chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Mass, Pyrexia, Tenderness
Clinical narrative: Redness, tenderness, lump, fever. No treatment except ice and Tylenol.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Hypersensitivity
Clinical narrative: Patient: Mother state that following vaccine. Patient was taken to hospital and diagnosed with an allergic reaction.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, pruritis at site of injection.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Vertigo
Clinical narrative: Patient experienced "spinning" sensation when getting out of bed in the early morning, nausea x 4 hours.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and 'swelling' from shoulder to elbow on Rt arm where client received vaccine.  States child uses arm with no voiced pain, though is tender to touch. Mother used cold compresses on 8/15/12.  Recommended intermittent warm compresses today with Tylenol or Ibuprofen for discomfort. Mother to contact physician if no improvement by 8/18/12.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Fever of 102, rashes, chicken pox like bumps.
Age: 0.46
Sex: F
Vaccine: RVX
Symptoms: Abdominal X-ray, Abdominal pain, Enema administration, Vomiting, White blood cell count increased
Clinical narrative: Abdominal pain, vomiting, no diarrhea.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site warmth, Oedema peripheral, Pruritus
Clinical narrative: Received Immunization on 8/6/12. Father states some redness noted on right upper am. States by next day, 8/7/12, arm was red, swollen, and looked hot to touch.  Child also c/o itching.   On visit to clinic today 8/9/12, has hot redden area the size of a baseball on the upper right arm. States child was taken to the ER 8/8/12 and was given a "steroid shot" and was to take Benadryl every eight hours.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Skin warm
Clinical narrative: Received Immunization on 8/6/12. Father states some redness noted on right upper am. States by next day, 8/7/12, arm was red, swollen, and looked hot to touch.  Child also c/o itching.   On visit to clinic today 8/9/12, has hot redden area the size of a baseball on the upper right arm. States child was taken to the ER 8/8/12 and was given a "steroid shot" and was to take Benadryl every eight hours.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: MEDICATION ERROR - PT GIVEN PEDIARIX (dTAP, IPOL, HEPB) and IPOL.
Age: 56.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Broke out with red, itchy rash. This has continued on and off with 3 more outbreaks since.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site haematoma, Injection site pain, Pruritus
Clinical narrative: Bruising and mild pain at administration site, two days later redness had spread about three inches in diameter, it feels like a welt, itchy, pain had increased, still a bruise at administration site.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Cough, Dizziness, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Per Pt had received immunizations around 11:00am (TDaP, MCV4, VAR, Hep A, HPV).  Pt had stayed 15mins after immunizations were given and was ok before left off-site clinic-per Mom.   After left off-site clinic, went walking around school and then to the bank, after got at the bank Pt started c/o of sore throat so Mom got Pt a soda and she consumed 1/2 of it-per Mom.  At 11:50am Mom had brought Pt back to off-site clinic.  Pt was c/o runny nose, cough, HA, shake, dizzy, and sore/tight throat.  Pt assessment done-sitting in chair, skin color pink and dry, lungs CTA, resp rate strong and regular, no cough noted, heart sounds strong and regular, nail beds pink, oriented x3.  Pt stated she had only eaten 1/2 cup turkey salad at 8:30am today.  Mom stated Pt has history of seasonal allergies and asthma, but no asthma flare-up since 6yrs of age.  Pt was monitored for approx 30mins, still no resp distress noted.  Pt stated she felt some better before leaving off-site clinic again.  Mom was instructed if Pt was to have this episode again to go to the nearest ER or seek medical attention and would need to get next imm at doctor office.  Mom verbalized understanding.  Mom stated she was going to get Pt some OTC Benadryl to have at home in case.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Throat tightness, Tremor
Clinical narrative: Per Pt had received immunizations around 11:00am (TDaP, MCV4, VAR, Hep A, HPV).  Pt had stayed 15mins after immunizations were given and was ok before left off-site clinic-per Mom.   After left off-site clinic, went walking around school and then to the bank, after got at the bank Pt started c/o of sore throat so Mom got Pt a soda and she consumed 1/2 of it-per Mom.  At 11:50am Mom had brought Pt back to off-site clinic.  Pt was c/o runny nose, cough, HA, shake, dizzy, and sore/tight throat.  Pt assessment done-sitting in chair, skin color pink and dry, lungs CTA, resp rate strong and regular, no cough noted, heart sounds strong and regular, nail beds pink, oriented x3.  Pt stated she had only eaten 1/2 cup turkey salad at 8:30am today.  Mom stated Pt has history of seasonal allergies and asthma, but no asthma flare-up since 6yrs of age.  Pt was monitored for approx 30mins, still no resp distress noted.  Pt stated she felt some better before leaving off-site clinic again.  Mom was instructed if Pt was to have this episode again to go to the nearest ER or seek medical attention and would need to get next imm at doctor office.  Mom verbalized understanding.  Mom stated she was going to get Pt some OTC Benadryl to have at home in case.
