chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates the patients possibly received improperly stored doses of (wistar ra 27-3) M-M-R II (lot # L036853 with expiry date: 24-SEP-2017, L043702 with expiry date: 03-NOV-2017, M007277 with expiry date: 09-FEB-2018) (incorrect product storage). The temperature and timeframe that the (wistar ra 27-3) M-M-R II were exposed to were as follows: Temperature. 50.4F. Time frame: 19.5 hours total cumulative. Lot numbers and expiry dates of these specific vaccines that administered were unknown. Lot # M008589 with expiry date: 16-FEB-2018 were administered on 10-AUG-2016, 11-AUG-2016 and 12-AUG-2106 (on 10-AUG-2016, temperature excursion of 47.7 and 47.3 degree Celsius happened for a duration of 1 hour, on 11-AUG-2016, temperature excursion of 50.4-46.8 degree Celsius happened for a duration of 6 hours). Lot # L049316 with expiry date: 03-DEC-2017 were administered on 12-AUG-26 and 15-AUG-216 (on 12-AUG-2016, temperature excursion of 45.5 and 47.7 degree Celsius happened for a duration of 6 hours, on 15-AUG-2016, temperature excursion of 44.6-47.3 degree Celsius happened for a duration of 1 hour 45 min and on 16-AUG-2016, temperature excursion of 46.8 degree Celsius happened for a duration of 1 hour). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 37.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 37-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 16-MAR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K000174 and expiration date 08-JAN-2016 (dose and route of administration were not reported). It was reported that the refrigerator was out of range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II lot # L013601 and expiration date 08-JAN-2016 (dose and route of administration were not reported). It was reported that the refrigerator was out of range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Vaccine given SQ at 1032, rt leg. 1040: This RN in room. Pt C/O itching to site. Site with redness 4.5X5.5cm with 1 cm whelp noted. No other symptoms. Lungs clear. No other hives. 1047: Benadryl 12.5mg given PO. Cool compress applied to site. 1105: Redness decreased 3X3.5cm No hives. No itching. Pt discharged home.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Haemorrhage, Pruritus, Rash pustular
Clinical narrative: Morning after vaccine, open sore with puss/blood and below that was a fluid filled blister. No fever or pain but mild itching. By the third day blister had white half moon shaped striation on top of it surrounded by dry flakey skin.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Skin ulcer
Clinical narrative: Morning after vaccine, open sore with puss/blood and below that was a fluid filled blister. No fever or pain but mild itching. By the third day blister had white half moon shaped striation on top of it surrounded by dry flakey skin.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Lt arm swelling and redness noted and warm to touch Lt arm circumference 9.25" and Rt arm circumference 8". Rx for Prednisolone 15mg/5ml-10ml p.o. q day. EpiPen 0.3 mg also ordered. Swelling not relieved with BENADRYL q 6 hours p.o. No fever. On 9/9/16 at 1526 Tdap and Flu given IM in Lt deltoid.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient received two vaccines. Was in the process of checking out and fainted. She also hit her head on the counter and fell to the floor.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Pain in extremity, Radiculitis brachial
Clinical narrative: Pain in left arm after Tdap vaccination-worsened by next morning. Diagnosed at pmd with brachial neuritis on 08/22/2016 seen pmd 09/06/2016 with continue to have pain and weakness in left arm. Pt states she is unable to fully extend left arm. Has had 3 physical therapy sessions.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Patient noticed warmness and soreness of LEFT arm (the arm in which the influenza vaccine was administered) while shopping in the afternoon on 9/13/2016. She later noticed a red rash on her LEFT ARM. The rash was a few inches long and a couple inches wide. On 9/14, the rash already begin to decrease in size but the rash still was warm. For completeness, the right arm in which the Tdap was administered did NOT have any rash nor other side effects.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pruritus, Skin mass
Clinical narrative: Red, inflamed circle around injection site with swelling.  Patient described it as having a knot under the skin that was itchy and warm to the touch.  Patient went to her family physician and was prescribed Cephalexin and Naproxen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Red, inflamed circle around injection site with swelling.  Patient described it as having a knot under the skin that was itchy and warm to the touch.  Patient went to her family physician and was prescribed Cephalexin and Naproxen.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10mm x 10mm area of redness and warmth at reaction site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: First day it was pinkish around injection site and odd shape but not large.  The second day it was larger, very red and raised.  Itches and is painful.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Spinal pain
Clinical narrative: Complained of aches in spine, hips, and knees that lasted a few weeks. Also, reported having a headache for a few days. Has been taking ibuprofen and is feeling better.
