chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Anxiety, Asthenia, Body temperature increased, Condition aggravated
Clinical narrative: First symptom occurred several hours after receiving shot, around 2 am. I woke up with pain in my upper stomach which lead to diarrhea. The diarrhea wasn't too bad but throughout the day I was feeling weak from not eating and the stomach pain came and went.  The next day around 2 pm, around 18 hrs after the flu shot, I felt hot and had a mild headache so I check my temperature and it was at 100.5. I took some Tylenol and a cold shower. Around this time I started feeling anxious and a bit paniced. I'm not sure if that's from the flu shot or my generalized anxiety disorder, but I wasn't feeling good so I took a lorazepam pill and went to sleep, around 7pm.  The next day I felt myself again and went through the whole day without a fever or any other symptom. Then around 6pm I experienced my body getting itchy. Upon further inspection I found red patches all over my body. It looked liked hives or an allergic reaction, so I took Benadryl and it went away after some time. The following day I was fine again, but I am noticing small areas with red patches, usually around my legs or hips. They seem to go away without taking any meds, but it is now 3 days with the red patches.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Erythema, Feeling abnormal, Feeling hot, Headache
Clinical narrative: First symptom occurred several hours after receiving shot, around 2 am. I woke up with pain in my upper stomach which lead to diarrhea. The diarrhea wasn't too bad but throughout the day I was feeling weak from not eating and the stomach pain came and went.  The next day around 2 pm, around 18 hrs after the flu shot, I felt hot and had a mild headache so I check my temperature and it was at 100.5. I took some Tylenol and a cold shower. Around this time I started feeling anxious and a bit paniced. I'm not sure if that's from the flu shot or my generalized anxiety disorder, but I wasn't feeling good so I took a lorazepam pill and went to sleep, around 7pm.  The next day I felt myself again and went through the whole day without a fever or any other symptom. Then around 6pm I experienced my body getting itchy. Upon further inspection I found red patches all over my body. It looked liked hives or an allergic reaction, so I took Benadryl and it went away after some time. The following day I was fine again, but I am noticing small areas with red patches, usually around my legs or hips. They seem to go away without taking any meds, but it is now 3 days with the red patches.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Panic reaction, Pruritus
Clinical narrative: First symptom occurred several hours after receiving shot, around 2 am. I woke up with pain in my upper stomach which lead to diarrhea. The diarrhea wasn't too bad but throughout the day I was feeling weak from not eating and the stomach pain came and went.  The next day around 2 pm, around 18 hrs after the flu shot, I felt hot and had a mild headache so I check my temperature and it was at 100.5. I took some Tylenol and a cold shower. Around this time I started feeling anxious and a bit paniced. I'm not sure if that's from the flu shot or my generalized anxiety disorder, but I wasn't feeling good so I took a lorazepam pill and went to sleep, around 7pm.  The next day I felt myself again and went through the whole day without a fever or any other symptom. Then around 6pm I experienced my body getting itchy. Upon further inspection I found red patches all over my body. It looked liked hives or an allergic reaction, so I took Benadryl and it went away after some time. The following day I was fine again, but I am noticing small areas with red patches, usually around my legs or hips. They seem to go away without taking any meds, but it is now 3 days with the red patches.
Age: 67.0
Sex: M
Vaccine: MMRV
Symptoms: Hypertension, Rash
Clinical narrative: A painful rash starting on the ankle and eventually covering  the whole body,  No temperature, blood pressure was high.
