chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: On 2/28/2019 administering RN received call from employee. Reported client was seen by FNP for vaccination reaction. Administering RN and second immunization RN travelled to facility to inspect  reported vaccine reaction. Day 1 client received 1 dose of Tdap in right deltoid on 2/21/2019 . Reports soreness at injection site on day 1  of vaccination. Client reports soreness and redness at injection site day 2. Client states at day 3 site was normal, no signs or symptoms of reaction. Client states at day 7,  2/27/2019 had symptoms of redness, swelling and hardness at injection site which extended from injection site approximately 4 inches down arm. Client was taken to FNP for evaluation. FNP reported that the signs and symptoms at injection site appeared to be cellulitis. Client was prescribed antibiotics for presumed cellulitis. Reporting RN viewed injection site, signs as described. redness, swelling starting at injection site and extending down arm approximately 4 inches. Client reports currently taking antibiotics for symptoms.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cyst, Pain, X-ray
Clinical narrative: On 2/14/19 patient reported that she was still sore and wasn't sure if it was from the shingles vaccine but that she was going to call her physician that day and would get back to me. On 3/1/19 I called patient to follow up since I hadn't heard from her and she said she had an X-ray that showed a cyst in her shoulder area. It may or may not be related to the vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dysstasia, Feeling hot, Nausea
Clinical narrative: 12 hours after immunization, began to feel nauseous and dizzy - could not stand up. He went from shivering to feeling hot. He went to urgent care and received IV fluids, and he thinks injections of anti-nausea med and maybe a steroid. Symptoms subsided 12 hours after onset, but he took 2 days off of work to recover.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Hard, red, warm, painful site.
Sex: F
Vaccine: HPV9
Symptoms: Abortion spontaneous, Biopsy foetal abnormal, Exposure during pregnancy, Placental disorder
Clinical narrative: This spontaneous retrospective pregnancy report has been received from a physician referring to a female patient of unknown age. No information was knew by the reporter regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications. On an unknown date, during early pregnancy, the patient was vaccinated with one dose GARDASIL 9 (strength,anatomical location, route of administration, lot# and expiration date were not provided) for prophylaxis. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The patient miscarried on an unspecified date (abortion spontaneous). Furthermore, it was reported that the pathology for the fetus showed: "placenta with unusual changes that looked like they were more viral, biopsy nuclear changes" (placental disorder). The outcome of abortion spontaneous and placental disorder, and the causality between the aforementioned events and GARDASIL 9 were not reported. The event abortion spontaneous was determined to be medically significant.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In October 2009, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-NOV-2014, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX : shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer on 22-FEB-2019 regarding a case in litigation concerning a female patient, medical history not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long term prevention of shingles and zoster related conditions. On or about 01-JUN-2015, at age 69, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy.  On an unspecified date the patient was treated by a physician for the following injuries resulting from ZOSTAVAX use: shingles. Outcome was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age (pediatric population) and gender. The patient's concurrent conditions, past medical history, concomitant medications or drug reactions and allergies were not reported. On an unknown date in November 2018, the patient was vaccinated with an adult dose of VAQTA (exact dose, route and site of administration were not reported) lot # R009799, expiry date 02-JUN-2019 for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1903USA000454.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age (pediatric population) and gender. The patient's concurrent conditions, past medical history, concomitant medications or drug reactions and allergies were not reported. On an unknown date in January 2019, the patient was vaccinated with an adult dose of VAQTA (exact dose, route and site of administration were not reported) lot # R009799, expiry date 02-JUN-2019 for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1903USA000213.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, 2 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient did not have a history of immunosuppressive treatments or disease states. The age at vaccination was not reported but the patient could be 75 or 76 years old. The nurse reported that the patient experienced shingles 2 days after receiving SHINGRIX. The physician provided the patient with VALTREX on 19th February 2019. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 29th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 25th January 2019, 210 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the bell's palsy was not recovered/not resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient woke up with bell's palsy. The patient's 2nd dose was due after 29th August 2018, but the pharmacy was in short supply of the vaccine for a while. The patient still did not receive her 2nd shot of SHINGRIX. At the time of reporting, the patient was concerned about the bell's palsy. The patient wanted to know, if it would had some kind of effect on her if she receives the 2nd shot of SHINGRIX at the time of reporting. The patient asked, whether it would be safe for her to take it or wait until the bell's palsy had gone away. The patient understood that bell's palsy could last from 3 to 6 months so it would be longer than the 6 months that was recommended to take the 2nd dose.