Age: 48.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: PATIENT REPORTED SEVERE ARM REDNESS, TENDERNESS BELOW INJECTION SITES. FEVERISH FOR ABOUT 24HRS.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Severe swelling, pain at injection site: 7 days; Severe headache, day 7-12; fatigue and flu-like fatigue and body aches, day 12-21; extreme diarrhea, day 12-present; nausea and vomiting, day 12-21; severe rash, day 21-present.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pain, Rash, Vomiting
Clinical narrative: Severe swelling, pain at injection site: 7 days; Severe headache, day 7-12; fatigue and flu-like fatigue and body aches, day 12-21; extreme diarrhea, day 12-present; nausea and vomiting, day 12-21; severe rash, day 21-present.
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Malaise, Pallor, Presyncope, Syncope, Vomiting
Clinical narrative: 0.5ml HPV administered in the right deltoid. Within one minute the patient went pale & states that he did not feel well. Pt placed in supine position and a sip of water given. Color came back to the patient's face, heart rate 56. Dr to bedside. Vasovagal reaction. Three minutes later patient experienced two episodes of emesis, pale. Dr evaluated patient. Dr advised patient to stay in clinic longer for monitoring. Mom and nurse or dr at bedside entire time. Patient sat up, color good, states feeling better. Drank a sip of water. No further emesis. Patient sat on table with legs down for 5 minutes, states feeling fine. Slowly stood up. Walked slowly toward door, turned around and went pale. Started to faint against wall, slowly went down with mom and reaching for him. Did not hit head. Laid patient supine on floor. Yelled for help and AED. Dr at side. Attached AED, no shock advised. Heart rate per Dr auscultation of heart in 30s. Pt talking, aware of surroundings, asking what happened. Reassured patient he is being taken care of. EMS called by another staff member. BP 98/64 oxygen 100%, Heart rate per palpation by myself at 60. Pulse ox registered 47 for HR. Patient color pale, talking and responsive to location. EMS arrived, I gave report of vitals, no family history of syncope, though patient and mom report patient has experienced 4-5 episodes of near syncope-syncope in past. Reassured mom. EMS took over care and patient transported to ER.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Breast pain, Injected limb mobility decreased, Injection site swelling, Tenderness
Clinical narrative: Patient is complaining of swelling of the arm from the shoulder to the elbow, pain on touch and pain into her breast region and unable to move the arm. Patient was seen by her primary care physician and she was started on Keflex 500mg cap and Benadryl. She was told to go get blood work for cellulitis.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Pneumovax23 was administered Sub-Q in left arm, Blistering, redness, swelling at injection site started on 9-13-16 and has progressed to a large 3cm consolidated blister surrounded by a 10cm by 12cm roughly circular erythematic swollen area. Diphenhydramine 5omg IM and Solumedrol 125mg IM was given on 9-14-16 @1450PM.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Dehydration, Fatigue, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Body aches, fatigue, fever, sore throat, dehydration.
Age: 55.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Injection site pruritus, Vaccination site rash
Clinical narrative: Rash and itching developed on arm where vaccine was administered.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme soreness in arm followed by swelling and redness for several days before symptoms subsided.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: Patient reported redness of the arm that was pointed out to him on 09/13/16 in the afternoon. He reported pain but able to move the arm.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Joint swelling, Mobility decreased, Muscle spasms
Clinical narrative: Difficulty with moving; headache; joint pain; muscle aching or cramping; muscle pains or stiffness; nausea; swollen joints.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Difficulty with moving; headache; joint pain; muscle aching or cramping; muscle pains or stiffness; nausea; swollen joints.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Blood test, Pyrexia, Seizure, Ultrasound scan, Urine analysis
Clinical narrative: Fever developed in the morning and progressively got worse. It went down to 101 then increased to 103, when he had a seizure. Paramedics required transport via ambulance.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Joint swelling, Movement disorder, Muscle spasms
Clinical narrative: Difficulty with moving; headache; joint pain; muscle aching or cramping; muscle pains or stiffness; nausea; swollen joints.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Difficulty with moving; headache; joint pain; muscle aching or cramping; muscle pains or stiffness; nausea; swollen joints.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site mass
Clinical narrative: Patient has a lump in the area where the injection was given.  He noticed it after the immunization but it has not went down since the immunization 12 days ago.
