chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Thrombocytopenia, Ultrasound kidney, Urine abnormality, Urine analysis abnormal, Urine bilirubin decreased
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, White blood cell count increased, White blood cells urine positive
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: pH urine normal
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Balance disorder, Chest pain, Fall, Loss of consciousness
Clinical narrative: Apprx 10 after injections patient, while sitting on exam table, all of a sudden appeared to passout stiffen up and fell on her back with legs straightout, arms on her chest with fingers in eractic shapes and stiffened, eyes closed, her face and mouth tight as if she presented a seizure posture.  Her skin was very pale/white.  I yelled at her, lightly smacked her first, but no reaction whatsoever.  I opened exam room door and yelled for help.  Aides came in, applied wet cold paper towels to her forehead, and one used a flinch took on the bottom of her feet and sides of her legs without any normally expected twitch/movement.  In about a half hour, she started mumbling in her speak, barely audible, and said she could not not feel her legs from the middle of both upper leg thigh areas down to her toes.   Again the flinch tool was used and no reaction whatsoever.  It took a while for to sit up, and when attempting to stand was extremely weak and wobbly.  She reached a point where she felt she could go home and was wheeled to our car by a nurse.  I was NOT made aware of any possible or known side effects, and when I asked the Dr I was told there are no known effects.  However, the After Visit Summary report says to the contrary in particular with the HPV.  July 30th patient had slept until apprx 2pm.  I and my wife often checked on her while sleeping in order to determine if there was any stress to be noted.  She was very weak and wobbly when standing and walking.  She complained of mid-center chest pain.  I called Dr's office, spoke with her nurse for whom said that Dr stated patient may have been having psycho-systemic reaction to the shots, and to keep an eye on her.  If conditions worsen then take her to the ER for further testing.  However, patient never worsened, but never methodically started to recovering as her weakness continued into today (July 31, 2019).  Her vitals were taken at home but no off-scale indications of BP, temp, or pulse.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Oral disorder, Pallor, Seizure, Sensory loss
Clinical narrative: Apprx 10 after injections patient, while sitting on exam table, all of a sudden appeared to passout stiffen up and fell on her back with legs straightout, arms on her chest with fingers in eractic shapes and stiffened, eyes closed, her face and mouth tight as if she presented a seizure posture.  Her skin was very pale/white.  I yelled at her, lightly smacked her first, but no reaction whatsoever.  I opened exam room door and yelled for help.  Aides came in, applied wet cold paper towels to her forehead, and one used a flinch took on the bottom of her feet and sides of her legs without any normally expected twitch/movement.  In about a half hour, she started mumbling in her speak, barely audible, and said she could not not feel her legs from the middle of both upper leg thigh areas down to her toes.   Again the flinch tool was used and no reaction whatsoever.  It took a while for to sit up, and when attempting to stand was extremely weak and wobbly.  She reached a point where she felt she could go home and was wheeled to our car by a nurse.  I was NOT made aware of any possible or known side effects, and when I asked the Dr I was told there are no known effects.  However, the After Visit Summary report says to the contrary in particular with the HPV.  July 30th patient had slept until apprx 2pm.  I and my wife often checked on her while sleeping in order to determine if there was any stress to be noted.  She was very weak and wobbly when standing and walking.  She complained of mid-center chest pain.  I called Dr's office, spoke with her nurse for whom said that Dr stated patient may have been having psycho-systemic reaction to the shots, and to keep an eye on her.  If conditions worsen then take her to the ER for further testing.  However, patient never worsened, but never methodically started to recovering as her weakness continued into today (July 31, 2019).  Her vitals were taken at home but no off-scale indications of BP, temp, or pulse.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Apprx 10 after injections patient, while sitting on exam table, all of a sudden appeared to passout stiffen up and fell on her back with legs straightout, arms on her chest with fingers in eractic shapes and stiffened, eyes closed, her face and mouth tight as if she presented a seizure posture.  Her skin was very pale/white.  I yelled at her, lightly smacked her first, but no reaction whatsoever.  I opened exam room door and yelled for help.  Aides came in, applied wet cold paper towels to her forehead, and one used a flinch took on the bottom of her feet and sides of her legs without any normally expected twitch/movement.  