chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Malaise, Mucous membrane disorder
Clinical narrative: The first two days after the shot I felt not too well. On the second day I touched the site of the shot, just above my elbow, and found a quite warm swelling at least the size of a golf ball. My symptoms became progressively worse. I was very lethargic - almost like the onset of the flu - and felt generally quiet poorly. I had periods of dry mouth, of very moist mucous membranes, and at times a medicinal taste in my mouth. I was getting up to urinate at night very frequently. Near the end of the first week I had a dizzy spell, which may or may not have been related to the shot. The symptoms slowly abated. After eight days I felt relatively normal and the last of the redness at the shot site was gone. I attempted to speak with my physician at one point, but his nurse did not pass on my message clearly. By this time a regular appointment was just a few days off so I waited for that opportunity to discuss the situation with him. I did speak with the pharmacist several days after the shot and he suggested I might want to contact you.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pollakiuria, Product taste abnormal
Clinical narrative: The first two days after the shot I felt not too well. On the second day I touched the site of the shot, just above my elbow, and found a quite warm swelling at least the size of a golf ball. My symptoms became progressively worse. I was very lethargic - almost like the onset of the flu - and felt generally quiet poorly. I had periods of dry mouth, of very moist mucous membranes, and at times a medicinal taste in my mouth. I was getting up to urinate at night very frequently. Near the end of the first week I had a dizzy spell, which may or may not have been related to the shot. The symptoms slowly abated. After eight days I felt relatively normal and the last of the redness at the shot site was gone. I attempted to speak with my physician at one point, but his nurse did not pass on my message clearly. By this time a regular appointment was just a few days off so I waited for that opportunity to discuss the situation with him. I did speak with the pharmacist several days after the shot and he suggested I might want to contact you.
Age: 0.18
Sex: M
Vaccine: DTAP, RVX
Symptoms: Crying, Irritability
Clinical narrative: Inconsolable crying off and on all day, very irritable. Per urgent care doc, sdoc site of injection may be sore, use Tylenol.
Age: 39.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site pain, Oedema, Pain in extremity
Clinical narrative: Severe pain at injection site radiating throughout arm.  Very slight erythema and edema. Required IV narcotics for pain control. Follow up w/ PCP Dr 07/12/2012.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site injection.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Pt. was given Tdap instead of Dtap.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Muscle rigidity, Syncope, Tremor
Clinical narrative: Within a minute of receiving 3rd Gardasil client reported feeling faint, followed by syncope episode (become unconscious) followed by rigidity and then tremors, repeated the rigidity and tremors one more time prior to being lower to the ground from the chair she was being supported in. Client then become conscious.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Wheezing
Clinical narrative: WHEEZING.
Age: 0.19
Sex: F
Vaccine: DTAPH, HEP, MMR, RVX
Symptoms: Faeces discoloured, Lethargy, Mucous stools, Pyrexia, Somnolence
Clinical narrative: Extreme lethargy (my screaming rambunxious toddler could not even wake her), fever (103 degrees) that lasted until 4/8/2012, green mucousy stool with blood (starting 4/7/2012).  This type of stool still continues intermittently and never started until she received her 2 months vaccines.  This is why I have selected "NO" below in the Patient Recovered (Box 9) area.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Pain, Tenderness
Clinical narrative: Initial Shot (7/10/12)-arm was tender Next Day (7/11/12)- deep pain when arm is moved in any direction other than forward and onset of nausea (7/12/12)-pain and nausea continue
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Antinuclear antibody negative, Antinuclear antibody positive, Arthralgia, Depressed mood, Fatigue
Clinical narrative: Joint aches mostly in knees, wrists, fingers and hip as well as mild muscle aches mainly in arms and shoulders. Chronic fatigue which led into depressing moods. OTC medicines with no avail.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Mixed connective tissue disease, Myalgia
Clinical narrative: Joint aches mostly in knees, wrists, fingers and hip as well as mild muscle aches mainly in arms and shoulders. Chronic fatigue which led into depressing moods. OTC medicines with no avail.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Pt had about 10 episodes of vomiting in a 3 hour period.  Tolerating no fluid, and it became bilious towards the end.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Discomfort, Muscle twitching
Clinical narrative: When lying down to sleep, patient began to twitch intermittently across his upper body. He also said it felt like he was being bitten by a mosquito at the area where he was twitching.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blister, Body temperature increased, Erythema, Induration, Pruritus
Clinical narrative: Area was "itching" on afternoon of 7-10-12; on 7-11-12 at 6:00 p.m. mother noticed area to be very red and hot with slight amount of "puffiness", firm to touch in center of reddened area with few small clear vesicles noted. Low grade temperature.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Skin warm, Swelling
Clinical narrative: Area was "itching" on afternoon of 7-10-12; on 7-11-12 at 6:00 p.m. mother noticed area to be very red and hot with slight amount of "puffiness", firm to touch in center of reddened area with few small clear vesicles noted. Low grade temperature.