Age: 19.0
Sex: M
Vaccine: FLU4, MENB, TDAP
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever, body aches, flu-like symptoms.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Flushing, Headache, Malaise
Clinical narrative: Flushing, headache, general malaise.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient develop a raised red rash at the injection site. Approximately 1 to 1 and 1/2 inch in circumference.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Ear pain, Eyelid ptosis, Lacrimation increased, Ocular hyperaemia, Pyrexia
Clinical narrative: Right eye droopy, watery, red....fever 101.2 r ear pain, no stiff neck at this time.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Myalgia
Clinical narrative: Patient had severe muscle pain and soreness. Also, experience dizziness.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out a few minutes after shot administered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt c/o tenderness at site after immunization, but there was nothing indicating pt had even rcvd vaccine. Pt went to school with no problems, ate dinner with no problems, but when mom went to bathe pt the area was bright red, hard and swollen as well as very warm at area of injection.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Dyspnoea, Headache, Nausea, Pain
Clinical narrative: Pt reposrts on 9/14/16 that 3 hours after recieving vaccinations he experiences fever of 103 F, chills, HA, body aches, nausea, vomited 6 times and had difficulty breathing. Sx lasted for 12-24 hours.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt reposrts on 9/14/16 that 3 hours after recieving vaccinations he experiences fever of 103 F, chills, HA, body aches, nausea, vomited 6 times and had difficulty breathing. Sx lasted for 12-24 hours.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV, TD
Symptoms: Dizziness, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Severe pain on the arm, swollen and red area.  Slight fever. Started approximately at 7pm yesterday and continues today.  Today has some dizziness and feels exhausted.  I put some ice on the arm and took 2 Panadol to lower the fever.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV, TD
Symptoms: Pyrexia
Clinical narrative: Severe pain on the arm, swollen and red area.  Slight fever. Started approximately at 7pm yesterday and continues today.  Today has some dizziness and feels exhausted.  I put some ice on the arm and took 2 Panadol to lower the fever.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Back pain, Eye pain, Feeling hot, Gait disturbance, Influenza like illness
Clinical narrative: Patient returned to pharmacy on 9/14/16 did not report specific timeline when questioned.  She says her arm was swollen, then body felt hot, eyes hurt, had trouble walking and had back pain.  She felt like she had the flu. Patient stated she was going to ER.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling
Clinical narrative: Patient returned to pharmacy on 9/14/16 did not report specific timeline when questioned.  She says her arm was swollen, then body felt hot, eyes hurt, had trouble walking and had back pain.  She felt like she had the flu. Patient stated she was going to ER.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: PT states that the Pharmacist hurt her while providing the vaccination.  Patient hasn't mentioned any specific details and isn't available to get in contact with to see what Pharmacy can do next/check her status.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives covering body.  Gave Benadryl.  She still has hives at this time.  It has been a month.  We have been to three doctors.  Taking 20mL of Zyrtec to help with hives.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Some swelling and pain.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Headache, Menstruation irregular, Pain
Clinical narrative: After receiving the GARDASIL vaccine patient lost her periods. They came back but very infrequently. When they do come she experienced severe pain and headaches.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates in 2014, doses of ROTATEQ (lot # K001198 with expiry date: 25-OCT-2015, number of doses unspecified) that were improperly stored were administered to the patients. Reported excursion occurred in 2014 but it was not discovered until recent audit of temperature log in August 2016. The reporter confirmed administration of improperly stored vaccine doses. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient experienced rash and swelling of upper arm within 2 hours of receiving flu shot. Patient stated that she gets flu vaccine yearly and always has this reaction.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Itching of arm-swelling (slight) and warmth/reddish.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Itching of whole arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching, warmth at injection site. Physician prescribed MEDROL DOSEPAK.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Five minutes after receiving GARDASIL. Pt experienced vasovagal syncopal episode. Recovered without difficulty. Incident happened in office.
Age: 59.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Red and inflamed around site of immunization. Patient is now on antibiotics.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Donor developed rash at site a day after immunization was given. Site is warm to the touch, red, and has little raised bumps.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had red (raised and warm) area develop around injection site.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Cough, Rash generalised, Rash macular, Rhinorrhoea, Streptococcus test negative
Clinical narrative: Developed extensive reddish brown, mostly macular, some-elevated rash, all over but mostly on truck, not itching, has little clear runny nose and mild cough, no fever, no red eyes, no SOB. Observe at home, CALADRYL lotion topical, advised oral hydroxyzine to give if itches.
