chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Tenderness, Tuberculin test
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 17-year-old female patient who received Bexsero for prophylaxis. On 22nd June 2018, the patient received the 1st dose of Bexsero. In June 2018, less than a week after receiving Bexsero, the patient experienced back pain, photophobia, headache and muscle pain. On 22nd June 2018, the patient experienced fever. On 24th June 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the back pain, photophobia, headache and muscle pain were unknown. It was unknown if the reporter considered the fever, back pain, photophobia, headache and muscle pain to be related to Bexsero. Additional details were provided as follows: The patient was 17.5 years old at the time of the event onset. The patient had a PPD skin test on 22nd June 2018. Latency of fever was less than a day. On 22nd, 23rd and 24th June 2018, the patient experienced fever that finally resolved on 24th June 2018. The patient also complained about throbbing on the front of her head, back pain, pain when moving her head and photophobia. The patient visited her physician on 29th June 2018 for the headache, photophobia, back muscle pain and tenderness on her back. The sales representative did not have any details on whether events were still continuing or resolved. It was reported that, sales representative was having an MSL following up with the physician.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received Shingrix for prophylaxis. In April 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced influenza-like symptoms, swelling arm and fever. On an unknown date, the outcome of the influenza-like symptoms, swelling arm and fever were recovered/resolved. The reporter considered the influenza-like symptoms, swelling arm and fever to be probably related to Shingrix. Additional information was reported as follows: The patient received Shingrix in the left deltoid. After vaccination with Shingrix, the patient experienced swelling of the arm that lasted for 4 to 5 days. She had a low grade fever. The patient had denied permission to contact her physician.
Sex: F
Vaccine: VARZOS
Symptoms: Laceration, Product container issue, Product quality issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of laceration of finger in a 31-year-old female patient who intended to administer the Shingrix (batch number B9739, expiry date 22nd November 2020) and (batch number D3L5G, expiry date 22nd November 2020) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced laceration of finger and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration of finger to be related to Shingrix. Additional information reported as follows: The reporter would not provide her date of birth. The reporter went to prepare Shingrix for administration. She pulled out a vial of the adjuvant suspension and cut her finger because the vial was broken. The base of the vial was broken off. After inspection of the box it was noted there was one other vial that was missing its base with a crack running up the side. No damage was noted to the blister tray and carton. The evidence of leakage was visible at the bottom of the carton. The glass pieces were visible in the carton. The product was stored in a vaccine only refrigerator on the top shelf. No product was present in the vials. The product was not administered to a consumer. The pharmacy would email picture of defect to GlaxoSmithKline and mail back broken vials. The credit request template was completed to arrange credit.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 56-year-old female patient who received Shingrix for prophylaxis. On 12th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On 13th July 2018, 1 days after receiving Shingrix, the patient experienced pain in extremity, nausea, exhaustion, erythema, dizziness and arm discomfort. In July 2018, the patient experienced upset stomach and headache. On an unknown date, the outcome of the pain in extremity, nausea, erythema, dizziness and arm discomfort were recovered/resolved and the outcome of the upset stomach, exhaustion and headache were not recovered/not resolved. It was unknown if the reporter considered the pain in extremity, nausea, upset stomach, exhaustion, headache, erythema, dizziness and arm discomfort to be related to Shingrix. Additional details were received as follows: In the evening, the patient received a dose of Shingrix. The patient was fine at the night of vaccination, but woke up in the middle of the night with extreme pain and discomfort in her arm and redness. In the next night, after vaccination, the patient experienced nausea, dizziness and absolute exhaustion. Most of the symptoms were resolved, but the patient still had the severe exhaustion that prevents her from doing all her usual activities, along with headaches and an upset stomach. The patient reported that nausea was resolved but upset stomach was a separate problem for her.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 56-year-old female patient who received Shingrix for prophylaxis. On 12th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On 13th July 2018, 1 days after receiving Shingrix, the patient experienced pain in extremity, nausea, exhaustion, erythema, dizziness and arm discomfort. In July 2018, the patient experienced upset stomach and headache. On an unknown date, the outcome of the pain in extremity, nausea, erythema, dizziness and arm discomfort were recovered/resolved and the outcome of the upset stomach, exhaustion and headache were not recovered/not resolved. It was unknown if the reporter considered the pain in extremity, nausea, upset stomach, exhaustion, headache, erythema, dizziness and arm discomfort to be related to Shingrix. Additional details were received as follows: In the evening, the patient received a dose of Shingrix. The patient was fine at the night of vaccination, but woke up in the middle of the night with extreme pain and discomfort in her arm and redness. In the next night, after vaccination, the patient experienced nausea, dizziness and absolute exhaustion. Most of the symptoms were resolved, but the patient still had the severe exhaustion that prevents her from doing all her usual activities, along with headaches and an upset stomach. The patient reported that nausea was resolved but upset stomach was a separate problem for her.