Age: 55.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: 11/15/20 pt came in and stated he has constant arm pain in the arm I gave him his flu shot in on 10/30/20. He said when he got the shot it didn't hurt at all. As time went on he noticed pain in his arm (NOT in his shoulder, more in the outside of the arm where the shot goes). Started to hurt part of the day and now he said it hurts all the time.  He showed me his arm. He has a tattoo and he said the inject safe bandaid was right above it, which is in an appropirate location for the shot (not to high). I told him to try apap and heat tonight and call his dr if the pain persists
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Injection site erythema
Clinical narrative: nausea, headache, fever, chills, diarrhea, joint pain, redness at injection sites
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: nausea, headache, fever, chills, diarrhea, joint pain, redness at injection sites
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: pt reports red rash extending from inj site down around arm to elbow. started later in the day after vaccination. Reported initial soreness and redness at inj site on 11/13.  Pt called to report that the redness had gone to the elbow but felt that it was improving with less pain on 11/15.  No angio edema, hives, itching etc.  Rash is not weeping or inflamed. Advised to mark the margin to watch for continued advancing (indicating possible cellulitis).  No reports of fever or other constitutional symptoms.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site nodule
Clinical narrative: Small nodule formed immediately after injecting vaccine. Patient reported no pain. Did not feel warm. Advised patient to ice it, and take ibuprofen and benadryl when she got home. Called patient 4 hours later to check on her. She reported nodule had gotten smaller, and had no pain or shortness of breath. Counseled patient to monitor nodule and contact her doctor if it worsened or did not improve.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Day AFTER vaccination:  -Fatigue -Chills -Queasy  Very sore arm for 5 days
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: 2nd Day: -Fatigue -Chills -Queasy 5 Days: Sore arm
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Flushing, Rash macular
Clinical narrative: patient called to report a reaction which he thinks was attributed to his flu shot. about 30 minutes after, he experienced flushing and hot face. noticed quite red in the face. he thought he looked a little "blotchy" for a while. symptoms were subsiding, but he was planning to take a benadryl or two. pt reported getting flu shots many times in past with no rxn. he did get tested for an allergy to penicillin and the md said while he did not show a allergy to penicillin, he did seem to have an allergy to an "additive".
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Eye irritation, Eye pruritus, Headache
Clinical narrative: 12 hrs after injection the following adverse events occurred Extreme chills Headache Nausea  Low grade fever101 Excessive thirst Eyes burning watering Extreme muscle weakness Then it was next day 14 th and 15 the following symptoms Going on day 3 with muscle weakness, headache,itchy eyes, chest tightness
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Lacrimation increased, Muscular weakness, Nausea, Pyrexia, Thirst
Clinical narrative: 12 hrs after injection the following adverse events occurred Extreme chills Headache Nausea  Low grade fever101 Excessive thirst Eyes burning watering Extreme muscle weakness Then it was next day 14 th and 15 the following symptoms Going on day 3 with muscle weakness, headache,itchy eyes, chest tightness
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Product administered at inappropriate site
Clinical narrative: * pain in shoulder even when not moving arm - might be able to move arm but too much pain * pt thinks RPH injected too high
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: -LT shoulder, deltoid muscle, upper arm pain - Treatment - ice, Ibuprofen and range of motion exercise
Age: 18.0
Sex: F
Vaccine: MNQ, MENB, MNQ
Symptoms: Erythema, Injection site reaction, Rash, Rash erythematous, Urticaria
Clinical narrative: Orbital (eye) swelling; hives on both arms; Redness to face, arms, left and back; Hyperventilation; This case was reported by a nurse via call center representative and described the occurrence of hives in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA384A, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 2022) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included benadryl (nos) (Benadryl).   On 9th October 2020, the patient received Menveo (intramuscular), Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 9th October 2020, less than a day after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced hives (serious criteria clinically significant/intervention required), erythema (serious criteria clinically significant/intervention required) and hyperventilation (serious criteria clinically significant/intervention required). On 10th October 2020, the patient experienced eye swelling (serious criteria clinically significant/intervention required). The patient was treated with prednisone. On 9th November 2020, the outcome of the hives, erythema and eye swelling were recovered/resolved. On an unknown date, the outcome of the hyperventilation was recovered/resolved.   It was unknown if the reporter considered the hives, erythema, hyperventilation and eye swelling to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that patient developed hives on both arms, redness to face, arms, left and back after being administered Menveo and Bexsero vaccinations on 9th October 2020.  On 10th October 2020, patient developed orbital (eye) swelling.  Patient took Benadryl on day of vaccinations 9th October 2020 and was started on prednisone the day after the vaccinations 10th October 2020.  LPN also requested to order vaccinations for allergist to create an allergy shot for patient (potential off-label use) and potential off-label use was not captured as it was not confirmed if belongs to GSK or not. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MNQ, MENB, MNQ
