chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing
Clinical narrative: PATIENT'S FACE BECAME EXTREMELY FLUSHED ABOUT 1 MINUTE AFTER ADMINISTRATION OF SHINGRIX. WE HAD PATIENT SIT DOWN AND GOT HIM SOME WATER. PATIENT SEEMED TO IMPROVE MOMENTARILY, AND ABOUT ANOTHER 1 TO 2 MINUTES LATER BECAME EXTREMELY FLUSHED AGAIN. I THEN TOLD PATIENT I WANTED TO CALL 911 AND HE AGREED. I ADMINISTERED CONTENTS OF 1 PREFILLED EPINEPHRINE PEN WHILE MY TECHNICIAN WAS ON THE PHONE WITH 911.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Muscular weakness
Clinical narrative: Significant arm pain. 9/10 on pain scale. Large knot at injection site, bumpy/itchy rash around swelling, increase in pain and enlarged pain site from top of shoulder to elbow, weakness in arm, body pain and aches, low grade fever. Increasing pain on day 2
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Nodule, Pain, Pain in extremity, Pyrexia
Clinical narrative: Significant arm pain. 9/10 on pain scale. Large knot at injection site, bumpy/itchy rash around swelling, increase in pain and enlarged pain site from top of shoulder to elbow, weakness in arm, body pain and aches, low grade fever. Increasing pain on day 2
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperaesthesia
Clinical narrative: Patient experienced fatigue, chills (temperature 99.8 F), increased touch sensitivity, headache for one day. Symptoms improved without medication or medical treatment.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: No adverse event
Clinical narrative: None.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine given on 4/6/18, on 4/8/18 patient developed a red patch 2 inches below the SHINGRIX injection site. The patch is 3-4 inches in diameter and is an irregular shape. She states it is hot to touch and swollen. On 4/10/18 the patch was gone in the morning then reappeared in the afternoon, the patch has been present since 4/10/18, still hot, red and swollen. It is not blistering.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Condition aggravated, Ear pain, Herpes zoster, Nausea, Pain
Clinical narrative: She developed shingles 3 days after receiving SHINGRIX. On day 1, three hours after the vaccine administered, she developed fever, body ache, and nausea. 12 hours later, she developed shingles breakout and earache (she has a history of shingles in ears for 6 times), next day she went to see a doctor, who advised to monitor and symptoms are due to immune reaction to SHINGRIX, however, symptoms got worse and on day 4 she was diagnosed with shingles. The doctor prescribed valacyclovir 1 grams 3 times a day for 7 days. Gabapentin 300mg up to 6 capsules per day. Cephalexin 250mg 4 times a day for 7 days.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: She developed shingles 3 days after receiving SHINGRIX. On day 1, three hours after the vaccine administered, she developed fever, body ache, and nausea. 12 hours later, she developed shingles breakout and earache (she has a history of shingles in ears for 6 times), next day she went to see a doctor, who advised to monitor and symptoms are due to immune reaction to SHINGRIX, however, symptoms got worse and on day 4 she was diagnosed with shingles. The doctor prescribed valacyclovir 1 grams 3 times a day for 7 days. Gabapentin 300mg up to 6 capsules per day. Cephalexin 250mg 4 times a day for 7 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Neck pain, Pain, Paraesthesia
Clinical narrative: I had a pain/stiff neck and pain up my head. It was sudden and really hurt. Like I had wrenched my neck. Then I developed some bumps on my scalp, kind of in a line from my hairline to the crown of my head. These itched and tingled and hurt. Then I developed patches of rash on the right side of my neck, in my hair line and a patch under my right ear on my jaw.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: I had a pain/stiff neck and pain up my head. It was sudden and really hurt. Like I had wrenched my neck. Then I developed some bumps on my scalp, kind of in a line from my hairline to the crown of my head. These itched and tingled and hurt. Then I developed patches of rash on the right side of my neck, in my hair line and a patch under my right ear on my jaw.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Rash pruritic
Clinical narrative: I had a pain/stiff neck and pain up my head. It was sudden and really hurt. Like I had wrenched my neck. Then I developed some bumps on my scalp, kind of in a line from my hairline to the crown of my head. These itched and tingled and hurt. Then I developed patches of rash on the right side of my neck, in my hair line and a patch under my right ear on my jaw.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: She called the following day to report a pain, warmth, and redness  "2 inch diameter" area around the site of injection. We had used an Inject-safe Barrier Bandage there may have been an allergic reaction.
