chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Rash morbilliform, Vaccination complication, Viral infection
Clinical narrative: 2-5-2019 @ 4:00pm Low grade fever, a couple small spots by mouth in late evening. 2-6-2019 @ 6:00am Low grade fever, small red spots/rash all over face and upper chest area. Scheduled same day doctor appointment for 8:30am. 2-6-2019 @ 9:00am Rash and symptoms identified as viral infection. 2-6-2019 @ 8:00pm Rash spread from face and trunk to arms and legs. Called pediatrician on call due to symptoms escalating and resembling measles rash. Doctor confirmed diagnosis as reaction to MMRV vaccine on 1-25-2019. 2-7-2019 @ 4:00am Measles rash advanced to complete body coverage. Spots had increased in size drastically. Patient was extremely uncomfortable. Took to emergency room; where diagnosis was confirmed as a vaccine reaction to MMRV. Patient was discharged at approximately 7:00am with no treatment plan (rest, time and TYLENOL as needed).
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Red & itchy at the injection site. Vaccine given on 2/4/19, started on 2/6/19; almost cleared on 2/7/19; patient did not take any medications for the rash.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Received injection at approximately 10:00am. I had a slight reaction (aches, malaise) with the first dose so I took two Aspirin 325mg tablets with the second injection. Did not feel bad the rest of the day. Woke up around 11:30 pm that evening with horrible chills and felt as if I had a fever, but I was too cold to get up and check my temperature. The extreme chilling lasted until about 3:30am on Feb 1 at which time I felt able to get up and take more aspirin. I realize this is a known adverse reaction to the SHINGRIX vaccine, but this was extreme. I did not feel well until about 3:30pm on Feb 1.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood bilirubin increased, Condition aggravated
Clinical narrative: Graft-versus-host disease flare including rash >50% of body, itching, and liver lab elevation. Patient woke up the morning of 10/12/18 (day after influenza vaccination) with some itching to his chest, which quickly progressed to severe itching with bright red rash to his arms, legs, buttocks, back and torso, so he was asked to come in for evaluation. He tried taking 50 mg of Benadryl without any relief.  Triamcinolone cream and lotion did not help either. He reported some relief from the cold air when he was outside. He was admitted to the hospital and given high dose intravenous steroids (methylprednisolone 100 mg daily x 2 days) and this immediately helped the rash and itching. He was discharged on 10/13/18 on prednisone 60 mg daily, to be tapered outpatient per clinic direction. From review on 2/7/19, it appears that patient may still be on prednisone 35 mg PO daily (unclear if this drug has been further tapered - prescription remains in chart as 35 mg daily).
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Graft versus host disease, Pruritus, Rash, Rash erythematous
Clinical narrative: Graft-versus-host disease flare including rash >50% of body, itching, and liver lab elevation. Patient woke up the morning of 10/12/18 (day after influenza vaccination) with some itching to his chest, which quickly progressed to severe itching with bright red rash to his arms, legs, buttocks, back and torso, so he was asked to come in for evaluation. He tried taking 50 mg of Benadryl without any relief.  Triamcinolone cream and lotion did not help either. He reported some relief from the cold air when he was outside. He was admitted to the hospital and given high dose intravenous steroids (methylprednisolone 100 mg daily x 2 days) and this immediately helped the rash and itching. He was discharged on 10/13/18 on prednisone 60 mg daily, to be tapered outpatient per clinic direction. From review on 2/7/19, it appears that patient may still be on prednisone 35 mg PO daily (unclear if this drug has been further tapered - prescription remains in chart as 35 mg daily).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever of 100 degrees, fatigue, chills, body aches; All lasted 10 hours
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: I also had an allergy shot and the same day. I have chills, aching body, feels like the flu. I feel horrible.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Hypoaesthesia, Pain in extremity
Clinical narrative: Severe pain in entire arm lasted 2 weeks, and numbness in hand. Numbness continues four and half months out and redness in hand.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Pt given vaccine on 2/5/19 that was expired on 1/29/19. Discussed with the CDC and pt will return to repeat the immunization ASAP with vaccine that is not expired.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Crying, Headache, Pain
Clinical narrative: Severe headache, crying, chills 13:30 pain level from 1-10 being the worst 10. 15:31 much better pain 3.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site mass, Injection site swelling
Clinical narrative: Short after receiving vaccine pt developed some bruising and a lump about 1 in in size, there was a small amount of blood after injection, put a cotton ball on site of injection with some pressure and then gave pt ice pack to put on site, seemed to help reduce swelling although not completely gone after 20 min, no other symptoms.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: PATIENT DEVELOPED RED KNOT IN LEFT DELTOID WITHIN 7 DAYS OF VACCINATION.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Seizure