Age: 43.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Fatigue, Pyrexia, Stomatitis
Clinical narrative: Pt states that when he left work at aproximately 5pm he felt worn out.  When he got home later that evening he started running a fever of 102. He continued running a fever the following day and when he came in to the clinic on the 11th of July his temp was 100.5 orally.  At this time it was noticed that he had sores in the inside of his mouth.  Pt seen by DR to evaluate. Pt given Motrin and told to follow up as needed. There was no difficulty breathing at any time. Pt was given his first Hep B and was also given typhoid but he has received this before.  A PPD was also placed.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Aphagia, Cold-stimulus headache, Headache, Insomnia, Torticollis
Clinical narrative: Left arm severe swelling of arm administered area of vaccination, Torticollis, severe headaches (stabbing pain and equivalent brain freeze continual pain,) locked jaw, inability to eat or sleep while taking Doctor recommended prescriptions.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Trismus, Vaccination site swelling
Clinical narrative: Left arm severe swelling of arm administered area of vaccination, Torticollis, severe headaches (stabbing pain and equivalent brain freeze continual pain,) locked jaw, inability to eat or sleep while taking Doctor recommended prescriptions.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash erythematous, Vaccination complication
Clinical narrative: LEFT SIDE OF NECK ITCHING, BEGINNING OF SLIGHT RASH; BY THE AM THE RASH WAS MORE PRONOUNCED- LARGE RED, ITCHING, BURNING BUMPS. THIS PROGRESSED THROUGHOUT THE DAY. ON THE AM OF 7/12/12 I WENT TO THE URGENT CARE AT MY DOCTORS OFFICE. SHE COULD FIND NO OTHER EXPLANATION FOR THE RASH THAN THE VACCINE. IT IS STILL LIMITED TO THE LEFT SIDE OF THE NECK, AND LEFT EARLOBE. I RECEIVED A PRESCRIPTION FOR FAMCICLOVIR- 7 DAY COURSE OF EVERY 8 HRS. FIRST DOSE TAKEN ABOUT 1000AM.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Apnoeic attack, Blood culture negative, Bradycardia, C-reactive protein normal, Full blood count normal
Clinical narrative: Infant received vaccine and within 24 hrs had increased apneic, bradycardic and desaturation episodes. CBC and blood cultures obtained are normal, no growth on culture. Infant placed on NIPPV x 24 hrs then removed. Episodes required bag and mask ventilation. No episodes in prior 72 hrs.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Mechanical ventilation, Neonatal respiratory distress syndrome, Oxygen saturation decreased
Clinical narrative: Infant received vaccine and within 24 hrs had increased apneic, bradycardic and desaturation episodes. CBC and blood cultures obtained are normal, no growth on culture. Infant placed on NIPPV x 24 hrs then removed. Episodes required bag and mask ventilation. No episodes in prior 72 hrs.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Apnoeic attack, Blood culture negative, Bradycardia, C-reactive protein increased, Full blood count normal
Clinical narrative: Infant received vaccine and within 24 hrs had significant apneic and bradycardic episodes requiring bag and mask ventilation. Had staring episodes. No seizure within 24 hrs of onset - episodes disappeared. No apnea, bradycardia or desaturation in prior 72 hrs placed on NIPPC art 30% O2.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Mechanical ventilation, Staring
Clinical narrative: Infant received vaccine and within 24 hrs had significant apneic and bradycardic episodes requiring bag and mask ventilation. Had staring episodes. No seizure within 24 hrs of onset - episodes disappeared. No apnea, bradycardia or desaturation in prior 72 hrs placed on NIPPC art 30% O2.
Sex: U
Vaccine: PNC13
Symptoms: Meningitis
Clinical narrative: This is a spontaneous report by a contactable physician through a Pfizer sales representative on behalf of a currently 7-month-old patient who was administered with PREVNAR13 single dose on unknown date for immunisation. Relevant medical history and concomitant medications were unknown. On unknown date, the patient experienced meningitis that required hospitalization. Relevant lab data was unknown. At the time of report the patient was recovering from the event.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ecchymosis, Inflammation, Local reaction
Clinical narrative: Pt w/ localized inflammatory reaction - 11 x 11 cm, & ecchymosis surrounding this.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site haematoma, Injection site swelling, Pruritus
Clinical narrative: Pt w/ localized inflammatory reaction - 11 x 11 cm, & ecchymosis surrounding this.
