chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Breast cancer female, Erythema, Full blood count, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report by a contactable nurse. This nurse reported on behalf of a 84 year old female patient who was administered with a dose of PREVNAR 13 (LOT# G13185, expiration date: 31May2014) intramuscularly on right deltoid at 2.30 pm on 13Nov2012. Relevant medical history included hypertension, diabetes, high cholesterol which was still ongoing during the events onset. Relevant concomitant medications included glimepiride 2mg, PRAVACHOL 40mg, AZOR 5/40mg, LASIX 40mg, tramadol 50mg as needed, and potassium 10mEq all ongoing during the events onset. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 15Nov2012, she had excessive swelling, soreness and redness at the injection site, and 10 X 6 cm erythema in the area which covered entire arm, shoulder and elbow and "the area peeled". In Nov2012, she was diagnosed with breast cancer. On 21Nov2012, her white blood count was elevated. Therapeutic measures taken in response to excessive swelling, soreness and redness at the injection site included TYLENOL every 6 hours as needed, BENADRYL every 6 hours as needed, and ibuprofen as needed. Relevant lab data included complete blood count (CBC) test on 21 Nov2012 and the results showed that her white blood count was elevated and unspecified fasting lab tests on 21Nov2012 for which the results were unknown. At the time of the report the clinical outcome of breast cancer and white blood count was elevated was unknown, she was recovering from the other events.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Laboratory test, Skin exfoliation, White blood cell count increased
Clinical narrative: This is a spontaneous report by a contactable nurse. This nurse reported on behalf of a 84 year old female patient who was administered with a dose of PREVNAR 13 (LOT# G13185, expiration date: 31May2014) intramuscularly on right deltoid at 2.30 pm on 13Nov2012. Relevant medical history included hypertension, diabetes, high cholesterol which was still ongoing during the events onset. Relevant concomitant medications included glimepiride 2mg, PRAVACHOL 40mg, AZOR 5/40mg, LASIX 40mg, tramadol 50mg as needed, and potassium 10mEq all ongoing during the events onset. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 15Nov2012, she had excessive swelling, soreness and redness at the injection site, and 10 X 6 cm erythema in the area which covered entire arm, shoulder and elbow and "the area peeled". In Nov2012, she was diagnosed with breast cancer. On 21Nov2012, her white blood count was elevated. Therapeutic measures taken in response to excessive swelling, soreness and redness at the injection site included TYLENOL every 6 hours as needed, BENADRYL every 6 hours as needed, and ibuprofen as needed. Relevant lab data included complete blood count (CBC) test on 21 Nov2012 and the results showed that her white blood count was elevated and unspecified fasting lab tests on 21Nov2012 for which the results were unknown. At the time of the report the clinical outcome of breast cancer and white blood count was elevated was unknown, she was recovering from the other events.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Dyspnoea, Wheezing
Clinical narrative: Initial report was received 29 November 2012 from a consumer, who is also the patient. A 35-year-old female patient with a history of a cat allergy, had received an intramuscular left deltoid injection of FLUZONE, lot number UT427AA (also reported as UT427AAI) and on the day of vaccination, she experienced an asthmatic reaction, trouble breathing and wheezing 6-8 hours after the vaccine. The patient took BENADRYL and was fine after that. An event outcome was not reported. The patient had not been taking any concomitant medications and she had previously received many doses of FLUZONE in the past. Documents held by sender: None.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Pyrexia
Clinical narrative: 1 day after flu shot given, pt c/o weakness, fever of 103 degrees, not able to walk (secondary to weakness) & did have fever, (happened at school). Denied CP / SOB / N/V /dizziness / no chills no shakiness. No rash.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Blood culture, Full blood count, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccine on 11/13/12. On 11/15/12 there was a dark red, hot, circular area around the injection site approximately 1 1/2 x 2 inches with swelling surrounding it. On 11/16/12 the vaccination site was larger, hotter & redness with severe swelling encircling the upper arm. Sent to ER.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Metabolic function test
Clinical narrative: Received vaccine on 11/13/12. On 11/15/12 there was a dark red, hot, circular area around the injection site approximately 1 1/2 x 2 inches with swelling surrounding it. On 11/16/12 the vaccination site was larger, hotter & redness with severe swelling encircling the upper arm. Sent to ER.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Discomfort, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site infection
Clinical narrative: Received vaccine on 11/13/12. On 11/15/12 there was a dark red, hot, circular area around the injection site approximately 1 1/2 x 2 inches with swelling surrounding it. On 11/16/12 the vaccination site was larger, hotter & redness with severe swelling encircling the upper arm. Sent to ER.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Received vaccine on 11/13/12. On 11/15/12 there was a dark red, hot, circular area around the injection site approximately 1 1/2 x 2 inches with swelling surrounding it. On 11/16/12 the vaccination site was larger, hotter & redness with severe swelling encircling the upper arm. Sent to ER.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Pt reports 2 hours after injection arm became very swollen & tender. Upon examination pt had circumferential edema (L) UE. No erythema very tender to palpation. No dyspnea. Pt refused further exam or tx.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: On Dec. 07, 2010, I received the immunization injection of ZOSTAVAX vial at the pharmacy order by dr. I feel that it activated 2 dormant viruses in my system-chickenpox & papillomavirus, Unsightly skin lesions appeared within days of the injection basically following the same path that the shingles usually follows (mid section around to the back). Nothing has helped to get rid of it. I am now trying occlusion using duct tape.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Mass, Musculoskeletal discomfort
