chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Abdominal pain, Diarrhoea, Headache, Pyrexia, Rash morbilliform
Clinical narrative: Recipient of the vaccine experienced low grade fever initially about 9 days after the vaccine.  The following day, she presented with a very light measles like rash that I thought was possibly heat rash. On the 11th day she had tummy ache, headache and said "it hurts to look up" the motion you would do to roll your eyes. As in, "Come on crazy lady (eye roll) do you really think that is a symptom we need to record?" I attributed all of this to her ballet recital on that same day, chalking it up to nerves. After the recital, though, she felt hot to me and we spent about 45 minutes in the bathroom of the facility where she had performed. She had explosive diarrhea that seemed to have no end. In fact, I ended up bringing a wad of toilet paper with us (they needed to close the facility, so she had to stop) for the drive home. She fell asleep while I carried her to the car.  It was only about 6 PM.  She woke briefly on the ride home and then fell asleep again once home.  She woke up about an hour later and had 102.5 fever taken by a Braun in ear thermometer.  I gave her a popsicle because she would only take a few sips of water.  It was a homemade popsicle made of juice. (Are you rolling your eyes again at this point of excessive description?) As I put her to bed I noticed her rash was more pronounced and had spread from just a few spots on tummy and back to many spots (maybe 8 - 10 per square inch) and was now on her neck, cheeks, butt, and upper thighs.  The rash and diarrhea remained through the next morning.  I finally put together that she had a mild form of the measles, though diarrhea wasn't listed as a symptom and she never had a persistent cough or runny nose.  She had the rash through Monday with it finally disappearing ( rather abruptly actually) Monday afternoon.  I never called the doctor as I didn't think it was a big deal. Her fever never got too high and she continued to eat enough popsicles and drink enough liquid to urinate.  I am only reporting this at the suggestion of a friend so that you guys can have better data.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2019, the patient received Shingrix. On 8th January 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. A patient experienced arm soreness after a Shingrix injection. The reporter did not consent to follow-up. Sister of patient was the reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Influenza like illness, Pain, Rash
Clinical narrative: Started getting aches and pains within 30 min of vaccine. After two hours my temp was up to 100.7 and I had flu-like symptoms (aches, pains, chills, etc). After 24 hours a rash showed up above my left ankle. Managed symptoms with ibuprofen and bed rest. This was the second vaccination in the two part series. I had no issues with the first vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, aches all over, dizziness, nausea.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeding disorder, Headache, Loss of personal independence in daily activities, Lymph node pain
Clinical narrative: I came home after receiving the vaccine and fell asleep at 6 pm.  I woke up later and didn?t sleep much more overnight. By morning I had a blasting headache and my glands under my ears were very painful.  I was literally incapacitated! I was in bed all day fading in and out and unable to eat. My husband wanted to take me to the emergency room.  The headache was blinding.  By about 8 pm I started to wake up a bit and this morning I?m much better.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Tenderness, Ultrasound scan normal
Clinical narrative: 4/22 pneumovax given. 4/24 pain redness, swelling below area of inj L mid arm. Tx'd Keflex, warm compresses 4/26 LUE swelling axilla to wrist medially, 4 cm oval swellng medial to antecubital area, tender
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Pruritus, Rash, Urticaria
Clinical narrative: Rash, ErythemaMultiform & UrticariaPruritus CEPHALEXIN 500 MG QID
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pain, Skin warm, Swelling
Clinical narrative: Cellulitis vs vaccine reaction Right upper arm s/p shingrix vaccine - Received Shingrix vaccine in right deltoid on 08/24/2018. Noted minor pain at injection site for a couple of days after injection. Noted increased pain and redness around 08/27/2018. On 08/29/2018, redness seemed to be worsening. Patient was evaluated on 08/30/2018, given increasing redness, pain and warmth cephalexin x 7 days was prescribed for possible cellulitis. Reports symptoms seemed to peak on 09/03/2018. Then redness and swelling resolved. UrticariaPruritus & swelling, redness CEPHALEXIN
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Symptoms: Rash & arm swelling and redness Treatment : DIPHENHYDRAMINE 25 MG PRN
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Fatigue, Feeling cold, Feeling hot, Headache
Clinical narrative: 36 hours - extreme sensation of cold as though running a high fever - went to bed. Fatigue. 48 hours - sensation of heat and pain at and around injection site [radius 3"]  day 3-7 pain at injection site migrated down arm and across upper shoulder into back of neck. Sharp pain in back of neck one day. Overall flu like symptoms [ headaches, body aches, fatigue, etc.] Contacted Dr's office on day 5 - no action - patient told that this was within the range of normal reaction.  Day 8 awoke to swollen face, puffy eyes - unable to work.  Seen by Dr. who started a medrol dose pack. Day 9 Only minimal relief. Was started on 20 mg prednisone 3x day for 3 days, 2x day for 3 days etc. until symptoms were gone. Total duration of symptoms was approximately 2 weeks.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Injection site pain, Neck pain, Pain