Age: 35.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in toes of left foot and numbness in palm of left hand.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash on both feet.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Induration, Pain
Clinical narrative: 24 hrs. experienced pain, redness, induration approximately 1 inch adjacent to injection site. Treated with Loratadine 10mg Qd and topical hydrocortisone cream.
Sex: U
Vaccine: HPV4, TTOX
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender regarding himself/herself. Medical history and concomitant medications were not reported. On an unknown date the patient went to physician's office for a tetanus shot(tetanus toxoid). But the nurse wrongly administered a fourth dose of GARDASIL, intramuscularly. The patient did not have any adverse effects at that time. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Eye swelling, Lip swelling, Pruritus, Rash erythematous
Clinical narrative: Child woke up 9/14/16 around 0100 AM with skin itching - described rash that was red and small bumps at time. States there was swelling to right eye and lips. Visit to office on 9/14/16 with mild lip swelling, no eye swelling, and no visible rash. Symptoms improved with BENADRYL.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: 3 1/2cm x 1/2cm hives on (L) foot.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Pt has swelling and redness in the arm for 2 days. Area is about the size of a grapefruit. Area was also felt hard to touch.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Back pain, Dizziness, Fatigue, Limb discomfort, Myalgia
Clinical narrative: Dizziness/nausea at onset of Influenza vaccination in left arm administration 9/14/2016 at 0700. Initial symptoms of lower back pain/heaviness in legs from hips down, muscle aches and fatigue occurred at 9:15am-10:30am.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Nausea
Clinical narrative: Dizziness/nausea at onset of Influenza vaccination in left arm administration 9/14/2016 at 0700. Initial symptoms of lower back pain/heaviness in legs from hips down, muscle aches and fatigue occurred at 9:15am-10:30am.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt developed urticaria and low-grade temp 4 hours after vaccines.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Hot flush, Myalgia, Nausea
Clinical narrative: Moderate fever > 101. Severe headache, myalgias, dizziness, intense heat hot-flashes, nausea. Required Ibuprofen, rest, PO BENADRYL 1 dose.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Moderate fever > 101. Severe headache, myalgias, dizziness, intense heat hot-flashes, nausea. Required Ibuprofen, rest, PO BENADRYL 1 dose.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Vaccine administered 9-9-16. On that evening, the patient experienced vomiting, headache, and low grade fever (100 F). On 9-10-16, the patient awoke with redness, swelling and heat in left arm from injection site down to her elbow. On 9-12-16 reaction was sublining.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vaccine administered 9-9-16. On that evening, the patient experienced vomiting, headache, and low grade fever (100 F). On 9-10-16, the patient awoke with redness, swelling and heat in left arm from injection site down to her elbow. On 9-12-16 reaction was sublining.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Large area of redness, induration, warmth and swelling. Measuring 16 x 17 cm. Advised to apply ice and give ibuprofen. Administered 1 tsp BENADRYL and RTC if no improvement/worsen.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Pt had immediate site reaction redness, irritation, pain redness continued to increase and spread until pt went to urgent care the following day.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Pt reported to have received the Anthrax vaccine in the early stages of her pregnancy (before she was aware of the pregnancy). She was vaccinated in the military and informed our practice of vaccination at 1st visit on 8/12/16 at 32 wks pregnant.
