chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Breast pain, Erythema, Headache, Local swelling
Clinical narrative: States felt fine day of flu vaccine. Had preservative free flu vaccine in 2012 and 2013. On 10/31/14 had FLUZONE with preservative. At 0300 on 11/1/14 woke up with a "Breast and frontale headache. Slightly better with TYL and ibuprofen. States every joint and continues to ache. Fingers are swollen. (L) middle distal knuckle is red and swollen. On 11/4/14 - cont to feel achy in her joints. Waiting to hear back from her PMD.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Flushing, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Pt received employee flu vaccine. Within 30 min inj site very red/swollen ice pack applied. 15' later entire upper body red/flushed/widespread itching. Epi 0.30 given IM then BENADRYL 25 mg PO and prednisone 20 mg PO. Symptoms resolved quickly.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient wanted Qaud flu vaccine. Gave then FLUVIRIN multidose. No adverse event.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Diarrhoea, Headache, Nasal congestion, Nausea
Clinical narrative: Within 4 day of receiving pt had HA, body aches, fever, NVD, nasal congest, cough and itching.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain, Pruritus, Pyrexia, Vomiting
Clinical narrative: Within 4 day of receiving pt had HA, body aches, fever, NVD, nasal congest, cough and itching.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain
Clinical narrative: Left upper arm pain since injection of flu vaccine 10/22/14. Bursitis in (L) shoulder.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Paraesthesia, Sensation of heaviness, Sensory loss
Clinical narrative: Husband reports. 10/5/14 L leg tingling, heavy numb and L arm  numb, L shoulder tingling, L tips of fingers and loss sensation . 10/15/14 L arm heavy. As of 11/4/14 only sx L hand loss sensation can't hold onto things and top of L foot loss sensation.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Weight bearing difficulty, X-ray limb normal
Clinical narrative: Father reports 10/10/14 R leg would bend when standing, unable to bear weight. 10/13/14 to urgent care R leg x-ray done. Father told x-ray WNL - ortho recommended if persists. Ortho appt not pursued.
Age: 0.24
Sex: M
Vaccine: HIBV, RV1, HIBV, RV5
Symptoms: Crying, Diarrhoea, Insomnia, Urine output decreased, Vomiting
Clinical narrative: Not given here in our office - Mom called us - We are the PCP. Mother called and wants to have report filed with adverse reaction committee due to his reaction from vaccine. Mother reports that baby has been vomiting multiple times between feeds (at least 10 times), severe diarrhea and no sleep at all for 7 days. Mother reports that baby decreased in diapers during those 7 days of being ill. Mother reports that child is not a crying baby and he has been severely crying since vaccines on October 23rd. Pt has been seen at medical facility on Friday October 31st and the after hours medical facility on October 25th. Mother reports that both physicians who seen the child claim that the illness came from the vaccines. Mother reports that these vaccines came from the health department and were active for the HIB and ROTATEQ for the rotavirus. She will contact the health department to report pt adverse reaction. Mother said that pt has been better since rehydration regimen that was advised from physicians seen over the week. In addition, mother reports that child has been diagnosed with mylingual malasia and has been affected greatly from all the throwing up.
Age: 0.24
Sex: M
Vaccine: HIBV, RV1, HIBV, RV5
Symptoms: Abdominal distension, Condition aggravated, Dehydration, Diarrhoea, Diet refusal
Clinical narrative: Not given here in our office - Mom called us - We are the PCP. Mother called and wants to have report filed with adverse reaction committee due to his reaction from vaccine. Mother reports that baby has been vomiting multiple times between feeds (at least 10 times), severe diarrhea and no sleep at all for 7 days. Mother reports that baby decreased in diapers during those 7 days of being ill. Mother reports that child is not a crying baby and he has been severely crying since vaccines on October 23rd. Pt has been seen at medical facility on Friday October 31st and the after hours medical facility on October 25th. Mother reports that both physicians who seen the child claim that the illness came from the vaccines. Mother reports that these vaccines came from the health department and were active for the HIB and ROTATEQ for the rotavirus. She will contact the health department to report pt adverse reaction. Mother said that pt has been better since rehydration regimen that was advised from physicians seen over the week. In addition, mother reports that child has been diagnosed with mylingual malasia and has been affected greatly from all the throwing up.
