chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a male patient who received SHINGRIX (batch number 4492P, expiry date unknown). Concurrent medical conditions included hypertension. Concomitant products included Lisinopril. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced injection site swelling, injection  site pain, malaise and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, injection site pain, malaise and influenza-like symptoms were recovered/resolved. The reporter considered the injection site swelling, injection site pain, malaise and influenza-like symptoms to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The patient received SHINGRIX in the left arm. The reporter did not have batch number expiration date. The symptoms resolved after 3 to 4 days. No medical intervention was taken. The reporting medical assistant stated that patient's physician was almost certain that symptoms were caused by SHINGRIX.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pallor, Vomiting
Clinical narrative: Child received Tdap vaccine at approximately 9:20 AM, left immunization area. Brought back to immunization area at 9:33am. Color pale, he stated he was sick to his stomach. Child laid down on floor. BP 80/40. O2 sat at 9:40am-99% Pulse 88. Vomited small amt clear fluid. Scool notified parent. BP at 9:44am 84/60, Pulse-78, O2 sat - 98%. Emergency Crew arrived at 9:47 am, child's color improving, child oriented to person and place. Child left with Emer. Crew at 9:52am. Child back in school on 6/8/18, he was not taken to ER. Parent took child home on 6/7/18.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Rash
Clinical narrative: Rash noted to trunk, neck, and proximal extremities.
Age: 12.0
Sex: M
Vaccine: HPV9, MMRV, MNQ
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Redness, swelling of the arm- treating for cellulitis.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 12 year old male patient came in for a Well Child Check (physical) and he received an adult dose of the Hepatitis A vaccine. On 5/25/18 I finally made contact with mom and informed her of the dose error and reassured her vaccines are safe and more than likely, no adverse reaction. She said her son never complained about it.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: Softball sized hot, pruritic, erythematous rash has developed around injection site.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: The next day after injection, patient felt soreness and tenderness on left arm. On the second day, there's redness, bumps, rashes and swelling around the injection site. Per patient, she only had triple antibiotic and applied it on affected area and helped with the itching a little bit. I advised patient to take BENADRYL and apply hydrocortisone cream. I left a message to follow up with patient to see how if it's getting better.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: The next day after injection, patient felt soreness and tenderness on left arm. On the second day, there's redness, bumps, rashes and swelling around the injection site. Per patient, she only had triple antibiotic and applied it on affected area and helped with the itching a little bit. I advised patient to take BENADRYL and apply hydrocortisone cream. I left a message to follow up with patient to see how if it's getting better.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt complained of arm still hurting from immunization.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Swelling, Tremor
Clinical narrative: Patient's Home Health Aide reported patient had PCV13 on 5/11/2018, this morning when patient got up, upper body trembling, also noticed swelling below injection site about 1-2" with skin rash, ate breakfast, still tremble, called 911, sent to ER.
Sex: U
Vaccine: PNC13
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 21-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported) and on 10-APR-2018, the patient was vaccinated with (crm197)PREVNAR 13 (manufacturer unknown) (dose, strength, frequency, lot#, expiration date, route of administration and indication were not reported). No adverse effects were reported. No product quality complain was present.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-DEC-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 July 2016, the patient was treated at a physician's office for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a health 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 July 2016, the patient was treated at a health facility for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, 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 or about 18-DEC-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 and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-JUL-2016, the patient was treated by a physician for a vesicular outbreak, accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX, 'methyl-prednisone', and gabapentin for management of her painful symptoms and excruciating pain. 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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. In December 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-JUL-2016, the patient was treated by a physician assistant for a severe 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In June 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 condition of herpes zoster. On or about 01-JUL-2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms, which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JUN-2016, 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. Later in July 2016, the patient was treated at a physician's office 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. 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. In December 2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, 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. In July 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
