chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (did not have any side effects after the 1st dose of SHINGRIX in December 2018). On 9th March 2019, the patient received SHINGRIX. On 10th March 2019, 1 days after receiving SHINGRIX, the patient experienced swelling, tenderness, fever, arthralgia, chills, pain, walking difficulty and bedridden. On 13th March 2019, the outcome of the swelling, tenderness, fever, arthralgia, chills, pain, walking difficulty and bedridden were recovered/resolved. It was unknown if the reporter considered the swelling, tenderness, fever, arthralgia, chills, pain, walking difficulty and bedridden to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the Left deltoid. The events were lasted for 3 days.
Age: 81.0
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 81-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 21st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. In August 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on and experienced soreness in the arm which lasted for about a week. The reporter did not consent to follow-up. This case is 1 of 3 cases reported.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Adverse drug reaction, Chills, Headache, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 7th March 2019, the patient received Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX (intramuscular). On 8th March 2019, 1 days after receiving Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX, the patient experienced fever, chills and headache. On 12th March 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the fever, chills and headache to be related to Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX. Additional details were provided as follows: The patient experienced fever, chills and headache after receiving Flu vaccine and SHINGRIX vaccine. The patient always experiences the events after receiving Flu vaccine. All the events resolved except headache which was worsening and the patient finds it debilitating. The headache started at the back of her eye going down the back of her head to her neck. The patient felt nauseous due to the large amount of pain medication she was taking for the headache. This case is linked to case US2019GSK052355, same patient.
Sex: M
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 73-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the reporter for one of her friend. Age at vaccination was not reported. The patient received a dose of SHINGRIX vaccine and experienced soreness in the arm which was still present at the time of report. This case is 1 of 3 cases reported.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 1st dose of SHINGRIX. On 12th March 2019, 3 hrs after receiving SHINGRIX, the patient experienced muscle pain and fatigue. On an unknown date, the outcome of the muscle pain and fatigue were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: On 12th March 2019, about 3 hours after receiving the SHINGRIX, the patient begun to experience muscle aches and fatigue. The reporter did not consent to follow-up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Product supply issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 67-year-old male patient who received SHINGRIX (batch number 3AF9E, expiry date 3rd February 2021) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 11th March 2019, 173 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The patient was subsequently diagnosed with an episode of shingles. Due to the product being on backorder and due to on-going episode of shingles, the patient had not yet received the second dose. The request for medical information received through request from field representative, agent unable to confirm that field representative previously reported adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Macule, Nausea, 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 adult female patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 2nd dose of SHINGRIX. On 13th March 2019, unknown after receiving SHINGRIX, the patient experienced wrong injection technique. On 14th March 2019, the patient experienced pain in arm, bruise, skin red, nausea and fever. On an unknown date, the outcome of the pain in arm, bruise, skin red, nausea and fever were recovering/resolving and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the pain in arm, bruise, skin red, nausea, fever and wrong injection technique to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. After vaccination with SHINGRIX the patient experienced pain in right arm, bruise, skin red, nausea and fever. The reporter stated that, during the injection, the pharmacist hit a blood vessel which led to wrong injection technique. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vascular injury, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 2nd dose of SHINGRIX. On 13th March 2019, unknown after receiving SHINGRIX, the patient experienced wrong injection technique. On 14th March 2019, the patient experienced pain in arm, bruise, skin red, nausea and fever. On an unknown date, the outcome of the pain in arm, bruise, skin red, nausea and fever were recovering/resolving and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the pain in arm, bruise, skin red, nausea, fever and wrong injection technique to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. After vaccination with SHINGRIX the patient experienced pain in right arm, bruise, skin red, nausea and fever. The reporter stated that, during the injection, the pharmacist hit a blood vessel which led to wrong injection technique. Did not consent to follow-up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Feeling hot, Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose on 10th September 2018, refer case US2019GSK052144). On 27th February 2019, the patient received the 2nd dose of SHINGRIX. On 27th February 2019, several hours after receiving SHINGRIX, the patient experienced fever, chills, myalgia, feeling bad, feeling hot and pain. The patient was treated with TYLENOL and naproxen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills, myalgia, feeling bad, feeling hot and pain were recovered/resolved. The reporter considered the fever, chills, myalgia, feeling bad, feeling hot and pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist for her husband. The patient felt bad after receiving the 1st dose of SHINGRIX, so he did not want to have the second dose. On 27th February 2019, the patient received the dose in the late afternoon. Then by 7 PM that night, he said he was not feeling good and started to get chills, grade 3 fever, hot to touch, myalgia and shivering. On 28th February 2019 (the next morning), patient's fever (body temperature) was 103.8 degree F. The symptoms were not treated the first time. The patient took second injection of extra strength TYLENOL, then he still felt bad so he took 500 mg Naproxen. It took a full 24 hours, the patient started to feel better. The reporter believed that, the symptoms were related to the SHINGRIX. Lab Comments: On 28th February 2019, the patient's body temperature was recorded as 103.8 degree F.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose on 10th September 2018, refer case US2019GSK052144). On 27th February 2019, the patient received the 2nd dose of SHINGRIX. On 27th February 2019, several hours after receiving SHINGRIX, the patient experienced fever, chills, myalgia, feeling bad, feeling hot and pain. The patient was treated with TYLENOL and naproxen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills, myalgia, feeling bad, feeling hot and pain were recovered/resolved. The reporter considered the fever, chills, myalgia, feeling bad, feeling hot and pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist for her husband. The patient felt bad after receiving the 1st dose of SHINGRIX, so he did not want to have the second dose. On 27th February 2019, the patient received the dose in the late afternoon. Then by 7 PM that night, he said he was not feeling good and started to get chills, grade 3 fever, hot to touch, myalgia and shivering. On 28th February 2019 (the next morning), patient's fever (body temperature) was 103.8 degree F. The symptoms were not treated the first time. The patient took second injection of extra strength TYLENOL, then he still felt bad so he took 500 mg Naproxen. It took a full 24 hours, the patient started to feel better. The reporter believed that, the symptoms were related to the SHINGRIX. Lab Comments: On 28th February 2019, the patient's body temperature was recorded as 103.8 degree F.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of ear pain in a 78-year-old female patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis. On 12th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced ear pain. On an unknown date, the outcome of the ear pain was unknown. It was unknown if the reporter considered the ear pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient complained of ear pain starting after she received SHINGRIX vaccine on Tuesday. The pharmacist reported via chat that they might have reported events related to the patient.
Sex: U
Vaccine: FLU4
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown demographic adult patient who experienced allergy to tetanus, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to vaccine (Unknown latency) following the administration of Influenza Quadrival A-B Vaccine. Other relevant tests were not reported. Final diagnosis was allergy to vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to vaccine. List of documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Erythema, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 83-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 11th March 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced dizziness, injection site pain, diarrhea, fever, tremor, difficulty sleeping and erythema of extremities. On an unknown date, the outcome of the dizziness, injection site pain, diarrhea, fever, tremor, difficulty sleeping and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the dizziness, injection site pain, diarrhea, fever, tremor, difficulty sleeping and erythema of extremities to be related to SHINGRIX. Additional case details were provided as follows: The reporter stated that, the patient received 2nd dose of SHINGRIX vaccine in left arm and experienced. She experienced dizziness, pain at injection site, diarrhea, fever, shakiness all over the body, trouble sleeping and her right arm has turned red around the same area as the injection site on her left arm. The patient still experiencing the symptoms, and patient has a physician visit scheduled on the day of reporting. The reporter has been given consent for follow up. This case has been linked to US2019047142, reported by same reporter for his wife.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 83-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 11th March 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced dizziness, injection site pain, diarrhea, fever, tremor, difficulty sleeping and erythema of extremities. On an unknown date, the outcome of the dizziness, injection site pain, diarrhea, fever, tremor, difficulty sleeping and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the dizziness, injection site pain, diarrhea, fever, tremor, difficulty sleeping and erythema of extremities to be related to SHINGRIX. Additional case details were provided as follows: The reporter stated that, the patient received 2nd dose of SHINGRIX vaccine in left arm and experienced. She experienced dizziness, pain at injection site, diarrhea, fever, shakiness all over the body, trouble sleeping and her right arm has turned red around the same area as the injection site on her left arm. The patient still experiencing the symptoms, and patient has a physician visit scheduled on the day of reporting. The reporter has been given consent for follow up. This case has been linked to US2019047142, reported by same reporter for his wife.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Abdominal pain upper, Asthma, Atopy, Disturbance in attention, Dyspnoea