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Fall, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of malaise in a 71-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (received 1st dose on unknown date refer case US2018GSK133649.). Concomitant products included Aspirin. On 17th July 2018 09:00, the patient received the 2nd dose of Shingrix (intramuscular). On 17th July 2018, 3 hrs after receiving Shingrix, the patient experienced malaise, shivering and sweating. On 18th July 2018, the patient experienced dizziness, fall, generalized muscle aches and upset stomach. On an unknown date, the outcome of the malaise was unknown and the outcome of the shivering, sweating, dizziness, fall, generalized muscle aches and upset stomach were recovered/resolved. It was unknown if the reporter considered the malaise, shivering, sweating, dizziness, fall, generalized muscle aches and upset stomach to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix on right arm. Three to four hours after getting the vaccine, the patient started feeling malaise. After driving home she started shivering and sweating. The next morning she felt better and while she was walking to teach her class she felt dizzy and fell on the side walkway. The medic and ambulance arrived on site and they checked her blood pressure and temperature came out normal. She refused going to the hospital since she started feeling better. The patient then went on to teaching her class, and she came back home and slept all day. The patient also had muscle ache all over her body along with stomach sickness. On the day of reporting, she was completely fine and everything had resolved. The patient had denied permission to contact their physician. This case has been linked with case US2018GSK133649, reported by the same reporter for 1st dose.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of malaise in a 71-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (received 1st dose on unknown date refer case US2018GSK133649.). Concomitant products included Aspirin. On 17th July 2018 09:00, the patient received the 2nd dose of Shingrix (intramuscular). On 17th July 2018, 3 hrs after receiving Shingrix, the patient experienced malaise, shivering and sweating. On 18th July 2018, the patient experienced dizziness, fall, generalized muscle aches and upset stomach. On an unknown date, the outcome of the malaise was unknown and the outcome of the shivering, sweating, dizziness, fall, generalized muscle aches and upset stomach were recovered/resolved. It was unknown if the reporter considered the malaise, shivering, sweating, dizziness, fall, generalized muscle aches and upset stomach to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix on right arm. Three to four hours after getting the vaccine, the patient started feeling malaise. After driving home she started shivering and sweating. The next morning she felt better and while she was walking to teach her class she felt dizzy and fell on the side walkway. The medic and ambulance arrived on site and they checked her blood pressure and temperature came out normal. She refused going to the hospital since she started feeling better. The patient then went on to teaching her class, and she came back home and slept all day. The patient also had muscle ache all over her body along with stomach sickness. On the day of reporting, she was completely fine and everything had resolved. The patient had denied permission to contact their physician. This case has been linked with case US2018GSK133649, reported by the same reporter for 1st dose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient experienced pain at injection site that lasted for about total of 3 weeks. The patient gave permission to contact her physician. The patient would follow up with her physician in a week from the date of reporting. No further details were provided. This case has been linked with case US2018GSK135535, reported by the same reporter (same patient for 2nd dose).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Lethargy, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, cold, lethargy, shivering, myalgia and headache. On an unknown date, the outcome of the injection site pain, cold, lethargy, shivering, myalgia and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, cold, lethargy, shivering, myalgia and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. After receiving SHINGRIX, the patient experienced reported side effects.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, cold, lethargy, shivering, myalgia and headache. On an unknown date, the outcome of the injection site pain, cold, lethargy, shivering, myalgia and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, cold, lethargy, shivering, myalgia and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. After receiving SHINGRIX, the patient experienced reported side effects.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included LIPITOR (used LIPITOR in the past) and Shingles vaccine (past administration of live Shingles vaccine in 2017). 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 fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine and does not remember when the injection was given but thought it was either in December 2017 or on 26th April 2018. The patient was scheduled for his 2nd shot of SHINGRIX on 30th July 2018. It was administered at his Medical doctor office. The patient experienced a painful arm and a fever. With respect to the painful arm the patient said he had to hold his arm to avoid using it. The events resolved after 2 to 3 days. No further information was provided.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cluster headache, Condition aggravated, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of cluster headache in a 64-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included cluster headache. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGIRX, the patient experienced cluster headache. On an unknown date, the patient experienced fever and chills. On an unknown date, the outcome of the cluster headache was not recovered/not resolved and the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the cluster headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of cluster headaches but did not have a cluster headache in about 9 years since it was controlled last. The patient reported that the day after having the first injection of SHINGRIX he experienced cluster headaches and had been experiencing 3 to 4 headaches per day since then.  In 2018, less than a year after receiving 1st dose of SHINGRIX, the patient experienced chills and fever as well. The patient had the second dose of SHINGRIX in late June.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Myalgia, Swelling, Uveitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of uveitis in a 57-year-old male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 7 days after receiving SHINGRIX, the patient experienced uveitis (serious criteria GSK medically significant), erythema, tiredness, swelling and muscle pain. In April 2018, the outcome of the erythema, tiredness, swelling and muscle pain were recovered/resolved. On an unknown date, the outcome of the uveitis was not recovered/not resolved. It was unknown if the reporter considered the uveitis, erythema, tiredness, swelling and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. About one week later after receiving SHINGRIX, the patient experienced uveitis. Less than a day after receiving SHINGRIX, the patient experienced redness, tiredness, swelling and muscle pain, which lasted for about two days. The patient was questioning if the vaccine could have caused the condition. The patient was asked for the name and number of his physician or a form could be sent requesting additional information about his situation, but the patient did not answer the question. Follow up received from consumer on 23rd July 2018: The reporter details were updated. On 24th April 2018, the patient received SHINGRIX. The reporter provided updated information regarding uveitis. The reporter stated that it develeoped around 15th May 2018, which was about 2 weeks after 1st dose of SHINGRIX. The caller also provided ophthalmologist contact information and permission to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Arrhythmia, Chills, Oxygen saturation decreased, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of arrhythmia in a 78-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included atrial fibrillation. On 19th July 2018, the patient received the 2nd dose of SHINGRIX. On 19th July 2018, several hours after receiving SHINGRIX, the patient experienced chills, fever and abdominal pain. On 20th July 2018, the patient experienced arrhythmia (serious criteria GSK medically significant), skin peeling and oxygen saturation decreased. On an unknown date, the outcome of the arrhythmia, chills, oxygen saturation decreased, fever and abdominal pain were recovered/resolved and the outcome of the skin peeling was not recovered/not resolved. It was unknown if the reporter considered the arrhythmia, chills, skin peeling, oxygen saturation decreased, fever and abdominal pain to be related to SHINGRIX. The reporting physician was the concerned patient. In the next morning after vaccination, the patient experienced skin peeling on hands and the patient's heart rate was 122 for almost a half of a day, along with decreased pulse oxygen at 88 to 90 percent. The reporter did not have the dose, route, lot number or expiry date of SHINGRIX dose given.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of arrhythmia in a 78-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included atrial fibrillation. On 19th July 2018, the patient received the 2nd dose of SHINGRIX. On 19th July 2018, several hours after receiving SHINGRIX, the patient experienced chills, fever and abdominal pain. On 20th July 2018, the patient experienced arrhythmia (serious criteria GSK medically significant), skin peeling and oxygen saturation decreased. On an unknown date, the outcome of the arrhythmia, chills, oxygen saturation decreased, fever and abdominal pain were recovered/resolved and the outcome of the skin peeling was not recovered/not resolved. It was unknown if the reporter considered the arrhythmia, chills, skin peeling, oxygen saturation decreased, fever and abdominal pain to be related to SHINGRIX. The reporting physician was the concerned patient. In the next morning after vaccination, the patient experienced skin peeling on hands and the patient's heart rate was 122 for almost a half of a day, along with decreased pulse oxygen at 88 to 90 percent. The reporter did not have the dose, route, lot number or expiry date of SHINGRIX dose given.