Age: 1.33
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Decreased appetite, Extra dose administered, Irritability, Somnolence, Wrong drug administered
Clinical narrative: Patient was given MMRV (instead of MMR) and varicella. Patient received extra dose of varicella. Treatment per Dr. is to medicate with TYLENOL and monitor for fever. Update: Called mother 4/12/18 - no observed fever, mom medicating w/TYLENOL. Patient napping at time of call. Perhaps some increased fussiness, decreased appetite, and increased sleepiness. Pt now stable, eating, drinking, voiding.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test abnormal, Lumbar puncture abnormal, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: In the year 2007, I received the 3 doses of the shot GARDASIL. In the year 2015, I was diagnosed with Multiple Sclerosis. Now, there is no family history of MS in my family. So it had to come from somewhere. I recently saw a few articles on how bad this shot is and most recently I read an article and MS was the first side effect to GARDASIL. So now my assumption of maybe the shot caused the MS has now turned into IT DEFINITELY DID.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQHIB
Symptoms: Incomplete course of vaccination, Pain, Rash
Clinical narrative: GARDASIL admin. 2/12/18 (L) arm. Day 1 pain. Day 2-4 large local rash plum size photo taken. Not reported until 4/12/18. Declined 2nd due to rash after first injection.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Lethargy
Clinical narrative: Received 1st dose of SHINGRIX 50 Mcg Inj Glax, NDC: 58160-0823-11 and within 8 hours had loose stools and diarrhea, stomach pain, bloating and lethargy. This is continuing into the 2nd day.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Bruise on left breast (line under nipple) on same side vaccine was administered left arm (deltoid) - Patient takes baby aspirin, however doesn't remember hitting himself.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Last evening she developed pain in left arm and it became very red and swollen. She is nauseous and feels poorly overall.
Age: 0.75
Sex: M
Vaccine: IPV, PNC13
Symptoms: Full blood count, Grunting, Hypovolaemia, Pyrexia
Clinical narrative: Fever up to 103, grunting. Hypovolemia.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis day after vaccination.
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, Foetal hypokinesia, In vitro fertilisation, Pruritus
Clinical narrative: Initial unsolicited pregnancy report received from the health authority (under reference number: 720923) on 03-Apr-2018. This case involves 34 year old female patient who was vaccinated with first dose of FLUBLOK QIV (batch number: 305017) (expiry date, dose not reported) intramuscularly in left arm on 25-Sep-2017 while she was pregnant. Pregnancy information including last menstrual period, pregnancy trimester were not reported. Estimated delivery date is 02 Jul 2018. Medical history including endometriosis. It was also reported that current illness including Cold 1 week prior. Patient had no history of any drug or food allergies. No problems with previous influenza immunizations. Concomitant medication included women's multivitamin. On 27-Sep-2017, two days following the vaccination, patient had severe itching from neck to upper thigh for 2 days and decreased fetal movement for 2 days. IVF pregnancy d/t endometriosis. Corrective treatment was not reported. The outcome of the events was recovered. Upon internal review, the company decided to consider the case as serious due to important medical event: Foetal hypokinesia. List of documents held by sender: none. Sender's Comments: This case concerns an pregnant patient who experienced pruritus and also reported with fetal hypokinesia following exposure to FLUBLOK QIV (FLUR4) during pregnancy. The time to onset is compatible with the role of vaccine. However, her condition and fetal condition at the time of vaccination was not reported and there is no lab and other information ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 86.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 86-year-old female patient of unknown race/ethnicity received on 09Mar2018 PREVNAR 13 at single dose for immunization. Medical history and concomitant medications were not reported. On 10Mar2018, subject was really weak, still very weak with outcome of not recovered. On the same date patient had also fatigue, sleepy, joint pain, all with outcome of unknown. On an unknown date in 2018 she experienced decreased appetite, chills, rash on my chest, lost 3 lbs, all with outcome of unknown. Patient was getting worst. Information on the batch number has been requested.
