chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2015, the patient was treated for a vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Provider ordered these vaccines. HIB should not have been ordered. MA gave per provider orders.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site rash, Injection site scab
Clinical narrative: Pain and inflammation at injection site that has now progressed to pain scabbing rash 16 days later.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Gait disturbance, Impaired work ability, Pain, Pain in extremity
Clinical narrative: Approximately 30 minutes after receiving the third dose of Hepatitis B vaccine, client states he started having pain in his right calf muscle. It was difficult and painful for him to walk around a store. He denies redness, tenderness, streaking in his right lower extremity. Denies fever. On day one post vaccine, he is still having soreness in his calf, making it hard to do his work, which requires climbing a ladder and steps. He has tried to massage it, but that does not improve the pain. It feels "ok" when he is at rest, but with movement the pain worsens.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain, Dysphagia, Nausea, Swelling face
Clinical narrative: Dysphagia, facial swelling, abdominal pain and nausea. Given BENADRYL, PEPCID, and IV SOLO-MEDROL. Send home w/prednisone burst.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient's husband contacted me 3 hours after vaccination to inform me that she passed out in the tub and wanted to know if it could be related to the vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Noticed a slight headache the evening 8:30 pm - of the injection (Friday night ) 07/06/18. Injection site was slightly sore- just like when I get the flu vaccine. Went to bed around 11 pm. Work up at 2 am with a myriad of reactions. Splitting headache/ migraine / sensitive to light, fever, chills, body aches over entire body, swollen arm at injection site, rock hard and extremely painful and hot to the touch, nauseous, dizzy, weak, fatigue. Could not get out of bed. Felt worse than any flu I have ever had. Finally feeling better after day 6, on 7/12/18.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Middle insomnia
Clinical narrative: Noticed a slight headache the evening 8:30 pm - of the injection (Friday night ) 07/06/18. Injection site was slightly sore- just like when I get the flu vaccine. Went to bed around 11 pm. Work up at 2 am with a myriad of reactions. Splitting headache/ migraine / sensitive to light, fever, chills, body aches over entire body, swollen arm at injection site, rock hard and extremely painful and hot to the touch, nauseous, dizzy, weak, fatigue. Could not get out of bed. Felt worse than any flu I have ever had. Finally feeling better after day 6, on 7/12/18.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Mobility decreased, Nausea, Pain, Photophobia
Clinical narrative: Noticed a slight headache the evening 8:30 pm - of the injection (Friday night ) 07/06/18. Injection site was slightly sore- just like when I get the flu vaccine. Went to bed around 11 pm. Work up at 2 am with a myriad of reactions. Splitting headache/ migraine / sensitive to light, fever, chills, body aches over entire body, swollen arm at injection site, rock hard and extremely painful and hot to the touch, nauseous, dizzy, weak, fatigue. Could not get out of bed. Felt worse than any flu I have ever had. Finally feeling better after day 6, on 7/12/18.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Noticed a slight headache the evening 8:30 pm - of the injection (Friday night ) 07/06/18. Injection site was slightly sore- just like when I get the flu vaccine. Went to bed around 11 pm. Work up at 2 am with a myriad of reactions. Splitting headache/ migraine / sensitive to light, fever, chills, body aches over entire body, swollen arm at injection site, rock hard and extremely painful and hot to the touch, nauseous, dizzy, weak, fatigue. Could not get out of bed. Felt worse than any flu I have ever had. Finally feeling better after day 6, on 7/12/18.
Age: 26.0
Sex: F
Vaccine: MNQ, RAB, TYP
Symptoms: Rash, Rash pruritic
Clinical narrative: Developed itchy rash on Arms, Fingers, Feet.
Age: 1.42
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Ataxia, Cerebellar ataxia, Mental status changes, Somnolence
Clinical narrative: Pt reportedly developed AMS (extreme sleepiness) and ataxia. Presented to local ER and was admitted for observation, hospitalist felt that he had acute cerebellar ataxia related to vaccination.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt. received injection on Monday, July 9 presented at pharmacy July 11 with a swollen, red hot arm. We advised BENADRYL and TYLENOL, and contacted M.D. He will not receive second shot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: Had fever and redness around site, body aches. Noticed redness 7/11/18.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Feeling cold
Clinical narrative: Patient was walking to the elevators when she started to feel cold, light headed, and dizzy. Patient stated she felt as if she was going to faint. A medical emergency was called and PCP responded along with his medical assistant and other healthcare staff. Patient was placed in a wheelchair and took back to a room where she could lay down until patient felt ok to walk.