Age: 0.24
Sex: M
Vaccine: HIBV, RV1, HIBV, RV5
Symptoms: Fatigue, Flatulence, Insomnia, Laryngomalacia, Vaccination complication
Clinical narrative: Not given here in our office - Mom called us - We are the PCP. Mother called and wants to have report filed with adverse reaction committee due to his reaction from vaccine. Mother reports that baby has been vomiting multiple times between feeds (at least 10 times), severe diarrhea and no sleep at all for 7 days. Mother reports that baby decreased in diapers during those 7 days of being ill. Mother reports that child is not a crying baby and he has been severely crying since vaccines on October 23rd. Pt has been seen at medical facility on Friday October 31st and the after hours medical facility on October 25th. Mother reports that both physicians who seen the child claim that the illness came from the vaccines. Mother reports that these vaccines came from the health department and were active for the HIB and ROTATEQ for the rotavirus. She will contact the health department to report pt adverse reaction. Mother said that pt has been better since rehydration regimen that was advised from physicians seen over the week. In addition, mother reports that child has been diagnosed with mylingual malasia and has been affected greatly from all the throwing up.
Age: 0.24
Sex: M
Vaccine: HIBV, RV1, HIBV, RV5
Symptoms: Vomiting
Clinical narrative: Not given here in our office - Mom called us - We are the PCP. Mother called and wants to have report filed with adverse reaction committee due to his reaction from vaccine. Mother reports that baby has been vomiting multiple times between feeds (at least 10 times), severe diarrhea and no sleep at all for 7 days. Mother reports that baby decreased in diapers during those 7 days of being ill. Mother reports that child is not a crying baby and he has been severely crying since vaccines on October 23rd. Pt has been seen at medical facility on Friday October 31st and the after hours medical facility on October 25th. Mother reports that both physicians who seen the child claim that the illness came from the vaccines. Mother reports that these vaccines came from the health department and were active for the HIB and ROTATEQ for the rotavirus. She will contact the health department to report pt adverse reaction. Mother said that pt has been better since rehydration regimen that was advised from physicians seen over the week. In addition, mother reports that child has been diagnosed with mylingual malasia and has been affected greatly from all the throwing up.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Severe headache in back of head and neck - started Oct 16 and has lasted 10 days - subsiding pain each day. Pain so bad I was considering going to Emergency. Thought I was dying.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Eye movement disorder, Posture abnormal, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Student received nasal vaccine and within 1 minute had a seizure like episode with no response to verbal stimuli, eye rolling, head tilted to side while seated upright this lasted 3 minutes. Student recovered and became alert and oriented.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Student developed, headache, fever and body aches. Several hours after vaccine that lasted much of the next day.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pain, Pyrexia, Vomiting
Clinical narrative: Student developed fatigue, body aches, vomiting x 1 and fever several hours after vaccine and into the next day.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 11-3-14 mom noticed pt left deltoid was red, swollen, itching, pain when scratching, warm to touch.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Decreased appetite, Fatigue, Nausea
Clinical narrative: Mother reports symptoms started following day x 5 days; nausea, fatigue, loss of appetite, back pain.
Age: 71.0
Sex: U
Vaccine: FLU3
Symptoms: Asthma, Dyspnoea, Ear congestion, Fatigue, Pain
Clinical narrative: Asthma, arm/body aches, congested sinus, ears, runny nose. Hard to breathe for 4 days, arm body ache 7-10 days, congestion over 2 wks, fatigue terrible 2 weeks.
Age: 71.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity, Rhinorrhoea, Sinus congestion
Clinical narrative: Asthma, arm/body aches, congested sinus, ears, runny nose. Hard to breathe for 4 days, arm body ache 7-10 days, congestion over 2 wks, fatigue terrible 2 weeks.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Child developed vomiting and fever that afternoon and evening. (Note: younger sibling had similar symptoms a few days earlier).
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left upper arm with area of erythema, warmth, tenderness. Treated with KEFLEX 11/4/14.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Received annual Flu vac injection and developed localized swelling, redness and increased warmth over Lt deltoid and back area within 5 mins of injec. Tx with ice pack, BENADRYL IM, monitored with V/S.
Age: 16.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Patient experienced syncopal event with incontinence of urine.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site nerve damage, Injection site warmth
Clinical narrative: According to the first pharmacist, the person administering the Flu shot did not hit the muscle, instead a nerve. A large brownish/yellow bruise is evident. Warm to the touch at injection site.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Two hours after administering the flu vaccine, patient complained of headache. (throbbing). BP 140/90 mmHg at 3pm. BP 120/88 after 30 mins.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient reports tingling down the left arm which began a few hours after immunization. Patient was seen by PCP and prescribed MEDROL Dosepak as treatment.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Client 62 years old given High Dose Flu vaccine.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash. Itching hives.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Immediate post-injection reaction, Pain
Clinical narrative: Pain set in immediately lasting 4 days. Headache occurred from evening of administration, continued for 4 more days, became severe on day 3, pt. took IBU for pain.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient stated their shoulder was sore and they were unable to raise their arm (decreased mobility in arm).
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient stated their shoulder was sore and they were unable to raise their arm (decreased mobility in arm).
