chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 17-SEP-2018, the patient was vaccinated with a properly stored but expired dose of VAQTA lot # N023954 (expiration date: 31-AUG-2018) for prophylaxis (additional dosage regimen information was not provided). No adverse event was reported.
Age: 0.83
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 10-month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of ROTATEQ, orally, lot # N021308, expiration date 05-MAR-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccine experienced a temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This is one of several reports with the same reporter.
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 9-month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of ROTATEQ, orally, lot # N021308, expiration date 05-MAR-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccine experienced a temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This is one of several reports with the same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Death, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program comScore Monthly DTC Tracker. A contactable consumer reported similar events for two patients. This is 1st of two reports. An elderly patient of an unspecified gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for pneumonia. The patient's medical history and concomitant medications were not reported. The patient had the darn pneumonia shots and 5 months later the patient died from pneumonia. Before the patient got the shot the patient was as healthy as can be. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018378995 same reporter/product/event, different patients; Reported Cause(s) of Death: died from pneumonia; died from pneumonia.
Sex: U
Vaccine: PNC13
Symptoms: Death, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for two patients. This is 2nd of two reports. An elderly patient of an unspecified gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for pneumonia. The patient medical history and concomitant medications were not reported. The patient had the pneumonia shots and 5 months later the patient died from pneumonia. Before got the shot the patient was as healthy as could be. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018378783 different patient, same product/event; Reported Cause(s) of Death: 5 months later they both died from pneumonia; 5 months later they both died from pneumonia.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bedridden, Influenza like illness, Myalgia, Peripheral swelling
Clinical narrative: Initial information received on 17-Apr-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an 82 years old female patient who experienced swelling in her hands, flu like symptoms, intense joint pain in her hands and very painful and strong muscles aches, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included mold allergies. The patient was overdosed with mold by her allergist. The patient experienced intense pain and was diagnosed with Lupus, which was overruled and re-diagnosed as mold overdose. The patient was bedridden 11.5 weeks and treated with prednisone for 14 months. The patient's past vaccination(s) and family history were not provided. On 07-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported in the left upper arm. On an unknown date, the patient developed a non-serious swelling in her hands, flu like symptoms, intense joint pain in her hands and very painful and strong muscles aches, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was very painful and strong muscles aches, intense joint pain in her hands, flu like symptoms and swelling in her hands. The patient was treated with CBD hemp oil 0.25mL twice daily with breakfast and dinner as well as topically on her left wrist. On an unknown date, the patient was recovered from the events. List of documents held by the sender: none.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site warmth, Lethargy
Clinical narrative: Patient came into pharmacy 9/21 to report that 9/19-20 she was feeling exhausted, lethargic, dizzy, her arm below injection site was red and hot (approx 3 inches in diameter, not surrounding shot, but approx 1/2 inch below), and a sore at edge of Band-Aid of unknown cause.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Wound
Clinical narrative: Patient came into pharmacy 9/21 to report that 9/19-20 she was feeling exhausted, lethargic, dizzy, her arm below injection site was red and hot (approx 3 inches in diameter, not surrounding shot, but approx 1/2 inch below), and a sore at edge of Band-Aid of unknown cause.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Oropharyngeal pain
Clinical narrative: Swelling, redness and pain at injection site, joint pain, body aches, sore throat. Sore throat, joint pain and body aches are better today however I still have swelling, redness and pain at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Swelling, redness and pain at injection site, joint pain, body aches, sore throat. Sore throat, joint pain and body aches are better today however I still have swelling, redness and pain at injection site.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Patient describes inflammation, redness, and swelling at the injection site. She says that it was warm to the touch and lasted for a full 7 days.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Loss of range of movement in right arm hurts to move arm in certain positions.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: At the site, it was raised and red, a bump. As the night wore on, it started itching, then I noticed a rash on my neck, arms, back, face and legs. Started BENADRYL and using a itch relief cream.  After that wasn't helping, I called my doctor's office for an appt. He gave me prednisone to take.  Four days after injection, went to Dr to receive medical attention.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Induration, Swelling, Urticaria
Clinical narrative: At the site, it was raised and red, a bump. As the night wore on, it started itching, then I noticed a rash on my neck, arms, back, face and legs. Started BENADRYL and using a itch relief cream.  After that wasn't helping, I called my doctor's office for an appt. He gave me prednisone to take.  Four days after injection, went to Dr to receive medical attention.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm redness and swelling noted to be approximately the size of a baseball. Instructed to apply ice, may take BENADRYL for itching. Returned call on August 17, 2018 stating redness was 8 inches by 5 inches to upper right arm..