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 77-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of stomatitis (also experienced blistering of mouth after 1st dose received on 3rd October 2018, refer case US2019032482). Concurrent medical conditions included sores mouth and blistering of mouth. On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In January 2019, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: In January 2019, the patient started experiencing a rash on legs and arms. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Hypersomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced tiredness, sweating, pain in arm, chills and sleep excessive. On 21st January 2019, the patient experienced headache. On 23rd January 2019, the patient experienced presyncope. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, tiredness, sweating, pain in arm, chills, sleep excessive and presyncope were recovered/resolved. It was unknown if the reporter considered the headache, tiredness, sweating, pain in arm, chills, sleep excessive and presyncope to be related to SHINGRIX. Additional details were provided as follows: The patient had a headache towards the evening around 9 PM. After that she experienced tiredness, sweating, fatigue, sore arm and chills. Later she took TYLENOL and slept a lot. The patient tried to get to work on Wednesday and she took a shower and 2 days after receiving SHINGRIX she almost passed out. The symptoms lasted for 3 to 4 days except sore arm which lasted for 7 to 8 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Presyncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced tiredness, sweating, pain in arm, chills and sleep excessive. On 21st January 2019, the patient experienced headache. On 23rd January 2019, the patient experienced presyncope. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, tiredness, sweating, pain in arm, chills, sleep excessive and presyncope were recovered/resolved. It was unknown if the reporter considered the headache, tiredness, sweating, pain in arm, chills, sleep excessive and presyncope to be related to SHINGRIX. Additional details were provided as follows: The patient had a headache towards the evening around 9 PM. After that she experienced tiredness, sweating, fatigue, sore arm and chills. Later she took TYLENOL and slept a lot. The patient tried to get to work on Wednesday and she took a shower and 2 days after receiving SHINGRIX she almost passed out. The symptoms lasted for 3 to 4 days except sore arm which lasted for 7 to 8 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 59-year-old female patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of swelling (1st dose received on an unknown date, for tolerance refer case US2019GSK037152). On 21st February 2019, the patient received the 2nd dose of SHINGRIX. On 21st February 2019, immediately after receiving SHINGRIX, the patient experienced injection site hemorrhage, contusion and injection site swelling. On an unknown date, the outcome of the injection site hemorrhage, contusion and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site hemorrhage, contusion and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on an unknown arm. The patient began swelling immediately following vaccination, directly under the injection site. The patient experienced purple bruising and bleeding down the arm described as not profusely, but dripped down the arm. The reporter noted bleeding resolved, and swelling had begun to go down.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, not applicable after receiving SHINGRIX and an unknown time after starting VALTREX, the patient experienced shingles and incomplete course of vaccination. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist on the line with the patient who was at the 7 month mark for receiving the 2nd dose and the patient did not receive second dose till the time of reporting, which led incomplete course of vaccination. The patient had Shingles and she went to the doctor on the previous day before the time of reporting and they filled VALTREX for her. The information regarding the vaccine administered filed away. The caller stated that he did not know when the patient developed Shingles. The batch number and expiry date was unknown.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of foot pain in a 65-year-old male patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. Concomitant products included SHINGRIX. On 19th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 20th February 2019, 1 days after receiving SHINGRIX, the patient experienced foot pain. On an unknown date, the outcome of the foot pain was not recovered/not resolved. It was unknown if the reporter considered the foot pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist on the line reported that the patient got their 2nd dose and then woke up the morning on 20th February 2019, the patient's right foot was painful, it hurts all the time and more when he walks on it. It has not improved, it has worsened and the pain was very significant. It does not go past his ankle, just his foot.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Hyperhidrosis