Clinical narrative: Same day sever reaction. High fever 104/105 and trouble breathing took to ER. Was told by ER PA that it was just a cold and to alternate Tylenol and Motrin for fever. That weekend she continued to get worse. She was losing color. She could not focus. She could not stand or hold her head up. Er visit was Friday or Saturday night. I took her in Monday morning first available appointment with her PCM. She was immediately admitted. Her oxygen saturation was dangerously low. She was in the hospital for almost 2 weeks. She now has asthma allergies, allergy shiners, and stomach pains.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Dysstasia, Hypersensitivity, Laboratory test, Oxygen saturation decreased, Pallor
Clinical narrative: Same day sever reaction. High fever 104/105 and trouble breathing took to ER. Was told by ER PA that it was just a cold and to alternate Tylenol and Motrin for fever. That weekend she continued to get worse. She was losing color. She could not focus. She could not stand or hold her head up. Er visit was Friday or Saturday night. I took her in Monday morning first available appointment with her PCM. She was immediately admitted. Her oxygen saturation was dangerously low. She was in the hospital for almost 2 weeks. She now has asthma allergies, allergy shiners, and stomach pains.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Same day sever reaction. High fever 104/105 and trouble breathing took to ER. Was told by ER PA that it was just a cold and to alternate Tylenol and Motrin for fever. That weekend she continued to get worse. She was losing color. She could not focus. She could not stand or hold her head up. Er visit was Friday or Saturday night. I took her in Monday morning first available appointment with her PCM. She was immediately admitted. Her oxygen saturation was dangerously low. She was in the hospital for almost 2 weeks. She now has asthma allergies, allergy shiners, and stomach pains.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein, Cellulitis, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: Patient contacted our office on 3/21/19 to let us know her left arm was hot, red and swollen to the elbow. Patient was directed to UC for assessment. Dx with cellulitis and given one dose of IV antibiotic in clinic and discharged with prescription of oral antibiotic.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, Metabolic function test
Clinical narrative: Patient contacted our office on 3/21/19 to let us know her left arm was hot, red and swollen to the elbow. Patient was directed to UC for assessment. Dx with cellulitis and given one dose of IV antibiotic in clinic and discharged with prescription of oral antibiotic.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein increased, Erythema, Full blood count, Peripheral swelling, Skin warm
Clinical narrative: Patient contacted our office on 3/21/19 to let us know her left arm was hot, red and swollen to the elbow. Patient was directed to UC for assessment. Dx with cellulitis and given one dose of IV antibiotic in clinic and discharged with prescription of oral antibiotic.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced severe pain, swelling and redness at the injection site on 10/18/18.  Patient then started having severe cases of dizziness starting 10/22/18 and continues to this day.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Patient experienced severe pain, swelling and redness at the injection site on 10/18/18.  Patient then started having severe cases of dizziness starting 10/22/18 and continues to this day.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hypokinesia, Insomnia, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Muscles and joint gradually became stiff, sore, and painful over the course of the evening and night after vaccination. By approximately 12 hours after the vaccination, it was difficult to move or sleep because of extreme joint and muscle stiffness. Aspirin had only a minor effect on the stiffness and pain. There was no fever. By about 18 hours after the vaccination, the symptoms began improving, which allowed for some movement and sleep, but I was unable to go to work in the morning (after the vaccination on the previous afternoon). By approximately 24 hours after vaccination, the symptoms started to improve rapidly, finally enabling me to go to work at about 24 hours after vaccination.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscles and joint gradually became stiff, sore, and painful over the course of the evening and night after vaccination. By approximately 12 hours after the vaccination, it was difficult to move or sleep because of extreme joint and muscle stiffness. Aspirin had only a minor effect on the stiffness and pain. There was no fever. By about 18 hours after the vaccination, the symptoms began improving, which allowed for some movement and sleep, but I was unable to go to work in the morning (after the vaccination on the previous afternoon). By approximately 24 hours after vaccination, the symptoms started to improve rapidly, finally enabling me to go to work at about 24 hours after vaccination.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Laboratory test, Pain in extremity, Pyrexia, Rash generalised