Age: 9.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: KINRIX GIVEN INSTEAD OF ADACEL FOR 9 YR OLD TETANUS.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt given Pediarix and Hep B injections both and no HIB vaccine. No reaction from patient noted.
Age: 27.0
Sex: F
Vaccine: TDAP, HEP, TDAP
Symptoms: Discomfort, Mobility decreased, Muscle spasms, Pain
Clinical narrative: Severe muscle spasms in back from cervical region to sacral region.  Feels completely locked up, I can't turn or bend.  Cannot find a comfortable position and still in severe pain 3 days later with pain meds and muscle relaxers.
Age: 27.0
Sex: F
Vaccine: TDAP, HEP, TDAP
Symptoms: Activities of daily living impaired, Back pain
Clinical narrative: Severe muscle spasms in back from cervical region to sacral region.  Feels completely locked up, I can't turn or bend.  Cannot find a comfortable position and still in severe pain 3 days later with pain meds and muscle relaxers.
Age: 32.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Lightheaded, nausea, profuse diaphoresis which disspiated after 30 mins. Tx with cool water to drink, ice pack to back of neck. VS remained stable throughout reaction. BP 120/78, P-70 and regular.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Light headed after leaving clinic while driving.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling and numbness in left deltoid after getting Anthrax #3 on 10 Jul 2012, immunization clinic.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Pimple like rash started (1) spot on 7/2/12 & spread to neck, wrist, thigh, chin & chest. Looked as if it were a bug bite at 1st. When mom saw it was spreading, she sought medical treatment approx. 7 spots total. Treatment with calamine lotion per dr.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Flushing, Syncope, Vomiting
Clinical narrative: Vaccines administered child left clinic without distress. Grandmother returned to clinic with child stating child had fainted and vomited at restaurant. Child appeared flushed, warm and dry. Blood pressure 108/58, pulse 114, temp 98.2. No respiratory distress. One and half teaspoon of Benadryl given. Child observed by FNP in clinic for 30 minutes. Telephone consult with Dr., who recommended follow with pcp. Facility notified and patient transported to clinic by grandmother.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Cough, Dyskinesia, Dyspnoea, Erythema, Feeling cold
Clinical narrative: Vaccines administered child left clinic without distress. Grandmother returned to clinic with child stating child had fainted and vomited at restaurant. Child appeared flushed, warm and dry. Blood pressure 108/58, pulse 114, temp 98.2. No respiratory distress. One and half teaspoon of Benadryl given. Child observed by FNP in clinic for 30 minutes. Telephone consult with Dr., who recommended follow with pcp. Facility notified and patient transported to clinic by grandmother.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Heart rate increased, Injection site pain, Pruritus, Staring, Syncope
Clinical narrative: Vaccines administered child left clinic without distress. Grandmother returned to clinic with child stating child had fainted and vomited at restaurant. Child appeared flushed, warm and dry. Blood pressure 108/58, pulse 114, temp 98.2. No respiratory distress. One and half teaspoon of Benadryl given. Child observed by FNP in clinic for 30 minutes. Telephone consult with Dr., who recommended follow with pcp. Facility notified and patient transported to clinic by grandmother.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Tremor, Vomiting
Clinical narrative: Vaccines administered child left clinic without distress. Grandmother returned to clinic with child stating child had fainted and vomited at restaurant. Child appeared flushed, warm and dry. Blood pressure 108/58, pulse 114, temp 98.2. No respiratory distress. One and half teaspoon of Benadryl given. Child observed by FNP in clinic for 30 minutes. Telephone consult with Dr., who recommended follow with pcp. Facility notified and patient transported to clinic by grandmother.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Cough, Dyskinesia, Erythema, Feeling jittery, Hyperhidrosis
Clinical narrative: Vaccines administered child left clinic without distress. Grandmother returned to clinic with child stating child had fainted and vomited at restaurant. Child appeared flushed, warm and dry. Blood pressure 108/58, pulse 114, temp 98.2. No respiratory distress. One and half teaspoon of Benadryl given. Child observed by FNP in clinic for 30 minutes. Telephone consult with Dr., who recommended follow with pcp. Facility notified and patient transported to clinic by grandmother.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Pruritus, Staring, Syncope, Vomiting
Clinical narrative: Vaccines administered child left clinic without distress. Grandmother returned to clinic with child stating child had fainted and vomited at restaurant. Child appeared flushed, warm and dry. Blood pressure 108/58, pulse 114, temp 98.2. No respiratory distress. One and half teaspoon of Benadryl given. Child observed by FNP in clinic for 30 minutes. Telephone consult with Dr., who recommended follow with pcp. Facility notified and patient transported to clinic by grandmother.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Employee describe left deltoid very dull achy arm never went away thinking really lasted long time 1 month to 6 weeks.  Difficulty to move normally.  Had to go to physical therapy for 3 sessions.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelling (golfball to ping-pong ball size), itching, dolor, rubor, erythema(3-3 1/2 inches in diameter) appeared about hours post injection. Not treated. Symptoms are improving.