Clinical narrative: Seizure began hours after this round of vaccines, lasting 10 to 15 minutes. Stopped by EMT with VERSED. One additional seizure occurred between this vaccination and the 3rd doses. After 3rd dose, a cluster of seizures occurred, and patient has been diagnosed with a seizure condition. Patient still has seizures as recently as last week.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Immediate post-injection reaction, Nausea
Clinical narrative: The patient reports that he had electric shocklike pain immediately after the injection that radiated from his right arm to the hand. He additionally had similar shocklike pain on the right leg and even the left leg. On his way home from the office he develops severe headache while driving.  Additionally he had nausea and lightheadedness with body aches. Overnight, nearly 12 hours after the injection he developed tactile fever and body chills along with diffuse body aches.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: The patient reports that he had electric shocklike pain immediately after the injection that radiated from his right arm to the hand. He additionally had similar shocklike pain on the right leg and even the left leg. On his way home from the office he develops severe headache while driving.  Additionally he had nausea and lightheadedness with body aches. Overnight, nearly 12 hours after the injection he developed tactile fever and body chills along with diffuse body aches.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: My arm from the injection site to my elbow gradually got swollen throughout the day on 2/5/19. By 2:30 pm I had a lump the size of a tennis ball above the elbow. It was hot and itchy. I went back to the doctor's office. I was given injections of both of BENADRYL and a steroid. The swelling went down. Today is the 2/7/2019 and my arm is almost back to normal.
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure to product, Exposure via mucosa, Occupational exposure to product
Clinical narrative: This spontaneous report was received from a nurse referring to herself. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient stated that she got PROQUAD (dose, lot# and expiry date were not reported) into her mouth while she was drawing the product up into a syringe (accidental exposure to product, exposure via mucosa and occupational exposure to product). She stated that she had discarded the syringe and did not use it for any patients. No adverse symptoms reported.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Diarrhoea, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a nurse and refers to a 19-year-old female patient. The patient did not have pertinent medical history and drug reactions or allergies. The patient did not take any concomitant medications. On 14-DEC-2018, the patient was vaccinated with a first dose of M-M-R II subcutaneous, lot # R000552, expiration date 08-JAN-2020, albumin status rHA (recombinant Human albumin) (exact dose was not reported) for prophylaxis. On 14-DEC-2018, the patient experienced a fever, diarrhea, weakness and a rash. The outcome of a fever, diarrhea, weakness and a rash was reported as recovered on approximately 18-DEC-2018 (reported as 3-4 days after vaccination). The relatedness between the events and M-M-R II was not reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On 30-JAN-2019, the patient was vaccinated with improperly stored vaccines: LIQUID PEDVAXHIB injection, intramuscularly, lot # R021076, expiry date: 11-JUN-2021 (dose and anatomical location were not provided) and with ROTATEQ orally, lot # R025732, expiry date: 25-MAR-2020 (dose was not provided), both for prophylaxis. The vaccines were stored in temperature above 47 degrees Fahrenheit (47.3) for 18 minutes. On unknown date in the past, there was one more temperature excursion, the vaccines were stored in temperature above 47 degrees Fahrenheit for 4 minutes. Digital data logger was involved in this case. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA000784.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration in Dec2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband both had pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) shots in the beginning of Dec2018. On 01Jan2019, she was diagnosed with pneumonia and her biggest fear was that her husband can get it too because they had same shot. The patient was wondering how secure it was because she was having side effects. The outcome of pneumonia was unknown. The information on the lot number and expiry date has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Eating disorder, Lethargy
Clinical narrative: This is a spontaneous report from contactable nurse. A male patient of unspecified age received PREVNAR 13; (Lot number and Expiration date: Unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization, CELLCEPT, via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The reporter said that they gave PREVENAR 13 and they have one gentleman that was on immunosuppressant CELLCEPT. On unspecified date, he was just lethargic and not eating. The action taken in response to the events for CELLCEPTwas unknown. The outcome of the events was unknown.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Urticaria
Clinical narrative: Local reaction only - erythematous wheal approx 10 cm diameter.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, FLU3, PNC13
