chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Fatigue, drowsy; vertigo with nausea (very dizzy at rest, with position changes and when walking); on 09/08/2013 called personal physician and began taking Antivert 25 mg once a day; vertigo lessening on 09/09/2013; unable to leave home to symptoms from 09/06/2013 5:00 p.m. through 09/09/2013.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Injection site discolouration, Injection site infection, Injection site inflammation, Injection site reaction
Clinical narrative: Patient came in with Right arm, were injection site was all Black and Blue and was inflamed.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood glucose normal, Feeling abnormal, Malaise
Clinical narrative: Felt bad but blood sugars were normal; went home and did nothing.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Chest pain, Injection site pain
Clinical narrative: Pain in arm where shot was given and in underarm and chest.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, FLU3
Symptoms: Headache, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Pt reported slight fever and redness at or below injection sites. Pt returned to pharmacy at 10 am 9/9/13 to show his arm. Says headache gone, pain in arm continues. I advised dr visit.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, FLU3
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: Pt reported slight fever and redness at or below injection sites. Pt returned to pharmacy at 10 am 9/9/13 to show his arm. Says headache gone, pain in arm continues. I advised dr visit.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Headache, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: TEMP 103, DIARRHEA, VOMITING.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: TEMP 103, DIARRHEA, VOMITING.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Urticaria
Clinical narrative: Woke up in night with hives on legs and stomach. Would describe as moderate discomfort. Took 2 Benadryl and went back to bed. Woke up next day. Hives on legs worse. progressed to arms, chest, face, scalp, back through out the day. Would describe as severe discomfort. Covered head to toe by 330pm on 9/6. Went to doctor office, received a steriod shot at 4pm in arm to counteract hives. Prescribed Prednisone, told to fill next day (9/7) if necessary. Took 2 more Benadryl after doctor visit on 9/6. By 10pm hives were pretty much gone. Woke up at 2am on 9/7 with more hives on legs and arms. Would describe at moderate discomfort. Took 2 more Benadryl. Filled prednisone and took around 1230pm. Hives had progressed to head to toe and servere by 4pm but started to slightly receed around 6pm. Went to bed that night around 12am after 2 Benadryl. Hives moderate at that point. Next morning (9/8) hives were severe on legs and feet. Took prednisone with lunch around 1230pm. Mostly cleared up by next morning (9/9) some mild hives on legs and feet, prednisone taken with breakfast at 930am.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Pain, redness, swelling at injection site. Fever, malaise. Took Acetaminophen and Ibuprofen.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Blood test, Erythema multiforme, Injection site nodule, Pyrexia
Clinical narrative: Pain, redness, swelling at injection site. Fever, malaise. Took Acetaminophen and Ibuprofen.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Induration, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Aching, bruising progressing to extensive redness which spread outward and posteriorly from injection site. Paresthesias and weakness to arm, firm. Dx cellulitis- started on Keflex, warm compresses, ibuprofen for pain.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Aching, bruising progressing to extensive redness which spread outward and posteriorly from injection site. Paresthesias and weakness to arm, firm. Dx cellulitis- started on Keflex, warm compresses, ibuprofen for pain.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling, erythema, itching and tenderness in a 12x18 cm area around the injection site (left upper arm) responding well to cephtriaxone IM.
Age: 74.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received FluMist and was above the approved age for the medication. Have reached out to patient with no response as of 09/09/2013. No adverse events were experienced at the time of vaccination but she was notified of what to watch for and to contact us with any problems.
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Patient had a positive HCG. Patient's last LMP was 17 July 2013 and received vaccination on 12 Aug 2013. Patient's positive pregnancy test was on 9 September 2013.
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Patient had a positive HCG. Patient's last LMP was 17 July 2013 and received vaccination on 12 Aug 2013. Patient's positive pregnancy test was on 9 September 2013.
Age: 33.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: POSITIVE HCG.