Age: 9.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram
Clinical narrative: Seizure occurred during sleep; lasted approx. 2 minutes; checked out at ER; CT scan showed no bleeds/infection. There was no fever prior to or following seizure. Followed up with Dr. same day.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Rash papular
Clinical narrative: Left deltoid region with 4 x 8 cm red erythematous lesion with warmth and slight induration noted, minimal amoth of raised papulovesicular region about 2 x 2 cm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Left deltoid region with 4 x 8 cm red erythematous lesion with warmth and slight induration noted, minimal amoth of raised papulovesicular region about 2 x 2 cm.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Woke up at 6:00 am with high fever and body aches, along with massive headache. Left arm was also extremely sore from injection.
Age: 34.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pruritus
Clinical narrative: Itchiness across back and chest, no rash, did change laundry soap a couple of weeks ago.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Chills, Erythema, Feeling abnormal, Infection
Clinical narrative: Came down with fevers and chills by 06/15/2012 and went home not feeling well. On 06/16/2012, she ran a fever of 101F, went to Urgent Care where it was up to 103F. She was told that she had an "infection" as her arm was red, hot and swollen. She felt like she was "hit by a truck". She missed 2 days of work.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Came down with fevers and chills by 06/15/2012 and went home not feeling well. On 06/16/2012, she ran a fever of 101F, went to Urgent Care where it was up to 103F. She was told that she had an "infection" as her arm was red, hot and swollen. She felt like she was "hit by a truck". She missed 2 days of work.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion
Clinical narrative: Stated her arm has a dark purple circle spreading approximately the size of quarter. Denies feeling ill or having fever and chills.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Loss of consciousness, Syncope
Clinical narrative: Patient had syncopal episode almost immediately following administration of the Menactra vaccine. The child fainted and landed on the floor and was unconscious for almost 1 minute. The child had headache for several hours and felt dizzy for several hours as well.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Large swollen hard red lump on thigh where injection was given.  Pt currently taking Zyrtec at bedtime, no Benadryl given.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmth over left upper arm.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Confusional state, Deafness unilateral, Dyspnoea, Hyperhidrosis, Vertigo
Clinical narrative: Sudden onset vertigo, hearing loss in left ear, diaphoresis, shortness of breath, and confusion.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a health professional concerning a 13 year old female with no pre-existing allergies or medical condition or illness at time of vaccination who on 11-JUN-2012 was vaccinated with the first dose of GARDASIL (lot # 672834/0131AE) into her left arm. There was no concomitant medication. In the morning of 11-JUN-2012, the patient complained of dizziness. The patient moved to upon room, head and feet elevated. Ice pack was applied. The patient rested additional 20 minutes. The physician monitored the patient. The patient stated she was ok and left facility. The patient had no further complaint. No labs/diagnostics studies were performed. Subsequently, the patient recovered from the events. This is one of several reports received from the same source. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an 89 year old female patient with no drug reactions or allergies who on 07-JUL-2012 was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (Merck) (lot# 669692/0615AA; expiration date 02-JUL-2012). The patient noticed redness and swelling at her injection site starting on Saturday, 09-JUN-2012. The patient called the pharmacy on Saturday, 09-JUN-2012, and stated that the site did not hurt or itch, nor was warm to the touch. The patient visited the pharmacy on 11-JUN-2012, and she asked another pharmacist to look at her injection site. No treatment was given for the events. The pharmacist told the reporting pharmacist that the site of redness and swelling was "about a couple of inches in diameter" and that the patient reported that the redness and swelling was improving. Additional information has been requested.