In about a half hour, she started mumbling in her speak, barely audible, and said she could not not feel her legs from the middle of both upper leg thigh areas down to her toes.   Again the flinch tool was used and no reaction whatsoever.  It took a while for to sit up, and when attempting to stand was extremely weak and wobbly.  She reached a point where she felt she could go home and was wheeled to our car by a nurse.  I was NOT made aware of any possible or known side effects, and when I asked the Dr I was told there are no known effects.  However, the After Visit Summary report says to the contrary in particular with the HPV.  July 30th patient had slept until apprx 2pm.  I and my wife often checked on her while sleeping in order to determine if there was any stress to be noted.  She was very weak and wobbly when standing and walking.  She complained of mid-center chest pain.  I called Dr's office, spoke with her nurse for whom said that Dr stated patient may have been having psycho-systemic reaction to the shots, and to keep an eye on her.  If conditions worsen then take her to the ER for further testing.  However, patient never worsened, but never methodically started to recovering as her weakness continued into today (July 31, 2019).  Her vitals were taken at home but no off-scale indications of BP, temp, or pulse.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain in extremity
Clinical narrative: About 2 AM I woke up with a headache, some chills, felt a little feverish, and had some nausea.  I have some pain in arm and shoulder by injection site. These are still present now at about 4:30AM
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: About 2 AM I woke up with a headache, some chills, felt a little feverish, and had some nausea.  I have some pain in arm and shoulder by injection site. These are still present now at about 4:30AM
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Nausea, Pain in extremity, Retching
Clinical narrative: tiredness in the afternoon of the shot (napped from 5-7) then, nausea, vomiting, dry heaves from about 10pm the day of the shot until 3.30 the following morning (so, for about 5-6 hours). Also, one bout of diarrhea at the beginning of all the nausea. sore arm for almost a week Note: I did not file an adverse reaction with the first shot, but the reactions were similar, the only difference being that they came on sooner with the first shot.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: tiredness in the afternoon of the shot (napped from 5-7) then, nausea, vomiting, dry heaves from about 10pm the day of the shot until 3.30 the following morning (so, for about 5-6 hours). Also, one bout of diarrhea at the beginning of all the nausea. sore arm for almost a week Note: I did not file an adverse reaction with the first shot, but the reactions were similar, the only difference being that they came on sooner with the first shot.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Headache, muscle aches, chills, arm soreness
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Confusional state, Hypotonia, Presyncope
Clinical narrative: Shortly after receiving gardasil vaccine (<5 minutes), patient was walking to the front of the office to checkout when she became presyncopal. Unclear whether she fully lost consciousness but she became confused, unable to support herself, and limp. Medical professionals were nearby and we were able to lower her to the ground and move her back into an exam room. She was laid on the floor initially, vital signs were taken and stable, and she quickly regained consciousness. She was then moved to the exam table where she remained for 15-20 minutes for further monitoring. All symptoms resolved and she was able to walk out of the office independently.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, UNK
Symptoms: Dyspnoea, Hyporesponsive to stimuli, Laboratory test normal, Lethargy, Pyrexia
Clinical narrative: Within 24 hours patient had spiked a fever of over 100. He became lethargic, nearly unresponsive though awake. His face/body began to swell and he showed difficulty in breathing. The swelling and difficulty breathing resolved within a couple of hours. The fever decreased with Motrin and resolved about 48 hours after vaccination. Prior to this vaccine patient had been vocalizing frequently and even made distinguishable words (a happy surprise for a 5-6 month old). In the weeks after the vaccine his vocalization/speech decreased and became minimal by 8 months, at which time we offered spiraling as a supplement. Within 12 hours he began vocalizing again. We're waiting on his speech to return  and continue developing.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, UNK
Symptoms: SARS-CoV-2 test negative, Speech disorder, Swelling, Swelling face