Symptoms: Erythema, Eye swelling, Hyperventilation, Urticaria
Clinical narrative: Orbital (eye) swelling; hives on both arms; Redness to face, arms, left and back; Hyperventilation; This case was reported by a nurse via call center representative and described the occurrence of hives in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA384A, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 2022) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included benadryl (nos) (Benadryl).   On 9th October 2020, the patient received Menveo (intramuscular), Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 9th October 2020, less than a day after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced hives (serious criteria clinically significant/intervention required), erythema (serious criteria clinically significant/intervention required) and hyperventilation (serious criteria clinically significant/intervention required). On 10th October 2020, the patient experienced eye swelling (serious criteria clinically significant/intervention required). The patient was treated with prednisone. On 9th November 2020, the outcome of the hives, erythema and eye swelling were recovered/resolved. On an unknown date, the outcome of the hyperventilation was recovered/resolved.   It was unknown if the reporter considered the hives, erythema, hyperventilation and eye swelling to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that patient developed hives on both arms, redness to face, arms, left and back after being administered Menveo and Bexsero vaccinations on 9th October 2020.  On 10th October 2020, patient developed orbital (eye) swelling.  Patient took Benadryl on day of vaccinations 9th October 2020 and was started on prednisone the day after the vaccinations 10th October 2020.  LPN also requested to order vaccinations for allergist to create an allergy shot for patient (potential off-label use) and potential off-label use was not captured as it was not confirmed if belongs to GSK or not. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Gait disturbance, Pain in extremity, Paraesthesia
Clinical narrative: Increased pins & needles in my right foot & hand occuring several days after shot.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Paraesthesia
Clinical narrative: Increased pins & needles in my right foot & hand occuring several days after shot.
Age: 82.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Pharmacist said to put ice on site which Idid. In 4 hours I had a temp of 99.6-100 degrees with excruciating pain. Went to another pharmacy who said vac was injected into a Bursa. For 5 weeks pain persisted then double vision started and dizziness, loss of equilibrium Went to Retinologist who said nothing wrong with my eyes. Something wrong in my brain MRI scheduled for 11/14/20
Age: 82.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Balance disorder, Diplopia, Dizziness, Pain, Pyrexia
Clinical narrative: Pharmacist said to put ice on site which Idid. In 4 hours I had a temp of 99.6-100 degrees with excruciating pain. Went to another pharmacy who said vac was injected into a Bursa. For 5 weeks pain persisted then double vision started and dizziness, loss of equilibrium Went to Retinologist who said nothing wrong with my eyes. Something wrong in my brain MRI scheduled for 11/14/20
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site discomfort, Pain, Wrong technique in product usage process
Clinical narrative: On the afternoon of October 26, 2020, Patient called Clinic. The client stated, ?I went to the flu clinic at the school [on 10/08/2020].  I don?t know if I should have talked to someone sooner or not.?  She went on to explain that receiving her flu vaccine was an experience unlike one she had ever experienced when receiving a vaccine.  She reported waiting in the waiting area in her car for the recommended timeframe, and then went home, as nothing seemed off after the waiting period.  She stated that one of the nurses "gave me the shot right on the corner of my shoulder ? much higher than I?ve ever gotten a shot before.?  She reports having felt a very odd sensation as the needle and fluid went into her shoulder, but in the ten minutes following, everything felt fine.  That night as she was getting ready for bed she thought that's when ?it started going bad on me.?  Since her flu vaccine on October 8, she noticed that her symptoms would come and go. However, in later part of October she described that her symptoms became much worse and possibly becoming permanent. She stated, ?Now I am pretty much unable to use my arm.  I can?t pull the covers up when I?m in bed, I can?t raise it to put a shirt on.  I?m just unable to use it at all.?  She also stated that she had done some research and was concerned about SIRVA (shoulder injury related to vaccine administration), and had learned about accurate vaccine placement.  ?I know Google isn?t the best place to go for research, but from what I read, my flu shot was done wrong, and I?m really worried that it?s going to be permanent.? She was encouraged her to see her primary provider and report her signs and symptoms to VAERS.  She was provided with the information she would need to complete the report (vaccine manufacturer, lot number, expiration date).  We followed up with the client after her visit with her primary care provider and she reported that she will need to continue to have multiple provider appointments, including physical therapy appointments for the foreseeable future in order to regain use of her affected arm.  She suspects that the injury was caused by inaccurate placement of injection (i.e. in the shoulder joint rather than the intramuscular tissue).  The injection was performed by a nursing student under the observation of an clinic nurse. The nurse does not recall witnessing an injection placed into a shoulder joint during the flu clinic but considers that it may be possible.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site reaction, Loss of personal independence in daily activities, Musculoskeletal disorder, Product administered at inappropriate site, Sensory disturbance