Clinical narrative: 36 hours - extreme sensation of cold as though running a high fever - went to bed. Fatigue. 48 hours - sensation of heat and pain at and around injection site [radius 3"]  day 3-7 pain at injection site migrated down arm and across upper shoulder into back of neck. Sharp pain in back of neck one day. Overall flu like symptoms [ headaches, body aches, fatigue, etc.] Contacted Dr's office on day 5 - no action - patient told that this was within the range of normal reaction.  Day 8 awoke to swollen face, puffy eyes - unable to work.  Seen by Dr. who started a medrol dose pack. Day 9 Only minimal relief. Was started on 20 mg prednisone 3x day for 3 days, 2x day for 3 days etc. until symptoms were gone. Total duration of symptoms was approximately 2 weeks.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Swelling face
Clinical narrative: 36 hours - extreme sensation of cold as though running a high fever - went to bed. Fatigue. 48 hours - sensation of heat and pain at and around injection site [radius 3"]  day 3-7 pain at injection site migrated down arm and across upper shoulder into back of neck. Sharp pain in back of neck one day. Overall flu like symptoms [ headaches, body aches, fatigue, etc.] Contacted Dr's office on day 5 - no action - patient told that this was within the range of normal reaction.  Day 8 awoke to swollen face, puffy eyes - unable to work.  Seen by Dr. who started a medrol dose pack. Day 9 Only minimal relief. Was started on 20 mg prednisone 3x day for 3 days, 2x day for 3 days etc. until symptoms were gone. Total duration of symptoms was approximately 2 weeks.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient was given vaccine after stating not ill, etc. 12 hours later called to say diagnosed with flu. Within 48 hours pt said arm deltoid left was warm to touch and sore, red. Patient could not come to be evaluated but did take some benadryl. Patient states benadryl calmed the arm. When she returned to pharmacy, arm was red. Appeared to be injection site reaction. Patient stated did not have that issue with the first round of shingles vaccine.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Urticaria, Vomiting
Clinical narrative: 2 hours after shot to right arm, right leg broke out in hives and pocks, does not appear to bother child, goes away within a day (April 22) 7 days after shot, diarrhea in each diaper (April 27th) 9 days after shot, vomited 3 times when given milk or formula on, diarrhea  continues day and night during her bowel movement times (April 30th)
Age: 11.0
Sex: M
Vaccine: MMRV
Symptoms: Candida infection, Chest X-ray normal, Influenza virus test negative, Mononucleosis heterophile test negative, Oral candidiasis
Clinical narrative: First vaccine given for this 11 year old patient on 4/19/19. No previous Hx of any vaccinations. On 4/28/19 he developed a fever Tmax 103 degrees F. On 4/29/19 he was evaluated at an urgent care facility, negative for strep, flu, mono. Negative chest xray. Had low WBC count. He was seen at PCP office on 4/30/19 after developing a diffuse rash over chest/back/trunk/face/neck/hairline, with fever of 102 degrees F. He also had candidiasis of mouth. He was treated for thrush, physician consulted with peds infectious disease physician and suspected vaccine reaction to MMRV.
Age: 11.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Streptococcus test negative, Vaccination complication, White blood cell count decreased
Clinical narrative: First vaccine given for this 11 year old patient on 4/19/19. No previous Hx of any vaccinations. On 4/28/19 he developed a fever Tmax 103 degrees F. On 4/29/19 he was evaluated at an urgent care facility, negative for strep, flu, mono. Negative chest xray. Had low WBC count. He was seen at PCP office on 4/30/19 after developing a diffuse rash over chest/back/trunk/face/neck/hairline, with fever of 102 degrees F. He also had candidiasis of mouth. He was treated for thrush, physician consulted with peds infectious disease physician and suspected vaccine reaction to MMRV.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: Immediate arm pain, so bad I had difficulty driving within a hour of injection.   Cough with subsequent feeling of  irritation of airways, like a feather duster rubbing down the center of my chest,  I then developed a feeling of having a rock in my throat around the area of the Adam?s apple , which continued to worsen.   I went to Hospital at around 415 pm but they could not see any swelling, however, the area of concern was lower than could be visualized by looking inside my mouth.  The arm pain began to lessen, due to having taken a Tylenol at around  2 pm.  I went home around 5:30.  Eyes were extremely bloodshot, I had extreme fatigue.  I awoke at 11:14 with chilling and shaking, had low grade temp, nasal congestion, severe headache.  On Thursday I was extremely fatigued and felt very unwell and had also developed a rash all over my torso and upper arms.  I had stomach cramping and diarrhea.  The rash lasted for 3 days and I did not feel well for the remainder of the week.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Immediate post-injection reaction, Impaired driving ability, Malaise, Nasal congestion
Clinical narrative: Immediate arm pain, so bad I had difficulty driving within a hour of injection.   Cough with subsequent feeling of  irritation of airways, like a feather duster rubbing down the center of my chest,  I then developed a feeling of having a rock in my throat around the area of the Adam?s apple , which continued to worsen.   I went to Hospital at around 415 pm but they could not see any swelling, however, the area of concern was lower than could be visualized by looking inside my mouth.  The arm pain began to lessen, due to having taken a Tylenol at around  2 pm.  I went home around 5:30.  Eyes were extremely bloodshot, I had extreme fatigue.  I awoke at 11:14 with chilling and shaking, had low grade temp, nasal congestion, severe headache.  On Thursday I was extremely fatigued and felt very unwell and had also developed a rash all over my torso and upper arms.  I had stomach cramping and diarrhea.  The rash lasted for 3 days and I did not feel well for the remainder of the week.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pain in extremity, Pyrexia, Rash, Respiratory tract irritation
Clinical narrative: Immediate arm pain, so bad I had difficulty driving within a hour of injection.   Cough with subsequent feeling of  irritation of airways, like a feather duster rubbing down the center of my chest,  I then developed a feeling of having a rock in my throat around the area of the Adam?s apple , which continued to worsen.   I went to Hospital at around 415 pm but they could not see any swelling, however, the area of concern was lower than could be visualized by looking inside my mouth.  The arm pain began to lessen, due to having taken a Tylenol at around  2 pm.  I went home around 5:30.  Eyes were extremely bloodshot, I had extreme fatigue.  I awoke at 11:14 with chilling and shaking, had low grade temp, nasal congestion, severe headache.  On Thursday I was extremely fatigued and felt very unwell and had also developed a rash all over my torso and upper arms.  I had stomach cramping and diarrhea.  The rash lasted for 3 days and I did not feel well for the remainder of the week.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of foreign body, Tremor
Clinical narrative: Immediate arm pain, so bad I had difficulty driving within a hour of injection.   Cough with subsequent feeling of  irritation of airways, like a feather duster rubbing down the center of my chest,  I then developed a feeling of having a rock in my throat around the area of the Adam?s apple , which continued to worsen.   I went to Hospital at around 415 pm but they could not see any swelling, however, the area of concern was lower than could be visualized by looking inside my mouth.  The arm pain began to lessen, due to having taken a Tylenol at around  2 pm.  I went home around 5:30.  Eyes were extremely bloodshot, I had extreme fatigue.  I awoke at 11:14 with chilling and shaking, had low grade temp, nasal congestion, severe headache.  On Thursday I was extremely fatigued and felt very unwell and had also developed a rash all over my torso and upper arms.  I had stomach cramping and diarrhea.  The rash lasted for 3 days and I did not feel well for the remainder of the week.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Full blood count normal, Injection site pain, Pain, Rheumatoid factor negative
Clinical narrative: Patient reported that early next morning following the vaccine she woke up with severe arm pain around the injection site.  The pain then progressed down the arm and throughout the body over the next few days.  She then went to her physician for lab work after 10 days of discomfort because she was concerned that she had rheumatoid arthritis.  The lab testing did not show any abnormalities and it was thought to be either an immune response to the shot, a viral infection, or fibromyalgia.  The patient then called the pharmacy to report her experience.  The pharmacist suggested using either acetaminophen or ibuprofen to help with the aches. She did state that ibuprofen had helped her a little bit.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Rash erythematous, Swelling
Clinical narrative: Moderately painful raised circular swollen area surrounded by red rash. Started one day after vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, X-ray limb normal
Clinical narrative: The shots did hurt a little in the beginning, but as time goes on, the pain has gotten much worse.      I can not lift my arms over my head or even do routine motions without pain'  The only time I have no pain is when my arms are completely still by my side.  It is very hard to get dressed, take a shower, wash  my hair' It has been 6 months since the first shot and 3 months since the second shot.  I have no relief.  I have tried, advil, aleve, aspercreme with lidocaine, emu oil = nothing helps.  My Dr doesn't have any answers, I called my insurance provider, and they suggested I contact you.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Headache, Loss of control of legs, Nausea