Age: 45.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a 45-year-old female patient who received FLUARIX QUADRIVALENT 2017-2018 season (batch number 34RE5, expiry date 30th June 2018) for prophylaxis. The patient's past medical history included chronic pancreatitis. Concurrent medical conditions included multiple allergies (Cefoperazone and Granisetron). Concomitant products included PREVENAR 13. On an unknown date, the patient received FLUARIX QUADRIVALENT 2017-2018 season (intramuscular). On an unknown date, unknown after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional details were provided as follows: The age at vaccination was not reported. There was a temperature excursion for FLUARIX QUADRIVALENT 2017-2018 season, which led to incorrect storage of drug. The information regarding this event has not been submitted to the US Food and Drug Administration and has not been reported to the agency. No culture was performed. No treatment was required.   Follow up information received from Nurse on 18th July 2018: The patient details were updated. On 19th October 2017, the patient received 1st dose of Fluarix Quadrivalent 0.5 ml. Fluarix was given after multiple shot of temperature excursions but not exceded the manufacturer's allotted time slot. No adverse events were reported. This was an accidental medication error without harm. The VAERS details were updated.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Influenza, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 71-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes. On 16th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza, headache, pain in arm, sweating and shivering. On 17th July 2018, the patient experienced muscle pain. On 18th July 2018, the outcome of the sweating and shivering were recovered/resolved. On an unknown date, the outcome of the influenza was unknown and the outcome of the headache, muscle pain and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the influenza, headache, muscle pain, pain in arm, sweating and shivering to be related to SHINGRIX. Additional details were provided as follows: About 11:00 pm on the day of vaccination, the patient developed a headache. She then broke out in a sweat and started to shiver. The patient's arm became sore about 4 hours after the vaccination. The patient woke up this morning (1 day after receiving vaccination) with a severe headache and muscles ache through her body. The patient compared it to the flu.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 71-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes. On 16th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza, headache, pain in arm, sweating and shivering. On 17th July 2018, the patient experienced muscle pain. On 18th July 2018, the outcome of the sweating and shivering were recovered/resolved. On an unknown date, the outcome of the influenza was unknown and the outcome of the headache, muscle pain and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the influenza, headache, muscle pain, pain in arm, sweating and shivering to be related to SHINGRIX. Additional details were provided as follows: About 11:00 pm on the day of vaccination, the patient developed a headache. She then broke out in a sweat and started to shiver. The patient's arm became sore about 4 hours after the vaccination. The patient woke up this morning (1 day after receiving vaccination) with a severe headache and muscles ache through her body. The patient compared it to the flu.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site reaction, Rash macular, Vomiting
Clinical narrative: Redness, splotchy around injection site, headache, vomiting.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Scar
Clinical narrative: Patient stated started off as bug bite looking pimple which spread into rash covering waist/back/arm area that lasted a few days that resolved from steroid pills/shots from the doctor and then it came back after the pills wore off. The rash has lasted for approximately eight months. Patient reports that it stings still everyday. The rash has resolved, but still has chicken pox-like marks on waist/back/arm area.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Arthropod bite, Biopsy skin abnormal, Burning sensation, Hypersensitivity