Age: 0.13
Sex: F
Vaccine: RV5
Symptoms: Immunology test normal, Polymerase chain reaction, Vomiting
Clinical narrative: This case occurred during a study. Initial SAE Report received on 28-Jun-2012. Case is medically confirmed. A 6-week-old female subject developed vomiting on 11 January 2012 after she had received the first dose of ROTATEQ (batch number not reported) on 09-Jan-2012. Route and site of administration were not reported. The subject developed vomiting leading to hospitalization on 11-Jan-2012.  A sample was performed on 12-Jan-2012. There was no result from the laboratory in hospital. The result for ELISA was negative. PCR result showed PCR G:pos Sequencing G: to be done PCR P: P[8]. Differentiation to be done. According to the co-investigator it was confirmed that the diagnosis was not an acute gastroenteritis. No treatment was reported and the patient was discharged on 12-Jan-2012. At the time of reporting, the outcome was not provided. No causality was provided. No further information expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old male patient with no pertinent medical history and no drug reactions/allergies who on 12-JUN-2012, was vaccinated with a dose of ZOSTAVAX (lot# 672608/1715AA, exp date: 02-FEB-2013). No other co-suspects were reported. Concomitant medications included AMBIEN, FLEXERIL, baby aspirin and multivitamins. The nurse reported that the patient developed chickenpox after receiving ZOSTAVAX. The patient came down with rashes about 3-4 days ago "approximately on 28-JUN-2012" and they were described as "3-4 eruptions, fluid-filled, blistered, itch lesions on his legs and moving up his body". The patient did not receive any treatment for chickenpox. There was no lab diagnostic performed. At the time of the report, the patient's outcome was unknown. The patient sought medical attention at physician's office. The relatedness for chickenpox is unknown for ZOSTAVAX. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Joint stiffness, Muscle spasms, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Pt reported onset of pain & stiffness in her legs. Joints stiff, with sore knees, ankle, shoulder, neck aching muscles in legs - feels like "spasms", in thighs. Waken up at night in pain - No rash, joint swelling, fever or chills. 2 weeks prior, had received a TDAP - Date of appt 6/29/12.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Myalgia, Neck pain, Pain in extremity
Clinical narrative: Pt reported onset of pain & stiffness in her legs. Joints stiff, with sore knees, ankle, shoulder, neck aching muscles in legs - feels like "spasms", in thighs. Waken up at night in pain - No rash, joint swelling, fever or chills. 2 weeks prior, had received a TDAP - Date of appt 6/29/12.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Guillain-Barre syndrome, Increased upper airway secretion, Lumbar puncture abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal cord normal
Clinical narrative: Tingling in hands/feet, something in throat 3 weeks after vaccination. Dx with Guillain Barre 7/9/12.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Paraesthesia
Clinical narrative: Tingling in hands/feet, something in throat 3 weeks after vaccination. Dx with Guillain Barre 7/9/12.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Left arm redness & swelling. Treated with KEFLEX and follow up in 5 days. A: Cellulitis. P - KEFLEX & ER warnings.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Injection site swelling
Clinical narrative: Right arm swollen (upper arm). No pain or itchiness. No fever.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anaemia, Dizziness, Headache, Laboratory test abnormal
Clinical narrative: Stomach cramps, nausea, dizziness, headache, mood swings.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Mood swings, Nausea
Clinical narrative: Stomach cramps, nausea, dizziness, headache, mood swings.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 7/4/12 Patient came in with redness & swelling & a bump at and around injection site. She said it was warm to touch. 7/5 improvement ZYRTEC HS & QDRYL topical bump smaller & redness decreased.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right thigh +1 swelling & +1 erythema.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Vaccine received Mon. 7/2/12 - after a few hours Pt. got a red welt. On Tues. 7/3/12, pt experienced flu-like symptoms (achy, nausea, headache) that lasted until Thurs. (7/5/12).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Vaccine received Mon. 7/2/12 - after a few hours Pt. got a red welt. On Tues. 7/3/12, pt experienced flu-like symptoms (achy, nausea, headache) that lasted until Thurs. (7/5/12).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Throat tightness
Clinical narrative: Patient complained about being dizzy after about 1 minute after receiving shot, said throat felt closed too. We administered an EPIPEN.