Age: 19.0
Sex: M
Vaccine: FLU3, IPV, JEV1, TYP, YF
Symptoms: Dyskinesia, Grand mal convulsion, Head injury, Laceration, Loss of consciousness
Clinical narrative: At approximately 11 am, pt. received several vaccines: Polio booster, typhoid (inactivated), influenza (thimerasol-free), Ixiaro (Japanese Encephalitis - inactived) and Yellow Fever (live vaccine). Almost immediately after giving the YF vaccine, he became unconscious and began having a tonic-clonic seizure. Client was not breathing. RN performed a jaw thrust and was able to do rescue breathing for approximately 4-5 breaths until client started spontaneous respirations. Seizure activity (which had waned slightly) intensified. He was moved from the chair to the floor in a sliding motion, but sat up and started thrashing and flailing. He rolled under the table and, and this time, or prior to being lowered to the floor, hit his head on the consult table. An approximately 1 inch laceration was sustained to the upper L forehead - minimal bleeding. Seizure activity lasted approximately 1-1.5 minutes. During this time, administrative staff was calling 911 and getting assistance to the facility. When client regained consciousness, he was alert and oriented x3. Kept him on the floor until EMS personnel arrived. Called father to notify him of situation. Per EMS VS his BP was 142/78 and HR was 64. He was able to walk to EMS stretcher. After departure, father was called with event and transport details. Father contacted; we were unable to get in contact with client's mother at the time of the event. It is most likely that this event occurred as a reaction to the Yellow Fever vaccine. Client was discharged home from hospital.
Age: 19.0
Sex: M
Vaccine: FLU3, IPV, JEV1, TYP, YF
Symptoms: Respiratory arrest
Clinical narrative: At approximately 11 am, pt. received several vaccines: Polio booster, typhoid (inactivated), influenza (thimerasol-free), Ixiaro (Japanese Encephalitis - inactived) and Yellow Fever (live vaccine). Almost immediately after giving the YF vaccine, he became unconscious and began having a tonic-clonic seizure. Client was not breathing. RN performed a jaw thrust and was able to do rescue breathing for approximately 4-5 breaths until client started spontaneous respirations. Seizure activity (which had waned slightly) intensified. He was moved from the chair to the floor in a sliding motion, but sat up and started thrashing and flailing. He rolled under the table and, and this time, or prior to being lowered to the floor, hit his head on the consult table. An approximately 1 inch laceration was sustained to the upper L forehead - minimal bleeding. Seizure activity lasted approximately 1-1.5 minutes. During this time, administrative staff was calling 911 and getting assistance to the facility. When client regained consciousness, he was alert and oriented x3. Kept him on the floor until EMS personnel arrived. Called father to notify him of situation. Per EMS VS his BP was 142/78 and HR was 64. He was able to walk to EMS stretcher. After departure, father was called with event and transport details. Father contacted; we were unable to get in contact with client's mother at the time of the event. It is most likely that this event occurred as a reaction to the Yellow Fever vaccine. Client was discharged home from hospital.
Age: 28.0
Sex: M
Vaccine: HEPAB, IPV, TDAP, TYP
Symptoms: Migraine, Pruritus, Rash
Clinical narrative: Developed a flat rash approximately the size of a hand in the middle of chest. Area itches with perspiration and is still present 3 years later. Shaving area does fade the rash. Has not tried any topical or systemic remedies. Also developed mirgraine headaches. Has the headache approximately 1 time per week. Ibuprofen 400-800mg alleviates headache. (This information was taken via a phone call. Patient was not examined)
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Aldolase, Blood creatine phosphokinase, C-reactive protein, Myositis, Nuclear magnetic resonance imaging
Clinical narrative: Myositis
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Myositis
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Patient called pharmacy saying she had muscle pain from injection site to elbow. Suggest patient to apply cold compress for 15 mins to the site and take an analgesic. If still bothersome, seek medical attention and contact PCP. Called her PCP's answering service, left message explaining patient's reaction and ask for them to call patient as well as pharmacy .
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4
Symptoms: Injection site reaction, Injection site swelling, Pyrexia, Rash erythematous, Vomiting
Clinical narrative: High fever throughout night. Next day: Arm swelled at injection site, injection site swelled and next day: red rash grew from shoulder to elbow (approximately). Vomited in morning. All signs dissipated by Saturday afternoon and were gone fully by Sunday.
