chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Nodule, Swelling, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in a 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 bruising of arm, local swelling, erythema urticarial and nodule. On an unknown date, the outcome of the bruising of arm, local swelling, erythema urticarial and nodule were unknown. It was unknown if the reporter considered the bruising of arm, local swelling, erythema urticarial and nodule to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received the SHINGRIX vaccine approximately a month ago and experienced a raised bruised area several inches below the injection site, whelps on the bruised area as well as around the bruise, and a nodule in her eye. The pharmacist indicated that there was a little bit of redness where the whelps were on her arm at the time of reporting. The pharmacist did not provide the consent to follow up. The pharmacist was unable to provide additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Limb mass, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of upper extremity mass in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 22nd March 2019, the patient received the 1st dose of SHINGRIX. On 22nd March 2019, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 23rd March 2019, the patient experienced upper extremity mass and injection site erythema. On an unknown date, the outcome of the upper extremity mass and injection site erythema were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the upper extremity mass, injection site erythema and vaccine administered at inappropriate site to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine on left side. One day after receiving SHINGRIX, the patient experienced golf ball sized bump on her crease at the elbow. The injection site was also red. The pharmacist who injected noted that the patient was very thin, and he injected the dose into the triceps area rather than the deltoid, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX (batch number 273BZ, expiry date 15th May 2021) for prophylaxis. On 15th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. Initially, the patient experienced injection site pain along with redness and swelling after the injection that lasted for one week and resolved. However approximately 8 weeks after receiving the 2nd dose of SHINGRIX, the patient reported recurrence of the injection site pain in her left arm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling of body temperature change, Impaired work ability, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of generalized pruritus in a 52-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced generalized pruritus, injection site pain, injection site erythema, feeling hot and cold, muscle weakness lower limb and feeling bad. On an unknown date, the outcome of the generalized pruritus, injection site pain, injection site erythema, feeling hot and cold and muscle weakness lower limb were recovered/resolved and the outcome of the feeling bad was not reported. It was unknown if the reporter considered the generalized pruritus, injection site pain, injection site erythema, feeling hot and cold, muscle weakness lower limb and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient felt so bad after getting SHINGRIX that she missed work for 2 days. Her body itched, she had a lot of pain and redness at the injection site, she felt hot and cold and felt like her legs were not strong enough. This is 1 of the 5 cases, reported by the same reporter.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pruritus generalised
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of generalized pruritus in a 52-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced generalized pruritus, injection site pain, injection site erythema, feeling hot and cold, muscle weakness lower limb and feeling bad. On an unknown date, the outcome of the generalized pruritus, injection site pain, injection site erythema, feeling hot and cold and muscle weakness lower limb were recovered/resolved and the outcome of the feeling bad was not reported. It was unknown if the reporter considered the generalized pruritus, injection site pain, injection site erythema, feeling hot and cold, muscle weakness lower limb and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient felt so bad after getting SHINGRIX that she missed work for 2 days. Her body itched, she had a lot of pain and redness at the injection site, she felt hot and cold and felt like her legs were not strong enough. This is 1 of the 5 cases, reported by the same reporter.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received SHINGRIX for prophylaxis. On 23rd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, joint pain and fever. On an unknown date, the outcome of the injection site pain, muscle pain, joint pain and fever were recovered/resolved. It was unknown if the reporter considered the injection site pain, muscle pain, joint pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. Within 3 to 4 hours after receiving SHINGRIX, the patient experienced muscle aches, joint pain and a fever. There was soreness at the injection but it was minimal. The symptoms lasted for 24 hours. The reporter consented to follow up. For tolerance to second dose of SHINGRIX, refer case US2019GSK060256.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, exhaustion headache, sore arm.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Blister, Fatigue, Injection site erythema, Injection site irritation
