chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area around injection site became red within 30 minutes. As time progressed it became swollen, hot and the redness continued toward the elbow. On Friday she used oral benadryl and motrin. She applied topical benadryl and hydrocortisone 1% cream. By Saturday there was some improvement. As of 10/11/12 she still has a little pinkness to the area.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Angiogram retina, C-reactive protein increased, Dizziness, Erythema, Musculoskeletal stiffness
Clinical narrative: Awakened with fever of 100.2 (not small, considering I'm usually running a 97.0 body temp). Dizziness. Half baseball size lump on right arm, very red, swollen, painful, achy, stiff. Had this for two whole days and nights. Caused me to have a small infarction of the retina, raising my C Reactive Protein Levels to 4.5 and raising my white blood count.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Retinal exudates, Retinal infarction
Clinical narrative: Awakened with fever of 100.2 (not small, considering I'm usually running a 97.0 body temp). Dizziness. Half baseball size lump on right arm, very red, swollen, painful, achy, stiff. Had this for two whole days and nights. Caused me to have a small infarction of the retina, raising my C Reactive Protein Levels to 4.5 and raising my white blood count.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Retinogram abnormal, Upper extremity mass, White blood cell count increased
Clinical narrative: Awakened with fever of 100.2 (not small, considering I'm usually running a 97.0 body temp). Dizziness. Half baseball size lump on right arm, very red, swollen, painful, achy, stiff. Had this for two whole days and nights. Caused me to have a small infarction of the retina, raising my C Reactive Protein Levels to 4.5 and raising my white blood count.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Injection site rash, Pruritus, Skin warm
Clinical narrative: He was noticed to have been itching his arm, checked it Monday night around 6:30, it was red, warm to the touch and had raised bumps that extended from just at the site of injection and down approximately 4 inches and was about 2 inches across. Gave Benadryl orally, continued to monitor. The next day it was still red, bumpy, warm to the touch and itchy. This continued, took him into the doctors office Thursday evening when it was observed to be hard under the injection site in addition to the other continued symptoms. Topical Benadryl continues to be applied.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Injection site pain, Nausea, Neck pain
Clinical narrative: Serious pain from injection site shooting up through shoulder and up neck toward ear. Strong pain - I get the flu shot each year and have never had this before. Some nausea and weakness. Had to lie down for a while to get control over pain. Still hurts on neck area bad.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal pain, Pain, Pyrexia, Rash
Clinical narrative: Pt. states that her shoulder hurt, she had a fever, and pain level was 9. She said she developed a rash and the area was hot and bright red.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Pt. states that her shoulder hurt, she had a fever, and pain level was 9. She said she developed a rash and the area was hot and bright red.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: A few hours following vaccination, my left deltoid around the vaccine site was mildly painful. Generalized pain in the left arm became gradually more painful over the next 24 hours leading to severe pain on any movement, especially with lateral arm movements and when laying on the affected side. The severe pain ended after about 72 hours and changed to a more nerve-like sharp pain on lateral lifting and is gradually dissipating. I have noticed this pain following annual flu vaccines is increasing slightly each year.
Age: 13.0
Sex: F
Vaccine: DTAPH, VARCEL, VARCEL
Symptoms: Activities of daily living impaired, Injection site discomfort, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Fever, large welt (approx. 5 inches by 3 inches) the site of shot was hot and getting larger. Also blisters formed. 2 forms of antibiotics were given. ER visit and 2 trips to the Dr. Patient missed 2 days of school.
Age: 13.0
Sex: F
Vaccine: DTAPH, VARCEL, VARCEL
Symptoms: Injection site vesicles, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Fever, large welt (approx. 5 inches by 3 inches) the site of shot was hot and getting larger. Also blisters formed. 2 forms of antibiotics were given. ER visit and 2 trips to the Dr. Patient missed 2 days of school.