Clinical narrative: Within 24 hours patient had spiked a fever of over 100. He became lethargic, nearly unresponsive though awake. His face/body began to swell and he showed difficulty in breathing. The swelling and difficulty breathing resolved within a couple of hours. The fever decreased with Motrin and resolved about 48 hours after vaccination. Prior to this vaccine patient had been vocalizing frequently and even made distinguishable words (a happy surprise for a 5-6 month old). In the weeks after the vaccine his vocalization/speech decreased and became minimal by 8 months, at which time we offered spiraling as a supplement. Within 12 hours he began vocalizing again. We're waiting on his speech to return  and continue developing.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pruritus
Clinical narrative: Patient developed shingles across her belly to her back about 3 inches in width. Patient said it was itchy and red blister. Patient has a history of shingles.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Chills, Migraine, Neck pain, Rash
Clinical narrative: Severe migraine headaches, chills, shaking, neck pain, rash -red dots on back
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Scan brain, Tremor
Clinical narrative: Severe migraine headaches, chills, shaking, neck pain, rash -red dots on back
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Redness/pain at injection site, pain radiates to upper shoulder starting night of vaccination, not resolved @ 72 hours. Fever, body aches, chills starting night of vaccination and lasting ~30 hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea, Pain
Clinical narrative: Body Aches, Nausea, Pain at injection site, headache
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Disorientation, Dizziness, Flushing
Clinical narrative: My 14 year old felt flush, dizzy, disoriented and light headed the day after his HPV vaccine, which was unusual especially b/c his younger brother who also had the vaccine and had similar symptoms. They have both received all their childhood vaccinations and never had any adverse reactions until now.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Neuralgia
Clinical narrative: Patient's husband reports that she had difficulty raising her arm after going home from the vaccination.  Patient asked her physician about it and he said it would get better.  Patient says that has subsided but still feels twinges of nerve pain in neck about injection site.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Disorientation, Dizziness, Nausea
Clinical narrative: A few hours after my younger son received the HPV vaccine he felt light headed, dizzy, disoriented and nausea
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness/vertigo  for 36 hours. Was bad enough that I just day slept or sat in a chair for 36 hours. No vomiting. Dizziness is getting less as of 11:30am,  August 1st.  Benadryl and Meclizine taken
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Pain, Tinnitus
Clinical narrative: Dizzy,Ringing of ears,weakness,severe aches and pain
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Pain in extremity, Skin warm
Clinical narrative: It started with a lot of pain...which I expected, was red and hot to the touch and then a patch about 4-5 inches in height and 2-3inches wide went across my bicep and there was what looked like slight bruising and a water-mark effect around the redness.  I iced it the first and second day and by Sunday, 07/26/2020 it had cleared up.  I did speak to my doctor's office both 07/23/2020 and 07/24/2020 and they said to keep an eye on it and call back if any other symptoms arose.  They also asked me if I was short of breath which I was not.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Fatigue, Injection site swelling, Malaise, Pyrexia
Clinical narrative: patient experienced fatigue, fever, malaise and reported swelling in her right arm at the injection site
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient started getting swelling, redness, and tenderness around her upper left arm.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache last night, body aches and chills this morning - reviewed online sources and indicates not a "typical" reaction.  Not really concerned but thought I should report
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Arthralgia, headache, nausea, diahhrea, exhaustion
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reported red area (about 8.5" and wrapped around arm) that traveled down arm from injection site. Area was warm to touch and very sore. Patient refuses second dose based on reaction to this dose.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Fatigue
Clinical narrative: pt got shot at around 11:25, pt stated did not want to wait around, called about 11:30 saying he was having sharp chest pain (coming and going) in middle of chest.  Came back to pharmacy around 11:38 rested in pharmacy, took a few BP readings, pt stated he was feeling better and left at 11:50.  Contacted pt twice and he states he was just tied and pain was much less if any
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Patient came to pharmacy on 7/31/20 complaining of a rash after receiving the shingrix vaccine on 7/28/20.  He stated 8 hours after receiving the vaccine 3 rashes began to form on his torso.  On 7/31/20 he presented with multiple rashes on his torso with one appearing to have previously blistered.  He was told to see his doctor because the rashes appeared to be shingles.