Age: 40.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Activities of daily living impaired, Adverse drug reaction, Blood test, Diarrhoea, Flank pain
Clinical narrative: 1. Immunization administered 8/10/2012 (MMR, Tdap, Hepatitis B).  2. Client returned to clinic on 08/15/2012 with c/o and visible swelling to upper lip (onset 08/14/2012) and c/o diarrhea on 08/11/2012. Denied any prior reaction to any vaccine or vaccine components. Also c/o pain to (r) flank area with deep breath. One prior occasion of similiar incident several years ago, not corresponding with vaccine. Referred to ER for evaluation, instructed to call with update.  3. 8/16/2012 no call from patient on 8/15/2012 as instructed. Call placed to client informed writer that ER MD diagnosed with reaction to current BP med. (Lisinopril) and introduction of vaccine into system creating an adverse event. States given a cortisone shot, BP med changed, and relieved from work until Saturday.
Age: 40.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Lip swelling, Painful respiration
Clinical narrative: 1. Immunization administered 8/10/2012 (MMR, Tdap, Hepatitis B).  2. Client returned to clinic on 08/15/2012 with c/o and visible swelling to upper lip (onset 08/14/2012) and c/o diarrhea on 08/11/2012. Denied any prior reaction to any vaccine or vaccine components. Also c/o pain to (r) flank area with deep breath. One prior occasion of similiar incident several years ago, not corresponding with vaccine. Referred to ER for evaluation, instructed to call with update.  3. 8/16/2012 no call from patient on 8/15/2012 as instructed. Call placed to client informed writer that ER MD diagnosed with reaction to current BP med. (Lisinopril) and introduction of vaccine into system creating an adverse event. States given a cortisone shot, BP med changed, and relieved from work until Saturday.
Age: 16.0
Sex: M
Vaccine: RAB
Symptoms: Cough, Decreased appetite, Nausea
Clinical narrative: Cough, nausea, loss of appetite.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Dizziness, Headache, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: HA, dizziness, myalgia, malaise, swollen (axillary) lymph node, nightsweats, fever, rash, pruritis. Clinical evaluation.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Night sweats, Pruritus, Pyrexia, Rash
Clinical narrative: HA, dizziness, myalgia, malaise, swollen (axillary) lymph node, nightsweats, fever, rash, pruritis. Clinical evaluation.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Eye haemorrhage
Clinical narrative: Mother calling to state daughter developed a 1/4 inch broken blood vessel in the outer rt aspect of her eye that she noticed at around 3pm this afternoon.  Mother states pt has no other sx and denies headache, fever or vision loss.  Mothers state her only concern is that pt had her vaccines yesterday.  Mother would like to know what to watch for.  Mother aware to monitor the eye and contact our clinic or ER in the event that pt develops headache, fever, or visual problems.  Mother will call a medical facility if other sx occur in which she has questions about.  CDC paperwork to be completed.  Mother will report to the our office tomorrow to inform us of her sx.
Age: 36.0
Sex: F
Vaccine: HEPAB, IPV, HEPAB, IPV
Symptoms: Arthralgia, Back pain, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatine phosphokinase normal
Clinical narrative: Patient states: "severe muscle pain, lower back pain, joint pain, and just hurt all over, including neck and shoulders, can't even make a fist, or hold my child's hand without pain".  Also complains of tenderness to touch on arms and back.