Clinical narrative: 4/3/2019 at 12:30 pm-Patient presented to OH with complaints of redness, swelling and irritation to her right posterior arm at varicella injection site. Patient received varicella injection in OH on 4/2/2019. Area raised, small fluid-filled vesicles noted. Patient denied rash anywhere else on her body and reported a localized reaction to her right posterior arm only. Patient also reported weakness, fatigue, and feeling febrile. Temp 98.2 oral. Patient was advised that she may not work in any high-risk areas or with immunocompromised patients until the rash has resolved. Patient stated that she works in the Room and does not have direct patient contact. Patient was instructed to apply cool compresses to the area several times a day, take MOTRIN OTC or other anti-inflammatory medication as directed, and take BENADRYL PRN for itching. Patient was also instructed to follow-up with OH in the morning for re-evaluation of rash/localized reaction. Patient verbalized understanding and denied further questions or concerns at this time. RN. 4/4/2019 at 7 am-Patient presented to OH for re-evaluation of varicella vaccine injection site. Increased redness and swelling noted with large fluid-filled blisters present at injection site. Redness and swelling now extends around the posterior to arm to the right medial and lateral arm. Patient complained of increased pain and generalized feelings of fatigue and malaise. Patient was referred to Clinic for evaluation per an OH medical provider, location chosen per Patient's preference. Patient was instructed to follow-up with OH after her evaluation at Clinic. Patient verbalized understanding and denied further questions or concerns at this time. RN.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site vesicles, Local reaction, Malaise, Pyrexia
Clinical narrative: 4/3/2019 at 12:30 pm-Patient presented to OH with complaints of redness, swelling and irritation to her right posterior arm at varicella injection site. Patient received varicella injection in OH on 4/2/2019. Area raised, small fluid-filled vesicles noted. Patient denied rash anywhere else on her body and reported a localized reaction to her right posterior arm only. Patient also reported weakness, fatigue, and feeling febrile. Temp 98.2 oral. Patient was advised that she may not work in any high-risk areas or with immunocompromised patients until the rash has resolved. Patient stated that she works in the Room and does not have direct patient contact. Patient was instructed to apply cool compresses to the area several times a day, take MOTRIN OTC or other anti-inflammatory medication as directed, and take BENADRYL PRN for itching. Patient was also instructed to follow-up with OH in the morning for re-evaluation of rash/localized reaction. Patient verbalized understanding and denied further questions or concerns at this time. RN. 4/4/2019 at 7 am-Patient presented to OH for re-evaluation of varicella vaccine injection site. Increased redness and swelling noted with large fluid-filled blisters present at injection site. Redness and swelling now extends around the posterior to arm to the right medial and lateral arm. Patient complained of increased pain and generalized feelings of fatigue and malaise. Patient was referred to Clinic for evaluation per an OH medical provider, location chosen per Patient's preference. Patient was instructed to follow-up with OH after her evaluation at Clinic. Patient verbalized understanding and denied further questions or concerns at this time. RN.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: 4/3/2019 at 12:30 pm-Patient presented to OH with complaints of redness, swelling and irritation to her right posterior arm at varicella injection site. Patient received varicella injection in OH on 4/2/2019. Area raised, small fluid-filled vesicles noted. Patient denied rash anywhere else on her body and reported a localized reaction to her right posterior arm only. Patient also reported weakness, fatigue, and feeling febrile. Temp 98.2 oral. Patient was advised that she may not work in any high-risk areas or with immunocompromised patients until the rash has resolved. Patient stated that she works in the Room and does not have direct patient contact. Patient was instructed to apply cool compresses to the area several times a day, take MOTRIN OTC or other anti-inflammatory medication as directed, and take BENADRYL PRN for itching. Patient was also instructed to follow-up with OH in the morning for re-evaluation of rash/localized reaction. Patient verbalized understanding and denied further questions or concerns at this time. RN. 4/4/2019 at 7 am-Patient presented to OH for re-evaluation of varicella vaccine injection site. Increased redness and swelling noted with large fluid-filled blisters present at injection site. Redness and swelling now extends around the posterior to arm to the right medial and lateral arm. Patient complained of increased pain and generalized feelings of fatigue and malaise. Patient was referred to Clinic for evaluation per an OH medical provider, location chosen per Patient's preference. Patient was instructed to follow-up with OH after her evaluation at Clinic. Patient verbalized understanding and denied further questions or concerns at this time. RN.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Severe pain and swelling to upper arm. Nausea and vomiting during the night. Took ADVIL; applied ice pack, slept intermittently. Severe pain has subsided but still very sore.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Incomplete course of vaccination, Irritability, Pyrexia
Clinical narrative: Fever of 102, fussy but no rash or other Sxs. Had GI Sxs after Rotavirus vaccine - so #2 was not given on this day.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Arthralgia, Bone pain, Inflammation, Insomnia, Middle insomnia
Clinical narrative: At 6pm joint and muscles in legs started hurting, did not have dinner and went to bed. At about 3 a.m. woke up because of pain in joints/bones, inflammation/swelling in hands so took an Aspirin. The Aspirin helped enough to be able to go back to sleep. Patient called doctor in the morning, but was on vacation; called a week later to let them know what was going on. The doctor offered some prescription medicine but patient refused. Pain continued after the day of vaccination and the only way to get some relief was with Aspirin. Patient took Aspirin thru January and then started taking Turmeric, Ginger root, and Cat Claw daily. It took about 1 week to see improvement after taking the supplements. Today, patient is pain free and inflammation is under control as long as taking supplements. Pain was so severe that could not sleep unless took meds. Pain was severe from the onset, did not decrease over time and was worse in hips. Patient has regularly scheduled appointment with doctor for June. Patient reports receiving Flu and shingles vaccines with no problem. Patient is not sure if vaccine administered correctly. Patient received Flu vaccine on September 2018.