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Chickenpox type rash on several areas of body. Rash began on right buttocks, moved to left side of upper back and right forearm. There is a little in left forearm. It is now 09/21, and itchy rash still exists on right forearm, with more breaking out overnight. I have used SARNA LOTION and cold cloths to ease the itching.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Oedema mucosal
Clinical narrative: Within 2 hours swelling in mucosa of mouth similar to the feeling of getting a novacaine injection in mouth. One hour later swelling in area above eye. Took Benadryl which resolved mouth issue but eye swelling persisted for longer.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal death
Clinical narrative: Fetal demise @ 29wks gestation.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash erythematous
Clinical narrative: Fine red rash uppear immediate 1x on face after Hep B Adult given. Client was given BENADRYL L25mg PO with wow ounces of sterile water, and was given another BENADRYL 25mg POT over the next six hours. Client immediately went to her health care provider. "My doctor was not there and I seen another doctor the rash had went away on my face." Recommended to have blood work done immediately to see if you are allergy to any component in the vaccine (Hep A Adult, ENGERIX-B Adult. Also on 09-17-2018 client took the PPD skin test Manu Factor (PAR), (Lot No) 315566. (Ex. Date) 12-2019 TB skin test was given (LFA).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Pt. called office to report that starting 9/15/18 AM she started with headache, vomiting and dizziness that lasted into the next morning. Pt. was not seen at clinic due to happened over the weekend. Sx's Tx'd at home and resolved on their own.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling, Ultrasound scan normal
Clinical narrative: Swelling, pain, redness, ice NSAIDS.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Coma, Gait inability, Imaging procedure abnormal, Intraventricular haemorrhage, Skull fractured base
Clinical narrative: Patient drove himself to the facility for an appt. for a blood draw. His appt. was the next week....so while he was there he decided to get the Influenza vaccine (9:49 a.m. on Sept. 22, 2016). At 10:18 a.m. he had collapsed outside the double doors as he was exiting the hospital and hit the concrete. He was seen sitting and scooting on his walker after receiving the shot which was unusual. When he reached the exit doorway, he stood up, walked out to drive home and collapsed.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Subarachnoid haemorrhage, Syncope, Unresponsive to stimuli
Clinical narrative: Patient drove himself to the facility for an appt. for a blood draw. His appt. was the next week....so while he was there he decided to get the Influenza vaccine (9:49 a.m. on Sept. 22, 2016). At 10:18 a.m. he had collapsed outside the double doors as he was exiting the hospital and hit the concrete. He was seen sitting and scooting on his walker after receiving the shot which was unusual. When he reached the exit doorway, he stood up, walked out to drive home and collapsed.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non-valid report was received from a registered nurse and refers to three unspecified patients. No information about the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown dates, one unspecified patient was vaccinated with a dose of PNEUMOVAX 23 lot # N030111, expiration date 21-APR-2019 (dose, route of administration were not reported) and two unspecified patients were vaccinated with a dose of ROTATEQ given orally, lot # N013393, expiration date 11-DEC-2018 and lot #N021308, expiration date 05-MAR-2019 (dose was not reported). Temperature excursion was from 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous temperature excursion was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The information was obtained from the data logger. No adverse effects were reported in any of the patients. Lot Number N021308 is valid for ROTATEQ. As of 06-SEP-2018, all telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested. Follow up information was received from the registered nurse on 10-SEP-2018. This spontaneous report concerns a 10 week old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 13-FEB-2018, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # N013393 and expiration date: 11-DEC-2018), (strength and dose were not reported) orally for prophylaxis. It was reported that the vaccine was stored between 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous cold temperature excursion (09-FEB-2018) was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the many reports from the same source. Sender's Comments: US-009507513-1809USA008677: US-009507513-1809USA008678: US-009507513-1809USA008679: US-009507513-1809USA008676.