Age: 36.0
Sex: F
Vaccine: HEPAB, IPV, HEPAB, IPV
Symptoms: Full blood count normal, Hepatitis B core antibody negative, Hepatitis B surface antigen negative, Musculoskeletal pain, Myalgia
Clinical narrative: Patient states: "severe muscle pain, lower back pain, joint pain, and just hurt all over, including neck and shoulders, can't even make a fist, or hold my child's hand without pain".  Also complains of tenderness to touch on arms and back.
Age: 36.0
Sex: F
Vaccine: HEPAB, IPV, HEPAB, IPV
Symptoms: Neck pain, Pain, Platelet disorder, Tenderness, Urine analysis normal
Clinical narrative: Patient states: "severe muscle pain, lower back pain, joint pain, and just hurt all over, including neck and shoulders, can't even make a fist, or hold my child's hand without pain".  Also complains of tenderness to touch on arms and back.
Age: 36.0
Sex: F
Vaccine: HEPAB, IPV, HEPAB, IPV
Symptoms: Blood test, Muscular weakness, Myalgia
Clinical narrative: Patient states: "severe muscle pain, lower back pain, joint pain, and just hurt all over, including neck and shoulders, can't even make a fist, or hold my child's hand without pain".  Also complains of tenderness to touch on arms and back.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, pain, itching at left deltoid x one day.  10x11 cm area of erythema on exam.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Cough, Urticaria
Clinical narrative: Severe cough, whelps on face. Visited emergency department and was given epinephrine, Benadryl and Rx for prednisone.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Laceration, Penile haemorrhage, Penile operation
Clinical narrative: This spontaneous report as received from a consumer refers to a 51 years old husband with no drug allergies or reactions. The patient's medical history included shingles and restless leg syndrome. The patient was vaccinated subcutaneously with, .65 ZOSTAVAX (lot # not reported) on 16-JUN-2012. No other co-suspects were reported. Concomitant medications included acetaminophen, LORTAB, warfarin and AMBIEN. The patient's wife reported that on 14-JUL-2012, her husband developed a tear in his penis after having ZOSTAVAX vaccination. She explained that her husband's penis filled with blood as if he were having an erection after already having had intercourse immediately before this event, after this occurred the skin on the penis broke and began to "bleed out". Reporter explained that her husband has had to have surgeries beginning on 18-JUL-2012 to correct this issue and had received various forms of treatment associated with these surgeries (medically significant upon internal review). At the time of the report, the reporter's husband had also developed a shingles outbreak in large half dollar sized lesions all over his body. Unspecified tests had been conducted. The outcome of the events was reported as recovering/resolving. The patient sought medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Loss of consciousness
Clinical narrative: Patient passed out three times, starting 15 minutes after injection given. All happened over 10-15 minute time span. She was given food and drink. Felt better. Reported feeling tired. All happened at patients home.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash to forearms, legs, chest and abdomen developed one day after vaccine administered. Denies use of new skin laundry products or new foods.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Dizziness, Dyspnoea, Headache, Injection site erythema
Clinical narrative: Erythema, swelling, warmth, feeling of heaviness and pain at injection site. Patient experienced headache, dizziness, palpitations and SOB. After several days patients arm felt like it had a bruise. Had a lump.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Palpitations, Sensation of heaviness
Clinical narrative: Erythema, swelling, warmth, feeling of heaviness and pain at injection site. Patient experienced headache, dizziness, palpitations and SOB. After several days patients arm felt like it had a bruise. Had a lump.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Upper extremity mass
Clinical narrative: Erythema, swelling, warmth, feeling of heaviness and pain at injection site. Patient experienced headache, dizziness, palpitations and SOB. After several days patients arm felt like it had a bruise. Had a lump.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster (shingles). Pt treated w/ FAMVIR 50, 1 po TID and given NEURONTIN 100 mg 1 po TID
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 102*, body aches.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Gaze palsy, Malaise, Muscle twitching
Clinical narrative: Pt received HPV while sitting in a chair in exam room.  Nursing staff stepped out to get a supply for a blood draw and came back in to notice patient not looking well.  Patient stated she was seeing stars so nursing staff assisted her to exam table and had her lie down.  As patient was lying down her eyes rolled back and she had some twitching of her right arm. Pulse oximeter applied.  Read at 98%. O2 administered.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Crying, Eye irritation, Fatigue, Headache
Clinical narrative: 102 temperature, severe body aches, muscle tenderness, fatigue, uncontrollable crying, severe headache, "burning" eyes.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pain
Clinical narrative: 102 temperature, severe body aches, muscle tenderness, fatigue, uncontrollable crying, severe headache, "burning" eyes.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Terrible pain upper left shoulder radiating down to fore arm. Hasn't let up for 12 or more hours. To Primary Doc-given steroids.