Age: 86.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: No adverse event
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 86-year-old female patient of unknown race/ethnicity received on 09Mar2018 PREVNAR 13 at single dose for immunization. Medical history and concomitant medications were not reported. On 10Mar2018, subject was really weak, still very weak with outcome of not recovered. On the same date patient had also fatigue, sleepy, joint pain, all with outcome of unknown. On an unknown date in 2018 she experienced decreased appetite, chills, rash on my chest, lost 3 lbs, all with outcome of unknown. Patient was getting worst. Information on the batch number has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Hypotension, Pain in extremity, Thirst
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site discomfort in a 68-year-old female patient who received SHINGRIX. On 3rd April 2018 09:45, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site discomfort, dry mouth, lightheadedness and low blood pressure. On an unknown date, the outcome of the injection site discomfort, dry mouth, lightheadedness and low blood pressure were unknown. It was unknown if the reporter considered the injection site discomfort, dry mouth, lightheadedness and low blood pressure to be related to SHINGRIX. Additional details were reported as follows: The case was reported by GlaxoSmithKline on behalf of the healthcare professional. Severe lightheadedness. The patient's husband called the physician's office and the physician told him to take a blood pressure. The ambulance was called and patient was rushed to the emergency room. The patient was administered 2 liters of fluid and the blood pressure came to 110/60. The Electrocardiography came back normal. No additional information was reported.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dry mouth, Electrocardiogram normal, Hypotension, Injection site discomfort
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site discomfort in a 68-year-old female patient who received SHINGRIX. On 3rd April 2018 09:45, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site discomfort, dry mouth, lightheadedness and low blood pressure. On an unknown date, the outcome of the injection site discomfort, dry mouth, lightheadedness and low blood pressure were unknown. It was unknown if the reporter considered the injection site discomfort, dry mouth, lightheadedness and low blood pressure to be related to SHINGRIX. Additional details were reported as follows: The case was reported by GlaxoSmithKline on behalf of the healthcare professional. Severe lightheadedness. The patient's husband called the physician's office and the physician told him to take a blood pressure. The ambulance was called and patient was rushed to the emergency room. The patient was administered 2 liters of fluid and the blood pressure came to 110/60. The Electrocardiography came back normal. No additional information was reported.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Erythema, Injection site erythema, Musculoskeletal pain, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 29-year-old female patient who received BOOSTRIX (batch number 9PD92, expiry date 30th May 2020. On 3rd April 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 3rd April 2018, less than a day after receiving BOOSTRIX, the patient experienced vomiting, nausea and fever. In April 2018, the patient experienced injection site pain, back pain, shoulder pain and erythema of extremities. On an unknown date, the outcome of the injection site pain, back pain, shoulder pain, erythema of extremities, vomiting, nausea and fever were unknown. The reporter considered the injection site pain and erythema of extremities to be almost certainly related to BOOSTRIX. It was unknown if the reporter considered the back pain, shoulder pain, vomiting, nausea and fever to be related to BOOSTRIX. Additional information was reported as follows: The case was reported by the registered nurse (RN). At 12:00, the patient received a dose of BOOSTRIX in left deltoid and the patient experienced nausea, vomiting and a fever the afternoon after getting BOOSTRIX. The patient went to the office the next day with redness at the injection site, radiating down the arm, and pain at the injection site radiating to the shoulder and back. The patient sent to the emergency room, but the reporter did not know what further actions occurred from there.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 29-year-old female patient who received BOOSTRIX (batch number 9PD92, expiry date 30th May 2020. On 3rd April 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 3rd April 2018, less than a day after receiving BOOSTRIX, the patient experienced vomiting, nausea and fever. In April 2018, the patient experienced injection site pain, back pain, shoulder pain and erythema of extremities. On an unknown date, the outcome of the injection site pain, back pain, shoulder pain, erythema of extremities, vomiting, nausea and fever were unknown. The reporter considered the injection site pain and erythema of extremities to be almost certainly related to BOOSTRIX. It was unknown if the reporter considered the back pain, shoulder pain, vomiting, nausea and fever to be related to BOOSTRIX. Additional information was reported as follows: The case was reported by the registered nurse (RN). At 12:00, the patient received a dose of BOOSTRIX in left deltoid and the patient experienced nausea, vomiting and a fever the afternoon after getting BOOSTRIX. The patient went to the office the next day with redness at the injection site, radiating down the arm, and pain at the injection site radiating to the shoulder and back. The patient sent to the emergency room, but the reporter did not know what further actions occurred from there.