chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site mass, Myalgia, Wrong product administered
Clinical narrative: Wrong shot. I was supposed to get Prevnar 13 -- the first one. They mistakenly gave me the 2nd shot. When I looked at my record online the next morning, it showed that my shot was postponed until next year. I was feeling terrible with a hard lump at the site and muscle aching all over my body. I wrote via online and wrote about the muscle aches and and hard lump. I also asked if I got the right shot. I got a message back telling me I got the right shot and to apply ice. Same a couple of weeks later, as I still had muscle aches and site was still very sore, with a little smaller lump. I was again told I got the right shot and to apply ice. The site eventually had no lump or pain, but the muscle aches continued for 7 weeks. When I went to my next appointment; my doctor logged into the computer from the exam room and said something like "you know what happened." I said no, and I wanted to. I was then told I had been given the 2nd shot, instead of the first shot and they'd had a meeting about it. I said I should have been told; and I had written twice and was not told what happened. The constant muscle aches for weeks were difficult to bear. I asked why online showed I got Prevnar 13 on my after visit summary; but online also showed my shot was postponed until next year. I said I was leery of having another shot because of the problems and was told I wouldn't be blamed if I didn't want to get the Prevnar 13 next year. I want information. Am I protected since I got the wrong shot first and will it be OK/helpful to get the 1st shot after getting the 2nd one? I also don't want this to happen to anyone else. I seem to be still having a lot of muscle aches on and off -- sometimes for days; but i don't if they are related to the vaccination. Mainly I want to know how protected am I?
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Acne, Rash erythematous, Rash macular, Swelling, Swollen tongue
Clinical narrative: Recevied Pediarix & Prevnar 13 3/6/19 On 3/11/19 - red rash (blotchy on body) w/pimples. 3/12/19 generalized swelling including tongue. Treated w/ Benadryl.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Musculoskeletal disorder, Skin reaction
Clinical narrative: Patient reported feeling weak a few hours after shot. He had local skin reaction at the injection site which included redness and swelling. Patient stated on 4/6/19 he lost use of his limbs from the waist down. On 4/6/19 he was admitted to the hospital for two days.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Varicella rash after 1 week post vaccination  Mom had Varicella zoster 1 week prior vaccines
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Erythema, Pain, Pruritus, Swelling
Clinical narrative: 4" x 6" swelling, erythema, pain. 1" center  multiple small blisters  No drainage, mild itching  Recommended benadryl q 6 - 8 hrs ibuprofen q 6 - 8 hrs Ice 20 mg 2 - 3/day.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives @ injection   site + down legs
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient receives the pneumovax 23 on 4/9/19 at 2pm. She Later reports that she experienced severe pain to the left shoulder around 8 pm that night. This was reported to us on 4/11/9. She notes the area was painful at injection site, swollen and red to left arm. It started off bright red/swelling but now has decreased to a mild red color. Patient reports only mild itching the redness by the 2nd day has decrease. The pain has also decreased in severity. The redness moved down to the elbow possibly due to gravity. She was started on Bactrim DS 1 Bid x 5 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: red, hot, hard, painful, redness growing down pt arm
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: developed red lesion on the R thigh.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at injection site typical of varicella  3rd such reaction this mo. Must be related to properties of this lot of vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling at injection site, itchy w/in few hrs of vaccine - worsening over next few days. Improved w/oral BENADRYL.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain, Rash
Clinical narrative: Vaccine on 03/22/2019 Pain at injection site and in shoulder for 4 days. 03/23 and 03/24 muscle aches down my back like a bad flu. 03/25 and 03/26 a 6-inch patch of skin on my left hip "burned" at any touch or if clothing rubbed against it. 03/27 a "pimple" appeared in the center of my back. 03/28/2019 'multiple pimple-like blisters' appeared in the center of my back and by later in the day had spread around my body along my rib cage and beneath and between my breasts. 03/28/2019 I visited my doctor and she diagnosed 'Shingles'.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Blister, Herpes zoster, Influenza like illness, Injection site pain
