chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes ophthalmic in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ACE inhibitors with an associated reaction of anaphylactic reaction. Concurrent medical conditions included implantable defibrillator insertion (in 2005), supraventricular tachycardia and allergy (Penicillin). Concomitant products included Aspirin, Probiotics), vitamin B complex, vitamin D, Calcium, Coreg, Crestor, hydrochlorothiazide, Dyazide, glucosamine, omeprazole, Co Q 10 and verapamil. On 4th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a year after receiving SHINGRIX, the patient experienced blurred vision. On 20th May 2018, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and eye irritation. On an unknown date, the outcome of the herpes ophthalmic was not recovered/not resolved and the outcome of the eye irritation and blurred vision were unknown. The reporter considered the herpes ophthalmic to be related to SHINGRIX. It was unknown if the reporter considered the eye irritation and blurred vision to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant medication included multivitamins. After 16 days of vaccination, the patient reported that the she experienced irritation in the right eye while on vaccination and upon return to home, she was seen by ophthalmologist and diagnosed with herpetic infection in that eye. The patient reported that she experienced irritation and blurry vision in the eye, at the time of reporting, as a result as an infection and that it had not responded to antiviral eye drops. The patient reported that the vision had gotten worse since diagnosis. The reporter unable to provide full demographics for the pharmacy or her ophthalmologist. The representative researched the data to saw if there was any similar report. There were no reports. The call center representative taken patient's physician contact for further information, so that he could contact them.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Colonoscopy normal, Haematochezia, Pain, Rectal haemorrhage
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of general body pain in a 83-year-old female patient who received SHINGRIX (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. On 16th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 16th May 2018, 3 hrs 42 min after receiving SHINGRIX, the patient experienced general body pain (serious criteria disability). On 21st May 2018, the patient experienced rectal bleeding (serious criteria disability and GSK medically significant) and blood in stool (serious criteria disability and GSK medically significant). On 25th May 2018, the outcome of the rectal bleeding and blood in stool were recovered/resolved. 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, rectal bleeding and blood in stool to be related to SHINGRIX. Additional details were provided as follows: This case was reported by Certified Medical Assistant (CMA). At 11:18 hours, the patient received SHINGRIX in the left deltoid. At 03:00 in afternoon, the patient experienced body aches. The patient spent the next three days at home recovering and she felt better by the weekend (unknown date in May 2018). On 21st May 2018, 5 days after vaccination the patient had rectal bleeding and also it was described as blood in stool. On 23rd May 2018 Wednesday, the patient visited the office. On 1st June 2018, the patient underwent colonoscopy that showed no cause for the bleeding.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Hyperhidrosis, Loss of consciousness, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 56-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included omeprazole (Prilosec). On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st May 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain. On 2nd May 2018, the patient experienced passed out (serious criteria GSK medically significant), nausea, blood pressure decreased, sweating and fever. On an unknown date, the outcome of the passed out, general body pain, nausea, blood pressure decreased, sweating and fever were recovered/resolved. The reporter considered the passed out, general body pain, nausea, blood pressure decreased, sweating and fever to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included supplements. The patient received SHINGIRX on right arm. The patient experienced mild body aches began in evening on the day of vaccination and became more severe on next day. On 2nd May 2018, the patient felt nauseous but did not vomit. The patient was passed out on bathroom floor (while feeling nauseous). The patient was thinking passing out might have been related to decreased blood pressure. The patient moved to her bed where she experienced incredible body sweats for the remainder of the day. The patient did not take her temperature but felt that she might have had a fever.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 56-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included omeprazole (Prilosec). On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st May 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain. On 2nd May 2018, the patient experienced passed out (serious criteria GSK medically significant), nausea, blood pressure decreased, sweating and fever. On an unknown date, the outcome of the passed out, general body pain, nausea, blood pressure decreased, sweating and fever were recovered/resolved. The reporter considered the passed out, general body pain, nausea, blood pressure decreased, sweating and fever to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included supplements. The patient received SHINGIRX on right arm. The patient experienced mild body aches began in evening on the day of vaccination and became more severe on next day. On 2nd May 2018, the patient felt nauseous but did not vomit. The patient was passed out on bathroom floor (while feeling nauseous). The patient was thinking passing out might have been related to decreased blood pressure. The patient moved to her bed where she experienced incredible body sweats for the remainder of the day. The patient did not take her temperature but felt that she might have had a fever.