Age: 44.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: Given PREVNAR 13 on 09-08-16 noted the next morning redness, edema and warm to touch. Instructed heat/ice/antihistamine call if worsening/no improvement in 5 days.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea and dizziness
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Mobility decreased, Pain, Skin discolouration
Clinical narrative: Very bad pain and limited movement night of administration. Iced the area and rested arm. Yellow, purple bruising and discoloration. Still has some pain. Getting better
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates in 2014, doses of RECOMBIVAX HB (lot # J014855 with expiry date: 16-APR-2016 and lot # K008986 with expiry date: 01-APR-2016, number of doses unspecified) that were improperly stored were administered to the patients. Reported excursion occurred in 2014 but it was not discovered until recent audit of temperature log in August 2016. The reporter confirmed administration of improperly stored vaccine doses. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection 2.5/0.5 lot # K008334, expiration date 09-JUN-2016 (exact dose and route of administration were not provided). There were no concomitant medications reported. There were no adverse effects reported and no product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates in 2014, doses of VAQTA (lot # K005323 with expiry date: 10-FEB-2017, lot # J000985 with expiry date: 20-AUG-2015 and lot # J011712 with expiry date: 21-SEP-2015, number of doses unspecified) that were improperly stored were administered to the patients. Reported excursion occurred in 2014 but it was not discovered until recent audit of temperature log in August 2016. The reporter confirmed administration of improperly stored vaccine doses. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot # M000442, expiration date 31-MAR-2018; dose and route were not reported). No adverse effects were reported. The vaccines were stored in 33 F for 60 days. The call was made because of the data logger. No previous temperature excursion was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. On 04-JAN-2016, the patient was vaccinated with an improperly stored dose of the GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L016429 with expiration date 09-AUG-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. On 29-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L027282 with expiration with expiration date reported as 29-JAN-2016). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 53 years old patient of unknown gender. Patient's medical history, concurrent conditions and drug reactions/allergies were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of (wistar ra 27-3) M-M-R II  (Concentration, dose, lot#, expiration date and route were unknown by the reporter). Patient's concomitant therapy was unknown by the reporter. On an unknown date, the patient experienced viral titre decrease reported as "the patient had low titers", the pharmacist stated that the patient asked to receive a booster dose of (wistar ra 27-3) M-M-R II, which was needed for her employment. It was unknown by the reporter if lab diagnostics studies were performed to the patient and also if there was treatment given for the event. The outcome of viral titre decreased was unknown. The relationship regarding (wistar ra 27-3) M-M-R II and viral titre decreased was unknown. A product quality complaint was not involved. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an 83 year old non-pregnant female patient. The patient did not have any pertinent medical history. The patient was allergic to angiotensin-converting-enzyme (ACE) inhibitors. The patient's historical medication included PREVNAR 13 received on 04-SEP-2015. On 02-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M005287, expiration date: 08-OCT-2016, once, intramuscular in the right arm). Concomitantly, she received a flu shot in her left arm. On the same day (also reported as on 03-SEP-2016), the patient experienced a swollen and red injection site on her right arm. She had no injection site reaction on her left arm. The patient went to the urgent care and received an antibiotic injection. There was no laboratory tests performed. The pharmacist requests a lot check. It was reported that the patient continued vaccination with PNEUMOVAX 23. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an 83 year old non-pregnant female patient. The patient did not have any pertinent medical history. The patient was allergic to angiotensin-converting-enzyme (ACE) inhibitors. The patient's historical medication included PREVNAR 13 received on 04-SEP-2015. On 02-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M005287, expiration date: 08-OCT-2016, once, intramuscular in the right arm). Concomitantly, she received a flu shot in her left arm. On the same day (also reported as on 03-SEP-2016), the patient experienced a swollen and red injection site on her right arm. She had no injection site reaction on her left arm. The patient went to the urgent care and received an antibiotic injection. There was no laboratory tests performed. The pharmacist requests a lot check. It was reported that the patient continued vaccination with PNEUMOVAX 23. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Erythema, Inflammation
Clinical narrative: (R) upper arm with 20x23 induration, warm and tender, Medrol dose pack.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Induration, Skin warm, Tenderness
Clinical narrative: (R) upper arm with 20x23 induration, warm and tender, Medrol dose pack.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Erythema, Hypoaesthesia, Neuralgia, Paraesthesia