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This non-valid spontaneous report was received from a pharmacy technician and refers to an unspecified number of patients' of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Between 06-AUG-2018 and 08-AUG-2018, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # R003557, expiration date: 20-NOV-2020 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. On 06-AUG-2018, the vaccines experienced temperature excursion of - 3.4 degrees Celsius for 2 hours 42 minutes. There was no previous temperature excursion.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever 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, 6 hrs after receiving SHINGRIX, the patient experienced fever, nausea, gastrointestinal upset, injection site pain, myalgia and activities of daily living impaired. On an unknown date, the outcome of the fever, nausea, gastrointestinal upset, injection site pain, myalgia and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the fever, nausea, gastrointestinal upset, injection site pain, myalgia and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was reported that starting 6 to 8 hours after receiving the 1st dose of SHINGRIX, the patient reported fairly serious adverse events including a fever of 101 degrees F, myalgia, Gastrointestinal upset, and nausea as well as pain at the injection site. These events resulted in 1 missed day of work, which was the day after vaccination.  On day 2 after vaccination, the patient felt ok, but not great and by day 3 after vaccination felt back to normal.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever 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, 6 hrs after receiving SHINGRIX, the patient experienced fever, nausea, gastrointestinal upset, injection site pain, myalgia and activities of daily living impaired. On an unknown date, the outcome of the fever, nausea, gastrointestinal upset, injection site pain, myalgia and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the fever, nausea, gastrointestinal upset, injection site pain, myalgia and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was reported that starting 6 to 8 hours after receiving the 1st dose of SHINGRIX, the patient reported fairly serious adverse events including a fever of 101 degrees F, myalgia, Gastrointestinal upset, and nausea as well as pain at the injection site. These events resulted in 1 missed day of work, which was the day after vaccination.  On day 2 after vaccination, the patient felt ok, but not great and by day 3 after vaccination felt back to normal.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Incorrect route of product administration, Neuralgia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 61 years old female patient who received SHINGRIX for an unknown indication. In April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced numbness of upper extremities, pain in arm and nerve pain. On an unknown date, the outcome of the numbness of upper extremities, pain in arm, nerve pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the numbness of upper extremities, pain in arm and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the retired health care professional who reported for her wife. The patient was administered SHINGRIX in the left deltoid subcutaneously instead of intramuscularly, which led to incorrect route of administration. Since the vaccination (less than a 6 months after vaccination), the patient had been experiencing intermittent pain going from her left deltoid down to her left hand. Sometimes this pain was accompanied by numbness. Since then, for the past few months, the patient continued to have intermittent nerve pain, extending down to her hand with numbness. The reporter wanted to know was this normal, or were there any side effects such as this when the vaccine was administered. There appears to be some confusion as to whether or not a booster was required and when and the reporter needed advice from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Influenza like illness, Product preparation issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received SHINGRIX. On 5th September 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In September 2018, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Wednesday, 5th September 2018, the patient was administered only the adjuvant component of SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Less than a week after receiving SHINGRIX, the patient experienced flu-like symptoms. The healthcare professional was in the car and did not have additional information.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia, Swelling
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 patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, fever, chills and swelling. On an unknown date, the outcome of the injection site pain, fever, chills and swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, chills and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 66 or 67 years. The caller reported adverse event for patient. The reporter stated that the patient had pain, swelling, fever and chills for about 2 days after injection. The permission to be contacted healthcare professional was given by caller.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 66-year-old female patient who received Shingrix for prophylaxis. On 16th August 2018, the patient received the 1st dose of Shingrix (intramuscular). On 17th August 2018, 1 days after receiving Shingrix, the patient experienced fever. On 18th August 2018, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: This case was reported by the retired physician for herself. On Tuesday, the patient had a dose of the Shingrix and woke up with a 99 degree F fever on Friday morning. The fever went up to 101 degree F by Friday afternoon. The fever went away on Saturday afternoon. The patient denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site cellulitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a adult female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. On an unknown date, less than 5 months after receiving SHINGRIX, the patient experienced injection site cellulitis and fatigue. On an unknown date, the outcome of the injection site cellulitis and fatigue were unknown. It was unknown if the reporter considered the injection site cellulitis and fatigue to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The patient reported that she developed cellulitis on her arm at the site of the injection. The patient also experienced fatigue. During the report, the patient also reported that her pharmacist, who also had a SHINGRIX dose, felt sick refer case US2018GSK167939. No specific details were shared at the time of report. The patient had denied permission to contact their physician. The reporter did not wish to answer questions for a safety report.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 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 age at vaccination was not reported. The patient reported arm soreness after receiving an injection of SHINGRIX. The event resolved after one day after the dose. The patient had denied permission to contact their physician. The caller did not wish to participate in an adverse event report, she said it was nothing.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a 75-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain, malaise and fever. On an unknown date, the outcome of the pain, malaise and fever were recovered/resolved. It was unknown if the reporter considered the pain, malaise and fever to be related to SHINGRIX. Additional details were reported as follows: The patient experienced aches beginning within 24 hours after SHINGRIX and lasting for 5 days. The dose of SHINGRIX was not administered at the healthcare professional's office. The lot number or expiration date and further details of administration were not available.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 2-month-old female patient who received PEDIARIX for prophylaxis. Co-suspect products included ROTATEQ for prophylaxis, PREVNAR 13 for prophylaxis and ACTHIB for prophylaxis. In July 2018, the patient received the 1st dose of PEDIARIX (intramuscular), ROTATEQ, PREVNAR 13 and ACTHIB. In July 2018, less than an hour after receiving PEDIARIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to PEDIARIX. Additional details reported as follows: The reporter called from the allergy and asthma consultant office. The patient received vaccination at primary care physician. In mid of July 2018, the patient received the PEDIARIX along with the ROTATEQ, PREVNAR 13 and ACTHIB. The batch number and expiry date were not reported. After vaccination, within 10 minutes the patient broke out in hives. The patient kept at the clinic for a couple of hours and monitored afterwards. The origin of the hives was unknown because several vaccines were given on the same day. The patient's family wanted the patient to undergo skin allergy testing and try to figure out which vaccine the patient was reacted to, before the patient received her 4 month vaccines. It was reported that, the insurance company would not pay so, the reporter called for allergy physician or allergy and asthma consultant office and tried to get samples or a small batch of PEDIARIX for a skin test.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 46-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (2 cases of shingles prior to SHINGRIX) and chickenpox (at 24 years of age). Previously administered products included ZOSTAVAX (received in 2011). On 11th June 2018, the patient received the 1st dose of SHINGRIX. On 5th September 2018, 86 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 patient has had shingles twice in his life and the last shingles outbreak was the worst in terms of symptoms. Symptoms were not specified. The patient had denied permission to contact the physician. The patient requested anonymity for this report. The age was reported as 46 years, however it was unclear if indeed the patient was vaccinated at incorrect age. Clarification had been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 63-year-old female patient who received SHINGRIX (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis. Concomitant products included FLUCONAZOLE (FLUZONE (FLUCONAZOLE)). On 8th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 9th September 2018, 1 days after receiving SHINGRIX, the patient experienced welts and fever. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the welts and fever were unchanged. It was unknown if the reporter considered the welts and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of FLUZONE vaccine on 8th September 2018 on left deltoid intramuscularly. The patient reported 5 welts all down her right arm as well as fever. The patient visited her physician for these symptoms, who referred her to the pharmacy where the vaccine was administered. The pharmacist recommended managing symptoms with Benadryl. The patient stated that she did not have a thermometer, so did not actually know her body temperature, but felt certain she had a fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 7th September 2018, the patient received the 1st dose of SHINGRIX. On 8th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: At 12:00, the patient was administered SHINGRIX in the left arm. The reporter reported redness and swelling at the injection site the morning after receiving the injection. The swelling was the size of a baseball and was not resolved.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced upset stomach and feeling unwell. On an unknown date, the outcome of the upset stomach and feeling unwell were recovered/resolved.  It was unknown if the reporter considered the upset stomach and feeling unwell 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 had some side effects that lasted about a day. The reporter did not have a lot of information about the symptoms.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) 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 shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The health care professional reported that, the patient developed shingles after vaccination with SHINGRIX.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis.  On 28th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than 4 months after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The caller states that her husband (patient) received a dose of SHINGRIX and he had flu-like symptoms for about 3 days. The patient did not report this information to his healthcare professional. This case has been linked with case US2018GSK164957, patient's wife's case (reporter).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Intraocular pressure increased, Intraocular pressure test abnormal, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of increased intraocular pressure in a 71-year-old male patient who received SHINGRIX for prophylaxis.  The patient's past medical history included glaucoma. On 19th June 2018, the patient received the 1st dose of SHINGRIX. On 19th June 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, injection site pain and fever. On 29th June 2018, the patient experienced increased intraocular pressure. On an unknown date, the outcome of the increased intraocular pressure was unknown and the outcome of the shivering, injection site pain and fever were recovered/resolved.  It was unknown if the reporter considered the increased intraocular pressure, shivering, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follow: The patient received SHINGRIX vaccine in the left arm. On 7th or 8th June 2018, the patient's eye pressure was 19, 20 or 21 (unit not reported). The patient's eye pressure had increased to 35 (unit not reported) after he had the SHINGRIX vaccine. The patient also experienced low fever and some shivering the same day that lasted approximately 24 hours and had some soreness at the injection site that lasted a couple of days. The patient had denied permission to contact their physician.This case is linked with US2018164427, reported for the patient's wife. Lab Comments: On 7th or 8th June 2018, the patient had eye pressure of 19, 20 or 21.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of increased intraocular pressure in a 71-year-old male patient who received SHINGRIX for prophylaxis.  The patient's past medical history included glaucoma. On 19th June 2018, the patient received the 1st dose of SHINGRIX. On 19th June 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, injection site pain and fever. On 29th June 2018, the patient experienced increased intraocular pressure. On an unknown date, the outcome of the increased intraocular pressure was unknown and the outcome of the shivering, injection site pain and fever were recovered/resolved.  It was unknown if the reporter considered the increased intraocular pressure, shivering, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follow: The patient received SHINGRIX vaccine in the left arm. On 7th or 8th June 2018, the patient's eye pressure was 19, 20 or 21 (unit not reported). The patient's eye pressure had increased to 35 (unit not reported) after he had the SHINGRIX vaccine. The patient also experienced low fever and some shivering the same day that lasted approximately 24 hours and had some soreness at the injection site that lasted a couple of days. The patient had denied permission to contact their physician.This case is linked with US2018164427, reported for the patient's wife. Lab Comments: On 7th or 8th June 2018, the patient had eye pressure of 19, 20 or 21.