Clinical narrative: Tdap injection given in (R) deltoid on 11/26/12 at 4PM. Pt noted discomfort at base of neck at (R) clavicle on 11/28/12 10AM. There is small lump at above noted area on 11/28/12 1:30PM.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Erythema, color to area from high upper thigh to above the knee, anterior & medial thigh. Small papule on anterior thigh did not appear to be at injection site.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash showed up on left side of the face and moved to the right side.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient stated her right arm was still hurting. Patient said it hurt in the shoulder joint and she was having trouble raising her right arm. Patient stated she had trouble fastening her seatbelt, getting dressed, and cleaning off her table. The patient told me all of this on 12/05/2012.  Patient stated she had not seen a physician and a friend who was a nurse told her a nerve may have been hit during administration of the vaccine. I advised her to see her MD to see if the pain could be caused by anything else.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Nausea, Pharyngeal oedema, Vomiting
Clinical narrative: Patient states that she began feeling nausea, then vomiting, then throat swelling around 5 or 6pm. She then remembered that she has had a reaction to influenza vaccine before. She has an Epi Pen for a nut allergy so she used the epi pen on herself. She states that her throat swelling discontinued but she still had nausea and vomiting.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain
Clinical narrative: Body aches beyond the injection site, body chills.  Body aches are continuing into the following day more intensely.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site pain, Injection site erythema
Clinical narrative: Red sore area around administration site. Suggested Benadryl capsules and hydrocortisone cream.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test, Hypoaesthesia, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Pain and weakness in right thigh. Area numb to being touched, but touch is painful in the muscle.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: X-ray of pelvis and hip
Clinical narrative: Pain and weakness in right thigh. Area numb to being touched, but touch is painful in the muscle.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Arthralgia, Dysstasia, Gait disturbance
Clinical narrative: Complains of pain in the knees, has difficulty walking and getting up from seated position.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Left shoulder pain.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site streaking
Clinical narrative: Pt called office the day after the immunization (12/04) and c/o redness, streaking rash about Right deltoid- area of recent pneumonia injection. Pt was seen by urgent care facility that evening and prescribed Benadryl. Pt was then re-evaluated here on 12/05 by his Provider- redness was decreasing, pt was advised to continue Ibuprofen and Benadryl.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had redness, swelling, and warmth on right arm from shoulder to elbow. Pt also had two blisters that had popped on right arm. Pt using Benadryl and Tylenol for treatment.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling noted that has worsened, afebrile. Cool compresses, Ibuprofen, Benadryl.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: Chills, High Fever (102 Degrees), body aches especially head and neck, headache. Took Ibuprofen (800 mg), Nyquil. Fever stayed at 100+ degrees the following day.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeling abnormal, Nausea, Vomiting
Clinical narrative: Came home right after Flu Shot. Had a late lunch and watched TV as I ate.  When I finished, I got up to go into the kitchen and was so very dizzy I thought I would fall down.  Held onto my chair and tried to cont. to the kitchen.  It just got worse..I was so shocked to feel so badly so quickly.  Then I got very nauseated and began to throw up....afterwards, I laid down and slept solid for about 4 hours....When I got up, I felt much better, still a little weak and dizzy but not bad.  Went to bed for the night and woke up today feeling much better yet still just a little dizzy and a little nauseated....Very strange.  Have taken the flu shot numerous times and never had this happen.  I am not allergic to eggs but that is what I had for lunch--2 scrambled eggs, toast and milk....Don't know if that had anything to do with it or not. Just FYI.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Ear discomfort, Exophthalmos, Hypoaesthesia, Lip swelling
Clinical narrative: Burning sensation in mouth. Tongue and lips swollen. Eyes feel like bulging. Ears ringing and burning. Face swollen. Numb face and dizziness. Lasted all night and into next day. On-going.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Oral discomfort, Swelling face, Swollen tongue, Tinnitus
Clinical narrative: Burning sensation in mouth. Tongue and lips swollen. Eyes feel like bulging. Ears ringing and burning. Face swollen. Numb face and dizziness. Lasted all night and into next day. On-going.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Severe abdominal cramps/pain accompanied by 4 bouts of very watery diarrhea.  Lasted approximately 90 minutes.  No treatment. (This is similar, although much more intense, to symptoms I experience on accidentally ingesting gluten).