Clinical narrative: This spontaneous report was received from a physician referring to a 74 year old male patient with diabetes mellitus and hypercholesterolaemia. The patient's medical history was not reported. On 26-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, by subcutaneous route (strength, lot number, expiration date were not provided). The patient's concomitant therapies were atorvastatin, ZYRTEC, sitagliptin phosphate (manufacturer unknown), glipizide and metformin. On 26-AUG-2016, the patient experienced a fever and malaise (reported as "the patient didn't feel well") for 5 to 7 days. Then he experienced ten chickenpox type lesions on his body and numbness in his right lower leg and had petechiae type rash to bottom of the right foot and had formed scabs over the lesion. On approximately 2016, reported as over the last couple of days, the patient began to lose sensation in his right lower leg and foot as well as the patient was having bruising on the soles of his feet. The physician stated that over the weekend the patient had received treatment for his symptoms and was prescribed ZOVIRAX. The physician stated that the patient's rash was subsiding and the numbness in his leg and foot are less generalized but it has not subsided. The reporter stated that the patient sought medical attention on an unknown date and no laboratory diagnostics test were performed to him. The outcome of the events was recovering and no product quality complain was involved. The relationship between the events and the ZOSTAVAX was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Contusion, Hypoaesthesia, Malaise, Petechiae, Pyrexia
Clinical narrative: This spontaneous report was received from a physician referring to a 74 year old male patient with diabetes mellitus and hypercholesterolaemia. The patient's medical history was not reported. On 26-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, by subcutaneous route (strength, lot number, expiration date were not provided). The patient's concomitant therapies were atorvastatin, ZYRTEC, sitagliptin phosphate (manufacturer unknown), glipizide and metformin. On 26-AUG-2016, the patient experienced a fever and malaise (reported as "the patient didn't feel well") for 5 to 7 days. Then he experienced ten chickenpox type lesions on his body and numbness in his right lower leg and had petechiae type rash to bottom of the right foot and had formed scabs over the lesion. On approximately 2016, reported as over the last couple of days, the patient began to lose sensation in his right lower leg and foot as well as the patient was having bruising on the soles of his feet. The physician stated that over the weekend the patient had received treatment for his symptoms and was prescribed ZOVIRAX. The physician stated that the patient's rash was subsiding and the numbness in his leg and foot are less generalized but it has not subsided. The reporter stated that the patient sought medical attention on an unknown date and no laboratory diagnostics test were performed to him. The outcome of the events was recovering and no product quality complain was involved. The relationship between the events and the ZOSTAVAX was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scab, Sensory loss, Varicella
Clinical narrative: This spontaneous report was received from a physician referring to a 74 year old male patient with diabetes mellitus and hypercholesterolaemia. The patient's medical history was not reported. On 26-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, by subcutaneous route (strength, lot number, expiration date were not provided). The patient's concomitant therapies were atorvastatin, ZYRTEC, sitagliptin phosphate (manufacturer unknown), glipizide and metformin. On 26-AUG-2016, the patient experienced a fever and malaise (reported as "the patient didn't feel well") for 5 to 7 days. Then he experienced ten chickenpox type lesions on his body and numbness in his right lower leg and had petechiae type rash to bottom of the right foot and had formed scabs over the lesion. On approximately 2016, reported as over the last couple of days, the patient began to lose sensation in his right lower leg and foot as well as the patient was having bruising on the soles of his feet. The physician stated that over the weekend the patient had received treatment for his symptoms and was prescribed ZOVIRAX. The physician stated that the patient's rash was subsiding and the numbness in his leg and foot are less generalized but it has not subsided. The reporter stated that the patient sought medical attention on an unknown date and no laboratory diagnostics test were performed to him. The outcome of the events was recovering and no product quality complain was involved. The relationship between the events and the ZOSTAVAX was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Gait disturbance, Herpes zoster, Hypoaesthesia, Insomnia
Clinical narrative: This spontaneous report was received from a physician referring to a 74 year old male patient with diabetes mellitus and hypercholesterolaemia. The patient's medical history was not reported. On 26-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, by subcutaneous route (strength, lot number, expiration date were not provided). The patient's concomitant therapies were atorvastatin, ZYRTEC, sitagliptin phosphate (manufacturer unknown), glipizide and metformin. On 26-AUG-2016, the patient experienced a fever and malaise (reported as "the patient didn't feel well") for 5 to 7 days. Then he experienced ten chickenpox type lesions on his body and numbness in his right lower leg and had petechiae type rash to bottom of the right foot and had formed scabs over the lesion. On approximately 2016, reported as over the last couple of days, the patient began to lose sensation in his right lower leg and foot as well as the patient was having bruising on the soles of his feet. The physician stated that over the weekend the patient had received treatment for his symptoms and was prescribed ZOVIRAX. The physician stated that the patient's rash was subsiding and the numbness in his leg and foot are less