Age: 69.0
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 69-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX. On 29th June 2018, 10 days 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 provided as follows: The reporter was the husband of the patient. The patient received SHINGRIX vaccine in the left arm. The patient had some soreness at the injection site that lasted a couple of days. The patient had denied permission to contact their physician.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Shingrix for prophylaxis. On 3rd August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd August 2018, less than a day after receiving Shingrix, the patient experienced pain in arm. In August 2018, the patient experienced injection site discoloration. On an unknown date, the outcome of the pain in arm and injection site discoloration were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and injection site discoloration to be related to Shingrix. Additional details were reported as follows: Since the injection her arm had been painful. The first day she did not thought it would be too bad, but the next day it was very painful whenever she moved her arm. This had persisted since, and by the end of the day her arm hurts even when at rest. It really hurts in the injection area and hurts in the whole upper arm until maybe 1 by 3 of the way to her elbow. She saw her physician two weeks after the injection, but her physician did not know what to do. Her physician did notice that she had a white circle about 3 by 4 inch in diameter at the injection site. The representative was very nice, she spoke very well, she asked me the questions that I imagine your company asked her to ask me, she expressed her sorrow that  the patient was experiencing this problem. The patient  called because the patient want relief. The patient had an adverse reaction to the Shingrix vaccination, my arm continually hurts, and I'd like to know what to do. I'd like to know how long it's going to continue to hurt. And she, of course, was not able to give me those answers. Given the fact that the arm is really sore, I would really like to know what to do, and how long this is going to continue. So that's it.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Herpes zoster, Neuralgia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Shingrix (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 16th August 2018, the patient received the 1st dose of Shingrix. On 23rd August 2018, 7 days after receiving Shingrix, the patient experienced shingles, nerve pain and painful rash. The patient was treated with Valtrex. On an unknown date, the outcome of the shingles, nerve pain and painful rash were unknown. It was unknown if the reporter considered the shingles, nerve pain and painful rash to be related to Shingrix. Additional information was received as follows: The shingles rash and associated nerve pain ran along the left side of the abdomen and around into the back. The physician said that the patient came down with Shingles on 26th August 2018. The rash developed in the left groin area and extended to lower knee area. The patient reported the rash being very painful. The physician did not say if the patient's outbreak of shingles was resolved. The reporter agree to follow up from GlaxoSmithKline.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, 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 83-year-old female patient who received Shingrix (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 30th July 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. 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 the Shingrix on left arm. The pharmacist stated that, the patient had been experiencing sore arm since getting the dose of Shingrix vaccine. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. After receiving the vaccination, the patient experienced pain in her left arm at the injection site. This case has been linked with case US2018GSK169435, for the same patient for 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult 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 fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was taken based on the product indication as no other patient details were provided. The healthcare professional stated that the patient experienced fever and chills with dose 1 of Shingrix. The healthcare professional heard this information about a patient's experience from a healthcare professional outside of her facility. The healthcare professional did not had any patient information or vaccine information regarding this adverse event. The healthcare professional heard it second hand, and had no access to the patient or the vaccine. For tolerance to 2nd dose refer linked case US2018GSK169159, for same patient.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site induration, Injection site pain, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site swelling (for tolerance to the 1st dose received on 19th May 2018, refer case US2018GSK171067). On 23rd August 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 24th August 2018, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site induration and injection site erythema. On 8th September 2018, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the injection site pain, injection site induration and injection site erythema were recovered/resolved. It was unknown if the reporter considered the shingles, injection site pain, rash, injection site induration and injection site erythema to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the right arm and on next day the patient experienced severe pain, severe redness and severe induration at the injection site (right arm) that lasted at least 1 week, before subsiding. Sixteen days after receiving vaccination, the patient stated that she started having prodromal symptoms (for shingles) in the middle of last week and noticed a rash on her forehead that started on Saturday, on 8th September 2018 and it got progressively worse. The patient stated that the rash was along the facial nerve on her forehead and she was officially diagnosed with shingles on the date of reporting at the physician's office.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 81-year-old female patient who received Shingrix for prophylaxis. On 10th September 2018, the patient received Shingrix. On 10th September 2018, less than a day after receiving Shingrix, the patient experienced insomnia. On 11th September 2018, the patient experienced pain in arm. On an unknown date, the outcome of the insomnia and pain in arm were unknown. It was unknown if the reporter considered the insomnia and pain in arm to be related to Shingrix. Additional details were reported as follows: The patient reported that should could not sleep the evening after receiving a Shingrix dose. She reported that she was up all night and alert. The patient reported that the next morning, she felt some soreness in the arm. The patient had denied permission to contact their physician.