Age: 13.0
Sex: F
Vaccine: DTAPH, VARCEL, VARCEL
Symptoms: Dizziness, Induration, Injection site urticaria, Nausea, Pyrexia
Clinical narrative: Fever, large welt (approx. 5 inches by 3 inches) the site of shot was hot and getting larger. Also blisters formed. 2 forms of antibiotics were given. ER visit and 2 trips to the Dr. Patient missed 2 days of school.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Inflammation, Influenza like illness, Pruritus
Clinical narrative: Flu like symptoms, headache, tired. This lasted two days, the after five days I developed a rash on my ankle.  Weeping, itchy, inflamed.  The rash spread to my torso, chest, back, lower legs and then upper legs.    Heat would cause the symptoms to increase.  Called physician six days after vaccine. He prescribed prednisone and zertex.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Secretion discharge
Clinical narrative: Flu like symptoms, headache, tired. This lasted two days, the after five days I developed a rash on my ankle.  Weeping, itchy, inflamed.  The rash spread to my torso, chest, back, lower legs and then upper legs.    Heat would cause the symptoms to increase.  Called physician six days after vaccine. He prescribed prednisone and zertex.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Pruritus, Rash
Clinical narrative: Rash appeared in groin area; spread over 36 hours down right thigh to knee; itching; pain; round blistery rash.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: I received my first Gardasil vaccine today. Within a few minutes, I felt a "rush" in my head, as though all the blood was draining from it.  Everything started to become blurry, then black dots, then just black when I became dizzy. I felt like I was going to faint. It was a very scary situation that caused me to panic. I became very hot and sweaty following the injection. I was told I was "pale as a ghost". The nurse got me a glass of water and put a cold compress behind my neck. I put my head down and tried deep-breathing techniques. I laid down on an examination table for a few minutes. I felt recovered within 15 minutes, but feel very traumatized over what happened. I do not at all look forward to my next vaccine of Gardasil. I was not told about the possibility of fainting or feeling as though I would faint before the vaccine was administered.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Panic reaction, Vision blurred, Visual impairment
Clinical narrative: I received my first Gardasil vaccine today. Within a few minutes, I felt a "rush" in my head, as though all the blood was draining from it.  Everything started to become blurry, then black dots, then just black when I became dizzy. I felt like I was going to faint. It was a very scary situation that caused me to panic. I became very hot and sweaty following the injection. I was told I was "pale as a ghost". The nurse got me a glass of water and put a cold compress behind my neck. I put my head down and tried deep-breathing techniques. I laid down on an examination table for a few minutes. I felt recovered within 15 minutes, but feel very traumatized over what happened. I do not at all look forward to my next vaccine of Gardasil. I was not told about the possibility of fainting or feeling as though I would faint before the vaccine was administered.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Mobility decreased, Sensory loss
Clinical narrative: Described loss of sensation in her lower arm and inability to move her fingers or grasp her right hand.
Age: 1.27
Sex: M
Vaccine: DTIPV, HIBV, MMR
Symptoms: Blood test, Convulsion, Electroencephalogram, Hypotonia, Lumbar puncture
Clinical narrative: Woke up to my son having a seizure in the middle of the night 4 days after he had some vaccines. I believe it was a reaction to the MMR shot. I called 911 because I didn't know what was wrong with him at the time. He was just limp and unresponsive. He was taken to Hospital, then transferred to another Hospital. While there, he had another seizure due to his high fever. His pediatrician then transferred him to a third hospital. His fever was so high, even the hospitals couldn't get it to always break. While in the third hospital, they ran several tests while constantly alternating giving him childrens Tylenol and ibuprofen every 2 hours. They never found a "cause" for his fever so said it was probably a virus. When his fever finally broke 5 days after the seizures began, he broke out with a rash all over his body, mainly his back, stomach and areas on his neck. After doing research and having a nurse look at the rash, we believe it looked like the measles.
Age: 1.27
Sex: M
Vaccine: DTIPV, HIBV, MMR
Symptoms: Pyrexia, Rash generalised, Rash morbilliform, Unresponsive to stimuli, Viral infection
Clinical narrative: Woke up to my son having a seizure in the middle of the night 4 days after he had some vaccines. I believe it was a reaction to the MMR shot. I called 911 because I didn't know what was wrong with him at the time. He was just limp and unresponsive. He was taken to Hospital, then transferred to another Hospital. While there, he had another seizure due to his high fever. His pediatrician then transferred him to a third hospital. His fever was so high, even the hospitals couldn't get it to always break. While in the third hospital, they ran several tests while constantly alternating giving him childrens Tylenol and ibuprofen every 2 hours. They never found a "cause" for his fever so said it was probably a virus. When his fever finally broke 5 days after the seizures began, he broke out with a rash all over his body, mainly his back, stomach and areas on his neck. After doing research and having a nurse look at the rash, we believe it looked like the measles.