Age: 0.53
Sex: F
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction
Clinical narrative: Co-worker called to state that child was diagnosed with whooping cough. Both mother and child placed on Zithromax and a nasal swab was done of child on 08/15/2012.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 4-6 inch diameter localized, reddish-purple, warm-to-touch, hard area around administration site.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Full blood count normal, Tremor, X-ray normal
Clinical narrative: Given Tylenol after left clinic (10:45), Tylenol 4 hours later, after that time patient was "asleep", shaking lasted 10-15 minutes. Denies eye rolling, severe stiff, jerky movements. Patient was taken to ER via ambulance. All labs, X-rays negative at hospital.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Cellulitis, Chills, Cough, Fatigue
Clinical narrative: Rash on arm in area of injection, followed over the next days by myalgias, chills, sweats, malaise and fatigue, and on 8/16 by cough.  White blood cells are elevated at 14.5.  She has a rash that could be cellulitis, but several smaller circular rashes a few cm away from the main rash also.  Drug reaction vs cellulitis vs both suspected.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Granulocyte percentage, Hyperhidrosis, Injection site rash, Malaise, Myalgia
Clinical narrative: Rash on arm in area of injection, followed over the next days by myalgias, chills, sweats, malaise and fatigue, and on 8/16 by cough.  White blood cells are elevated at 14.5.  She has a rash that could be cellulitis, but several smaller circular rashes a few cm away from the main rash also.  Drug reaction vs cellulitis vs both suspected.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Rash, White blood cell count increased
Clinical narrative: Rash on arm in area of injection, followed over the next days by myalgias, chills, sweats, malaise and fatigue, and on 8/16 by cough.  White blood cells are elevated at 14.5.  She has a rash that could be cellulitis, but several smaller circular rashes a few cm away from the main rash also.  Drug reaction vs cellulitis vs both suspected.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and Swelling around injection site noticed around 2:00 PM.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Cough, Erythema, Flushing, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Patient started coughing, had a runny nose, and watery bloodshot eyes as we were leaving the doctor's office.  We got to the car and we knew something was not right with him, drinking water was not calming his cough.  Patient had an allergic reaction to a walnut about a year prior, and it started this way.  We went back into the doctor's office, and a nurse brought us into a room and brought in Benadryl immediately.  Patient's face was now red/flushed.  The nurses and doctor we had just seen came in and looked him over, and listened to his breathing.  Patient's pediatrician said she could hear some faint wheezing when he breathed deeply.  They observed patient for approximately 20 - 30 minutes, the coughing and runny nose had calmed and slowed down, but Dr patient was not recovering enough from the Benadryl and she made the decision to administer an Epipen and call an ambulance to transport us to the ER.  At the hospital, patient was given more Benadryl, a steroid and Pepcid.  We were in the hospital for observation for approx. 5 hours before being discharged.  Patient is currently taking a 4-day steroid and has not had any more reactions so far.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rhinorrhoea, Wheezing
Clinical narrative: Patient started coughing, had a runny nose, and watery bloodshot eyes as we were leaving the doctor's office.  We got to the car and we knew something was not right with him, drinking water was not calming his cough.  Patient had an allergic reaction to a walnut about a year prior, and it started this way.  We went back into the doctor's office, and a nurse brought us into a room and brought in Benadryl immediately.  Patient's face was now red/flushed.  The nurses and doctor we had just seen came in and looked him over, and listened to his breathing.  Patient's pediatrician said she could hear some faint wheezing when he breathed deeply.  They observed patient for approximately 20 - 30 minutes, the coughing and runny nose had calmed and slowed down, but Dr patient was not recovering enough from the Benadryl and she made the decision to administer an Epipen and call an ambulance to transport us to the ER.  At the hospital, patient was given more Benadryl, a steroid and Pepcid.  We were in the hospital for observation for approx. 5 hours before being discharged.  Patient is currently taking a 4-day steroid and has not had any more reactions so far.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Cough, Nasal congestion