Age: 34.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test normal, Dizziness, Electroencephalogram normal, Feeling abnormal, Feeling hot
Clinical narrative: 2/11/2011: Vaccine dose 1. 2/19/2011: swollen lymph node behind ear-prescribed Keflex. 3/2/2011: maculopapular rash on entire body, possible reaction to Keflex (resolved within a week). 4/5/2011: Vaccine dose 2. 6/2011 to 7/2011: sudden fingertip heat, lasting a few seconds - intermittent. 7/2011 to 8/2011: toes of right foot felt less sensitive, almost asleep. 7/2011 to PRESENT: memory issues - difficulty remembering familiar proper names, words, simple spellings, basic details of recent events - intermittent. 9/2011 to 10/2011: periods of dizziness/brain fog lasting several hours, once or twice a day - intermittent. 9/20/2011: possible panic attack (pounding heart, heat in chest, out of the blue) - never experienced prior. Opted out of taking vaccine dose 3.
Age: 34.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia, Incomplete course of vaccination, Lymphadenopathy, Memory impairment, Nuclear magnetic resonance imaging brain normal
Clinical narrative: 2/11/2011: Vaccine dose 1. 2/19/2011: swollen lymph node behind ear-prescribed Keflex. 3/2/2011: maculopapular rash on entire body, possible reaction to Keflex (resolved within a week). 4/5/2011: Vaccine dose 2. 6/2011 to 7/2011: sudden fingertip heat, lasting a few seconds - intermittent. 7/2011 to 8/2011: toes of right foot felt less sensitive, almost asleep. 7/2011 to PRESENT: memory issues - difficulty remembering familiar proper names, words, simple spellings, basic details of recent events - intermittent. 9/2011 to 10/2011: periods of dizziness/brain fog lasting several hours, once or twice a day - intermittent. 9/20/2011: possible panic attack (pounding heart, heat in chest, out of the blue) - never experienced prior. Opted out of taking vaccine dose 3.
Age: 34.0
Sex: M
Vaccine: HPV4
Symptoms: Palpitations, Rash generalised, Rash maculo-papular
Clinical narrative: 2/11/2011: Vaccine dose 1. 2/19/2011: swollen lymph node behind ear-prescribed Keflex. 3/2/2011: maculopapular rash on entire body, possible reaction to Keflex (resolved within a week). 4/5/2011: Vaccine dose 2. 6/2011 to 7/2011: sudden fingertip heat, lasting a few seconds - intermittent. 7/2011 to 8/2011: toes of right foot felt less sensitive, almost asleep. 7/2011 to PRESENT: memory issues - difficulty remembering familiar proper names, words, simple spellings, basic details of recent events - intermittent. 9/2011 to 10/2011: periods of dizziness/brain fog lasting several hours, once or twice a day - intermittent. 9/20/2011: possible panic attack (pounding heart, heat in chest, out of the blue) - never experienced prior. Opted out of taking vaccine dose 3.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain in extremity, Paraesthesia
Clinical narrative: Burning and soreness in arm, then tingling from shoulder to wrist. This has gone on for a month. I've been taking Advill.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Electromyogram, Neuropathy peripheral, Paraesthesia
Clinical narrative: Burning and soreness in arm, then tingling from shoulder to wrist. This has gone on for a month. I've been taking Advill.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site patient took BENADRYL to counter reaction.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: 9-5-13 Redness, "bumpy rash" above site of administration; itching. 9-9-13 Reported to pharmacy; BENADRYL to help with itching per doctor's office phone call.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Blister, Eye irritation, Pruritus, Swelling
Clinical narrative: Burning, swelling, itching, water blister on hand of injection (right hand). Treated with Hydrocortisone 1% cream and ice and oral BENADRYL.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Burning sensation, Hypersensitivity, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Burning, swelling, itching, water blister on hand of injection (right hand). Treated with Hydrocortisone 1% cream and ice and oral BENADRYL.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site scab, Injection site swelling, Injection site vesicles
Clinical narrative: Burning, swelling, itching, water blister on hand of injection (right hand). Treated with Hydrocortisone 1% cream and ice and oral BENADRYL.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema
Clinical narrative: 9/6/13 student complained of redness left arm. Erythema measured 3cm x 5cm. Instructed to apply ice/cold compress.
Age: 1.27
Sex: F
Vaccine: DTAP, FLU3, HIBV, VARCEL
Symptoms: Inflammation, Injection site erythema, Injection site mass
Clinical narrative: Red lump in the LVL size of 5 cm x 4 cm. Inflammatory reaction to the vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pallor, Injection site pruritus
Clinical narrative: 2 d after MMRV administered pt developed redness at injection site; 3 d after inj erythema, pallor increased from elbow to shoulder with sl itching at site; No vesicles no fever; 9/9/13: decreased pallor/decreased erythema; site improving.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Musculoskeletal stiffness, Staring
Clinical narrative: Patient's left arm stiff in air. Patient staring not responding right away. Patient starting responding 1-2 minutes later. Was able to answer questions correctly and could tell us where he was. B/P 110/60 pulse 68. Juice was given and a sucker.