Symptoms: Crying, Eye movement disorder, Hypotonia, Pallor, Posture abnormal
Clinical narrative: Baby was asleep in crib and started high pitch cry. I wen to tend to her but when I picked her up she wouldn't open her eyes and her body was limp. She couldn't hold her head up and the white of her eyes was visibly rolling back almost as if she was paralyzed. She was extremely pale. This happened for about 10 minutes. I stopped vaccinating and this has not occurred again. I spoke with the doctors office the next day and they advised it was a " night terror" and not vaccine related and would see my baby for a check up, they had a nurse call me back to explain this.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, FLU3, PNC13
Symptoms: Sleep terror
Clinical narrative: Baby was asleep in crib and started high pitch cry. I wen to tend to her but when I picked her up she wouldn't open her eyes and her body was limp. She couldn't hold her head up and the white of her eyes was visibly rolling back almost as if she was paralyzed. She was extremely pale. This happened for about 10 minutes. I stopped vaccinating and this has not occurred again. I spoke with the doctors office the next day and they advised it was a " night terror" and not vaccine related and would see my baby for a check up, they had a nurse call me back to explain this.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Pyrexia, Seizure
Clinical narrative: Received all 4 vaccines at 11:30AM, by 6pm the same night she had a fever of 101, then increased to 103 deg F. She has 2- 1 minute seizures. She was stabilized in clinic- given ibuprofen and improved.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Atrial fibrillation, Blood magnesium, Blood osmolarity, Blood thyroid stimulating hormone, Chest X-ray
Clinical narrative: Respiratory distress, tachycardia, rapid a-fib, fever, severe inflammatory response, pleural effusions.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Inflammation, Metabolic function test, Pleural effusion, Pyrexia, Respiratory distress
Clinical narrative: Respiratory distress, tachycardia, rapid a-fib, fever, severe inflammatory response, pleural effusions.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Tachycardia, Troponin
Clinical narrative: Respiratory distress, tachycardia, rapid a-fib, fever, severe inflammatory response, pleural effusions.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received HAV 1 day prior to 6 months interval/non-countable dose.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Blood urine present, Diarrhoea, Irritability, Mucous stools, Urine analysis
Clinical narrative: 02/04/19 - 4 month well child check and vaccines. 2/5/19 - Woke with red spot in diaper - tested positive for blood per urinalysis. Pt had looser, mucus stools, more fussy. Follow-up bag urine was negative for blood.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body aches, headache, fever, shivering, fatigue.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Incomplete course of vaccination
Clinical narrative: Pain, redness and swelling at site; headache, shivering, muscle pain, upset stomach and vomited and tiredness. Saw my doctor who advised me to NOT take the 2nd shot. Adverse reactions lasted 3 days.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Vomiting
Clinical narrative: Pain, redness and swelling at site; headache, shivering, muscle pain, upset stomach and vomited and tiredness. Saw my doctor who advised me to NOT take the 2nd shot. Adverse reactions lasted 3 days.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient had vaccines given, 1 in each leg, on 2/5/19 at 7:46 pm. Mom states that the morning of 2/6/19 that the pt developed a fever of 101, and was experiencing swelling and erythema in both thighs around injection site. Today 2/7/19 the swelling and erythema has worsened on the left leg. The right leg experienced no change.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: Was no "adverse event" Patient was given vaccine too early. Patient only 13 and no supporting diagnosis to explain the need to get this early.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt had an area of induration about the size of a quarter in left deltoid, range of motion in his left arm limited due to pain, pt informed to use warm compresses and ADVIL for pain, pain and range of motion should get better in about a week.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Extreme fatigue, extreme myalgia, chills, soreness at injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling of left arm noted 2/6/19 and was increasing in redness and itchy-applied ice pack. Non tender swelling and redness left arm extending from just below the shoulder to above elbow encircling left arm.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Gait inability, Immediate post-injection reaction