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Erythema, Injection site pain, Musculoskeletal pain, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 29-year-old female patient who received BOOSTRIX (batch number 9PD92, expiry date 30th May 2020. On 3rd April 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 3rd April 2018, less than a day after receiving BOOSTRIX, the patient experienced vomiting, nausea and fever. In April 2018, the patient experienced injection site pain, back pain, shoulder pain and erythema of extremities. On an unknown date, the outcome of the injection site pain, back pain, shoulder pain, erythema of extremities, vomiting, nausea and fever were unknown. The reporter considered the injection site pain and erythema of extremities to be almost certainly related to BOOSTRIX. It was unknown if the reporter considered the back pain, shoulder pain, vomiting, nausea and fever to be related to BOOSTRIX. Additional information was reported as follows: The case was reported by the registered nurse (RN). At 12:00, the patient received a dose of BOOSTRIX in left deltoid and the patient experienced nausea, vomiting and a fever the afternoon after getting BOOSTRIX. The patient went to the office the next day with redness at the injection site, radiating down the arm, and pain at the injection site radiating to the shoulder and back. The patient sent to the emergency room, but the reporter did not know what further actions occurred from there.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Migraine, Nausea
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of migraine headache in a 59-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (on the head), shingles (on the back and waist), shingles (on the buttocks and sacrum) and post herpetic neuralgia (pain down her leg, she was taking Gabapentin for treatment). Concurrent medical conditions included drug allergy (Sulfa) and milk allergy. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st March 2018, 1 days after receiving SHINGRIX, the patient experienced migraine headache, stiffness, feeling hot, itchy upper limbs, nausea, vomiting, general body pain, photophobia, urticarial, mobility decreased, erythema, unexpected therapeutic effect and swelling. The patient was treated with Sumatriptan Succinate and (NOS) BENADRYL. On an unknown date, the outcome of the migraine headache and photophobia were recovering/resolving and the outcome of the stiffness, nausea, mobility decreased, erythema, unexpected therapeutic effect and swelling were unknown and the outcome of the feeling hot, itchy upper limbs and urticarial were not recovered/not resolved and the outcome of the vomiting and general body pain were recovered/resolved. The reporter considered the migraine headache, stiffness, feeling hot, itchy upper limbs, nausea, vomiting, general body pain, photophobia, urticarial, mobility decreased and unexpected therapeutic effect to be probably related to SHINGRIX. It was unknown if the reporter considered the erythema and swelling to be related to SHINGRIX. Additional details were reported as follows: The patient had 3 bouts with shingles and after the last bout in October she developed PHN in her leg and the pain persisted until not and it was hard for her to walk. Last Friday before the date of reporting, the patient received shingles shot (name of the shot not provided). It had been 5 days since the shot and the patient continued to have headache, welts on arm, stiffness, and very very hot to touch (assumed arm but not stated). The patient called back and reported that she developed a long area of raised skin that is red, hot and itchy that extended from the injection site to her shoulder blades and down 3/4 of the way to her elbow. The patient reported that since receiving the SHINGRIX vaccine the Postherpetic neuralgia (PHN) pain had resolved. The patient took a Sumatriptan tablet but it did not work to relieve her migraine headache. She also used MOTRIN but did not work. The patient applied ice on the hives and welts and it did not work to keep the heat and itching down. The patient took BENADRYL last night and it helped her to sleep but her arm was still hot and itchy.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of migraine headache in a 59-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (on the head), shingles (on the back and waist), shingles (on the buttocks and sacrum) and post herpetic neuralgia (pain down her leg, she was taking Gabapentin for treatment). Concurrent medical conditions included drug allergy (Sulfa) and milk allergy. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st March 2018, 1 days after receiving SHINGRIX, the patient experienced migraine headache, stiffness, feeling hot, itchy upper limbs, nausea, vomiting, general body pain, photophobia, urticarial, mobility decreased, erythema, unexpected therapeutic effect and swelling. The patient was treated with Sumatriptan Succinate and (NOS) BENADRYL. On an unknown date, the outcome of the migraine headache and photophobia were recovering/resolving and the outcome of the stiffness, nausea, mobility decreased, erythema, unexpected therapeutic effect and swelling were unknown and the outcome of the feeling hot, itchy upper limbs and urticarial were not recovered/not resolved and the outcome of the vomiting and general body pain were recovered/resolved. The reporter considered the migraine headache, stiffness, feeling hot, itchy upper limbs, nausea, vomiting, general body pain, photophobia, urticarial, mobility decreased and unexpected therapeutic effect to be probably related to SHINGRIX. It was unknown if the reporter considered the erythema and swelling to be related to SHINGRIX. Additional details were reported as follows: The patient had 3 bouts with shingles and after the last bout in October she developed PHN in her leg and the pain persisted until not and it was hard for her to walk. Last Friday before the date of reporting, the patient received shingles shot (name of the shot not provided). It had been 5 days since the shot and the patient continued to have headache, welts on arm, stiffness, and very very hot to touch (assumed arm but not stated). The patient called back and reported that she developed a long area of raised skin that is red, hot and itchy that extended from the injection site to her shoulder blades and down 3/4 of the way to her elbow. The patient reported that since receiving the SHINGRIX vaccine the Postherpetic neuralgia (PHN) pain had resolved. The patient took a Sumatriptan tablet but it did not work to relieve her migraine headache. She also used MOTRIN but did not work. The patient applied ice on the hives and welts and it did not work to keep the heat and itching down. The patient took BENADRYL last night and it helped her to sleep but her arm was still hot and itchy.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Migraine, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of migraine headache in a 59-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (on the head), shingles (on the back and waist), shingles (on the buttocks and sacrum) and post herpetic neuralgia (pain down her leg, she was taking Gabapentin for treatment). Concurrent medical conditions included drug allergy (Sulfa) and milk allergy. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st March 2018, 1 days after receiving SHINGRIX, the patient experienced migraine headache, stiffness, feeling hot, itchy upper limbs, nausea, vomiting, general body pain, photophobia, urticarial, mobility decreased, erythema, unexpected therapeutic effect and swelling. The patient was treated with Sumatriptan Succinate and (NOS) BENADRYL. On an unknown date, the outcome of the migraine headache and photophobia were recovering/resolving and the outcome of the stiffness, nausea, mobility decreased, erythema, unexpected therapeutic effect and swelling were unknown and the outcome of the feeling hot, itchy upper limbs and urticarial were not recovered/not resolved and the outcome of the vomiting and general body pain were recovered/resolved. The reporter considered the migraine headache, stiffness, feeling hot, itchy upper limbs, nausea, vomiting, general body pain, photophobia, urticarial, mobility decreased and unexpected therapeutic effect to be probably related to SHINGRIX. It was unknown if the reporter considered the erythema and swelling to be related to SHINGRIX. Additional details were reported as follows: The patient had 3 bouts with shingles and after the last bout in October she developed PHN in her leg and the pain persisted until not and it was hard for her to walk. Last Friday before the date of reporting, the patient received shingles shot (name of the shot not provided). It had been 5 days since the shot and the patient continued to have headache, welts on arm, stiffness, and very very hot to touch (assumed arm but not stated). The patient called back and reported that she developed a long area of raised skin that is red, hot and itchy that extended from the injection site to her shoulder blades and down 3/4 of the way to her elbow. The patient reported that since receiving the SHINGRIX vaccine the Postherpetic neuralgia (PHN) pain had resolved. The patient took a Sumatriptan tablet but it did not work to relieve her migraine headache. She also used MOTRIN but did not work. The patient applied ice on the hives and welts and it did not work to keep the heat and itching down. The patient took BENADRYL last night and it helped her to sleep but her arm was still hot and itchy.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Photophobia, Pruritus, Swelling
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of migraine headache in a 59-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (on the head), shingles (on the back and waist), shingles (on the buttocks and sacrum) and post herpetic neuralgia (pain down her leg, she was taking Gabapentin for treatment). Concurrent medical conditions included drug allergy (Sulfa) and milk allergy. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st March 2018, 1 days after receiving SHINGRIX, the patient experienced migraine headache, stiffness, feeling hot, itchy upper limbs, nausea, vomiting, general body pain, photophobia, urticarial, mobility decreased, erythema, unexpected therapeutic effect and swelling. The patient was treated with Sumatriptan Succinate and (NOS) BENADRYL. On an unknown date, the outcome of the migraine headache and photophobia were recovering/resolving and the outcome of the stiffness, nausea, mobility decreased, erythema, unexpected therapeutic effect and swelling were unknown and the outcome of the feeling hot, itchy upper limbs and urticarial were not recovered/not resolved and the outcome of the vomiting and general body pain were recovered/resolved. The reporter considered the migraine headache, stiffness, feeling hot, itchy upper limbs, nausea, vomiting, general body pain, photophobia, urticarial, mobility decreased and