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: At 6pm joint and muscles in legs started hurting, did not have dinner and went to bed. At about 3 a.m. woke up because of pain in joints/bones, inflammation/swelling in hands so took an Aspirin. The Aspirin helped enough to be able to go back to sleep. Patient called doctor in the morning, but was on vacation; called a week later to let them know what was going on. The doctor offered some prescription medicine but patient refused. Pain continued after the day of vaccination and the only way to get some relief was with Aspirin. Patient took Aspirin thru January and then started taking Turmeric, Ginger root, and Cat Claw daily. It took about 1 week to see improvement after taking the supplements. Today, patient is pain free and inflammation is under control as long as taking supplements. Pain was so severe that could not sleep unless took meds. Pain was severe from the onset, did not decrease over time and was worse in hips. Patient has regularly scheduled appointment with doctor for June. Patient reports receiving Flu and shingles vaccines with no problem. Patient is not sure if vaccine administered correctly. Patient received Flu vaccine on September 2018.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever over 100, chills, headache that lasted approximately 16 hours; Symptoms relieved with TYLENOL, then ADVIL.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Patient got a shingles vaccine at a different pharmacy but reported to us here at other pharmacy. Patient complains of headache, neck pain, neck stiffness, arm pain, and has a red discoloration on the upper arm. Advised patient to go to ER.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Rash macular, Somnolence, Urticaria
Clinical narrative: Mom reported baby had been sleepy since getting vaccines on 4/1/2019. Mom called on 4/2/2019 @ 8:45 pm to report the sleepiness and that baby had hives on left forearm and elbow. Blotchy area on right arm back and chest. Follow-up by phone 4/3/2019. Baby is eating well. Is alert and more wakeful. Marked decrease in all areas of redness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash occurred on hand about a week after vaccination, more pronounced rash occurred on elbow started about a week ago, 3/25/19 ish.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pruritus generalised, Pyrexia
Clinical narrative: FEVER, CHILLS, MYALGIA, FATIGUE, TACHYCARDIA, ITCHING ALL OVER. SYMPTOMS LASTED FOR 36 HOURS.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: FEVER, CHILLS, MYALGIA, FATIGUE, TACHYCARDIA, ITCHING ALL OVER. SYMPTOMS LASTED FOR 36 HOURS.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Localized redness at injection site. Per patient, redness began on 04/02/19 and increased in size by 04/03/19. No swelling noted, patient denies any pain. Erythema area measured 4 in. x 2 1/2 in. and warm to touch.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: None. Pt was erroneously given a Hep B injection when he was supposed to get a Tdap.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 18-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of VAQTA 20/0.5, intramuscularly (exact dose, anatomical location, lot # and expiry date were not provided) for prophylaxis. The patient received the first pediatric dose while he was 18 years old. On an unknown date (reported as recent), the patient received the second pediatric dose of VAQTA 20/0.5 while he was 19 years old. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose about 2 months ago, refer case US2019GSK057627). On 24th March 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever and chills. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was experiencing low grade temperature and chills. She stated that she took some TYLENOL and at the time of reporting she was feeling a bit better.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister rupture, Injection site bruising, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 61-year-old female patient who received SHINGRIX (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis. On 13th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site itching, injection site swelling, injection site blisters, injection site bruising and blister rupture. On an unknown date, the outcome of the injection site itching, injection site swelling, injection site blisters, injection site bruising and blister rupture were unknown. It was unknown if the reporter considered the injection site itching, injection site swelling, injection site blisters, injection site bruising and blister rupture to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of the SHINGRIX vaccine in left deltoid. Within 3 to 4 days, the consumer began to experience itching and swelling at the injection site. This got progressively worse and a bruise developed that had blisters on it. The blisters opened up and the consumer had a depression that was approximately 2 inches long and half inch wide. He said the area looks like it had been scooped off and raw. The health care professional did not diagnose blisters as being a Herpes Zoster rash. The registered pharmacist did mention the word rash at injection site during conversation. The consumer was in the pharmacy and provide permission for her physician to be contacted.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Pain in extremity, Panic attack
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 23rd March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 25th March 2019, the patient experienced shivering and panic attack. On 25th March 2019 05:30, the patient experienced cold sweat. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the shivering was recovered/resolved and the outcome of the panic attack and cold sweat were unknown. It was unknown if the reporter considered the pain in arm, shivering, panic attack and cold sweat to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the left arm. The patient's arm became sore on Saturday and it was still sore at the time of reporting but was resolving. 