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dry mouth, Dyspnoea, Heart rate increased, Oropharyngeal pain
Clinical narrative: My mother began to expeience increased heart rate, cotton mouth and SOB at approximately 6PM.  Within an hour she began vomiting, which persisted for 3 hours.  This was followed by diarrhea.  Today, Dec 6th she is experiencing symptoms common following flu vaccine, including sore throat and congestion.  GI symptoms have resolved.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Vomiting
Clinical narrative: My mother began to expeience increased heart rate, cotton mouth and SOB at approximately 6PM.  Within an hour she began vomiting, which persisted for 3 hours.  This was followed by diarrhea.  Today, Dec 6th she is experiencing symptoms common following flu vaccine, including sore throat and congestion.  GI symptoms have resolved.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Ophthalmological examination, Visual impairment, Vitreous floaters
Clinical narrative: Dark mark and lines appeared in right eye.  Pharmacist said to go to Emergency Room or Critical Care Clinic.  Doctor was called immediately and they also said go to ER.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Fatigue, Paraesthesia
Clinical narrative: Patient experienced weakness, fatigue, dizziness, and tingling of her arms and rest of body the morning after she received the vaccine.
Age: 60.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Electromyogram, Inflammation, Muscular weakness, Musculoskeletal pain, Nerve conduction studies
Clinical narrative: Pain R shoulder and arm; weakness R arm - found to have brachial plexus inflammation.
Age: 60.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain R shoulder and arm; weakness R arm - found to have brachial plexus inflammation.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture normal, Nerve conduction studies
Clinical narrative: Distal paresthesias involving upper and lower extremities. Not sure when this exactly started (~ week or so after flu vaccine). Started as mild tingling, but then spread through her leg. Neurology was involved, nerve conduction study performed. LP done was negative, MRI of the lumbar spine done supportive of diagnosis of Guillain Barre. Received IVIG x 4 days. Numbness and tingling did improve (started using a cane) and was referred to physical therapy as an outpatient.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal cord abnormal, Paraesthesia, Walking aid user
Clinical narrative: Distal paresthesias involving upper and lower extremities. Not sure when this exactly started (~ week or so after flu vaccine). Started as mild tingling, but then spread through her leg. Neurology was involved, nerve conduction study performed. LP done was negative, MRI of the lumbar spine done supportive of diagnosis of Guillain Barre. Received IVIG x 4 days. Numbness and tingling did improve (started using a cane) and was referred to physical therapy as an outpatient.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Pt felt nauseated, went extremely pale, got dizzy/lightheaded. Pt had not eaten anything the morning prior to her immunizations.