Clinical narrative: Vaccine on 03/22/2019 Pain at injection site and in shoulder for 4 days. 03/23 and 03/24 muscle aches down my back like a bad flu. 03/25 and 03/26 a 6-inch patch of skin on my left hip "burned" at any touch or if clothing rubbed against it. 03/27 a "pimple" appeared in the center of my back. 03/28/2019 'multiple pimple-like blisters' appeared in the center of my back and by later in the day had spread around my body along my rib cage and beneath and between my breasts. 03/28/2019 I visited my doctor and she diagnosed 'Shingles'.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Skin burning sensation
Clinical narrative: Vaccine on 03/22/2019 Pain at injection site and in shoulder for 4 days. 03/23 and 03/24 muscle aches down my back like a bad flu. 03/25 and 03/26 a 6-inch patch of skin on my left hip "burned" at any touch or if clothing rubbed against it. 03/27 a "pimple" appeared in the center of my back. 03/28/2019 'multiple pimple-like blisters' appeared in the center of my back and by later in the day had spread around my body along my rib cage and beneath and between my breasts. 03/28/2019 I visited my doctor and she diagnosed 'Shingles'.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: 5 hours after shot, soreness in upper arm, noticeable with any arm movement. Next day, redness and swelling, soreness continued. Third day, redness and swelling pronounced. Area felt warm. Fourth day, redness and swelling persist, but reduced. Area feels somewhat itchy and warm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: 5 hours after shot, soreness in upper arm, noticeable with any arm movement. Next day, redness and swelling, soreness continued. Third day, redness and swelling pronounced. Area felt warm. Fourth day, redness and swelling persist, but reduced. Area feels somewhat itchy and warm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site nodule, Pyrexia
Clinical narrative: Patient called the next day complaining of a high 3 inch in diameter knot on her arm at the site of injection, low grade fever, joint pain in her knees and elbows. I spoke with her later that evening and she said she still had all of those symptoms. She said she had called her primary care Doctor and she said to take some Ibuprofen and she should be fine, it was normal in her opinion.
Age: 66.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: pt has been experiencing itching, and a rash all over body. he states that during that week after he received the vaccines he began to feel the itching. he states he bought otc bendaryl but experienced no relief. it has been over 2 months after the vaccines and he is still having itching and a rash. he states it has improved a little.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, Redness, Hot to the touch (all 3 at a couple of inches below injection site).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Pruritus, Wheezing
Clinical narrative: Itchy palms and feet, wheezy cough.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Musculoskeletal disorder, Nausea, Pain, Pain in extremity
Clinical narrative: After about three hours, my arm started hurting.  That progressed to an unimaginable throbbing pain.  I also was nauseous and shivering.  My arm was useless.  Today, the pain is better.  The throbbing has ceased but I am still having trouble using my arm.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Peripheral swelling
Clinical narrative: Patient reported swelling in her arm. She complained it was red and burning.
Age: 65.0
Sex: M
Vaccine: YF
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood bilirubin normal
Clinical narrative: Suspected Yellow Fever Vaccine Associated Viscerotrophic Disease: Admitted with persisting fever, chills, sweats, myalgias, nausea, and mild headache which started 2 days after immunization. Diarrhea with C-diff positive PCR started on day #2. Briefly admitted for IV fluids from 4/7 to 4/8. Readmitted with persisting fever on 4/10.  Has worsening thrombocytopenia, liver function elevations, AKI. Remains hemodynamically stable and no bleeding on hospital day #4.
Age: 65.0
Sex: M
Vaccine: YF
Symptoms: Blood creatine phosphokinase normal, Blood creatinine increased, Blood culture positive, Chills, Clostridium test positive
Clinical narrative: Suspected Yellow Fever Vaccine Associated Viscerotrophic Disease: Admitted with persisting fever, chills, sweats, myalgias, nausea, and mild headache which started 2 days after immunization. Diarrhea with C-diff positive PCR started on day #2. Briefly admitted for IV fluids from 4/7 to 4/8. Readmitted with persisting fever on 4/10.  Has worsening thrombocytopenia, liver function elevations, AKI. Remains hemodynamically stable and no bleeding on hospital day #4.
Age: 65.0
Sex: M
Vaccine: YF
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Liver function test increased, Myalgia
Clinical narrative: Suspected Yellow Fever Vaccine Associated Viscerotrophic Disease: Admitted with persisting fever, chills, sweats, myalgias, nausea, and mild headache which started 2 days after immunization. Diarrhea with C-diff positive PCR started on day #2. Briefly admitted for IV fluids from 4/7 to 4/8. Readmitted with persisting fever on 4/10.  Has worsening thrombocytopenia, liver function elevations, AKI. Remains hemodynamically stable and no bleeding on hospital day #4.