unexpected therapeutic effect to be probably related to SHINGRIX. It was unknown if the reporter considered the erythema and swelling to be related to SHINGRIX. Additional details were reported as follows: The patient had 3 bouts with shingles and after the last bout in October she developed PHN in her leg and the pain persisted until not and it was hard for her to walk. Last Friday before the date of reporting, the patient received shingles shot (name of the shot not provided). It had been 5 days since the shot and the patient continued to have headache, welts on arm, stiffness, and very very hot to touch (assumed arm but not stated). The patient called back and reported that she developed a long area of raised skin that is red, hot and itchy that extended from the injection site to her shoulder blades and down 3/4 of the way to her elbow. The patient reported that since receiving the SHINGRIX vaccine the Postherpetic neuralgia (PHN) pain had resolved. The patient took a Sumatriptan tablet but it did not work to relieve her migraine headache. She also used MOTRIN but did not work. The patient applied ice on the hives and welts and it did not work to keep the heat and itching down. The patient took BENADRYL last night and it helped her to sleep but her arm was still hot and itchy.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Therapeutic response unexpected, Urticaria, Vomiting
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of migraine headache in a 59-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (on the head), shingles (on the back and waist), shingles (on the buttocks and sacrum) and post herpetic neuralgia (pain down her leg, she was taking Gabapentin for treatment). Concurrent medical conditions included drug allergy (Sulfa) and milk allergy. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st March 2018, 1 days after receiving SHINGRIX, the patient experienced migraine headache, stiffness, feeling hot, itchy upper limbs, nausea, vomiting, general body pain, photophobia, urticarial, mobility decreased, erythema, unexpected therapeutic effect and swelling. The patient was treated with Sumatriptan Succinate and (NOS) BENADRYL. On an unknown date, the outcome of the migraine headache and photophobia were recovering/resolving and the outcome of the stiffness, nausea, mobility decreased, erythema, unexpected therapeutic effect and swelling were unknown and the outcome of the feeling hot, itchy upper limbs and urticarial were not recovered/not resolved and the outcome of the vomiting and general body pain were recovered/resolved. The reporter considered the migraine headache, stiffness, feeling hot, itchy upper limbs, nausea, vomiting, general body pain, photophobia, urticarial, mobility decreased and unexpected therapeutic effect to be probably related to SHINGRIX. It was unknown if the reporter considered the erythema and swelling to be related to SHINGRIX. Additional details were reported as follows: The patient had 3 bouts with shingles and after the last bout in October she developed PHN in her leg and the pain persisted until not and it was hard for her to walk. Last Friday before the date of reporting, the patient received shingles shot (name of the shot not provided). It had been 5 days since the shot and the patient continued to have headache, welts on arm, stiffness, and very very hot to touch (assumed arm but not stated). The patient called back and reported that she developed a long area of raised skin that is red, hot and itchy that extended from the injection site to her shoulder blades and down 3/4 of the way to her elbow. The patient reported that since receiving the SHINGRIX vaccine the Postherpetic neuralgia (PHN) pain had resolved. The patient took a Sumatriptan tablet but it did not work to relieve her migraine headache. She also used MOTRIN but did not work. The patient applied ice on the hives and welts and it did not work to keep the heat and itching down. The patient took BENADRYL last night and it helped her to sleep but her arm was still hot and itchy.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rectal haemorrhage, Vaginal haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rectal bleeding in a 63-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 26th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th March 2018, 1 days after receiving SHINGRIX, the patient experienced rectal bleeding (serious criteria GSK medically significant), pain in arm and vaginal bleeding. In March 2018, the outcome of the rectal bleeding, pain in arm and vaginal bleeding were recovered/resolved. It was unknown if the reporter considered the rectal bleeding and vaginal bleeding to be related to SHINGRIX. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX vaccine in the left deltoid. The health care professional reported that the patient developed sore arm, rectal and vaginal bleeding the day after receiving SHINGRIX vaccine. The patient did not seek any medical treatment. The patient's symptoms lasted for 24 hours and then resolved. The batch number for the suspect vaccine SHINGRIX was reported as 7Y3X4,  however it was changed to ZY3X4 as per latest sales data sheet.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Rectal haemorrhage, Vaginal haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rectal bleeding in a 63-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 26th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th March 2018, 1 days after receiving SHINGRIX, the patient experienced rectal bleeding (serious criteria GSK medically significant), pain in arm and vaginal bleeding. In March 2018, the outcome of the rectal bleeding, pain in arm and vaginal bleeding were recovered/resolved. It was unknown if the reporter considered the rectal bleeding and vaginal bleeding to be related to SHINGRIX. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX vaccine in the left deltoid. The health care professional reported that the patient developed sore arm, rectal and vaginal bleeding the day after receiving SHINGRIX vaccine. The patient did not seek any medical treatment. The patient's symptoms lasted for 24 hours and then resolved. The batch number for the suspect vaccine SHINGRIX was reported as 7Y3X4,  however it was changed to ZY3X4 as per latest sales data sheet.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Computerised tomogram head normal, Dysaesthesia, Dyspnoea, Dyspraxia, Hypersensitivity
Clinical narrative: 4/3/18 soreness in right shoulder. 4/4/18 Stiffness in right leg, flash of pain in left temple, dizziness, heart palpitations, shortness of breath, intense body cramps, immobility, feeling of imminent demise. 4/5/18 Severe fatigue, muscle tightness. 4/6/18 Abnormal shuffling gait, slowed speech, inability to move legs. Examined by Dr. Sent to Emergency room. Examined by Dr. Blood tests performed. Told in both locations that it was a reaction to the vaccine.  BENADRYL prescribed. 4/7/18 Difficulty walking, slowed speech. Went to emergency room.  Examined by Dr. Blood tests, EKG, CT scan performed. Told it was a reaction to the vaccine. Nothing prescribed. 4/8/18 Near inability to move, spasmodic attack  of uncontrolled violent rocking (10 minutes). Frozen in place (only eyes and fingers moving - 1 hour). 4/9/18 Frozen in place (only eyes and fingers moving - 1 + hours). 4/10/18 Near frozen motion.  Monosyllabic speech.  Visited emergency room, examined by Dr. Blood tests performed. Informed that it was all in my mind. 4/11/18 muscle stiffness. Examined by Dr. He issued a referral for a neurological exam. Symptoms still continue.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Laboratory test normal, Paraesthesia, Parkinsonian gait
Clinical narrative: 4/3/18 soreness in right shoulder. 4/4/18 Stiffness in right leg, flash of pain in left temple, dizziness, heart palpitations, shortness of breath, intense body cramps, immobility, feeling of imminent demise. 4/5/18 Severe fatigue, muscle tightness. 4/6/18 Abnormal shuffling gait, slowed speech, inability to move legs. Examined by Dr. Sent to Emergency room. Examined by Dr. Blood tests performed. Told in both locations that it was a reaction to the vaccine.  BENADRYL prescribed. 4/7/18 Difficulty walking, slowed speech. Went to emergency room.  Examined by Dr. Blood tests, EKG, CT scan performed. Told it was a reaction to the vaccine. Nothing prescribed. 4/8/18 Near inability to move, spasmodic attack  of uncontrolled violent rocking (10 minutes). Frozen in place (only eyes and fingers moving - 1 hour). 4/9/18 Frozen in place (only eyes and fingers moving - 1 + hours). 4/10/18 Near frozen motion.  Monosyllabic speech.  Visited emergency room, examined by Dr. Blood tests performed. Informed that it was all in my mind. 4/11/18 muscle stiffness. Examined by Dr. He issued a referral for a neurological exam. Symptoms still continue.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Anxiety, Blood test normal, Computerised tomogram normal, Dizziness, Dyspnoea
Clinical narrative: 4/3/18 soreness in right shoulder. 4/4/18 Stiffness in right leg, flash of pain in left temple, dizziness, heart palpitations, shortness of breath, intense body cramps, immobility, feeling of imminent demise. 4/5/18 Severe fatigue, muscle tightness. 4/6/18 Abnormal shuffling gait, slowed speech, inability to move legs. Examined by Dr. Sent to Emergency room. Examined by Dr. Blood tests performed. Told in both locations that it was a reaction to the vaccine.  BENADRYL prescribed. 4/7/18 Difficulty walking, slowed speech. Went to emergency room.  Examined by Dr. Blood tests, EKG, CT scan performed. Told it was a reaction to the vaccine. Nothing prescribed. 4/8/18 Near inability to move, spasmodic attack  of uncontrolled violent rocking (10 minutes). Frozen in place (only eyes and fingers moving - 1 hour). 4/9/18 Frozen in place (only eyes and fingers moving - 1 + hours). 4/10/18 Near frozen motion.  Monosyllabic speech.  Visited emergency room, examined by Dr. Blood tests performed. Informed that it was all in my mind. 4/11/18 muscle stiffness. Examined by Dr. He issued a referral for a neurological exam. Symptoms still continue.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Electrocardiogram normal, Fatigue, Gait disturbance, Headache, Immobile
Clinical narrative: 4/3/18 soreness in right shoulder. 4/4/18 Stiffness in right leg, flash of pain in left temple, dizziness, heart palpitations, shortness of breath, intense body cramps, immobility, feeling of imminent demise. 4/5/18 Severe fatigue, muscle tightness. 4/6/18 Abnormal shuffling gait, slowed speech, inability to move legs. Examined by Dr. Sent to Emergency room. Examined by Dr. Blood tests performed. Told in both locations that it was a reaction to the vaccine.  BENADRYL prescribed. 4/7/18 Difficulty walking, slowed speech. Went to emergency room.  Examined by Dr. Blood tests, EKG, CT scan performed. Told it was a reaction to the vaccine. Nothing prescribed. 4/8/18 Near inability to move, spasmodic attack  of uncontrolled violent rocking (10 minutes). Frozen in place (only eyes and fingers moving - 1 hour). 4/9/18 Frozen in place (only eyes and fingers moving - 1 + hours). 4/10/18 Near frozen motion.  Monosyllabic speech.  