Clinical narrative: Same day as shots spiked an extremely high fever 103 and a rash near injection. Called nurses hotline at Clinic was told this is normal. Next day even higher fever 104, full body rash and began to sieze. Took her to the ER. They gave her TYLENOL and prescribed TYLENOL and MOTRIN for fever. Was told to follow up with PCM. Her rash did not go away and she seized on and off. By the time we saw her PCM her rash was going down and her seizure had stopped. Was told by the PCM that she doesn't have anymore vaccines for a while so she should be OK she has complained of her legs hurting and we monitor her for seizures anytime her temperature gets high.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Seizure
Clinical narrative: Same day as shots spiked an extremely high fever 103 and a rash near injection. Called nurses hotline at Clinic was told this is normal. Next day even higher fever 104, full body rash and began to sieze. Took her to the ER. They gave her TYLENOL and prescribed TYLENOL and MOTRIN for fever. Was told to follow up with PCM. Her rash did not go away and she seized on and off. By the time we saw her PCM her rash was going down and her seizure had stopped. Was told by the PCM that she doesn't have anymore vaccines for a while so she should be OK she has complained of her legs hurting and we monitor her for seizures anytime her temperature gets high.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on the arm.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt suffered from redness under injection site and some swelling under injection site.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever coming and going for over 24 hours up to 102.6 (rectal temp).
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal, Immune system disorder, Laboratory test normal
Clinical narrative: Client verbalized she experienced chest heaviness and SOB the following day after recieved the immunization. Client reported to ER as advised by nursing staff and multiple tests ran, including EKG and PE work up. CLient stated she has factor 5, so ER wanted to rule out PE and everything was normal. Client stated O2 sats normal. Client stated ER discharged with no concerns stating "it was a immune response".
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Crying, Erythema of eyelid, Eyelid rash, Irritability, Lacrimation increased
Clinical narrative: Skin around left eye became red and blotchy and left eye started watering. No hives. No wheezing. Rash very localized to the area around left eye and forehead and scalp. He sneezed and cried during this time. Seemed fussy.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Rash, Rash macular, Sneezing
Clinical narrative: Skin around left eye became red and blotchy and left eye started watering. No hives. No wheezing. Rash very localized to the area around left eye and forehead and scalp. He sneezed and cried during this time. Seemed fussy.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Pt is in her trimester of pregnancy. Patient came back one day after the vaccine injection if she need to worry about the swelling she has (just a little bit of swelling), no redness or fever noted. A little pain and a touch of warmness at the injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Administration site bruise, Haemorrhage, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: When the immunization was administered- there was quite a bit of bleeding. The immunization was angled down. Patient had itching at the site the evening following vaccine administration. It was noted to be at least 3 inches long of redness and swelling. It was about 2 inches wide as well. This entire area of swelling was noted approximately 1 inch below administration site. There was a purple circle of bruising around the administration site.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: This is patient's second pregnancy. She was given a dose of Tdap as recommended in third trimester on 1/16/19. Then, at her next prenatal visit, the prior dose was overlooked by the ordering provider and a second dose of the same vaccine was recommended and administered. The patient did not recall or realize she had already received the vaccine, and the medical assistant who administered the shot also did not notice that it had already been given two weeks prior. The patient did NOT have any reaction from the shot, but just received an additional dose.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Zoster Vaccine Recombinant - Second Injection. I experienced dizziness, nausea, fever, extreme body aches and headache and some congestion starting the evening of the day I received the injection, and lasting almost three days.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Zoster Vaccine Recombinant - Second Injection. I experienced dizziness, nausea, fever, extreme body aches and headache and some congestion starting the evening of the day I received the injection, and lasting almost three days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Vomiting
Clinical narrative: Patient had soreness on arm. Chills. Vomiting. Tired.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Administered patient acquired MMR (acquired from Pharmacy) to left thigh on 3/19/2019. On 3/21/2019 received notification that the patient spiked a 104F temperature and suffered a seizure. Patient was transported by ambulance to the local emergency room for evaluation. Patient was evaluated and discharged with diagnosis of fever seizure.