Clinical narrative: I received the first of two doses of the Recombinant Zoster (Shingles) Vaccine, RZV. About 12 hours after the shot, I woke up sweating and with a rapid heartbeat. I got up and drank some fluids, and after about 5-7 minutes my heartbeat started going back to somewhat normal but still slightly elevated. I was able to go back to sleep. The next morning I felt fine.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Muscle aches, fever, chills, nausea, weakness, fatigue for 5-6 days.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Muscle aches, fever, chills, nausea, weakness, fatigue for 5-6 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Hyperhidrosis, Muscular weakness, Nausea
Clinical narrative: EXTREME GASTRIC PAIN, NAUSEA, SLIGHT FEVER WITH SWEATING, MUSCLE WEAKNESS, LIGHT-HEADED. SENSATIONS LASTED FOR ABOUT 5-6 HOURS IN DURATION.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: EXTREME GASTRIC PAIN, NAUSEA, SLIGHT FEVER WITH SWEATING, MUSCLE WEAKNESS, LIGHT-HEADED. SENSATIONS LASTED FOR ABOUT 5-6 HOURS IN DURATION.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Asthenia, Chest discomfort, Dizziness, Erythema
Clinical narrative: On eve of 2/21/2019 at home begin feeling lightheaded, left arm begin to hurt real bad and had some chest tightness with stomach pain. Parent did give some ibuprofen and applied warm pack to arm. On Saturday noted to have a fine rash about arm and redness on left arm started getting bigger. No longer with chest tightness Saturday but continued to feel bad with lightheadness and pain in left arm and very weak. Came to Dr. office on Monday due to continues rash and still feeling a little weak.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Pain in extremity, Rash
Clinical narrative: On eve of 2/21/2019 at home begin feeling lightheaded, left arm begin to hurt real bad and had some chest tightness with stomach pain. Parent did give some ibuprofen and applied warm pack to arm. On Saturday noted to have a fine rash about arm and redness on left arm started getting bigger. No longer with chest tightness Saturday but continued to feel bad with lightheadness and pain in left arm and very weak. Came to Dr. office on Monday due to continues rash and still feeling a little weak.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying, Urticaria
Clinical narrative: Per phone call from mother. Child woke up from his nap and was crying for about 1/2 hours. Mother changed his diaper and noticed that he had started breaking out in hives. She called his PCP and was told to give him BENADRYL.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Diet refusal, Emotional distress, Screaming, Urticaria
Clinical narrative: Per phone call from mother. Child woke up from his nap and was crying for about 1/2 hours. Mother changed his diaper and noticed that he had started breaking out in hives. She called his PCP and was told to give him BENADRYL.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ, FLU4, HPV9, MENB, MNQ
Symptoms: Induration, Limb mass
Clinical narrative: Noticed a hard lump in left arm.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ, FLU4, HPV9, MENB, MNQ
Symptoms: Limb mass
Clinical narrative: Noticed a hard lump in left arm.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Chills, Cyanosis, Dyspnoea, Nausea, Pallor
Clinical narrative: Patient began having shortness of breath about 5-10 minutes after vaccines were given, she complained of feeling like her throat was closing. Provider assessed throat and lungs, RN gave 50 mg Diphenhydramine and brought in EPI PEN. Patient took Diphenhydramine without issue, she said her throat was feeling better but then became nauseated. Vital signs were taken, oxygen and blood pressure were within normal limits. Provider ordered 8 mg Ondasteron which was given. Patient remained nauseated but stated her throat felt fine and her breathing was improving. Patient was being observed in clinic but was pale and still feeling nauseated. 911 was called for transport. About 40 minutes after vaccines were given, patient began complaining of her throat itching, difficulty breathing and severe chills, she was extremely pale and lips had blue tint. 15 liters non-rebreather oxygen started and 0.3 mg IM epinephrine given. About 5 minutes after EPI was given, ambulance arrived and transferred patient to ED.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Throat irritation
Clinical narrative: Patient began having shortness of breath about 5-10 minutes after vaccines were given, she complained of feeling like her throat was closing. Provider assessed throat and lungs, RN gave 50 mg Diphenhydramine and brought in EPI PEN. Patient took Diphenhydramine without issue, she said her throat was feeling better but then became nauseated. Vital signs were taken, oxygen and blood pressure were within normal limits. Provider ordered 8 mg Ondasteron which was given. Patient remained nauseated but stated her throat felt fine and her breathing was improving. Patient was being observed in clinic but was pale and still feeling nauseated. 911 was called for transport. About 40 minutes after vaccines were given, patient began complaining of her throat itching, difficulty breathing and severe chills, she was extremely pale and lips had blue tint. 15 liters non-rebreather oxygen started and 0.3 mg IM epinephrine given. About 5 minutes after EPI was given, ambulance arrived and transferred patient to ED.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Disorientation, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Expected level of arm soreness, followed by feverish chills during the night. Morning lethargy and disorientation.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Cellulitis, Gait disturbance, Lip swelling
Clinical narrative: Cellulitis, swelling of thigh that started a little more than 24 hours after vaccine was given but increased by a lot at around 26 hours after vaccine was given. Some limp/change in gait.