Age: 18.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: After vaccine admin. pt went out to eat breakfast; began feeling nauseous; vomited and developed a non raised rash on central face and around eyes.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pharyngeal oedema, Pyrexia, Rhinitis
Clinical narrative: NO INITIAL REACTION IN FIRST 20 MINUTES AFTER HER FIRST EVER FLU SHOT.  HOWEVER, ABOUT 40 MINUTES LATER, SHE NOTICED SWELLING IN HER THROAT.  SHE TOOK A BENADRYL PILL & 15 MIN LATER THE LUMP IN HER THROAT STAYED, BUT DID NOT WORSEN- THEN IT DECREASED TO NORMAL WITHIN 1-2 HOURS.  ON MONDAY, 11/12/12, SHE DEVELOPED CHILLS, FEVERISH, SINUS CONGESTION & PURULENT DRAINAGE WHICH LASTED FOR 2 WEEKS & THEN SPORADIC.  THE NEXT DAY 11/13/12, SHE HAD SEVERE DIARRHEA WHICH LASTED 12 DAYS.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of foreign body, Sinus congestion
Clinical narrative: NO INITIAL REACTION IN FIRST 20 MINUTES AFTER HER FIRST EVER FLU SHOT.  HOWEVER, ABOUT 40 MINUTES LATER, SHE NOTICED SWELLING IN HER THROAT.  SHE TOOK A BENADRYL PILL & 15 MIN LATER THE LUMP IN HER THROAT STAYED, BUT DID NOT WORSEN- THEN IT DECREASED TO NORMAL WITHIN 1-2 HOURS.  ON MONDAY, 11/12/12, SHE DEVELOPED CHILLS, FEVERISH, SINUS CONGESTION & PURULENT DRAINAGE WHICH LASTED FOR 2 WEEKS & THEN SPORADIC.  THE NEXT DAY 11/13/12, SHE HAD SEVERE DIARRHEA WHICH LASTED 12 DAYS.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Aphagia, Asthenia, Body temperature increased, Chills, Dizziness
Clinical narrative: I began having chills which rapidly progressed into severe trembling.  By the time I reached my home, I was barely able to control my body movements. I took 2 Tylenol, crawled under an electric blanket and took my temperature, using an ear thermometer. Temp was 100.7. My normal temp is 97.6. I was trembling so badly that I could not even text my son to come check on me or read the side effects on the Rx sheet. I was finally able to call my son, an EMT, on speed dial. When he got to me about 10 minutes later, he confirmed that I had no breathing problems or rash, only the elevated temperature. My temperature continued to rise during the next 36 hours, eventually reaching 102.6. I was weak, unable to eat, dizzy, and had severe headaches. I treated myself by taking 2 Tylenol every 4-6 hours. I did not seek medical assistance. My temperature did not return to normal until around 04:00 AM on December 6, 2012.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Tremor
Clinical narrative: I began having chills which rapidly progressed into severe trembling.  By the time I reached my home, I was barely able to control my body movements. I took 2 Tylenol, crawled under an electric blanket and took my temperature, using an ear thermometer. Temp was 100.7. My normal temp is 97.6. I was trembling so badly that I could not even text my son to come check on me or read the side effects on the Rx sheet. I was finally able to call my son, an EMT, on speed dial. When he got to me about 10 minutes later, he confirmed that I had no breathing problems or rash, only the elevated temperature. My temperature continued to rise during the next 36 hours, eventually reaching 102.6. I was weak, unable to eat, dizzy, and had severe headaches. I treated myself by taking 2 Tylenol every 4-6 hours. I did not seek medical assistance. My temperature did not return to normal until around 04:00 AM on December 6, 2012.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: On 11/19/2012, client reported that left shoulder and left side of neck painful since receiving flu shot.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Feeling hot, Flushing, Formication, Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm became swollen and red at injection site. Patient c/o "flushed"feeling and warmth in face last night and a skin felt like it was "crawling". Patient given Benadryl and an antibiotic ointment to apply topically to affected area.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain
Clinical narrative: Client began complaining of "internal" eye pain. Mother instructed to call doctor, who instructed her to have child lay down with cold pack over eyes and watch.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, HEPA, MMRV
Symptoms: Erythema, Local swelling
Clinical narrative: Localized redness and sweeling.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED. WAS SEEN BY PHYSICIAN AFTER FAINTING EPISODE. QUICKLY REGAINED CONSCIOUSNESS AND WAS BACK TO HIS NORMAL SELF WITHIN A FEW MINUTES. BP WAS 100/70 AND WAS OKAY TO BE DISCHARGED HOME.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Pt stated the night after receiving Gardasil she started itching all over body. Went to ER 11/18/2012. Was given Zyrtec, Hydrozine, Benadryl but continues itching.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Fatigue, Pyrexia
Clinical narrative: Exhaustion, fever, felt uncomfortable.