Clinical narrative: Patient stated started off as bug bite looking pimple which spread into rash covering waist/back/arm area that lasted a few days that resolved from steroid pills/shots from the doctor and then it came back after the pills wore off. The rash has lasted for approximately eight months. Patient reports that it stings still everyday. The rash has resolved, but still has chicken pox-like marks on waist/back/arm area.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Perivascular dermatitis, Pruritus, Rash, Rash vesicular
Clinical narrative: Patient stated started off as bug bite looking pimple which spread into rash covering waist/back/arm area that lasted a few days that resolved from steroid pills/shots from the doctor and then it came back after the pills wore off. The rash has lasted for approximately eight months. Patient reports that it stings still everyday. The rash has resolved, but still has chicken pox-like marks on waist/back/arm area.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Viral infection
Clinical narrative: Patient stated started off as bug bite looking pimple which spread into rash covering waist/back/arm area that lasted a few days that resolved from steroid pills/shots from the doctor and then it came back after the pills wore off. The rash has lasted for approximately eight months. Patient reports that it stings still everyday. The rash has resolved, but still has chicken pox-like marks on waist/back/arm area.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Scar
Clinical narrative: 8-9-17 shingles shot. 8-17-17 stinging, burning rash on biceps and under left breast. 8-19-17 Looked like he had chicken pox-like -rash. 8/17/17 thru Sept 1st, 2017 - tried ZOSTRIX, BENADRYL medicated cream, BENADRYL tablets, BENADRYL gel lotion, Calamine lotion, ZYRTEC, CORTIZONE 10 (max. strength) Clobetasol Cream (.05%). 9-1 to 9-4-17 (family Dr.'s office closed). 9-5-17 At Dr.s office Received a Prednisone shot and Prednisone prescription (for 5 days), and Clobetasol (.05%). 9-14-17 Dr. (Dermatologist) Biopsy on back. Take 3 ZYRTEC daily, Eucerin, Dove unscented soap, Triamcinolone, Clobetasol .05%, dry skin procedure. Results from biopsy-medicine related reaction. Stop PRILOSEC, Vitamin E and SIMPLY SLEEP and MEGA RED. 10-12-17 Dermatologist repeat above directions for another 4 weeks. Increase ZYRTEC to 4 daily. Come back in 4 weeks. 11-2-17 Dermatologist, patient couldn't wait for the 4th week appt. Continue 4 ZYRTEC daily. Stop Triamcinolone, Betamethasone. Make sure not to take PRILOSEC and SIMPLY SLEEP and vitamins. 11-14-17 Dr. said it was neurodermatitis. Scripts for Doxepin and Betamethasone .1%. Use CERAVE over break out area's after Betamethasone absorbs. ZYRTEC in morning. 11-30-17 Dr., KENALOG shot (40mg) and Cyproheptadine 1 every 8 hours. If no change, patient should get another opinion. 12-7-17 Patient started taking my Gabapentin (300 mg). Doctors weren't helping him at all. 4-11-18 Dr. said it was a reaction to the Shingles shot. Scripts for Halobetasol .05%, Gabapentin 300 mg, Triamcinolone .01%, Doxycycline Hyclate 100 mg, (patient itched like crazy after taking Doxycycline-pharmacy said it was probably an allergic reaction). Stopped. Took biopsy. Results said superficial perivascular lymphocytic dermatitis consistent with drug reaction, insect bite or viral etiology. 6-6-18 Dr. Continue halobetasol and gabapentin. May want to try Ultraviolet lights.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Arthropod bite, Biopsy skin abnormal, Burning sensation, Hypersensitivity
Clinical narrative: 8-9-17 shingles shot. 8-17-17 stinging, burning rash on biceps and under left breast. 8-19-17 Looked like he had chicken pox-like -rash. 8/17/17 thru Sept 1st, 2017 - tried ZOSTRIX, BENADRYL medicated cream, BENADRYL tablets, BENADRYL gel lotion, Calamine lotion, ZYRTEC, CORTIZONE 10 (max. strength) Clobetasol Cream (.05%). 9-1 to 9-4-17 (family Dr.'s office closed). 9-5-17 At Dr.s office Received a Prednisone shot and Prednisone prescription (for 5 days), and Clobetasol (.05%). 9-14-17 Dr. (Dermatologist) Biopsy on back. Take 3 ZYRTEC daily, Eucerin, Dove unscented soap, Triamcinolone, Clobetasol .05%, dry skin procedure. Results from biopsy-medicine related reaction. Stop PRILOSEC, Vitamin E and SIMPLY SLEEP and MEGA RED. 10-12-17 Dermatologist repeat above directions for another 4 weeks. Increase ZYRTEC to 4 daily. Come back in 4 weeks. 