2 days after receiving SHINGRIX vaccination, on the day of reporting, the patient woke up at 5:30am in the morning with cold sweats. The patient got up and dried himself off and went back to bed at which time he started shivering involuntarily. The patient said it almost felt like he was having a panic attack. The shivering lasted for 15 to 30 minutes and then resolved. The patient did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, 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 72-year-old female patient who received SHINGRIX for prophylaxis. On 26th March 2019, the patient received the 1st dose of SHINGRIX. On 27th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm and myalgia of lower extremities. On an unknown date, the outcome of the pain in arm and myalgia of lower extremities were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and myalgia of lower extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. After vaccination, the patient experienced muscle pain in legs, upper thigh and little in claves. The left arm was sore. There was no consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a 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 month after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Couple of weeks after receiving SHINGRIX, the patient experienced rash. The consent for follow up was declined. The reporter declined to provide patient details or demographics for themselves.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old male patient who received SHINGRIX (batch number GZ29L, expiry date 23rd May 2021) for prophylaxis. On 15th January 2019, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The batch number of SHINGRIX was updated from G729L to GZ29L, as per sales data sheet. The patient experienced redness and soreness at injection site after receiving SHINGRIX vaccine.
Age: 36.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Body temperature increased, Erythema, Injection site swelling, Myalgia, Rash macular
Clinical narrative: Within 1 hour after administration patient called her PCP office with complaints of severe muscle pain, swelling over her entire deltoid, redness, blotchy raised rash, and temp 100.8.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Severe Shivering and now a low grade fever.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Headache, Injection site erythema, Injection site pruritus, Pain
Clinical narrative: Patient reported: fever greater than 101, redness itching at injection site, flushing, generalized body aches, headache. Was seen in emergency department, not in physician's office.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported: fever greater than 101, redness itching at injection site, flushing, generalized body aches, headache. Was seen in emergency department, not in physician's office.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Patient noticed significant swelling within about 2 hours after the injection. She reported it being warm to the touch but not particularly painful. Now two days later the swelling has subsided but is still noticeable.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Tendon pain
Clinical narrative: Head ache, joint pain, tendon pain....symptoms lasted about 24 hours.
Age: 21.0
Sex: F
Vaccine: FLUC4, MENB
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Patient's skin has red raised itchy irregularly shaped patches (hives) on left arm around injection sites and all across her back from shoulders to hips. No discharge, bleeding or other c/o. BENADRYL tablets by mouth as directed with significant improvement noted by client. Denies any other side effects.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Pt presented with a red rash around the injection site, he stated that the he noticed the rash on 04/03/2019 and received the vaccine on 04/01/2019.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Developed a lot of flu like symptoms (chills, feverish, a little weak), soreness at injection site. Thats resolved then developed rash 2 days after (yesterday). This is when he noticed it at least. The rash is on abdomen on both sides. A little itchy. Not painful. Not spreading but is a little more red today. Gets reactions to laundry soap in the same area.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Developed a lot of flu like symptoms (chills, feverish, a little weak), soreness at injection site. Thats resolved then developed rash 2 days after (yesterday). This is when he noticed it at least. The rash is on abdomen on both sides. A little itchy. Not painful. Not spreading but is a little more red today. Gets reactions to laundry soap in the same area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Mom in with the child to show the nurse her left arm where she had reddened area of induration about 3 inches wide and 3 inches long. Denies any fever, nausea, pain, red streaks and the child has been eating and playing as usual. Mom to apply warm compress to child's arm and to seek care of MD or Er if needed and comfort measures discussed.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Diarrhoea, Discomfort, Eye pruritus, Eyelid irritation
Clinical narrative: Eyelids first started feeling burned - woke up next morning face was burnt and peeling - started having diarrhea and stomach cramps - Have a rash that looks like it is under the skin -  Rash comes out at night when I get hot or during the day when I get hot - Eyes and ears itching  - very uncomfortable and starting to get concerned because it is staying with me - Concerned about follow up shot- Feels like I am being stuck with pins. - Anti itch pills seem not to be working.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling hot, Paraesthesia, Pruritus, Rash, Skin exfoliation
Clinical narrative: Eyelids first started feeling burned - woke up next morning face was burnt and peeling - started having diarrhea and stomach cramps - Have a rash that looks like it is under the skin -  Rash comes out at night when I get hot or during the day when I get hot - Eyes and ears itching  - very uncomfortable and starting to get concerned because it is staying with me - Concerned about follow up shot- Feels like I am being stuck with pins. - Anti itch pills seem not to be working.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Rash at injection site and low grade fever. Started on zyrtec and told to FU with any s/sx of cellulitis.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 25-MAR-2019 from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-APR-2014, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a healthcare provider. On an unspecified date, the patient was treated by a nurse practitioner for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Incorrect route of product administration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received the SHINGRIX subcutaneously, which led to incorrect route of vaccine administration. No specific details were provided. For tolerance after 2nd dose refer case US2019GSK059447.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pruritus generalised, Skin lesion