Clinical narrative: On the afternoon of October 26, 2020, Patient called Clinic. The client stated, ?I went to the flu clinic at the school [on 10/08/2020].  I don?t know if I should have talked to someone sooner or not.?  She went on to explain that receiving her flu vaccine was an experience unlike one she had ever experienced when receiving a vaccine.  She reported waiting in the waiting area in her car for the recommended timeframe, and then went home, as nothing seemed off after the waiting period.  She stated that one of the nurses "gave me the shot right on the corner of my shoulder ? much higher than I?ve ever gotten a shot before.?  She reports having felt a very odd sensation as the needle and fluid went into her shoulder, but in the ten minutes following, everything felt fine.  That night as she was getting ready for bed she thought that's when ?it started going bad on me.?  Since her flu vaccine on October 8, she noticed that her symptoms would come and go. However, in later part of October she described that her symptoms became much worse and possibly becoming permanent. She stated, ?Now I am pretty much unable to use my arm.  I can?t pull the covers up when I?m in bed, I can?t raise it to put a shirt on.  I?m just unable to use it at all.?  She also stated that she had done some research and was concerned about SIRVA (shoulder injury related to vaccine administration), and had learned about accurate vaccine placement.  ?I know Google isn?t the best place to go for research, but from what I read, my flu shot was done wrong, and I?m really worried that it?s going to be permanent.? She was encouraged her to see her primary provider and report her signs and symptoms to VAERS.  She was provided with the information she would need to complete the report (vaccine manufacturer, lot number, expiration date).  We followed up with the client after her visit with her primary care provider and she reported that she will need to continue to have multiple provider appointments, including physical therapy appointments for the foreseeable future in order to regain use of her affected arm.  She suspects that the injury was caused by inaccurate placement of injection (i.e. in the shoulder joint rather than the intramuscular tissue).  The injection was performed by a nursing student under the observation of an clinic nurse. The nurse does not recall witnessing an injection placed into a shoulder joint during the flu clinic but considers that it may be possible.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Discomfort, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Fever of up to 100 degrees F; loss of appetite; injection site sorness; shivering; extremely nauseous; to bathroom to throw up; dry heaves; Sweated through night clothes; Mild muscle aches; Slept intermittently; moderate fatigue; This case was reported by a consumer and described the occurrence of shivering in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Please refer the 1st dose case US2020AMR218334).   On 31st October 2020 16:00, the patient received the 2nd dose of Shingrix. On 1st November 2020, 1 days after receiving Shingrix, the patient experienced appetite lost. In November 2020, the patient experienced shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue and injection site pain. On an unknown date, the patient experienced fever. On 2nd November 2020, the outcome of the shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue, appetite lost and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue, appetite lost, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: On 31st October 2020 about 4 PM, the patient received 2nd dose of vaccination. The patient woke up about 2:30 am to use restroom and was shivering. After return to bed became extremely nauseous. Went back to bathroom to throw up; only had dry heaves. Sweated through night clothes. Mild muscle aches. Slept intermittently.  On 01st November 2020, moderate fatigue and loss of appetite. fever of up to 100 degrees F. Temperature normal at 11 pm. Events resolved as of 02 Nov morning. In my opinion, related to second Shingrix injection. TTO has been corrected; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR218334:same patient
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Retching, Sleep disorder, Vaccination site pain
Clinical narrative: Fever of up to 100 degrees F; loss of appetite; injection site sorness; shivering; extremely nauseous; to bathroom to throw up; dry heaves; Sweated through night clothes; Mild muscle aches; Slept intermittently; moderate fatigue; This case was reported by a consumer and described the occurrence of shivering in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Please refer the 1st dose case US2020AMR218334).   On 31st October 2020 16:00, the patient received the 2nd dose of Shingrix. On 1st November 2020, 1 days after receiving Shingrix, the patient experienced appetite lost. In November 2020, the patient experienced shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue and injection site pain. On an unknown date, the patient experienced fever. On 2nd November 2020, the outcome of the shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue, appetite lost and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue, appetite lost, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: On 31st October 2020 about 4 PM, the patient received 2nd dose of vaccination. The patient woke up about 2:30 am to use restroom and was shivering. After return to bed became extremely nauseous. Went back to bathroom to throw up; only had dry heaves. Sweated through night clothes. Mild muscle aches. Slept intermittently.  On 01st November 2020, moderate fatigue and loss of appetite. fever of up to 100 degrees F. Temperature normal at 11 pm. Events resolved as of 02 Nov morning. In my opinion, related to second Shingrix injection. TTO has been corrected; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR218334:same patient