Age: 79.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Local reaction, Pain in extremity, Swelling
Clinical narrative: For 2 days achy arm and slight swelling. Now had a red area up by shoulder and down by elbow. No warmth to area, pain or temp. No itching. Pt seen 7/19/13. Localized reaction. No systemic symptoms. Continue with Benadryl, consider Zyrtec f/u as needed.
Age: 62.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Erythema, Skin warm, Vaccination complication
Clinical narrative: Bad reaction to shingles shot on 9/6/13. Local redness, hot to touch. Seen by ARNP for possible cellulitis - Rx' d
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Headache, Injection site reaction, Myalgia, Myosclerosis
Clinical narrative: Muscle tenderness, hardness from shoulder to elbow in vaccinated arm morning after vaccination, followed by onset of nausea, vomiting, dizziness, and headache at 4:45 pm day after vaccination. N/V resolved after a few hours. Tender, firm arm soreness, not at injection site, with rash continued > 48 hours after vaccination.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Muscle tenderness, hardness from shoulder to elbow in vaccinated arm morning after vaccination, followed by onset of nausea, vomiting, dizziness, and headache at 4:45 pm day after vaccination. N/V resolved after a few hours. Tender, firm arm soreness, not at injection site, with rash continued > 48 hours after vaccination.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Area around injection site raised 1/2 inch and approx 3 inches in diameter, painful. Took TYLENOL and BENADRYL also used ice to the area.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Feeling hot, Lip swelling, Local swelling, Muscle twitching, Pain
Clinical narrative: Hives on arm within 10 minutes, head to toe hives, lip and left arm swelling, left hand/finger tingling within 1 hour, involuntary left hand/finger twitching, did not want to go to ER, took Benadryl at home, relieved most symptoms but not arm swelling, pain and heat remain, instructed to follow up with OCC health. MD gave permission for vaccine,  known low WBC's, pharmacy also verified.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Urticaria
Clinical narrative: Hives on arm within 10 minutes, head to toe hives, lip and left arm swelling, left hand/finger tingling within 1 hour, involuntary left hand/finger twitching, did not want to go to ER, took Benadryl at home, relieved most symptoms but not arm swelling, pain and heat remain, instructed to follow up with OCC health. MD gave permission for vaccine,  known low WBC's, pharmacy also verified.
Sex: U
Vaccine: HPV4
Symptoms: Feeling abnormal, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Muscular weakness
Clinical narrative: This spontaneous report as received from a registered nurse refers to hundreds of patients of unknown aeg. Medical history and drug allergies were not reported. On an unknown date the patients were vaccinated with GARDASIL (5 ml, intramuscular). Lot number was not reported. The reporter stated they were administering the vaccine with a one inch needle. Concomitant therapies were not reported. Nurse referred patients complain that GARDASIL was painful when it was administrated, and they wince in pain when it was given. More girls than boys found the vaccination painful. Patients referred they could feel the medicine going into their arm. Also, the arm feels numb and weak right after administration. Nurse stated she had noticed this type of GARDASIL reaction in hundreds of patients. The patients sought medical attention in office. The reporter stated the symptoms did not seem to persist; short term duration, since patients did not call the office to complain afterwards. The outcome of the events was reported as recovered. Causality between the events and GARDASIL was not reported. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Blister, Herpes simplex serology negative, Hypersensitivity, Rash erythematous
Clinical narrative: Pt received vaccine at pharmacy at 1:30 PM. By 9:00 PM that evening developed rash with blisters at ankles and legs that progressed to wrists and fingers the next day. There was no rxn at inj site. 3-4 days later developed red rash at wrist line. Pt received mometasone cream and acyclovir from MD which failed to provide relief. Pt went to dermatologist who performed biopsy of blister(s) and stated that it was some type of allergic rxn unrelated to zoster. Pt stated she mowed the yard the day she received the zostavax vaccine at about 3PM. She normally does not do yard work. She stated the dermatologist gave her prednisone which helped to clear up her rash. No  more blisters developed afterward.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Varicella virus test negative
Clinical narrative: Pt received vaccine at pharmacy at 1:30 PM. By 9:00 PM that evening developed rash with blisters at ankles and legs that progressed to wrists and fingers the next day. There was no rxn at inj site. 3-4 days later developed red rash at wrist line. Pt received mometasone cream and acyclovir from MD which failed to provide relief. Pt went to dermatologist who performed biopsy of blister(s) and stated that it was some type of allergic rxn unrelated to zoster. Pt stated she mowed the yard the day she received the zostavax vaccine at about 3PM. She normally does not do yard work. She stated the dermatologist gave her prednisone which helped to clear up her rash. No  more blisters developed afterward.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The registered nurse reported that on 27-AUG-2010 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, route and anatomical location unspecified). On 05-JUN-2012, the patient received the second dose of GARDASIL (lot #, expiration date, route and anatomical location unspecified) and on 24-APR-2013 the patient received the third dose of GARDASIL (lot #, expiration date, route and anatomical location unspecified). No adverse event reported. The patient's outcome was unknown. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Depressed level of consciousness, Pallor
Clinical narrative: Patient became ash in color, demonstrated decrease level of consciousness. Medical immediately attended to pt. Assess vital. Monitor pt 45 mins after event. Prior to d/c-pt verbalized felt much better, ambulated without syncope.