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 76-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms and myalgia. On an unknown date, the outcome of the influenza-like symptoms and myalgia were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and myalgia to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a nurse practitioner. The nurse practitioner reported that the patient experienced significant myalgias and developed severe flu like symptoms within 12 hours of receiving SHINGRIX. The reporter stated that the patient stated that it was an awful experience and lasted upwards of an entire week. The nurse practitioner did not feel like the patient would be willing to receive the second dose of the SHINGRIX vaccine. The nurse practitioner stated that she would be unable to provide any more specifics since she could not recall the patient name to identify them in their medical records. This case was linked with US2018GSK082079 and US2018GSK082075, reported by the same reporter.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Induration, Rash
Clinical narrative: Large area of rash and induration for just over 2 weeks, self resolved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Thyroid disorder
Clinical narrative: The patient received the first dose on 4/13/18, on 4/17/18 the patient went in to the doctor and had blood work done that determined she had altered thyroid function. The patient was then prescribed Levothyroxine 25mcg (which she did not pick up). When she was tested again a week later, her thyroid levels were back to normal.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Fatigue, Headache
Clinical narrative: Left arm very red, painful and hot to touch. Headache, muscle pain, vomiting, stomach pain, fever 100.4 F, chills. Fatigue.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia, Skin warm, Vomiting
Clinical narrative: Left arm very red, painful and hot to touch. Headache, muscle pain, vomiting, stomach pain, fever 100.4 F, chills. Fatigue.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Disturbance in attention, Feeling abnormal, Headache, Neck pain
Clinical narrative: Patient reported after receiving the vaccine that their arm hurt (felt like a "shooting pain") and the pain did not dull or go away. The pain traveled to the patients neck and head. They also reported that they did not feel like eating and felt they could not concentrate or "felt out of it".
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reported after receiving the vaccine that their arm hurt (felt like a "shooting pain") and the pain did not dull or go away. The pain traveled to the patients neck and head. They also reported that they did not feel like eating and felt they could not concentrate or "felt out of it".
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Vomiting, Patient comforted. Provider with patient with parent. Vital Signs performed. PO Hydration tolerated.. Discharged to home on  June 11, 2018. Follow up on 06/12/2018, spoke with parent. No complaints offered.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Injection site abscess, Injection site discharge, Injection site induration, Injection site reaction, Purulent discharge
Clinical narrative: Following administration of vaccine (oral rotavirus and DTAP/Polio/IPV given on contralateral thigh) to R thigh, induration noted which did not improve, and eventually started to drain pustular material. Surgical consultation and U/S of soft tissue found features c/w abcess, however surgical I&D cancelled as lesion auto resolved ~3 months later. Subsequent 3rd dose of same vaccine to different location on same thigh 5/8/18 resulted in another large probable abscess at the site (presently 3x3.5cm), prompting allergy and surgery consultations.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Skin lesion, Ultrasound scan abnormal
Clinical narrative: Following administration of vaccine (oral rotavirus and DTAP/Polio/IPV given on contralateral thigh) to R thigh, induration noted which did not improve, and eventually started to drain pustular material. Surgical consultation and U/S of soft tissue found features c/w abcess, however surgical I&D cancelled as lesion auto resolved ~3 months later. Subsequent 3rd dose of same vaccine to different location on same thigh 5/8/18 resulted in another large probable abscess at the site (presently 3x3.5cm), prompting allergy and surgery consultations.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Burning sensation, Dizziness, Feeling cold, Headache
Clinical narrative: At injection site: extreme soreness, hot to touch for 3 days, itch on 4th day. Lungs and airways felt constricted and painful to breathe for two straight days, third day mild pain/constriction. Body cold yet injection site felt hot, then would feel like my whole body was on fire. Headache pretty much continuous for 3 days, dizzy for 2 days, upset raw feeling upper abdomen for 2 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Pain, Painful respiration