Age: 14.0
Sex: M
Vaccine: DTAP, HEP, MENB
Symptoms: Loss of consciousness
Clinical narrative: loss of consciousness on way out of medical office
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Myalgia, Nausea
Clinical narrative: Hot, swelling, red, full body muscle pain especially to touch, fever, aches, nausea, vomiting, headache now weird hive rash developing
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling, Urticaria, Vomiting
Clinical narrative: Hot, swelling, red, full body muscle pain especially to touch, fever, aches, nausea, vomiting, headache now weird hive rash developing
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Pain in arm shot was given, extremely tired, fever, decreased appetite, muscle aches pain, nausea, dizzy, high heart rate, headache,
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm shot was given, extremely tired, fever, decreased appetite, muscle aches pain, nausea, dizzy, high heart rate, headache,
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Fever and chills, beginning 14 hours post injection.  Lasted for 20 hours.  Alternated acetaminophen and ibuprofen.  Sore arm.  Began 14 hours post injection and continues, but improving 72 hours later. Redness, swelling and hot left shoulder, upper arm.  Continues but improving 72 hours post onset. Left shoulder/upper arm itches.  Onset 08/01/2020 at 09:30 a.m.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever and chills, beginning 14 hours post injection.  Lasted for 20 hours.  Alternated acetaminophen and ibuprofen.  Sore arm.  Began 14 hours post injection and continues, but improving 72 hours later. Redness, swelling and hot left shoulder, upper arm.  Continues but improving 72 hours post onset. Left shoulder/upper arm itches.  Onset 08/01/2020 at 09:30 a.m.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Cheilitis, Rash
Clinical narrative: Patient stated that he had a rash over his upper torso and inside his thighs, and his upper lip swelled. This was his second Shingrix shot given. He said it lasted into 3-4 days of taking loratadine.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Flushing, Irritability, Pyrexia, Vomiting
Clinical narrative: She received Prevnar injection at same time as Hep- A.  Parent of patient believes the brands noted were the ones used, around 2:30 pm same day as vaccine , my daughter started to show signs of excessive fussiness, flushed skin, and a fever of 103.3 that held for a full 24+ hours. Vomiting occurred several times over the course of the afternoon/night while asleep at 1:45am the following day (7/30/2020) and into the 31st. Fever broke and lowered after 30+ hours, around 8:30pm 7/31/2020  She was seen at a different location than the initial injection that triggered reaction. Dr. Was not thorough for follow up.  We were instructed to take my daughter back within 2 days of holding fever over 101.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills, tiredness & headache
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cardiac monitoring, Chest X-ray, Fatigue, Feeding disorder
Clinical narrative: Mild headache/fatigue on 6-28-20 (I had cut grass that day it was hot-blamed on that).  On 6-29-20 I was extremely tired. Slept after work.  Very tired again on 6-30-20 but now  barely able to eat or drink anything.  Slept after work until  approx. 7:30 pm and woke up with a 102.4 fever.   Taken to ER because the pharmacy and the Urgent care were closed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fluid intake reduced, Headache, Hyponatraemia, Malaise, Pyrexia
Clinical narrative: Mild headache/fatigue on 6-28-20 (I had cut grass that day it was hot-blamed on that).  On 6-29-20 I was extremely tired. Slept after work.  Very tired again on 6-30-20 but now  barely able to eat or drink anything.  Slept after work until  approx. 7:30 pm and woke up with a 102.4 fever.   Taken to ER because the pharmacy and the Urgent care were closed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative, Somnolence, Urine analysis, Vision blurred
Clinical narrative: Mild headache/fatigue on 6-28-20 (I had cut grass that day it was hot-blamed on that).  On 6-29-20 I was extremely tired. Slept after work.  Very tired again on 6-30-20 but now  barely able to eat or drink anything.  Slept after work until  approx. 7:30 pm and woke up with a 102.4 fever.   Taken to ER because the pharmacy and the Urgent care were closed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Heart rate increased, Injection site pain