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. In June 2016, 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. Later in July 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
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 or about 10-JAN-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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 or about 28-SEP-2013, 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 function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-JUL-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed acyclovir for management of her painful symptoms. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
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 or about 01-JAN-2010, 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 function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In July 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Rash
Clinical narrative: Parent "Mother" reported rash onset 06/07/2018 in the afternoon. Rash first appeared on the arms and is most notable on the arms then spread to abdomen, back, legs, cheeks, and around nose. Rash faded slightly overnight but was notable the next day 06/08/2018. No Fever; No Change in Appetite; No Fussiness. Parent notified Physician office, on 06/08/2018, was instructed to be seen at office today for assessment. Parent declined appointment. Parent instructed to seek immediate medical attention if condition worsened. Parent notified Health Department of rash. Parent was encouraged to see physician today for assessment. Parent declined. Parent instructed to seek immediate medical attention if condition worsened. Will follow up on Monday 06/11/2018.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Full body hives on arms legs and truck region.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Confusional state, Dizziness, Hypoaesthesia, Injection site haemorrhage, Loss of consciousness
Clinical narrative: THE PATIENT SAID THAT SHE WAS FEELING LIGHTHEADED, ABOUT 5 MINUTES LATER SHE PASSED OUT. IT LOOKED AS IF SHE WAS HAVING A SEIZURE. SHE LOST CONSCIOUSNESS FOR ABOUT 2 MINUTES(?). SHE REGAINED CONSCIOUSNESS QUICKLY AND WAS SLIGHTLY CONFUSED, BUT QUICKLY SAID SHE WAS OKAY. SHE ADMITTED THAT SHE HAD NOT EATEN SINCE BREAKFAST. SHE SAT UP IN THE CHAIR AND FELT FINE ABOUT 2 MINUTES AFTER PASSING OUT. THERE WAS SLIGHT BLEEDING AT THE INJECTION SITE. THE PATIENT STAYED IN THE STORE FOR ABOUT AN HOUR. SHE CALLED WHEN SHE ARRIVED HOME TO TELL US SHE MADE IT SAFELY. SHE ALSO SAID HER LEFT HAND WAS TINGLY AND HER LITTLE FINGER WAS NUMB.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Paraesthesia, Seizure
Clinical narrative: THE PATIENT SAID THAT SHE WAS FEELING LIGHTHEADED, ABOUT 5 MINUTES LATER SHE PASSED OUT. IT LOOKED AS IF SHE WAS HAVING A SEIZURE. SHE LOST CONSCIOUSNESS FOR ABOUT 2 MINUTES(?). SHE REGAINED CONSCIOUSNESS QUICKLY AND WAS SLIGHTLY CONFUSED, BUT QUICKLY SAID SHE WAS OKAY. SHE ADMITTED THAT SHE HAD NOT EATEN SINCE BREAKFAST. SHE SAT UP IN THE CHAIR AND FELT FINE ABOUT 2 MINUTES AFTER PASSING OUT. THERE WAS SLIGHT BLEEDING AT THE INJECTION SITE. THE PATIENT STAYED IN THE STORE FOR ABOUT AN HOUR. SHE CALLED WHEN SHE ARRIVED HOME TO TELL US SHE MADE IT SAFELY. SHE ALSO SAID HER LEFT HAND WAS TINGLY AND HER LITTLE FINGER WAS NUMB.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arrhythmia, Back pain, Injection site warmth, Muscle spasms, Pyrexia
Clinical narrative: Fever at injection site, fever overall, extreme back pain, severe muscle cramps, may have contributed to a cardiac arrythmitia that caused difibrulator to deliver a shock.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness
Clinical narrative: Gave injection in the left arm. Patient stated that she felt lightheaded and laid down.  She bent her knees on the bed and we put a damp cloth on her head.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: He had swelling and itching on his arm and some itching on his neck.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Inflammation, Injection site erythema, Injection site pruritus
Clinical narrative: Pain, inflammation of entire upper arm, joint pain in whole arm, redness. Pain lasted 10 days and then the injection site became itchy. As of 8 June, injection site still red, but there is no pain nor itchy.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain, inflammation of entire upper arm, joint pain in whole arm, redness. Pain lasted 10 days and then the injection site became itchy. As of 8 June, injection site still red, but there is no pain nor itchy.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient said she didn't notice anything until yesterday (6/7/18) but that it might have started earlier. Location surrounding  injection by about 2 inches was light/white, but the distal part of the upper arm was bright red and warm to the touch. It didn't look swollen but the patient said it was 'puffy'. Patient also mentioned she had gotten cellulitis in the past from a IV needle in her hand. I advised patient to call her doctor when she gets home and get checked to be safe.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Loss of personal independence in daily activities, Nausea