Age: 80.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: CSF protein increased, Electrophoresis protein abnormal, Guillain-Barre syndrome, Muscular weakness, Sensory loss
Clinical narrative: Symmetric proximal upper and lower extremity weakness, sensory deficits.
Age: 80.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Symmetric proximal upper and lower extremity weakness, sensory deficits.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Needle stick was painful and actual injection caused pain.  Arm ached that day.  Next morning I had increasing pain in the shoulder.  Noticed restriction in movement and increasing soreness by the next day.  Progressed to shoulder impingement syndrome.  Underwent 5 weeks of PT.  Improvement seen in first 2-3 weeks, then plateaued.  Had an ultrasound and x-rays (which were normal) followed by a cortisone injection on 11/21/12.  Immediate pain relief.  However, pain came back less than 2 weeks later.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Rotator cuff syndrome, Ultrasound scan normal, X-ray normal
Clinical narrative: Needle stick was painful and actual injection caused pain.  Arm ached that day.  Next morning I had increasing pain in the shoulder.  Noticed restriction in movement and increasing soreness by the next day.  Progressed to shoulder impingement syndrome.  Underwent 5 weeks of PT.  Improvement seen in first 2-3 weeks, then plateaued.  Had an ultrasound and x-rays (which were normal) followed by a cortisone injection on 11/21/12.  Immediate pain relief.  However, pain came back less than 2 weeks later.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: BOTH THIGHS RED AND SWOLLEN.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lip swelling, Oedema peripheral, Pharyngeal oedema
Clinical narrative: Swelling of lips, hands, throat, and difficulty breathing.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness swelling tenderness left upper arm.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Axillary pain and swollen nodes, afebrile.  Patient took ibuprofen. Pain is moderate and patient was told to contact physician if no improvement or worsening condition within 72 hours.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives. Received Influenza vaccine IM. Hives to (R) wrist noted approximately 20 minutes post injection. Received BENADRYL po & CELESTONE IM. Home on ORAPRED & ZYRTEC po.
Age: 36.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain, Pyrexia
Clinical narrative: Left deltoid onset started at time of injection and the same evening she started having swelling at site & it continued to swell. She started having shooting pain on Frid. noc - 11-30-12 intermittently & then the pain became constant on Sat. thru present. OV today - 12-3-12 lump at site 5 x 2.5 cm with 1 cm of pinkness states redness at site this AM was the size of a "quarter", fever 99.7-100 over the weekend.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Tingling in right hand and pain in right arm.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Night sweats, Pyrexia
Clinical narrative: Tactile fever with sweats and chills the night of administration of flu vacc.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swollen of left arm around vaccine area - on a 48 hr course. Treatment: BENADRYL 5ml. QHS.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Patient reported a large area of swelling, redness and warm to the touch about 3 inches below injection site, she says it started almost immediately. She took 2 BENADRYL the day following injection and that made it better, though at time of report it is still swollen and a little red/warm. Advised her to continue BENADRYL and let us know if it doesn't resolve.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Maternal exposure during pregnancy, Syncope
Clinical narrative: About 10 minutes after vaccination, the patient fainted. She fell and hit her head on the floor. 911 was called and EMT's came and took her to the emergency room.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation
Clinical narrative: 4 hrs after flu shot, felt burning in (R) ear, (R) side of neck and chest.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Swelling at injection site two days after vaccines / no itching. Treated with cephalexin 500 mg tabs 1 tab QID. Diagnosed with cellulitis.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Developed a large red raised area at injection site, followed by rash and fever.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Migraine
Clinical narrative: Migraine after FLUMIST.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient said she began having symptoms 2 AM on December 1. She described the injection site as "on fire" red and swollen she said she was going to call her doctor. Pt. saw Dr. he didn't know if she was having a reaction or an infection, but prescribed cephalexin.