Age: 1.27
Sex: M
Vaccine: DTIPV, HIBV, MMR
Symptoms: X-ray
Clinical narrative: Woke up to my son having a seizure in the middle of the night 4 days after he had some vaccines. I believe it was a reaction to the MMR shot. I called 911 because I didn't know what was wrong with him at the time. He was just limp and unresponsive. He was taken to Hospital, then transferred to another Hospital. While there, he had another seizure due to his high fever. His pediatrician then transferred him to a third hospital. His fever was so high, even the hospitals couldn't get it to always break. While in the third hospital, they ran several tests while constantly alternating giving him childrens Tylenol and ibuprofen every 2 hours. They never found a "cause" for his fever so said it was probably a virus. When his fever finally broke 5 days after the seizures began, he broke out with a rash all over his body, mainly his back, stomach and areas on his neck. After doing research and having a nurse look at the rash, we believe it looked like the measles.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dyspnoea, Erythema, Injection site rash, Palpitations
Clinical narrative: Started evening of 10/8/12 - she began itching, fever & chills, rash on upper arms & leg. Went to (medical walk-in) given an injection of DECADRON, ZANTAC 150 mg. po BID x 5 days & Methylprednisolone 4 mg. po dosepak.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Started evening of 10/8/12 - she began itching, fever & chills, rash on upper arms & leg. Went to (medical walk-in) given an injection of DECADRON, ZANTAC 150 mg. po BID x 5 days & Methylprednisolone 4 mg. po dosepak.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Pain in jaw, Swelling face
Clinical narrative: Patient had bilateral symmetric facial swelling in the area of parotid gland. Has pain with opening jaw due to tightness from swelling. Onset of symptoms occurred over 1 hour. She denies dysphagia, shortness of breath, and nausea, vomiting, diarrhea. Treated with cetirizine 10 mg, Famotidine 20 mg IV x 2, diphenhydramine 25 mg IV, & dexamethasone IV.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Dizziness, Eye colour change, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Patient experienced sweating, lightheadedness, nausea, vomiting, diarrhea, fever and numbness throughout his body. Patient also noticed his eyes were white without the normal coloring. Patient also had a site-reaction of swelling, and redness to his left arm.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient experienced sweating, lightheadedness, nausea, vomiting, diarrhea, fever and numbness throughout his body. Patient also noticed his eyes were white without the normal coloring. Patient also had a site-reaction of swelling, and redness to his left arm.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Head injury, Loss of consciousness, Mastication disorder, Nausea
Clinical narrative: Information has been received from a consumer regarding her daughter with no reported concomitant medications or medical conditions who in early February 2012 received her first dose of GARDASIL and the patient was "perfectly fine". On 24-SEP-2012 the patient received her second dose of GARDASIL. After the vaccine had been administered, the patient stood up and while waiting in line to pay for the vaccine, the patient passed on on the receptionist's laminate floor. The patient hit her jaw and she had a knot on her forehead. On 25-SEP-2012 the patient was lying in bed and she felt dizzy and very nauseous. It was very hard for the patient to chew her food. The patient received unspecified treatment. At the time of reporting, there was no additional information provided and the patient was recovering. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Nodule, Skeletal injury
Clinical narrative: Information has been received from a consumer regarding her daughter with no reported concomitant medications or medical conditions who in early February 2012 received her first dose of GARDASIL and the patient was "perfectly fine". On 24-SEP-2012 the patient received her second dose of GARDASIL. After the vaccine had been administered, the patient stood up and while waiting in line to pay for the vaccine, the patient passed on on the receptionist's laminate floor. The patient hit her jaw and she had a knot on her forehead. On 25-SEP-2012 the patient was lying in bed and she felt dizzy and very nauseous. It was very hard for the patient to chew her food. The patient received unspecified treatment. At the time of reporting, there was no additional information provided and the patient was recovering. Additional information is not expected.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a medical assistant to a female patient of unknown age. The patient was vaccinated with PNEUMOVAX 23 and influenza virus vaccine (manufacturer unknown) (lot number, dose, route and injection site were not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced allergic reactions to pneumonia and influenza vaccines brand names and manufacturers unspecified. Medical assistant reported that the patient described the reaction to the unspecified pneumonia vaccine as "quite severe." The outcome of was unknown at the time of report. It was unspecified if the patient seek medical attention. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Nausea, Pruritus, Sensation of foreign body