Clinical narrative: The side effects I experienced after Dose #1 of the SHINGRIX vaccine (administered July 2018 at same pharmacy) were the same after Dose #2 -- but the severity of all of the symptoms was more than double in Dose #2 and have lasted 5 days this time. After Dose #1, I had 1 really bad day of body aches, muscle pain, exhaustion and severe pain/inflammation/rash at the injection site. By the second day, these symptoms began to significantly diminish. For Dose #2, the symptoms have been MUCH more severe in nature and the duration has been extremely long. I was forced to bed rest for 2 1/2 days immediately after the injection and had such severe exhaustion/body pain that I couldn't leave the house. I looked up allergic reaction info on SHINGRIX.com and my symptoms appeared to be very magnified side effects rather than allergy. I notified GSK via email on Monday afternoon (02/04/2019) when I began to experience severe pain in my joints/ligaments -- particularly in an old foot fracture/torn ligaments from an accident in 2015. (The joint/ligament pain was similar to what I experienced with Tavanic allergy, so I was worried my body was reacting to SHINGRIX same way)  This joint pain prevented me from walking even to the restroom, but went away the next day. The severe and debilitating (Level 3 muscle pain and weakness, per the standard measurements I found when I googled SHINGRIX reaction) lasted until 02/06/2019. The injection area developed a large circular rashlike area that was raised and extremely hot and painful to the touch. It remains at a Level 3 pain and has prevented me from doing basic tasks since I got the shot. I used arnica gel and anti-itch gel on the area for temporary relief, but no amount of Voltafast 50mg powder or Excedrin extra strength tablets relieved the severe pain I continue to experience from the injection site. The rash is fading from the hot, bright red to a more muted red, but is still throbbing painful, Level 3.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Ligament pain
Clinical narrative: The side effects I experienced after Dose #1 of the SHINGRIX vaccine (administered July 2018 at same pharmacy) were the same after Dose #2 -- but the severity of all of the symptoms was more than double in Dose #2 and have lasted 5 days this time. After Dose #1, I had 1 really bad day of body aches, muscle pain, exhaustion and severe pain/inflammation/rash at the injection site. By the second day, these symptoms began to significantly diminish. For Dose #2, the symptoms have been MUCH more severe in nature and the duration has been extremely long. I was forced to bed rest for 2 1/2 days immediately after the injection and had such severe exhaustion/body pain that I couldn't leave the house. I looked up allergic reaction info on SHINGRIX.com and my symptoms appeared to be very magnified side effects rather than allergy. I notified GSK via email on Monday afternoon (02/04/2019) when I began to experience severe pain in my joints/ligaments -- particularly in an old foot fracture/torn ligaments from an accident in 2015. (The joint/ligament pain was similar to what I experienced with Tavanic allergy, so I was worried my body was reacting to SHINGRIX same way)  This joint pain prevented me from walking even to the restroom, but went away the next day. The severe and debilitating (Level 3 muscle pain and weakness, per the standard measurements I found when I googled SHINGRIX reaction) lasted until 02/06/2019. The injection area developed a large circular rashlike area that was raised and extremely hot and painful to the touch. It remains at a Level 3 pain and has prevented me from doing basic tasks since I got the shot. I used arnica gel and anti-itch gel on the area for temporary relief, but no amount of Voltafast 50mg powder or Excedrin extra strength tablets relieved the severe pain I continue to experience from the injection site. The rash is fading from the hot, bright red to a more muted red, but is still throbbing painful, Level 3.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Myalgia, Pain
Clinical narrative: The side effects I experienced after Dose #1 of the SHINGRIX vaccine (administered July 2018 at same pharmacy) were the same after Dose #2 -- but the severity of all of the symptoms was more than double in Dose #2 and have lasted 5 days this time. After Dose #1, I had 1 really bad day of body aches, muscle pain, exhaustion and severe pain/inflammation/rash at the injection site. By the second day, these symptoms began to significantly diminish. For Dose #2, the symptoms have been MUCH more severe in nature and the duration has been extremely long. I was forced to bed rest for 2 1/2 days immediately after the injection and had such severe exhaustion/body pain that I couldn't leave the house. I looked up allergic reaction info on SHINGRIX.com and my symptoms appeared to be very magnified side effects rather than allergy. I notified GSK via email on Monday afternoon (02/04/2019) when I began to experience severe pain in my joints/ligaments -- particularly in an old foot fracture/torn ligaments from an accident in 2015. (The joint/ligament pain was similar to what I experienced with Tavanic allergy, so I was worried my body was reacting to SHINGRIX same way)  This joint pain prevented me from walking even to the restroom, but went away the next day. The severe and debilitating (Level 3 muscle pain and weakness, per the standard measurements I found when I googled SHINGRIX reaction) lasted until 02/06/2019. The injection area developed a large circular rashlike area that was raised and extremely hot and painful to the touch. It remains at a Level 3 pain and has prevented me from doing basic tasks since I got the shot. I used arnica gel and anti-itch gel on the area for temporary relief, but no amount of Voltafast 50mg powder or Excedrin extra strength tablets relieved the severe pain I continue to experience from the injection site. The rash is fading from the hot, bright red to a more muted red, but is still throbbing painful, Level 3.