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Injection site pain, Loss of consciousness, Somnolence, Tremor
Clinical narrative: Patient was telling nurse how the HPV hurt more than the MENACTRA and then passed out and patient started shaking. Was passed out for a minute or two and then responsive to questions but very drowsy and laid down. Continue to monitor 30 mins with after injections.
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells Palsy - facial droop left side. Occurred 18 hours after shot.
Age: 1.54
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site nodule
Clinical narrative: (R) deltoid with a "knot" like mass. Treatment -> warm compress.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever and chills, nausea, headache. ER consult 10/28/2014 (may be secondary to Flu vaccine). (Temp 102.5).
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Fever and chills, nausea, headache. ER consult 10/28/2014 (may be secondary to Flu vaccine). (Temp 102.5).
Age: 19.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TDaP was ordered. DTaP was given in error. Physician notified. No adverse reactions expected.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain
Clinical narrative: 98.9 x 4 days-headache and body aches x 4 days. No rash or hives.
Age: 16.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Pt seen in clinic 2 days after receivng vaccine. Right upper arm w/ erythema 7.5x4 cm in diameter, warm to the touch. Firm to touch. No drainage. Start Clindamycin HCl 300mg.
Age: 16.0
Sex: F
Vaccine: FLU4, HEPA, MNQ, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Pruritus, Skin warm
Clinical narrative: 10/31/14 came back into office c/o redness and pain at site on (R) arm. 11 x 6 cm erythematous patch. No bleeding or oozing. Skin warm and tenderness at palpation. Cellulitis vs reaction to vaccine advised to take BENADRYL for itching and Ibuprofen for pain. Started clindamycin HCl 300mg.
Age: 16.0
Sex: F
Vaccine: FLU4, HEPA, MNQ, VARCEL
Symptoms: Tenderness, Vaccination complication
Clinical narrative: 10/31/14 came back into office c/o redness and pain at site on (R) arm. 11 x 6 cm erythematous patch. No bleeding or oozing. Skin warm and tenderness at palpation. Cellulitis vs reaction to vaccine advised to take BENADRYL for itching and Ibuprofen for pain. Started clindamycin HCl 300mg.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients. From August 2014 until the time of reporting, these patients were vaccinated with GARDASIL (lot#, dose not reported) which were improperly stored. No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Herpes type of eruptions lesions x3 across student left knuckles. Small area on left arm slight pink flat rash. Started fading before parent arrive. Parent admn. CLARITIN 10/30/14. No rash or eruptions lesions present.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye pain, Eye swelling, Lethargy
Clinical narrative: On 10/9/2014 at 1000, asymptomatic. Received the flu shot, higher dose as I am 79 years old. At 1600, both eyes became reddened, swollen and painful. Developed a cough, experienced chills, lethargy, hands became swollen and painful (for 48 hours).
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Ocular hyperaemia, Pain in extremity
Clinical narrative: On 10/9/2014 at 1000, asymptomatic. Received the flu shot, higher dose as I am 79 years old. At 1600, both eyes became reddened, swollen and painful. Developed a cough, experienced chills, lethargy, hands became swollen and painful (for 48 hours).
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site pain, Lethargy, Pain, Skin warm
Clinical narrative: Tues. became lethargic, felt like he had been stung by bees all over. In office 10/30 c/o pain Rt deltoid. Red, warm 7cm x 6cm area.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: She was given a trivalent influenza vaccine 10/15/14. She reported significant swelling 10/21/14 worse 10/28/14 and improving 10/29/14.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Painful arm for over 10 days.
Age: 1.04
Sex: F
Vaccine: FLU3, HIBV, MMR
Symptoms: Blood culture negative, Body temperature increased, C-reactive protein normal, Culture urine negative, Febrile convulsion
Clinical narrative: At approximately 3 pm 1/23 pt had a febrile seizure that lasted 30-60 sec. She came to the office and had a temp measured at 15:26 of 104.4 (rectal). Exam was non focal. U/A, urine cx, CBC, ESR, CRP and blood culture ordered.
Age: 1.04
Sex: F
Vaccine: FLU3, HIBV, MMR
Symptoms: Haematocrit normal, Haemoglobin normal, Platelet count increased, Red blood cell sedimentation rate increased, Urine analysis
Clinical narrative: At approximately 3 pm 1/23 pt had a febrile seizure that lasted 30-60 sec. She came to the office and had a temp measured at 15:26 of 104.4 (rectal). Exam was non focal. U/A, urine cx, CBC, ESR, CRP and blood culture ordered.