Age: 65.0
Sex: M
Vaccine: YF
Symptoms: Nausea, Platelet count decreased, Polymerase chain reaction positive, Pyrexia, Staphylococcus test positive
Clinical narrative: Suspected Yellow Fever Vaccine Associated Viscerotrophic Disease: Admitted with persisting fever, chills, sweats, myalgias, nausea, and mild headache which started 2 days after immunization. Diarrhea with C-diff positive PCR started on day #2. Briefly admitted for IV fluids from 4/7 to 4/8. Readmitted with persisting fever on 4/10.  Has worsening thrombocytopenia, liver function elevations, AKI. Remains hemodynamically stable and no bleeding on hospital day #4.
Age: 65.0
Sex: M
Vaccine: YF
Symptoms: White blood cell count increased, Yellow fever vaccine-associated viscerotropic disease
Clinical narrative: Suspected Yellow Fever Vaccine Associated Viscerotrophic Disease: Admitted with persisting fever, chills, sweats, myalgias, nausea, and mild headache which started 2 days after immunization. Diarrhea with C-diff positive PCR started on day #2. Briefly admitted for IV fluids from 4/7 to 4/8. Readmitted with persisting fever on 4/10.  Has worsening thrombocytopenia, liver function elevations, AKI. Remains hemodynamically stable and no bleeding on hospital day #4.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Pyrexia, Rash, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose and congestion day following vaccines until now (10 days after), fever of 102 eight days after vaccines lasting two days, and rash on back/torso/neck/face present 9 days after vaccines and still present at 10 days after vaccines. Treated fever with Tylenol, and not treating the rash because it does not seem to be bothering the baby.
Age: 95.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: BURNING PAIN ON THE INJECTION SITE AND HAS ALREADY SPREAD ALL OVER HIS BODY THAT PT ENDED UP GOING TO THE ER.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: Fever of 101; severe headache; severe neckache; body aches; extreme fatigue. Treated with sleep, taking time off of work, pain relievers, ice pack/heat pack. Fever resolved in 24 hours, though mild symptoms lingered for 48 hours.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Severe pain, right arm from wrist to shoulder, plus ache all over like flu systems. Weak for three days and aching limbs and body.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthma, Wheezing
Clinical narrative: I began wheezing approximately two days after the vaccine was administered to me and continued wheezing for approximately three months. I have never had breathing issues in the past. On 2/13/2019 I was diagnosed with asthma. I am unsure of the lot number, as I am unclear from the pharmacy receipt as to this. However, I do have the pharmacy receipt which clearly identifies the type of vaccine and date administered.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthma, Wheezing
Clinical narrative: The patient experienced wheezing starting 2 days after injection. She had these symptoms for 3 months after injection and was then diagnosed with asthma, where she had never had asthma before. The patient believes the vaccination led to her asthma diagnosis.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: CSF culture, Electroencephalogram, Nuclear magnetic resonance imaging brain, Pyrexia, Seizure
Clinical narrative: Fever, seizure.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: Patient stated that later the same evening her bottom lip swelled up, then her left jaw and cheek swelled up also. She called the next morning and said she was still swollen.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Pt stated arm soreness as well as pain, redness, and inflammation at the injection site - stated she had a difficult time completing daily activities - 2 days after the shot the patient report to the local emergency room where she was treated out patient. Patient states she received a shot at the ER. Based on context clues, we believe the shot to have been a steroid shot. She was also given a short course of oral cephalexin.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram, Erythema, Lymphadenopathy, Rash, Swelling
Clinical narrative: Swelling left neck the day after vaccine with erythema in neck.  Two days later developed rash that increased.  Seen in my facility, noting lymph nodes left neck.  No fever, SOB, chest pain, no angioedema to face. No dizziness.  VSS.   Pt given vaccine in MD office.  Seen in my facility.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Contusion, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, pain, redness running down arm, chills, fever, temperature over 100 degrees, bruising on arm from elbow to shoulder
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Swelling, pain, redness running down arm, chills, fever, temperature over 100 degrees, bruising on arm from elbow to shoulder
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site cellulitis, Injection site erythema, Injection site swelling, Pain
Clinical narrative: 2nd shot whole right arm swelled up and red - upper arm. Pharmacy gave me shot went to doctor said I got cellulitis from it. Also had problems after first shot in left arm but didn't relate till now. Had first shot  late Dec. 2018 left arm - 2 wks later arm tingly and numb. Went to therapy couldn't help then left knee ache and ache. Then second shot in March got cellulitis. Fine till after shots - body started to ache one place then another. Feel 90 yrs old. Please Note Patient filling this out. The pharmacy gave me both shots. Had first shot in Dec of 18. But didn't relate it back too all my problems after that till after second shot when whole upper (R) arm swollen and bright red, in March of 2019. I was fine or mostly fine till after first shot in late Dec. 2018. Not long after my blood pressure really took a spike up. Had to add more medicine. Then a wk or two after my Left arm where first shot went got tingly and numb. Went to therapy couldn't make better. Then same side knee all crappy in pain all the time. Have to use cane. Then second shot right arm blows up and infected with cellulitis. Have to take antibiotic. So I have 2 bad arms and one bad leg all after taking first shot. Never had problems with vaccines before!!  Looked on internet and see I am not the only on with this type of problem after these new shingle double-dose shot.No I don't want shingles. But if I knew I could get all the problems I now have I don't think I would of gotten the new double dose shingle shot. I just would of hoped the first one they came out with worked that I got. You need to check this out more. Too many people are getting severe crippling pain in arms and legs after these!!!!