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: The side effects I experienced after Dose #1 of the SHINGRIX vaccine (administered July 2018 at same pharmacy) were the same after Dose #2 -- but the severity of all of the symptoms was more than double in Dose #2 and have lasted 5 days this time. After Dose #1, I had 1 really bad day of body aches, muscle pain, exhaustion and severe pain/inflammation/rash at the injection site. By the second day, these symptoms began to significantly diminish. For Dose #2, the symptoms have been MUCH more severe in nature and the duration has been extremely long. I was forced to bed rest for 2 1/2 days immediately after the injection and had such severe exhaustion/body pain that I couldn't leave the house. I looked up allergic reaction info on SHINGRIX.com and my symptoms appeared to be very magnified side effects rather than allergy. I notified GSK via email on Monday afternoon (02/04/2019) when I began to experience severe pain in my joints/ligaments -- particularly in an old foot fracture/torn ligaments from an accident in 2015. (The joint/ligament pain was similar to what I experienced with Tavanic allergy, so I was worried my body was reacting to SHINGRIX same way)  This joint pain prevented me from walking even to the restroom, but went away the next day. The severe and debilitating (Level 3 muscle pain and weakness, per the standard measurements I found when I googled SHINGRIX reaction) lasted until 02/06/2019. The injection area developed a large circular rashlike area that was raised and extremely hot and painful to the touch. It remains at a Level 3 pain and has prevented me from doing basic tasks since I got the shot. I used arnica gel and anti-itch gel on the area for temporary relief, but no amount of Voltafast 50mg powder or Excedrin extra strength tablets relieved the severe pain I continue to experience from the injection site. The rash is fading from the hot, bright red to a more muted red, but is still throbbing painful, Level 3.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: The side effects I experienced after Dose #1 of the SHINGRIX vaccine (administered July 2018 at same pharmacy) were the same after Dose #2 -- but the severity of all of the symptoms was more than double in Dose #2 and have lasted 5 days this time. After Dose #1, I had 1 really bad day of body aches, muscle pain, exhaustion and severe pain/inflammation/rash at the injection site. By the second day, these symptoms began to significantly diminish. For Dose #2, the symptoms have been MUCH more severe in nature and the duration has been extremely long. I was forced to bed rest for 2 1/2 days immediately after the injection and had such severe exhaustion/body pain that I couldn't leave the house. I looked up allergic reaction info on SHINGRIX.com and my symptoms appeared to be very magnified side effects rather than allergy. I notified GSK via email on Monday afternoon (02/04/2019) when I began to experience severe pain in my joints/ligaments -- particularly in an old foot fracture/torn ligaments from an accident in 2015. (The joint/ligament pain was similar to what I experienced with Tavanic allergy, so I was worried my body was reacting to SHINGRIX same way)  This joint pain prevented me from walking even to the restroom, but went away the next day. The severe and debilitating (Level 3 muscle pain and weakness, per the standard measurements I found when I googled SHINGRIX reaction) lasted until 02/06/2019. The injection area developed a large circular rashlike area that was raised and extremely hot and painful to the touch. It remains at a Level 3 pain and has prevented me from doing basic tasks since I got the shot. I used arnica gel and anti-itch gel on the area for temporary relief, but no amount of Voltafast 50mg powder or Excedrin extra strength tablets relieved the severe pain I continue to experience from the injection site. The rash is fading from the hot, bright red to a more muted red, but is still throbbing painful, Level 3.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: The side effects I experienced after Dose #1 of the SHINGRIX vaccine (administered July 2018 at same pharmacy) were the same after Dose #2 -- but the severity of all of the symptoms was more than double in Dose #2 and have lasted 5 days this time. After Dose #1, I had 1 really bad day of body aches, muscle pain, exhaustion and severe pain/inflammation/rash at the injection site. By the second day, these symptoms began to significantly diminish. For Dose #2, the symptoms have been MUCH more severe in nature and the duration has been extremely long. I was forced to bed rest for 2 1/2 days immediately after the injection and had such severe exhaustion/body pain that I couldn't leave the house. I looked up allergic reaction info on SHINGRIX.com and my symptoms appeared to be very magnified side effects rather than allergy. I notified GSK via email on Monday afternoon (02/04/2019) when I began to experience severe pain in my joints/ligaments -- particularly in an old foot fracture/torn ligaments from an accident in 2015. (The joint/ligament pain was similar to what I experienced with Tavanic allergy, so I was worried my body was reacting to SHINGRIX same way)  This joint pain prevented me from walking even to the restroom, but went away the next day. The severe and debilitating (Level 3 muscle pain and weakness, per the standard measurements I found when I googled SHINGRIX reaction) lasted until 02/06/2019. The injection area developed a large circular rashlike area that was raised and extremely hot and painful to the touch. It remains at a Level 3 pain and has prevented me from doing basic tasks since I got the shot. I used arnica gel and anti-itch gel on the area for temporary relief, but no amount of Voltafast 50mg powder or Excedrin extra strength tablets relieved the severe pain I continue to experience from the injection site. The rash is fading from the hot, bright red to a more muted red, but is still throbbing painful, Level 3.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain, Crying, Decreased appetite, Diarrhoea, Dysphemia
Clinical narrative: Patient woke up every hour that night irritable. He complained of abdominal pain, loss of appetite, and diarrhea. Patient favored the leg where the shot was administered, complained of pain, was limping, and crying for 2-3 days are the shot. There was no redness or swelling at the injection site according to the patient's dad. Also, patient started to have stuttering that lasted for 1 week after receiving the vaccine. The stuttering has since completely resolved.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Irritability, Middle insomnia, Pain, Weight bearing difficulty
Clinical narrative: Patient woke up every hour that night irritable. He complained of abdominal pain, loss of appetite, and diarrhea. Patient favored the leg where the shot was administered, complained of pain, was limping, and crying for 2-3 days are the shot. There was no redness or swelling at the injection site according to the patient's dad. Also, patient started to have stuttering that lasted for 1 week after receiving the vaccine. The stuttering has since completely resolved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Chills, low grade fever, achy, nausea, some fatigue. Took TYLENOL for relief and it helped.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying, High-pitched crying
Clinical narrative: Had 3 hours of high pitched insonsolable crying post vaccine at 2 month visit.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Patient with rash that started after leaving the office. Lasted about a week and a half. Mom reports that patient had large red raised bumps all over her body that were itchy. Mom did not try any medications or take patient to seek medical assistance. Mother reported this event when she returned today 2/7/19 for the second step of the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: About 2 hours after receiving vaccination patient reported severe vomiting.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Headache, Muscle spasms, Muscular weakness, Nausea
Clinical narrative: "[S]hortness of breath, neck pain, headache, muscle spasms and weakness, nausea and vomiting, that the reaction lasted about 6 hours, then after she was able to fall asleep, she felt normal when she woke up."
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain, Vomiting
Clinical narrative: "[S]hortness of breath, neck pain, headache, muscle spasms and weakness, nausea and vomiting, that the reaction lasted about 6 hours, then after she was able to fall asleep, she felt normal when she woke up."
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Blood creatine phosphokinase, Burning sensation, C-reactive protein
Clinical narrative: Developed horrible headache and pain in right upper arm. Began to have tingling in hands and feet several days later. Now progressed up legs up to tailbone. Reports tightness in thighs and pain up to buttocks. Reports dry eyes and stabbing pain in left eye. Worse at night. Develops temporal pressure. Harder time breathing when taking deep breaths. Feels unsteadiness in calves with burning on inside of ankles. Weakness. No history of systemic reactions to vaccines.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Dry eye, Dyspnoea, Eye pain, Full blood count
Clinical narrative: Developed horrible headache and pain in right upper arm. Began to have tingling in hands and feet several days later. Now progressed up legs up to tailbone. Reports tightness in thighs and pain up to buttocks. Reports dry eyes and stabbing pain in left eye. Worse at night. Develops temporal pressure. Harder time breathing when taking deep breaths. Feels unsteadiness in calves with burning on inside of ankles. Weakness. No history of systemic reactions to vaccines.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: HIV test, Head discomfort, Headache, Injection site pain, Metabolic function test
Clinical narrative: Developed horrible headache and pain in right upper arm. Began to have tingling in hands and feet several days later. Now progressed up legs up to tailbone. Reports tightness in thighs and pain up to buttocks. Reports dry eyes and stabbing pain in left eye. Worse at night. Develops temporal pressure. Harder time breathing when taking deep breaths. Feels unsteadiness in calves with burning on inside of ankles. Weakness. No history of systemic reactions to vaccines.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle tightness, Musculoskeletal pain, Nuclear magnetic resonance imaging brain, Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: Developed horrible headache and pain in right upper arm. Began to have tingling in hands and feet several days later. Now progressed up legs up to tailbone. Reports tightness in thighs and pain up to buttocks. Reports dry eyes and stabbing pain in left eye. Worse at night. Develops temporal pressure. Harder time breathing when taking deep breaths. Feels unsteadiness in calves with burning on inside of ankles. Weakness. No history of systemic reactions to vaccines.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Vitamin B12
Clinical narrative: Developed horrible headache and pain in right upper arm. Began to have tingling in hands and feet several days later. Now progressed up legs up to tailbone. Reports tightness in thighs and pain up to buttocks. Reports dry eyes and stabbing pain in left eye. Worse at night. Develops temporal pressure. Harder time breathing when taking deep breaths. Feels unsteadiness in calves with burning on inside of ankles. Weakness. No history of systemic reactions to vaccines.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood test normal, Body temperature increased, Electrocardiogram normal, Heart rate increased
Clinical narrative: Resting heart rate reached 120 bpm. Blood pressure reached 172/111 at 10:44 pm on 2/5/19.  Arrived at emergency room (Medical Center at 11:01 pm on 2/5/19. Had EKG which was fine. Had blood work which was fine. Vitals were checked every few hours: 1:17 am on 2/6/19 -- BP 135/96, heart rate 113, temp 99.5. At 3:00 am 2/6/19 -- BP 159/93, heart rate 104, temp 100.0. At 4:02 on 2/6/19 -- BP 156/97, heart rate 103, temp 99.0. By 5:00 am, BP down to 96. Given 700 mg TYLENOL and discharged home. Heart rate and blood pressure continued to decrease throughout the day on 2/6/19.  Around 8:00 pm on 2/6/19, broke out in sweat and felt much better, BP 125/86, heart rate 86. By 2:00 am on 2/7/19, BP 112/76, heart rate 76. Feel almost 100% well now on 2/7/19 9:00 am.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis
Clinical narrative: Resting heart rate reached 120 bpm. Blood pressure reached 172/111 at 10:44 pm on 2/5/19.  Arrived at emergency room (Medical Center at 11:01 pm on 2/5/19. Had EKG which was fine. Had blood work which was fine. Vitals were checked every few hours: 1:17 am on 2/6/19 -- BP 135/96, heart rate 113, temp 99.5. At 3:00 am 2/6/19 -- BP 159/93, heart rate 104, temp 100.0. At 4:02 on 2/6/19 -- BP 156/97, heart rate 103, temp 99.0. By 5:00 am, BP down to 96. Given 700 mg TYLENOL and discharged home. Heart rate and blood pressure continued to decrease throughout the day on 2/6/19.  Around 8:00 pm on 2/6/19, broke out in sweat and felt much better, BP 125/86, heart rate 86. By 2:00 am on 2/7/19, BP 112/76, heart rate 76. Feel almost 100% well now on 2/7/19 9:00 am.
Age: 45.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Culture, Erythema, Skin lesion, Ultrasound scan abnormal
Clinical narrative: Red raised lesion right upper arm.
Age: 45.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Furuncle, Incisional drainage, Injection site reaction, Ultrasound scan abnormal
Clinical narrative: Red raised lesion right upper arm.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Pruritus, Skin exfoliation
Clinical narrative: At first it was just red and itched. Patient was recommended to get some hydrocortisone over the counter. The itching started on the shoulder and then moved down to the forearm. It has continued non stop since the shot.  He now comes in today and the area on his arm about 3 inches above elbow and 3 inches below elbow on the inside of the arm is dry and scaly and itching as usual.  There is a circle of scaly skin surrounding the entire area and scaly right in the center on the inside of the elbow.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient presented to the pharmacy today 2/7/19 with an rx for VALTREX and a rash on neck and face. He informed me that he had received his first dose of SHINGRIX on 2/2/19 and started developing symptoms on the morning of 2/3/19. During a visit with his doctor today, he was diagnosed with shingles and told it was on his neck, jaw, face, top and back of head, and possibly his eye.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient presented to the pharmacy today 2/7/19 with an rx for VALTREX and a rash on neck and face. He informed me that he had received his first dose of SHINGRIX on 2/2/19 and started developing symptoms on the morning of 2/3/19. During a visit with his doctor today, he was diagnosed with shingles and told it was on his neck, jaw, face, top and back of head, and possibly his eye.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Diagnosed with shingles on Feb 07 2019.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles on Feb 07 2019.
Age: 36.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Cellulitis, Chills, Erythema, Hypersensitivity
Clinical narrative: Follow-up after a Tdap injection 2 days ago. Today he presents with left arm pain, warmth and redness, fevers, chills, body aches, joint pain. He has taken ibuprofen and TYLENOL without relief. Patient was admitted to hospital for 2 days with cellulitis and hypersensitive.
Age: 36.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Follow-up after a Tdap injection 2 days ago. Today he presents with left arm pain, warmth and redness, fevers, chills, body aches, joint pain. He has taken ibuprofen and TYLENOL without relief. Patient was admitted to hospital for 2 days with cellulitis and hypersensitive.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Rash, Rash pruritic
Clinical narrative: Onset the day after administration of pain at the site of injection as well as itchy rash on the trunk. Rash has not resolved after more than 1 month.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Biopsy skin abnormal, Granuloma annulare, Rash
Clinical narrative: Onset the day after administration of pain at the site of injection as well as itchy rash on the trunk. Rash has not resolved after more than 1 month.
Age: 12.0
Sex: F
Vaccine: HPV9, MMRV, MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted after administration of the HPV vaccine.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Injection site erythema, Injection site swelling, Local reaction, Nausea
Clinical narrative: Pt was have nausea, headache, redness and swelling to the location of injection. Symptoms developed later on in the afternoon and into the next morning.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus
Clinical narrative: Patient presented 4 days after vaccination with erythema and mild itching around injection site. No swelling. She was diagnosed with cellulitis and prescribed KEFLEX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Pain and slight bruising at the injection site, immediate significant pain when the serum itself was injected, swelling, pain, inflammation, redness of the muscle where the injection was made starting almost immediately, significant itch began two days later.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Pain and slight bruising at the injection site, immediate significant pain when the serum itself was injected, swelling, pain, inflammation, redness of the muscle where the injection was made starting almost immediately, significant itch began two days later.
Age: 32.0
Sex: F
Vaccine: FLUN4
Symptoms: Pruritus, Rash, Rash erythematous, Skin warm, Soft tissue swelling
Clinical narrative: From telephone encounter notes: Had FLUMIST vaccine yesterday (1/10/2019). Today woke up feeling itchy this morning. Now rash (little red raised bumps, like freckles) over upper chest, upper back, neck, chin and right ear. Right ear, soft tissue is slightly swollen. Feels warm and itchy over rash area. No SOB or difficulty swallowing. No headache, dizziness or difficulty speaking. No fever. No nausea, vomiting or diarrhea. Has had the flu vaccine in previous years with no reaction, first mist vaccine. No change in diet, soaps, lotions or laundry detergent.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB lot # R014263, expiration date 26-MAR-2021 (exact doses, anatomical locations and routes of administration were not provided). There was no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of the lowest temperature below 2 degree Celsius (minimum 1.1 degrees Celsius) for 7 hours. Data logger was involved. There were no previous excursions reported. The outcome of product storage error and no adverse event was unknown. Follow up information has been received from the nurse on 05-FEB-2019. Referring to a currently 3 months and 16 days old patient of unknown gender. The reporter stated that the vaccine was exposed to a temperature excursion in the refrigerator below 2°C. It was also reported that the refrigerator had been checked and the temperature was stable. The reporter spoke with a company representative and the vaccine was considered viable as it was not exposed for a too long period that affect the vaccine adversely. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA002414: US-009507513-1902USA002412: US-009507513-1902USA002413.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pustular, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician's assistant via company representative and refers to a 16 year old female patient. Patient had no pertinent medical history, allergies or drug reaction. Concomitant medication and current conditions were not reported. On an unspecified date in 2007 ( reported as "when they were 4 year old"), the patient was vaccinated with VARIVAX  2 doses (frequency, strength, route of administration, Lot # and expiration date were not reported) (It could not be confirm if the doses were given together or separately) for prophylaxis. On an unspecified date in January 2019, the patient went to an unspecified emergency room and two days later on  04-JAN-2019 (reported as a "month ago") , the patient was seen by the physician's assistant and  diagnosed withchickenpox (Varicella), on the same date, she visited the emergency room and was admitted to the hospital for 2 days. The patient received treatment for the event and also was reported that an "Assisting a pustules" was performed  , however, the results were nor provided. The patient was recovered on an unspecified date in 2019. The reported did assessed the relation causality between Varicella and VARIVAX.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 15 months old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 17-JAN-2019, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB third dose, intramuscularly in the right vastus lateralis lot number R013572 and PROQUAD first dose, subcutaneously in the right vastus lateralis, lot number R018778. Other suspect therapies included INFANRIX fourth dose, intramuscularly, in the left vastus lateralis, lot number CX59C, HAVRIX first dose, intramuscularly, in the left vastus lateralis, lot number 3KT7B and PREVNAR 13 fourth dose, intramuscularly, in the left vastus lateralis, lot number W33490 all of them for prophylaxis (expiration date was not provided). No adverse events reactions thus no treatment was prescribed. Data logger was involved.  The vaccine was exposed to a temperature excursion in the refrigerator below 2°C. The reporter stated that the refrigerator had been checked and the temperature was stable. The reporter spoke with a company representative and the vaccine was considered viable as it was not exposed for a too long period that affect the vaccine adversely. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1902USA002414: US-009507513-1901USA011370: US-009507513-1902USA002413: