chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Proquad given at 6 months of age--no symptoms to date and no treatment.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site warmth, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Very sore and feverish at injection site. Arm and shoulder painful when movement occurs since time of injection. Neck and shoulders very painful 2 days later.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pityriasis lichenoides et varioliformis acuta, Pruritus generalised, Rash
Clinical narrative: Itching all over, then development of rash, on trunk then spread to extremities.  On exam 11/27, rash most consistent with PLEVA.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Itchy Rash/Urticaria on wrist; grew over several hours.  Treatment with antihistamine.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: INTENSE BACK MUSCLE PAIN.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe hives.  Pt went to an Urgent Care and was prescribed diphenhydramine 25mg 1 to 2 po q6h prn.  Diphenhydramine was not helping with itching so pt went pt PC physician on 11/25 and was prescribed cimetidine 400mg bid x30 and prednisone 10mg 1 tid x7 days.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood pressure increased, Blood test, Borrelia test, Brain injury
Clinical narrative: At 1am all muscles, inc. throat, started tightening up, chills, by morning I was completely paralyzed.  I could only lay and use the bathroom, I could barely move.  For the next 3 weeks, I suffered severe fatigue. I didn't move my bowels til day 9 and they were gray.  For the next 7 weeks, I only moved my bowels 6 times, w/ severe constipation, and Ive been regular my whole life. When I did attempt to do anything, I couldn't breathe. I put a call in to my Dr. cause it was so bad that while doing the dishes I sound like I ran up 10 flights of stairs.  She sent me to hospital, shocked by my breathing on the phone, and order a complete workup again.  Iwas also severely dizzy and nauseous all the time.  When I lay completely still, I was ok so I had to do that.  I couldn't work or take part in anything called life.  At hospital echo, EKG, lung xray, head, all done and found to be perfectly healthy.  They couldn't identify why I was so sick.  I knew exactly and tried to tell them.  One night in hospital I got up to take off the sheet and my blood pressure must have skyrocketed, cause anything I did w/ my upper body, I could not breathe and they rushed in.  My breathing is still not normal.  I was very aerobically fit.  Walked dogs everyday 3 - 4 mile.  Now even at a resting position, my breathing is not normal.  Went to pulmonary testing and she said I had trouble getting air out.  Neurologists speculate that I have a rare auto immune infection from the flu shot.  I have been so nauseous and dizzy that I have vomited in the last 10mos. more than my whole adult life, when I'm driving I have to pull over etc. neurologist sent me to vestibular testing saying that that part of my brain was damaged due to the initial attack.  I have an appt. w/ vng testing now coming up, and have had to file for disability etc.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Chills, Constipation, Dizziness, Dyspnoea
Clinical narrative: At 1am all muscles, inc. throat, started tightening up, chills, by morning I was completely paralyzed.  I could only lay and use the bathroom, I could barely move.  For the next 3 weeks, I suffered severe fatigue. I didn't move my bowels til day 9 and they were gray.  For the next 7 weeks, I only moved my bowels 6 times, w/ severe constipation, and Ive been regular my whole life. When I did attempt to do anything, I couldn't breathe. I put a call in to my Dr. cause it was so bad that while doing the dishes I sound like I ran up 10 flights of stairs.  She sent me to hospital, shocked by my breathing on the phone, and order a complete workup again.  Iwas also severely dizzy and nauseous all the time.  When I lay completely still, I was ok so I had to do that.  I couldn't work or take part in anything called life.  At hospital echo, EKG, lung xray, head, all done and found to be perfectly healthy.  They couldn't identify why I was so sick.  I knew exactly and tried to tell them.  One night in hospital I got up to take off the sheet and my blood pressure must have skyrocketed, cause anything I did w/ my upper body, I could not breathe and they rushed in.  My breathing is still not normal.  I was very aerobically fit.  Walked dogs everyday 3 - 4 mile.  Now even at a resting position, my breathing is not normal.  Went to pulmonary testing and she said I had trouble getting air out.  Neurologists speculate that I have a rare auto immune infection from the flu shot.  I have been so nauseous and dizzy that I have vomited in the last 10mos. more than my whole adult life, when I'm driving I have to pull over etc. neurologist sent me to vestibular testing saying that that part of my brain was damaged due to the initial attack.  I have an appt. w/ vng testing now coming up, and have had to file for disability etc.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Faeces pale, Fatigue, Impaired work ability, Mass