Age: 15.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Cold sweat, Limb discomfort, Pallor, Skin warm, Syncope
Clinical narrative: Parent here requesting vaccinations and TB screening for school entry, no complaints. Patient screening completed, no contraindications to vaccinations noted. Quantiferon-Gold blood specimen collected prior to vaccinations without complications. Informed mother of vaccinations due, Tdap, Hepatitis B, HPV, Meningococcal (MCV4), Influenza and Varicella vaccine. Mother accepted to have only vaccines required for school at this time (Tdap, Hepatitis B and Varicella), mother verbalized understanding. Administered Tdap vaccine on left deltoid, no complaints from patient. Hepatitis B vaccine administered on right deltoid, after administration of Hepatitis B vaccine patient began to complain of right arm feeling heavy. Noted patient becoming pale, clammy, warm to touch and then patient fainted while sitting in the chair, did not fall and did not suffer any injuries. While assisting patient, it was noted that he jumped up and tensed up flexing both arms momentarily. Mother began to scream, and stated "My son had a convulsion!" No uncontrollable muscle spasm/jerking noted, no loss of bowel/bladder control observed, no breathing cessation noted by nurse. Patient stated "my arm began feeling heavy and I began to see blue, and that's when it felt like I fell asleep". Upon noting patient becoming pale, and fainting this nurse began to provide assistance to patient to prevent injury or fall. Clinical nursing staff called and responded to assist. Further assessment included: called patient, responding to name, cold pack and wet towels placed on head and back. Provided apple juice and vitals taken at 2:00PM Blood pressure sitting:100/53, Pulse 58, Respirations: 20. Patient assisted to exam table without incidence, placed lying on left side, repeat vitals at 2:05PM Blood pressure 103/57, Pulse 65 and Respirations: 20, patient oriented to location, self, and time. Provided patient orange juice, and stated "I am feeling better now." Continued to assess patient, patient sitting on edge of exam table, repeat vitals at 2:15PM Blood pressure: 120/77, Pulse: 69, Respirations: 20. Clinical physician came in to evaluate patient, MD indicated "vasovagal syncope". MD assessment: Alert and oriented X 3, no acute distress, heart regular, clear breath sounds. MD recommended to defer varicella vaccine, patient to be discharged home, and to proceed to emergency room if not feeling well. Instructed mother that if she notices that patient gets worse or having an unusual behavior, to take her son to the nearest Emergency room right away. Mother verbalized understanding.