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Injection site pain
Clinical narrative: Fever of up to 100 degrees F; loss of appetite; injection site sorness; shivering; extremely nauseous; to bathroom to throw up; dry heaves; Sweated through night clothes; Mild muscle aches; Slept intermittently; moderate fatigue; This case was reported by a consumer and described the occurrence of shivering in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Please refer the 1st dose case US2020AMR218334).   On 31st October 2020 16:00, the patient received the 2nd dose of Shingrix. On 1st November 2020, 1 days after receiving Shingrix, the patient experienced appetite lost. In November 2020, the patient experienced shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue and injection site pain. On an unknown date, the patient experienced fever. On 2nd November 2020, the outcome of the shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue, appetite lost and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue, appetite lost, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: On 31st October 2020 about 4 PM, the patient received 2nd dose of vaccination. The patient woke up about 2:30 am to use restroom and was shivering. After return to bed became extremely nauseous. Went back to bathroom to throw up; only had dry heaves. Sweated through night clothes. Mild muscle aches. Slept intermittently.  On 01st November 2020, moderate fatigue and loss of appetite. fever of up to 100 degrees F. Temperature normal at 11 pm. Events resolved as of 02 Nov morning. In my opinion, related to second Shingrix injection. TTO has been corrected; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR218334:same patient
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Retching, Sleep disorder
Clinical narrative: Fever of up to 100 degrees F; loss of appetite; injection site sorness; shivering; extremely nauseous; to bathroom to throw up; dry heaves; Sweated through night clothes; Mild muscle aches; Slept intermittently; moderate fatigue; This case was reported by a consumer and described the occurrence of shivering in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Please refer the 1st dose case US2020AMR218334).   On 31st October 2020 16:00, the patient received the 2nd dose of Shingrix. On 1st November 2020, 1 days after receiving Shingrix, the patient experienced appetite lost. In November 2020, the patient experienced shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue and injection site pain. On an unknown date, the patient experienced fever. On 2nd November 2020, the outcome of the shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue, appetite lost and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue, appetite lost, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: On 31st October 2020 about 4 PM, the patient received 2nd dose of vaccination. The patient woke up about 2:30 am to use restroom and was shivering. After return to bed became extremely nauseous. Went back to bathroom to throw up; only had dry heaves. Sweated through night clothes. Mild muscle aches. Slept intermittently.  On 01st November 2020, moderate fatigue and loss of appetite. fever of up to 100 degrees F. Temperature normal at 11 pm. Events resolved as of 02 Nov morning. In my opinion, related to second Shingrix injection. TTO has been corrected; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR218334:same patient
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Fever of up to 100 degrees F; loss of appetite; injection site sorness; shivering; extremely nauseous; to bathroom to throw up; dry heaves; Sweated through night clothes; Mild muscle aches; Slept intermittently; moderate fatigue; This case was reported by a consumer and described the occurrence of shivering in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Please refer the 1st dose case US2020AMR218334).   On 31st October 2020 16:00, the patient received the 2nd dose of Shingrix. On 1st November 2020, 1 days after receiving Shingrix, the patient experienced appetite lost. In November 2020, the patient experienced shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue and injection site pain. On an unknown date, the patient experienced fever. On 2nd November 2020, the outcome of the shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue, appetite lost and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the shivering, nausea, vomiting, dry heaves, sweating, muscle pain, sleep disorder, fatigue, appetite lost, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: On 31st October 2020 about 4 PM, the patient received 2nd dose of vaccination. The patient woke up about 2:30 am to use restroom and was shivering. After return to bed became extremely nauseous. Went back to bathroom to throw up; only had dry heaves. Sweated through night clothes. Mild muscle aches. Slept intermittently.  On 01st November 2020, moderate fatigue and loss of appetite. fever of up to 100 degrees F. Temperature normal at 11 pm. Events resolved as of 02 Nov morning. In my opinion, related to second Shingrix injection. TTO has been corrected; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR218334:same patient
Age: 29.0
Sex: M
Vaccine: FLU4, FLUA3
Symptoms: Intensive care, Meningitis bacterial, Pyrexia
Clinical narrative: Patient father stated patient was feeling awkward from the vaccination. The next morning of 11/7/2020 his father gave him water for his fever. The father left home upon arrival patient was unresponsive he called 911.His brain is swollen, on dialysis and on life support. He has had several tests done MRI and test done. The physician is not certain the diagnosis however does believe the vaccination has a effect.