Age: 1.93
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: Patient is a 23 month old male. Vaccine record review of his foreign vacine card showed "INFANRIX" as his 2nd DTaP in the "DTaP-HIB" section of the card. I interpreted this as an insufficient HIB since INFANRIX is DTaP only. However on further research, a foreign country uses INFANRIX-HEP A with DTaP, IPV, Hep B and HIB. Therefore, he had an extra HIB booster.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 77 year old female patient who on 20-AUG-2013, was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # J003796, expiration date 28-JUN-2014). The pharmacist reported that the patient who received ZOSTAVAX, on 20-AUG-2013, presented to the pharmacy the following day with a raised, warm hive- or wheal-like area approximately 3 inches by one inch. She stated that the area was definitely not a rash; it looked more like an allergic reaction to the ZOSTAVAX. The pharmacist did not specify if this patient notified her physician, or if the affected area has resolved. She did state that she did not have a lot of patient's medical history on hand. The pharmacist was requesting a lot check for ZOSTAVAX (lot # J003796, expiration 28-JUN-2014), since two other patients have also reported adverse effects since receiving ZOSTAVAX of this lot. This is one of several reports from the same reporter source. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5, RV5
Symptoms: Irritability, Vomiting
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a 4 month old male patient. No medical history or drug reactions/allergies were reported. On 25-JUL-2013, the patient was vaccinated with the first dose of ROTATEQ (lot#, dose and route not provided). Around 25-JUL-2013, after receiving the first dose of ROTATEQ the patient "vomited after every feeding for 2 weeks and more after that dose", and also was irritable. The patient did not seek medical attention. The vomiting stopped around 08-AUG-2013. On 27-AUG-2013, the patient's mother brought him in for another dose, but they think the dose was not given. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5, RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a 4 month old male patient. No medical history or drug reactions/allergies were reported. On 25-JUL-2013, the patient was vaccinated with the first dose of ROTATEQ (lot#, dose and route not provided). Around 25-JUL-2013, after receiving the first dose of ROTATEQ the patient "vomited after every feeding for 2 weeks and more after that dose", and also was irritable. The patient did not seek medical attention. The vomiting stopped around 08-AUG-2013. On 27-AUG-2013, the patient's mother brought him in for another dose, but they think the dose was not given. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 62 year old female patient (who is also a nurse) with penicillin allergy and no pertinent medical history. The medical assistant reported that on 15-MAR-2012 the patient was vaccinated with ZOSTAVAX (lot # 1567AA, expiration date 05-NOV-2012), 0.65 ml, subcutaneously for physician recommendation and patient's occupation as a nurse. The medical assistant reported that on an unknown date (approximately in 2013) the patient got a mild case of shingles. The patient over the weekend of 31-AUG-2013 developed a rash. The patient had pain at an unspecified date (approximately in 2013) prior to the rash. Patient went to an unspecified regional first care center and called office to report. She received treatment with unspecified antiviral started on 03-SEP-2013. Laboratory tests were not performed. The patient's outcome was reported as recovering. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Healthcare Worker refers to a 85 year old female patient. In 2007 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the left arm. The reporter stated that the patient now had shingles. Onset date was unspecified. On an unknown date the patient was hospitalized. However, the reporter stated she did not know the date of when the client was hospitalized, whether it was yesterday, today, or when. Unspecified treatment was given. The outcome of shingles was reported as recovering/resolving. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 34 year old female patient. The nurse noted that patient, was administered her first two doses in the GARDASIL vaccination series on unspecified dates several years ago before she was 25 years of age (approximately in 2005). She was now in the office, is 34 years of age, and wants to get her third dose of GARDASIL today. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. On an unknown date the patient developed an injection site rash after vaccination with ZOSTAVAX. The outcome of the event was unknown. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report was received from a physician refers to a 11 years old male patient. The patient had attention deficit disorder and drug reactions/allergies to penicillin (unspecified)-rash. On 12-JUN-2013 the patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot # H019495, expiry date: 15-AUG-2015), intramuscular at an unspecified location. ON 12-AUG-2013 the patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot# 0459AE, expiry date: 13-DEC-2014), intramuscular at an unspecified location. Concomitant therapy include ADDERALL tablets. On 14-AUG-2013 the patient developed an itchy rash, over his entire body. BENADRYL was given for event. The patient had sought medical attention by phone call to physician from parent. On an unspecified date the outcome of the event was recovered. No lab diagnostics studies were performed. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a female patient of unknown age who on 22-AUG-2013, was vaccinated with an expired dose of PNEUMOVAX23 (lot # 672370/1851AA, expiration date, 05-AUG-2013) 0.5 ml, intramuscular. No adverse event reported. Additional information has been requested. A follow up information has been received from a licensed vocational nurse concerning to a currently 9 year old female patient with congenital anomaly heart and renal dysplasia. On 22-AUG-2013 at 10:40 am, the patient was vaccinated with PNEUMOVAX23 lot # 672370/1851AA, second dose, in the left deltoid. On 22-AUG-2013, the patient received an expired dose of PNEUMOVAX23. On an unknown date, the patient experienced convulsions/seizures (medically significant) and mild hemiparesis (medically significant). Gastrooesophageal reflux disease (GERD), hypertension and Attention deficit/hyperactivity disorder (ADHD). The patient did not seek medical attention. On 22-AUG-2013, the outcome of received an expired dose of PNEUMOVAX23, was reported as recovered. The outcome of convulsions/seizures and mild hemiparesis, Gastrooesophageal reflux disease (GERD), hypertension and Attention deficit/hyperactivity disorder (ADHD) was unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Attention deficit/hyperactivity disorder, Convulsion, Expired drug administered, Gastrooesophageal reflux disease, Hemiparesis
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a female patient of unknown age who on 22-AUG-2013, was vaccinated with an expired dose of PNEUMOVAX23 (lot # 672370/1851AA, expiration date, 05-AUG-2013) 0.5 ml, intramuscular. No adverse event reported. Additional information has been requested. A follow up information has been received from a licensed vocational nurse concerning to a currently 9 year old female patient with congenital anomaly heart and renal dysplasia. On 22-AUG-2013 at 10:40 am, the patient was vaccinated with PNEUMOVAX23 lot # 672370/1851AA, second dose, in the left deltoid. On 22-AUG-2013, the patient received an expired dose of PNEUMOVAX23. On an unknown date, the patient experienced convulsions/seizures (medically significant) and mild hemiparesis (medically significant). Gastrooesophageal reflux disease (GERD), hypertension and Attention deficit/hyperactivity disorder (ADHD). The patient did not seek medical attention. On 22-AUG-2013, the outcome of received an expired dose of PNEUMOVAX23, was reported as recovered. The outcome of convulsions/seizures and mild hemiparesis, Gastrooesophageal reflux disease (GERD), hypertension and Attention deficit/hyperactivity disorder (ADHD) was unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypertension
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a female patient of unknown age who on 22-AUG-2013, was vaccinated with an expired dose of PNEUMOVAX23 (lot # 672370/1851AA, expiration date, 05-AUG-2013) 0.5 ml, intramuscular. No adverse event reported. Additional information has been requested. A follow up information has been received from a licensed vocational nurse concerning to a currently 9 year old female patient with congenital anomaly heart and renal dysplasia. On 22-AUG-2013 at 10:40 am, the patient was vaccinated with PNEUMOVAX23 lot # 672370/1851AA, second dose, in the left deltoid. On 22-AUG-2013, the patient received an expired dose of PNEUMOVAX23. On an unknown date, the patient experienced convulsions/seizures (medically significant) and mild hemiparesis (medically significant). Gastrooesophageal reflux disease (GERD), hypertension and Attention deficit/hyperactivity disorder (ADHD). The patient did not seek medical attention. On 22-AUG-2013, the outcome of received an expired dose of PNEUMOVAX23, was reported as recovered. The outcome of convulsions/seizures and mild hemiparesis, Gastrooesophageal reflux disease (GERD), hypertension and Attention deficit/hyperactivity disorder (ADHD) was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 70 year old female patient with codeine allergy and no pertinent medical history. On 27-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J001010, exp.date 24-APR-2014), injection, subcutaneously, dose: 0.65 ml. On 28-AUG-2013 the patient had developed an injection site reaction. No concomitant medications were reported. The affected area was initially the size of a 50-cent coin but at the time of report the affected area was much bigger. It was confirmed that there was no rash. The patient sought medical attention - called the pharmacist. She told the pharmacist there was a lot of itching and the area looked like a "welt". None of lab diagnostics studies were performed. The outcome of events was reported as not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site urticaria