generalized but it has not subsided. The reporter stated that the patient sought medical attention on an unknown date and no laboratory diagnostics test were performed to him. The outcome of the events was recovering and no product quality complain was involved. The relationship between the events and the ZOSTAVAX was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a physician referring to a 74 year old male patient with diabetes mellitus and hypercholesterolaemia. The patient's medical history was not reported. On 26-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, by subcutaneous route (strength, lot number, expiration date were not provided). The patient's concomitant therapies were atorvastatin, ZYRTEC, sitagliptin phosphate (manufacturer unknown), glipizide and metformin. On 26-AUG-2016, the patient experienced a fever and malaise (reported as "the patient didn't feel well") for 5 to 7 days. Then he experienced ten chickenpox type lesions on his body and numbness in his right lower leg and had petechiae type rash to bottom of the right foot and had formed scabs over the lesion. On approximately 2016, reported as over the last couple of days, the patient began to lose sensation in his right lower leg and foot as well as the patient was having bruising on the soles of his feet. The physician stated that over the weekend the patient had received treatment for his symptoms and was prescribed ZOVIRAX. The physician stated that the patient's rash was subsiding and the numbness in his leg and foot are less generalized but it has not subsided. The reporter stated that the patient sought medical attention on an unknown date and no laboratory diagnostics test were performed to him. The outcome of the events was recovering and no product quality complain was involved. The relationship between the events and the ZOSTAVAX was unknown. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pruritus, Rash, Swelling
Clinical narrative: Severe puritis, redness swelling, pain, Continued to spread over 24 hours with hives developing and puritiis spreading to entire upper arm Physician visited day after injection.  Benadryl injection given with triamcinolone cream provided.  Redness and rash continued to spread.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Severe puritis, redness swelling, pain, Continued to spread over 24 hours with hives developing and puritiis spreading to entire upper arm Physician visited day after injection.  Benadryl injection given with triamcinolone cream provided.  Redness and rash continued to spread.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Cold sweat, Dizziness, Drug administered at inappropriate site, Heart rate increased
Clinical narrative: Initial unsolicited misuse report received from a nurse (registered) on 31 August 2016. This case involves a 53-year-old female patient, who was vaccinated with ADACEL via intramuscular route (batch number: U5271AA, expiry date: 10 February 2018) (dose, dose in series were not reported) at the right thigh on 23 August 2016. The patient's medical history was reported as none. Illness at the time of vaccination and allergies were also reported as none. Concomitant medications was not reported. On 23 August 2016, within 10 minutes following the vaccination, the patient developed anxiety, felt like patient was going to pass out, felt heart was racing, had intermittent elevated pulse rate, cool, clammy, and had decrease in oxygen saturation and palpitation (as diagnosed in ER visit). This was a case of drug administered at inappropriate site and product use issue. Reportedly, the patient required ER visit. The events' outcome was reported as unknown. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Oxygen saturation decreased, Palpitations, Product use issue
Clinical narrative: Initial unsolicited misuse report received from a nurse (registered) on 31 August 2016. This case involves a 53-year-old female patient, who was vaccinated with ADACEL via intramuscular route (batch number: U5271AA, expiry date: 10 February 2018) (dose, dose in series were not reported) at the right thigh on 23 August 2016. The patient's medical history was reported as none. Illness at the time of vaccination and allergies were also reported as none. Concomitant medications was not reported. On 23 August 2016, within 10 minutes following the vaccination, the patient developed anxiety, felt like patient was going to pass out, felt heart was racing, had intermittent elevated pulse rate, cool, clammy, and had decrease in oxygen saturation and palpitation (as diagnosed in ER visit). This was a case of drug administered at inappropriate site and product use issue. Reportedly, the patient required ER visit. The events' outcome was reported as unknown. List of documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: HPVX, MNQ
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Initial unsolicited report received from a nurse on 01 September 2016. This case involves a 13-year-old female patient who was vaccinated with a first dose of MENACTRA (batch number, expiration date, dose not reported) intramuscularly and third dose of HUMAN PAPILLOMA VIRUS VACCINE (HPV) (batch number, expiration date, route, dose and site not reported) in the arm on 20 Aug 2012. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as Latex, erythromycin, zithromycin, sinular, bactrim, neomycin, cefuroxime. Illness at time of vaccination was reported as none. Concomitant medications were not reported. On 20 Aug 2012, same day (reported as began in first 24 hours) following the vaccination, the patient experienced exaggerated local reaction of the upper arm to the elbow with swelling and redness of the arm at the injection site. It was reported that, the patient required ER or doctor visit. Lab data was not reported. Corrective treatment received was Benadryl. The patient was not recovered from the events. List of documents held by sender: none.