Age: 29.0
Sex: M
Vaccine: FLU4, FLUA3
Symptoms: Brain oedema, Dialysis, Feeling abnormal, Laboratory test, Life support
Clinical narrative: Patient father stated patient was feeling awkward from the vaccination. The next morning of 11/7/2020 his father gave him water for his fever. The father left home upon arrival patient was unresponsive he called 911.His brain is swollen, on dialysis and on life support. He has had several tests done MRI and test done. The physician is not certain the diagnosis however does believe the vaccination has a effect.
Age: 29.0
Sex: M
Vaccine: FLU4, FLUA3
Symptoms: Magnetic resonance imaging, Pyrexia, Unresponsive to stimuli, Vaccination complication
Clinical narrative: Patient father stated patient was feeling awkward from the vaccination. The next morning of 11/7/2020 his father gave him water for his fever. The father left home upon arrival patient was unresponsive he called 911.His brain is swollen, on dialysis and on life support. He has had several tests done MRI and test done. The physician is not certain the diagnosis however does believe the vaccination has a effect.
Age: 19.0
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: a patient got Varicella 6 months after the patient got the VARIVAX; This spontaneous report was received from a consumer referring to a currently 19 years old patient (gender unspecified). The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.   On 02-APR-2020, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, strength and route not provided; Lot No. S019584 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date not reported, but upon internal validation established as 25-JUN-2021) for prophylaxis.   The patient got varicella 6 months after the vaccination on an unspecified date in October 2020. Whether the patient had sought medical attention, lab diagnostics/studies were performed or treatment was given was not reported. After that, no more information was provided on case. The outcome of the event was unknown.   The causality between the event and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored VARIVAX administration; No adverse experience; This spontaneous report was received from a registered nurse referring to a patient (age and gender unspecified). The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 19-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# T012551, expiration date 10-APR-2022, exact doses and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature excursion between 6 degrees Fahrenheit (F) to 14F with an average of 11.8F for 31 hours. The data logger was involved. No previous temperature excursion was reported.  On 04-NOV-2020, an inbound call was performed and the reporter stated that the vaccines were all still viable and that she was unsure of the number of minutes that the vaccines underwent the temperature excursion. The reporter reported that there were no adverse experiences as a result of the temperature excursion.  This is one of three cases from the same reporter (same reporter link # 2010USA011004 and 2010USA010839).; Sender's Comments:  US-009507513-2010USA011004: US-009507513-2010USA010839:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered
Clinical narrative: partial dose ofMMR II administered; This spontaneous report was received from a nurse referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.       On 30-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5 ml, strength, route, lot# and expiration date were not reported) for prophylaxis. Partial dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered to the patient due to the patient moved during injection (incorrect dose administered).
Sex: F
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: Patient was administered a dose of MMR II that was reconstituted with a diluent other than the Merck supplied sterile diluent; This spontaneous report was received from a pharmacist referring to a 37-year-old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 30-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength was not reported) 0.5 milliliter as prophylaxis (lot # was S035352 and expiration date was 05-NOV-2021). The vaccine  was reconstituted with a diluent other than the Merck supplied sterile diluent (product preparation error). The reporter stated that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with "sterile water". The reporter requested if patient would need to be re-vaccinated.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional adverse effect reported; expired M-M-R II was inadvertently administered on 11/2/2020; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 02-NOV-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number: S013711, expiration date: 01-NOV-2020, dose and route of administration were not provided). No additional adverse effect was reported.  Lot number S013711 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Lot number S013711 is a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD).