Clinical narrative: Itching, headache, nausea, lump in throat feeling. Treatment 80mg DEPOMEDROL IM, PHENERGAN 25mg IM, BENADRYL 50mg PO, TYLENOL 1000mg PO.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) arm has multi raised red areas appox 3cm x 3cm on upper arm from site of injection to elbow pt states "painful" started appox. 1 hour after injection continued at visit today 10/10/12.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Syncope
Clinical narrative: Pt. received PNEUMOVAX 10/8/12 - and on 10/9 had orthostatic rxn seen 10/10/12; 10/11/12 presented with 11' x 12" erythematous indurated area (L) up. lat. arm.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Feeling hot, Headache, Musculoskeletal stiffness
Clinical narrative: I received the flu vaccine at 6 PM on 10/9/12. I woke up at 12 AM (6 hours later), with uncontrollable shivering, fever, chills, hot spells, vomiting, terrible headache that all lasted thru the next day. I experienced fatigue & muscle aches, and stiffness in my neck.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: I received the flu vaccine at 6 PM on 10/9/12. I woke up at 12 AM (6 hours later), with uncontrollable shivering, fever, chills, hot spells, vomiting, terrible headache that all lasted thru the next day. I experienced fatigue & muscle aches, and stiffness in my neck.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Convulsion
Clinical narrative: Seizure.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Patient developed what appears to be localized untreated rash with some mild induration about 12 days after vaccines. Exactly around injection site.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Nervousness, Presyncope, Syncope
Clinical narrative: Upon injection, had a vagal response and a syncopal event during which time she had tonic movements and postured upper arms. Within 30 seconds of lying down, she regained consciousness and had good color. Shaky but returned to normal state with water and carbohydrates.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Large sore area on upper arm where shot was injected. Lasted 1 week.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Computerised tomogram normal, Convulsion
Clinical narrative: Per grandmother, pt had a seizure in the back seat of car 2 1/2 hours after flu shot & Hep A shot given. No fever.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Blood electrolytes normal, Diarrhoea, Fatigue, Full blood count normal, Haematemesis
Clinical narrative: Fatigue, aching, vomiting blood, diarrhea beginning one day post vaccination.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: International normalised ratio normal, Liver function test normal, Pain
Clinical narrative: Fatigue, aching, vomiting blood, diarrhea beginning one day post vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Full blood count normal, Headache
Clinical narrative: Headache began at 2 pm on 10/9/12. Was unrelieved with rest and aspirin. Headache became progressively worse, so pt went to the ER. Was given DILAUDID injection which relieved the HA.
Sex: F
Vaccine: FLU3
Symptoms: Infection
Clinical narrative: Infection in muscle.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Reaction to preservatives
Clinical narrative: Patient felt redness/swelling at the injection site and mild shortness of breath. These symptoms happened within several hours of the injection. The patient had an unknown allergy to thimerisol.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haematoma, Myalgia, X-ray limb
Clinical narrative: Muscle pain in arm injection was given (left arm). Bruising starting below injection area and extending to inner arm to the elbow.
Age: 41.0
Sex: U
Vaccine: FLU3
Symptoms: Generalised erythema, Pruritus generalised
Clinical narrative: Itching & redness all over.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria, Vaccination complication
Clinical narrative: Rec'd FLUZONE vaccine 10-10-12 at 1345 - adm left deltoid IM. Tol. well & left health dept upon receipt of vaccine. Pt. called health dept at approx 1545, c/o itching & hives. She was concerned about adverse reaction to flu vaccine. Advised to seek medical attention immediately. Stated she has had allergic reaction to bee stings.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Throat tightness, Urticaria
Clinical narrative: Flush face, hives all over body-itching. Unable to breathe, throat closing up sent to hospital ER 911.
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Pruritus, Rash erythematous
Clinical narrative: Lightheaded, red rash around neck and arms, itching.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Cheeks red & chest with rash.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Fatigue
Clinical narrative: Dizziness, upset stomach, tired.