Sex: U
Vaccine: HEP, HPV9, PPV
Symptoms: Product storage error
Clinical narrative: This non-valid spontaneous report was received from a registered nurse and refers to unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients was vaccinated with improperly stored vaccines: RECOMBIVAX HB thimerosal-free, lot # R012001, expiration date 06-NOV-2020 and lot # R001530, expiration date 07-NOV-2020 (strength, dose and route of administration were not reported), with GARDASIL 9 (strength, dose, lot number and expiration date were not reported) and with PNEUMOVAX 23 lot # R027299, expiration date 09-APR-2020 and lot # R002354, expiration date 17-DEC-2019 (strength, dose and route of administration were not reported), all for prophylaxis. The vaccines were stored in 12.12 degrees Celsius for 1 hour 45 minutes. There was no previous temperature excursion. There was data logger involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 26-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # R020652, expiry date 18-JUL-2020 (strength, exact dose, route and site of administration were not reported) for prophylaxis. The suspected vaccine was reconstituted with sterile diluent. The suspected vaccine was stored in temperature from -9 degrees Celsius (C) to 8 C (-9.1 C) for 1 hour and 13 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1903USA000472:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 27-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # R020652, expiry date 18-JUL-2020 (strength, exact dose, route and site of administration were not reported) for prophylaxis. The suspected vaccine was reconstituted with sterile diluent. The suspected vaccine was stored in temperature from -9 degrees Celsius (C) to 8 C (-9.1 C) for 1 hour and 13 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1903USA000242:
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. The reporter considered the pain to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a painful reaction to the 1st SHINGRIX dose and did not complete the series. It was unknown if the events cause the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporting health care professional consider the events to be life threatening. It was unknown if the reporting health care professional consider the events to result in persistent or significant disability or incapacity. The patient did not die. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events were not result in a congenital anomaly or birth defect. The pharmacist mentioned that they received 1st dose of SHINGRIX and it resulted in pain that lasted about 5 to 7 days. They did not specify when they received the dose and if the pain resolved. Was not able to capture attendee's name or information.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 64-year-old male patient who received SHINGRIX (batch number TZ9L5, expiry date unknown) for prophylaxis. On 10th October 2018, the patient received SHINGRIX. On 26th October 2018, 16 days after receiving SHINGRIX, the patient experienced myalgia, hives and fatigue. On an unknown date, the outcome of the myalgia, hives and fatigue were unknown. It was unknown if the reporter considered the myalgia, hives and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient experienced myalgia, hives and fatigue after receiving a dose of SHINGRIX. It was unsure if issues were related to SHINGRIX vaccine. The reporter was agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as an adult as per vaccine indication. The patient developed shingles on leg 2 days after SHINGRIX administration. The reporter provided the consent for follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 7th December 2018, the patient received the 1st dose of SHINGRIX. On 9th December 2018, 2 days after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovered/resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on an unknown arm. Approximately 2 hours later, the patient experienced several bumps on her back which were itchy after receiving a t dose of SHINGRIX. The event resolved after 2 weeks. The patient was seen by a physician, but the reporter didnot know what discussion or diagnosis was made. The reporter consented to follow up. The patient received 2nd dose for tolerance see case US2019032491.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number T4952, expiry date 18th June 2021) for prophylaxis. On 12th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th February 2019, 2 days after receiving SHINGRIX, the patient experienced shingles and rash. In February 2019, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the shingles, rash, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The reporter stated that about two days later receiving SHINGRIX, the patient started having a rash. The reporter had a patient in their office with significant redness and swelling at the site as well as what appears to be a shingles outbreak on her hand, thigh and stomach. The patient came to the physicians' office today 18th February 2018 and was diagnosed with shingles. The physician seeing her would like to know if he could or should prescribe VALTREX.