Clinical narrative: At injection site: extreme soreness, hot to touch for 3 days, itch on 4th day. Lungs and airways felt constricted and painful to breathe for two straight days, third day mild pain/constriction. Body cold yet injection site felt hot, then would feel like my whole body was on fire. Headache pretty much continuous for 3 days, dizzy for 2 days, upset raw feeling upper abdomen for 2 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: At injection site: extreme soreness, hot to touch for 3 days, itch on 4th day. Lungs and airways felt constricted and painful to breathe for two straight days, third day mild pain/constriction. Body cold yet injection site felt hot, then would feel like my whole body was on fire. Headache pretty much continuous for 3 days, dizzy for 2 days, upset raw feeling upper abdomen for 2 days.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The updated immunization record was misfiled and a outdated immunization was looked at and the decision to give Hep A, MENVEO, and GARDASIL 9 was made. Later, the updated immunization record was found and an extra dose of Hep A, and GARDASIL 9 was given. No harm to patient.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Loss of personal independence in daily activities, Nausea, Pain, Pyrexia
Clinical narrative: My comment is that I had the full blown side effect of "not being able to perform normal daily tasks for 2 days!" I had the fever, chills, nausea, total body aches and soreness. It was awful... my question is that I have to get the second dose in August and I don't want to be that sick again! My PCP says I might ......what do you think?? Is it effective if I just have the 1 dose? Thank you.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Limb mass
Clinical narrative: She developed a lump on arm and flu like symptoms and felt flu like sickness for days to follow.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: SHINGRIX vaccine received on 5/07. The following day (5/08), the patient experienced flu-like symptoms and subsequently L-sided pain with eventual development of L T10-11 vesicular rash (first noted 5/13). He sought care in the ED and was diagnosed with shingles and prescribed valacyclovir. Symptoms have improved on antiviral therapy but with residual post-herpetic neuralgia.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Felt tired, had muscle pain, headache, shivering, fever. Bed rest for two days. Back to normal.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given KINRIX at 2yr7m instead of two seperate vaccines as his age would dictate.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Blood test normal, Computerised tomogram abdomen normal, Computerised tomogram pelvis
Clinical narrative: 2 days following the injection began to have back and stomach pains Day three pains got worse and felt as though it might be my appendix. Got an appt with Dr Tues the following week Upon examining me I was sent to the emergency room for blood work and a Ct scan Blood work came back negative Ct scan was done the next day outside the hospital. Was informed by Dr that No appendicitis present. 9 days after the shot all symptoms no longer there.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Decreased appetite, Dysphagia, Hyperhidrosis, Pyrexia, Rash
Clinical narrative: 5/11/2018 Fevers of 103 x 4 days, 5/11/2018 severe sweating during sleep x2 weeks, 5/13/2018 difficulty swallowing  and poor appetite, diagnosed with tonsillitis, 5/14/2018 rash and swelling, difficulty swallowing, 5/16/2018 severe rash and swelling.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Swelling, Tonsillitis
Clinical narrative: 5/11/2018 Fevers of 103 x 4 days, 5/11/2018 severe sweating during sleep x2 weeks, 5/13/2018 difficulty swallowing  and poor appetite, diagnosed with tonsillitis, 5/14/2018 rash and swelling, difficulty swallowing, 5/16/2018 severe rash and swelling.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: Left Arm went Red, swollen and very painful starting 24 hours after SHINGRIX given. Pain started in Left shoulder down to left wrist. Rates pain on 1-10 scale as 8. Tried TYLENOL, ALEVE and Naproxen, without much success. Massage and rubbing helped to lessen pain for a time. Redness, and swelling went away. Pain remained until first part of May.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Left Arm went Red, swollen and very painful starting 24 hours after SHINGRIX given. Pain started in Left shoulder down to left wrist. Rates pain on 1-10 scale as 8. Tried TYLENOL, ALEVE and Naproxen, without much success. Massage and rubbing helped to lessen pain for a time. Redness, and swelling went away. Pain remained until first part of May.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported via portal message fever to 101.8 resolving within 24 hours of vaccination. Not seen as symptoms resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Nausea, Pain
Clinical narrative: Upper arm three times the size and black and blue- still swollen, black and blue and itchy, fever, chilly, nausea, very weak, entire body ached I literally could not move out of bed for two days- it felt like I had a bad flu.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Skin discolouration
Clinical narrative: Upper arm three times the size and black and blue- still swollen, black and blue and itchy, fever, chilly, nausea, very weak, entire body ached I literally could not move out of bed for two days- it felt like I had a bad flu.