11-2-17 Dermatologist, patient couldn't wait for the 4th week appt. Continue 4 ZYRTEC daily. Stop Triamcinolone, Betamethasone. Make sure not to take PRILOSEC and SIMPLY SLEEP and vitamins. 11-14-17 Dr. said it was neurodermatitis. Scripts for Doxepin and Betamethasone .1%. Use CERAVE over break out area's after Betamethasone absorbs. ZYRTEC in morning. 11-30-17 Dr., KENALOG shot (40mg) and Cyproheptadine 1 every 8 hours. If no change, patient should get another opinion. 12-7-17 Patient started taking my Gabapentin (300 mg). Doctors weren't helping him at all. 4-11-18 Dr. said it was a reaction to the Shingles shot. Scripts for Halobetasol .05%, Gabapentin 300 mg, Triamcinolone .01%, Doxycycline Hyclate 100 mg, (patient itched like crazy after taking Doxycycline-pharmacy said it was probably an allergic reaction). Stopped. Took biopsy. Results said superficial perivascular lymphocytic dermatitis consistent with drug reaction, insect bite or viral etiology. 6-6-18 Dr. Continue halobetasol and gabapentin. May want to try Ultraviolet lights.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Perivascular dermatitis, Pruritus, Rash, Rash vesicular
Clinical narrative: 8-9-17 shingles shot. 8-17-17 stinging, burning rash on biceps and under left breast. 8-19-17 Looked like he had chicken pox-like -rash. 8/17/17 thru Sept 1st, 2017 - tried ZOSTRIX, BENADRYL medicated cream, BENADRYL tablets, BENADRYL gel lotion, Calamine lotion, ZYRTEC, CORTIZONE 10 (max. strength) Clobetasol Cream (.05%). 9-1 to 9-4-17 (family Dr.'s office closed). 9-5-17 At Dr.s office Received a Prednisone shot and Prednisone prescription (for 5 days), and Clobetasol (.05%). 9-14-17 Dr. (Dermatologist) Biopsy on back. Take 3 ZYRTEC daily, Eucerin, Dove unscented soap, Triamcinolone, Clobetasol .05%, dry skin procedure. Results from biopsy-medicine related reaction. Stop PRILOSEC, Vitamin E and SIMPLY SLEEP and MEGA RED. 10-12-17 Dermatologist repeat above directions for another 4 weeks. Increase ZYRTEC to 4 daily. Come back in 4 weeks. 11-2-17 Dermatologist, patient couldn't wait for the 4th week appt. Continue 4 ZYRTEC daily. Stop Triamcinolone, Betamethasone. Make sure not to take PRILOSEC and SIMPLY SLEEP and vitamins. 11-14-17 Dr. said it was neurodermatitis. Scripts for Doxepin and Betamethasone .1%. Use CERAVE over break out area's after Betamethasone absorbs. ZYRTEC in morning. 11-30-17 Dr., KENALOG shot (40mg) and Cyproheptadine 1 every 8 hours. If no change, patient should get another opinion. 12-7-17 Patient started taking my Gabapentin (300 mg). Doctors weren't helping him at all. 4-11-18 Dr. said it was a reaction to the Shingles shot. Scripts for Halobetasol .05%, Gabapentin 300 mg, Triamcinolone .01%, Doxycycline Hyclate 100 mg, (patient itched like crazy after taking Doxycycline-pharmacy said it was probably an allergic reaction). Stopped. Took biopsy. Results said superficial perivascular lymphocytic dermatitis consistent with drug reaction, insect bite or viral etiology. 6-6-18 Dr. Continue halobetasol and gabapentin. May want to try Ultraviolet lights.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Viral infection
Clinical narrative: 8-9-17 shingles shot. 8-17-17 stinging, burning rash on biceps and under left breast. 8-19-17 Looked like he had chicken pox-like -rash. 8/17/17 thru Sept 1st, 2017 - tried ZOSTRIX, BENADRYL medicated cream, BENADRYL tablets, BENADRYL gel lotion, Calamine lotion, ZYRTEC, CORTIZONE 10 (max. strength) Clobetasol Cream (.05%). 9-1 to 9-4-17 (family Dr.'s office closed). 9-5-17 At Dr.s office Received a Prednisone shot and Prednisone prescription (for 5 days), and Clobetasol (.05%). 9-14-17 Dr. (Dermatologist) Biopsy on back. Take 3 ZYRTEC daily, Eucerin, Dove unscented soap, Triamcinolone, Clobetasol .05%, dry skin procedure. Results from biopsy-medicine related reaction. Stop PRILOSEC, Vitamin E and SIMPLY SLEEP and MEGA RED. 10-12-17 Dermatologist repeat above directions for another 4 weeks. Increase ZYRTEC to 4 daily. Come back in 4 weeks. 11-2-17 Dermatologist, patient couldn't wait for the 4th week appt. Continue 4 ZYRTEC daily. Stop Triamcinolone, Betamethasone. Make sure not to take PRILOSEC and SIMPLY SLEEP and vitamins. 