Age: 1.04
Sex: F
Vaccine: FLU3, HIBV, MMR
Symptoms: White blood cell count normal
Clinical narrative: At approximately 3 pm 1/23 pt had a febrile seizure that lasted 30-60 sec. She came to the office and had a temp measured at 15:26 of 104.4 (rectal). Exam was non focal. U/A, urine cx, CBC, ESR, CRP and blood culture ordered.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Local erythema, edema, pruritis started about 12 hrs post the shot.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Terrible pain in left arm, could not move arm for 3 days. Pain pills and heating pad, day and night. Then pain moved over to right for 3 days. Pain pills and heating pad. Did not go to doctor as I did not think they could do any better. If I was still working I would have lost a week of work.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Received FLUZONE HD vaccine on 9/19/14. Developed rash on chest, arms, and legs on 9/20/14. Went to doctor and got MEDROL Dosepak. Patient is fine now.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Red, hard, warm to touch and painful per pt on right thigh.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site discharge, Purulent discharge, Skin lesion, Staphylococcal skin infection
Clinical narrative: Localized tenderness, drainage from injection site "pus". Improving spontaneously. Small elevated lesion with 2 mm surrounding erythema, without induration - c/w minor staph skin infection.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Localized tenderness, drainage from injection site "pus". Improving spontaneously. Small elevated lesion with 2 mm surrounding erythema, without induration - c/w minor staph skin infection.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Pt had PNEUMOVAX vaccine on 10/20/14 and began having symptoms of swelling, erythema at site, and pain to touch on 10/21/14. Pt has history of a plate and pins in right arm. Pt treated cellulitis on 10/27/14 and referred to primary physician for further evaluation and ortho patient.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Pain, Rash
Clinical narrative: Received inj on 10/25/14. Had severe pain and soreness for 3 weeks. MD Rash just extreme soreness in arm and under arm.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, erythema, and tenderness (R) upper arm (Bi upper bicep/tricep area increased 2-3 cmarea (L) arm diameter) - developed approx 1 day s/p getting TDaP, MENACTRA in that arm. Seen on exam 2 days s/p vaccine.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Blindness, Hyperhidrosis, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Within 5 minutes of administration of flu vaccine, patient complained of loss of vision. Patient fainted but was grabbed by mother so he didn't fall. Patient was pale, diaphoretic and sporadically unresponsive. After 45 minutes of laying flat and drinking fluids, patient recovered.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspepsia, Feeling cold, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Lump in throat, heartburn, vomiting, hot/sweating couple hrs later. Couldn't get warm at night/bedtime. Headache next day.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Sensation of foreign body, Vomiting
Clinical narrative: Lump in throat, heartburn, vomiting, hot/sweating couple hrs later. Couldn't get warm at night/bedtime. Headache next day.
Age: 46.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Itching, pain, swollen, redness on injections area. Pt. taking ibuprofen and applying ice to affected area. Pt. had a fever yesterday.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Burning sensation, Chest discomfort, Eye swelling, Skin warm
Clinical narrative: Within approximately 5 min of receiving Flu shot the recipient felt drowsy and warm on face. Recipient had makeup on so didn't notice rash or skin color changes, nor swelling. At 5:30PM while driving to her home she noticed eyes and face swelling, burning in face and chest pressure.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Somnolence, Swelling face
Clinical narrative: Within approximately 5 min of receiving Flu shot the recipient felt drowsy and warm on face. Recipient had makeup on so didn't notice rash or skin color changes, nor swelling. At 5:30PM while driving to her home she noticed eyes and face swelling, burning in face and chest pressure.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: 10-4-14 Immunization given (L) arm approximately 1215. By 1600, arm sore. By 1800 could not move arm away from body - much pain. No sleep that night. Mon. went to pharmacy and told no other reactions reported and to call you. Arm was 99% better by Thurs. (10-8).
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Injection site warmth, Local swelling, Malaise, Pyrexia
Clinical narrative: Pt stated swelling and heat at the injection site and that she developed a fever. Felt ill and stated arm was very swollen for 3 days.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Guillain Barre and/or transverse myelitis.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blister, Chills, Diarrhoea, Erythema, Fatigue
Clinical narrative: Nausea/diarrhea - headache for 2 wks. Chills/low grade fever. Muscle aches muscle spasms (legs) chronic fatigue saw PCP 10/21 (VALTREX - Blisters chest legs) (prednisone severe reaction red/swollen face).
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Muscle spasms, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea/diarrhea - headache for 2 wks. Chills/low grade fever. Muscle aches muscle spasms (legs) chronic fatigue saw PCP 10/21 (VALTREX - Blisters chest legs) (prednisone severe reaction red/swollen face).
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Swelling face
Clinical narrative: Nausea/diarrhea - headache for 2 wks. Chills/low grade fever. Muscle aches muscle spasms (legs) chronic fatigue saw PCP 10/21 (VALTREX - Blisters chest legs) (prednisone severe reaction red/swollen face).