Clinical narrative: Patient started coughing, had a runny nose, and watery bloodshot eyes as we were leaving the doctor's office.  We got to the car and we knew something was not right with him, drinking water was not calming his cough.  Patient had an allergic reaction to a walnut about a year prior, and it started this way.  We went back into the doctor's office, and a nurse brought us into a room and brought in Benadryl immediately.  Patient's face was now red/flushed.  The nurses and doctor we had just seen came in and looked him over, and listened to his breathing.  Patient's pediatrician said she could hear some faint wheezing when he breathed deeply.  They observed patient for approximately 20 - 30 minutes, the coughing and runny nose had calmed and slowed down, but Dr patient was not recovering enough from the Benadryl and she made the decision to administer an Epipen and call an ambulance to transport us to the ER.  At the hospital, patient was given more Benadryl, a steroid and Pepcid.  We were in the hospital for observation for approx. 5 hours before being discharged.  Patient is currently taking a 4-day steroid and has not had any more reactions so far.
Age: 19.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: No adverse event
Clinical narrative: Pt has reported no side effects as of 08-16-12.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Left arm swelling with redness & tenderness. He was evaluated in the office on 6/7/12. Rx - BENADRYL syrup was given. Course - improved with Rx.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal behaviour, Dizziness, Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: Severe swelling in arm past injection site (to shoulder). Pain in arm and rash at site. Pt has dizziness and fever. Husband claims she is not acting like herself.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe swelling in arm past injection site (to shoulder). Pain in arm and rash at site. Pt has dizziness and fever. Husband claims she is not acting like herself.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No physical adverse effects: Patient was given what was believed to be his first injection of MENACTRA today in our clinic. After patient left and this RN was transcribing off copied card it was found that a Meningococcal injection had been charted under polio on patients very full card. This patient received MENACTRA injection at another facility on 7/25/2011. So it has only been 1 yr 1 month since patients last dose of this immunization. MD called the number listed for the CDC who asked that we also fill out a form on line with question as to possibility of ill effect. No known problem from this second injection today per what MD was told. Suggest that when transcribing on immunization card that immunizations not be "fit" into any space on card. This would help stop this.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: No adverse events noted. Patient came to get a meningitis vaccine. I dispensed MENVEO but did not realize there were 2 components to vaccine to be reconstituted. Patient only received the MENCYW135 liquid conjugate.
Age: 20.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Cellulitis, Erythema nodosum, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Morning after injection, pt noted itching and small reddened area at injection site. On 8/16/12 red firm area noted at injection site approx. 1 1/2" x 2" and warm pink area on arm measuring 2" wide x 7" long. (Site if (R) arm- upper subcutaneous- site of varicella vaccination). Provider suspects erythema nodosum vs cellulitis. Treated with Amoxicillin 500 mg tid.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Laboratory test, Nerve conduction studies, Neuralgia
Clinical narrative: Neuralgia - diffuse, non specific, 24 hr onset (8/7/12). Neurology -> consult cannot r/o acute ascending sensory polyneuropathy. No evidence of motor disorder.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dyspnoea, Wheezing
Clinical narrative: Patient complaining of chest pain, SOB, wheezing.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Erythema, Fatigue, Induration, Injection site swelling, Local swelling
Clinical narrative: Mother states it started approx 24 hours after injections given. Hard, red, swollen area at & below injection site, warm to touch. Denies fever. States patient acting "tired". Progressively getting bigger (L) upper arm. Mother was bringing him to doctor 8/16/12.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Skin warm
Clinical narrative: Mother states it started approx 24 hours after injections given. Hard, red, swollen area at & below injection site, warm to touch. Denies fever. States patient acting "tired". Progressively getting bigger (L) upper arm. Mother was bringing him to doctor 8/16/12.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin exfoliation
Clinical narrative: Approx 1 day after receiving injections child developed red, scaly area of injection site. Area getting larger - swollen & warm to touch - non-tender. No other effects, mom states child otherwise acting normally. If gets worse mom will bring to doctor. (Reported to H.D. 8/16/12).