Clinical narrative: At 1am all muscles, inc. throat, started tightening up, chills, by morning I was completely paralyzed.  I could only lay and use the bathroom, I could barely move.  For the next 3 weeks, I suffered severe fatigue. I didn't move my bowels til day 9 and they were gray.  For the next 7 weeks, I only moved my bowels 6 times, w/ severe constipation, and Ive been regular my whole life. When I did attempt to do anything, I couldn't breathe. I put a call in to my Dr. cause it was so bad that while doing the dishes I sound like I ran up 10 flights of stairs.  She sent me to hospital, shocked by my breathing on the phone, and order a complete workup again.  Iwas also severely dizzy and nauseous all the time.  When I lay completely still, I was ok so I had to do that.  I couldn't work or take part in anything called life.  At hospital echo, EKG, lung xray, head, all done and found to be perfectly healthy.  They couldn't identify why I was so sick.  I knew exactly and tried to tell them.  One night in hospital I got up to take off the sheet and my blood pressure must have skyrocketed, cause anything I did w/ my upper body, I could not breathe and they rushed in.  My breathing is still not normal.  I was very aerobically fit.  Walked dogs everyday 3 - 4 mile.  Now even at a resting position, my breathing is not normal.  Went to pulmonary testing and she said I had trouble getting air out.  Neurologists speculate that I have a rare auto immune infection from the flu shot.  I have been so nauseous and dizzy that I have vomited in the last 10mos. more than my whole adult life, when I'm driving I have to pull over etc. neurologist sent me to vestibular testing saying that that part of my brain was damaged due to the initial attack.  I have an appt. w/ vng testing now coming up, and have had to file for disability etc.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle tightness, Nausea, Paralysis, Pulmonary function test abnormal
Clinical narrative: At 1am all muscles, inc. throat, started tightening up, chills, by morning I was completely paralyzed.  I could only lay and use the bathroom, I could barely move.  For the next 3 weeks, I suffered severe fatigue. I didn't move my bowels til day 9 and they were gray.  For the next 7 weeks, I only moved my bowels 6 times, w/ severe constipation, and Ive been regular my whole life. When I did attempt to do anything, I couldn't breathe. I put a call in to my Dr. cause it was so bad that while doing the dishes I sound like I ran up 10 flights of stairs.  She sent me to hospital, shocked by my breathing on the phone, and order a complete workup again.  Iwas also severely dizzy and nauseous all the time.  When I lay completely still, I was ok so I had to do that.  I couldn't work or take part in anything called life.  At hospital echo, EKG, lung xray, head, all done and found to be perfectly healthy.  They couldn't identify why I was so sick.  I knew exactly and tried to tell them.  One night in hospital I got up to take off the sheet and my blood pressure must have skyrocketed, cause anything I did w/ my upper body, I could not breathe and they rushed in.  My breathing is still not normal.  I was very aerobically fit.  Walked dogs everyday 3 - 4 mile.  Now even at a resting position, my breathing is not normal.  Went to pulmonary testing and she said I had trouble getting air out.  Neurologists speculate that I have a rare auto immune infection from the flu shot.  I have been so nauseous and dizzy that I have vomited in the last 10mos. more than my whole adult life, when I'm driving I have to pull over etc. neurologist sent me to vestibular testing saying that that part of my brain was damaged due to the initial attack.  I have an appt. w/ vng testing now coming up, and have had to file for disability etc.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Respiration abnormal, Skull X-ray normal, Throat tightness, Ultrasound scan normal, Vestibular function test