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: Flu Mist applied at 1425, client reported to have nose bleed at 1600, which resolved shortly after. No other symptoms or complications observed or reported. At this time no treatment required.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Dyspnoea, Myalgia, Pain
Clinical narrative: Obtained FLUZONE shot at approximately 11:00 AM in the morning. A friend was with me at the time. Walked to my car and suddenly had shortness of breath and chest discomfort. Proceeded with chores and within perhaps an hour my muscles began to ache in arms, legs, buttocks, etc. I arrived home and sat down and my temperature was starting to climb. I became very chilled and I called my friend to come over as she was with me when I got the shot. By about 8:00 PM my fever was 103 degrees and I called the doctor, and she suggested I take TYLENOL and I did so. I had to have assistance to the bathroom and assistance to sit on toilet. I was in pain and not thinking properly. At about 2:00 AM I turned on my right side to sleep and my heart started to throb and palpitate profusely. During the fever issue I applied cold towels to my face to bring fever down. I have visited with my primary care doctor. I visited on 10/20/14 and she was certain I had the flu from the shot. I will no longer take this double dose.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Pyrexia, Thinking abnormal
Clinical narrative: Obtained FLUZONE shot at approximately 11:00 AM in the morning. A friend was with me at the time. Walked to my car and suddenly had shortness of breath and chest discomfort. Proceeded with chores and within perhaps an hour my muscles began to ache in arms, legs, buttocks, etc. I arrived home and sat down and my temperature was starting to climb. I became very chilled and I called my friend to come over as she was with me when I got the shot. By about 8:00 PM my fever was 103 degrees and I called the doctor, and she suggested I take TYLENOL and I did so. I had to have assistance to the bathroom and assistance to sit on toilet. I was in pain and not thinking properly. At about 2:00 AM I turned on my right side to sleep and my heart started to throb and palpitate profusely. During the fever issue I applied cold towels to my face to bring fever down. I have visited with my primary care doctor. I visited on 10/20/14 and she was certain I had the flu from the shot. I will no longer take this double dose.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic shock
Clinical narrative: Flu shot was given at 6:00PM. He went into anaphylactic shock at 9:00PM. Ambulance had to be called at 11:00PM. Patient went to the hospital where he had a full recovery.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Dyspnoea, Erythema, Headache, Ocular hyperaemia
Clinical narrative: Rash, dyspnea. Given steroids 10/14/14 at U.C. Returned to urgent care 10/15/14 after waking up with face burning, red from eyes to shoulders, stabbing headache on top of head, ringing in ears (still present 10/28/14).
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Tinnitus
Clinical narrative: Rash, dyspnea. Given steroids 10/14/14 at U.C. Returned to urgent care 10/15/14 after waking up with face burning, red from eyes to shoulders, stabbing headache on top of head, ringing in ears (still present 10/28/14).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Decreased appetite, Dizziness, Erythema, Eye pain
Clinical narrative: Received PNEUMOVAX injection 9/29/14 about 1 pm at pharmacy. By that evening my arm was red, swollen and very sore - redness was large area surrounding the injection site which was in back of left arm. Next day 9/30/01 fever was 103 - called pharmacy and was told to take TYLENOL. 10/114 - area of redness had progressed with streaks of redness toward back - continued to be very sore, red and swollen - temp 101 - called pharmacy was told to go to ER. Was seen in ER - temp down by then - had taken TYLENOL, but arm still very reddened, swollen and sore - Picture attached that was taken in ER. See by MD and was told never to take vaccine again as the next time the reaction will be worse. Was sent home with prescription for KEFLEX which I started taking that evening. Had been sleeping almost non-stop since Monday evening with no appetite, very nauseated and weak. 10/2/14 - I awoke with lesion on left eyelid, red eye and sores in nose - I thought I had a stye - used moisture eye drops to relieve the symptoms - very painful eye. Still feeling very weak with no appetite with periods of lightheadedness and felt like I was going to pass out. Still sleeping most od the time. Gradually the redness went away, but arm continued to be sore, itching and hypersensitive to clothing. Eye continued to get worse. 10/7/14 - saw my eye doctor and was told I had herpes in eye and nose due to the low resistance from the pneumonia shot. Was prescribed Acyclovir for the herpes and an antibiotic eye ointment. Gradually started to feel better but lightheadedness remained for another week or so. Left arm continues to hurt, itches even after almost 5 weeks post injection.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Herpes ophthalmic, Hypersensitivity, Hypersomnia, Injection site erythema, Injection site streaking