Visited emergency room, examined by Dr. Blood tests performed. Informed that it was all in my mind. 4/11/18 muscle stiffness. Examined by Dr. He issued a referral for a neurological exam. Symptoms still continue.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Mobility decreased, Muscle spasms, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: 4/3/18 soreness in right shoulder. 4/4/18 Stiffness in right leg, flash of pain in left temple, dizziness, heart palpitations, shortness of breath, intense body cramps, immobility, feeling of imminent demise. 4/5/18 Severe fatigue, muscle tightness. 4/6/18 Abnormal shuffling gait, slowed speech, inability to move legs. Examined by Dr. Sent to Emergency room. Examined by Dr. Blood tests performed. Told in both locations that it was a reaction to the vaccine.  BENADRYL prescribed. 4/7/18 Difficulty walking, slowed speech. Went to emergency room.  Examined by Dr. Blood tests, EKG, CT scan performed. Told it was a reaction to the vaccine. Nothing prescribed. 4/8/18 Near inability to move, spasmodic attack  of uncontrolled violent rocking (10 minutes). Frozen in place (only eyes and fingers moving - 1 hour). 4/9/18 Frozen in place (only eyes and fingers moving - 1 + hours). 4/10/18 Near frozen motion.  Monosyllabic speech.  Visited emergency room, examined by Dr. Blood tests performed. Informed that it was all in my mind. 4/11/18 muscle stiffness. Examined by Dr. He issued a referral for a neurological exam. Symptoms still continue.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Palpitations, Slow speech, Speech disorder, Vaccination complication
Clinical narrative: 4/3/18 soreness in right shoulder. 4/4/18 Stiffness in right leg, flash of pain in left temple, dizziness, heart palpitations, shortness of breath, intense body cramps, immobility, feeling of imminent demise. 4/5/18 Severe fatigue, muscle tightness. 4/6/18 Abnormal shuffling gait, slowed speech, inability to move legs. Examined by Dr. Sent to Emergency room. Examined by Dr. Blood tests performed. Told in both locations that it was a reaction to the vaccine.  BENADRYL prescribed. 4/7/18 Difficulty walking, slowed speech. Went to emergency room.  Examined by Dr. Blood tests, EKG, CT scan performed. Told it was a reaction to the vaccine. Nothing prescribed. 4/8/18 Near inability to move, spasmodic attack  of uncontrolled violent rocking (10 minutes). Frozen in place (only eyes and fingers moving - 1 hour). 4/9/18 Frozen in place (only eyes and fingers moving - 1 + hours). 4/10/18 Near frozen motion.  Monosyllabic speech.  Visited emergency room, examined by Dr. Blood tests performed. Informed that it was all in my mind. 4/11/18 muscle stiffness. Examined by Dr. He issued a referral for a neurological exam. Symptoms still continue.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Myalgia, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 68-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date unknown). Concurrent medical conditions included muscle pain (had trigger point of upper right back muscle where she had sometimes pain before receiving SHINGRIX). Concomitant products included Alendronate. On 3rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd April 2018, immediately after receiving SHINGRIX, the patient experienced injection site warmth. In April 2018, the patient experienced welts and muscle pain. On an unknown date, the outcome of the welts, injection site warmth and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the welts, injection site warmth and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The reporter is a pharmacist at the pharmacy where the vaccine was administered. The patient had only recently filled an Alendronate prescription at the pharmacy. The reporter was not certain if she had been taking Alendronate since it was dispensed prior to the SHINGRIX vaccine being administered. At 14:25 hours, the patient received SHINGRIX in right deltoid. The patient's right arm felt warm around the injection site area after receiving SHINGRIX. The patient did not know over what exact area of the right arm to which the feeling of warmth extended, as the patient just described the warmth occurred around the injection site. Not right away, but later (less than a week) after receiving SHINGRIX, a large red welt appeared about two inches below the injection site which was described by the patient as being warm and hot upon touch and still felt warm to the touch. The patient did not know when the welt appeared relative to the other symptom of right arm warmth. Less than a week after receiving SHINGRIX, the patient had localized back muscle pain in that same trigger point area of her upper back which she still felt and not yet resolved. The patient did not state, how soon the localized upper right back muscle pain started after the vaccine was administered. The patient thought all the symptoms are all due to the SHINGRIX vaccine. The reporter was not sure if the symptoms are related to the SHINGRIX or not. The patient was referred to a physician instead for her request of him today for evaluation of the symptoms. The patient was hesitant to go to a physician. She might call GlaxoSmithKline (GSK) to further discuss as well. The reporter called to inquire if GSK had any similar data for these types of side effects and next best steps for this patient. The call was transferred to the Medical Information team for further research. The reporter gave consent to contact. The reporter described the funds for the vaccine as public and private because the patient paid co pay but insurance company covered most of the cost.