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: 2nd shot whole right arm swelled up and red - upper arm. Pharmacy gave me shot went to doctor said I got cellulitis from it. Also had problems after first shot in left arm but didn't relate till now. Had first shot  late Dec. 2018 left arm - 2 wks later arm tingly and numb. Went to therapy couldn't help then left knee ache and ache. Then second shot in March got cellulitis. Fine till after shots - body started to ache one place then another. Feel 90 yrs old. Please Note Patient filling this out. The pharmacy gave me both shots. Had first shot in Dec of 18. But didn't relate it back too all my problems after that till after second shot when whole upper (R) arm swollen and bright red, in March of 2019. I was fine or mostly fine till after first shot in late Dec. 2018. Not long after my blood pressure really took a spike up. Had to add more medicine. Then a wk or two after my Left arm where first shot went got tingly and numb. Went to therapy couldn't make better. Then same side knee all crappy in pain all the time. Have to use cane. Then second shot right arm blows up and infected with cellulitis. Have to take antibiotic. So I have 2 bad arms and one bad leg all after taking first shot. Never had problems with vaccines before!!  Looked on internet and see I am not the only on with this type of problem after these new shingle double-dose shot.No I don't want shingles. But if I knew I could get all the problems I now have I don't think I would of gotten the new double dose shingle shot. I just would of hoped the first one they came out with worked that I got. You need to check this out more. Too many people are getting severe crippling pain in arms and legs after these!!!!
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports arm swelling and pain beginning day vaccine was administered on 4/11/19 in the evening before bedtime. Patient returned to pharmacy on 4/12/19. Swelling observed on upper left arm and patient reported continued pain when lifting her arm. She was advised by the pharmacist to apply ice and to take an over the counter pain medication (Tylenol or Advil) and was instructed to return to the pharmacy if pain and swelling did not improve. Patient returned to pharmacy on 4/13/19 and reported improvement in swelling and pain after ice and Tylenol but that she was still symptomatic. Pharmacist advised to continue to apply ice and take Tylenol and to return/contact MD if no improvement or worsening conditions.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Major Leg swelling encompassing most of upper thigh, redness, warm to touch, fevers, pain with ambulation. Yes
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Worst vaccine response ever. Like having full-blown flu. Knocked on my back. So bad I don't want 2nd shot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pyrexia, Skin warm
Clinical narrative: fever of 101 - 102 started around 24 hours later lasted about 48 hours Inflamation from elbow to close to shoulder, red  and hot to the touch, improvement began on the 5th day
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Drug screen negative, Formication, Hallucination, Obsessive-compulsive symptom, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection
Clinical narrative: Received MMRV Vaccination on 4/4/19 at 3:00 pm. On 4/6/19 approx 4 pm child began to hallucinate that bugs were crawling all over her. No fever or other symptoms present. This episode lasted roughly 9 hrs where child was tearing off clothes and attempting to remove herself from car seat as she was hallucinating that she was covered in bugs, they were biting her and crawling in and out of her anus and vagina. No bugs present. 4/9/19 after consulting with Pediatrician child was taken to Clinic. Full drug screening by urine was clear. Bloodwork done for ASO Titers and Drug Panel. Still waiting on results. Doctor suggested PANDAS. Amoxicillin was started 400 mg twice per day. 4/11/19 Received call from daycare that child was hallucinating (no fever present) and terrified that bugs were crawling all over her at about 11:00 am. 4/12/19 4:00 am Child was hallucinating that bugs were crawling all over her and absolutely terrified. Child has had blank stare since and OCD tendencies. 4/14/19 Child vomiting from approx 9:30 am to 10:15 am no fever present. Doctors appt scheduled with Pediatrics for 4/15/19 at 3:00 PM. Dr. has cleared his schedule to see her and we were advised if she continues to deteriorate to bring her to Hospital.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Staring, Streptococcus test, Vomiting