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 70 year old female patient with codeine allergy and no pertinent medical history. On 27-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J001010, exp.date 24-APR-2014), injection, subcutaneously, dose: 0.65 ml. On 28-AUG-2013 the patient had developed an injection site reaction. No concomitant medications were reported. The affected area was initially the size of a 50-cent coin but at the time of report the affected area was much bigger. It was confirmed that there was no rash. The patient sought medical attention - called the pharmacist. She told the pharmacist there was a lot of itching and the area looked like a "welt". None of lab diagnostics studies were performed. The outcome of events was reported as not recovered. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient with no known drug allergies. On 03-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23, 0.5 ml, intramuscularly (lot number not reported) and FLUZONE high dose (route not reported). Other concomitant therapy was not reported. On 03-SEP-2013, for 24 hours after receiving the injection, the patient experienced a sensation of tingling all over her body described as "pins and needles" which kept her from sleeping. The patient called to pharmacy for medical attention. No lab test was performed. She did not seek treatment, and that the sensation resolved by itself. On 04-SEP-2013 the patient recovered from the events. Causality assessment was not provided. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Insomnia, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient with no known drug allergies. On 03-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23, 0.5 ml, intramuscularly (lot number not reported) and FLUZONE high dose (route not reported). Other concomitant therapy was not reported. On 03-SEP-2013, for 24 hours after receiving the injection, the patient experienced a sensation of tingling all over her body described as "pins and needles" which kept her from sleeping. The patient called to pharmacy for medical attention. No lab test was performed. She did not seek treatment, and that the sensation resolved by itself. On 04-SEP-2013 the patient recovered from the events. Causality assessment was not provided. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 57 year old female patient. On 04-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J001002 and 25-APR-2014 respectively, dose and route unspecified). Concomitant therapies included SEROQUEL, LAMICTAL, CHANTIX. On 06-SEP-2013, the patient developed itchy red spot at the injection site after receiving ZOSTAVAX. The red area was approximately 2.5 inches long by 3/8 inches wide. The patient sought medical attention (contacted pharmacist). It was unspecified if any treatment was given or if any lab tests were performed. The patient was not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 57 year old female patient. On 04-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J001002 and 25-APR-2014 respectively, dose and route unspecified). Concomitant therapies included SEROQUEL, LAMICTAL, CHANTIX. On 06-SEP-2013, the patient developed itchy red spot at the injection site after receiving ZOSTAVAX. The red area was approximately 2.5 inches long by 3/8 inches wide. The patient sought medical attention (contacted pharmacist). It was unspecified if any treatment was given or if any lab tests were performed. The patient was not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 57 year old female patient. On 04-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J001002 and 25-APR-2014 respectively, dose and route unspecified). Concomitant therapies included SEROQUEL, LAMICTAL, CHANTIX. On 06-SEP-2013, the patient developed itchy red spot at the injection site after receiving ZOSTAVAX. The red area was approximately 2.5 inches long by 3/8 inches wide. The patient sought medical attention (contacted pharmacist). It was unspecified if any treatment was given or if any lab tests were performed. The patient was not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Cheilitis, Lip dry, Lip pain, Lip pruritus, Lip swelling
Clinical narrative: My lips were swollen, red, itchy, and sensitive to the touch. Almost a slight burning sensation as well. They became covered with tiny bumps that are not easily seen but feel scaley when I rub my lips together. I have been taking an antihistamine and using vaseline but nothing seems to be helping.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Oral discomfort
Clinical narrative: My lips were swollen, red, itchy, and sensitive to the touch. Almost a slight burning sensation as well. They became covered with tiny bumps that are not easily seen but feel scaley when I rub my lips together. I have been taking an antihistamine and using vaseline but nothing seems to be helping.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Client came into the health dept 9/9/13 stating that her Rt arm was swollen from Td received on 9/6/13. No redness at site where Td was administered. Approx 1.5 inch below injection site was a red, swollen area approx 1.5 rectangle shape. Mild tenderness to touch. Stated doesn't recall any bites by insects. Advised to seek medical care if worsen. Instructed to use cool compress for 20 min, 4xc daily for 24 hrs.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Hypoaesthesia, Pain in extremity, Spinal pain
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 72 year old female patient. On 02-SEP-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J002869 and 14-JUN-2014 respectively), subcutaneously. No concomitant therapy was reported. Approximately on an unknown date in September 2013, the patient experienced pain and numbness in the lower bottom of spine that goes down her right leg that began after patient received ZOSTAVAX. The patient informed the reporter that the pain and numbness comes and goes and she cannot walk when she has the pain and numbness. On 05-SEP-2013, the patient could not walk but it was better on the date of report (on 06-SEP-2013). The patient sought medical attention (called the pharmacist). The patient was treated with a heating pad and ALEVE. It was unspecified if any lab tests were performed. The outcome of pain and numbness in the lower bottom of spine that goes down her right leg was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Gait disturbance, Impaired work ability, Muscular weakness, Tremor
Clinical narrative: Within a month after I received the vaccine I started having tremors in both my feet and weakness in my leg muscles which interferes with my being able to walk any appreciable distance or to stand for longer than 5 minutes. I now walk with a cane and need to use a riding cart to do my food shopping and am unable to work and am now on SSDI.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: Within a month after I received the vaccine I started having tremors in both my feet and weakness in my leg muscles which interferes with my being able to walk any appreciable distance or to stand for longer than 5 minutes. I now walk with a cane and need to use a riding cart to do my food shopping and am unable to work and am now on SSDI.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Back pain, Intensive care, Laboratory test normal, Myelitis transverse
Clinical narrative: Healthy 11 year old developed sudden onset of back pain, paresthesia and weakness, transfer to hospital ICU - diagnosis acute transverse myelitis.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia
Clinical narrative: Healthy 11 year old developed sudden onset of back pain, paresthesia and weakness, transfer to hospital ICU - diagnosis acute transverse myelitis.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Left arm pain status post Tdap administration. Numbness patient states "feels dead" feels weaker. Pt referred to neurologist and physical therapy pending appointments.
Sex: M
Vaccine: ADEN_4_7, DTP, FLU3, HEP, MNQ
Symptoms: Anaphylactic shock
Clinical narrative: A report was received from an observational study. A male, patient, 19-24 years of age, experienced other anaphylactic shock, NEC (serious, since 25-Jan-2012, until 25-Jan-2012), within 42 days of vaccination, while enrolled in the study, a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. The patient was an active recruit. Patient received Adenovirus Vaccine on 21-Dec-2011. At the time of the report the outcome of the AEs were: other anaphylactic shock, NEC: unknown. Patient began Prednisone 20 mg PO on 25-Jan-2012 which stopped 30-Jan-2012, and Cetirizine 10 mg PO from 25-Jan-2012 until 24-Feb-2013. The medical history of the patient was not specified. The patient's concomitant medication included DTP (since 21-Dec-2011); Meningococcal Vaccine (since 21-Dec-2011); Hepatitis B Vaccine (unknown; since 21-Dec-2011); Influenza Vaccine (since 21-Dec-2011); Ranitidine (since 12-Jan-2012). Lab tests were not reported. This case was considered serious based on the following criteria: (Disability or Permanent Damage). The medical monitor's causality assessment: no reasonable possibility, unknown severity.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture abnormal
Clinical narrative: Numbness in extremity and weakness.