Age: 15.0
Sex: M
Vaccine: TYP
Symptoms: C-reactive protein increased, Chills, Computerised tomogram head normal, Dysarthria, Hallucination
Clinical narrative: Acute onset of fever, chills, lethargy, slurred speech and hallucinations. Take to ED and observed/admitted/followed over 24 hours. Noted elevated WBC and CRP. Negative head CT. Given antibiotics, e.g. Rocephin and fluids. Cleared completely within 24 hours. and discharged. No further symptoms.
Age: 15.0
Sex: M
Vaccine: TYP
Symptoms: Lethargy, Pyrexia, White blood cell count increased
Clinical narrative: Acute onset of fever, chills, lethargy, slurred speech and hallucinations. Take to ED and observed/admitted/followed over 24 hours. Noted elevated WBC and CRP. Negative head CT. Given antibiotics, e.g. Rocephin and fluids. Cleared completely within 24 hours. and discharged. No further symptoms.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the expiration date.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Head injury, Restlessness, Syncope, Tooth injury
Clinical narrative: Pt collapsed to floor after waiting 5 min after vaccine was administered. Pt remained on exam table during that time. With help got down from exam table. Father was present and talking about his history of fainting and passing out with blood draws. RN tried to change subject multiple times to redirect the conversation. RN noticed pt became restless and anxious right before event occurred. Pt collapsed to floor few min after. Cold compress applied to back of neck. Pt was asked if she had breakfast which she denied. Provided with orange juice. Dr. then examined pt. She hit her right side of head and front tooth. Pt was discharged home with parent. Father stated he would take pt to dental for evaluation of tooth.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling and pain. Treated with benadryl and ice. Symptoms resolved in 72 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Hyperaesthesia, Inflammation, Malaise
Clinical narrative: After both the first and second vaccines, I ran a fever and didn't feel well from about 16 hrs post-vaccine to about 36 hours post-vaccine. Not a big deal, but it did slow me down. After the first vaccine, my arm got sore but I expected that. After the second vaccine, the same things happened which I was ready for this time, but in addition, I developed a large red welt on my shoulder, AND the reason for this report, is that I developed a severe rash. It looked like sun poisoning (which I have never gotten before). I noticed it a little less than 48 hours after the vaccine and it got worse over the next couple days. It covered my neck, chest and upper arms. It was inflamed, itchy and after about a week my skin felt like course sandpaper. Just to be clear, I was not sunburned even though the response fit the description of sun poisoning to some extent. I treated it with cortisone cream, kept covered up from the sun and slathered on sunblock for weeks. All the skin on my neck peeled after about 10 days. It has been about 6 weeks and I still get several red, itchy welts after working outside on hot weekends.  It doesn't matter if I stay covered or use sunblock. Maybe the form in response to the heat and sweat?  The response seems to lessen every week so I  believe my skin's sensitivity will eventually return to a normal state, but the experience makes me wonder if that vaccine just over sensitizes the immune system to uv radiation or heat or sweat. I haven't read any reports of that side effect, but I can't help but believe this is vaccine induced. The timing was right in line with an immune response to the vaccine and my work outside was not at all out of the ordinary for me. I have been doing the same for years.  I did take a picture or two and I told my Doctor though I did not visit him or ask him for any meds as it seems to be resolving with time and over the counter cream.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash, Rash pruritic, Skin exfoliation
Clinical narrative: After both the first and second vaccines, I ran a fever and didn't feel well from about 16 hrs post-vaccine to about 36 hours post-vaccine. Not a big deal, but it did slow me down. After the first vaccine, my arm got sore but I expected that. After the second vaccine, the same things happened which I was ready for this time, but in addition, I developed a large red welt on my shoulder, AND the reason for this report, is that I developed a severe rash. It looked like sun poisoning (which I have never gotten before). I noticed it a little less than 48 hours after the vaccine and it got worse over the next couple days. It covered my neck, chest and upper arms. It was inflamed, itchy and after about a week my skin felt like course sandpaper. Just to be clear, I was not sunburned even though the response fit the description of sun poisoning to some extent. I treated it with cortisone cream, kept covered up from the sun and slathered on sunblock for weeks. All the skin on my neck peeled after about 10 days. It has been about 6 weeks and I still get several red, itchy welts after working outside on hot weekends.  It doesn't matter if I stay covered or use sunblock. Maybe the form in response to the heat and sweat?  