Clinical narrative: At 1am all muscles, inc. throat, started tightening up, chills, by morning I was completely paralyzed.  I could only lay and use the bathroom, I could barely move.  For the next 3 weeks, I suffered severe fatigue. I didn't move my bowels til day 9 and they were gray.  For the next 7 weeks, I only moved my bowels 6 times, w/ severe constipation, and Ive been regular my whole life. When I did attempt to do anything, I couldn't breathe. I put a call in to my Dr. cause it was so bad that while doing the dishes I sound like I ran up 10 flights of stairs.  She sent me to hospital, shocked by my breathing on the phone, and order a complete workup again.  Iwas also severely dizzy and nauseous all the time.  When I lay completely still, I was ok so I had to do that.  I couldn't work or take part in anything called life.  At hospital echo, EKG, lung xray, head, all done and found to be perfectly healthy.  They couldn't identify why I was so sick.  I knew exactly and tried to tell them.  One night in hospital I got up to take off the sheet and my blood pressure must have skyrocketed, cause anything I did w/ my upper body, I could not breathe and they rushed in.  My breathing is still not normal.  I was very aerobically fit.  Walked dogs everyday 3 - 4 mile.  Now even at a resting position, my breathing is not normal.  Went to pulmonary testing and she said I had trouble getting air out.  Neurologists speculate that I have a rare auto immune infection from the flu shot.  I have been so nauseous and dizzy that I have vomited in the last 10mos. more than my whole adult life, when I'm driving I have to pull over etc. neurologist sent me to vestibular testing saying that that part of my brain was damaged due to the initial attack.  I have an appt. w/ vng testing now coming up, and have had to file for disability etc.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: At 1am all muscles, inc. throat, started tightening up, chills, by morning I was completely paralyzed.  I could only lay and use the bathroom, I could barely move.  For the next 3 weeks, I suffered severe fatigue. I didn't move my bowels til day 9 and they were gray.  For the next 7 weeks, I only moved my bowels 6 times, w/ severe constipation, and Ive been regular my whole life. When I did attempt to do anything, I couldn't breathe. I put a call in to my Dr. cause it was so bad that while doing the dishes I sound like I ran up 10 flights of stairs.  She sent me to hospital, shocked by my breathing on the phone, and order a complete workup again.  Iwas also severely dizzy and nauseous all the time.  When I lay completely still, I was ok so I had to do that.  I couldn't work or take part in anything called life.  At hospital echo, EKG, lung xray, head, all done and found to be perfectly healthy.  They couldn't identify why I was so sick.  I knew exactly and tried to tell them.  One night in hospital I got up to take off the sheet and my blood pressure must have skyrocketed, cause anything I did w/ my upper body, I could not breathe and they rushed in.  My breathing is still not normal.  I was very aerobically fit.  Walked dogs everyday 3 - 4 mile.  Now even at a resting position, my breathing is not normal.  Went to pulmonary testing and she said I had trouble getting air out.  Neurologists speculate that I have a rare auto immune infection from the flu shot.  I have been so nauseous and dizzy that I have vomited in the last 10mos. more than my whole adult life, when I'm driving I have to pull over etc. neurologist sent me to vestibular testing saying that that part of my brain was damaged due to the initial attack.  I have an appt. w/ vng testing now coming up, and have had to file for disability etc.
Age: 61.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Feeling hot, Inflammation, Injection site extravasation, Pain
Clinical narrative: Patient states are after Prevnar13 got progressivly inflamed, hot and painful. Patient went to PCP on 11/13/2015, who said that the Prevnar was leaking out of muscle tissue into subcutaneos tissue.  Patient was treated with Bactrim DS antibiotic and Prednisone.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pain with shoulder rotation. Some movements begin with a sort of locked inhibition to move, forced motion causes a burst of pain. Could not continue normal exercise routine. Push ups exacerbate shoulder pain.
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Decreased appetite, Headache, Hypersensitivity, Influenza like illness
Clinical narrative: Flu shot and pneumonia vaccination last week on the 24th. Arm was sore in a few hrs, that evening was worse. The next day could barely lift arm or use it. Also had low grade fever, chills, and headache. Nausea but no vomiting. Appetite was decreased. No diarrhea. Yesterday was a bit better, could eat. Arm less sore. Last night had some night sweats, noticed red patch over the left upper arm. Could have been there yesterday but did not notice. Took Dayquil for the flu like symptoms, took Advil yesterday. Did help some. Has had flu shots in the past--has been several years. No known allergies. This was his first pneumonia vaccination. ROS still has mild headache. Patient was seen today for allergic reaction. Appears to be a local vaccination reaction with some flu like symptoms. Recommend NSAID and ICE, rest. Watch area of erythema for increasing area, worsening induration or increased pain. Come in to the IC if worse. At this point there does not appear to be any infection but if worsening do not hesitate to be seen again. In the future do not get vaccinations together. Likely not an allergy, but use caution for vaccinations in the future.