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Patient reported on 8/16/12 she had rash from shoulder to shoulder & on face accompanying itching.
Age: 1.02
Sex: M
Vaccine: MMR, PNC
Symptoms: Varicella
Clinical narrative: Clinical chicken pox.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Malaise, Mobility decreased, Pain in extremity
Clinical narrative: Patient received pneumonia vaccine 8/13/12. Returned to office on 8/14/12 reporting painful L arm, decreased movement. Reported chills through the night & felt ill. Pt evaluated if officer no cellulitis or significant edema, but tender to touch.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Localized tissue reaction to (L) thigh (swelling, redness, warm to touch).
Age: 82.0
Sex: U
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed s/s shingles (R) 10th rib after shingle vaccine was administered 08/03/12.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Adverse reaction, Infection, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt c/o redness, warmth on right upper arm on 8/14/12. Along with pain, but no fever noted. Pt was seen at Dr office on 8/15/12 & dx with reaction vs early infection and placed on KEFLEX 500mg one tab q 12 hr for 10 days.
Age: 1.18
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: FLUMIST was given to child younger than 2 yrs of age. No reaction.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling left arm injection site.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 9 x 14 mm erythema, edema (R) upper arm non-tender site occurred 40- 48 hours after injection ice applied to (R) upper arm by parent.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report was received from a Doctor of Pharmacy concerning a 63 years old male patient with no pertinent medical history or drug reactions/allergies who on 13-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 672607/1716AA, expiration date on 02-FEB-2013). On 15-JUL-2012, the patient developed a large "welp" at the injection site after vaccination with ZOSTAVAX. At the time of the report, the patient had not recovered from the event. The patient contacted the pharmacist. The relatedness for large whelp at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first, second and the third dose of GARDASIL (Lot # unspecified) 0.5ml intramuscularly on 29-JUL-2009 and 01-AUG-2011. It was reported that the patient received the fourth dose of GARDASIL (Lot # unspecified) 0.5 intramuscularly on 01-AUG-2012 inadvertently. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report as received from a mother refers to her 10 years old daughter who was not pregnant with no pertinent medical history or any drug reactions/allergies. The patient was intramuscularly vaccinated into the left arm with first dose of GARDASIL (lot number provided) about 2 months ago approximately in June 2012. There were no concomitant medications. The patient had been experiencing extremely bad nose bleeds on average of 2-3 daily and about 2-3 times per week. The nose bleeds were random, caller also stated daughter's left arm was sore and hot to the touch and left arm was sore and hot to the touch for about a week after the injection. The patient had sought unspecified medical attention. No treatment was given. The outcome was unknown. The case of patient's brother was captured in MARRS# 1208USA003298. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. It was reported that the inadvertent administration of a dose of VARIVAX (Lot#unspecified) to the patient who should have received ZOSTAVAX on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with four doses of GARDASIL (Lot #, dose and route not reported) respectively on 16-JUN-2009, 17-DEC-2009, 26-JUL-2010 and 29-JUN-2012. It was not known if the patient sought for medical attention. No adverse reaction reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated IM with the first dose of GARDASIL in approximately 2011 ("about 1 year ago") and would be vaccinated with the second dose of GARDASIL on 08-AUG-2012. No known adverse effects. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report Was received from a physician concerning a 19 year old male patient who on unknown date was vaccinated with 3 pediatric doses of RECOMBIVAX HB 0.5 mL (route and lot # not provided) as a child. The physician stated that the now 19 year old patient required evidence of immunity for college. On an unknown date, the physician drew titers which showed negative immunity and the patient as then administered 1 pediatric dose of RECOMBIVAX HB 0.5 mL (route and lot #not provided) on 10-MAY-2012 and 1 pediatric dose of RECOMBIVAX HB 0.5 mL (route and lot # not  provided) on 16-JUL-2012. The relatedness for the event was unknown for RECOMBIVAX HB. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to himself, who is a male patient of unknown age with no known pertinent medical history and no known drug allergies. The patient was vaccinated with a dose of VARIVAX (lot # not reported) on 12-JUL-2012. Concomitant medications were reported as none. It was reported that on 12-JUL-2012 the patient experienced injection site sore and 12 days following vaccination the injection site was still sore, and had started to have a stinging sensation at the time of report as well. Consumer denied swelling and redness, denied that he could have been bitten or stung by an insect, and stated that he had full movement capability in the arm. The patient sought for unspecified medical attention via calling pharmacy. No treatment was given. The outcome was reported as not recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nursing supervisor refers to a patient of unknown age. On 07-AUG-2012, at time of the report the patient was in the office to receive the second dose of GARDASIL (Lot # unspecified) which would be late. The first dose was administered two years ago (in approximately August 2010). No symptoms reported. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female kindergarten student. The patient was vaccinated subcutaneously with VARIVAX (lot# unspecified) in July-2012, "about two weeks ago". The reporter did not know if the was the first or second dose of VARIVAX (merck) that the patient had been administered. On an unknown date, after being administered this dose of VARIVAX (merck), the patient developed chickenpox. The outcome of patient was reported as not recovered/not resolved. The patient sought medical attention at a physician's office. Additional information is not expected.