The response seems to lessen every week so I  believe my skin's sensitivity will eventually return to a normal state, but the experience makes me wonder if that vaccine just over sensitizes the immune system to uv radiation or heat or sweat. I haven't read any reports of that side effect, but I can't help but believe this is vaccine induced. The timing was right in line with an immune response to the vaccine and my work outside was not at all out of the ordinary for me. I have been doing the same for years.  I did take a picture or two and I told my Doctor though I did not visit him or ask him for any meds as it seems to be resolving with time and over the counter cream.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: After both the first and second vaccines, I ran a fever and didn't feel well from about 16 hrs post-vaccine to about 36 hours post-vaccine. Not a big deal, but it did slow me down. After the first vaccine, my arm got sore but I expected that. After the second vaccine, the same things happened which I was ready for this time, but in addition, I developed a large red welt on my shoulder, AND the reason for this report, is that I developed a severe rash. It looked like sun poisoning (which I have never gotten before). I noticed it a little less than 48 hours after the vaccine and it got worse over the next couple days. It covered my neck, chest and upper arms. It was inflamed, itchy and after about a week my skin felt like course sandpaper. Just to be clear, I was not sunburned even though the response fit the description of sun poisoning to some extent. I treated it with cortisone cream, kept covered up from the sun and slathered on sunblock for weeks. All the skin on my neck peeled after about 10 days. It has been about 6 weeks and I still get several red, itchy welts after working outside on hot weekends.  It doesn't matter if I stay covered or use sunblock. Maybe the form in response to the heat and sweat?  The response seems to lessen every week so I  believe my skin's sensitivity will eventually return to a normal state, but the experience makes me wonder if that vaccine just over sensitizes the immune system to uv radiation or heat or sweat. I haven't read any reports of that side effect, but I can't help but believe this is vaccine induced. The timing was right in line with an immune response to the vaccine and my work outside was not at all out of the ordinary for me. I have been doing the same for years.  I did take a picture or two and I told my Doctor though I did not visit him or ask him for any meds as it seems to be resolving with time and over the counter cream.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: The LPN inadvertently reconstituted MENVEO powder (MenA lyophilized conjugate component) with MENACTRA vaccine instead of the MenCYW-135 Liquid Conjugate Component). She injected the vaccine into the 18 year old patient. This was discovered during the inventory of vaccines and verified today 7/12/2018 by the LPN. DH notified and CDC consulted. Patient stated she did not have any extra redness or pain at the site of injection when asked. Per the CDC recommendations, the vaccine should be repeated. The provider was informed and decided not to repeat the vaccination. No known adverse effects.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt fainted after immunes given, woke right back up. Vital signs stable. Patient kept back for 15 mins and drank water.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Oropharyngeal pain, Rash, Rhinorrhoea
Clinical narrative: Pt. complains of rash, runny nose, sore throat, cough.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blindness, Cold sweat, Hypotension, Mydriasis, Nausea
Clinical narrative: Approx 5-10 min after vaccine administration pt complained of loss of vision. Pupils were extremely dilated and skin was pale and clammy to touch. Vision returned in approx. 5 minutes. Once vision returned pt felt nauseous and subsequently vomited. After vomiting her pupils dilated and skin went pale and clammy again and pt stated again she could not see. This again lasted for approx. 5 minutes. EMS was called when the second episode of loss of vision started. EMS stated BP was low and pt was transported to the local hospital via ambulance.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pallor, Vomiting
Clinical narrative: Approx 5-10 min after vaccine administration pt complained of loss of vision. Pupils were extremely dilated and skin was pale and clammy to touch. Vision returned in approx. 5 minutes. Once vision returned pt felt nauseous and subsequently vomited. After vomiting her pupils dilated and skin went pale and clammy again and pt stated again she could not see. This again lasted for approx. 5 minutes. EMS was called when the second episode of loss of vision started. EMS stated BP was low and pt was transported to the local hospital via ambulance.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Headache, Hyperaesthesia, Pain
Clinical narrative: Fever, chills, body ache, severe headache/earache, patient was unable to wear clothing for several hours because the feeling of clothes cause painful sensation on her skin.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Pyrexia