Clinical narrative: Progressive worsening fatigue, fevers/chills, severe nausea and headache, fatigue prevented patient from all activities 6/7/18 -all symptoms resolved by 6/8 10am.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Progressive worsening fatigue, fevers/chills, severe nausea and headache, fatigue prevented patient from all activities 6/7/18 -all symptoms resolved by 6/8 10am.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness to right thigh, provider ordered KEFLEX 125/5ml and BENADRYL 12.5/5ml.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient developed red, raised, itchy rash on face, neck and chest. It developed within 24 hours of vaccination starting on the face area then spreading to neck and chest. Patient still had rash 7 days after onset.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Condition aggravated, Tendonitis
Clinical narrative: Patient is complaining of Tendinitis aggravation resulting from the vaccine. Patient is experiencing symptoms on both elbows.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess
Clinical narrative: Redness at injection site started day after injection. No itching or unusual swelling. May be spreading and patient will monitor.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Vaccination site swelling
Clinical narrative: Very severe back pain. Had swelling at vaccine site the day after shot. Back pain started two days after shot.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain
Clinical narrative: Very severe back pain. Had swelling at vaccine site the day after shot. Back pain started two days after shot.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt had no reaction to vaccine after administration but the next morning had a lot of soreness.  Later that afternoon developed redness on the whole shoulder. Soreness has gone down over the past day but redness is still there. It is warm to the touch.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: PATIENT COMPLAIN OF FATIGUE, LOSS OF APPETITE, HEADACHE. REDNESS AT INJECTION SITE AND TENDER TO TOUCH. HEADACHE WAS RESOLVED WITH TYLENOL 500-MG.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On May 24 arm was sore at site and to lift. On May 25 saw that upper arm was slightly swollen, warm and red. The warmness went away by May 27, however whole upper arm was red from shoulder to elbow. Redness wrapped around arm. By May 28 the redness was less and by May 30 was gone.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: On May 24 arm was sore at site and to lift. On May 25 saw that upper arm was slightly swollen, warm and red. The warmness went away by May 27, however whole upper arm was red from shoulder to elbow. Redness wrapped around arm. By May 28 the redness was less and by May 30 was gone.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Moderate to severe pain for 5 days. Shoulder felt as if it was seriously injured. Could not raise arm overhead.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal distension, Chills, Crying, Feeling abnormal
Clinical narrative: Patient returned home after vaccine and that evening she developed severe shivering and body pain. She stated that the shivering was severe enough to cause significant jaw pain and the body pain was bad enough to make the patient cry. She stated that her stomach was also affected and she experienced dry heaving and bloating. She said the symptoms lasted through the night interfering with her sleep and well into the next day. She said this afternoon the shivering was a little better but her body was "wiped out" and she asked if there was something over the counter to help with all of the stomach discomfort.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in jaw, Retching
Clinical narrative: Patient returned home after vaccine and that evening she developed severe shivering and body pain. She stated that the shivering was severe enough to cause significant jaw pain and the body pain was bad enough to make the patient cry. She stated that her stomach was also affected and she experienced dry heaving and bloating. She said the symptoms lasted through the night interfering with her sleep and well into the next day. She said this afternoon the shivering was a little better but her body was "wiped out" and she asked if there was something over the counter to help with all of the stomach discomfort.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Gait disturbance, Headache, Heart rate increased
Clinical narrative: I got the 2nd dose (the 'booster shot') of the SHINGRIX shingles vaccine and had what I believe was a negative reaction over and above the reaction that can be normally anticipated. About 4 hours after I received the vaccine I developed extreme muscle pains in my neck, shoulders, arms, legs - all over my body. For a while it was so bad that I could barely lift my arms or walk. I also developed a headache that was far worse than any headache I had ever had. I also had the chills and shivering that is listed as one of the side effects and a slight temperature (99 degrees). But the thing that really alarmed me was that my blood pressure went up to the high 140s from its normal range of the 120s, and my heart rate went up from where it usually is in the middle 60s to around 80. This all lasted around 12 hours. I'm fine now but the doctor described this as a 'worrying reaction' and advised me not to get the hepatitis B shot or the pneumonia shot that I was planning to get. (BTW, I had absolutely no reaction to the 1st of the two SHINGRIX shots, and I have never had a reaction to a flu shot).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pyrexia
Clinical narrative: I got the 2nd dose (the 'booster shot') of the SHINGRIX shingles vaccine and had what I believe was a negative reaction over and above the reaction that can be normally anticipated. About 4 hours after I received the vaccine I developed extreme muscle pains in my neck, shoulders, arms, legs - all over my body. For a while it was so bad that I could barely lift my arms or walk. I also developed a headache that was far worse than any headache I had ever had. I also had the chills and shivering that is listed as one of the side effects and a slight temperature (99 degrees). But the thing that really alarmed me was that my blood pressure went up to the high 140s from its normal range of the 120s, and my heart rate went up from where it usually is in the middle 60s to around 80. This all lasted around 12 hours. I'm fine now but the doctor described this as a 'worrying reaction' and advised me not to get the hepatitis B shot or the pneumonia shot that I was planning to get. (BTW, I had absolutely no reaction to the 1st of the two SHINGRIX shots, and I have never had a reaction to a flu shot).
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Fatigue, Injection site erythema, Pain
Clinical narrative: Vaccine was administered 5/21/18. Patient started to feel achy and tired 6/1/18. 6/2/18 she developed erythematous popular vesicular lesions of face, neck, back, abdomen, arms, (L) leg, redness at injection site.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Papule, Skin lesion
Clinical narrative: Vaccine was administered 5/21/18. Patient started to feel achy and tired 6/1/18. 6/2/18 she developed erythematous popular vesicular lesions of face, neck, back, abdomen, arms, (L) leg, redness at injection site.
Age: 58.0
Sex: F
Vaccine: HEPA, TDAP, YF
Symptoms: Injection site pain, Neck pain, Pain in extremity, Paraesthesia, Wrong technique in product usage process
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received BOOSTRIX (batch number BF252, expiry date 13th September 2020). Co-suspect products included HAVRIX (batch number TB995, expiry date 25th October 2020) and STAMARIL (batch number M53121V, expiry date unknown). On 15th May 2018 10:15, the patient received BOOSTRIX (intramuscular) .5 ml. On 15th May 2018, the patient received the 2nd dose of HAVRIX (intramuscular) and STAMARIL (subcutaneous). In May 2018, less than a week after receiving BOOSTRIX and not applicable after receiving HAVRIX, the patient experienced injection site pain, pain in arm, tingling and neck pain (with radiation). On 15th May 2018, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site pain, pain in arm, tingling, neck pain (with radiation) and wrong injection technique were unknown. The reporter considered the injection site pain, pain in arm, tingling and neck pain (with radiation) to be related to BOOSTRIX. It was unknown if the reporter considered the tingling and neck pain (with radiation) to be related to HAVRIX. Additional details were provided as follows. This case was previously reported to a doctor. The patient received BOOSTRIX vaccine on left deltoid, HAVRIX in right deltoid and a dose of STAMARIL in the left arm. The patient experienced left arm soreness for three or four days. Around day five or six, the arm soreness progressed into left arm pain and tingling that radiates down the arm and up into her neck. It was unknown if the reporter considered injection site pain, pain in arm, tingling and neck pain (with radiation) to be related to STAMARIL. The reporter did not have the expiration dates for the vaccination and were obtained lots for GSK products with lot recall locator.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were reported as follows: This case was reported for coworkers who was sick after receiving SHINGRIX. The age at vaccination was not reported. The reporter reported that the patient's got sick. The reporter indicated that the adverse events experienced by her son and coworkers were reported to the health department where they received the vaccination. The reporter would not provide additional information. This case is 1 of the 3 linked cases.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Red, painful, warm spot on left arm.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however it could be 50 and above. The patient developed shingles approximately 2 months later and the patient experienced visible rash and no pain was associated with it. The reporter was not sure of correlation with vaccine. The reporter did not provide the details and information on completion of dosing regiment, specifically whether the patient received the 2nd dose. The reported agreed to be followed up. This case was considered as suspected vaccination failure as primary vaccination schedule completion and confirmation of lab test details were unknown.
Sex: M
Vaccine: HEP
Symptoms: Seizure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a male patient who received Hepatitis B vaccine. Concurrent medical conditions included eczema nummular (Discoid eczema), allergic reaction to antibiotics (Neomycin allergy) and rubber sensitivity. On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, less than a day after receiving Hepatitis B vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was recovered/resolved. The reporter considered the seizure to be possibly related to Hepatitis B vaccine. Additional details were provided as follows: This case was previously reported to a doctor. The reporter was the patient's father. The age at vaccination was not reported, but the patient could be 12 or 13 years old. The reporter stated that in 2001, the patient received a Hepatitis B vaccine and experienced a seizure within two hours of getting the vaccination. The reporter was unable to provide any additional information and did not know the name of the product administered. The patient had denied permission to contact their physician.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (On 23rd January 2018, the patient received 1st dose and experienced flu like symptoms (refer case US2018075854)). On 20th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In April 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The patient received 2nd dose and experienced arm pain and flu like symptom.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 67-year-old female patient who received SHINGRIX. On 29th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain, feeling hot, fever, injection site erythema and injection site swelling. On an unknown date, the outcome of the pain, feeling hot, fever, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the pain, feeling hot, fever, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The patient complained redness and swelling at the injection site, fever and body temperature was recorded as 100 F, soreness, hot to touch and pain.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 82-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than an hour after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. This case was previously not reported to anyone. The patient received SHINGRIX on the left arm, approximately two months ago from the date of reporting. Within half an hour after receiving SHINGRIX, her arm became sore. The soreness has almost fully resolved although sometimes she does get an ache in the arm. The patient would not provide additional information. The patient denied permission to contact their physician. This case is 1 of the 3 linked cases reported by the same reporter.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at site of Dtap injection on left arm. DECADRON given in office (10 mg oral).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphoedema
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and lymphedema. On an unknown date, the outcome of the injection site swelling and lymphedema were unknown. It was unknown if the reporter considered the injection site swelling and lymphedema to be related to SHINGRIX. Additional details were reporter as follows: The age at vaccination was not reported. The field representative called to report adverse events that three different patients experienced on SHINGRIX as reported to her by the nurse. The patient experienced lymphedema and swelling at the injection site. The field representative had very limited information. Attempted to call nurse twice to get further information on the events but was not able to reach her. She also stated that nurse had reported the event to VAERS. This was 1 of 3 cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and fever. On an unknown date, the outcome of the influenza-like symptoms and fever were unknown. It was unknown if the reporter considered the influenza-like symptoms and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend. The age at the vaccination was not reported, however the patient was in the 60s. The reporter refused to provide demographic information or any information pertaining to her two friends. The reporter stated she did not want to share information pertaining to this report. The patient had denied permission to contact their physician. This case is linked to the case US2018GSK102616, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At the time of this report, the physician did not have any other information.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received HAVRIX. On an unknown date, the patients received HAVRIX. On an unknown date, unknown after receiving HAVRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist mentioned that a few people complained of pain at the injection site after receiving the vaccine and it lasted 1 to 2 days and then resolved. The information in this report was all that the reporter had provided.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. Previously administered products included small pox vaccine (received 4 years ago), yellow fever vaccine, tetanus vaccine (every year), cholera vaccine, typhoid vaccine and shingles vaccine (had first shingles vaccine shot a few years ago). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Four years ago and the patient probably had every shot known to man that was like small pox-every six months-insisted on by crew doing small pox eradication, yellow fever, gamma globulin, tetanus every year, cholera, typhoid, and others vaccines that he did not remember. The patient had first shingles vaccine shot a few years ago. The patient had side effects like Pain, redness, and swelling at the injection site, Muscle pain, Tiredness, Headache, Shivering, fever and upset stomach with new SHINGRIX. The patient stated that, warn the physicians to tell patients to take aspirin or TYLENOL in good doses before getting each of the two SHINGRIX shots, because SHINGRIX is goofy to him.