Age: 1.7
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse via a field representative refers to a 20 months old patient. The patient was vaccinated with, 0.5 ml VARIVAX (merck) (lot# was unknown)(0.5mL dose/1 time or two doses 3 months apart) on 03-AUG-2012. The patient had none medical history. The nurse told that "patient received VARIVAX (merck) on Friday(3-AUG-2012), a rash at the injection site on Saturday(04-AUG-2012) and Monday(06-AUG-2012) presented with Chickenpox". The patient sought medical attention and got" ADARAX" for itching. The outcome of chickenpox was not recovered. Additional information is not expected.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 36 years old male patient with no pertinent medical history and no drug allergy. The patient was vaccinated with, 0.5 ml VARIVAX (lot#reported as 00181AE, expire date 03-JAN-2014) subcutaneous on 31-JUL-2012. No other suspect therapies were reported. Concomitant medications included iron (unspecified). On 02-AUG-2012 the patient experienced raised, red area that is 2.5 diameter circle and pain at the injection site. The patient had sought medical attention via pharmacy visit. There was no treatment and no laboratory performed gave for this event. The outcome was reported as not recovered. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Swelling face, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 18 years old male patient. The patient had no pertinent medical history and no drug reaction/allergies. The patient was subcutaneously vaccinated with the first dose of 0.5 ml VARIVAX (Lot#0572AE, Exp: 15-MAR-2014) on 06-AUG-2012. No other co-suspects were reported. No concomitant medication was used. It was reported that the patient experienced hives and facial swelling 1-2 hours after administration of his first dose of VARIVAX (merck) on 06-AUG-2012. The patient called the office and was directed to take BENADRYL at home and the reported to the local emergency room. By the time of reporting the patient had sought medical attention and arrived at the emergency room, the symptoms had resolved so no further treatment was required. No lab diagnostic studies performed. The outcome was reported as recovered/resolved on 06-AUG-2012. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a female consumer refers to herself. The patient was vaccinated with ZOSTAVAX (lot # was not reported) and had a headache the day of the shot and redness and swelling at the injection site. No other co-suspects were reported. No concomitant medications were reported. The outcome and relationship were not reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse refers to a patient of unknown age. The patient was vaccinated intramuscularly with a dose of 0.5 ml RECOMBIVAX HB (lot# 666028/1379Y, expired date: 05-AUG-2012) on 07-AUG-2012, no adverse effects reported. Additional information is not available.
Age: 98.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site abscess sterile, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to her mother, a 98 years old patient with high blood pressure and allergy to hydrocodone. On 19-JUL-2012 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# reported as 0255AE, exp. date 14-MAR-2013) for prevention of shingles. Concomitant medications included unspecified high blood pressure medication. In approximately July, 2012 (reported as soon after vaccination) the patient experienced redness and pain at the injection site. She noted that her mother could not touch or lie down because of the pain. She took her mother to an unspecified dermatologist yesterday on 07-AUG-2012 who stated that the reaction was a sterile abscess. The consumer stated that the area around her mother's injection site was still very red, dark, uncomfortable and 4 inches long and 3 inches wide. No treatment was given for the adverse events. No lab diagnostics studies performed. The outcome of the patient was reported as recovering. Additional information has been requested.