Clinical narrative: Fever, chills, body ache, severe headache/earache, patient was unable to wear clothing for several hours because the feeling of clothes cause painful sensation on her skin.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: First noticed this AM. Raised slightly red swollen site Left Deltoid region. Warm to the touch. No rash to the body, no shortness of breath, no fever. No other complaint noted. Advised parent to continue to watch, apply cold pack, continue to give Ibuprofen drops as necessary. Call PCP or go to ER if condition worsens.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Myalgia, Pyrexia, Rash
Clinical narrative: Day after injection muscle aches and mild fever. Day 2 woke with shingles rash and blisters over face.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: 7/11/18 Patient was given the KINRIX vaccine in the left thigh. The following morning mother noticed a 5-7 inch area of redness, swelling, and warmth to touch. 7/12/18 at 1015 she was seen at our clinic for evaluation of site, home instruction for monitoring and home care given. Cool compress and pain relievers. At 1628 spoke to mother again and she reports area of inflammation has increased. Will discuss with provider.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Flushing, Injection site pain, Muscle spasms, Myalgia
Clinical narrative: Moderate fever, fatigue, muscle soreness and cramps, soreness at injection site, flushed skin during fever.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Moderate fever, fatigue, muscle soreness and cramps, soreness at injection site, flushed skin during fever.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever, lethargy.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Body temperature increased, Extra dose administered, Lethargy, Rash
Clinical narrative: We recently moved and needed to find a new doctor for our 3 children. We chose these associates because they have many locations and convenient hours. Prior to our initial visit, we had their previous Doctor's office fax all of their records to the new Doctor and confirmed with the new office that they received them when making an appointment. We had our first visit on Thursday, July 5, 2018. My youngest was 3 weeks away from turning 3. The doctor and the nurse said she was due to receive the HepA vaccine, nurse administered it. The next day (Friday, July 6, 2018), my child was very quiet and sleepy (not like her at  all). Then as the day went on, she was burning up and very lethargic. We took her temperature and it was 102.6. She also had a very light rash around her face. I looked at the paper they gave with her height/weight stats to see if it mentioned what she got and if this was a normal reaction, because I only remember hearing from her previous doctor that low grade fevers could occur. It only showed milestones for age 2 and what to expect at a 2 ½ year visit (which made me wonder why she had another 2 year visit instead of 2 ½ or 3 yr or just new patient. So then I logged on to their site to see exactly what she received (it in fact was HepA). Then I checked her vaccine record that I had from previous doctor and what the new doctor had on her online record for her. They both matched, and showed that she already previously received both of her HepA vaccines. I then began to really worry, so I called into the new doctor's office to let them know that she received a third dose of HepA and was having a fever and wanted to know if this was normal or if I should bring her in. She said she would have a nurse call me back. We waited and waited. No one ever called. The next day (Saturday, July 7, 2018), no one still called us, so we drove in to the doctors office to try and get some answers. At this point, the rash around her face was worse, but thankfully the fever was down. A different doctor came out and sat with us to talk over our concerns, but she was newer to the practice, so she had a receptionist sit in with us. They somehow did not pay any attention to her records, and treated her as a 2 year old (instead of a 2 ½ or 3 year old) and instead of verifying her vaccines, they assumed that she needed another does of Hep A just because she is still 2 years old for 3 more weeks, when she in fact had already received both doses, and their records clearly showed that. Today, July 12, 2018, the rash is still slightly present around the mouth, fever is gone.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Somnolence