Age: 74.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal pain, Malaise, Nausea, Pain, Vomiting
Clinical narrative: Patient came in 6/12 and stated that after we administered the vaccines she went home and started feeling sick. Chief complaints were abdominal/body pain and nausea/vomiting.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Amnesia, Asthenia, Balance disorder, Confusional state, Deafness
Clinical narrative: Day 1: As soon as I got it: Dizzy, light headed, blurry vision, pounding head, going to faint, adrenaline, then seizure no more than 30 seconds later. Jolting legs, couldn't hear anything, couldn't understand, confusion, felt like I was dreaming, uncomfortable, no memory of what had happened or where I was, no control, emotional disturbance. Later that day before I went to bed: Felt like I was going to throw up, light headed, blurry vision, very loud buzzing sound in my ears, felt hot, couldn't stand up so I laid down, had hard time saying what I was feeling, pounding head, headache, dry mouth. Day 2: Sore arm, lost balance when I got off of the school bus, headache, low energy in class and arm went numb several times, sensitive hearing, hard to concentrate, poor memory of even simple things, low appetite, always thirsty, wanted to rest. Day 3: Sore arm, arm went numb several times, sometimes my arm was hot and the area I got the shot felt hard, tiredness. Day 4-6: Sore arm and brain fog.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Decreased appetite, Discomfort, Disturbance in attention, Dizziness, Dry mouth
Clinical narrative: Day 1: As soon as I got it: Dizzy, light headed, blurry vision, pounding head, going to faint, adrenaline, then seizure no more than 30 seconds later. Jolting legs, couldn't hear anything, couldn't understand, confusion, felt like I was dreaming, uncomfortable, no memory of what had happened or where I was, no control, emotional disturbance. Later that day before I went to bed: Felt like I was going to throw up, light headed, blurry vision, very loud buzzing sound in my ears, felt hot, couldn't stand up so I laid down, had hard time saying what I was feeling, pounding head, headache, dry mouth. Day 2: Sore arm, lost balance when I got off of the school bus, headache, low energy in class and arm went numb several times, sensitive hearing, hard to concentrate, poor memory of even simple things, low appetite, always thirsty, wanted to rest. Day 3: Sore arm, arm went numb several times, sometimes my arm was hot and the area I got the shot felt hard, tiredness. Day 4-6: Sore arm and brain fog.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dyskinesia, Dysstasia, Emotional disorder, Fatigue, Feeling abnormal
Clinical narrative: Day 1: As soon as I got it: Dizzy, light headed, blurry vision, pounding head, going to faint, adrenaline, then seizure no more than 30 seconds later. Jolting legs, couldn't hear anything, couldn't understand, confusion, felt like I was dreaming, uncomfortable, no memory of what had happened or where I was, no control, emotional disturbance. Later that day before I went to bed: Felt like I was going to throw up, light headed, blurry vision, very loud buzzing sound in my ears, felt hot, couldn't stand up so I laid down, had hard time saying what I was feeling, pounding head, headache, dry mouth. Day 2: Sore arm, lost balance when I got off of the school bus, headache, low energy in class and arm went numb several times, sensitive hearing, hard to concentrate, poor memory of even simple things, low appetite, always thirsty, wanted to rest. Day 3: Sore arm, arm went numb several times, sometimes my arm was hot and the area I got the shot felt hard, tiredness. Day 4-6: Sore arm and brain fog.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Feeling hot, Headache, Hyperacusis, Hypoaesthesia, Injection site induration
Clinical narrative: Day 1: As soon as I got it: Dizzy, light headed, blurry vision, pounding head, going to faint, adrenaline, then seizure no more than 30 seconds later. Jolting legs, couldn't hear anything, couldn't understand, confusion, felt like I was dreaming, uncomfortable, no memory of what had happened or where I was, no control, emotional disturbance. Later that day before I went to bed: Felt like I was going to throw up, light headed, blurry vision, very loud buzzing sound in my ears, felt hot, couldn't stand up so I laid down, had hard time saying what I was feeling, pounding head, headache, dry mouth. Day 2: Sore arm, lost balance when I got off of the school bus, headache, low energy in class and arm went numb several times, sensitive hearing, hard to concentrate, poor memory of even simple things, low appetite, always thirsty, wanted to rest. Day 3: Sore arm, arm went numb several times, sometimes my arm was hot and the area I got the shot felt hard, tiredness. Day 4-6: Sore arm and brain fog.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Pain in extremity, Seizure, Skin warm, Thirst