Age: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Feeling hot, Flushing, Headache
Clinical narrative: Flushed face. Feeling hot. General feeling of exhaustion. Headache. All s/s gone by 6 p.m.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Nausea, PO2 decreased
Clinical narrative: 3:45 pm T 97.8 P-86 R-12 PO2 92-96% BP 139/99. C/O intermittent nausea, dizziness, shortness of breath. PO2 drops to 85% for 5-10 sec then returns to 98-100% c/o nausea, dizziness, shortness of breath when PO2 decreases to 90%. Transported to Emergency Room by ambulance at 5:15 pm.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Body temperature increased
Clinical narrative: Temperature of 101.8.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Rash papular
Clinical narrative: Vaccine given 8/17, noticed 4 days later, (R) arm swollen, warm, tender to touch, firm. No fever no chills raised papular rash noted, skin intact.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Possible rxn to tdap vaccine. Developed swelling, redness, severe itchiness to (L) upper arm where vaccine was administered. Site is also very warm to touch.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Developed chills, body aches, site swelling, redness, & pain the nov after receiving TDAP. AVONEX taken 8/16/12 - feeling better.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Flank pain, Herpes zoster, Hyperaesthesia, Varicella virus test
Clinical narrative: Flu vaccine 9-25-12. (L) flank pain & hyperesthesia 9-26-12. Hx & exam c/w zoster.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Dyspnoea, Pain, Swelling
Clinical narrative: 1 hr after vaccine noticed pain and swelling. Overnight temp 101. Felt SOB but responded to inhaler.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Seen in office 10/1/12 vomiting & diarrhea illness within 48 hours of receiving FLUMIST vaccine.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 4-5 inch area of redness & swelling going down left arm. Using ice pack on & off TYLENOL & MOTRIN PRN.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Patient experienced dizziness, shortness of breath, and a rapid heartbeat within 5 minutes of receiving the flu shot. Patient was taken to the emergency room where she was monitored for about 1 hour and then released.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: Pt called 10-10-12. Said he had a shingles shot on 10-8-12 and had a swollen place on back of his arm the size of a lemon. No pain or itching at site. Recommended him call MD & to take BENADRYL & ice the site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, redness, itchy and warm to the touch, 2 days after vaccination. Treated in ER. DECADRON 8mg P.O. dose. KEFLEX 7.5 ml every 8 hours x 5 days.
Age: 34.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injection site pain
Clinical narrative: 8-27-12: Received call from Cl. c/o's pain/soreness in LD area. Advised Cl to use cool packs to area & massage area. If no improvement call Dr - voices understanding. 10-4-12: Cl calls office & c/o's soreness in LD area - stated she had called her Dr. & he said maybe a nerve had been hit. Required no Tx.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 15 x 7 cm area of warmth and redness on left shoulder at site of recent flu shot. Close observation, patient instructed to call if sxs worsen, or do not resolve in few days.
Sex: U
Vaccine: FLU3
Symptoms: Injection site rash, Myalgia, Pyrexia, Vomiting
Clinical narrative: Rash on arm around injection site, in the hour post site. Then fever, 100 degrees for 4 days & vomited, myalgia for 3 days.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives over torso & neck - progressed over 2 days before reported. BENADRYL 25 mg x 2 doses resolved.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Ocular hyperaemia, Wheezing
Clinical narrative: About 2 hrs after receiving flu shot at medical center, patient developed wheezing and red, itchy eyes. This lasted about 2 hrs and cleared with antihistamine (next day).
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomited one time about 1 1/2 hrs. after receiving flu vaccine. Pt stated he felt better after vomiting. Followed up with pt and he says he's fine.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Induration, Nodule
Clinical narrative: Immediately after vaccination, patient developed a hard nodule about 1" in diameter. She said it did not hurt and she had previous vaccinations without issue.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Electromyogram, Hypoaesthesia, Muscular weakness, Nerve conduction studies
Clinical narrative: 9-20-2012 low back pain, right leg pain, foot numbness, 9-22-2012 weakness both legs. Flu shot on 9-17-2012.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 9-20-2012 low back pain, right leg pain, foot numbness, 9-22-2012 weakness both legs. Flu shot on 9-17-2012.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Patient has low grade fever, aches/pains, cough and experienced severe chills/numbing of fingers/toes on 10/5/12, 10/7/12 and 10/11/12.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4 x 4 cm indurated erythematous area to injection site at (RT) outer thigh.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Oedema peripheral, Skin warm
Clinical narrative: Pt came into pharmacy at 8pm on 10/10/12, claiming she was diagnosed with cellulitis, which she stated that her doctor claimed was from the flu shot she received on 10/8/12. Pharmacist on duty on 10/10 stated that pts arm was majorly swollen & hot.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Headache, Oedema peripheral
Clinical narrative: Given Tdap, MENACTRA & HPV on 10/9/12 started with swelling of Lt arm & headache yesterday. As per mother better today.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vision blurred
Clinical narrative: Rash on arm and blurry vision blurry occurred on 10/09/12 and continued through 10/10/12.
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Eye irritation, Urticaria
Clinical narrative: (Per patient) patient broke out in hives from the shot and eyes were burning.
Age: 36.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Neck pain
Clinical narrative: Pain in right shoulder and neck starting in the evening of 10/03/2012. No pain, inflammation or redness around injection site. Pt. reported to clinic to receive medical care on 10/11/12.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pt started experiencing pain in left anterior shoulder & then difficulty raising left arm due to extreme pain; PCP prescribed hydrocodone for pain, which helped a little.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Mobility decreased
Clinical narrative: Pt started experiencing pain in left anterior shoulder & then difficulty raising left arm due to extreme pain; PCP prescribed hydrocodone for pain, which helped a little.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site rash, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Patient received FLUZONE HD on Wednesday 10/9/12 and reported hot, swollen rash local to injection on 10/11/12. He felt very ill. Pharmacist recommended TYLENOL for pain/fever/chills. Patient was advised to see a doctor.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Patient received FLUZONE HD on Wednesday 10/9/12 and reported hot, swollen rash local to injection on 10/11/12. He felt very ill. Pharmacist recommended TYLENOL for pain/fever/chills. Patient was advised to see a doctor.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. reported to pharmacy on 10/11/12 with redness and mild swelling on right arm extending from tricep to bicep.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Bilateral upper arm redness, warmth and itching at site of Varicella and MMR vaccine. Treated with warm compresses, TYLENOL and BENADRYL.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient has hives all over backside for 4 days since given vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: 1" red circle on left arm, warm to touch.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: Hot to touch, swollen and red, itchy and tender to touch.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood culture, Erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Began with painful itching and swelling 10/10 evening at injection site - (L) upper arm midway between elbow and axilla. This AM, erythema, warm to touch, swelling - (L) arm 26 cm circ. TMP - SMX DS bid x 10 days. No fever. No c/o feeling ill. Clindamycin 150 qid x 10 days.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Local swelling, Skin warm
Clinical narrative: Began with painful itching and swelling 10/10 evening at injection site - (L) upper arm midway between elbow and axilla. This AM, erythema, warm to touch, swelling - (L) arm 26 cm circ. TMP - SMX DS bid x 10 days. No fever. No c/o feeling ill. Clindamycin 150 qid x 10 days.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Oedema peripheral
Clinical narrative: Began with painful itching and swelling 10/10 evening at injection site - (L) upper arm midway between elbow and axilla. This AM, erythema, warm to touch, swelling - (L) arm 26 cm circ. TMP - SMX DS bid x 10 days. No fever. No c/o feeling ill. Clindamycin 150 qid x 10 days.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse practitioner via a company representative concerning a female who on 25-SEP-2012 received her second dose of GARDASIL (lot number not provided) accompanied by a dose of influenza vaccine (manufacturer unknown) in a separate arm. Four hours after receiving her injections, the patient became seriously ill with nausea, vomiting, fever and diarrhea. The patient went to the emergency room, she was treated and released (treatment not specified). The patient received her first dose of GARDASIL without any adverse events (date not specified). The patient has recovered. No further information has been provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot # not reported) on 10-JUL-2012, received the second dose of GARDASIL (Lot # not reported) early on 07-AUG-2012 and the third dose of GARDASIL (Lot # not reported) early on 02-OCT-2012. No symptoms were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Syncope
Clinical narrative: Information has been received from a field representative who was advised by a 15 year old female who was vaccinated with the first dose of GARDASIL on 20-SEP-2012. While on GARDASIL, the patient had fainted. On 21-SEP-2012, the patient had a severe headache. The patient sought medical attention and recovered from both events (dates not provided). No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a consumer who reported that her daughter had received 2 doses of GARDASIL and fell out of the 0, 2 and 6 months dosage periods as they forgot to return for the third vaccination. The patient was not experiencing any known symptoms. No additional information was provided. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Corneal reflex decreased, Tic
Clinical narrative: This spontaneous report as received from a physician via a company representative referring to a male patient of unknown age who on an unknown date was vaccinated with dose 1 of GARDASIL, IM (dose and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that on 04-OCT-2012 "Boy" experienced ticks and he was blinking a lot. No treatment information was reported. Therapy with GARDASIL was discontinued. The outcome of ticks and blinking a lot was unknown. The physician also stated that "don't believe so" that the patient had sought medical attention. The relatedness for ticks and blinking a lot is unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL on 24-JUL-2012 (dose, route and lot number not reported). On 24-SEP-2012, the patient received the second dose of GARDASIL (lot number 666162/0565Z, expiration date 15-SEP-2012) (dose and route not reported which was expired). No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported) on 12-SEP-2008 and the second dose of GARDASIL (Lot #, dose and route not reported) on 24-SEP-2012. No adverse effect. It was not known if the patient sought for medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient who was vaccinated IM with the three doses of GARDASIL on 07-JUN-2012, 10-AUG-2012 and 09-OCT-2012, respectively. No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 1.28
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Pruritus, Rash, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 23 months old female patient with no drug reactions/allergies, who was preemie baby born at 36 weeks. On 01-FEB-2012 the patient was vaccinated with a dose of VARIVAX (Merck) 0.5 ml subcutaneously (lot # reported as 1206AA - in validation process). Other secondary suspect therapies included: M-M-R II (lot #, route and dose not reported) given on the same date. Concomitant therapy included FLUZONE administered on the same day. The nurse reported that the patient developed chickenpox which presented with rash and itchiness on 23-SEP-2012. The patient received treatment for the events: BENADRYL, calamine lotion and AVEENO bath. The outcome of chickenpox was reported as recovering/resolving. No laboratory diagnostic studies were performed. The patient sought medical attention - contacted physician. The relatedness for chickenpox was unknown for VARIVAX (Merck) and M-M-R II. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two elderly patients. The patients had unspecified "adverse effect" after the use of PNEUMOVAX23 (Lot#, dose/frequency, route and duration were unspecified) on an unknown date. At the time of reporting the outcome of unspecified adverse effect was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The reporter reported that the patient, who was intended to receive ZOSTAVAX, was inadvertently administered 0.5 ml VARIVAX (merck)(subcutaneously) (lot # was unknown, SC)on 25-SEP-2012. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous report as received from a clinical scientist refers to a child of unknown age and gender, who on unknown date was vaccinated with a dose of VARIVAX (merck)(lot#, dose and route not reported) and experienced a cold (date unspecified). The outcome of patient and the relatedness for cold for VARIVAX (Merck) were not reported by reporter. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a 67 years old female consumer with polymyalgia rheumatica and no drug reactions or allergies. The patient was vaccinated with a single 0.5 ml dose of PNEUMOVAX23 intramuscularly or subcutaneously (lot # not reported) on 05-OCT-2012. No other co-suspects were reported. Concomitant medications included: prednisone (manufacturer unknown) and unspecified blood pressure medication. On the same date, the patient experienced pain in her arm and shoulder after the injection. The patient said the pain was so severe that she could not move her arm. She did not contact her health care professional but self-medicated with "pain pill" and used ice. No lab diagnostics/studies were performed. The outcome of pain in her arm and shoulder was reported as recovering, the patient had regained mobility in arm. The relationship between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no drug reactions or allergies and no pertinent medical history. On 04-SEP-2012, the patient was vaccinated with ZOSTAVAX. Lot number and the dosing details were not reported. No concomitant medications were reported. On 07-SEP-2012, the patient experienced redness around injection site after receiving ZOSTAVAX. No treatment was given. No laboratories diagnostic test were performed. The patient sought medical attention spoke with the pharmacist. The outcome of redness around injection site was reported as not recovered/not resolved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site rash, Mobility decreased, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with drug reaction or allergy to codeine. The patient was vaccinated with a dose of PNEUMOVAX 23 on 05-SEP-2012 (lot number reported as 1947AA with expiration date 20-OCT-2013) (dose and route not reported). No other co-suspects were reported. Concomitant medications included VYTORIN and BENADRYL. It was reported that on 05-SEP-2012, the patient developed a fever that persisted for 3 days, pain, swelling, inflammation that extended to the patient's shoulder, difficulty in moving her arm and rash around the injection site after receiving PNEUMOVAX 23. On an unknown date, ultrasound was performed to check for blood clots, results were negative. FLEXERIL, ADVIL and MEDROL