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Local reaction, Mobility decreased, Nausea, Night sweats
Clinical narrative: Flu shot and pneumonia vaccination last week on the 24th. Arm was sore in a few hrs, that evening was worse. The next day could barely lift arm or use it. Also had low grade fever, chills, and headache. Nausea but no vomiting. Appetite was decreased. No diarrhea. Yesterday was a bit better, could eat. Arm less sore. Last night had some night sweats, noticed red patch over the left upper arm. Could have been there yesterday but did not notice. Took Dayquil for the flu like symptoms, took Advil yesterday. Did help some. Has had flu shots in the past--has been several years. No known allergies. This was his first pneumonia vaccination. ROS still has mild headache. Patient was seen today for allergic reaction. Appears to be a local vaccination reaction with some flu like symptoms. Recommend NSAID and ICE, rest. Watch area of erythema for increasing area, worsening induration or increased pain. Come in to the IC if worse. At this point there does not appear to be any infection but if worsening do not hesitate to be seen again. In the future do not get vaccinations together. Likely not an allergy, but use caution for vaccinations in the future.
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Flu shot and pneumonia vaccination last week on the 24th. Arm was sore in a few hrs, that evening was worse. The next day could barely lift arm or use it. Also had low grade fever, chills, and headache. Nausea but no vomiting. Appetite was decreased. No diarrhea. Yesterday was a bit better, could eat. Arm less sore. Last night had some night sweats, noticed red patch over the left upper arm. Could have been there yesterday but did not notice. Took Dayquil for the flu like symptoms, took Advil yesterday. Did help some. Has had flu shots in the past--has been several years. No known allergies. This was his first pneumonia vaccination. ROS still has mild headache. Patient was seen today for allergic reaction. Appears to be a local vaccination reaction with some flu like symptoms. Recommend NSAID and ICE, rest. Watch area of erythema for increasing area, worsening induration or increased pain. Come in to the IC if worse. At this point there does not appear to be any infection but if worsening do not hesitate to be seen again. In the future do not get vaccinations together. Likely not an allergy, but use caution for vaccinations in the future.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Persistent soreness in arm. Patient has used a heating pad, but has not felt any relief.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A LARGE RED PATCH, SWELLING AROUND INJECTON SITE.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea
Clinical narrative: Diarrhea, has lasted 23 hours so far.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope 5 minutes after administration of Fluvirin mdv vaccine. Patient regained consciousness within 30 seconds.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Local area of inflammation around injection site, approximately 3 1/2 inches long and 1 inch wide.  There was a darker red, swollen area within the inflamed area that was 2 1/2 inches long and 1 inch wide.  Reaction resolved without treatment by 11/25/15.  Pt reported reaction to me.
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of a roughly 6 inch diameter around injection site in right arm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient developed a rash over her trunk that spread towards the extremities.  She has been getting flu shots for over 20 years (and had gotten the Fluzone High-Dose in 2014 as well as this year); she has never had a reaction before. She is unaware of any other possible causes for the rash. She was not in any discomfort from the rash.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Arm was painful at injection site. Arm has continued to be painful over period of time since vaccine administered. Patient finds it difficult to raise arm above shoulder.
Age: 13.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Got varicella 11/7/2015 and started having some redness and today has a swollen, warm to touch red area around the injection site, not itchy, not painful, hasn't taken any OTC meds, no dyspnea/throat tightness/throat swelling/lip swelling/dysphagia/tongue swelling. R lat upper arm with a 5 cm in diam red swollen warm to touch area, not ttp, full ROM of his arm--good perfusion and sensation. Benadryl 25-50 mg orally every 4-6 hours regularly if not going to school otherwise Claritin or Zyrtec every morning daily as directed, and Benadryl 50mg at bedtime after rash resolves, warm heat and gentle massage for 20 minutes then cool compresses for 20 minutes 3-4 times a day, can use cool compresses/baking soda compresses or baths or calamine lotion for itching, inc fluids, return or go to ER if sx worsen otherwise f/u with PCP.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Dizziness, Feeling cold
Clinical narrative: Neck pain and in back of head, twitching hands, dizzy, nauseous, cold feeling, fever, feeling very weak. Patient was admitted for meningitis symptoms. All tests came back negative.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Lumbar puncture normal, Meningitis, Muscle twitching, Nausea
Clinical narrative: Neck pain and in back of head, twitching hands, dizzy, nauseous, cold feeling, fever, feeling very weak. Patient was admitted for meningitis symptoms. All tests came back negative.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Neck pain and in back of head, twitching hands, dizzy, nauseous, cold feeling, fever, feeling very weak. Patient was admitted for meningitis symptoms. All tests came back negative.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Nasal congestion, Pruritus, Respiratory tract congestion, Skin warm
Clinical narrative: 7:00am admin. within 20 minutes itching, swelling, and hot to touch. Then nasal congestion within the hour. Then by 10:30 pm throat felt tight and congested with shortness of breath.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Throat tightness
Clinical narrative: 7:00am admin. within 20 minutes itching, swelling, and hot to touch. Then nasal congestion within the hour. Then by 10:30 pm throat felt tight and congested with shortness of breath.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pain, Pain in extremity, Rash
Clinical narrative: Sore arm, dizziness, rash lasting unitl present day. Was sore.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eyelid oedema, Injection site swelling, Pruritus generalised
Clinical narrative: 30 minutes after receiving injection her hands, face and arms began to turn red. Her eyes lids became swollen, she developed swelling at injection sight, and she started itching all over her body. Employee was given 25 mg of BENADRYL.
Age: 0.78
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 1.05
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Body temperature increased, Seizure
Clinical narrative: Temp 103.8. Seizure 17 minutes.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle soreness for 2 weeks. Following Flu shot in Left Deltoid the pain has increase as week when on.
Age: 51.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood culture, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling, redness and large blisters (L) upper arm at site of PCV 13 injection.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Pt has two blisters around the injection site that appeared on 11/25/15 (the day after the shot). Pt started itching the morning of 11/27/15 on the upper arm around the injection site. Pt says she is feeling ok, in general. First blister = small 11/25/15 1 AM. Second blister = bigger 11/25/15 10 AM.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Patient noticed rash on left arm at injection site circular rash 1 1/2 inches to 2 inches diameter. Warm to touch, sensitive> Noticed 2 days later 11/25/15. Saw dr on same day 11/25/15.Dr prescribed antibiotic (cephalexin) and TYLENOL. Rash cleared up by next day - 11/26/15 per patient.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received PREVNAR 13 vaccine - a few hours after receiving left upper arm near injection site swelled up and is tender and warm to touch - informed to use ice and NSAID to help reduce swelling and to follow up w/MD if no improvement.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Loss of consciousness
Clinical narrative: Pt had reaction to unknown vaccine several years ago, had flu vaccine last year without any reaction. Once vaccine was administered, pt became hot and passed out. Woke up feeling ok and able to communicate effectively. Patient moved while unconscious, unknown whether or not convulsions.
Age: 32.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Tendonitis
Clinical narrative: (L) deltoid tendonitis.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Headache
Clinical narrative: Received PREVNAR 13 vaccine approximately 36 hours after vaccination had severe headache lasting for approximately 48 hours.
Age: 5.0
Sex: F
Vaccine: DTAP, FLUN4, HEPA, IPV
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Next day... pain, red, "swollen to size of a Lemon". Iced and frozen peas/carrots, and oral children's MOTRIN given. Swelling completely gone by morning. Site still slightly red and still slightly tender.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant swelling and redness on injection site ((L) upper arm).
Age: 30.0
Sex: F
Vaccine: FLUR3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Patient was given egg free vaccine. Had hives, trouble breathing was given 1 mg of EPI and symptoms resolved. Was advised to follow up in emergency room, but she declined.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Headache, Myalgia, Pain in extremity
Clinical narrative: Myalgia, headache, arm pain, weakness.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Swollen and rash at injection site.