Clinical narrative: Received MMRV Vaccination on 4/4/19 at 3:00 pm. On 4/6/19 approx 4 pm child began to hallucinate that bugs were crawling all over her. No fever or other symptoms present. This episode lasted roughly 9 hrs where child was tearing off clothes and attempting to remove herself from car seat as she was hallucinating that she was covered in bugs, they were biting her and crawling in and out of her anus and vagina. No bugs present. 4/9/19 after consulting with Pediatrician child was taken to Clinic. Full drug screening by urine was clear. Bloodwork done for ASO Titers and Drug Panel. Still waiting on results. Doctor suggested PANDAS. Amoxicillin was started 400 mg twice per day. 4/11/19 Received call from daycare that child was hallucinating (no fever present) and terrified that bugs were crawling all over her at about 11:00 am. 4/12/19 4:00 am Child was hallucinating that bugs were crawling all over her and absolutely terrified. Child has had blank stare since and OCD tendencies. 4/14/19 Child vomiting from approx 9:30 am to 10:15 am no fever present. Doctors appt scheduled with Pediatrics for 4/15/19 at 3:00 PM. Dr. has cleared his schedule to see her and we were advised if she continues to deteriorate to bring her to Hospital.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient had redness and swelling about 3-4 inches in diameter about 3 inches below the injection site. It is warm to the touch.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Hot flush, Pain, Pyrexia, Tremor
Clinical narrative: Shakes, fever, hot flashes, soreness all over body. Really awful. Spent day in bed. Responds to TYLENOL.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nodule, Rash
Clinical narrative: patient showed me her arm today 04/14/2019. patient says she has been putting alcohol on the spots but nothing on the knots.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Pain, Paraesthesia, Seizure, Trigeminal neuralgia
Clinical narrative: Patient Presented with signs of stroke in the evening after getting the vaccine. The husband rushed her to hospital Emergency room on 3/23/19 and she was kept overnight. Upon admittance to ER all symptoms resolved (similar to TIA per husband) and there was no proof of obstruction. They kept her overnight and she was seen by two neurologist which diagnosed her with seizure. They prescribed to her KEPPRA and the patient did not use it. Yesterday 4/13/19 patient woke up with severe pain and continuous shocks because of Trigeminal Neuralgia (which patient had a history of over a year ago and was fully treated for with radiation) so husband started her on KEPPRA.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Influenza, Injection site pain
Clinical narrative: Shoulder pain beginning evening of injection. Muscle soreness at injection site. (4/11/2019) Lightheadedness that evening and very aware of my left arm including a numbness of two fingers on left hand. (4/12/2019) Overall feeling of weakness similar to flu symptoms but no fever. (4/11 to 4/13/ 2019) Much improved by (4/14/2019) however warm red rash at injection site.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Musculoskeletal pain, Rash erythematous
Clinical narrative: Shoulder pain beginning evening of injection. Muscle soreness at injection site. (4/11/2019) Lightheadedness that evening and very aware of my left arm including a numbness of two fingers on left hand. (4/12/2019) Overall feeling of weakness similar to flu symptoms but no fever. (4/11 to 4/13/ 2019) Much improved by (4/14/2019) however warm red rash at injection site.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Back pain, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: The first night he did not feel good, body ache The second day he still felt even worst and it continued until  the 5th day he had more body ache and head ache and his back ache was very bad but now he had low grade fever the 6th day he had fever and his body ache, head ache and back ache were worse. Fever now was 100.2 FH, He had Nausea  the 7th day he had a little less body ache, head ache and back ache no fever and it continues until now the 11th day
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Pyrexia
Clinical narrative: The first night he did not feel good, body ache The second day he still felt even worst and it continued until  the 5th day he had more body ache and head ache and his back ache was very bad but now he had low grade fever the 6th day he had fever and his body ache, head ache and back ache were worse. Fever now was 100.2 FH, He had Nausea  the 7th day he had a little less body ache, head ache and back ache no fever and it continues until now the 11th day
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Migraine, Nuclear magnetic resonance imaging brain abnormal, White matter lesion
Clinical narrative: Headaches started 12/2017 migraines per Neurology, but also MRI with hyperintense lesion on T2 flair, stable over 6 months.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Injection site hypoaesthesia, Injection site pruritus
Clinical narrative: Approximately 1 week after the shingles shot that my right arm felt numb from the tip of the shoulder down approximately 6 inches on my arm, right around the area I received the shingles shot.  It has also had periodic itching, and when I scratch there I can feel the pressure of scratching but not the actual scratching like I do on all other parts of my body