Clinical narrative: Received PNEUMOVAX injection 9/29/14 about 1 pm at pharmacy. By that evening my arm was red, swollen and very sore - redness was large area surrounding the injection site which was in back of left arm. Next day 9/30/01 fever was 103 - called pharmacy and was told to take TYLENOL. 10/114 - area of redness had progressed with streaks of redness toward back - continued to be very sore, red and swollen - temp 101 - called pharmacy was told to go to ER. Was seen in ER - temp down by then - had taken TYLENOL, but arm still very reddened, swollen and sore - Picture attached that was taken in ER. See by MD and was told never to take vaccine again as the next time the reaction will be worse. Was sent home with prescription for KEFLEX which I started taking that evening. Had been sleeping almost non-stop since Monday evening with no appetite, very nauseated and weak. 10/2/14 - I awoke with lesion on left eyelid, red eye and sores in nose - I thought I had a stye - used moisture eye drops to relieve the symptoms - very painful eye. Still feeling very weak with no appetite with periods of lightheadedness and felt like I was going to pass out. Still sleeping most od the time. Gradually the redness went away, but arm continued to be sore, itching and hypersensitive to clothing. Eye continued to get worse. 10/7/14 - saw my eye doctor and was told I had herpes in eye and nose due to the low resistance from the pneumonia shot. Was prescribed Acyclovir for the herpes and an antibiotic eye ointment. Gradually started to feel better but lightheadedness remained for another week or so. Left arm continues to hurt, itches even after almost 5 weeks post injection.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Nasal ulcer, Nausea, Ocular hyperaemia, Pain in extremity
Clinical narrative: Received PNEUMOVAX injection 9/29/14 about 1 pm at pharmacy. By that evening my arm was red, swollen and very sore - redness was large area surrounding the injection site which was in back of left arm. Next day 9/30/01 fever was 103 - called pharmacy and was told to take TYLENOL. 10/114 - area of redness had progressed with streaks of redness toward back - continued to be very sore, red and swollen - temp 101 - called pharmacy was told to go to ER. Was seen in ER - temp down by then - had taken TYLENOL, but arm still very reddened, swollen and sore - Picture attached that was taken in ER. See by MD and was told never to take vaccine again as the next time the reaction will be worse. Was sent home with prescription for KEFLEX which I started taking that evening. Had been sleeping almost non-stop since Monday evening with no appetite, very nauseated and weak. 10/2/14 - I awoke with lesion on left eyelid, red eye and sores in nose - I thought I had a stye - used moisture eye drops to relieve the symptoms - very painful eye. Still feeling very weak with no appetite with periods of lightheadedness and felt like I was going to pass out. Still sleeping most od the time. Gradually the redness went away, but arm continued to be sore, itching and hypersensitive to clothing. Eye continued to get worse. 10/7/14 - saw my eye doctor and was told I had herpes in eye and nose due to the low resistance from the pneumonia shot. Was prescribed Acyclovir for the herpes and an antibiotic eye ointment. Gradually started to feel better but lightheadedness remained for another week or so. Left arm continues to hurt, itches even after almost 5 weeks post injection.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Skin lesion
Clinical narrative: Received PNEUMOVAX injection 9/29/14 about 1 pm at pharmacy. By that evening my arm was red, swollen and very sore - redness was large area surrounding the injection site which was in back of left arm. Next day 9/30/01 fever was 103 - called pharmacy and was told to take TYLENOL. 10/114 - area of redness had progressed with streaks of redness toward back - continued to be very sore, red and swollen - temp 101 - called pharmacy was told to go to ER. Was seen in ER - temp down by then - had taken TYLENOL, but arm still very reddened, swollen and sore - Picture attached that was taken in ER. See by MD and was told never to take vaccine again as the next time the reaction will be worse. Was sent home with prescription for KEFLEX which I started taking that evening. Had been sleeping almost non-stop since Monday evening with no appetite, very nauseated and weak. 10/2/14 - I awoke with lesion on left eyelid, red eye and sores in nose - I thought I had a stye - used moisture eye drops to relieve the symptoms - very painful eye. Still feeling very weak with no appetite with periods of lightheadedness and felt like I was going to pass out. Still sleeping most od the time. Gradually the redness went away, but arm continued to be sore, itching and hypersensitive to clothing. Eye continued to get worse. 10/7/14 - saw my eye doctor and was told I had herpes in eye and nose due to the low resistance from the pneumonia shot. Was prescribed Acyclovir for the herpes and an antibiotic eye ointment. Gradually started to feel better but lightheadedness remained for another week or so. Left arm continues to hurt, itches even after almost 5 weeks post injection.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Pain, Photophobia
Clinical narrative: Whole arm turned red across from shot - hot, body aches, sensitive to light, couldn't go in sun, fever, broke out in rash, red some on chest, face, itching, diarrhea, exhaustion. By evening I was experiencing symptoms.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Pyrexia, Rash, Skin warm