Age: 17.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Urticaria
Clinical narrative: Hives ? within 24 hours after receiving Nasal Flu vaccine '12-'13 and HPV #2. ? 24 - 36 hours by chart review.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site mass
Clinical narrative: After receiving the varicella vaccine on left arm deltoid area, child developed a lump.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Blood pressure increased, Chest pain, Dysphonia, Muscular weakness
Clinical narrative: Employee received vaccine 11-30-12. Informed Emp. Health nurse 12-6-12 that she went to ER on 12-2-12 at 6 p for symptoms she developed at 5 p same day. C/O chest pain, abdominal pain, hoarseness, sore throat, high B/P reading, (R) leg weakness, shaky feeling. No increased temperature.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Nervousness, Oropharyngeal pain
Clinical narrative: Employee received vaccine 11-30-12. Informed Emp. Health nurse 12-6-12 that she went to ER on 12-2-12 at 6 p for symptoms she developed at 5 p same day. C/O chest pain, abdominal pain, hoarseness, sore throat, high B/P reading, (R) leg weakness, shaky feeling. No increased temperature.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Vaccine admin on 11/26 by pharmacist. Pt came in on 11/30 saying that there was some slight itching at site. On exam site was slightly red in appearance w/ no swelling. Advise pt to watch site. Use hydrocortisone to reduce itching. If gets worse, see MD & call us.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Mood swings
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 14 years old female patient with depression, attention deficit disorder (ADD) and none drug reactions/allergies. The patient was intramuscularly vaccinated with a third dose of 0.5 ml GARDASIL (lot number not provided) on an unknown date. No other co-suspects were reported. Concomitant medications included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharide, ADDERALL (tablets), TEGRETOL and trazodone hydrochloride. The patient developed a headache and mood swings, after receiving her third dose of GARDASIL approximately in 2012, which "last couple of months". The patient had sought medical attention via contacting the nurse practitioner by the patient's parents. The treatment of TYLENOL was given for headache. There were no laboratory diagnostics studies performed. The outcome of mood swings and headache was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient received 2 doses of GARDASIL (Lot #, dose and route not reported) in 2008 (day and month unspecified), and 2 doses of GARDASIL (Lot #, dose and route not reported) in 2010 (day and month unspecified). No adverse effects reported. It was not known if the patient sought medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, refers to a 23 years old female patient who is a smoker and refused "flu shot". The patient had no drug allergy. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the first dose of GARDASIL (lot# unspecified) in June 2012 and the second dose (lot# unspecified) in November 2012. Concomitant medications included ARMOUR THYROID (tablets) and prenatal vitamins (unspecified). Subsequently, the patient became pregnant on 02-NOV-2012 with an LMP of 18-OCT-2012 (gestation reported as 5 weeks and 4 days at time of the report). EDD was on 25-JUL-2013. The patient was exposed to GARDASIL during trimester 1. The patient had not suffered any adverse effects. The patient had her first OB/GYN visit on 26-NOV-2012. During this visit, the nurse advised the patient to discontinue the GARDASIL series until after she completed childbirth and nursing. No lab tests were performed. No treatment was given. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown demographics. The nurse reported that her office had improperly stored GARDASIL. It was possible that on an unspecified date, an unspecified number of patient might have been administered with this improperly stored GARDASIL (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. No symptoms reported. This is one of the several reports received from the same reporter (MARRS# 1211USA012714, 1211USA012715, 1211USA012716 and 1211USA012717). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Pharm. T. refers to a 4 patients of unknown age and genders. On unspecified date, the patients were vaccinated with PROQUAD (lot #, dose and route not provided). No concomitant medications were reported. The healthcare worker reported that on unspecified date, 4 patients received PROQUAD that was stored at 36-46 degrees F. for possibly 816 hours. No adverse effect reported. The outcome of incorrect storage was unknown. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test
Clinical narrative: Flu shot 9/28, feeling weak/fatigue numbness 10/12 hospital 10/14 (set us home) Dr 10/16 - upstate 10/16 - admitted w/ GBS.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture
Clinical narrative: Flu shot 9/28, feeling weak/fatigue numbness 10/12 hospital 10/14 (set us home) Dr 10/16 - upstate 10/16 - admitted w/ GBS.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an approximately 12-year old female patient with no pertinent medical history and drug reactions/allergies. On 08-AUG-2012, the patient was vaccinated with dose 1 of 0.5 milliliter (ml) GARDASIL (lot number and expiry date were not reported) intramuscularly. No concomitant medications were reported. Approximately on 22-AUG-2012 (reported as 2 weeks after vaccination) the patient developed plantar warts. Warts were not cultured and no lab diagnostic studies were performed. The patient sought medical attention for the events by calling the physician. No treatment was given. The outcome of the event was unknown at the time of this report. 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 registered nurse refers to a patient of unknown age. The patient received the first dose of GARDASIL (Lot#, dose and route not reported) 2 years ago, in November 2010. The patient was in the office today, on 20-NOV-2012, to receive the second dose. No adverse effect reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning one female patient of five patients who on an unspecified dates were vaccinated with lot # (671786/0254AE, Exp: 08-MAR-2013) ZOSTAVAX (doses and routes not reported) and developed a similar injection site reaction described as a rash following vaccination. No other co-suspects were reported. No concomitant medications were reported. The patient was reported to have developed a hot, raised, red, itchy "4 by 4" area that was about 2 inches below the injection site (pharmacist called it a rash), but no vesicles or bumps were present. The pharmacist reported that the injection site reaction developed about a day or two after ZOSTAVAX vaccination and that the injection site reaction had resolved at the time of the call (exact dated of vaccination, developed of rash and date of resolution was not available at the time of the call). The pharmacist reported that the injection site reactions reported with ZOSTAVAX, occurred between this August (2012) and the end of September of this year (2012). The patient had sought unspecified medical attention - contacted pharmacist. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. No concomitant medications were reported. The reporter reported that patient was administered an expired dose of ROTATEQ (oral, lot# reported as 1344AA; exp 01-DEC-2012) on 03-DEC-2012. That was the first and only dose of ROTATEQ the patient had received. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. The nurse reported that an unknown number of patient may have received (Merck) VARIVAX injection (lot#, dose and route were not reported) stored on multiple occasions at higher than recommended temperatures. No adverse effect reported. No additional information reported. Additional information has been requested. Incorrect product storage.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Serology test
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 years old female patient with no drug reactions or allergies. The patient's medical history included knee surgery in 2001. The patient was vaccinated with dose 1 and dose 2 VARIVAX (Merck) (lot #, dose and route not reported) on 09-JUN-2004 and 09-JUL-2004 respectively as a starting nursing school requirement. No other co-suspects were reported. Concomitant medications included: ORTHO-CYCLEN. The registered nurse reported that another unspecified employer previously had the patient get a varicella titer on an unspecified date, which was found to be equivocal. No treatment was given for the event. The outcome of the event was unknown. The relatedness for varicella titer which was found to be equivocal was not provided for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that her office had improperly stored ROTATEQ. It was possible that on an unspecified date, an unspecified number of patients might have been administered with this improperly stored ROTATEQ (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. No symptoms reported. No symptoms reported. This is one of the several reports received from the same reporter (MARRS# 1211USA012711, 1211USA012715, 1211USA012716 and 1211USA012717). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender who on 15-NOV-2012 was vaccinated with a third dose of ROTATEQ after the vaccine expired (lot number reported as 0257AA, expiration date: 28-OCT-2012) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse reaction reported. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 7 years old female patient. On 23-JUN-2006, the patient was vaccinated with VARIVAX (Merck) (lot# 652868/0267F) subcutaneously. On 13-OCT-2009, the patient was vaccinated with VARIVAX (Merck) (lot# 665181/1007Y) subcutaneously. No other co-suspects were reported. Concomitant medications included ZONEGRAN and lactase. On 19-NOV-2012, the patient experienced 20 papular chickenpox lesions after receiving VARIVAX (Merck). No treatment information was reported. The patient sought medical attention and saw the physician. At the time of the report, the patient was not recovered from the event of 20 papular chickenpox lesions. The relatedness for 20 papular chickenpox lesions was unknown for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a refers to a patient of unknown age (gender unspecified). On an unknown date, the nurse reported that the patient was vaccinated with PNEUMOVAX 23, (lot number, expiration date and route not reported) within a month of each other. No concomitant medications were reported. The pharmacist reported that an unspecified nurse informed her that an unspecified patient was inadvertently administered 2 doses of PNEUMOVAX within a month of each other on unspecified dates and no adverse effects were reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 69 years old male patient with diabetes, polyneuropathy and allergy to penicillin. The patient was vaccinated with ZOSTAVAX (single dose, Subcutaneous on left arm, lot # unknown) on 30-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 30-NOV-2012 the patient had developed a 8 cm, area of redness and swelling at the injection site of the left upper arm. The patient was evaluated in the office and the physician had prescribed a 5 day course of MEDROL. The outcome of event was reported as not recovered/not resolved. No lab diagnosis studies performed. The patient sought medical attention via office visiting. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Asthenia, Chromaturia, Dysuria