Clinical narrative: Day 1: As soon as I got it: Dizzy, light headed, blurry vision, pounding head, going to faint, adrenaline, then seizure no more than 30 seconds later. Jolting legs, couldn't hear anything, couldn't understand, confusion, felt like I was dreaming, uncomfortable, no memory of what had happened or where I was, no control, emotional disturbance. Later that day before I went to bed: Felt like I was going to throw up, light headed, blurry vision, very loud buzzing sound in my ears, felt hot, couldn't stand up so I laid down, had hard time saying what I was feeling, pounding head, headache, dry mouth. Day 2: Sore arm, lost balance when I got off of the school bus, headache, low energy in class and arm went numb several times, sensitive hearing, hard to concentrate, poor memory of even simple things, low appetite, always thirsty, wanted to rest. Day 3: Sore arm, arm went numb several times, sometimes my arm was hot and the area I got the shot felt hard, tiredness. Day 4-6: Sore arm and brain fog.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Day 1: As soon as I got it: Dizzy, light headed, blurry vision, pounding head, going to faint, adrenaline, then seizure no more than 30 seconds later. Jolting legs, couldn't hear anything, couldn't understand, confusion, felt like I was dreaming, uncomfortable, no memory of what had happened or where I was, no control, emotional disturbance. Later that day before I went to bed: Felt like I was going to throw up, light headed, blurry vision, very loud buzzing sound in my ears, felt hot, couldn't stand up so I laid down, had hard time saying what I was feeling, pounding head, headache, dry mouth. Day 2: Sore arm, lost balance when I got off of the school bus, headache, low energy in class and arm went numb several times, sensitive hearing, hard to concentrate, poor memory of even simple things, low appetite, always thirsty, wanted to rest. Day 3: Sore arm, arm went numb several times, sometimes my arm was hot and the area I got the shot felt hard, tiredness. Day 4-6: Sore arm and brain fog.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Dry skin, Eczema, Erythema, Rash
Clinical narrative: Patient complained of red scaly and dry area on legs below knee and above ankle. He has slight discomfort due to rash. He is unsure if this is related to the ZOSTAVAX or present before. His md stated that the leg condition is eczema. He has a dry scaly scalp that is completely unrelated to the vaccine according to the patient. Patient is unsure of time course and unsure if this was present before the ZOSTAVAX but wanted to report.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Patient complained of red scaly and dry area on legs below knee and above ankle. He has slight discomfort due to rash. He is unsure if this is related to the ZOSTAVAX or present before. His md stated that the leg condition is eczema. He has a dry scaly scalp that is completely unrelated to the vaccine according to the patient. Patient is unsure of time course and unsure if this was present before the ZOSTAVAX but wanted to report.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Baby developed rash on cheeks. Notified pediatrician at follow up visit, and she explained that some children develop rash after vaccine. It was the first time she received that vaccine.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Loss of consciousness, Vision blurred
Clinical narrative: Patient is hot, dizzy, blurry, black out (cannot see anything-black), sweating, warm but still responsive when I ask her questions. Her breathing seems ok. I get a wet paper towel and tap on her face to cool her down. Give her a sip of water here and there. Her husband said she hasn't eaten, then he bought a chocolate chip cookie and put a small amount in her mouth. She is eating and swallowing slowly. After about 7 minutes, she starts opening her eyes and see things around. We make a paper fan and cool her down. After approximately 7 more minutes she feels ok. She is alert and back to normal. I suggest her to wait for 10 more minutes. Then patient decides to leave. She leaves by her own and we give her and her husband instructions of emergency situations if happened.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Discomfort, Headache, Hypoaesthesia, Insomnia
Clinical narrative: Patient reported on 6/12/18 at 9am that after vaccination she had ate lunch at noon and shortly after lay down. Had a pounding headache, nauseated, couldn't lift hand of arm that was vaccinated and fingers were numb. Pulse of 90-100. Took Alprazolam 0.25mg to relieve anxiety and one acetaminophen tablet. Was too uncomfortable to ice and had all over aching. Had a sleepless night but it the morning symptoms began to subside. Spoke with her at 7pm on 6/12/18 and symptoms were continuing to subside.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Pain
Clinical narrative: Patient reported on 6/12/18 at 9am that after vaccination she had ate lunch at noon and shortly after lay down. Had a pounding headache, nauseated, couldn't lift hand of arm that was vaccinated and fingers were numb. Pulse of 90-100. Took Alprazolam 0.25mg to relieve anxiety and one acetaminophen tablet. Was too uncomfortable to ice and had all over aching. Had a sleepless night but it the morning symptoms began to subside. Spoke with her at 7pm on 6/12/18 and symptoms were continuing to subside.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Nausea, Pain, Pain in extremity, Pruritus generalised