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of generalized pruritus in a 77-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced generalized pruritus, joint pain and skin lesion. The patient was treated with MEDROL. On an unknown date, the outcome of the generalized pruritus, joint pain and skin lesion were unknown. It was unknown if the reporter considered the generalized pruritus, joint pain and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient received SHINGRIX at the pharmacy one month ago. The over the counter product did not work. The reporter agreed to follow from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Incorrect route of product administration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received on an unknown date, refer case US2019AMR056261). On an unknown date, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction and intramuscular formulation administered by other route. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the adverse reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received the SHINGRIX subcutaneously, which led to incorrect route of vaccine administration. The patient had experienced increased adverse reaction. No specific details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Monoplegia, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arm paralysis in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced arm paralysis (serious criteria GSK medically significant) and shoulder pain. On an unknown date, the outcome of the arm paralysis and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the arm paralysis and shoulder pain to be related to SHINGRIX. Additional details were reported as follows: Additional details were reported as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced shoulder pain and at the time of report his arm was still paralyzed. The reporter declined to provide any of her information.
Sex: M
Vaccine: DTAP
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of adverse drug reaction in a child male patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to DTaP vaccine. Additional details were reported as follows: This case was reported by the physician for her son. The age at vaccination was not reported. In 1986, the patient had a reaction to a DTap vaccine (unknown manufacturer). However the reporter was not clear on which vaccine the patient received or when. The reporter disconnected the call before any contact information could be obtained. The reporter stated that she was not able to sue the company and had to go through vaccine court and was not allowed to have an attorney and she had to wait 7 to 8 years. No additional information was available.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th March 2019, 1 days after receiving SHINGRIX, the patient experienced shingles, erythema and blister. On an unknown date, the outcome of the shingles, erythema and blister were unknown. It was unknown if the reporter considered the shingles, erythema and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife, along with the patient was on the line. The patient received a dose of SHINGRIX on the right arm. The patient noticed that, a quarter inch to one inch red line behind his groin area. The next day it broke out with blisters and a new red line appeared on the right back near the waist line. The next day the red line on his back broke out with blisters. The patient went to see his physician on Friday and his physician told that it looks like Shingles. At the time of reporting, there were two more red lines appeared, one next to groin and one his back. The redness had gotten more red since the first time the red line appeared. The patient also casually mentioned that, the patient had read online where people were experiencing similar side effects as his and they were worse with the second dose. The patient did not provide any specific details. No further details were provided. The reporter did not consent to follow up.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of muscle pain in a 35-year-old female patient who received BOOSTRIX (batch number EY273, expiry date 18th March 2019) for prophylaxis. On 22nd March 2019, the patient received BOOSTRIX. In March 2019, less than a week after receiving BOOSTRIX, the patient experienced muscle pain, shoulder pain and neck pain. On 22nd March 2019, the patient experienced expired vaccine used. On an unknown date, the outcome of the muscle pain, shoulder pain, neck pain and expired vaccine used were unknown. It was unknown if the reporter considered the muscle pain, shoulder pain and neck pain to be related to BOOSTRIX. Additional details were provided as follows: The health care professional reported that she inadvertently administered an expired dose of BOOSTRIX to a patient, which was already expired on 18th March 2019. The reporter stated that the patient complained of muscle aches, shoulder and neck pain.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a 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 rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash after the first dose of SHINGRIX. No further details were available. The reporter did not give consent to follow up. The reporter declined to provide the patient identifiers and full demographics for herself. For tolerance to next dose, refer case US2019GSK058541.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Hypoacusis, Injection site erythema
Clinical narrative: Pt states he developed shakes/shivers, fever, lack of hunger, joint pain all over, dry heaves, redness at injection site, and trouble hearing after getting the vaccines. I recommend he call his doctor now.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Retching, Tremor
Clinical narrative: Pt states he developed shakes/shivers, fever, lack of hunger, joint pain all over, dry heaves, redness at injection site, and trouble hearing after getting the vaccines. I recommend he call his doctor now.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Hypoaesthesia, Neurological examination normal, Paraesthesia, Pyrexia
Clinical narrative: Tingling in left and leg, shot was given in left arm, then developed fever and numbness in the left hand and headache. Was advised by pediatrics to go to emergency room if numbness developed or if she got a headache.