Age: 15.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Tension, Visual impairment
Clinical narrative: Parent here requesting vaccinations and TB screening for school entry, no complaints. Patient screening completed, no contraindications to vaccinations noted. Quantiferon-Gold blood specimen collected prior to vaccinations without complications. Informed mother of vaccinations due, Tdap, Hepatitis B, HPV, Meningococcal (MCV4), Influenza and Varicella vaccine. Mother accepted to have only vaccines required for school at this time (Tdap, Hepatitis B and Varicella), mother verbalized understanding. Administered Tdap vaccine on left deltoid, no complaints from patient. Hepatitis B vaccine administered on right deltoid, after administration of Hepatitis B vaccine patient began to complain of right arm feeling heavy. Noted patient becoming pale, clammy, warm to touch and then patient fainted while sitting in the chair, did not fall and did not suffer any injuries. While assisting patient, it was noted that he jumped up and tensed up flexing both arms momentarily. Mother began to scream, and stated "My son had a convulsion!" No uncontrollable muscle spasm/jerking noted, no loss of bowel/bladder control observed, no breathing cessation noted by nurse. Patient stated "my arm began feeling heavy and I began to see blue, and that's when it felt like I fell asleep". Upon noting patient becoming pale, and fainting this nurse began to provide assistance to patient to prevent injury or fall. Clinical nursing staff called and responded to assist. Further assessment included: called patient, responding to name, cold pack and wet towels placed on head and back. Provided apple juice and vitals taken at 2:00PM Blood pressure sitting:100/53, Pulse 58, Respirations: 20. Patient assisted to exam table without incidence, placed lying on left side, repeat vitals at 2:05PM Blood pressure 103/57, Pulse 65 and Respirations: 20, patient oriented to location, self, and time. Provided patient orange juice, and stated "I am feeling better now." Continued to assess patient, patient sitting on edge of exam table, repeat vitals at 2:15PM Blood pressure: 120/77, Pulse: 69, Respirations: 20. Clinical physician came in to evaluate patient, MD indicated "vasovagal syncope". MD assessment: Alert and oriented X 3, no acute distress, heart regular, clear breath sounds. MD recommended to defer varicella vaccine, patient to be discharged home, and to proceed to emergency room if not feeling well. Instructed mother that if she notices that patient gets worse or having an unusual behavior, to take her son to the nearest Emergency room right away. Mother verbalized understanding.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 20-FEB-2019, the patient was vaccinated with a dose of improperly stored PROQUAD injection, lot # R006216 with expiration date 28-AUG-2019, subcutaneously for prophylaxis. The dose of the vaccines were reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 30 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effect was reported.
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 2015, the patient was inoculated with the ZOSTAVAX vaccine, at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, and on an unknown date, the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-FEB-2019, the patient was vaccinated with improperly stored ROTATEQ (lot # R025732, expiry date: 25-MAR-2020) for prophylaxis (Product storage error). Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported (no adverse event). The outcome of product storage error and no adverse event was unknown. This was five of nine reports mentioned in the report. Sender's Comments: US-009507513-1903USA009054:Master case.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 27-FEB-2019, the patient was vaccinated with improperly stored ROTATEQ (lot # R025732, expiry date: 25-MAR-2020) for prophylaxis (Product storage error). Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported (no adverse event). The outcome of product storage error and no adverse event was unknown. This was six of nine reports mentioned in the report.; Sender's Comments:  US-009507513-1903USA009054:Master case#.