Age: 98.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Infection, Pain, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to her mother, a 98 years old patient with high blood pressure and allergy to hydrocodone. On 19-JUL-2012 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# reported as 0255AE, exp. date 14-MAR-2013) for prevention of shingles. Concomitant medications included unspecified high blood pressure medication. In approximately July, 2012 (reported as soon after vaccination) the patient experienced redness and pain at the injection site. She noted that her mother could not touch or lie down because of the pain. She took her mother to an unspecified dermatologist yesterday on 07-AUG-2012 who stated that the reaction was a sterile abscess. The consumer stated that the area around her mother's injection site was still very red, dark, uncomfortable and 4 inches long and 3 inches wide. No treatment was given for the adverse events. No lab diagnostics studies performed. The outcome of the patient was reported as recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was in the office now (on 09-AUG-2012) to receive the second dose of GARDASIL (dose, route and lot # not reported), which would be late. The first dose was administered a year ago (unspecified date). No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was administered her first two doses of GARDASIL (lot # not reported) in the GARDASIL vaccination schedule in 2008 and would be IM administered her third dose of GARDASIL (lot # not reported) in the GARDASIL vaccination schedule on 31-JUL-2012 ("today"). No adverse effect reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Doctor of Pharmacy concerning a 70 year old male patient who on 25-JUL-2012 was vaccinated SQ with an expired dose of ZOSTAVAX (lot # 669639/0613AA, expiration date on 30-JUN-2012), 0.65 mL, in his left arm, The vaccine had been reconstituted with and expired sterile water diluent (lot # 0762Z, expiration date in January 2012). No adverse events were reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 16 years old patient who on 25-JUL-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). It was reported that the patient received ZOSTAVAX in error. No known adverse effects were reported. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash papular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 22 month old patient who on 01-NOV-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# 670169/0339AA). The nurse mentioned that on 01-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow up information has been received from the registered nurse concerning the male patient with dermatitis, meningioma and no illness at the time of vaccination. The patient's medical history included bronchiolitis. The patient was vaccinated subcutaneously with lot# (670169/0339AA) dose 1 of VARIVAX (merck) on 01-NOV-2011 at 16:00hrs. No other co-suspects and no concomitant medications were reported. On 01-JUN-2012 the patient went to the clinic for rash described as "small vesicular appearing papules on an erythematous base, in various stages, on trunk, no lesions on palms or soles'. The patient was diagnosed with varicella. No lab diagnostics tests were performed. No treatment information was reported. The patient was seen on 10-JUL-2012 and had no rash, the outcome of the patient's events was reported as recovered. The relatedness for the reported events was not provided for VARIVAX (Merck). A lot check has been initiated. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report has been received from a physician refers to a 11 years old male who was vaccinated with a dose of GARDASIL. No other co-suspects were reported. No concomitant medications were reported. The patient was shaking prior to getting the GARDASIL and fainted after receiving the vaccine. The physician thought that the patient fainted because of being nervous and not due the vaccine. The patient sought medical attention by seeing the physician. At the time of report, the patient was recovered. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Joint stiffness, Mobility decreased, Rash pruritic
Clinical narrative: This spontaneous report was received from a 65 year old female consumer reporting on herself with high blood pressure and no drug reactions/allergies who on 26-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). No other co-suspects were reported. Concomitant medications included: enalapril maleate (manufacturer unknown). On 26-JUL-2012, the patient developed itchy rash around the injection site after she received ZOSTAVAX and it was sore. She also stated that on 27-JUL-2012 "the next day", her hip became very stiff and could not move. The consumer visited the physician's office and was applied kinesiology. No laboratory tests were performed. At the time of the report, the patient was recovering from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 63 years old female patient with penicillin allergy and with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot# 671611/1161AA, expired date 18-OCT-2012, dose and route not reported) on 07-JAN-2012. No other co-suspects or concomitant medications. On 31-JUL-2012 the patient experienced rash. The patient visited office for medical attention and was diagnosed with a case of shingles by the physician on 01-AUG-2012. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.