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebral disorder, Demyelination, Electromyogram abnormal, Multiple sclerosis, Neurological symptom
Clinical narrative: In November 2015 (I am unsure of the date so I just picked one) I received a flu vaccine from my employer. I did not want one, but I was told it was mandatory. Unfortunately I did not know to read the manufacturers' insert. I developed neurological complications about 72 hours afterward - tingling of the hands and feet etc. I progressively declined from there. I presently have severe multiple sclerosis symptoms, and have had them continually with zero relief since this incident.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: In November 2015 (I am unsure of the date so I just picked one) I received a flu vaccine from my employer. I did not want one, but I was told it was mandatory. Unfortunately I did not know to read the manufacturers' insert. I developed neurological complications about 72 hours afterward - tingling of the hands and feet etc. I progressively declined from there. I presently have severe multiple sclerosis symptoms, and have had them continually with zero relief since this incident.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states that her arm still feels sore from the shot, sometimes shooting pain. She said she  feels it moreso when she lifts weights or sometimes when she lifts her arm to drive.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red rash on body but not at the site of injection.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Bad headache, nausea, fatigue, arm pain, dizziness.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient stated she had trouble moving her arm after getting vaccine.  Soreness in the area.  Could not move after a while.  Has needed physical therapy.  Just told the pharmacy on 4/10/19.
Age: 21.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Generalised erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: EMPLOYEE HAS ITCHING AND REDNESS  TO THE ENTIRE BODY. SHE ALSO HAS SWELLING, WARMTH, AND REDNESS AT THE INJECTION SITE. SHE ALSO COMPLAINS OF PAIN TO THE RIGHT ARM AND SHOULDER. EMPLOYEE WAS GIVEN ICE PACKS TO APPLY TO AREAS OF REDNESS AND ITCHING AREAS. SHE STATED ICEPACK CAUSE SOME RELIEF AFTER A FEW MINUTES OF APPLICATION.
Age: 21.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain in extremity, Pruritus generalised
Clinical narrative: EMPLOYEE HAS ITCHING AND REDNESS  TO THE ENTIRE BODY. SHE ALSO HAS SWELLING, WARMTH, AND REDNESS AT THE INJECTION SITE. SHE ALSO COMPLAINS OF PAIN TO THE RIGHT ARM AND SHOULDER. EMPLOYEE WAS GIVEN ICE PACKS TO APPLY TO AREAS OF REDNESS AND ITCHING AREAS. SHE STATED ICEPACK CAUSE SOME RELIEF AFTER A FEW MINUTES OF APPLICATION.
Age: 21.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: EMPLOYEE HAS ITCHING AND REDNESS  TO THE ENTIRE BODY. SHE ALSO HAS SWELLING, WARMTH, AND REDNESS AT THE INJECTION SITE. SHE ALSO COMPLAINS OF PAIN TO THE RIGHT ARM AND SHOULDER. EMPLOYEE WAS GIVEN ICE PACKS TO APPLY TO AREAS OF REDNESS AND ITCHING AREAS. SHE STATED ICEPACK CAUSE SOME RELIEF AFTER A FEW MINUTES OF APPLICATION.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Ischaemic stroke, Nuclear magnetic resonance imaging brain
Clinical narrative: Ischemic stroke treated with TPA at Hospital. Hospitalized November 22-24, 2018. CT scans of brain, MRI of brain.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever for approximately 24hrs.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: One day after SHINGRIX administration, patient developed inflammation and redness at the site of injection. The next day the inflammation got worse but on the 3rd day which was today the symptoms are getting better and patient just wanted to let us know. The pharmacist told her to continue taking TYLENOL every 4-6 hours as needed for pain, apply cold compress at the site for 10-15 minutes and use anti-histamine to bring the swelling down. If the symptoms are getting worse or no changes then contact the physician as well as the pharmacy.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Extreme soreness around the area of injection. For 4 to 5 days.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Seizure
Clinical narrative: Very high subjective fever- per mother- no working thermometer, convulsions
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site erythema, Injection site inflammation, Injection site irritation, Injection site swelling
Clinical narrative: Patient described having an inflammatory reaction around the injection site with swelling, warm to the touch, redness and irritation, about 5 inches in diameter. The adverse reactions began a few hours after receiving the vaccination.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient described having an inflammatory reaction around the injection site with swelling, warm to the touch, redness and irritation, about 5 inches in diameter. The adverse reactions began a few hours after receiving the vaccination.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Decreased appetite, Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: reaction on her deltoid, shoulder and elbow; This is a spontaneous report from a contactable pharmacist.   A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced reaction on her deltoid, shoulder and elbow on an unspecified date with outcome of recovering. Therapeutic measures were taken as a result of reaction on her deltoid, shoulder and elbow included Benadryl.  The information on the lot number has been requested.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site warmth
