chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Injection site pain, Pain, Skin discolouration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 25th May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced skin discoloration. On 5th June 2018, the patient experienced shingles. In June 2018, the patient experienced pain and blister. On an unknown date, the patient experienced injection site pain. The patient was treated with VALTREX, NORCO and prednisone. On an unknown date, the outcome of the injection site pain, pain and blister were recovered/resolved and the outcome of the shingles was recovering/resolving and the outcome of the skin discoloration was not recovered/not resolved. The reporter considered the injection site pain, shingles, pain and blister to be related to SHINGRIX. It was unknown if the reporter considered the skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported case for herself. On 2nd March 2018, the patient received 1st dose of SHINGRIX. The patient received 2nd dose SHINGRIX in the left arm. Less than a month after receiving SHINGRIX, the patient experienced pain in her arm at site of injection, pain and blister from the outbreak and patch of discoloration. The patient experienced Shingles on her right abdomen and was seen by her physician and treated with antiviral, steroids and pain medication. The patient reported that the pain and blisters from the outbreak had resolved but patch of discoloration was still visible. On the date of reporting, the patient developed another shingles outbreak very close to the first location on her right abdomen. The patient's pharmacy already had submitted a VAERS form for the first shingles outbreak. For tolerance after 1st dose refer US2018GSK116103.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 76-year-old male patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX. On 19th June 2018, 1 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovering/resolving. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: On 18th June 2018, the patient also initiated treatment with an unknown brand over the counter pain patch, which was applied to the patient's leg. The patient experienced a red rash under their breast area. The patient did not require an emergency room or doctor visit, and the patient's symptoms US2018110606were not considered life threatening or disabling. At the time of reporting, the patient was seen in the pharmacy and the rash was improving.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 76-year-old male patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX. On 19th June 2018, 1 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovering/resolving. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: On 18th June 2018, the patient also initiated treatment with an unknown brand over the counter pain patch, which was applied to the patient's leg. The patient experienced a red rash under their breast area. The patient did not require an emergency room or doctor visit, and the patient's symptoms US2018110606were not considered life threatening or disabling. At the time of reporting, the patient was seen in the pharmacy and the rash was improving.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Blood test normal, Computerised tomogram normal, Dyskinesia, Electroencephalogram normal, Generalised tonic-clonic seizure
Clinical narrative: Baby was found seizing 15 hours after, arms/legs jerking staring blankly to the ceiling and making hiccupping sound. Seizure lasted 8 mins approx. Was taken to the ER at Hospital by ambulance after calling 911. EEG normal, no signs of infection. Then transferred to different hospital. Second seizure (grand mal 45 mins long). Taken to ER at hospital, CAT scan normal/transferred to different hospital, MRI normal.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Hiccups, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Seizure, Staring
Clinical narrative: Baby was found seizing 15 hours after, arms/legs jerking staring blankly to the ceiling and making hiccupping sound. Seizure lasted 8 mins approx. Was taken to the ER at Hospital by ambulance after calling 911. EEG normal, no signs of infection. Then transferred to different hospital. Second seizure (grand mal 45 mins long). Taken to ER at hospital, CAT scan normal/transferred to different hospital, MRI normal.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea
Clinical narrative: Amenorrhea.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Axillary pain, Injection site pain, Pain in extremity, Peripheral swelling, Skin tightness
Clinical narrative: Right arm swelling, tenderness after vaccine. History of Present Illness: Patient received BEXSERO vaccine on 6/21 - Right arm. Started on 6/22 with pain swelling to right arm. The next day had pain under arm. Now with pain to inside of right arm from axilla to forearm. Arm feels tight, tender. No redness noted. Pt being seen in office for second time today, 7/2/18, for continued site pain and tenderness.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Right arm swelling, tenderness after vaccine. History of Present Illness: Patient received BEXSERO vaccine on 6/21 - Right arm. Started on 6/22 with pain swelling to right arm. The next day had pain under arm. Now with pain to inside of right arm from axilla to forearm. Arm feels tight, tender. No redness noted. Pt being seen in office for second time today, 7/2/18, for continued site pain and tenderness.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Pain
Clinical narrative: The first night: Chills, area of injection swelling, and entire body aches. The second day: area of injection a swelling and entire body aches. The third day: area of injection swelling. The fourth day: area of injection swelling.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Low-grade fever (99 degrees F to 100 degrees F), muscle aches, nausea, headache, mild weakness.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from registered nurse, and refers to a female patient of unknown age. The patient's pertinent medical history and concomitant therapies were unspecified. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) were not reported. On 08-JUN-2018, the patient was vaccinated with GARDASIL 9, intramuscular, lot # N022727, expiration date 12-JUN-2018, for prophylaxis (vaccine exposure during pregnancy). The pregnancy outcome was pending.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from the nurse regarding a patient of unknown age. Past medical history, drug reactions/allergies and concomitant medications were not reported. On 27-JUL-2016, the patient received GARDASIL for prophylaxis. On 12-MAR-2018, the patient received GARDASIL 9 lot# N020138 with expiry date of 14-FEB-2020 for prophylaxis. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 10-MAR-2018, the patient  was administered VARIVAX (lot N007930,expiration date 08-AUG-2019) that was reconstituted with SHRINGRIX adjuvant suspension component (lot B5EK2, expiration date 28-APR-2020). The pharmacist also reported that on an unspecified date, the zoster rgE vaccine (mammalian)(SHRINGRIX) adjuvant suspension had a "temperature excursion of 71 degrees Farenhit  for 8 hours" prior to being administered. No adverse effects reported.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of rash in a 71-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Baby Aspirin. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th May 2018, 6 hrs after receiving SHINGRIX, the patient experienced rash. The patient was treated with BENADRYL Spray. On 12th May 2018, the outcome of the rash was recovered/resolved. The reporter considered the rash to be almost certainly related to SHINGRIX. Additional information was received as follows: This case was previously reported to a physician. Concomitant products included COCOAVIA supplement. The patient received the SHINGRIX vaccine on the left arm. After about 6 hours of vaccination, the patient experienced rash which begun on the inside of the forearms and spread to the chest and abdomen. The patient applied a spray of BENADRYL on the rash and noticed improvement after 1 day and complete resolution after 3 days. The patient stated that, he was very impressed with the GlaxoSmithKline's response and patience in dealing with a question asked about the SHINGRIX vaccine who gave the best possible advice.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Influenza like illness, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 94-year-old female patient who received SHINGRIX (batch number B9739, expiry date 30th November 2018) for prophylaxis. Concomitant products included Aspirin, Calcium, estradiol and fish oil. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 7th June 2018, less than a day after receiving SHINGRIX, the patient experienced diarrhea, pain in arm, general body pain, influenza-like symptoms, skin warm and tiredness. On 8th June 2018, the patient experienced welts. In June 2018, the patient experienced feeling unwell. On an unknown date, the outcome of the diarrhea, pain in arm, general body pain, influenza-like symptoms, welts, skin warm, tiredness and feeling unwell were recovered/resolved. The reporter considered the diarrhea, pain in arm, general body pain, influenza-like symptoms, welts, skin warm and tiredness to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. This case was reported by the patient's daughter. The patient took CENTRUM SILVER as an concomitant medication. The patient received the SHINGRIX vaccine at around 10:30 AM. The patient experienced sore arm, diarrhea, she did not feel good and she had a one inch welt on her arm which was warm to the touch.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 94-year-old female patient who received SHINGRIX (batch number B9739, expiry date 30th November 2018) for prophylaxis. Concomitant products included Aspirin, Calcium, estradiol and fish oil. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 7th June 2018, less than a day after receiving SHINGRIX, the patient experienced diarrhea, pain in arm, general body pain, influenza-like symptoms, skin warm and tiredness. On 8th June 2018, the patient experienced welts. In June 2018, the patient experienced feeling unwell. On an unknown date, the outcome of the diarrhea, pain in arm, general body pain, influenza-like symptoms, welts, skin warm, tiredness and feeling unwell were recovered/resolved. The reporter considered the diarrhea, pain in arm, general body pain, influenza-like symptoms, welts, skin warm and tiredness to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. This case was reported by the patient's daughter. The patient took CENTRUM SILVER as an concomitant medication. The patient received the SHINGRIX vaccine at around 10:30 AM. The patient experienced sore arm, diarrhea, she did not feel good and she had a one inch welt on her arm which was warm to the touch.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Chills, Dizziness, Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included biotin, Cetirizine, Levothyroxine, Omega 3 Fish Oil, RESTASIS, Vitamin B12, vitamin D, melatonin, PREMARIN Vaginal Cream and XOPENEX. On 30th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 31st May 2018, the patient experienced shivering, influenza-like symptoms, fever, blood pressure decreased and lightheadedness. On an unknown date, the outcome of the pain in arm, shivering, influenza-like symptoms, fever, blood pressure decreased and lightheadedness were recovered/resolved. The reporter considered the pain in arm, shivering, influenza-like symptoms, fever and blood pressure decreased to be related to SHINGRIX. It was unknown if the reporter considered the lightheadedness to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX on left arm and reported that day of injection, the patient experienced sore arm and that the following day she experienced a fever of 101 degrees F, drop in blood pressure to 90/60 which resulted in feeling lightheaded. The reporter noted that her blood pressure normally was around 112/72. The patient reported also experiencing flu like symptoms and shivering. The patient was seen by physician on 31st May 2018 due to low blood pressure and it was 106/61 in the office on that visit. The patient reported that all events were resolved by the 3rd or 4th day post dose of SHINGRIX.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included biotin, Cetirizine, Levothyroxine, Omega 3 Fish Oil, RESTASIS, Vitamin B12, vitamin D, melatonin, PREMARIN Vaginal Cream and XOPENEX. On 30th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 31st May 2018, the patient experienced shivering, influenza-like symptoms, fever, blood pressure decreased and lightheadedness. On an unknown date, the outcome of the pain in arm, shivering, influenza-like symptoms, fever, blood pressure decreased and lightheadedness were recovered/resolved. The reporter considered the pain in arm, shivering, influenza-like symptoms, fever and blood pressure decreased to be related to SHINGRIX. It was unknown if the reporter considered the lightheadedness to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX on left arm and reported that day of injection, the patient experienced sore arm and that the following day she experienced a fever of 101 degrees F, drop in blood pressure to 90/60 which resulted in feeling lightheaded. The reporter noted that her blood pressure normally was around 112/72. The patient reported also experiencing flu like symptoms and shivering. The patient was seen by physician on 31st May 2018 due to low blood pressure and it was 106/61 in the office on that visit. The patient reported that all events were resolved by the 3rd or 4th day post dose of SHINGRIX.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Vasculitic rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vasculitic rash in a 76-year-old male patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received in 2012 without reactions as per healthcare professional). On 17th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 3 days after receiving SHINGRIX, the patient experienced vasculitic rash, injection site erythema and injection site rash. On an unknown date, the outcome of the vasculitic rash, injection site erythema and injection site rash were recovering/resolving. The reporter considered the vasculitic rash, injection site erythema and injection site rash to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The healthcare professional (HCP) reported that the patient experienced a vascular rash around the left upper arm (localized to the injection site and it did not radiate) and erythema around the same area as well. On 26th May 2018, the patient went to the convenient care clinic. It was stated that, the reaction was improved but it had not fully resolved at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Flank pain, Gait inability, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of renal failure in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included shingles vaccine (received in 2016). Concurrent medical conditions included pinched nerve, tremor (rolling tremor in hands occurred in 1996), diabetes and iodine allergy (deathly allergic to iodine). Concomitant products included gabapentin, Metformin, omeprazole, Baby Aspirin and primidone. On 6th March 2018, the patient received the 1st dose of SHINGRIX. On 6th March 2018, 2 hrs after receiving SHINGRIX, the patient experienced nausea, tiredness, burning sensation and blurred vision. On 15th March 2018, the patient experienced renal failure (serious criteria GSK medically significant) and renal pain. On 23rd March 2018, the patient experienced sleepiness. On an unknown date, the patient experienced unable to walk. On an unknown date, the outcome of the renal failure, renal pain, sleepiness and tiredness were not recovered/not resolved and the outcome of the nausea, burning sensation and blurred vision were recovered/resolved and the outcome of the unable to walk was unknown. The reporter considered the renal failure, renal pain, nausea, sleepiness, tiredness, burning sensation, blurred vision and unable to walk to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX on the left shoulder and he felt like they used the biggest needle on him. Immediately after vaccination, the patient experienced a burning sensation in his arm and nausea, blurred vision and was tired two hours later. The clinic told him that the base of the serum contains iodine and now he may need kidney dialysis. On 15th March 2018, the patient had some labs done and checked urine (result unknown). On 23rd March 2018, the patient ended up in the emergency room. The patient felt asleep in the lobby and they never took him back to be admitted. The patient claimed that after he left the emergency room, he slept for 24 hours. The patient claimed that he had kidney pain with organ shutdown which was described as flank pain with left kidney. The patient claimed that he was deathly allergic to iodine and he was provided iodine with a stress test many years ago and they had to give him a shot of something to reverse the reaction. The patient was relating that experience to his current experience with SHINGRIX. The patient used to walk a few miles per day and at the time of reporting he could not walk because of the kidney issues and he was extremely tired. The patient claimed that he had a legal case against pharmacy and GSK because the company did not provide a list of ingredients to the pharmacy for the vaccine. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Loss of personal independence in daily activities, Nausea, Renal failure, Renal pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of renal failure in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included shingles vaccine (received in 2016). Concurrent medical conditions included pinched nerve, tremor (rolling tremor in hands occurred in 1996), diabetes and iodine allergy (deathly allergic to iodine). Concomitant products included gabapentin, Metformin, omeprazole, Baby Aspirin and primidone. On 6th March 2018, the patient received the 1st dose of SHINGRIX. On 6th March 2018, 2 hrs after receiving SHINGRIX, the patient experienced nausea, tiredness, burning sensation and blurred vision. On 15th March 2018, the patient experienced renal failure (serious criteria GSK medically significant) and renal pain. On 23rd March 2018, the patient experienced sleepiness. On an unknown date, the patient experienced unable to walk. On an unknown date, the outcome of the renal failure, renal pain, sleepiness and tiredness were not recovered/not resolved and the outcome of the nausea, burning sensation and blurred vision were recovered/resolved and the outcome of the unable to walk was unknown. The reporter considered the renal failure, renal pain, nausea, sleepiness, tiredness, burning sensation, blurred vision and unable to walk to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX on the left shoulder and he felt like they used the biggest needle on him. Immediately after vaccination, the patient experienced a burning sensation in his arm and nausea, blurred vision and was tired two hours later. The clinic told him that the base of the serum contains iodine and now he may need kidney dialysis. On 15th March 2018, the patient had some labs done and checked urine (result unknown). On 23rd March 2018, the patient ended up in the emergency room. The patient felt asleep in the lobby and they never took him back to be admitted. The patient claimed that after he left the emergency room, he slept for 24 hours. The patient claimed that he had kidney pain with organ shutdown which was described as flank pain with left kidney. The patient claimed that he was deathly allergic to iodine and he was provided iodine with a stress test many years ago and they had to give him a shot of something to reverse the reaction. The patient was relating that experience to his current experience with SHINGRIX. The patient used to walk a few miles per day and at the time of reporting he could not walk because of the kidney issues and he was extremely tired. The patient claimed that he had a legal case against pharmacy and GSK because the company did not provide a list of ingredients to the pharmacy for the vaccine. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence, Urine analysis, Vision blurred
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of renal failure in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included shingles vaccine (received in 2016). Concurrent medical conditions included pinched nerve, tremor (rolling tremor in hands occurred in 1996), diabetes and iodine allergy (deathly allergic to iodine). Concomitant products included gabapentin, Metformin, omeprazole, Baby Aspirin and primidone. On 6th March 2018, the patient received the 1st dose of SHINGRIX. On 6th March 2018, 2 hrs after receiving SHINGRIX, the patient experienced nausea, tiredness, burning sensation and blurred vision. On 15th March 2018, the patient experienced renal failure (serious criteria GSK medically significant) and renal pain. On 23rd March 2018, the patient experienced sleepiness. On an unknown date, the patient experienced unable to walk. On an unknown date, the outcome of the renal failure, renal pain, sleepiness and tiredness were not recovered/not resolved and the outcome of the nausea, burning sensation and blurred vision were recovered/resolved and the outcome of the unable to walk was unknown. The reporter considered the renal failure, renal pain, nausea, sleepiness, tiredness, burning sensation, blurred vision and unable to walk to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX on the left shoulder and he felt like they used the biggest needle on him. Immediately after vaccination, the patient experienced a burning sensation in his arm and nausea, blurred vision and was tired two hours later. The clinic told him that the base of the serum contains iodine and now he may need kidney dialysis. On 15th March 2018, the patient had some labs done and checked urine (result unknown). On 23rd March 2018, the patient ended up in the emergency room. The patient felt asleep in the lobby and they never took him back to be admitted. The patient claimed that after he left the emergency room, he slept for 24 hours. The patient claimed that he had kidney pain with organ shutdown which was described as flank pain with left kidney. The patient claimed that he was deathly allergic to iodine and he was provided iodine with a stress test many years ago and they had to give him a shot of something to reverse the reaction. The patient was relating that experience to his current experience with SHINGRIX. The patient used to walk a few miles per day and at the time of reporting he could not walk because of the kidney issues and he was extremely tired. The patient claimed that he had a legal case against pharmacy and GSK because the company did not provide a list of ingredients to the pharmacy for the vaccine. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a 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 year after receiving SHINGRIX, the patient experienced general body pain and influenza-like symptoms. On an unknown date, the outcome of the general body pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the general body pain and influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter had no information about the vaccine lot number or expiry date. The health care professional (HCP) reported that the patient received SHINGRIX and experienced body aches and felt like he had the flu. The adverse event (AE) collected via chat.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lethargy
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 75-year-old male patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Concomitant products included SHINGRIX. On 19th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 19th June 2018, several hours after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site pain and lethargy. The patient was treated with BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site pain and lethargy were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site pain and lethargy to be almost certainly related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. The healthcare professional stated that the patient experienced redness and swelling at injection site were approximately 4 inches in diameter. The healthcare professional stated that the patient did not seek medical attention. The healthcare professional declined to provide the patient's date of birth.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 55-year-old female patient who received SHINGRIX (batch number LN9TL, expiry date 30th January 2020) for prophylaxis. On 11th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythematous rash and raised rash. On an unknown date, the outcome of the erythematous rash and raised rash were recovered/resolved. The reporter considered the erythematous rash and raised rash to be probably related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) was unsure of vaccine lot number and stated the first letter could be a H. The HCP stated that the patient developed a large red raised rash, size of a dollar bill that lasted a month then not completely gone until a few weeks later.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Skin exfoliation, Skin lesion, Skin swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. The patient's past medical history included open heart surgery. Concomitant products included Aspirin, Vitamin C, vitamin D, Flax Seed and SYNTHROID. On 24th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 18th June 2018, 25 days after receiving SHINGRIX, the patient experienced skin lesion, skin swelling and peeling. On an unknown date, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were recovered/resolved and the outcome of the skin lesion was recovering/resolving and the outcome of the skin swelling and peeling were unknown. The reporter considered the pain in arm and skin lesion to be related to SHINGRIX. It was unknown if the reporter considered the pain, skin swelling and peeling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 72 or 73 years old. The patient received SHINGRIX vaccine on the left arm. The patient received multivitamin as concomitant drug. The patient experienced arm pain and soreness after the injection which lasted for about 7 days and resolved.  25 days after vaccination, the patient experienced 2 skin lesions on her head, one on her forehead and one on her cheek. The lesion on her forehead was about the size of a dime, was raised and almost swollen and was peeling. The lesion on her check was about the size of a pea and was clearing up.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a child female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The patient was vaccinated as a child with the 3 doses of Hepatitis B series (unknown brand and unknown manufacturer). At the time of reporting, the patient was going to dental school and she got her titers drawn. The patient's Hepatitis B titers were less than 10 mIU per mL. The healthcare professional could not confirm that if the patient received ENGERIX B or another Hepatitis B vaccine as a child. The healthcare professional did not wish to be contacted by the patient safety. Lab Comments: On an unknown date, patient's antibody titer for hepatitis B was less than 10 miU per ml.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included eczema (during childhood any closeness to allergy items would trigger immediate breakout). Previously administered products included TUSSIONEX ER (Caused itching in the past) and Aspirin (Too many pills would cause stomach burning). Concurrent medical conditions included vaginal dryness (Controlled with medication), multiple allergies (Chlorine, dust, wool, pollen, soap, cats, dogs and formaldehyde, Tree pollen, Hay fever, dust and perfume) and drug allergy (INDOCIN, DIMETAPP, FELDENE, SYNALGOS -DC). Concomitant products included RESTASIS, Calcium With Vitamin D, Fluocinonide Cream and lovastatin. On 21st May 2018, the patient received the 1st dose of SHINGRIX. On 23rd May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site warmth and erythromacular rash. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, injection site warmth and erythromacular rash were recovered/resolved. The reporter considered the injection site erythema, injection site pain, injection site swelling, injection site warmth and erythromacular rash to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported, but it could be either 73 or 74 year of age. The patient received SHINGRIX on left deltoid. The patient noticed two days after the injection, at the site, her skin was red, puffy, warm to the touch and sore. The patient said that she was unsure as when the reaction occurred because she was packing to move out of state. It was not until she removed a bandage over the injection site two days later, that she noticed the reaction to the vaccine. In addition to the actual site, she said that there were two red and puffy spots just below where she got the shot. Before she left for the move, she went by another pharmacy to ask the pharmacist to look at her arm. The pharmacist described what he saw to her as being if it was a live vaccine. He had given other customers injections of the same vaccine, but had not seen anything like this. The pharmacist did recommend to the patient to contact her pharmacy where she received the injection and to report the incident to them. She said that all the side effects had resolved in about two weeks after being given the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX. On 21st June 2018, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, at the evening of 21st June 2018, the patient noticed a rash on her chest below her breastbone and on her stomach. The patient was not sure if it was related to the vaccine. Called and left message with patient.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced fatigue and pain in arm. In May 2018, the outcome of the fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the fatigue and pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The pharmacist reported the case for himself. The patient experienced delayed arm pain. The patient mentioned to the field representative that it hurt a lot. The patient had denied permission to contact his physician, and him for further information.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Myalgia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 17th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, malaise and myalgia. In March 2018, the outcome of the injection site pain, injection site erythema, injection site swelling, fever, malaise and myalgia were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, malaise and myalgia to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who is a pharmacist. The patient received the SHINGRIX in an unknown deltoid. The patient experienced pain, erythema and swelling at the injection site within 24 hours and resolved in 5 days. The patient also experienced fever, malaise, and myalgia which resolved in 24 hours. No further details were provided by the field representative.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 17th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, malaise and myalgia. In March 2018, the outcome of the injection site pain, injection site erythema, injection site swelling, fever, malaise and myalgia were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, malaise and myalgia to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who is a pharmacist. The patient received the SHINGRIX in an unknown deltoid. The patient experienced pain, erythema and swelling at the injection site within 24 hours and resolved in 5 days. The patient also experienced fever, malaise, and myalgia which resolved in 24 hours. No further details were provided by the field representative.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Extensive swelling of vaccinated limb, Flushing, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included pulmonary arterial hypertension, blood pressure high, multiple allergies and asthma. Concomitant products included Aspirin, CRESTOR, Cetirizine, gabapentin, Levothyroxine, ATIVAN, Metformin, vitamin D, Clonidine Patch, dorzolamide, hydrochlorothiazide, latanoprost, lisinopril, Mag Oxide, metoprolol, PRILOSEC and lorazepam. On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache were unchanged. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache to be almost certainly related to SHINGRIX. Additional details reported as follows: The patient stated she received the shot of SHINGRIX 50 mcg/mg on Monday at around 10:30 AM on right arm. The patient experienced redness and swelling at the injection site which was spreading up to her arm and down to the elbow. It was covering area which was 10 by 8 inches in size and was hot to touch. The patient had paperwork from the pharmacy that stated she was given the vaccine intramuscularly, but she thought it was given to her on the outside of her arm on the flabby part which she described as the fatty area. The patient had a follow up appointment with her doctor on the reporting day. The patient gave permission to contact her healthcare provider and provided contact details for the same. No further information was provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included pulmonary arterial hypertension, blood pressure high, multiple allergies and asthma. Concomitant products included Aspirin, CRESTOR, Cetirizine, gabapentin, Levothyroxine, ATIVAN, Metformin, vitamin D, Clonidine Patch, dorzolamide, hydrochlorothiazide, latanoprost, lisinopril, Mag Oxide, metoprolol, PRILOSEC and lorazepam. On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache were unchanged. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache to be almost certainly related to SHINGRIX. Additional details reported as follows: The patient stated she received the shot of SHINGRIX 50 mcg/mg on Monday at around 10:30 AM on right arm. The patient experienced redness and swelling at the injection site which was spreading up to her arm and down to the elbow. It was covering area which was 10 by 8 inches in size and was hot to touch. The patient had paperwork from the pharmacy that stated she was given the vaccine intramuscularly, but she thought it was given to her on the outside of her arm on the flabby part which she described as the fatty area. The patient had a follow up appointment with her doctor on the reporting day. The patient gave permission to contact her healthcare provider and provided contact details for the same. No further information was provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included pulmonary arterial hypertension, blood pressure high, multiple allergies and asthma. Concomitant products included Aspirin, CRESTOR, Cetirizine, gabapentin, Levothyroxine, ATIVAN, Metformin, vitamin D, Clonidine Patch, dorzolamide, hydrochlorothiazide, latanoprost, lisinopril, Mag Oxide, metoprolol, PRILOSEC and lorazepam. On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache were unchanged. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache to be almost certainly related to SHINGRIX. Additional details reported as follows: The patient stated she received the shot of SHINGRIX 50 mcg/mg on Monday at around 10:30 AM on right arm. The patient experienced redness and swelling at the injection site which was spreading up to her arm and down to the elbow. It was covering area which was 10 by 8 inches in size and was hot to touch. The patient had paperwork from the pharmacy that stated she was given the vaccine intramuscularly, but she thought it was given to her on the outside of her arm on the flabby part which she described as the fatty area. The patient had a follow up appointment with her doctor on the reporting day. The patient gave permission to contact her healthcare provider and provided contact details for the same. No further information was provided.