Age: 78.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Skin discolouration
Clinical narrative: This spontaneous report as received from a Pharmacy Doctor referred to a 78 years old female patient with drug reactions/allergy to niacin, LESCOL and SOMA. The patient was administered the pneumococcal vaccine (manufacturer unspecified) several years ago. The patient was vaccinated SQ with a dose of ZOSTAVAX (lot number 0168AE, site and dose not reported) on 26-JUN-2012. No other co-suspects were reported. Concomitant medications included TDAP. On 02-JUL-2012, 7 days after onset of therapy, the patient experienced itching, pain and a darkened rash-like area around the injection site. The patient called the reporting pharmacist for medical attention. The pharmacist recommended hydrocortisone cream to be used as a treatment for the adverse event. At the time of the report, the outcome of the events was not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Feeling hot, Pain, Pruritus, Seborrhoeic dermatitis
Clinical narrative: Information has been received from a 72 year old male consumer reporting on himself with a history of seborrheic dermatitis without pain around the outer ear area and penicillin allergy who on 17-APR-2012, was vaccinated SC with 0.65 ml dose of ZOSTAVAX (Merck) (lot# not provided). Concomitant therapy included levothyroxine and unspecified vitamins. The patient explained that he began to develop a skin reaction after having his ZOSTAVAX (Merck) vaccination. The patient explained that he was told that the reaction was not a shingle outbreak by his physician. The reaction was diagnosed as seborrheic dermatitis. The patient did not feel that this diagnosis was accurate. He stated that the breakout started on an around his shoulders about 1 month after receiving the vaccine "approximately on 17-MAY-2012". The breakout spread down to parts of the patient back and torso and was not predominantly on either side of the body. The patient said that the breakout areas felt warm all the time. The breakout also affected the area around the patient's hair; he stated that in this area it not only itches it "it kind of hurts" like the area was bruised. The patient said that the skin itself was dry, however underneath the affected areas there was liquid and when scratched or punctured it started oozing. The patient also said that when pressure was applied to these areas it was slightly painful. The patient was treated with CLARITIN and unspecified topical creams. The patient had regular testing performed. Last laboratory test were taken in February and March 2012 (results not provided). At the time of the report, the patient had not recovered. He sought medical attention. Doctor visit and specialist visit. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Secretion discharge, Skin reaction
Clinical narrative: Information has been received from a 72 year old male consumer reporting on himself with a history of seborrheic dermatitis without pain around the outer ear area and penicillin allergy who on 17-APR-2012, was vaccinated SC with 0.65 ml dose of ZOSTAVAX (Merck) (lot# not provided). Concomitant therapy included levothyroxine and unspecified vitamins. The patient explained that he began to develop a skin reaction after having his ZOSTAVAX (Merck) vaccination. The patient explained that he was told that the reaction was not a shingle outbreak by his physician. The reaction was diagnosed as seborrheic dermatitis. The patient did not feel that this diagnosis was accurate. He stated that the breakout started on an around his shoulders about 1 month after receiving the vaccine "approximately on 17-MAY-2012". The breakout spread down to parts of the patient back and torso and was not predominantly on either side of the body. The patient said that the breakout areas felt warm all the time. The breakout also affected the area around the patient's hair; he stated that in this area it not only itches it "it kind of hurts" like the area was bruised. The patient said that the skin itself was dry, however underneath the affected areas there was liquid and when scratched or punctured it started oozing. The patient also said that when pressure was applied to these areas it was slightly painful. The patient was treated with CLARITIN and unspecified topical creams. The patient had regular testing performed. Last laboratory test were taken in February and March 2012 (results not provided). At the time of the report, the patient had not recovered. He sought medical attention. Doctor visit and specialist visit. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Scab, Skin haemorrhage
Clinical narrative: This spontaneous report as received from a physician refers to a 72 years old male patient with penicillin allergy, diabetes and unspecified cardiac condition. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX lot# (670980/0731AA), on 17-MAY-2012. No other co-suspects were reported. Concomitant medications included JANUVIA, WARFARIN, colchicine, spironolactone, glipizide, digoxin, hydralazine, allopurinol, NEXIUM, folic acid, magnesium oxide, iron (unspecified), ferrous sulfate and testosterone. The physician reported that the patient possibly developed chickenpox in the beginning of June 2012. The patient had developed itching on both of his arms. He scratched so hard that this arms started to bleed. The patient visited the dermatologist who told him to use mineral oil, EUCERIN calming cream. The dermatologist did not diagnose the patient with chickenpox but the reporting physician thought it could possibly be chickenpox. The patient currently had scabs on his arms from the bleeding. The patient could not remember if he had chickenpox in the past. No lab diagnostic tests were performed. At the time of the report the patient was recovering from the adverse events. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site haematoma, Injection site pain, Injection site pruritus
Clinical narrative: Patient noticed raised, red, swollen, bruised area on right arm (injection site) on 7/7/12 evening; she stated that area was itchy & painful & had a headache. She informed me on 7/8 & I recommended cold compress to injection site, TYLENOL and/or BENADRYL, and to contact Dr.; I contacted MD on 7/8 & she noted that there's nothing she would do differently.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient noticed raised, red, swollen, bruised area on right arm (injection site) on 7/7/12 evening; she stated that area was itchy & painful & had a headache. She informed me on 7/8 & I recommended cold compress to injection site, TYLENOL and/or BENADRYL, and to contact Dr.; I contacted MD on 7/8 & she noted that there's nothing she would do differently.