Clinical narrative: reaction on her deltoid, shoulder and elbow; This is a spontaneous report from a contactable pharmacist.   A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced reaction on her deltoid, shoulder and elbow on an unspecified date with outcome of recovering. Therapeutic measures were taken as a result of reaction on her deltoid, shoulder and elbow included Benadryl.  The information on the lot number has been requested.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Adverse reaction
Clinical narrative: reaction on her deltoid, shoulder and elbow; This is a spontaneous report from a contactable pharmacist.   A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced reaction on her deltoid, shoulder and elbow on an unspecified date with outcome of recovering. Therapeutic measures were taken as a result of reaction on her deltoid, shoulder and elbow included Benadryl.  The information on the lot number has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: The patient got a MMRIII vaccine and found out that she is pregnant; This spontaneous prospective pregnancy report was received from a 30 year old female patient concerning to herself. The patient's medical history included bronchitis. Her concurrent conditions included allergy to penicillin. Concomitant medications included an unspecified steroid shot and azithromycin.   On 03-APR-2019, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  (lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis.   On 09-APR-2019, the patient found out that she was pregnant (exposure during pregnancy). She had her last menstrual period in March 2019 (reported as one month ago). A nurse called to inform that the patient's estimated date of delivery (EDD) would be around 12-DEC-2019. The pregnancy outcome was pending. On an unspecified date, she was performed an urinalysis (result not provided). She saw her physician and sought for medical attention.
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy, Urine analysis
Clinical narrative: The patient got a MMRIII vaccine and found out that she is pregnant; This spontaneous prospective pregnancy report was received from a 30 year old female patient concerning to herself. The patient's medical history included bronchitis. Her concurrent conditions included allergy to penicillin. Concomitant medications included an unspecified steroid shot and azithromycin.   On 03-APR-2019, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  (lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis.   On 09-APR-2019, the patient found out that she was pregnant (exposure during pregnancy). She had her last menstrual period in March 2019 (reported as one month ago). A nurse called to inform that the patient's estimated date of delivery (EDD) would be around 12-DEC-2019. The pregnancy outcome was pending. On an unspecified date, she was performed an urinalysis (result not provided). She saw her physician and sought for medical attention.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain and stiffness in left upper arm and shoulder. Limited mobility.
Age: 18.0
Sex: M
Vaccine: ANTH, HEPA, JEV1, SMALL, TYP
Symptoms: Dizziness, Dysphonia, Dyspnoea, Pain, Pain in extremity
Clinical narrative: PT with vaccination adverse effects one hour after receiving multiple vaccines. PT received 1st anthrax, 1st JEV, 1st smallpox, 1st typhoid, 2nd hep A vaccinations (1st one without adverse reaction) and been having blotchy rash on basically whole body including hands, feet, and chest, fever, hoarseness, SOB, swollen hands, lightheadedness, stinging pain in hands etc. for last 4 days. PT was sent to ER and admitted for continuous care and monitoring. Measles was ruled out. Requested medical records and pictures of the patient's skin rash from hospital.
Age: 18.0
Sex: M
Vaccine: ANTH, HEPA, JEV1, SMALL, TYP
Symptoms: Pyrexia, Rash generalised, Rash macular, Vaccination complication
Clinical narrative: PT with vaccination adverse effects one hour after receiving multiple vaccines. PT received 1st anthrax, 1st JEV, 1st smallpox, 1st typhoid, 2nd hep A vaccinations (1st one without adverse reaction) and been having blotchy rash on basically whole body including hands, feet, and chest, fever, hoarseness, SOB, swollen hands, lightheadedness, stinging pain in hands etc. for last 4 days. PT was sent to ER and admitted for continuous care and monitoring. Measles was ruled out. Requested medical records and pictures of the patient's skin rash from hospital.