11-14-17 Dr. said it was neurodermatitis. Scripts for Doxepin and Betamethasone .1%. Use CERAVE over break out area's after Betamethasone absorbs. ZYRTEC in morning. 11-30-17 Dr., KENALOG shot (40mg) and Cyproheptadine 1 every 8 hours. If no change, patient should get another opinion. 12-7-17 Patient started taking my Gabapentin (300 mg). Doctors weren't helping him at all. 4-11-18 Dr. said it was a reaction to the Shingles shot. Scripts for Halobetasol .05%, Gabapentin 300 mg, Triamcinolone .01%, Doxycycline Hyclate 100 mg, (patient itched like crazy after taking Doxycycline-pharmacy said it was probably an allergic reaction). Stopped. Took biopsy. Results said superficial perivascular lymphocytic dermatitis consistent with drug reaction, insect bite or viral etiology. 6-6-18 Dr. Continue halobetasol and gabapentin. May want to try Ultraviolet lights.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: MENVEO vaccine given by CMA during a WCC visit, pt developed immediate redness and itching on vaccine site. RN and vaccine coordinator notified. He was given an ice pack within 5 min of reaction  and held it in place. VS checked and stable, Benadryl 25 mg PO given by verbal order 6-7 min after onset of reaction. 3 minutes after the Benadryl  his R upper arm redness and itching had resolved. Vital signs checked 13 minutes after medication administration and still stable. Pt denied diff breathing, swelling, nausea, dizziness, HA. He was cleared to leave the clinic.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Chills, fever at 6:30 PM. Awoke with redness, swelling, itching upper arm, Tuesday, July 24. Severe tenderness. Continued swelling for 48h. Presented to MD Wednesday afternoon. Intense redness, swelling, warmth to touch, very tender to touch. Given IM injection of ROCEPHIN, 1 gram in addition to cephalexin 500 mg Q8h for 10 days, prednisone 10 mg, tapering schedule, 30 tabs, oxycodone for cellulitis pain 5-325 mg PRN pain.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Chills, fever at 6:30 PM. Awoke with redness, swelling, itching upper arm, Tuesday, July 24. Severe tenderness. Continued swelling for 48h. Presented to MD Wednesday afternoon. Intense redness, swelling, warmth to touch, very tender to touch. Given IM injection of ROCEPHIN, 1 gram in addition to cephalexin 500 mg Q8h for 10 days, prednisone 10 mg, tapering schedule, 30 tabs, oxycodone for cellulitis pain 5-325 mg PRN pain.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Seizure like phenomena, Urinary incontinence
Clinical narrative: As soon as injection was given, he began to have seizure like activity as reported by RN that administered the injection. He urinated on himself. Seizure like activity lasted an estimated 2-3 min. then he was awake alert and oriented.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Incoherent, Posture abnormal
Clinical narrative: PT VACCINATED IN CHAIR. PT LEANED FORWARD AND BECAME INCOHERENT. PT ASSISTED TO RECLINING CHAIR AND FEET ELEVATED. PT BECAME ORIENTED TO PERSON, PLACE, AND TIME. PT GIVEN SNACK AND WATER. PT MONITORED. VITAL SIGNS WNL. NURSE PRACTITIONER ASSESSMENT WNL.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Injection site pain, Vomiting
Clinical narrative: Severe pain at the injection site, numbness in arm, severe headache, and vomiting that lasted 3 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX. On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right deltoid. For the tolerance of 2nd dose of SHINGRIX, refer linked case US2018GSK134394 for same patient. This case has been linked with case US2018GSK129131, US2018GSK129134 and US2018GSK129168 reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling arm in a adult 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 swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional information was reported as follows: During the escalated call from the physician, he stated that he didn't want to have another swollen arm from an extra shot of SHINGRIX  since the SHINGRIX vaccine was not available at the time of reporting, which led to product availability issue. No additional details were available. The patient has denied permission to contact their physician.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced injection site swelling, injection site induration and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site induration and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling, injection site induration and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: The patient was 74 years old at the time of reporting. The patient might have received BOOSTRIX vaccine, when the patient was 30 and more years old. The healthcare professional reported that she had a reaction to an unspecified dtp vaccine when she was younger. The healthcare professional developed swelling rock hard and red at the injection site. It was unsure if this was a GlaxoSmithKline vaccine, the healthcare professional did not provide date of birth. As per clarification received from team, by considering the age suspect was considered as BOOSTRIX.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Auricular swelling, Blister, Feeling hot, Peripheral swelling, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 3 to 5 years ago before the time of reporting). On 12th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th July 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm and extremities hot feeling of. On 14th July 2018, the patient experienced urticaria. On 18th July 2018, the patient experienced auricular swelling and vesicles. On an unknown date, the outcome of the swelling arm, urticaria and extremities hot feeling of were recovered/resolved and the outcome of the auricular swelling and vesicles were not recovered/not resolved. It was unknown if the reporter considered the swelling arm, auricular swelling, urticaria, vesicles and extremities hot feeling of to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient was the nurse. The patient did not receive any concomitant medication. On 12th July 2018, the patient swelling and hotness of left arm and resolved. On 14th July 2018, 2 days later the patient experienced huge welt on her right arm in the antecubital space and a welt on her 2nd toe of the right foot, both of these had resolved as well. On 17th July 2018, the patient had hives of her left forearm that resolved. On 18th July 2018, at night (the day before reporting) the patient noted vesicles on her left ear lobe and her ear lobe was swollen 4 times its normal size. The patient had not reported to her physician at this time reporting, but was encouraged to do so. The patient had declined HCP at this time as he was in other state and the patient was currently in other state.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (30 years ago). Concurrent medical conditions included chronic lymphocytic leukemia and nerve pain. Concomitant products included acyclovir and gabapentin. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 28 days after receiving SHINGRIX, the patient experienced shingles, headache and painful rash. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the headache and painful rash were recovering/resolving. It was unknown if the reporter considered the shingles, headache and painful rash to be related to SHINGRIX. Additional details were reported as follows: The reporter was wife of the patient. The patient also reported the information. The patient received SHINGRIX on left arm. Four to five weeks later, the patient experienced a painful rash on his head. The patient also experienced shooting pains in his head, a low grade headache. The patient went to see his physician and he was diagnosed with shingles. The patient's physician prescribed acyclovir (7 day regimen) and gabapentin for the nerve pain.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Hypokinesia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, sweating, headache and movements reduced. On an unknown date, the outcome of the fever, chills, sweating, headache and movements reduced were unknown. It was unknown if the reporter considered the fever, chills, sweating, headache and movements reduced to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, he experienced fever, chills, he could barely move and sweats when the fever broke down. The patient experienced 101 degrees. The events were updated after call review. This case was linked with case US2018GSK133629, reported by the same reporter for the same patient. Lab Comments: On an unknown date, the patient's body temperature was found to be 101 degree C.