chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX. On 14th June 2018, 15 days after receiving SHINGRIX, the patient experienced shingles (serious criteria other: as per reporter) and pain. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain was unknown. The reporter considered the shingles to be possibly related to SHINGRIX. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: After receiving 1st dose of SHINGRIX, the patient developed full blown shingles. The patient went to the doctor on the day of reporting and was diagnosed with shingles. The healthcare professional stated that it was very painful for the patient and it was painful for her when clothes touch that area. The physician started her on shingles treatment. The healthcare professional believed that this was very coincidental since she received the vaccine 2 weeks ago. The healthcare professional did not have lot number or expiration date because the vaccine was administered at another location.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Fall, Groin pain, Limb discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In June 2018, the patient experienced woozy, disorientation, feeling unwell, groin pain, pain upon movement, heaviness in limbs and fall. On an unknown date, the patient experienced fainting. On 6th June 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the fainting, woozy, disorientation, feeling unwell, groin pain, pain upon movement, heaviness in limbs and fall were unknown. It was unknown if the reporter considered the fainting, pain in arm, woozy, disorientation, feeling unwell, groin pain, pain upon movement, heaviness in limbs and fall to be related to SHINGRIX. Additional details were provided as follows: The patient was already aware of the sore arm and feeling unwell after vaccination with SHINGRIX but the patient's arm became more and more sore as the day and evening progressed. The patient was so painful once she returned for the night that the blanket's touch caused pain. At 3:00 am, after using the bathroom, the patient felt very woozy and was unable to get to the bed and fainted landing very hard on the carpet. The arm of the patient was extremely sore and felt like a dead weight. The patient was totally disoriented and feeling generally unwell, the patient's husband helped her to be back to bed. The next morning, the result of the fall was that the patient's right groin was sore enough that walking was extremely painful. The pain in patient's arm gradually subsided and was fully resolved. The patient's groin did not start feeling better till 5th June 2018. The patient notified her primary care physician the advised to contact GlaxoSmithKline and also to advised to wait for six months (rather than the two suggested by the pharmacy) to get the second dose. The patient was not looking forward to the second dose based upon what she experienced.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity, Syncope, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In June 2018, the patient experienced woozy, disorientation, feeling unwell, groin pain, pain upon movement, heaviness in limbs and fall. On an unknown date, the patient experienced fainting. On 6th June 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the fainting, woozy, disorientation, feeling unwell, groin pain, pain upon movement, heaviness in limbs and fall were unknown. It was unknown if the reporter considered the fainting, pain in arm, woozy, disorientation, feeling unwell, groin pain, pain upon movement, heaviness in limbs and fall to be related to SHINGRIX. Additional details were provided as follows: The patient was already aware of the sore arm and feeling unwell after vaccination with SHINGRIX but the patient's arm became more and more sore as the day and evening progressed. The patient was so painful once she returned for the night that the blanket's touch caused pain. At 3:00 am, after using the bathroom, the patient felt very woozy and was unable to get to the bed and fainted landing very hard on the carpet. The arm of the patient was extremely sore and felt like a dead weight. The patient was totally disoriented and feeling generally unwell, the patient's husband helped her to be back to bed. The next morning, the result of the fall was that the patient's right groin was sore enough that walking was extremely painful. The pain in patient's arm gradually subsided and was fully resolved. The patient's groin did not start feeling better till 5th June 2018. The patient notified her primary care physician the advised to contact GlaxoSmithKline and also to advised to wait for six months (rather than the two suggested by the pharmacy) to get the second dose. The patient was not looking forward to the second dose based upon what she experienced.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in hip in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in hip, feels awful, tiredness and sickness. On an unknown date, the outcome of the pain in hip, feels awful, tiredness and sickness were unknown. It was unknown if the reporter considered the pain in hip, feels awful, tiredness and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX shot a little over 3 weeks before the date of reporting. The patient had never experienced side effects from shots or medications until this experience. The first few days, the patient felt horrible, spacey, tired and sick. The patient also had pain in a hip that she never had before, and still at times had this same pain. The patient said that she was an active person and healthy. The patient was very concerned about taking the follow up shot and asked for recommendation.
Sex: F
Vaccine: MEN
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a consumer via digital media and described the occurrence of passed out in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The patient got the shot of Meningitis-B vaccine and it made her pass out. The nurse said it had happened to everyone she had given it to at that point and they would not recommend in its current form. The patient did not go back for the booster dose. This case was linked to the case US2018GSK109359, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received SHINGRIX for prophylaxis. On 8th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced diarrhea, chills, injection site pain and injection site erythema. On an unknown date, the outcome of the diarrhea, chills, injection site pain and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the diarrhea, chills, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At the date of reporting, the patient had some diarrhea and chills and the patient was asking is there anything to help that. The reporter was asking, how long the pain and redness at injection site would last.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever after the 1st dose of SHINGRIX which was recorded as 100 degree F. Lab comments: Lab test was done on an unknown date.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of chills in a 60-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, without experiencing any adverse event). On 11th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced chills, general body pain and fever. In June 2018, the outcome of the chills, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the chills, general body pain and fever to be related to SHINGRIX. Additional information was received as follows: The nurse reported that the patient experienced chills, body aches and slight fever for 24 hours or less. The reporter did not agree for follow up contact. This case was linked with case US2018GSK106729, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shivers in a 65-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date unknown) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX the patient experienced shivers, general body pain and upset stomach. On an unknown date, the outcome of the shivers, general body pain and upset stomach were unknown. It was unknown if the reporter considered the shivers, general body pain and upset stomach to be related to SHINGRIX.Additional information was received as follows: The patient had upset stomach, shivers, and body aches after SHINGRIX vaccination. The reporter did not agree for follow up contact. This case was linked with case US2018GSK106719, reported by the same reporter.
Age: 19.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient was given Varicella 6/12/18 - pregnancy test was negative in Employee Health clinic. Last menses 5/22/18 on 6/19/18. Patient did home pregnancy test that was positive and Employee health repeated and was positive one week after Varicella vaccine administration.
Age: 37.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Rash generalised
Clinical narrative: Full body rash/pruritis, not clearing up at day 8.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Influenza like illness
Clinical narrative: That afternoon I noticed my arm becoming more and more sore. The next day, late morning I started feeling achy and tired like I was getting sick. Over the weekend I noticed the feeling of nausea starting...By Monday I felt like I had the flu. I hurt all over, very tired and weak feeling, nausea, diarrhea, headache and my arm was sore from my shoulder all the way down almost to my elbow. It hurt to move or touch it, however it never turned red or got hot. This lasted until the next Friday, one week and one day after the shots. The teatnus shot in the other arm never got sore or bothered me in any way. The literature regarding SHINGRIX states 2-3 days, but I had every symptom for a full week.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: That afternoon I noticed my arm becoming more and more sore. The next day, late morning I started feeling achy and tired like I was getting sick. Over the weekend I noticed the feeling of nausea starting...By Monday I felt like I had the flu. I hurt all over, very tired and weak feeling, nausea, diarrhea, headache and my arm was sore from my shoulder all the way down almost to my elbow. It hurt to move or touch it, however it never turned red or got hot. This lasted until the next Friday, one week and one day after the shots. The teatnus shot in the other arm never got sore or bothered me in any way. The literature regarding SHINGRIX states 2-3 days, but I had every symptom for a full week.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Tenderness
Clinical narrative: That afternoon I noticed my arm becoming more and more sore. The next day, late morning I started feeling achy and tired like I was getting sick. Over the weekend I noticed the feeling of nausea starting...By Monday I felt like I had the flu. I hurt all over, very tired and weak feeling, nausea, diarrhea, headache and my arm was sore from my shoulder all the way down almost to my elbow. It hurt to move or touch it, however it never turned red or got hot. This lasted until the next Friday, one week and one day after the shots. The teatnus shot in the other arm never got sore or bothered me in any way. The literature regarding SHINGRIX states 2-3 days, but I had every symptom for a full week.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling drunk, Muscle disorder
Clinical narrative: Pt received 2nd SHINGRIX at 11:45am on 6/7/18. He felt fine the rest of the day and went to sleep that evening. He woke at 3am on 6/8/18 and felt that he couldn't move muscles below his neck.  He was able to get out of bed and check his facial muscles in the mirror to rule out stroke. He determined all was well and went back to sleep. He then woke and took shower at 9am. He describes he "felt drunk." He then went to get a massage and at about noon on 6/8 felt better.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Strong muscle pain in arm/shoulder/armpit causing immobilization of entire left arm for 3 days.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Half dollar sized red area at injection site. Area is warm to touch with slight swelling. Afebrile. Advised to give TYLENOL and apply cool compress.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertently gave expired ACTHIB vaccination to child. Mother informed immediately and she will return patient to clinic on 6-21-18 for revaccination with valid dose of ACTHIB. Mother did not report any adverse effects in the child to this nurse.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Arthralgia, Back pain, Cyanosis, Fatigue
Clinical narrative: Immediately after Hep-B Shot: Burning hot face, tingly feeling in face; Sore injection site; Generally unwell. After a few days: Sore arm; Tingly/pins and needles in fingers on the arm of injection site. January 2018: Sore arm; Tingly/Pins and Needles in fingers/hands; Extreme back pain - knots along sciatica; flu-like sickness. Feb 2018: Mouth ulcers - 4 or more; Achy elbows (both arms); Tingly/pins and needles in both hands; Tiredness; Sun/heat sensitivity. March and April 2018: Hair loss, Mouth ulcers 4 or more; Achy elbows (both arms); Achy Knees - feet throbbing when standing still - big toes turning blue; Tingly/pins and needles in both hands; Tiredness; Sun/heat sensitivity. May 2018: Same as March and April; Numbness in face - 2 days; Fatigue lessening. June 2018: Same as March and April: Hair loss lessening; Fewer mouth ulcers (2); Wrists/hands ache.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Hypoaesthesia, Immediate post-injection reaction, Influenza like illness, Injection site pain
Clinical narrative: Immediately after Hep-B Shot: Burning hot face, tingly feeling in face; Sore injection site; Generally unwell. After a few days: Sore arm; Tingly/pins and needles in fingers on the arm of injection site. January 2018: Sore arm; Tingly/Pins and Needles in fingers/hands; Extreme back pain - knots along sciatica; flu-like sickness. Feb 2018: Mouth ulcers - 4 or more; Achy elbows (both arms); Tingly/pins and needles in both hands; Tiredness; Sun/heat sensitivity. March and April 2018: Hair loss, Mouth ulcers 4 or more; Achy elbows (both arms); Achy Knees - feet throbbing when standing still - big toes turning blue; Tingly/pins and needles in both hands; Tiredness; Sun/heat sensitivity. May 2018: Same as March and April; Numbness in face - 2 days; Fatigue lessening. June 2018: Same as March and April: Hair loss lessening; Fewer mouth ulcers (2); Wrists/hands ache.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Mouth ulceration, Nodule, Pain in extremity, Paraesthesia
Clinical narrative: Immediately after Hep-B Shot: Burning hot face, tingly feeling in face; Sore injection site; Generally unwell. After a few days: Sore arm; Tingly/pins and needles in fingers on the arm of injection site. January 2018: Sore arm; Tingly/Pins and Needles in fingers/hands; Extreme back pain - knots along sciatica; flu-like sickness. Feb 2018: Mouth ulcers - 4 or more; Achy elbows (both arms); Tingly/pins and needles in both hands; Tiredness; Sun/heat sensitivity. March and April 2018: Hair loss, Mouth ulcers 4 or more; Achy elbows (both arms); Achy Knees - feet throbbing when standing still - big toes turning blue; Tingly/pins and needles in both hands; Tiredness; Sun/heat sensitivity. May 2018: Same as March and April; Numbness in face - 2 days; Fatigue lessening. June 2018: Same as March and April: Hair loss lessening; Fewer mouth ulcers (2); Wrists/hands ache.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Temperature intolerance
Clinical narrative: Immediately after Hep-B Shot: Burning hot face, tingly feeling in face; Sore injection site; Generally unwell. After a few days: Sore arm; Tingly/pins and needles in fingers on the arm of injection site. January 2018: Sore arm; Tingly/Pins and Needles in fingers/hands; Extreme back pain - knots along sciatica; flu-like sickness. Feb 2018: Mouth ulcers - 4 or more; Achy elbows (both arms); Tingly/pins and needles in both hands; Tiredness; Sun/heat sensitivity. March and April 2018: Hair loss, Mouth ulcers 4 or more; Achy elbows (both arms); Achy Knees - feet throbbing when standing still - big toes turning blue; Tingly/pins and needles in both hands; Tiredness; Sun/heat sensitivity. May 2018: Same as March and April; Numbness in face - 2 days; Fatigue lessening. June 2018: Same as March and April: Hair loss lessening; Fewer mouth ulcers (2); Wrists/hands ache.
Age: 24.0
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Urticaria
Clinical narrative: CLIENT HAD WELTS/HIVES THE EVENING FOLLOWING HIS VACCINES ON BOTH ARMS, HIS BACK LASTING LESS THAN 24 HOURS. CLIENT DENIED SHORTNESS OF BREATH.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Hives, arm swelling.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Moderate pain, swelling, and redness at injection site, flulike symptoms, aches in muscles, stomach ache, headache, left leg pain.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pain in extremity
Clinical narrative: Moderate pain, swelling, and redness at injection site, flulike symptoms, aches in muscles, stomach ache, headache, left leg pain.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 01-JUN-2018, the patient was vaccinated with a improperly stored dose of PROQUAD injection, lot # R002939, expiration date 29-JUL-2019 (strength, route of administration were not reported) for prophylaxis, that was reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 5 hours. Data logger was involved. Previous excursions included temperature from 15 degrees Fahrenheit  to 46 degrees Fahrenheit  for 1 hour and 39 minutes.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-APR-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-APR-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-APR-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lethargy, Rash
Clinical narrative: Patient has facial rash, lethargic after few minutes getting the vaccines.
Age: 47.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Back pain, Motor dysfunction, Musculoskeletal stiffness, Neck pain
Clinical narrative: Client complaining of stiffness and achiness in back, neck, knuckles, and wrist that started 24 hours after vaccinations given. She reports she has dropped objects when trying to pick them up due to discomfort in hands.
Age: 47.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pain in extremity
Clinical narrative: Client complaining of stiffness and achiness in back, neck, knuckles, and wrist that started 24 hours after vaccinations given. She reports she has dropped objects when trying to pick them up due to discomfort in hands.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: SHINGRIX mixed with sterile diluent instead of recommended diluent and administered to patient. Patient had no adverse reactions at time of administration or after before leaving clinic. Clinic has not heard from patient since.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: On day 2, patient noted that he has limited range of motion in his right arm with pain. He is unable to do normal activities of daily living such as dressing, toweling off, lifting to the side is painful. He has continued to experience pain and decreased ROM over the past 10 days. He has sharp, shooting pain down from his right shoulder into his elbow if he moves wrong. At the end of the day, his arm starts to ache. He called doctor's office for evaluation on 6/20/18, but was referred back to the Health Department. He has not seen a doctor yet.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, skin tightness, pain and fever at injection site for 24 hours after injection.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Skin tightness
Clinical narrative: Swelling, redness, skin tightness, pain and fever at injection site for 24 hours after injection.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Discomfort, Dizziness, Headache, Loss of consciousness, Seizure
Clinical narrative: Vaccine administered at 10am. Possible side effects explained and patient instructed to wait following administration. Approximately 2 minutes later mom called out for help. This RN entered patient room and witnessed patient had lost consciousness and appeared to be convulsing.  Consciousness was regained soon after (3-4 seconds later). At this time patient was alert, but endorsing continued lightheadedness and a headache. Patient was helped onto exam table, feet elevated. Tried to sit up to take sips of water, but patient c/o "heaviness" and blurred vision so was encouraged to lie back down. Vitals at this time: HR in the high 40s, BP 90/40; vitals approximately 10 minutes later: HR 70s, BP 110/60. Patient stable, alert at this time (approximately 15 minutes from onset of LOC). While patient was being monitored, patient's mother fainted in the hallway. Paramedics were called (arrived at 10:13am) and both patient and mother were escorted via ambulance. Dr., patient's PCP, was present at time of event and agreed to contact family to discuss any additional follow up actions required.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Vision blurred
Clinical narrative: Vaccine administered at 10am. Possible side effects explained and patient instructed to wait following administration. Approximately 2 minutes later mom called out for help. This RN entered patient room and witnessed patient had lost consciousness and appeared to be convulsing.  Consciousness was regained soon after (3-4 seconds later). At this time patient was alert, but endorsing continued lightheadedness and a headache. Patient was helped onto exam table, feet elevated. Tried to sit up to take sips of water, but patient c/o "heaviness" and blurred vision so was encouraged to lie back down. Vitals at this time: HR in the high 40s, BP 90/40; vitals approximately 10 minutes later: HR 70s, BP 110/60. Patient stable, alert at this time (approximately 15 minutes from onset of LOC). While patient was being monitored, patient's mother fainted in the hallway. Paramedics were called (arrived at 10:13am) and both patient and mother were escorted via ambulance. Dr., patient's PCP, was present at time of event and agreed to contact family to discuss any additional follow up actions required.
Age: 61.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Rash generalised
Clinical narrative: Patient reported to our office with full body rash and itching that started the day before. Patient is under observation, it is being reported as patient is still in the clinic
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Injection site swelling, Pain
Clinical narrative: Fever for 18hrs, Headache, Body ache, diarrhea, stomach cramps, swelling of injection area.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever for 18hrs, Headache, Body ache, diarrhea, stomach cramps, swelling of injection area.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pruritus, Rash
Clinical narrative: First pain at injection sight. Rash and profuse itching by next day. Rash scalp, ears, down back and buttocks, under breasts all over chest and arms.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hot flush, Migraine, Swelling
Clinical narrative: Redness, swelling, migraines and hot flashes.
Age: 29.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Immediate post-injection reaction, Neurological examination normal, Posture abnormal, Seizure
Clinical narrative: Per nursing note, patient "Pt received TWINRIX and tdap IM per order. Pt received TWINRIX in right deltoid and immediately started to exhibit a light convulsion lasting 5-5.5 seconds and slumped forward. Pt then sat up and was talking coherently. She denied any allergies. Vital signs were stable at 119/70 with a pulse of 58 and respirations of 16 and unlabored." "exhibited a strong, steady gait." "all neuro checks were within normal limits."
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Vomiting
Clinical narrative: PT'S MOTHER CALLED AT AROUND 8:35 AM TO REPORT THAT THE PT HAD BEEN VOMITING UNABLE TO "HOLD ANYTHING DOWN". SHE READ ON HER VIS THAT DTAP MIGHT CAUSE VOMITING AND THE DTAP WAS SUPPOSED TO BE GIVEN AT 15-18 MONTHS NOT 12 MONTHS WHICH IS WHEN IT WAS GIVEN. I EXPLAINED TO THE MOTHER THAT DTAP CAN BE GIVEN AT 12 MONTHS AS LONG AS THERE IS AT LEAST 6 MONTHS BETWEEN DOSE 3 AND 4. PARENT ALSO STATED THAT PT HAD NOT HAD VOMITING WITH ANY OF THE PREVIOUS VACCINES SHE HAD HAD INCLUDING DTAP IN A COMBINED VACCINE (PENTACEL). THE PARENT EXPLAINED THAT PATIENT DID NOT HAVE ANY FEVER. I RECOMMENDED THAT SHE SHOULD KEEP THE PT HYDRATED, IF VOMITING CONTINUOUS TAKE HER TO HER PROVIDER/HOSPITAL, ALSO IF A FEVER/OTHER S/S DEVELOP SHE SHOULD GO TO THE DR/HOSPITAL. PT VOICED UNDERSTANDING.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine was given in subcutaneous tissue and not in the deltoid as recommended. Later that same day of injection (19 June 2018) the right arm injection site became red, swollen, and painful. Over the next couple of days the redness area became larger, remain swollen and painful and the area became warm to touch. Noted temp 99.5. The site remain sore, red, swollen and warm today 21 June 2018.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine was given in subcutaneous tissue and not in the deltoid as recommended. Later that same day of injection (19 June 2018) the right arm injection site became red, swollen, and painful. Over the next couple of days the redness area became larger, remain swollen and painful and the area became warm to touch. Noted temp 99.5. The site remain sore, red, swollen and warm today 21 June 2018.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 31-MAY-2018, the patient was vaccinated with properly stored M-M-R II (recombinant human albumin (RHA), lot # M004063, expiration date 25-JAN-2018, dose and route of administration were not reported) for prophylaxis. No information about sterile diluent used for reconstitution of the vaccine was provided. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 06-JUN-2018, the patient was inadvertently vaccinated with VAQTA of lot # N002921 and expiration date of 08-APR-2018 for prophylaxis (expired vaccine used). No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 4 year old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 08-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (rHa) lot number: N021727 (expiration date: 06-FEB-2019) for prophylaxis (strength, route and dosage schedule were not provided). The sterile diluent used to reconstitute the vaccine, was properly stored. There was digital data logger involved. The storage characteristics were the following: - Temperature: 15°F to 46°F for 36 minutes. Previous temperature excursion: 15°F to 46°F for 1 hour and 15 minutes. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-FEB-2014, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-MAR-2015, he was treated at the same clinic for a severe vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of his painful symptoms. As a direct and proximate result of 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at an unspecified facility as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated at a hospital for a vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
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 an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, 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. In February 2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. 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. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2014, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. 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. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from approximately 59-year-old female patient refers to herself. The patient's concurrent conditions included anaemia, arthritis and penicillin allergy. At the end of 2016, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis. It was reconstituted with sterile diluent. Concomitant therapies included NEURONTIN, acetaminophen, VICODIN and LYRICA. At the end of 2016, the patient experienced shingles. She had blisters and rash all over her bottom and private parts and reported having a fever. She also experienced extreme nerve pain. On an unknown date, the patient was hospitalized and treated. The outcome of events was reported as not recovered/not resolved. Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) on 04-OCT-2016 from a pharmacy, for its intended purpose: the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 [reported as shortly after receiving ZOSTAVAX], the patient developed an intermittent, sharp, throbbing pain and blisters on her back. The patient was diagnosed with shingles lesions and postherpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses as a direct result of the use of ZOSTAVAX. ZOSTAVAX did not prevent shingles, persistent strain of herpes zoster/shingles lesions, and postherpetic neuralgia were considered to be disabling. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse, and refers to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates, the patients started therapy with ROTATEQ, (lot # and expiry date were not reported) for prophylaxis. The nurse reported, some unspecified patients had received dose 2 or 3 of the series later than recommended (timing unspecified) due to unspecified family situations not related to the vaccine. No adverse effects were noted in these patients. Follow up information was received from the health care professional who administered the vaccines on 11-JUN-2018. Upon follow up, it was determined that the patient is an 8 month female patient; therefore this case is now valid. It was also reported that an expired dose of ROTATEQ was administered orally to the patient on 24-APR-2018; lo# M025568 expiration date 07-NOV-2017. This was the patient's 3rd dose of ROTATEQ. The patient was also administered the 3rd dose of PREVNAR 13, intramuscularly in the right vastus lateralis Lot# R49358; PENTACEL intramuscularly in the left vastus lateralis, lot # C5368AA, and the third dose of hepatitis b virus vaccine (Glaxo Smith Kline) in the rigth vastus lateralis lot# FB2X4. No other adverse events were reported. This is one of 2 cases from the same reporter. Sender's Comments: US-009507513-1805USA002592.