dosepak were given as treatment for the adverse events. The outcome of inflammation that extended to the patient's shoulder, rash around the injection site, pain, swelling and difficulty in moving her arm was reported as not recovered/not resolved. The outcome of fever was reported as recovered/resolved (persisted for 3 days). The relatedness for inflammation that extended to the patient's shoulder, pain, swelling, rash around the injection site, difficulty in moving her arm and fever is unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Ultrasound Doppler normal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with drug reaction or allergy to codeine. The patient was vaccinated with a dose of PNEUMOVAX 23 on 05-SEP-2012 (lot number reported as 1947AA with expiration date 20-OCT-2013) (dose and route not reported). No other co-suspects were reported. Concomitant medications included VYTORIN and BENADRYL. It was reported that on 05-SEP-2012, the patient developed a fever that persisted for 3 days, pain, swelling, inflammation that extended to the patient's shoulder, difficulty in moving her arm and rash around the injection site after receiving PNEUMOVAX 23. On an unknown date, ultrasound was performed to check for blood clots, results were negative. FLEXERIL, ADVIL and MEDROL dosepak were given as treatment for the adverse events. The outcome of inflammation that extended to the patient's shoulder, rash around the injection site, pain, swelling and difficulty in moving her arm was reported as not recovered/not resolved. The outcome of fever was reported as recovered/resolved (persisted for 3 days). The relatedness for inflammation that extended to the patient's shoulder, pain, swelling, rash around the injection site, difficulty in moving her arm and fever is unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old female patient with codeine allergy. On 27-SEP-2012, the patient was vaccinated with, 0.5 ml PNEUMOVAX23 Lot # H009826 Exp date: 11-FEB-2014. Pharmacist reported that on 27-SEP-2012, the patient experienced very swollen arm after receiving PNEUMOVAX23 and complained of difficulty moving the arm. The patient did not received any treatment for the event. The patient sought medical attention by spoke to pharmacist. The outcome of adverse events was unknown. The relatedness for adverse events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Oral herpes
Clinical narrative: This spontaneous report as received from a 60 years old female consumer with codeine allergy and no pertinent medical history. The patient was vaccinated with 1 dose of ZOSTAVAX (route and lot # not reported) on 05-OCT-2012. Concomitant medications included hydrochlorothiazide (+) losartan potassium, rifabutin, LEXAPRO and trazodone hydrochloride. The patient stated that after she had gotten the ZOSTAVAX, she got a cold sore on her lip, on 07-OCT-2012. In addition, the patient was still itchy at the injection site of her arm. The patient sought medical attention by a doctor visit. No lab diagnostic/studies were performed. The patient was given cold sore medicine and valacyclovir for the events. The outcome of cold sore on her lip was reported as recovering. The relationship for the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 08-OCT-2012, was vaccinated with a dose of ZOSTAVAX (lot number 665522/1765Y) (dose and route not reported) that was expired. The vaccine expired on 15-MAR-2011. No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Dyspnoea, Heart rate increased, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a 65 year old female registered nurse regarding herself. Patient's current condition included chronic obstructive pulmonary disease (COPD), hypertension and codeine allergy. The patient's medical history included hip replacement, swelling and soreness at the injection site following multiple prior doses of unspecified influenza vaccines (brand name and manufacturer unknown). On an unknown date in September 2006 (approximately 6 years ago), the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number unspecified). Concomitant medications included TOPROL XL tablets, hydrochlorothiazide (manufacturer unknown), SPIRIVA and FLOVENT. On an unknown date, the patient was hospitalized for a hip replacement. On 19-SEP-2012, while she was hospitalized for a hip replacement, she was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number unspecified). On 19-SEP-2012, approximately 6 hours following the vaccination, she experienced short of breath, asthmatic, pulse oximetry reading dropped from 96 to 70, her heart rate increased to 140 beats per minute that she needed to use oxygen and albuterol therapy way too often. On the same day, she experienced swelling and soreness at the injection site. Hospitalization was not prolonged. She was discharged on the following day (20-SEP-2012) but the patient was still experiencing the shortness of breath. She followed up with an unspecified physician on the next day the doses of SPIRIVA, FLOVENT were increased. On 22-SEP-2012, her respiratory symptoms were resolved. The outcome of swelling and soreness at the injection site was unknown. The relatedness for all the events was unknown was unknown for PNEUMOVAX 23. This case is related to 1210USA004946 (Same Patient Link). Additional information is not expected.