Clinical narrative: This spontaneous report as received from a 69 years old female patient via laboratories regarding herself. The patient's medical history included rectal hemorrhage. Current condition included sulfa drugs hypersensitivity, multiple sclerosis and osteoporosis. On an unknown date in October 2012, the patient vaccinated with a dose of zoster vaccine live(manufacturer unknown)(reported as ZOSTER IMMUNOGLOBULIN)(lot number, expiry date and dose were not reported) intramuscularly. Other suspect therapies included GELNIQUE(strength : 10%) gel (1 sachet, every day) topically from 18-OCT-2012 for spasm bladder and zoledronic acid (dose and frequency not reported) intravenously from an unknown date, for osteoporosis. No concomitant medications were reported. On 21-OCT-2012, the patient experienced burning while urination, feeling weak, stomach hurting and bloating, urine more yellow, blood in stool and stomach hurting and bloating. The event feeling weak and not confirmed by the patient physician. No treatment was provided. The outcome of burning while urination, urine more yellow and stomach hurting and bloating was reported as not recovered. The outcome of feeling weak and blood in stool was reported as recovering. The patient indicated that feeling weak was possibly caused by her multiple sclerosis. On 21-OCT-2012, GELNIQUE was discontinued and on an unknown date in October 2012, zoledronic acid was discontinued for an unknown reason. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Haematochezia
Clinical narrative: This spontaneous report as received from a 69 years old female patient via laboratories regarding herself. The patient's medical history included rectal hemorrhage. Current condition included sulfa drugs hypersensitivity, multiple sclerosis and osteoporosis. On an unknown date in October 2012, the patient vaccinated with a dose of zoster vaccine live(manufacturer unknown)(reported as ZOSTER IMMUNOGLOBULIN)(lot number, expiry date and dose were not reported) intramuscularly. Other suspect therapies included GELNIQUE(strength : 10%) gel (1 sachet, every day) topically from 18-OCT-2012 for spasm bladder and zoledronic acid (dose and frequency not reported) intravenously from an unknown date, for osteoporosis. No concomitant medications were reported. On 21-OCT-2012, the patient experienced burning while urination, feeling weak, stomach hurting and bloating, urine more yellow, blood in stool and stomach hurting and bloating. The event feeling weak and not confirmed by the patient physician. No treatment was provided. The outcome of burning while urination, urine more yellow and stomach hurting and bloating was reported as not recovered. The outcome of feeling weak and blood in stool was reported as recovering. The patient indicated that feeling weak was possibly caused by her multiple sclerosis. On 21-OCT-2012, GELNIQUE was discontinued and on an unknown date in October 2012, zoledronic acid was discontinued for an unknown reason. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a 74 year old male patient regarding himself. The patient's wife currently had shingles for the last two months and the patient was symptom free. On 12-NOV-2012, the patient was vaccinated with ZOSTAVAX (lot number, expiry date, route and dose were not reported) on recommendation of his physician. Concomitant medications were none. Two days after receiving the vaccine, approximately on 14-NOV-2012 the patient developed a rash and two red blisters, the area was itchy and painful. No laboratory test was performed. The patient sought medical attention (unspecified). The patient was treated with valacyclovir 3 times daily and TYLENOL. All the reported events were not recovered at the time of this report. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 42 years old female patient. The patient was vaccinated with a 0.1 ml dose of PNEUMOVAX23 (lot number not provided) intradermally in the forearm on 27-NOV-2012. Unspecified which arm. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported at the reporting time. It was unspecified if the patient had sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated with an improperly stored dose of 0.5 ml LIQUID PEDVAXHIB (lot# unknown) intramuscular on 29-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified number of infants(patients) of unknown age. The reporter noticed on the immunization records of an unspecified number of infants, that RECOMBIVAX HB had been given on an alternate dosing schedule. On an unspecified date, they were vaccinated with the first dose of RECOMBIVAX HB(lot number, expiry date, route and dose were not reported) at 2 months of age, the second dose at 4 months of age and the third dose at 6 months of age. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain
Clinical narrative: None stated.
Age: 34.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.