Clinical narrative: Severe pain in upper at, (delt): Knot at injection site; itching all over body occasionally; constant nausea; soreness all over body.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Felt feverish and chills.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2019) for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, less than an hour after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth. The patient was treated with TYLENOL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient received the SHINGRIX on left arm. Within 30 minutes of vaccination, the patient experienced a fever (101 degree F), severe muscle aches, headache, and flu like symptoms. The patient also experienced a red, hot, and swollen arm from the elbow to the shoulder on the arm they received the vaccine and it took about 3 to 4 days to start improving but really took full 7 days to fully improve. The patient called her physician for advice on how to manage the reaction and was taking TYLENOL. The patient was reported she could not go to the gym and also reported she never experienced a reaction to a vaccine before.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Headache, Myalgia, Pain, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2019) for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, less than an hour after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth. The patient was treated with TYLENOL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient received the SHINGRIX on left arm. Within 30 minutes of vaccination, the patient experienced a fever (101 degree F), severe muscle aches, headache, and flu like symptoms. The patient also experienced a red, hot, and swollen arm from the elbow to the shoulder on the arm they received the vaccine and it took about 3 to 4 days to start improving but really took full 7 days to fully improve. The patient called her physician for advice on how to manage the reaction and was taking TYLENOL. The patient was reported she could not go to the gym and also reported she never experienced a reaction to a vaccine before.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2019) for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, less than an hour after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth. The patient was treated with TYLENOL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient received the SHINGRIX on left arm. Within 30 minutes of vaccination, the patient experienced a fever (101 degree F), severe muscle aches, headache, and flu like symptoms. The patient also experienced a red, hot, and swollen arm from the elbow to the shoulder on the arm they received the vaccine and it took about 3 to 4 days to start improving but really took full 7 days to fully improve. The patient called her physician for advice on how to manage the reaction and was taking TYLENOL. The patient was reported she could not go to the gym and also reported she never experienced a reaction to a vaccine before.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Headache, Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2019) for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, less than an hour after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth. The patient was treated with TYLENOL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient received the SHINGRIX on left arm. Within 30 minutes of vaccination, the patient experienced a fever (101 degree F), severe muscle aches, headache, and flu like symptoms. The patient also experienced a red, hot, and swollen arm from the elbow to the shoulder on the arm they received the vaccine and it took about 3 to 4 days to start improving but really took full 7 days to fully improve. The patient called her physician for advice on how to manage the reaction and was taking TYLENOL. The patient was reported she could not go to the gym and also reported she never experienced a reaction to a vaccine before.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2019) for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, less than an hour after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth. The patient was treated with TYLENOL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, fever, headache, muscle pain, flu like symptoms, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient received the SHINGRIX on left arm. Within 30 minutes of vaccination, the patient experienced a fever (101 degree F), severe muscle aches, headache, and flu like symptoms. The patient also experienced a red, hot, and swollen arm from the elbow to the shoulder on the arm they received the vaccine and it took about 3 to 4 days to start improving but really took full 7 days to fully improve. The patient called her physician for advice on how to manage the reaction and was taking TYLENOL. The patient was reported she could not go to the gym and also reported she never experienced a reaction to a vaccine before.