Sex: F
Vaccine: MMR, MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient received PROQUAD and VARIVAX instead of MMR II and VARIVAX.; This spontaneous report was received from a registered nurse refers to a 12-months-old female patient. Information regarding the patient's concurrent condition, pertinent medical history, known allergies and concomitant medications was not provided.     On 04-NOV-2020, the patient was accidently administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # T021300, expiration date reported and validated as 19-FEB-2020) with virus vaccine live (oka/merck) (VARIVAX) for prophylaxis. The patient was supposed to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, route, lot # and expiration date were not reported)and virus vaccine live (oka/merck) (VARIVAX) but received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered).
Age: 1.25
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: a patient received MMRII, VARIVAX, and PREVNAR 13 on 3/4/2020 and experienced hives in lower extremities on 3/6/2020.; This spontaneous report was received from a physician referring to a 15-month-old female patient.  The patient's concurrent conditions included a urinary tract infection.  The patient did not have known allergies or concomitant therapies.   On 04-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028919, exp date reported as 16-JUL-2021, but validated as 16-SEP-2021 , subcutaneously as recommended immunization (dose, dose number were not reported), also received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA (recombinant human albumin), lot # S007814, exp date: 14-MAR-2021 (dose, route, dose number were not reported), and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (dose, route, dose number, lot and exp date were not reported) both as prophylaxis.    On 06-MAR-2020, experienced hives in lower extremities.  The patient received medical attention, and the physician reported the patient received diphenhydramine (BENADRYL) for her hives, laboratory tests were not performed, and she recovered on 07-MAR-2020.   The relatedness of hives in lower extremities and varicella virus vaccine live (oka/merck)(VARIVAX); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), and pneumococcal 13v conj vaccine (crm197)(PREVNAR) was not reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: an expired PROQUAD vaccine was given to a 4 year old; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported.  On 05-NOV-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA (recombinant Human albumin) (PROQUAD) 2nd dose/ 2 dose series (dose, strength, route of administration and anatomical site of vaccination were not reported, lot # S013713, expiration date reported and validated as 01-NOV-2020)for prophylaxis (expired product administered). The outcome of expired product administered was unknown. The nurse would like to know what they should do regard revaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 25-JUL-2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date (reported as shortly after the vaccination), the patient suffered a bad case of the shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), her symptoms have resulted in physical limitations not present prior to using the product. Patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of shingles was considered as not recovered. The reporter considered the event to be disable and related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; Expired dose of RECOMBIVAX HB ( expiration date: 11/09/2020) was administered to a 2 week old patient today.; This spontaneous report has been received from a medical assistant, referring to a 2-week-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 10-NOV-2020, the patient received an expired dose of vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose reported as 0.5 milliliter (route of administration, vaccine scheme, and anatomical location were not provided; lot number R006746 has been verified to be a valid lot number, expiration date reported as 09-NOV-2020), as prophylaxis. No additional adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: shingles/painful blisters across her abdomen and back and was diagnosed with shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 14-NOV-2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date (reported as shortly after the vaccination), the patient suffered painful blisters across her abdomen and back and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), her symptoms have resulted in physical limitations not present prior to using the product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of shingles was considered as not recovered. The reporter considered the event to be disable and related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient experienced vaccination failure and shingles after receiving both the doses of Shingrix in last year. This case was considered as suspected vaccination failure as the details regarding laboratory confirmation were unknown at the time of reporting. The patient was asking, why did he experience shingles even after taking the shingrix shots. Consent to follow up has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Mouth swelling, Pharyngeal swelling
Clinical narrative: Throat swelling after Fluarix injection; Mouth swelling after Fluarix injection; This case was reported by a other health professional via sales rep and described the occurrence of throat swelling in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced throat swelling and swollen mouth. On an unknown date, the outcome of the throat swelling and swollen mouth were unknown.   It was unknown if the reporter considered the throat swelling and swollen mouth to be related to Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced both throat and mouth swelling after Fluarix injection.