Age: 1.03
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 18-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiration date 17-JAN-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # L006184; Expiration date: 13-DEC-2016 and Lot# L013188; Expiration date: 02-NOV-2016) (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 3 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-JUL-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was not provided) lot # K023534, expiration date: 22-MAY-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K023432, expiration date 18-JUN-2016) (strength, dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 11-NOV-2015 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030589, expiration date 10-FEB-2017; dose and route not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning an unspecified number of patients who since January 2015 had been vaccinated with doses of oral ROTATEQ (Batch and lot No. K013410, exp. 27-FEB-2016; Batch and lot No. L004466, exp. 02-AUG-2016; Batch and lot No. "K0110222", exp. 12-MAY-2016) (dose and site not reported), doses who on unknown dates underwent temperature excursions. No adverse effects reported. Lot number K0110222 is not a valid lot for ROTATEQ. Follow up information has been received from Medical assistant on 25-NOV-2015 via a phone call. The physician was unavailable at the time of call. The phone call was transferred to Medical Assistant. The M.A stated that information was not available on patients, over the phone. Please send a written request. This report is linked to MARRS 1510USA007265, 1510USA007262, 1510USA007263 and 1510USA006129 from the same reporter. Additional information has been requested. Narrative was updated.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a male patient of unknown age was the son of the physician. Information about concurrent conditions, medical history and concomitant medication was not provided. The patient was vaccinated with GARDASIL on 27-SEP-2012, 04-SEP-2015 and 20-NOV-2015 (lot#, dose and route unknown) (inappropriate schedule of drug administration on 04-SEP-2015 and 20-NOV-2015). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning an unspecified number of patients who since January 2015 had been vaccinated with doses of VAQTA (Batch and lot No. K004856, exp. 07-DEC-2016; Batch and lot No. L018499, exp. 25-FEB-2017; Batch and lot No. K026529, exp. 02-JUN-2017) (doses and sites not reported), vaccines who on unknown dates underwent temperature excursions. No adverse effects reported. Follow up information has been received from Medical assistant on 25-NOV-2015 via a phone call. The physician was unavailable at the time of call. The phone call was transferred to Medical Assistant. The M.A stated that information was not available on patients, over the phone. Please send a written request. This report is linked to MARRS 1510USA006129, 1510USA007263, 1510USA007264 and 1510USA007265 from the same reporter. Additional information has been requested. Narrative was updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 (lot # K026246, expiry date 28-JAN-2017) (strength, dose and route were unspecified). No adverse effects had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a health care worker refers to multiple unspecified patients of unknown demographics. No medical history was reported. On an unspecified dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and frequency unknown) (Lot no: L015049, Expiry date: 29-APR-2017; Lot no: L013068, Expiry date: 14-APR-2017; Lot no: K021485, Expiry date: 3-NOV-2016; Lot no: L020004, Expiry date: 2-JUN-2017; Lot no: L021214, Expiry date: 10-JUN-2017; Lot no: K010437, Expiry date: 2-JUL-2016. No concomitant therapy was reported. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a licensed practical nurse via field representative refers to a 65 year old male patient. Patient's current conditions included prostate cancer, heart disease and hypertension. Drug reactions/allergies were none. On 30-OCT-2014, 0.5 ml, intramuscular in the right arm) (physician recommended). Concomitant medications were none. On 01-NOV-2013, the patient was seen in the office because his right arm and was red, swollen (unspecified location on right arm) and he had developed a fever. The patient was prescribed KEFLEX (manufacturer unknown) as treatment at that time. No lab diagnostic studies were performed. The outcome of the events was reported as recovered/resolved on an unknown date. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored dose of VAQTA (Lot # L004743; Expiration date: 01-JUN-2017) (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified doses of improperly stored PNEUMOVAX23 (lot# K019561, expiry date 20-APR-2016, strength, dose and route were unspecified). No adverse effects had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified dose of improperly stored ROTATEQ (oral, strength and dose were unspecified). No adverse effects had been reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 25-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K023432, expiration date 18-JUN-2016) (strength, dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medications and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified dose of improperly stored LIQUID PEDVAXHIB (lot # L006545, expiry date 16-NOV-2017; lot # L012838, expiry date 10-MAR-2018) (strength, dose and route were unspecified). No adverse effects had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No pertinent or historical conditions were reported. On 27-JUL-2015, the patient was inadvertently administered a dose of ROTATEQ orally (strength and dose unknown, lot # J011340, expiration date 15-MAY-2015). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not reported), for prevention of shingles. On an unknown date, within 9 years, the patient was vaccinated with the second dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not reported), for prevention of shingles. The patient did not seek medical attention. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-AUG-2015 and 15-OCT-2015, the patient was vaccinated with two separate doses of improperly stored oral, ROTATEQ (doses were not provided) lot # K023534, expiration date: 22-MAY-2016 and lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 28-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L011846, expiration date 16-JUN-2017 (strength, dose and route of administration were not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 18-SEP-2015, the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot # K010221, expiration date 12-MAY-2016 (strength and dose were not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-SEP-2015, the patient was vaccinated with a dose of improperly stored, oral ROTATEQ (dose was not provided) lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K023432, expiration date 18-JUN-2016) (strength, dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient (age and gender not reported). In 2009, the patient received dose 1 of GARDASIL (dose, route, location and batch number were not reported). On 03-NOV-2015, the patient was vaccinated with dose 2 of GARDASIL (dose, route, location and batch number were not reported). No adverse effect reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Injection site rash
Clinical narrative: Information has been received from a Licensed practitioner nurse concerning to a 12 month old male patient with dermatitis. On 15-OCT-2015, the patient was vaccinated with dose 1 of MMR II (Lot No. K026366, exp. 15-DEC-2016), 0.5 ml, subcutaneous. Concomitant therapies included hydrocortisone (manufacturer unknown). On 30-OCT-2015, the patient developed a rash at the injection site. The patient sought medical attention and was seen at the office on 05-NOV-2015 but no treatment was given. No laboratory test were performed. No intervention to prevent serious criteria was made. No cancer, disability, hospitalization nor life threatening were reported. The outcome of injection site rash was not reported. Relationship between rash at the injection site and therapy with MMR II was not reported. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 53 year old male patient. The patient's medical history and concurrent conditions were not reported. The patient had no drug reactions/allergies. On 09-NOV-2015, the patient was vaccinated with ZOSTAVAX (dose, dose number, strength unspecified) lot # L024997, expiry date 06-OCT-2015, subcutaneous in the upper left deltoid region for the prevention of shingles. Concomitant therapies included ANDRODERM and ELIQUIS for unspecified reasons. On an unspecified date, reported as since she started the use ANDRODERM, the patient experienced mild acne. Also, the reporter noticed mild acne on patient's face at the time of reporting. The reporter stated that the patient also experienced a raised, not draining, not itchy rash at the injection site, rash was red but not vesicular, slightly painful to touch on an unspecified date in November 2015. The patient sought medical attention and visited the physician's office on 12-Nov-2015 for the adverse events. The physician ordered doxycycline for the rash. But the physician advised that, he may not need doxycycline but it would be useful for acne. No further information was provided. Product quality complaint was not reported. The outcome of the events was not recovered/not resolved. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 18-NOV-2015, the patient was inadvertently administered with an expired dose of PNEUMOVAX 23 (lot # K007824, expiration date: 05-NOV-2015) intramuscularly (dose and frequency was unknown). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Menstruation delayed
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient with penicillin allergy. On 28-AUG-2015, the patient was vaccinated with the first dose of GARDASIL lot # K010215 exp. 05-MAY-2015 in the deltoid. Concomitant therapies included ZYRTEC. In 2015, after administration of GARDASIL, the patient experienced menstruation delayed as she missed menstruation which was abnormal for her. On 02-NOV-2015, the patient received the second dose of GARDASIL (same lot number). Then 2 days later on 04-NOV-2015, the patient experienced a severe headache. The resolution of the patient's headache had not been verified at this time. The patient received treatment with ibuprofen 400mg 4x per day. No lab diagnostics studies were performed. It was not verified if the patient plans to continue the three dose series of GARDASIL but the physician stated that it was "unlikely" that she would be administered her third and final dose of the GARDASIL series. The outcome of menstruation delayed and headache was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse referring to multiple patients of unknown genders and ages. Patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored GARDASIL lot # K007828, expiration date 03-FEB-2017, (route, anatomical location and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route, Lot # and expiration date were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.