Age: 39.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Pruritus, Skin lesion, Urticaria
Clinical narrative: Appt for vaccines 10:30 AM 7/6/12, guardian noticed several hives on patient's torso. Patient c/o puritis of lesions. Guardian called H.D and was told to administer BENADRYL, seek medical evaluation if becomes worse, 7/9/12 presented for a PPD reading. 5-6 healing hive-like lesions noted on torso. Advised follow-up with MD prior to 2nd Hep B vaccine.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 18-JUN-2012 was inadvertently vaccinated with a dose of improperly stored MMR II (lot # 670621/0568AA, expired on 15-APR-2012). No adverse effect reported. It was unknown if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Vaccines given 7/9/12 at noon. 7/10/12 9 am mild (R) ankle pain. 9 pm swelling & moderately sever pain (R) ankle - no redness or warmth almost fully relieved with 600 mg ibuprofen - ice/topicals by next am/ Reactive Arthritis?
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient who was vaccinated with an expired dose of MMR II (Lot # not reported expiration date 06-APR-2012) on 26-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered 7/2/12, went to MD on 7/5/12 AM 5cm x 5cm angry red hot and raised patch surrounding slight. MD prescribed doxycycline 100mg BID x 7d.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a licensed practical nurse in her early 60's reporting on herself, who "approximately one week ago" on 25-JUN-2012, was vaccinated with a dose of ZOSTAVAX (Lot # not reported) subcutaneously. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 25-JUN-2012, "one week ago", she experienced redness and swelling at the injection site. The patient used CORTIZONE cream. The patient did not seek medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 49 years old female patient with penicillin allergy and no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) on 09-SEP-2011. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 18-JUN-2012, "about 2 weeks ago", the patient developed shingles described as a painful bilateral rash that occurred on the patient's back. The patient was treated with unspecified painkillers. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 9 weeks old male patient. The patient was inadvertently vaccinated with lot # (671517/1068AA expiration date 09-MAY-2012) VAQTA intramuscularly in the right thigh on 25-APR-2012, instead of RECOMBIVAX HB. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The nurse reported that on 09-JUN-2012, the patient was vaccinated with, 0.5 ml VARIVAX (Merck) (Lot # not reported) SQ, instead of ZOSTAVAX. No adverse event was reported. There was no co-suspect reported. There were no concomitant medications reported. It was also reported that this was an office error and not a product confusion for any other reason. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Inflammation, Pain, Swelling
Clinical narrative: Vaccine administered 7/8/12. 7/9/12 in the evening patient noticed some swelling and discomfort. Patient woke up 7/10/12 with more pain, swelling, and inflammation went to emergency room. Received KEFLEX 500 1 Q6H 40 & Prednisone 20 mg 2 daily #10.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness, hot to touch, cellulitis to left I.M. thigh.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose normal, Headache, Presyncope, Vision blurred
Clinical narrative: Vaso-vagal episode - prolonged recovery though most likely due to fact w/o food/fluids due to visit. (45 min recovery) & blurry vision & headache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site rash, Rash, Vaccination site induration
Clinical narrative: Child developed a rash after receiving vaccines on 7/5/12. Right thigh with induration at site of vaccinations. Both anterior thighs with fine raised rash.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Itchiness on right arm. No fever. Swollen and red right arm.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ecchymosis, Inflammation, Local reaction
Clinical narrative: Local swelling on injection site (raised). Bruising at injection site for 2 days - itching her. Dr advised her to use ice bag on the affected area.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site haematoma, Injection site swelling, Pruritus
Clinical narrative: Local swelling on injection site (raised). Bruising at injection site for 2 days - itching her. Dr advised her to use ice bag on the affected area.
Age: 0.18
Sex: M
Vaccine: PPV
Symptoms: Crying, Dehydration, Diarrhoea, Vomiting
Clinical narrative: Diarrhea, excessive crying, vomiting; resulting in dehydration.
Age: 1.66
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion, Gaze palsy, Immediate post-injection reaction
Clinical narrative: The nurse began the vaccinations with the Prevnar 13 shot. She injected my son's right thigh and he instantly went into a seizure once the medication given. When the injections are given, most babies begin to scream, however, the scream never came. It was as if he got "stuck" trying to scream. His eyes rolled into the back of his head, his hands clenched and his arms twisted into an odd, stiff position. His mouth remained open and he was not breathing. After about 50-60 seconds, the nurse screamed for help and once other medical staff entered the room, he began screaming and breathing. After 10 minutes, the evaluation showed he had returned to a normal state. Later that evening, at 10:00 PM, he began to vomit. Other than that, no other symptoms.