Clinical narrative: Injection site pain, swelling, hot. Tingling lips and feet.  Increased heart rate (up avg 40-50 bpm for 24 hrs. Fever up to 102F. Headache,  body/joints ached. Dizzy/light headed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Paraesthesia, Paraesthesia oral
Clinical narrative: Injection site pain, swelling, hot. Tingling lips and feet.  Increased heart rate (up avg 40-50 bpm for 24 hrs. Fever up to 102F. Headache,  body/joints ached. Dizzy/light headed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection site pain, swelling, hot. Tingling lips and feet.  Increased heart rate (up avg 40-50 bpm for 24 hrs. Fever up to 102F. Headache,  body/joints ached. Dizzy/light headed.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Feeling abnormal, Feeling cold, Headache
Clinical narrative: By 10 PM I was freezing cold & sweating at the  same time. Felt terrible with shaking chills, headache. Headache became bad enough I vomited 3x's Temperature was 100.2 but felt more like 102 A few hours later I was able to keep a little bit  of gingerale down. Was able to sleep later &  Slept part of next day
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Tremor, Vomiting
Clinical narrative: By 10 PM I was freezing cold & sweating at the  same time. Felt terrible with shaking chills, headache. Headache became bad enough I vomited 3x's Temperature was 100.2 but felt more like 102 A few hours later I was able to keep a little bit  of gingerale down. Was able to sleep later &  Slept part of next day
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: I broke out in hives all over my upper body - neck, chest, breast, stomach and back.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT CAME IN 8/1/20 AND REPORTED THAT AFTER GETTING THIS VACCINE ON 1/18/20 HE DEVELOPED A MILD RASH, ESPECIALLY ON HIS HANDS. I ENCOURAGED HIM TO GET EXPLICIT PERMISSION / RECOMMENDATION FROM HIS DOCTOR BEFORE GETTING SECOND SHINGRIX. HE AGREED THAT WAS A GOOD IDEA.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Bruise, hot , hard and red injection site
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Malaise, Poor quality sleep, Pyrexia
Clinical narrative: Pt. received vaccine on 7/30/20.  She stated she did not sleep well that evening.  She stated that on the following day (7/1/20) she had a 100.4 fever, which I'd previously advised would be possible. On 8/1/20, after going out for lunch with friends, she stated she did not feel well after eating and subsequently went back to a friends house at which time she passed out (she stated she was assisted to the floor by friends).  She mentioned that she able to get back up moments later.  Pt. unaware if this would have been related to vaccine administration, but wanted to report accordingly.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Decreased appetite, Fatigue, Injection site pain
Clinical narrative: Very sore arm with puffiness and rash. Injection area was warm and throbbing. Second day- leg, back and muscle ache. Stomach ache and feeling very tired with loss of appetite.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Very sore arm with puffiness and rash. Injection area was warm and throbbing. Second day- leg, back and muscle ache. Stomach ache and feeling very tired with loss of appetite.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Day of vaccination, around 8pm I developed a 102.5 degree fever, with chills and aches. took Ibuprofen 800mg. Fever broke around 11:30pm. next day fever and chills returned around 11:00am. I stayed in bed with flu like symptoms until 5:30pm. Then the fever and chills subsided. Today os Sunday and my arm is still pretty sore and warm to the touch.   With the fist vaccine, I only developed a large, red, sore spot on my arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Day of vaccination, around 8pm I developed a 102.5 degree fever, with chills and aches. took Ibuprofen 800mg. Fever broke around 11:30pm. next day fever and chills returned around 11:00am. I stayed in bed with flu like symptoms until 5:30pm. Then the fever and chills subsided. Today os Sunday and my arm is still pretty sore and warm to the touch.   With the fist vaccine, I only developed a large, red, sore spot on my arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Myalgia, Skin warm