Clinical narrative: Whole arm turned red across from shot - hot, body aches, sensitive to light, couldn't go in sun, fever, broke out in rash, red some on chest, face, itching, diarrhea, exhaustion. By evening I was experiencing symptoms.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomiting = 2 pm-7 pm day of shot.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site approx 12 hrs later. Ice and BENADRYL.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Inflammation, Injection site swelling, Skin warm
Clinical narrative: 10-29-14 Right upper arm: inflamed, raised area around where vaccinated 3 inch height 4 1/2 inch diameter. Hard core 1 inch in size. Hot to touch, red. 10/30/14: about 1/3 of original size. Pt says no pain and no impediment to movement at all.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Feeling abnormal, Musculoskeletal stiffness
Clinical narrative: Stiff arm starting day after vaccine that continues to present day. On day 7-8, felt terrible for 24 hours (loss of appetite, weak). Biggest complaint is stiffness in arm. Did not take anything to treat.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: FLUZONE admin (R) del IM about 945a. C/O intense itching about 9:54am. Denies SOB/D/B. BP 104/76. BENADRYL 25mg IM about 9:58am. Expressed decreased itching about 10:04am. Monitored x 15 m. relays almost complete resolvement of itching 1015am. BP 110/70.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Osteoarthritis
Clinical narrative: Severe muscle aches and weakness in both legs within 24 hrs. after flu shot. After 1 week, right leg is better, but continues in left leg. Left leg flare up of osteoarthritis in knee.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Feeling cold, Feeling hot, Nausea, Pyrexia
Clinical narrative: Got shot 10/23. Pt. reports chills and fever. By 3.5 hrs after, 7PM felt chills, "heat", and "on the verge of nausea". Fell asleep, woke up next day at 10AM with temp of 100.5 F, but felt "as though it was 105 F". It lasted until 1-2PM Saturday 10/24, so about 18 hours, then symptoms went away abruptly.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient received 3 vaccines on 10-21-14 (FLUZONE HD, PNEUMOVAX 23 and ZOSTAVAX). On 10-24-14, patient reported to the pharmacist and store manager that she was unable to move her right arm. This was the arm where she got the ZOSTAVAX. Patient was advised to go to ER, where she was prescribed pain med and an antiinflammatory. Patient followed up with management after leaving the ER, but her phone # is disconnected.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: (L) upper arm swelling, N and V, 7 cm softball size knot in (L) deltoid area, warm and tender to touch. Advised ice and PO BENADRYL.
Age: 12.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Local swelling, Skin warm, Tenderness
Clinical narrative: Vaccinations for Tdap and Meningococcal given on 10-14-14. On 10/15/14, pt's arm was swollen and tender and warm to touch. Mother called our clinic on 10/16/14 and reports swelling has decreased, not tender or warm.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Pt reports redness and swelling in right arm 24 hours after vaccination administration. States that swelling and redness has spread significantly each day. Advised patient to seek medical care. Patient was reluctant to give info and claims she would be calling a lawyer.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician concerning an 8 week old female patient. The patient had no pertinent medical history and no known drug reactions or allergies. On 06-AUG-2014 the patient was vaccinated with her first dose of ROTATEQ (Lot # not provided) 2 ml, oral. Concomitant therapies administered on 06-AUG-2014 included RECOMBIVAX HB (dose, route and lot # not provided) and PENTACEL. Patient's mom reported that patient started having urticaria within 12-16 hours of receiving vaccines, on approximately 06-AUG-2014. Patient was not seen by physician for that first urticaria reaction and urticaria subsided quickly (on an unknown date in 2014). Then, patient received her second dose of ROTATEQ (Lot # not provided) 2 ml, oral, on 08-OCT-2014 and again within 24 hours of receiving ROTATEQ, the patient developed urticaria. Following day, patient was brought into the office and physician examined her and diagnosed urticaria. By the time physician saw the patient, urticaria has already started to subside and patient was not given any treatment. There were not laboratory tests or diagnostic studies performed. At the time of the report, the patient was recovering from urticaria. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Erythema, Eye discharge, Eyelid oedema
Clinical narrative: 5P Red - scratchy - discharge - eyes - 2 hrs. 6P Cough - 1 hr. 7P Chills - tremors - 6 hrs. 8P Swollen upper lip. 8P Swollen eyelids and under eyes > 20 hrs.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Scratch, Tremor
