic. Blood sugar taken, was normal. Pt taken to exam room. Vitals and EKG obtained. 2L O2 administered via nasal cannula. BP and pulse low. 1mg epinephrine given. IV started with normal saline. EMS called. Pt's BP and pulse still no improvement. Another 1mg of epinephrine given. EMS arrived and patient transported to hospital.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypotension, Pallor, Rash, Rash erythematous
Clinical narrative: Patient came in for 4 month f/u appt. Pt given flu vaccine at 09:30am during this appt. Pt kept in exam room for 15 min following vaccination to monitor for possible reaction. Pt went back to lab for bloodwork and started c/o red bumps on both lower forearms. Dr. observed and prescribed 125mg SOLU-MEDROL and 25mg BENADRYL. Immediately given in left deltoid. Pt became pale and diaphoretic. Blood sugar taken, was normal. Pt taken to exam room. Vitals and EKG obtained. 2L O2 administered via nasal cannula. BP and pulse low. 1mg epinephrine given. IV started with normal saline. EMS called. Pt's BP and pulse still no improvement. Another 1mg of epinephrine given. EMS arrived and patient transported to hospital.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Impaired work ability, Malaise, Pain in extremity
Clinical narrative: Patient called into work feeling ill, achy arm and mild temperature day after shot given.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacy student and refers to a 66 year old male patient. The patient's medical history included chickenpox as a child. It was reported that the patient had no drug reactions/allergies. No information regarding the patient's concomitant therapies was provided. On 17-SEP-2015, the patient was vaccinated at the pharmacy with ZOSTAVAX (lot # L016283, expiration date and dose were not provided), subcutaneously, for shingles. In approximately September 2015 (exact date not provided), the patient developed shingles on his lower back. On 29-SEP-2015, he presented at the pharmacy with a prescription for famciclovir. No PQC (product quality complaint) was involved. The outcome of shingles was reported as not recovered. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 66 year old male patient who was reporting on himself. On 24-SEP-2015 the patient was vaccinated with ZOSTAVAX subcutaneous (dose and lot# were not provided). On 28-SEP-2015, the patient noticed what appeared to be shingles. On 29-SEP-2015, he went to his primary care provider who confirmed shingles diagnosis. The patient was treated with famciclovir 500 mg 1 tablet 3 times per day. The outcome of shingles was reported as recovering. Causality assessment was not provided. Additional information is not expected as patient did not wish to be contacted and did not provide physician's contact details.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Eye swelling, Eyelid rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old male patient. Pertinent medical history was none. There was no history of drug allergies or reactions. On 02-OCT-2015 (today), the patient was vaccinated with PROQUAD (Merck) 0.5 ml, once subcutaneous lot # L014401 with expiry date of 23-OCT-2016. Concomitant medications were none. On 02-OCT-2015, an unspecified time after the patient received PROQUAD (Merck), the patient's eyes were swollen shut and he had a rash around both eyes. The patient's mother sought medical attention and called into the facility. No lab diagnostic procedures were performed. No treatment was received in response to the events. The outcome of the events was reported as not resolved. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Eyelid oedema, Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old male patient. Pertinent medical history was none. There was no history of drug allergies or reactions. On 02-OCT-2015 (today), the patient was vaccinated with PROQUAD (Merck) 0.5 ml, once subcutaneous lot # L014401 with expiry date of 23-OCT-2016. Concomitant medications were none. On 02-OCT-2015, an unspecified time after the patient received PROQUAD (Merck), the patient's eyes were swollen shut and he had a rash around both eyes. The patient's mother sought medical attention and called into the facility. No lab diagnostic procedures were performed. No treatment was received in response to the events. The outcome of the events was reported as not resolved. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 68 year old female patient. No concurrent conditions or medical history were reported. On 22-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot No., dose, route and anatomical location of administration were not reported). On the same day, the patient was also vaccinated with unspecified flu vaccination (manufacturer unknown). On 23-SEP-2015, following the administration of PNEUMOVAX 23, the patient developed pain, swelling, redness and blister at the injection site. The patient seek medical attention contacting the pharmacist. As treatment for the adverse events was prescribed MOTRIN and TYLENOL. No Product Quality Complaint (PQC) was involved. The outcome of injection site vesicles, injection site erythema, injection site swelling and injection site pain was reported as not recovered. Additional information is not expected as the reporter did not wish further contact.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 68 year old female patient. No concurrent conditions or medical history were reported. On 22-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot No., dose, route and anatomical location of administration were not reported). On the same day, the patient was also vaccinated with unspecified flu vaccination (manufacturer unknown). On 23-SEP-2015, following the administration of PNEUMOVAX 23, the patient developed pain, swelling, redness and blister at the injection site. The patient seek medical attention contacting the pharmacist. As treatment for the adverse events was prescribed MOTRIN and TYLENOL. No Product Quality Complaint (PQC) was involved. The outcome of injection site vesicles, injection site erythema, injection site swelling and injection site pain was reported as not recovered. Additional information is not expected as the reporter did not wish further contact.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling
Clinical narrative: Swollen at site within 1-2 hours after receiving vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Pt experienced redness and swelling went to urgent care. Received an oral steroid.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients might have been vaccinated with improperly stored doses of GARDASIL (lot # K011562 with expired date 08-APR-2017; dose and route were unknown). No concomitant medications were provided. No adverse effects were reported. This was one of two reports received from the same reporter (1510USA002079). Additional information has been requested.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients might have been vaccinated with improperly stored doses of GARDASIL (lot # K011562 with expired date 08-APR-2017; dose and route were unknown). No concomitant medications were provided. No adverse effects were reported. This was one of two reports received from the same reporter (1510USA002079). Additional information has been requested.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients might have been vaccinated with improperly stored doses of ROTATEQ (lot # K023537 with expired date 22-JUN-2016; dose and route were unknown). No concomitant medications were provided. No adverse effects were reported. This was one of two reports received from the same reporter (1510USA001923). Additional information has been requested.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients might have been vaccinated with improperly stored doses of ROTATEQ (lot # K023537 with expired date 22-JUN-2016; dose and route were unknown). No concomitant medications were provided. No adverse effects were reported. This was one of two reports received from the same reporter (1510USA001923). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse and a healthcare worker referring to unspecified patients of unknown age and gender. In June 2015 (also reported as since 15-JUN-2015), the patients were vaccinated with doses of GARDASIL (lot # K006960, expiration date: 19-FEB-2017, dose and route were unknown) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse and a healthcare worker referring to unspecified patients of unknown age and gender. In June 2015 (also reported as since 15-JUN-2015), the patients were vaccinated with doses of RECOMBIVAX HB (lot # K010535, expiration date: 27-AUG-2016, dose and route were unknown) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. The healthcare worker reported that doses of GARDASIL (lot # K006124, expiry date 02-FEB-2017 and lot # K011325, expiry date 08-APR-2017) (dosage, strength and route were not reported), which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 15-SEP-2015. At the time of the report, no adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients (age and gender of the patients were not reported). The patient's concurrent conditions, medical history and concomitant medications were not reported. Starting on 08-JUN-2015, an unspecified number of improperly stored doses of GARDASIL (Lot number K006960 and expiry date 19-FEB-2017, Lot number K006191 and expiry date 02-FEB-2017) were inadvertently administered to an unspecified number of patients (strength, dose and frequency were not reported). No adverse experiences have been reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Respiratory tract infection
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown demographics. Information regarding medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (unspecified dose, Lot number and expiry date). Other co-suspects had concomitant medication were not reported. On an unknown date, the patient developed a respiratory infection. No product quality complaint was reported. The outcome of respiratory tract infection was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Lyme disease
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date, dose and route not reported). On an unknown date the patient experienced Lyme's disease after receiving GARDASIL. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Flatulence, Irritability
Clinical narrative: Information has been received from a physician and a registered nurse referring to a male patient of unknown age. The patient was allergic to dairy and soy. On 31-JUL-2015 the patient was vaccinated with the first dose of ROTATEQ (lot # L000569 with unspecified expiration date; strength, dosage and frequency unspecified) orally. The patient also received PEDVAXHIB, PEDIARIX and PREVNAR (strength, dosage, frequency and route of all the vaccine were unspecified) during the same appointment that the first dose of all the vaccine. On an unspecified date in 2015 the patient became irritable and gassy. The patient did not seek medical attention and no treatment was given for the events. No further doses of ROTATEQ had been administered. The outcome of the events was reported as recovered/resolved on an unspecified date in 2015. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. It was reported that, on an unknown date, the patient received an expired dose of PNEUMOVAX 23 (lot, dose and expiration date unspecified). No concomitant therapy was reported. No adverse events were reported. No product quality complaint (PQC) was filed. The outcome of the event was unknown. The reporter considered the events to be not related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. The healthcare worker reported dose of oral, ROTATEQ (lot # K005394, expiry date 23-FEB-2016), which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 15-SEP-2015. No adverse effect has been requested. This is one of several reports received from the same reporter. Addiitonal information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 24 year old female patient. No pertinent medical history conditions were reported. On 11-AUG-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # L008271, expiration date 11-MAR-2017, strength, dose and route unknown). There was no concomitant medication reported. After vaccination, the patient immediately experienced left arm swelling and redness from the injection site to her elbow. The patient did not seek medical attention and no lab test was performed to the patient. The reaction lasted about 2-3 weeks. Causality between the events and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # K007980, expiry date: 03-JUN-2016 and lot# L003777, expiry date of 04-FEB-2017). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # K014799, expiry date: 12-MAR-2016 and lot L010142, expiry date: 24-SEP-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored VAQTA (lot# L013380 with an expiry date of 04-NOV-2017 and lot K005958 with an expiry date of 09-FEB-2017). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with of improperly stored RECOMBIVAX HB (lot# L016959 with an expiry date of 12-MAR-2018 and lot K018334 with an expiry date of 09-JUN-2016). No adverse effects were reported. Additional information has been requested.