Clinical narrative: She went to lab for urinalysis and was called to come back when she became weak and was caught before falling by the lab staff. No LOC but patient reports she does not remember becoming weak. Patient placed her hand on her head and said she had a headache. She knew who she was and her birth date. Reported feeling weak and couldn't move her legs. -1155-Received call from lab that patient had become weak in lab.  RN went to lab to check on patient.  Was in reclined position.  C/o dizziness, nausea & headache.  BP obtained: left arm 118/78.  12:05 pm another BP left arm 120/70.   -1210 pm BP obtained left arm 116/68.  Patient reports feeling some better & moved to sitting position.   1220 pm- sitting up BP left arm 110/62.  1225 pm BP 110/68 in left arm.  Still with c/o headache and not feeling legs well.   1230 pm-stood with assistance BP in left arm 110/62.  Reports that "head is not telling legs to move".  1243 pm made to stand alone.  Continues to c/o headache & not hold herself up with her legs.  1237 pm-FNP called & advised to check on patient.  12:48 pm FNP in room.  BP 110/72 in left arm.  Assessed heart & lungs-WNL.  Moved with help from wheelchair to table.  Patient shaky but oriented X's 3.  1255 pm Dr. in room to talk with patient & parent.  Discussed sign and symptoms of worsening & to call back. Patient to car via wheelchair.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: She went to lab for urinalysis and was called to come back when she became weak and was caught before falling by the lab staff. No LOC but patient reports she does not remember becoming weak. Patient placed her hand on her head and said she had a headache. She knew who she was and her birth date. Reported feeling weak and couldn't move her legs. -1155-Received call from lab that patient had become weak in lab.  RN went to lab to check on patient.  Was in reclined position.  C/o dizziness, nausea & headache.  BP obtained: left arm 118/78.  12:05 pm another BP left arm 120/70.   -1210 pm BP obtained left arm 116/68.  Patient reports feeling some better & moved to sitting position.   1220 pm- sitting up BP left arm 110/62.  1225 pm BP 110/68 in left arm.  Still with c/o headache and not feeling legs well.   1230 pm-stood with assistance BP in left arm 110/62.  Reports that "head is not telling legs to move".  1243 pm made to stand alone.  Continues to c/o headache & not hold herself up with her legs.  1237 pm-FNP called & advised to check on patient.  12:48 pm FNP in room.  BP 110/72 in left arm.  Assessed heart & lungs-WNL.  Moved with help from wheelchair to table.  Patient shaky but oriented X's 3.  1255 pm Dr. in room to talk with patient & parent.  Discussed sign and symptoms of worsening & to call back. Patient to car via wheelchair.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Blood test normal, Nausea, Pallor, Palpitations, Tremor
Clinical narrative: Uncontrollable shaking, pale, heart racing 135 rate, nausea
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Feeling of body temperature change, Headache, Injection site pain
Clinical narrative: Patient described having achy joints, an uncharacteristic headache, stomach ache, very painful/tender injection site area, feelings of being hot and cold but an unknown fever.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise, Myalgia
Clinical narrative: headache, malaise, muscle pain, pain at injection site
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia oral, Neuralgia, Swelling
Clinical narrative: Received vaccine 4/18/2019 (2nd Shingrix Dose) was seen in Doctors 4/22/19 for increased swelling and redness. Numbing lips, nerve pain on vaccinated arm.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anion gap, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: Rash started on both wrists and then spread to inner thighs, sides of trunk, top of feet, back of legs, back of knees, upper arms, bra area and both breasts. Almost all areas itch, some worse than others. BENADRYL 50 mg po q 4 hrs ATC WA helps the best. It does not make me sleepy. I get a buzz from it. I take Chlor-Trimetron at HS so I can sleep, but it is not very effective. I stopped the Atarax 25 mg po at HS that Dr. prescribed after I fell trying to get to the bathroom on Monday, April 22nd at 1:30 AM. It was not very effective in decreasing the itching anyway. Dr. tried to prescribe Prednisone for me, but I declined as Dr., my osteoporosis physician, had always told me to never take steroids. I was so miserable by Tuesday that I emailed Dr. and asked him if this warranted an exception. He said I should not suffer any further in the wake of this advancing rash and take the Prednisone, it would not hurt my bones. The topical Triamcinolone Acetonide 0.1% steroid cream was not effective at all. I stopped it after about three applications. The most effective topical has been Nivea Lotion with Clove Oil, a remedy that I used from my hospice and palliative care days. Ice/ cooling packs have also been very soothing and once I get an area numb from the cold, it usually does not itch for 1-2 hours. Shingrix shot given on 4.18. Shingrix Representative said that out of the 30,000 people in their clinical trials, NO ONE has reported a rash like mine - except those experiencing anaphylaxis. Digest Gold i capsule po tid, 4.18-4.20 (3 days). Dr. who recommended it, does not believe it caused the rash. Their representative said that rashes were common. However, the rash should have dissipated after 24 hours as that is the longest that the enzymes last. The digestive enzymes in the product are to assist the gut in getting rid of toxins and cleanings the GI tract - thus helping heal SIBO (Small Intestinal Bacterial Overgrowth). TRU Niagen ii caps po q AM 4.18-4.20 (3 days). Dr., who recommended it, does not believe it caused the rash. The representatives here were not forthcoming. They would not give me any information about their rash rates. I am still trying to find out more information from them. Dr. thought I should continue to take Epicor, which I have taken since 12/17 to improve my immune health. I met with my family physician, Dr. on 4/24/19. Based on the limited data that he had at the time, his best guess was that the rash was caused by the Shingrix shot, although he has not seen rashes in other patients. He prescribed a Prednisone taper which is beginning to provide relief.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal
Clinical narrative: Rash started on both wrists and then spread to inner thighs, sides of trunk, top of feet, back of legs, back of knees, upper arms, bra area and both breasts. Almost all areas itch, some worse than others. BENADRYL 50 mg po q 4 hrs ATC WA helps the best. It does not make me sleepy. I get a buzz from it. I take Chlor-Trimetron at HS so I can sleep, but it is not very effective. I stopped the Atarax 25 mg po at HS that Dr. prescribed after I fell trying to get to the bathroom on Monday, April 22nd at 1:30 AM. It was not very effective in decreasing the itching anyway. Dr. tried to prescribe Prednisone for me, but I declined as Dr., my osteoporosis physician, had always told me to never take steroids. I was so miserable by Tuesday that I emailed Dr. and asked him if this warranted an exception. He said I should not suffer any further in the wake of this advancing rash and take the Prednisone, it would not hurt my bones. The topical Triamcinolone Acetonide 0.1% steroid cream was not effective at all. I stopped it after about three applications. The most effective topical has been Nivea Lotion with Clove Oil, a remedy that I used from my hospice and palliative care days. Ice/ cooling packs have also been very soothing and once I get an area numb from the cold, it usually does not itch for 1-2 hours. Shingrix shot given on 4.18. Shingrix Representative said that out of the 30,000 people in their clinical trials, NO ONE has reported a rash like mine - except those experiencing anaphylaxis. Digest Gold i capsule po tid, 4.18-4.20 (3 days). Dr. who recommended it, does not believe it caused the rash. Their representative said that rashes were common. However, the rash should have dissipated after 24 hours as that is the longest that the enzymes last. The digestive enzymes in the product are to assist the gut in getting rid of toxins and cleanings the GI tract - thus helping heal SIBO (Small Intestinal Bacterial Overgrowth). TRU Niagen ii caps po q AM 4.18-4.20 (3 days). Dr., who recommended it, does not believe it caused the rash. The representatives here were not forthcoming. They would not give me any information about their rash rates. I am still trying to find out more information from them. Dr. thought I should continue to take Epicor, which I have taken since 12/17 to improve my immune health. I met with my family physician, Dr. on 4/24/19. Based on the limited data that he had at the time, his best guess was that the rash was caused by the Shingrix shot, although he has not seen rashes in other patients. He prescribed a Prednisone taper which is beginning to provide relief.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fall, Glomerular filtration rate, Haematocrit normal, Haemoglobin normal, Mean cell haemoglobin concentration normal
Clinical narrative: Rash started on both wrists and then spread to inner thighs, sides of trunk, top of feet, back of legs, back of knees, upper arms, bra area and both breasts. Almost all areas itch, some worse than others. BENADRYL 50 mg po q 4 hrs ATC WA helps the best. It does not make me sleepy. I get a buzz from it. I take Chlor-Trimetron at HS so I can sleep, but it is not very effective. I stopped the Atarax 25 mg po at HS that Dr. prescribed after I fell trying to get to the bathroom on Monday, April 22nd at 1:30 AM. It was not very effective in decreasing the itching anyway. Dr. tried to prescribe Prednisone for me, but I declined as Dr., my osteoporosis physician, had always told me to never take steroids. I was so miserable by Tuesday that I emailed Dr. and asked him if this warranted an exception. He said I should not suffer any further in the wake of this advancing rash and take the Prednisone, it would not hurt my bones. The topical Triamcinolone Acetonide 0.1% steroid cream was not effective at all. I stopped it after about three applications. The most effective topical has been Nivea Lotion with Clove Oil, a remedy that I used from my hospice and palliative care days. Ice/ cooling packs have also been very soothing and once I get an area numb from the cold, it usually does not itch for 1-2 hours. Shingrix shot given on 4.18. Shingrix Representative said that out of the 30,000 people in their clinical trials, NO ONE has reported a rash like mine - except those experiencing anaphylaxis. Digest Gold i capsule po tid, 4.18-4.20 (3 days). Dr. who recommended it, does not believe it caused the rash. Their representative said that rashes were common. However, the rash should have dissipated after 24 hours as that is the longest that the enzymes last. The digestive enzymes in the product are to assist the gut in getting rid of toxins and cleanings the GI tract - thus helping heal SIBO (Small Intestinal Bacterial Overgrowth). TRU Niagen ii caps po q AM 4.18-4.20 (3 days). Dr., who recommended it, does not believe it caused the rash. The representatives here were not forthcoming. They would not give me any information about their rash rates. I am still trying to find out more information from them. Dr. thought I should continue to take Epicor, which I have taken since 12/17 to improve my immune health. I met with my family physician, Dr. on 4/24/19. Based on the limited data that he had at the time, his best guess was that the rash was caused by the Shingrix shot, although he has not seen rashes in other patients. He prescribed a Prednisone taper which is beginning to provide relief.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Platelet count normal, Pruritus
Clinical narrative: Rash started on both wrists and then spread to inner thighs, sides of trunk, top of feet, back of legs, back of knees, upper arms, bra area and both breasts. Almost all areas itch, some worse than others. BENADRYL 50 mg po q 4 hrs ATC WA helps the best. It does not make me sleepy. I get a buzz from it. I take Chlor-Trimetron at HS so I can sleep, but it is not very effective. I stopped the Atarax 25 mg po at HS that Dr. prescribed after I fell trying to get to the bathroom on Monday, April 22nd at 1:30 AM. It was not very effective in decreasing the itching anyway. Dr. tried to prescribe Prednisone for me, but I declined as Dr., my osteoporosis physician, had always told me to never take steroids. I was so miserable by Tuesday that I emailed Dr. and asked him if this warranted an exception. He said I should not suffer any further in the wake of this advancing rash and take the Prednisone, it would not hurt my bones. The topical Triamcinolone Acetonide 0.1% steroid cream was not effective at all. I stopped it after about three applications. The most effective topical has been Nivea Lotion with Clove Oil, a remedy that I used from my hospice and palliative care days. Ice/ cooling packs have also been very soothing and once I get an area numb from the cold, it usually does not itch for 1-2 hours. Shingrix shot given on 4.18. Shingrix Representative said that out of the 30,000 people in their clinical trials, NO ONE has reported a rash like mine - except those experiencing anaphylaxis. Digest Gold i capsule po tid, 4.18-4.20 (3 days). Dr. who recommended it, does not believe it caused the rash. Their representative said that rashes were common. However, the rash should have dissipated after 24 hours as that is the longest that the enzymes last. The digestive enzymes in the product are to assist the gut in getting rid of toxins and cleanings the GI tract - thus helping heal SIBO (Small Intestinal Bacterial Overgrowth). TRU Niagen ii caps po q AM 4.18-4.20 (3 days). Dr., who recommended it, does not believe it caused the rash. The representatives here were not forthcoming. They would not give me any information about their rash rates. I am still trying to find out more information from them. Dr. thought I should continue to take Epicor, which I have taken since 12/17 to improve my immune health. I met with my family physician, Dr. on 4/24/19. Based on the limited data that he had at the time, his best guess was that the rash was caused by the Shingrix shot, although he has not seen rashes in other patients. He prescribed a Prednisone taper which is beginning to provide relief.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Red blood cell count normal, Red cell distribution width normal, White blood cell count normal
Clinical narrative: Rash started on both wrists and then spread to inner thighs, sides of trunk, top of feet, back of legs, back of knees, upper arms, bra area and both breasts. Almost all areas itch, some worse than others. BENADRYL 50 mg po q 4 hrs ATC WA helps the best. It does not make me sleepy. I get a buzz from it. I take Chlor-Trimetron at HS so I can sleep, but it is not very effective. I stopped the Atarax 25 mg po at HS that Dr. prescribed after I fell trying to get to the bathroom on Monday, April 22nd at 1:30 AM. It was not very effective in decreasing the itching anyway. Dr. tried to prescribe Prednisone for me, but I declined as Dr., my osteoporosis physician, had always told me to never take steroids. I was so miserable by Tuesday that I emailed Dr. and asked him if this warranted an exception. He said I should not suffer any further in the wake of this advancing rash and take the Prednisone, it would not hurt my bones. The topical Triamcinolone Acetonide 0.1% steroid cream was not effective at all. I stopped it after about three applications. The most effective topical has been Nivea Lotion with Clove Oil, a remedy that I used from my hospice and palliative care days. Ice/ cooling packs have also been very soothing and once I get an area numb from the cold, it usually does not itch for 1-2 hours. Shingrix shot given on 4.18. Shingrix Representative said that out of the 30,000 people in their clinical trials, NO ONE has reported a rash like mine - except those experiencing anaphylaxis. Digest Gold i capsule po tid, 4.18-4.20 (3 days). Dr. who recommended it, does not believe it caused the rash. Their representative said that rashes were common. However, the rash should have dissipated after 24 hours as that is the longest that the enzymes last. The digestive enzymes in the product are to assist the gut in getting rid of toxins and cleanings the GI tract - thus helping heal SIBO (Small Intestinal Bacterial Overgrowth). TRU Niagen ii caps po q AM 4.18-4.20 (3 days). Dr., who recommended it, does not believe it caused the rash. The representatives here were not forthcoming. They would not give me any information about their rash rates. I am still trying to find out more information from them. Dr. thought I should continue to take Epicor, which I have taken since 12/17 to improve my immune health. I met with my family physician, Dr. on 4/24/19. Based on the limited data that he had at the time, his best guess was that the rash was caused by the Shingrix shot, although he has not seen rashes in other patients. He prescribed a Prednisone taper which is beginning to provide relief.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Rash started on both wrists and then spread to inner thighs, sides of trunk, top of feet, back of legs, back of knees, upper arms, bra area and both breasts. Almost all areas itch, some worse than others. BENADRYL 50 mg po q 4 hrs ATC WA helps the best. It does not make me sleepy. I get a buzz from it. I take Chlor-Trimetron at HS so I can sleep, but it is not very effective. I stopped the Atarax 25 mg po at HS that Dr. prescribed after I fell trying to get to the bathroom on Monday, April 22nd at 1:30 AM. It was not very effective in decreasing the itching anyway. Dr. tried to prescribe Prednisone for me, but I declined as Dr., my osteoporosis physician, had always told me to never take steroids. I was so miserable by Tuesday that I emailed Dr. and asked him if this warranted an exception. He said I should not suffer any further in the wake of this advancing rash and take the Prednisone, it would not hurt my bones. The topical Triamcinolone Acetonide 0.1% steroid cream was not effective at all. I stopped it after about three applications. The most effective topical has been Nivea Lotion with Clove Oil, a remedy that I used from my hospice and palliative care days. Ice/ cooling packs have also been very soothing and once I get an area numb from the cold, it usually does not itch for 1-2 hours. Shingrix shot given on 4.18. Shingrix Representative said that out of the 30,000 people in their clinical trials, NO ONE has reported a rash like mine - except those experiencing anaphylaxis. Digest Gold i capsule po tid, 4.18-4.20 (3 days). Dr. who recommended it, does not believe it caused the rash. Their representative said that rashes were common. However, the rash should have dissipated after 24 hours as that is the longest that the enzymes last. The digestive enzymes in the product are to assist the gut in getting rid of toxins and cleanings the GI tract - thus helping heal SIBO (Small Intestinal Bacterial Overgrowth). TRU Niagen ii caps po q AM 4.18-4.20 (3 days). Dr., who recommended it, does not believe it caused the rash. The representatives here were not forthcoming. They would not give me any information about their rash rates. I am still trying to find out more information from them. Dr. thought I should continue to take Epicor, which I have taken since 12/17 to improve my immune health. I met with my family physician, Dr. on 4/24/19. Based on the limited data that he had at the time, his best guess was that the rash was caused by the Shingrix shot, although he has not seen rashes in other patients. He prescribed a Prednisone taper which is beginning to provide relief.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Anxiety, Chest pain, Dyspepsia, Erythema, Odynophagia
Clinical narrative: Acute onset of chest pain, feeling of doom, facial & scalp rash, "heart burn", discomfort with swallowing, followed by diffuse erythema of neck, chest and part of face.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Acute onset of chest pain, feeling of doom, facial & scalp rash, "heart burn", discomfort with swallowing, followed by diffuse erythema of neck, chest and part of face.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported pain, redness, heat, and softball sized swelling around injection site.  She also reported flu-like symptoms.  Patient did not require medical treatment.  Patient was advised to use an ice pack and /or an OTC pain reliever, such as ibuprofen or acetaminophen for reaction symptoms.  Reaction resolved within one week.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Nasopharyngitis
Clinical narrative: patient experienced  inflammation of arm down to elbow. also cold symptoms
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain, Pain in extremity, Tenderness
Clinical narrative: 2 days after patient reported arm soreness (pain with arm abduction over 90 degrees) and swelling at injection site; denies redness, fever, tender to touch; currently plans on starting ice treatment and contact clinic if not improved in next 5 days.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Pt reports one day after administration of vaccines. Pt has swelling and redness at HPV injection site (Right arm) and reports flat red patches moving down upper and lower right arm. Pt states she first noticed patches when she woke up at 0600 today but disappear by 0900. No itchiness nor any other symptoms reported.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: Patient reported that a couple of days after receiving second Shingrix vaccine she developed itching and a rash at the injection site,underarms,lower hip near buttocks and scalp. She does not recall eating anything unusual or using any new products. She took medication she had on hand for itching and got some relief.  I contacted primary physician's office and they will follow up with her.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test
Clinical narrative: pain, redness, swelling to left upper arm  2 smaller round lesions approx 1 cm in the center of the larger reg swollen area.  Tried zytec, ibuprofen and ice.  given Keflex to start on 4/25/19
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: pain; Information was received from a lawyer and a currently 65 year old male via a fact Sheet for zoster vaccine live (ZOSTAVAX) (see case # US-009507513-1801USA002349).  Within the Fact Sheet, the pt was asked to identify all vaccines that he had received.  He responded that he received a vaccine for pneumonia (manufacturer not specified) on an unspecified date.  When asked if he experienced any adverse reactions or side effects, he responded "pain."  The outcome of the events was unknown.  Causality assessment was related.  This is one of two reports referring to the same patient.; Sender's Comments:  US-009507513-1801USA002349:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Arm became red, afebrile resolved on its own
Age: 1.25
Sex: F
Vaccine: HEPA, MMR
Symptoms: Wrong product administered
Clinical narrative: dtap was to be given but instead kinrix was administered.
Age: 19.0
Sex: F
Vaccine: PPV, RAB, YF
Symptoms: Cellulitis, Full blood count, Metabolic function test, Shift to the left, White blood cell count increased
Clinical narrative: cellulitis to R arm - treated with antibiotics, currently completing prescription
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: Very sore arm, especially in the front of arm.  Body aches,  besides the arm my calf muscles are really sore. Headache. Cold, but no fever at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: localized erythema and swelling 4.5 x 4 cm, on right thigh.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was suppose to receive Meningococcal B (Trumenba), instead received Meningococcal A, C, Y and W-135 (Menactra). No adverse effect noted. Attempting to reach patient to give Trumenba in addition to the Menactra.
Age: 20.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Joint range of motion decreased, Pain, X-ray limb normal
Clinical narrative: After tetanus immunization, pt. complains of left shoulder pain and decrease range of motion. Xrays negative for acute fracture or dislocation. Pt currently using ibuprofen 800mg 3x daily and was given prednisone dose pack on 4/29/19 for continued pain and decreased ROM. As of 4/29/19, pt still complains of pain with left shoulder flexion and adduction.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PNeumovax 23 given instead of PCV 13 was given by mistake.As of today almost 24 hrs later Mom states she has had not had any adverse reaction.
Age: 74.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: FEVER,HEADACHE,BODYACHES
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Disorientation, Dysstasia
Clinical narrative: disoriented, stomach pain, diarrhea, high fever(patient didn't state), unable to stand, and chills.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: disoriented, stomach pain, diarrhea, high fever(patient didn't state), unable to stand, and chills.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Had the 4 year well visit on 04/29/2019, had the 4 year immunizations. Today has an erythematous swelling at the site, some tenderness, no fever.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cardioversion, Cold sweat, Heart rate increased
Clinical narrative: Per patient reports, a few days after vaccine administration patient developed rapid heart rate, broke out into cold sweat, went into A-Fib, was put on ELIQUIS, patient was later put in the hospital for rapid heartrate in the 160's, was given IV meds and had cardioversion, A-fib now under control but on medication. Patient has seen Dr.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient said that on Sunday she had noticed a small rash around the injection site, She said it was slightly itchy and she had iced it. By today, when she had called, it had progressed to the size of a 1 cup measuring spoon. She said she did not have a rash elsewhere and did not experience any swelling or shortness of breath.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Pt came in for 2nd Shingrix immunization.  Due to low supply I have not given a shingles vaccine in sometime.  Gave to pt subcutaneously instead of intramuscular.  Realized when doing my 2nd patient shortly after.  Contacted my supervisor. She advised that IM was preferred but that immunization should be effective and not harmful.  I came in contact with pt shortly thereafter and told her it should be fine.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Emergency care, Exposure during pregnancy, Hepatic enzyme increased, Hepatic function abnormal
Clinical narrative: Elevated liver enzymes and low platelet counts, kidneys shutting down, liver shutting down. Estimated delivery date was July 31, 2018, Patient needed emergency c-section to save mother's life and babies life.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Platelet count decreased, Renal impairment
Clinical narrative: Elevated liver enzymes and low platelet counts, kidneys shutting down, liver shutting down. Estimated delivery date was July 31, 2018, Patient needed emergency c-section to save mother's life and babies life.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Pt states she experienced redness and severe itching on her arm x 2 weeks. It has now resolved.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness, swelling, and pain from injection sight down through elbow area and spreading into lymph tissue in crook of armpit
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Chills, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Angioedema - Right eye very rapidly swelled shut. I already had sore throat,  Non-specific myalgias, and a temp of 38.6, mild rigors. I have never experienced angioedema before. I rapidly chewed 60mg  of Diphenhydramine. Seelling of eye went down over next hour or so. I have had no reoccurrence of facial swelling at this time.I am still having the fever and myalgias, but they seem fairly mild. Aside from the Benadryl I took nothing for treatment. Notified my PCP
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: Angioedema - Right eye very rapidly swelled shut. I already had sore throat,  Non-specific myalgias, and a temp of 38.6, mild rigors. I have never experienced angioedema before. I rapidly chewed 60mg  of Diphenhydramine. Seelling of eye went down over next hour or so. I have had no reoccurrence of facial swelling at this time.I am still having the fever and myalgias, but they seem fairly mild. Aside from the Benadryl I took nothing for treatment. Notified my PCP
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site streaking, Lymph node pain, Pain in extremity, Peripheral swelling
Clinical narrative: 42 Y female who presents with left arm swelling and red streak progressing up to her left neck.  Symptoms began after receiving a pneumococcal and Adacel vaccination in her left deltoid 3 days ago.  Having worsening left arm pains today.  Also feels a tender lymph node at her left clavicle.  She was prescribed doxycycline by telephone but has not started yet.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: extreme muscle pain in right upper arm .  body aches all over flu like feeling,  feverish, chills, felt like "hit by truck"   joint pain throughout body
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: extreme muscle pain in right upper arm .  body aches all over flu like feeling,  feverish, chills, felt like "hit by truck"   joint pain throughout body