Clinical narrative: Muscle pain, hotness and redness in upper arm, fatigue, muscle pain.  The fatigue and muscle pain lasted two days.  The upper arm symptoms were still present on the fourth day after the injection, but had lessened.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: pt reported what appeared to look like "cellulitis" day after receiving  shingrix shot. Pt did inform me, which was not known at the time, that she has history of lymphoma and lymphadenopathy, in her right arm. The shot was given in her left arm. Pt described site as red, warm to the touch. She requested me to call her doctor to request refills on antibiotics she has had in the past. I left the on-call doctor a message. The doctor sent in RX for the treatment but did not call me back. Called patient
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Lethargy, Pyrexia, Swelling
Clinical narrative: Patient reported feeling very lethargic, developed fever, swelling, redness and heat at injection site (more than expected). Patient reported symptoms lasting for 4 days.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Pain at injection site, Redness, Swelling
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Dehydration, Dizziness, Loss of consciousness, Posture abnormal
Clinical narrative: About 5 to 10 minutes after vaccination the patient said he felt light headed.  I rushed and grabbed a chair for him and he stated he was dehydrated and wanted water which I had my technician provide while I stayed with him.  As I was monitoring him he slumped to the side unconscious.  I had my technician call 911 while I called for help to lower him to the floor.  With help I lowered him to the floor and he immediately regained consciousness.  I monitored the patient until EMS arrived.  EMS took patient to the hospital for further evaluation.  He was discharged from the ER about an hour later.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Patient stated that a couple of days after she received her shingles shot she started to get fever blisters on her lip that she said reminded her of cold sores or what she thought shingles would look like. She has been self treating over the counter with vaseline and campho phenique, and said that this has been helping her symptoms.  She is also going to follow up with her doctor to see if they want to give her any additional treatment or if she should be seen.
Age: 87.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Malaise, Pain
Clinical narrative: Patient reports redness around and down from injection site to elbow, extreme soreness and "not feeling well"
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient complained of bilateral injection site soreness, nausea, vomiting, fever, and headache that lasted for approximately 2 days and began about 6 hours after receiving the vaccine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Extreme sharp stabbing pain in injection area, sometimes accompanied by movement other times doing no activity at all. This has impaired my daily activity.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Erythema, Nausea, Pruritus, Pyrexia
Clinical narrative: Pt got 3rd SHIGRIX dose by mistake (L Arm); R arm Pt had an adverse reaction. Pt calls Pharmacy 7/23/2020 stating that she is experiencing an adverse reaction in her "R arm with huge red reaised reaction, hot to touch, red, itchy, fever through the night 100.5 & 101 degree Fahrenheit fever, nauseous, chills, shaking." She stated she had taken TYLENOL already, I advised her to also try applying a cool compress to the area, and diphenhydramine, in addition to continuing the APAP. Also stated if not improving or seems to get worse to seek medical attention.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Skin warm, Tremor
Clinical narrative: Pt got 3rd SHIGRIX dose by mistake (L Arm); R arm Pt had an adverse reaction. Pt calls Pharmacy 7/23/2020 stating that she is experiencing an adverse reaction in her "R arm with huge red reaised reaction, hot to touch, red, itchy, fever through the night 100.5 & 101 degree Fahrenheit fever, nauseous, chills, shaking." She stated she had taken TYLENOL already, I advised her to also try applying a cool compress to the area, and diphenhydramine, in addition to continuing the APAP. Also stated if not improving or seems to get worse to seek medical attention.
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Blood creatinine increased, Joint swelling, Rheumatoid factor increased
Clinical narrative: swelling of the leg and ankle; swelling of the leg and ankle; Fatigue; Jaw pain; Joint pain; Muscle pain; Pain from head to toe; This case was reported by a consumer via call center representative and described the occurrence of swelling of legs in a 63-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 15th May 2020, the patient received the 1st dose of Boostrix (intramuscular). On 28th May 2020, 13 days after receiving Boostrix, the patient experienced swelling of legs, ankle swelling, fatigue, jaw pain, joint pain, muscle pain and general body pain. On an unknown date, the outcome of the swelling of legs, ankle swelling, fatigue, jaw pain, joint pain, muscle pain and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the swelling of legs, ankle swelling, fatigue, jaw pain, joint pain, muscle pain and general body pain to be related to Boostrix.  Additional details were provided as follows: After receiving Boostrix, the patient experienced swelling of the leg and ankle, fatigue, jaw pain, joint and muscle pain, as well as pain from head to toe.  The patient also had abnormal lab results.  The patient was fine until she got the shot.  Healthcare professional was not aware of these adverse reactions till the time of reporting, but the patient did call the office. The reporter was consented to follow up. Not all information was available.
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Fatigue, Joint swelling, Laboratory test abnormal, Myalgia
Clinical narrative: swelling of the leg and ankle; swelling of the leg and ankle; Fatigue; Jaw pain; Joint pain; Muscle pain; Pain from head to toe; This case was reported by a consumer via call center representative and described the occurrence of swelling of legs in a 63-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 15th May 2020, the patient received the 1st dose of Boostrix (intramuscular). On 28th May 2020, 13 days after receiving Boostrix, the patient experienced swelling of legs, ankle swelling, fatigue, jaw pain, joint pain, muscle pain and general body pain. On an unknown date, the outcome of the swelling of legs, ankle swelling, fatigue, jaw pain, joint pain, muscle pain and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the swelling of legs, ankle swelling, fatigue, jaw pain, joint pain, muscle pain and general body pain to be related to Boostrix.  Additional details were provided as follows: After receiving Boostrix, the patient experienced swelling of the leg and ankle, fatigue, jaw pain, joint and muscle pain, as well as pain from head to toe.  The patient also had abnormal lab results.  The patient was fine until she got the shot.  Healthcare professional was not aware of these adverse reactions till the time of reporting, but the patient did call the office. The reporter was consented to follow up. Not all information was available.
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pain in jaw, Peripheral swelling
Clinical narrative: swelling of the leg and ankle; swelling of the leg and ankle; Fatigue; Jaw pain; Joint pain; Muscle pain; Pain from head to toe; This case was reported by a consumer via call center representative and described the occurrence of swelling of legs in a 63-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 15th May 2020, the patient received the 1st dose of Boostrix (intramuscular). On 28th May 2020, 13 days after receiving Boostrix, the patient experienced swelling of legs, ankle swelling, fatigue, jaw pain, joint pain, muscle pain and general body pain. On an unknown date, the outcome of the swelling of legs, ankle swelling, fatigue, jaw pain, joint pain, muscle pain and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the swelling of legs, ankle swelling, fatigue, jaw pain, joint pain, muscle pain and general body pain to be related to Boostrix.  Additional details were provided as follows: After receiving Boostrix, the patient experienced swelling of the leg and ankle, fatigue, jaw pain, joint and muscle pain, as well as pain from head to toe.  The patient also had abnormal lab results.  The patient was fine until she got the shot.  Healthcare professional was not aware of these adverse reactions till the time of reporting, but the patient did call the office. The reporter was consented to follow up. Not all information was available.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Abdominal pain upper, Bed rest, Nausea, Pyrexia
Clinical narrative: stomach pain and nausea for approximately 8 hours; slight fever for approximately 30 hours - no treatment for any symptoms other than bed rest. Complete resolution of symptoms within 36 hours.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Anti-HBs Antibody Negative; This spontaneous report was received from a registered nurse referring to an approximately 20 year old female patient. The patient pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported.    On an unknown date, when the patient was 19 or younger, she was vaccinated with a dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 5/0.5 micrograms/milliliters; 0.5 milliliters, intramuscular (anatomical location, lot # and expiration date were not provided) for immunisation.  On an unknown date in 2020,  the patient had her titres drawn which came back negatives (hepatitis b surface antibody negative). No product quality complaints were reported.  At the time of the report, the outcome of the event hepatitis b surface antibody negative was reported as not recovered.  The reporter did not assess a causal relationship between the event hepatitis b surface antibody negative and hepatitis b vaccine (recombinant)(RECOMBIVAX HB).
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event.; the patient was inadvertently administered a dose of VARIVAX, that had been improperly stored; This spontaneous report was received from a nurse, referring to a 5-year-old female patient. The patients' pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 20-JUL-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T002844, which has been verified to be valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis. A properly stored sterile diluent (MERCK STERILE DILUENT) was used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX). The vaccine experienced temperature of 70 degrees Fahrenheit (F)for a time frame of 48 hours, as record by a data logger. There was no previous temperature excursion. No additional adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's inoculation, she was treated by a healthcare provider at a medical center for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), she had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported; administered a dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant (also reported as a nurse) and refers to a 15-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were unknown.   On 13-JUL-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, injection, lot # S022917 and expiration date 19-JAN-2021 (strength, exact dose and route of administration were not reported) for prophylaxis (product storage error). A properly stored sterile diluent was used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). No adverse symptoms were reported. The temperature excursion was reported as 9 degrees Celsius to 25 degrees Celsius (18.5 degrees Celsius) for 20 minutes. There was no previous temperature excursion. There was a data logger involved in capturing the event.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA008679:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patient was administered an improperly stored Varivax; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-JUL-2020, the patient was inoculated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S036635, expiration date 14-NOV-2021 (dose, dose number, route of administration, anatomical site of vaccination were not reported) for prophylaxis.The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown).   The vaccine was stored at the temperature from -14 to -10 degrees Celsius (C) (-11.1) for 2 hours, at the temperature from -9 to 8 C (2.2 C) for 9 hours and 30 minutes, from -14 to -10 C (-9.8 C) for 2 hours and 30 minutes, and from -9 to 8 C (0.4 C) for 3 hours. The previous temperature excursion included temperature from -9 to 8 C (-6.1 C) for 8 hours. Digital data logger was involved. No additional adverse events were reported.
Sex: M
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Inadvertently administered a dose of VAQTA that was expired; This spontaneous report was received from a nurse referring to a 12 month old male patient. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 22-JUL-2020, the patient was inadvertently vaccinated with an expired dose hepatitis a vaccine, inactivated (VAQTA) (lot # S005725, expiration date: 10-JUL-2020) for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported). No additional adverse event was reported.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S005725; expirationdate: 10-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No additional adverse effect reported; Syringe broken; Poor quality device used; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 07-NOV-2019, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# and expiration date were unknown) and on 23-JUL-2020, was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Lot No. S008151, expiration date 20-NOV-2021) both intramuscularly for prophylaxis (strength, dose, route, anatomical site of administration and vaccination schedule were not provided). The reporter stated that, while she was administering the third dose, the syringe finger flange broke, but she was able to administer the full dose. No adverse effects reported.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S008151; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; operatorofdevice: Registered Nurse; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effects; received improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-JUL-2020, the patient was inoculated with an improperly stored 0.5 ml dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S017244, expiration date 01-DEC-2020  (anatomical site of vaccination and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).    The vaccine was stored at the temperature of 33 degrees of Fahrenheit for 3 hours and 27 minutes. There was no previous temperature excursion reported. Digital Data logger was involved. No additional adverse effects were reported.