Age: 2.0
Sex: F
Vaccine: HEPA, MMRV, PPV
Symptoms: Rash morbilliform
Clinical narrative: Measles-like rash.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site oedema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling, itching at injection site within 24 hrs of injection. 4cm X 4 cm area of redness and edema noted RD.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient's L thigh is red, swollen, hard, and tender to the touch.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Peripheral swelling
Clinical narrative: Left arm turned red then black and blue and swelling.Pt also had 3 intense headaches.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain and soreness since getting the vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Immediately after the injection, my arm started to get sore (10:05 am).  Around 9:30 pm I got severe chills. Arm continues to be sore on day 2. Can't lay on that side.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site warmth, Pain
Clinical narrative: Patient was given the immunization in the afternoon on 3/28/19. On Friday, 3/29/19 the patient reported all over body aches, trouble breathing, and the injection site was red and warm and measured 15X13cm. Sunday 3/31/19 the patient was feeling better.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Influenza like illness, Malaise
Clinical narrative: Pt felt very sick,spent next day in bed with chills, fever, lower back pain on left side, headache that started about 15 minutes after the immunization and over all aching like the flu.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt felt very sick,spent next day in bed with chills, fever, lower back pain on left side, headache that started about 15 minutes after the immunization and over all aching like the flu.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient had a mild rash/few bumps on the trunk under breast on opposite side of where the injection was given.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Middle insomnia, Pruritus, Throat tightness
Clinical narrative: Patient states she woke up in the middle of the night with tightness in her throat, redness and itching on face and chest. She took an antihistamine and did get some relief after taking that and drinking plenty of water.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer and a female patient regarding a case in litigation. In 2015, the then 90 year old patient was prescribed ZOSTAVAX for long term prevention of shingles and zoster related conditions. The patient was administered the vaccine by a pharmacist at a drug store. On an unspecified date the patient was treated by a physician for the following injuries resulting from her ZOSTAVAX use: herpes zoster. Outcome of herpes zoster was not provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Hypersensitivity, Pyrexia, Type I hypersensitivity
Clinical narrative: Information has been received from a pharmacist, via company representative, concerning a female patient of an unspecified age a little over 50 years old. The patient had no pertinent medical history, previously drug reactions, allergies or concurrent conditions reported. Her concomitant medications included an unspecified high blood pressure medication. On an unknown date in March 2019 (reported as: "earlier this week"), the patient was vaccinated with one dose of PNEUMOVAX 23 (strength, dose number, anatomical location, route of administration, lot number and expiration date were not provided), as prophylaxis. Right after PNEUMOVAX 23 vaccination, the patient experienced a "allergic reaction" (type I hypersensitivity); the pharmacist reported the patient also developed a fever and could not breath (dyspnoea) for a few minutes. It took an hour for the patient to fully recover. At the time of the report, it was unknown if patient sought medical attention, if laboratory diagnostics or studies were performed or if she received treatment for the adverse events. The causal relationship between aforementioned adverse events and PNEUMOVAX 23 was not reported. Upon internal review, the type I hypersensitivity was considered a medically significant event.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a unknown gender patient of unknown age. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On 02-APR-2019, the patient was inadvertently administered a dose of VARIVAX which expired on 24-MAR-2019 (lot #: N009766, expiration date: 24-MAR-2019, dose, frequency, route were not reported) for prophylaxis(expired product administered). No adverse effects reported.