Clinical narrative: We recently moved and needed to find a new doctor for our 3 children. We chose these associates because they have many locations and convenient hours. Prior to our initial visit, we had their previous Doctor's office fax all of their records to the new Doctor and confirmed with the new office that they received them when making an appointment. We had our first visit on Thursday, July 5, 2018. My youngest was 3 weeks away from turning 3. The doctor and the nurse said she was due to receive the HepA vaccine, nurse administered it. The next day (Friday, July 6, 2018), my child was very quiet and sleepy (not like her at  all). Then as the day went on, she was burning up and very lethargic. We took her temperature and it was 102.6. She also had a very light rash around her face. I looked at the paper they gave with her height/weight stats to see if it mentioned what she got and if this was a normal reaction, because I only remember hearing from her previous doctor that low grade fevers could occur. It only showed milestones for age 2 and what to expect at a 2 ½ year visit (which made me wonder why she had another 2 year visit instead of 2 ½ or 3 yr or just new patient. So then I logged on to their site to see exactly what she received (it in fact was HepA). Then I checked her vaccine record that I had from previous doctor and what the new doctor had on her online record for her. They both matched, and showed that she already previously received both of her HepA vaccines. I then began to really worry, so I called into the new doctor's office to let them know that she received a third dose of HepA and was having a fever and wanted to know if this was normal or if I should bring her in. She said she would have a nurse call me back. We waited and waited. No one ever called. The next day (Saturday, July 7, 2018), no one still called us, so we drove in to the doctors office to try and get some answers. At this point, the rash around her face was worse, but thankfully the fever was down. A different doctor came out and sat with us to talk over our concerns, but she was newer to the practice, so she had a receptionist sit in with us. They somehow did not pay any attention to her records, and treated her as a 2 year old (instead of a 2 ½ or 3 year old) and instead of verifying her vaccines, they assumed that she needed another does of Hep A just because she is still 2 years old for 3 more weeks, when she in fact had already received both doses, and their records clearly showed that. Today, July 12, 2018, the rash is still slightly present around the mouth, fever is gone.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Impaired work ability, Injection site pain, Pain
Clinical narrative: Pt had pain all over, not just at the injection site. Areas of the most pain were localized to weak areas and places of prior surgical procedures. Pt was fatigued and slept for 19 hours straight. She described it as an aching pain that was 7/10 or 8/10 on a pain scale. She took acetaminophen and rested until she felt better about 2 days later. Had to miss 2 days of work.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Became nauseated and diaphoretic with one episode of emesis. After emesis, patient improved quickly. He was able to tolerate PO and ambulate before leaving clinic.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site indentation, Injection site pruritus, Injection site reaction, Myalgia
Clinical narrative: Patient had injection site reaction starting as a dime size raised red welt and growing to a size around 1.5 inches in diameter. This reaction peaked approximately 1 week after the injection. Patient also experienced muscle soreness radiating into her neck and down her arm, this muscle soreness and residual visual evidence of redness remain 1 month after administration. Currently the patient is still experiencing muscle tenderness and itching at the injection site. She also describes, but is not visually evident to me, a slight indent in the deltoid muscle near the injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient had injection site reaction starting as a dime size raised red welt and growing to a size around 1.5 inches in diameter. This reaction peaked approximately 1 week after the injection. Patient also experienced muscle soreness radiating into her neck and down her arm, this muscle soreness and residual visual evidence of redness remain 1 month after administration. Currently the patient is still experiencing muscle tenderness and itching at the injection site. She also describes, but is not visually evident to me, a slight indent in the deltoid muscle near the injection site.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Contusion, Haemorrhage, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae
Clinical narrative: Patient developed severe bruising approximately 18 days after immunizations were given. Taken to the ER and platelets were found to be at 8000 on 10/21/2017. Diagnosed with acute Immune Thrombocytopenic Purpura (ITP). Pt was admitted treated with IVIG and discharged on 10/23/2017 when platelets rose to 44000. Patients levels rose to 140000 by 10/27/2017 from the effects of IVIG but experienced severe bruising, petechia and bleeding on 11/09/2017. Taken to the ER again with Platelets at 6000. Patient was admitted IVIG and SOLU MEDROL were given. Patient discharged 11/11/2017 with platelets at 47000. By 11/15/2017 platelets were at 261000 from effects of IVIG but fell to 59000 by 11/28/2017 when hematologist started oral prednisone 60mg twice a day as rescue. Patient responded to this regimen and the dose was tapered over a month and a half until discontinued. Patients platelets remained normal but falling until 6/05/2018 and by 07/05/2018 were down to 48000. Chronic therapy is now being considered and condition is begining to be considered chronic .
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Platelet count decreased
Clinical narrative: Patient developed severe bruising approximately 18 days after immunizations were given. Taken to the ER and platelets were found to be at 8000 on 10/21/2017. Diagnosed with acute Immune Thrombocytopenic Purpura (ITP). Pt was admitted treated with IVIG and discharged on 10/23/2017 when platelets rose to 44000. Patients levels rose to 140000 by 10/27/2017 from the effects of IVIG but experienced severe bruising, petechia and bleeding on 11/09/2017. Taken to the ER again with Platelets at 6000. Patient was admitted IVIG and SOLU MEDROL were given. Patient discharged 11/11/2017 with platelets at 47000. By 11/15/2017 platelets were at 261000 from effects of IVIG but fell to 59000 by 11/28/2017 when hematologist started oral prednisone 60mg twice a day as rescue. Patient responded to this regimen and the dose was tapered over a month and a half until discontinued. Patients platelets remained normal but falling until 6/05/2018 and by 07/05/2018 were down to 48000. Chronic therapy is now being considered and condition is begining to be considered chronic .
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Dizziness, Fatigue, Heart rate irregular
Clinical narrative: Approx. 6 hours after vaccine I became dizzy, with rapid heartbeat and chattering teeth. Major symptoms passed 2 hours after occurance. Fatigue persisted throughout.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: FEVER 102, BODY ACHES, CHILLS, ACHED FROM HEAD TO TOE LASTED 24 HOURS.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Developed urticaria.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Allergy test, Blood culture negative, Culture negative, Rash, Skin culture
Clinical narrative: Hives to patchy area of the skin, including chest and face. Patient was treated with oral steroids, antihistamines, and topical steroids. Patient's rash significantly improved.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Hives to patchy area of the skin, including chest and face. Patient was treated with oral steroids, antihistamines, and topical steroids. Patient's rash significantly improved.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Unevaluable event
Clinical narrative: Patient's family reported she was admitted to the hospital after receiving the vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient has a swollen and hard arm around the injection site and some redness and warm to the touch the last couple days since the date of shot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Eye pain, Fatigue, Feeling hot
Clinical narrative: Extreme pain while being injected. Same day and next, lethargy, joint pain, pain behind eyes, exhaustion, upset stomach. All three days, and contouring, swelling, heat, pain in shoulder. Square red rash about two inches square surrounding injection site. Too painful to lie on that shoulder in bed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Lethargy, Musculoskeletal pain, Rash erythematous
Clinical narrative: Extreme pain while being injected. Same day and next, lethargy, joint pain, pain behind eyes, exhaustion, upset stomach. All three days, and contouring, swelling, heat, pain in shoulder. Square red rash about two inches square surrounding injection site. Too painful to lie on that shoulder in bed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Extreme pain while being injected. Same day and next, lethargy, joint pain, pain behind eyes, exhaustion, upset stomach. All three days, and contouring, swelling, heat, pain in shoulder. Square red rash about two inches square surrounding injection site. Too painful to lie on that shoulder in bed.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Immediate pain on injection. In the following days nerve pain continued and hard to lift arm with large red swelling extending down the tricep from the injection site. Swelling resolve in a week and a half. Nerve pain persisted for 2 weeks.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Immediate pain on injection. In the following days nerve pain continued and hard to lift arm with large red swelling extending down the tricep from the injection site. Swelling resolve in a week and a half. Nerve pain persisted for 2 weeks.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, body aches. All symptoms resolved within 24 hours.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor, Vision blurred
Clinical narrative: Patient said she had blurry vision, hand tremors and chills lasting approximately 3 hours. No treatment was necessary but the patient stated had they been much worse or lasted much longer she would have seeked treatment.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Irritability, Pyrexia, Rash, Rash papular
Clinical narrative: 9 days after receiving vaccine child started with fever, very fussy and very irritable. On day 10 started with papular rash to trunk, left leg.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given the Meningococcal B vaccine earlier than the recommended age. She did not have any adverse reactions.
Age: 1.75
Sex: M
Vaccine: HEPA
Symptoms: Injection site urticaria
Clinical narrative: Hep A given 6/25/18 on (L) thigh. The following day, pt developed hives around injection site. Taken to ER, given BENADRYL, rash resolved (no other symptoms). Hives returned the next day on legs and arms, given BENADRYL, resolved. No other symptoms.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Tenderness
Clinical narrative: Large injection site reaction which has enlarged to 12 cm x 7 cm by day 6. Tenderness but no pain. No induration, fluctuance, abscess.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Nausea, Rash macular
Clinical narrative: Redness around injection extending 4-5 inch away. Blotches of redness. Day after - chills/nausea. Area warm to touch.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dizziness, Heart rate increased, Injection site pain, Injection site rash
Clinical narrative: Redness around injection extending 4-5 inch away. Blotches of redness. Day after - chills/nausea. Area warm to touch.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Nausea
Clinical narrative: Redness around injection extending 4-5 inch away. Blotches of redness. Day after - chills/nausea. Area warm to touch.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Skin tightness, Skin warm, Swelling
Clinical narrative: Redness, swelling. Warm to the touch. Skin tight. 10 mL prednisolone, 25 mg BENADRYL.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Pain, Rash erythematous, Rash papular
Clinical narrative: Rash - erythematous papular in large patches on the torso. Body aches, headache, fatigue.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Hyperventilation, Pyrexia, Respiratory rate increased, Swelling face
Clinical narrative: The same day of the vaccine: For about 6 to 8 hours describes he had feverish feeling with chills to the point of hard shaking (he did not take his temp) and he felt he was hyperventilating or at least breathing faster. Also had feeling of facial swelling. No SOB. No syncope. No rashes. He has been fine since.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: The same day of the vaccine: For about 6 to 8 hours describes he had feverish feeling with chills to the point of hard shaking (he did not take his temp) and he felt he was hyperventilating or at least breathing faster. Also had feeling of facial swelling. No SOB. No syncope. No rashes. He has been fine since.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chills, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 5th April 2018, the patient received the 1st dose of SHINGRIX. On 6th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever, pain and feeling unwell. In April 2018, the patient experienced headache and nerve pain. On an unknown date, the patient experienced burning sensation. On an unknown date, the outcome of the fever, pain and feeling unwell were recovered/resolved and the outcome of the headache was not recovered/not resolved and the outcome of the nerve pain was recovering/resolving and the outcome of the burning sensation was unknown. It was unknown if the reporter considered the fever, headache, nerve pain, pain, feeling unwell and burning sensation to be related to SHINGRIX. Additional details were received as follows: The patient thought that she had the flu when she woke up the morning after the vaccination. The patient went to the urgent care where it was confirmed that it was not the flu and the symptoms resolved within a few days. A week after receiving SHINGRIX, the patient experienced nerve pain in her left leg. It felt as if it was burning every 5 minutes which started intensely but had improved. The patient felt like heat going down her leg. The physician thought it might be from her back. Then a week after that, the patient started to get severe headaches at the back of her head on a daily basis. The patient went to several neurologists, as well as an acupuncturist.  The headache had improved with treatment but was not gone without some type of headache for over two months. The patient underwent five MRIs (nuclear magnetic resonance imaging) but nothing showed up. Lab Comments: On an unknown date, the patient underwent five MRI tests but nothing showed up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Headache, Malaise, Neuralgia, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 5th April 2018, the patient received the 1st dose of SHINGRIX. On 6th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever, pain and feeling unwell. In April 2018, the patient experienced headache and nerve pain. On an unknown date, the patient experienced burning sensation. On an unknown date, the outcome of the fever, pain and feeling unwell were recovered/resolved and the outcome of the headache was not recovered/not resolved and the outcome of the nerve pain was recovering/resolving and the outcome of the burning sensation was unknown. It was unknown if the reporter considered the fever, headache, nerve pain, pain, feeling unwell and burning sensation to be related to SHINGRIX. Additional details were received as follows: The patient thought that she had the flu when she woke up the morning after the vaccination. The patient went to the urgent care where it was confirmed that it was not the flu and the symptoms resolved within a few days. A week after receiving SHINGRIX, the patient experienced nerve pain in her left leg. It felt as if it was burning every 5 minutes which started intensely but had improved. The patient felt like heat going down her leg. The physician thought it might be from her back. Then a week after that, the patient started to get severe headaches at the back of her head on a daily basis. The patient went to several neurologists, as well as an acupuncturist.  The headache had improved with treatment but was not gone without some type of headache for over two months. The patient underwent five MRIs (nuclear magnetic resonance imaging) but nothing showed up. Lab Comments: On an unknown date, the patient underwent five MRI tests but nothing showed up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 5th April 2018, the patient received the 1st dose of SHINGRIX. On 6th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever, pain and feeling unwell. In April 2018, the patient experienced headache and nerve pain. On an unknown date, the patient experienced burning sensation. On an unknown date, the outcome of the fever, pain and feeling unwell were recovered/resolved and the outcome of the headache was not recovered/not resolved and the outcome of the nerve pain was recovering/resolving and the outcome of the burning sensation was unknown. It was unknown if the reporter considered the fever, headache, nerve pain, pain, feeling unwell and burning sensation to be related to SHINGRIX. Additional details were received as follows: The patient thought that she had the flu when she woke up the morning after the vaccination. The patient went to the urgent care where it was confirmed that it was not the flu and the symptoms resolved within a few days. A week after receiving SHINGRIX, the patient experienced nerve pain in her left leg. It felt as if it was burning every 5 minutes which started intensely but had improved. The patient felt like heat going down her leg. The physician thought it might be from her back. Then a week after that, the patient started to get severe headaches at the back of her head on a daily basis. The patient went to several neurologists, as well as an acupuncturist.  The headache had improved with treatment but was not gone without some type of headache for over two months. The patient underwent five MRIs (nuclear magnetic resonance imaging) but nothing showed up. Lab Comments: On an unknown date, the patient underwent five MRI tests but nothing showed up.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Laboratory test
Clinical narrative: Redness, pain, itching, swelling, heat starting within 3 hours after injection on 6-19-18 and gradually progressing down length of inner upper arm to elbow and to the outer lower arm just past the elbow, treated with ice, acetaminophen, cortisone cream; mostly gone by start of systemic symptoms on evening 6-25-18: chills and sweating, slight headache, joint pain especially hands, low-grade fever, fatigue; 6-27-18 additional symptoms of pain under right ribcage; 6-28-18 mucusy cough started evening; by 7-2-18 most symptoms gone, but some coughing continues until time of this report (7-13-18).
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: Redness, pain, itching, swelling, heat starting within 3 hours after injection on 6-19-18 and gradually progressing down length of inner upper arm to elbow and to the outer lower arm just past the elbow, treated with ice, acetaminophen, cortisone cream; mostly gone by start of systemic symptoms on evening 6-25-18: chills and sweating, slight headache, joint pain especially hands, low-grade fever, fatigue; 6-27-18 additional symptoms of pain under right ribcage; 6-28-18 mucusy cough started evening; by 7-2-18 most symptoms gone, but some coughing continues until time of this report (7-13-18).
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hyperhidrosis, Pain, Productive cough, Pruritus, Pyrexia
Clinical narrative: Redness, pain, itching, swelling, heat starting within 3 hours after injection on 6-19-18 and gradually progressing down length of inner upper arm to elbow and to the outer lower arm just past the elbow, treated with ice, acetaminophen, cortisone cream; mostly gone by start of systemic symptoms on evening 6-25-18: chills and sweating, slight headache, joint pain especially hands, low-grade fever, fatigue; 6-27-18 additional symptoms of pain under right ribcage; 6-28-18 mucusy cough started evening; by 7-2-18 most symptoms gone, but some coughing continues until time of this report (7-13-18).
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Redness, pain, itching, swelling, heat starting within 3 hours after injection on 6-19-18 and gradually progressing down length of inner upper arm to elbow and to the outer lower arm just past the elbow, treated with ice, acetaminophen, cortisone cream; mostly gone by start of systemic symptoms on evening 6-25-18: chills and sweating, slight headache, joint pain especially hands, low-grade fever, fatigue; 6-27-18 additional symptoms of pain under right ribcage; 6-28-18 mucusy cough started evening; by 7-2-18 most symptoms gone, but some coughing continues until time of this report (7-13-18).
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced allergic reaction, tremor, malaise and chills. On 23rd June 2018, the patient experienced fever, myalgia, headache, shoulder pain and nausea. On an unknown date, the outcome of the allergic reaction, tremor, malaise and chills were recovering/resolving and the outcome of the fever, myalgia, headache, shoulder pain and nausea were recovered/resolved. It was unknown if the reporter considered the allergic reaction, tremor, malaise and chills to be related to SHINGRIX. The reporter considered the fever, myalgia, headache, shoulder pain and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist and master of public health (MPH). The MPH was the patient's wife. The patient received SHINGRIX in left arm. On 23rd June 2018, at 22:40, several hours after vaccination, the patient experienced myalgia, febrile symptoms (fever), headache, left shoulder pain and nausea. The patient experienced an overall illness and category 3 allergic reaction with chills, malaise, and shakiness. The patient experienced those symptoms over time and by 26th June 2018 was feeling better. These adverse events were previously reported to the physician. The healthcare professional did not have any further information.  This case has been linked to the US2018115063, reported by the same reporter.