Age: 0.5
Sex: U
Vaccine: RV5, UNK
Symptoms: Pyrexia
Clinical narrative: Information has been received from the physician, via company representative referring to 6 months old patient of an unknown gender. No information was provided regarding the patient's medical history, current conditions or drug reactions or allergies. On 13-MAR-2019, the patient was vaccinated with the third dose of ROTATEQ orally for prophylaxis, with lot number R034700 and expiration date on 16-JUN-2020 (strength, dose, dose number, route of administration and anatomical injection site were not reported). In March 2019 (also reported as "within about 12 hours"), the patient started to have fever of 102. The fever resolved within 24 hours after TYLENOL was given. Other unspecified vaccinations were given at the same time as the dose of ROTATEQ. At the time of the report, the patient recovered from the adverse event and the causality assessment between ROTATEQ and the pyrexia was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included migraine. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to Shingrix. Additional details provided as follows: This case was reported by the patient who herself was a nurse. The age at vaccination was not reported however it could be 59 or 60. The patient received first dose of Shingrix and experienced body aches that lasted for 2 days. For tolerance to 2nd dose, refer case US2019045285
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a 54-year-old female patient who received Shingrix for prophylaxis. On 3rd October 2018, the patient received the 1st dose of Shingrix. In October 2018, less than a week after receiving Shingrix, the patient experienced erythema of extremities and fever. In October 2018, the outcome of the erythema of extremities and fever were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and fever to be related to Shingrix. Additional details were provided as follows: The patient experienced local redness of entire arm from shoulder to elbow and fever in 101 degree F range for 5 days from the vaccination date. In October 2018, the patient's body temperature was recorded as 101 degree F. The reporter did agree to follow up from GlaxoSmithKline and stated that she would like to talk about it.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Hypophagia, Impaired work ability
Clinical narrative: This case was reported by a nurse and described the occurrence of general body pain in a 60-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included migraine. Previously administered products included Shingrix (1st dose received on an unknown date experienced general body pain, refer case US2019AMR045749). On 8th March 2019, the patient received the 2nd dose of Shingrix. In March 2019, less than a week after receiving Shingrix, the patient experienced general body pain, fever, migraine headache, nausea, vomiting, diarrhea, fatigue, upset stomach, decreased appetite, inability to work and unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, fever, migraine headache, nausea, vomiting, diarrhea, fatigue, decreased appetite, inability to work and unwell were recovering/resolving and the outcome of the upset stomach was unknown. It was unknown if the reporter considered the general body pain, fever, migraine headache, nausea, vomiting, diarrhea, fatigue, upset stomach, decreased appetite, inability to work and unwell to be related to Shingrix. Additional details were reported as follows: The patient had been sick since receiving second dose of Shingrix. The patient had fever and body temperature was as high as 102 degrees Fahrenheit.  On 12th March 2019, the body temperature was 100 degrees at the time of reporting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse and described the occurrence of general body pain in a 60-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included migraine. Previously administered products included Shingrix (1st dose received on an unknown date experienced general body pain, refer case US2019AMR045749). On 8th March 2019, the patient received the 2nd dose of Shingrix. In March 2019, less than a week after receiving Shingrix, the patient experienced general body pain, fever, migraine headache, nausea, vomiting, diarrhea, fatigue, upset stomach, decreased appetite, inability to work and unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, fever, migraine headache, nausea, vomiting, diarrhea, fatigue, decreased appetite, inability to work and unwell were recovering/resolving and the outcome of the upset stomach was unknown. It was unknown if the reporter considered the general body pain, fever, migraine headache, nausea, vomiting, diarrhea, fatigue, upset stomach, decreased appetite, inability to work and unwell to be related to Shingrix. Additional details were reported as follows: The patient had been sick since receiving second dose of Shingrix. The patient had fever and body temperature was as high as 102 degrees Fahrenheit.  On 12th March 2019, the body temperature was 100 degrees at the time of reporting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of general body pain in a 60-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included migraine. Previously administered products included Shingrix (1st dose received on an unknown date experienced general body pain, refer case US2019AMR045749). On 8th March 2019, the patient received the 2nd dose of Shingrix. In March 2019, less than a week after receiving Shingrix, the patient experienced general body pain, fever, migraine headache, nausea, vomiting, diarrhea, fatigue, upset stomach, decreased appetite, inability to work and unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, fever, migraine headache, nausea, vomiting, diarrhea, fatigue, decreased appetite, inability to work and unwell were recovering/resolving and the outcome of the upset stomach was unknown. It was unknown if the reporter considered the general body pain, fever, migraine headache, nausea, vomiting, diarrhea, fatigue, upset stomach, decreased appetite, inability to work and unwell to be related to Shingrix. Additional details were reported as follows: The patient had been sick since receiving second dose of Shingrix. The patient had fever and body temperature was as high as 102 degrees Fahrenheit.  On 12th March 2019, the body temperature was 100 degrees at the time of reporting.