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Calcium and Cranberry. On 14th May 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema, muscle pain, tingling, chills, shoulder pain, injection site tenderness, injected limb mobility decreased and nerve injury. On an unknown date, the outcome of the pain in arm, tingling, shoulder pain, injection site tenderness, injected limb mobility decreased and nerve injury were not recovered/not resolved and the outcome of the injection site erythema, muscle pain and chills were recovered/resolved. The reporter considered the pain in arm, injection site erythema, muscle pain, tingling, chills and shoulder pain to be related to SHINGRIX. It was unknown if the reporter considered the injection site tenderness, injected limb mobility decreased and nerve injury to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included centrum and probiotic. The patient received SHINGRIX on left arm. After vaccination, the patient experienced some chills that went away quickly, some muscle pain that started to come on but also went away quickly, and redness at the injection site that has also resolved. The patient's shoulder began to hurt badly enough that she could not lift her arm. The pain had persisted and also experienced tingling down her arm to her fingers. The patient visited an orthopedist for about these symptoms and was told that the tingling indicates nerve involvement and maybe the nerve in her arm was grazed during the injection. The patient was going to see her regular orthopedist on Wednesday on 6th June 2018. The patient's arm was continuing to get worse because she had to use it. By the end of the day it hurts more than when she woke up and she noted that it still hurts to touch the area of her arm where she received the injection. The patient was not sure if she would get the 2nd dose or not but it would be probably be at 6 months instead of 2 months. This is 1 of 3 cases, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Calcium and Cranberry. On 14th May 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema, muscle pain, tingling, chills, shoulder pain, injection site tenderness, injected limb mobility decreased and nerve injury. On an unknown date, the outcome of the pain in arm, tingling, shoulder pain, injection site tenderness, injected limb mobility decreased and nerve injury were not recovered/not resolved and the outcome of the injection site erythema, muscle pain and chills were recovered/resolved. The reporter considered the pain in arm, injection site erythema, muscle pain, tingling, chills and shoulder pain to be related to SHINGRIX. It was unknown if the reporter considered the injection site tenderness, injected limb mobility decreased and nerve injury to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included centrum and probiotic. The patient received SHINGRIX on left arm. After vaccination, the patient experienced some chills that went away quickly, some muscle pain that started to come on but also went away quickly, and redness at the injection site that has also resolved. The patient's shoulder began to hurt badly enough that she could not lift her arm. The pain had persisted and also experienced tingling down her arm to her fingers. The patient visited an orthopedist for about these symptoms and was told that the tingling indicates nerve involvement and maybe the nerve in her arm was grazed during the injection. The patient was going to see her regular orthopedist on Wednesday on 6th June 2018. The patient's arm was continuing to get worse because she had to use it. By the end of the day it hurts more than when she woke up and she noted that it still hurts to touch the area of her arm where she received the injection. The patient was not sure if she would get the 2nd dose or not but it would be probably be at 6 months instead of 2 months. This is 1 of 3 cases, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Nerve injury, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Calcium and Cranberry. On 14th May 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema, muscle pain, tingling, chills, shoulder pain, injection site tenderness, injected limb mobility decreased and nerve injury. On an unknown date, the outcome of the pain in arm, tingling, shoulder pain, injection site tenderness, injected limb mobility decreased and nerve injury were not recovered/not resolved and the outcome of the injection site erythema, muscle pain and chills were recovered/resolved. The reporter considered the pain in arm, injection site erythema, muscle pain, tingling, chills and shoulder pain to be related to SHINGRIX. It was unknown if the reporter considered the injection site tenderness, injected limb mobility decreased and nerve injury to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included centrum and probiotic. The patient received SHINGRIX on left arm. After vaccination, the patient experienced some chills that went away quickly, some muscle pain that started to come on but also went away quickly, and redness at the injection site that has also resolved. The patient's shoulder began to hurt badly enough that she could not lift her arm. The pain had persisted and also experienced tingling down her arm to her fingers. The patient visited an orthopedist for about these symptoms and was told that the tingling indicates nerve involvement and maybe the nerve in her arm was grazed during the injection. The patient was going to see her regular orthopedist on Wednesday on 6th June 2018. The patient's arm was continuing to get worse because she had to use it. By the end of the day it hurts more than when she woke up and she noted that it still hurts to touch the area of her arm where she received the injection. The patient was not sure if she would get the 2nd dose or not but it would be probably be at 6 months instead of 2 months. This is 1 of 3 cases, reported by the same reporter.