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry mouth, Headache, Injection site pain, Pain, Rapid eye movements sleep abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in September 2018 and had no side effects afterwards). On 18th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th February 2019, less than a day after receiving SHINGRIX, the patient experienced headache, general body pain, sleep disturbance and rem sleep abnormal. On 19th February 2019, the patient experienced dry mouth, sniffles, renal pain and injection site pain. On an unknown date, the outcome of the headache, general body pain, dry mouth, sniffles and renal pain were not recovered/not resolved and the outcome of the sleep disturbance, rem sleep abnormal and injection site pain were unknown. It was unknown if the reporter considered the headache, general body pain, sleep disturbance, rem sleep abnormal, dry mouth, sniffles, renal pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: A day before reporting, the patient received 2nd dose of SHINGRIX and started experiencing a headache and body aches that evening. The patient kept waking up through the night and he used a device to monitor rapid eye movement (REM) sleep and he did not have any episodes of REM sleep through the night. 1 day after receiving SHINGRIX, the patient had some soreness at the injection site, a terrible headache, severe dry mouth and pain in the area of his left kidney. The patient also had some sniffles. The patient was not sure if it was actually kidney pain, or related to the general body aches he was experiencing. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Renal pain, Rhinorrhoea, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in September 2018 and had no side effects afterwards). On 18th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th February 2019, less than a day after receiving SHINGRIX, the patient experienced headache, general body pain, sleep disturbance and rem sleep abnormal. On 19th February 2019, the patient experienced dry mouth, sniffles, renal pain and injection site pain. On an unknown date, the outcome of the headache, general body pain, dry mouth, sniffles and renal pain were not recovered/not resolved and the outcome of the sleep disturbance, rem sleep abnormal and injection site pain were unknown. It was unknown if the reporter considered the headache, general body pain, sleep disturbance, rem sleep abnormal, dry mouth, sniffles, renal pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: A day before reporting, the patient received 2nd dose of SHINGRIX and started experiencing a headache and body aches that evening. The patient kept waking up through the night and he used a device to monitor rapid eye movement (REM) sleep and he did not have any episodes of REM sleep through the night. 1 day after receiving SHINGRIX, the patient had some soreness at the injection site, a terrible headache, severe dry mouth and pain in the area of his left kidney. The patient also had some sniffles. The patient was not sure if it was actually kidney pain, or related to the general body aches he was experiencing. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 1st February 2019, the patient received the 2nd dose of SHINGRIX. On 1st February 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine into the left shoulder bursa, which led to vaccine administered at inappropriate site and experienced a lot of pain. The reporter was unable to provide lot number or expiration for SHINGRIX.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Oral herpes, Paraesthesia oral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old male patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. Co-suspect products included SHINGRIX (batch number E3Z7E, expiry date unknown) for prophylaxis. The patient's past medical history included shingles (20 years before date of reporting). On 27th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th January 2019, the patient received the 2nd dose of SHINGRIX. On 30th November 2018, 3 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced cold sores lip and tingling lips. On an unknown date, the patient experienced shingles, cold sores lip, tingling lips and condition aggravated. The patient was treated with VALTREX and VASELINE. On an unknown date, the outcome of the shingles, tingling lips, cold sores lip, tingling lips and condition aggravated were unknown and the outcome of the cold sores lip was not recovered/not resolved. It was unknown if the reporter considered the shingles, cold sores lip and tingling lips to be related to SHINGRIX. It was unknown if the reporter considered the shingles, cold sores lip, tingling lips and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient experienced cold sore lips and tingling of lips after 1st dose of SHINGRIX. The cold sore lips and tingling of lips got worsened after 2nd dose of SHINGRIX. The patient was seen by a physician who diagnosed shingles. The patient was prescribed VALTREX and VASELINE to place on sores. The tingling and the sores are improved.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness in hand in a 66-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes, nerve pain, shingles, skin lesion (lesions on his left upper shoulder arm and his left hand) and scar. Concomitant products included Valacyclovir and gabapentin. On 22nd January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced numbness in hand and paresthesia hand. On an unknown date, the outcome of the numbness in hand and paresthesia hand were not recovered/not resolved. It was unknown if the reporter considered the numbness in hand and paresthesia hand to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the adverse event along with consumer on line. The patient received the SHINGRIX vaccine in the upper left shoulder. The patient denied any previous history of shingles. He completed the valacyclovir of 1 gram three times daily for 7 days. Since the patient got the SHINGRIX vaccine, he experienced numbness and tingling of his left inner palm, thumb and top of left hand. The patient also visited the physician office on 19th January 2019 for lesions on his left upper shoulder arm and his left hand. At that time, he was diagnosed with shingles and given valacyclovir to take. The patient stated that the spots were present not quite a week before he went to the physician. The spots on his left arm were present when he was given the SHINGRIX vaccine also. The numbness and tingling began about a week after the SHINGRIX vaccination. The patient stated that all the symptoms were present and scar areas of the lesions were visible till the time of reporting.