Clinical narrative: 5P Red - scratchy - discharge - eyes - 2 hrs. 6P Cough - 1 hr. 7P Chills - tremors - 6 hrs. 8P Swollen upper lip. 8P Swollen eyelids and under eyes > 20 hrs.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to an unspecified patients of unknown age and gender. On 02-AUG-2014, doses of RECOMBIVAX HB were exposed to an unsupported temperature excursion of -1C for "5 to 16 hours". On an unspecified dates since 02-AUG-2014, RECOMBIVAX HB (lot # J012567; expiration date: 30-JAN-2016) (dose and route were not reported) were administered to unspecified patients. No adverse effect has been observed or reported. Follow up has been received from a pharmacist on 14-OCT-2014 concerning 12 patients. For the 7 patients demographics was updated. This is one of several report received from the same reporter. Follow up has been received from a pharmacist on 20-OCT-2014 concerning a patient of an unknown age and gender. The reporter provided another RECOMBIVAX HB lot number J012520, expiration date: 30-JAN-2016 that was improperly stored and would have been included in the original report. Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 55 year old patient of unknown gender. On 08-OCT-2014, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # K009198 exp 27-SEP-2015) subcutaneously. The pharmacist reported that on approximately 29-OCT-2014, "three weeks after vaccination", the patient experienced rash at the injection site with a great deal of pain that goes deep into the muscle. The pharmacist stated that she did not believe rash was shingles. The patient did not receive treatment for the adverse events. There were no Lab diagnosis or studies performed. The outcome of rash at the injection site with great deal of pain that does deep into the muscle was reported as not recovered/not resolved (also reported as patient reported rash was showing improvement). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, Measles antibody positive, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to her daughter, a female patient of unknown age. Concurrent conditions and medical history was not reported. On an unknown date, the patent was vaccinated with MMR II injection (route, dose and lot number were unknown), but the facility did not record the first vaccination. On an unknown date, the reporter stated that her daughter received MMR II twice. No concomitant medications were reported. On an unknown date her daughter's blood titers were positive for measles and rubella, but was negative for mumps. The outcome of the event was unknown. Causality assessment was not reported. Product quality complaint was not reported. No additional adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to an unspecified patients of unknown age and gender. On 02-AUG-2014, doses of RECOMBIVAX HB were exposed to an unsupported temperature excursion of -1C for "5 to 16 hours". On an unspecified dates since 02-AUG-2014, RECOMBIVAX (lot # J012567; expiration date 30-JAN-2016) (dose and route were not reported) were administered to unspecified patients. No adverse effect has been observed or reported. Follow up has been received from a pharmacist on 14-OCT-2014 concerning 12 patients. For the 7 patients demographics was updated. This is one of several report received from the same reporter. Follow up has been received from a pharmacist on 20-OCT-2014 concerning a patient of an unknown age and gender. The reporter provided another RECOMBIVAX HB lot number J012520, expiration date: 30-JAN-2016 that was improperly stored and would have been included in the original report. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Feeling abnormal, Urinary incontinence
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself. Pertinent medical history included arthritis and drug reaction/allergies penicillin (dosage/frequency/manufacturer unknown). On 03-OCT-2014 the patient was vaccinated with ZOSTAVAX (1 single shot, route of administration and dose was not reported). Unspecified blood pressure medication was reported as concomitant medication. On 18-OCT-2014, patient felt funny, stood up and urine just came pouring out of her. She also experienced profuse cold sweating. No treatment was given for adverse event. No lab diagnostic studies performed. Patient did not seek medical attention. The outcome of the events was reported as recovered/resolved on 18-OCT-2014. Relatedness between events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to an unspecified patients of unknown age and gender. On 02-AUG-2014, doses of RECOMBIVAX HB were exposed to an unsupported temperature excursion of -1C for "6 to 16 hours". On an unspecified date since 020-AUG-2014, RECOMBIVAX HB (lot # J012567; expiration date; 30-JAN-2016) (dose and route were not reported) were administered to unspecified patients. No adverse effect has been observed or reported. This is one of several reports received from the same reporter.  Follow up has been received from the pharmacist on 20-OCT-2014 concerning a patient of unknown age and gender. The reporter provided another RECOMBIVAX HB lot number J012520, expiration date: 30-JAN-2016 that was improperly stored and would have been included in the original report. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to an unspecified patients of unknown age and gender. On 02-AUG-2014, doses of RECOMBIVAX HB were exposed to an unsupported temperature excursion of -1C for "5 to 16 hours". On an unspecified dates since 02-AUG-2014, RECOMBIVAX HB (lot # J012567; expiration date 30-JAN-2016) (dose and route were not reported were administered to unspecified patients. No adverse effect has been observed or reported.  Follow up has been received from a pharmacist on 14-OCT-2014 concerning 12 patients. For the 7 patients demographics was updated. This is one of several report received from the same reporter.   Follow up has been received from a pharmacist on 20-OCT-2014 concerning a patient of unknown age and gender. The reporter provided another RECOMBIVAX HB lot number J012520, expiration date: 30-JAN-2016 that was improperly stored and would have been included in the original report. Additional information has been requested.