Age: 1.66
Sex: M
Vaccine: PNC13
Symptoms: Movement disorder, Musculoskeletal stiffness, Respiratory arrest, Screaming, Vomiting
Clinical narrative: The nurse began the vaccinations with the Prevnar 13 shot. She injected my son's right thigh and he instantly went into a seizure once the medication given. When the injections are given, most babies begin to scream, however, the scream never came. It was as if he got "stuck" trying to scream. His eyes rolled into the back of his head, his hands clenched and his arms twisted into an odd, stiff position. His mouth remained open and he was not breathing. After about 50-60 seconds, the nurse screamed for help and once other medical staff entered the room, he began screaming and breathing. After 10 minutes, the evaluation showed he had returned to a normal state. Later that evening, at 10:00 PM, he began to vomit. Other than that, no other symptoms.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dysphagia, Erythema, Injection site erythema, Injection site pruritus, Oropharyngeal pain
Clinical narrative: At Apx 3:30PM, patient began having redness and extreme itching at the site of the injection.  She also had redness and mild swelling across her forehead, nose, cheeks and chin, but no itching on the face.  At Apx 3:45PM, patient began to complain of an extreme sore throat.  Patient also felt very hot to the touch, but a temperature was not taken.  At Apx 4:00PM, patient was attempting to eat and had a very difficult time swallowing.  Patient stated that she felt her throat was swelling.  At Apx 4:15PM, patient took 50mg of Diphenhydramine.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pharyngeal oedema, Skin warm, Swelling face
Clinical narrative: At Apx 3:30PM, patient began having redness and extreme itching at the site of the injection.  She also had redness and mild swelling across her forehead, nose, cheeks and chin, but no itching on the face.  At Apx 3:45PM, patient began to complain of an extreme sore throat.  Patient also felt very hot to the touch, but a temperature was not taken.  At Apx 4:00PM, patient was attempting to eat and had a very difficult time swallowing.  Patient stated that she felt her throat was swelling.  At Apx 4:15PM, patient took 50mg of Diphenhydramine.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Pt reports outbreak of rash to body 4-5 days after receiving varicella vaccine.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Crying, Injection site pain, Malaise, Pyrexia, Vomiting
Clinical narrative: Mother stated 12 MN Woke up not feeling well, legs hurting. 2 Am Up again crying not feeling good - fever - given ibuprofen. 700 A Given KEPPRA then started vomiting (see next pg). Took patient to hosp around 230. Was given IV fluids ZOFRAN. Improved. Discharged home.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Condition aggravated, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: 71 year old with a swollen and tender Right upper arm. Stiff right upper arm. Onset 6/22/12 no clear trigger except she got a Tdap vaccine on 6/19/12. Pt reports itchy area, no fever, no chills. Does not recall getting stung by a bee or other insect. No other skin rashes is feeling well except increased anxiety with this rash.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Musculoskeletal stiffness, Pruritus, Rash
Clinical narrative: 71 year old with a swollen and tender Right upper arm. Stiff right upper arm. Onset 6/22/12 no clear trigger except she got a Tdap vaccine on 6/19/12. Pt reports itchy area, no fever, no chills. Does not recall getting stung by a bee or other insect. No other skin rashes is feeling well except increased anxiety with this rash.
Age: 20.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Blood pressure decreased, Dyskinesia, Loss of consciousness
Clinical narrative: The pt. was receiving three shots at the clinic for upcoming travel.  Pt. was to receive Hep A, Meningococcal and Typhoid.  I administered Meningococcal and Typhoid and at the end of administering the Typhoid immunization the pt. started to jerk with eyes open and the incident lasted about 30 seconds.  pt. came to and was able to talk after about 30 seconds.  Her blood pressure dropped to about 82/60 during this time.  Physician was notified and came into the room advised blood pressure monitoring and gave the pt. some Coke as the pt. stated she had not eaten that morning.  Physician advised bp checks every ten minutes and to hold the Hep A immunization.  Pt. was released to home after about 30 minutes of observation.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Dehydration, Dizziness, Fatigue
Clinical narrative: Very fatigued on 6/14/2012 and 6/15/2012, Dizzy and re-injured joints and one year old incision, were hurting on 06/16/2012, Dizzy and sinus drainage on 06/17/2012, Headache on 06/18/2012, Sore throat on 06/19/2012, Headache and cough wheezing on 06/20/2012 (went to Multi Care Doctor, my doctor was on vacation, Dr said there was a nasty cold going around and prescribed 500MG Amoxicillin daily and told me to take Advil, by 7AM 06/21/2012 I was so sick and dehydrated my husband took me to Hospital, I was diagnosed with pneumonia, was given Levaquin intravenously and four tablets, 750MG each daily at home, and an Albuterol inhaler.