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthropod bite, Feeling hot, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extremities hot feeling of in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. Concurrent medical conditions included radioisotope scan, penicillin allergy and topical adhesive allergy. Concomitant products included Flu unspecified (Flu vaccine). In October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, several days after receiving SHINGRIX and an unknown time after receiving Flu vaccine, the patient experienced extremities hot feeling of and rash. On an unknown date, the outcome of the extremities hot feeling of and rash were recovered/resolved. It was unknown if the reporter considered the extremities hot feeling of and rash to be related to SHINGRIX. Additional details were provided as follows: The patient also received flu vaccine on left arm on the same day of when SHINGRIX was received. The patient received a dose of SHINGRIX in the right arm. The patient had a reaction from elbow to shoulder on her right arm several days later. The area was very hot after the injection and then a rash came several days after the shot. The patient visited her physician and by the time he saw her, the rash was almost gone. The patient reported that she had a mosquito bite near the rash but there was no inflammation just a little rash.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th January 2019, 1 days after receiving SHINGRIX, the patient experienced facial swelling and disorientation. The patient was treated with Steroid Injection. On an unknown date, the outcome of the facial swelling and disorientation were recovered/resolved. It was unknown if the reporter considered the facial swelling and disorientation to be related to SHINGRIX. Additional details were provided as follows: The patient's face swelled after receiving SHINGRIX vaccine. The patient also felt disoriented when she woke up in the middle of the night, then her face swelled up. The patient visited her doctor and got a steroid injection. The event resolved after 3 days. Emergency Room (ER) visit was required. Consented to follow up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 84-year-old male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced feeling unwell and pain in arm. On an unknown date, the outcome of the feeling unwell and pain in arm were recovered/resolved. It was unknown if the reporter considered the feeling unwell and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient received the 1st dose of SHINGRIX around 12:00 noon. The exact date was not known. The patient had pain in his left arm that evening that lasted a day or two. The patient also said he did not feel well for approximately four days following the vaccination. The reporter did not give consent to follow up. This case was 1 of the 3 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Crying, Injected limb mobility decreased, Injection site discomfort, 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 female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 3 hrs after receiving SHINGRIX, the patient experienced injection site pain and injection site discomfort. On an unknown date, the patient experienced injected limb mobility decreased and crying. The patient was treated with cortisone acetate. On an unknown date, the outcome of the injection site pain and injection site discomfort were recovered/resolved and the outcome of the injected limb mobility decreased and crying were unknown. It was unknown if the reporter considered the injection site pain, injection site discomfort, injected limb mobility decreased and crying to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st shot in the middle of September 2018 on left arm, the exact date was unknown. She reported experiencing severe pain in her left arm. The pain presented 3 to 4 hours following the vaccination and lasted 9 to 10 days. She had a cortisone shot in the 4th day which helped with the pain. The pain was so bad that she couldn't lift her arm and she was in tears. She also described the feeling of a lump being injected at the time the vaccine was administered. She said it felt like a large amount of liquid was going in. Her husband felt the same thing. The reporter gave consent to follow up. This case has been linked with case US2019031696, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, 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 male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 hrs after receiving SHINGRIX, the patient experienced injection site pain and injection site lump. On an unknown date, the outcome of the injection site pain and injection site lump were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site lump to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient experienced soreness in left arm. The soreness presented in his left arm 3 to 4 hours after receiving the injection. The patient described the injection as feeling like lump of liquid was injected. The soreness lasted for approximately one week. The reporter did not consent to follow-up.