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Low grade fever (101 degrees F), chills, body aches, headache, fatigue, malaise, soreness at injection site? Took 1g acetaminophen to help with fever.
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever (101 degrees F), chills, body aches, headache, fatigue, malaise, soreness at injection site? Took 1g acetaminophen to help with fever.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: 7 minutes after injection was administered patient developed hives and a pink rash on the injeciton site arm.  The provider was notified.  She checked his lungs and throat.  He was not experiencing any breathing difficulties or cough.  No swelling of the throat or limbs.  He was administered a dose of benadryl.  He was kept in the clinic.  The symptoms started to subside about 30 minutes after benadryl administration.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Diarrhoea haemorrhagic, Faeces discoloured
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of bloody diarrhea in a 2-month-old male patient who received PEDIARIX for prophylaxis. Co-suspect products included ROTARIX lyophilized formulation for an unknown indication, PEDVAXHIB for prophylaxis and PREVNAR for prophylaxis. On an unknown date, the patient received PEDIARIX .5 ml, ROTARIX lyophilized formulation at an unknown dose, PEDVAXHIB at an unknown dose and PREVNAR at an unknown dose. On an unknown date, 1 day after receiving PEDIARIX, ROTARIX lyophilized formulation and PEDVAXHIB, the patient experienced bloody diarrhea (serious criteria GSK medically significant) and black stools. On an unknown date, the outcome of the bloody diarrhea and black stools were unknown.  It was unknown if the reporter considered the bloody diarrhea and black stools to be related to PEDIARIX. The reporter considered the bloody diarrhea and black stools to be related to ROTARIX lyophilized formulation. The next day after vaccination, the patient experienced severe liquid diarrea, it was black and with blood. The  mother took the patient to emergency room and call the nurse to report. The nurse believed that this happened because of the ROTARIX vaccine, that is the one that is for gastroenteritis. They are waiting for the patient to come back and they don't know what vaccine to administer at 4 months because registered nurse is worried.
Age: 59.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report has been received from a 59 years old female pharmacy technician, who is also a healthcare worker referring to herself. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. In September 2018, the patient was vaccinated with GARDASIL 9 (dose 1; route, batch/lot# and expiration date were unknown) for prophylaxis (inappropriate age at vaccine administration). In October 2018, the patient was vaccinated with GARDASIL 9 (dose 2; route, batch/lot# and expiration date were unknown) for prophylaxis. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) presented.
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Expired vaccine used; This spontaneous report has been received from a nurse referring to two female patients (twin girls) of unknown age. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-MAR-2019, both of the patients were vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # N024562, expiration date 06-MAR-2019; dose number and route were unknown) for prophylaxis (expired vaccine used). No adverse effects reported. The outcome of the events was unknown. No product quality compliant (PQC) presented.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster
Clinical narrative: "a pretty good case of shingles"; This spontaneous report was received from a registered nurse via a company representative referring to an approximately 70 year old female patient who was an unspecified employee from an unspecified doctor's office. Information about medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date, "a couple of years ago", the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) reconstituted with diluent for shingles prevention and developed "a pretty good case of shingles". At the time of the report, the outcome of the event was reported as recovered.
Sex: U
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information concerning patients' pertinent medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, the patients were vaccinated with GARDASIL 9 (lot# reported as 17457 and expiration date: unknown day in April 2021) (dose and route of administration not provided) for prophylaxis. The staff at the reporter's clinic had difficulty holding the syringe with GARDASIL 9 since there was not much of a lip or area to put your fingers to get a good grip on it. A couple of the members of the staff almost dropped the syringe or it slipped as the health care professionals were starting to give the injection. The outcome of the event was unknown. Lot # 17457 is an invalid lot # for GARDASIL 9.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; patient received RECOMBIVAX and PEDIARIX at the same visit; did receive a hepatitis B vaccination on 17Feb2017. When the patient came in today 19Mar2019 they accidentaly received both Recombivax HB; This spontaneous report was received from a registered nurse and refers to a 2-years-old female patient. Patient's pertinent medical history included being very behind on immunizations. The patient received an unspecified hepatitis B vaccination on 17-FEB-2017. No information about patient's concomitant medications, concurrent diseases or allergies was provided.  On 19-MAR-2019, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # R021370, expiration date: 07-NOV-2020, 0.5 milliliter (also reported as mgl)) (route of administration was not provided) to immunize her against hepatitis B. On the same day, the patient was vaccinated with diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX) (dose, lot#, expiration date, route of administration were not provided). There was no adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1903USA010025: US-009507513-1903USA010026: