chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Infertility female
Clinical narrative: Unexplained Infertility. I started experiencing it in 2016 when trying to conceive but was not diagnosed until 2017. Please note that the first vaccine and date given were the first of a series of 3. The other two shots were given on 2/22/2007 and 6/15/2007.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Erythema, Fatigue, Myalgia
Clinical narrative: Upset stomach, muscle pain, nausea, light headed, tired, swollen red arm and 6 hives. Lasted for 72 hour.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Urticaria
Clinical narrative: Upset stomach, muscle pain, nausea, light headed, tired, swollen red arm and 6 hives. Lasted for 72 hour.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Muscular weakness, Nausea, Vomiting
Clinical narrative: After receiving the SHINGRIX vaccine, the patient was so weak that she could not get out of bed for three days. She was nauseous and vomited multiple times. She is still light headed. Her arm was so weak that she could not lift anything. What she experienced was more than general malaise.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pustular, Varicella
Clinical narrative: Pt stated had pustules after 1st dose of SHINGRIX and developed chickenpox after the 2nd dose. Is on allergy shots, and likely immunocompromised.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: Headache, tired, nausea, aching joints. After about 36 hours, I started putting hot packs on my arm. I felt better in the morning.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Cold sweat, Myalgia, Pyrexia
Clinical narrative: Fever, chills, cold sweats, joint pain all over, muscles are soar, hot to touch. Started at 0200 at 7/24-could not get out of bed until the next day on Wednesday 7/27.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Fever, chills, cold sweats, joint pain all over, muscles are soar, hot to touch. Started at 0200 at 7/24-could not get out of bed until the next day on Wednesday 7/27.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Nausea, Pain
Clinical narrative: Fever, chills, sweats, nausea, muscle ache all over. Pain near injections site. Felt very like flu without the respiratory issues. Slowly abated and as of today (day 3) I'm mostly back to normal. Tylenol helped.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, sweats, nausea, muscle ache all over. Pain near injections site. Felt very like flu without the respiratory issues. Slowly abated and as of today (day 3) I'm mostly back to normal. Tylenol helped.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-JUL-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # M046008, expiration date 29-JUN-2018, 1 dose, orally for prophylaxis (exact dose and dose number were not reported). No adverse effects were reported in the patient.
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Information has been received from a nurse via a company representative referring to a male patient of unknown age. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On an unspecified date, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly (strength, dose, lot # and expiration date were not provided) for vaccination. The nurse reported that after an unspecified amount of time, the patient passed out after receiving dose. The patient bashed head and had to go to emergency room at a Hospital, where the patient received unspecified treatment. No lab diagnostics/studies performed. The patient returned to physician's office 1 day later and he was fine. The outcome of the event was reported as recovered. The causality assessment was not provided. Upon internal review, the event of "passed out" was considered to be medically significant.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Injection site erythema, Injection site inflammation, Injection site pain, Joint swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, injection site erythema and injection site inflammation. On 23rd July 2018, the patient experienced abdominal pain and ankle swelling. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, injection site inflammation, abdominal pain and ankle swelling were unknown. It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, injection site inflammation, abdominal pain and ankle swelling to be related to SHINGRIX. Additional details were provided as follows: The patient experienced injection site reaction over the weekend which included redness, swelling and pain at the injection site which appeared to have worsened as of 23rd July 2018 as inflamed area moved more around the arm. Three days after receiving SHINGRIX, the patient also experienced ankle swelling and pain in the abdomen. It was reported that, the patient did not have any evidence of issues with breathing or other signs of an allergic reaction.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: HCP report's patient got SHINGRIX two days ago and is now reporting it's very itchy on the area, and pretty red and tender. This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a female patient who received SHINGRIX for prophylaxis.  On 24th July 2018, the patient received SHINGRIX. In July 2018, less than a week after receiving Shingrix, the patient experienced pruritus, tenderness and erythema. On an unknown date, the outcome of the pruritus, tenderness and erythema were unknown. It was unknown if the reporter considered the pruritus, tenderness and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The lot number of SHINGRIX was not provided. The health care professional reported that the patient received SHINGRIX two days ago and experienced very itchy on the area, and pretty red and tender.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a elderly 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 week after receiving SHINGRIX, the patient experienced injection site reaction, pain in arm, injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site reaction and pain in arm were recovering/resolving and the outcome of the injection site erythema and injection site tenderness were unknown. It was unknown if the reporter considered the injection site reaction, pain in arm, injection site erythema and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The caller was a patient who left afterhours voicemail. The age at vaccination was not reported. At the beginning of the week from the date of reporting, the patient experienced a sore arm for 2 days and since then redness has continued around the injection site 4 inches by 2 inches in size and that it remains tender to the touch. The caller stated that she was going to have physician look at it as soon as she can get an appointment. The caller's phone number was not provided in the voicemail message. No other details was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a male patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 24th July 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the erythema of extremities and swelling arm were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was administered in the fatty tissue in the back of the arm instead of into the deltoid muscle, which led to inappropriate site of vaccination. When he got home his arm was red and swollen. This case has been linked with the case US2018134620, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 24th July 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the erythema of extremities and swelling arm were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was administered in the fatty tissue in the back of the arm instead of into the deltoid muscle, which led to inappropriate site of vaccination. When he got home his arm was red and swollen. This case has been linked with the case US2018134619, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). Concurrent medical conditions included chronic lymphocytic leukemia (diagnosed in December 2017). On 19th July 2018 09:30, the patient received the 2nd dose of SHINGRIX (intramuscular). In July 2018, 1 day after receiving SHINGRIX, the patient experienced axillary pain. On an unknown date, the outcome of the axillary pain was unchanged. It was unknown if the reporter considered the axillary pain to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX in the left arm. The patient stated that a day after getting the shot of SHINGRIX vaccine, she experienced tenderness in her arm pits. Her condition was still unchanged. The patient had denied permission to contact their physician. No further details were provided by the patient. The patient was referred to her physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Incorrect dose administered, Pain in extremity, Product preparation error
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 19th July 2018, the patient received the 2nd dose of SHINGRIX. On 19th July 2018, not applicable after receiving SHINGRIX and unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the patient experienced chills, headache and pain in arm. On an unknown date, the outcome of the chills and headache were recovered/resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the chills, headache and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination for 1st dose could be 61 or 62 years and for 2nd dose was 62 years. On an unspecified date, months before the administration of 2nd dose, the patient received 1st dose of SHINGRIX in the arm. Less than a day after receiving SHINGRIX, the patient experienced chills and headache later that night. Less than a year after receiving SHINGRIX, the patient experienced, the patient had a sore arm that lasted for about 2 weeks and was resolving. The patient received a second dose of SHINGRIX in the left arm. The pharmacist did not use the liquid suspension to mix with the powder that came with the total dose of SHINGRIX. The pharmacist used an unknown liquid diluent, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered. The patient was instructed after the error was found to return for another dose. This case has been linked with case US2018134658, reported by same reporter.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Incorrect route of drug administration, Pain in extremity, Product preparation error
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 19th July 2018, the patient received the 2nd dose of SHINGRIX. On 19th July 2018, not applicable after receiving SHINGRIX and unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The received her first dose of SHINGRIX on an unspecified date months ago and less than a year after vaccination, the patient experienced a sore arm. The arm was sore for just a day and then resolved. The patient received SHINGRIX vaccine on left arm. The patient received a second dose of SHINGRIX on 19th July 2018. The pharmacist did not use the liquid suspension to mix with the powder that came with the total dose of SHINGRIX. The pharmacist used an unknown liquid diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The patient was instructed after the error was found to return for another dose. The wife of the patient was the reporter. This case has been linked with case US2018134654, reported by same reporter.
Age: 62.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 62-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. Co-suspect products included MMR vaccine for prophylaxis. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and MMR vaccine. On an unknown date, less than a year after receiving SHINGRIX and MMR vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to SHINGRIX and MMR vaccine. Additional details reported as follows: A patient experienced hives after receiving SHINGRIX on right deltoid which was given on the same day as the MMR vaccine. The healthcare professional was unable to read lot number last digit could be 3, J, or S. Unsure of when hives started after vaccination. The reported batch number HG4PS for SHINGRIX did not exist and was updated to HG4P3 as per the sales database.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced pain, swelling, fever and erythema. On an unknown date, the outcome of the pain, swelling, fever and erythema were recovered/resolved. It was unknown if the reporter considered the pain, swelling, fever and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on unknown deltoid. Limited information was provided by the sales representative from the physician.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of localized erythema in a 52-year-old male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a day after receiving SHINGRIX, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was recovered/resolved. It was unknown if the reporter considered the localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness on chest. Limited information was provided by the sales representative from the physician.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a elderly female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and less than a week after vaccination, the patient experienced injection site tenderness, pain ankle and ankle swelling. The patient was treated with Ice Pack (Nos) and TYLENOL. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site tenderness were unknown and the outcome of the pain ankle and ankle swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site tenderness, pain ankle and ankle swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received Cortisone (NOS) shot in knee, a week before SHINGRIX shot. The patient received first dose of SHINGRIX about 9 days ago from the date of reporting. The reporter reported that the patient experienced injection site reaction at 24 hours after dose that included swollen, red whelp that almost looked infected and was seen by urgent care and determined to just be injection site reaction. The reporter reported that this had improved since, but still was sore to touch and had 3 inch diameter swelling at injection site. The reporter reported that a couple days ago from the date of reporting (less than a week after receiving SHINGRIX), the patient developed swelling and pain in her ankle, was seen by ortho doctor for x rays which were negative for infection or gout. The reporter reported that now after 4 days of ankle pain and using ice pack and TYLENOL that the ankle pain persisted.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray limb normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a elderly female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and less than a week after vaccination, the patient experienced injection site tenderness, pain ankle and ankle swelling. The patient was treated with Ice Pack (Nos) and TYLENOL. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site tenderness were unknown and the outcome of the pain ankle and ankle swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site tenderness, pain ankle and ankle swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received Cortisone (NOS) shot in knee, a week before SHINGRIX shot. The patient received first dose of SHINGRIX about 9 days ago from the date of reporting. The reporter reported that the patient experienced injection site reaction at 24 hours after dose that included swollen, red whelp that almost looked infected and was seen by urgent care and determined to just be injection site reaction. The reporter reported that this had improved since, but still was sore to touch and had 3 inch diameter swelling at injection site. The reporter reported that a couple days ago from the date of reporting (less than a week after receiving SHINGRIX), the patient developed swelling and pain in her ankle, was seen by ortho doctor for x rays which were negative for infection or gout. The reporter reported that now after 4 days of ankle pain and using ice pack and TYLENOL that the ankle pain persisted.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 65-year-old male patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th July 2018, several hours after receiving SHINGRIX, the patient experienced shivering. On 25th July 2018, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: The Pharmacist reported that the patient experienced shivering few hours after receiving vaccine. The shivering resolved the next day. Warm tx'd to MIS for information on efficacy with only one dose.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Electrocardiogram normal, Nausea, Troponin normal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chest pain in a 69-year-old male patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. The patient's past medical history included heart disorder and panic disorder. On 3rd July 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 17 hrs after receiving SHINGRIX, the patient experienced chest pain and nausea. On an unknown date, the outcome of the chest pain and nausea were recovered/resolved. The reporter considered the chest pain to be unlikely related to SHINGRIX. The reporter considered the nausea to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right deltoid. On 4th July 2018, at 3 am, the patient woke up complaining of chest pain and nausea. The patient went to the emergency room, troponins was negative, electrocardiogram (EKG) showed no ST segment elevation myocardial infarction and no interventions. The patient was declining his 2nd dose of SHINGRIX. The healthcare professional stated adverse event reported to VAERs.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 13th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. In July 2018, 28 days 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 provided as follows: The case was reported by a pharmacy student. The pharmacy student reported that the patient developed shingles 4 weeks after getting SHINGRIX. The reported batch number for SHINGRIX 29RR4 did not exist and was updated from 29RR4 to Z9RR4 as per sales database.
Age: 92.0
Sex: M
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 male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 16th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 7 days 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 provided as follows: The health care professional reported that a patient developed shingles about one week after receipt of SHINGRIX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The health care professional stated that female patient received her 1st dose of SHINGRIX in April 2018 and had a large area of redness and swelling at injection site. The patient also stated that the area was warm to the touch. The health care professional did not see this reaction but patient came in to get their 2nd dose of SHINGRIX (not administered yet) and told the health care professional about her reaction to her first dose of SHINGRIX she had back in April 2018.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and erythematous rash. On an unknown date, the outcome of the injection site erythema and erythematous rash were unknown. It was unknown if the reporter considered the injection site erythema and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced palm sized red area around the injection site and bilateral red band from back to abdomen. The health care professional stated that affected areas look like bad sunburn. The health care professional who reported the adverse event did not have patient or vaccine information. The health care professional was reporting information for another health care professional.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Fall, 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 75-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (patient had shingles in his 40's). Concomitant products included Tamsulosin. On 19th July 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, dizziness, fall and dysequilibrium. On an unknown date, the outcome of the pain in arm and fall were unknown and the outcome of the dizziness and dysequilibrium were recovering/resolving. It was unknown if the reporter considered the pain in arm, dizziness, fall and dysequilibrium to be related to SHINGRIX. Additional details were provided as follows: The patient has reported this event to via VAERS.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles 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 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 patient's age group was taken based on the product indication as no other patient details were provided. The healthcare professional reported that the patient developed Shingles sometime after the 1st dose of SHINGRIX, but prior to administration of the 2nd dose.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Lymphangitis, Thyroiditis subacute
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lymphangitis in a 64-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received SHINGRIX. In June 2018, immediately after receiving SHINGRIX, the patient experienced lymphangitis (serious criteria GSK medically significant). On an unknown date, the patient experienced granulomatous thyroiditis. On an unknown date, the outcome of the lymphangitis was resolved with sequelae and the outcome of the granulomatous thyroiditis was unknown. It was unknown if the reporter considered the lymphangitis and granulomatous thyroiditis to be related to SHINGRIX. Additional information was received as follows: At the time of reporting, the patient was 64 years old. The age at vaccination was not reported, however, it could be 63 or 64 years. The physician stated that the patient received SHINGRIX in the middle of June. The physician reported that the patient developed lymphangitis which resolved after 4 to 5 days. The patient later showed signs of subacute granulomatous thyroiditis. The physician was out of office at the time of call and did not have additional information.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 58-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) for prophylaxis. The patient's past medical history included shingles (the patient had prior). On 7th May 2018 15:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain and bedridden. On an unknown date, the outcome of the muscle pain and bedridden were unknown. It was unknown if the reporter considered the muscle pain and bedridden to be related to SHINGRIX. Additional details were received as follows: The reporter had a patient that received a dose of SHINGRIX vaccine in left deltoid and experienced bad muscle pain and could barely get out of bed for a day after the vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles 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, less than a year 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 information was received as follows: The age at vaccination was not reported. As per reporter the patient received SHINGRIX and was subsequently diagnosed with shingles.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Heart rate abnormal, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced erythema of extremities, rash and heart rate abnormal. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the rash and heart rate abnormal were unknown. It was unknown if the reporter considered the erythema of extremities, rash and heart rate abnormal to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The caller declined all questions except what information the reporter provided in his conversation. The caller stated that 4 months before the reporting date, the patient received SHINGRIX and he had redness of arm that lasted longer than the normal. The patient noted the second reaction with his heart rate, but did not specify what happened with it and the rash appeared at the same time as the heart rate issue. The caller was asking about immunity with the 1st dose, as he did not plan to get the 2nd dose of SHINGRIX. The caller was open to receiving a questionnaire from safety to complete on the patient's experience but declined information gathering over the phone. The phone number the reporter provided was incorrect, when it was called back so it was removed. No ID appeared in contact to collect or attempt to call as alternate.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, burning sensation and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, burning sensation and injection site erythema were recovered/resolved. The reporter considered the injection site pain, injection site swelling, burning sensation and injection site erythema to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown deltoid. The reporter stated that the patient experienced pain, redness, and swelling at the SHINGRIX injection site which was described to the field representative as severe. The patient had burning with swelling and all of the side effects have since resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of nausea in a adult male 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 year after receiving SHINGRIX, the patient experienced nausea, vomiting, fever, swelling arm, pain in arm and activities of daily living impaired. On an unknown date, the outcome of the nausea, vomiting, swelling arm, pain in arm and activities of daily living impaired were unknown and the outcome of the fever was recovered/resolved. The reporter considered the nausea, vomiting, fever, swelling arm, pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had nausea, vomiting, fever (103 degree F), arm swelling and pain. The patient missed 3 days of work. The fever lasted for 3 days. The reporter agreed to be followed up. Lab Comments: Lab test was done on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of nausea in a adult male 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 year after receiving SHINGRIX, the patient experienced nausea, vomiting, fever, swelling arm, pain in arm and activities of daily living impaired. On an unknown date, the outcome of the nausea, vomiting, swelling arm, pain in arm and activities of daily living impaired were unknown and the outcome of the fever was recovered/resolved. The reporter considered the nausea, vomiting, fever, swelling arm, pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had nausea, vomiting, fever (103 degree F), arm swelling and pain. The patient missed 3 days of work. The fever lasted for 3 days. The reporter agreed to be followed up. Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain, Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a female patient who received BEXSERO for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and MENACTRA at an unknown dose. On an unknown date, less than a year after receiving BEXSERO, the patient experienced pain and tingling. BEXSERO was discontinued. On an unknown date, the outcome of the pain and tingling were recovered/resolved. It was unknown if the reporter considered the pain and tingling to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient was in her early 20's at the time of reporting. The age at vaccination was not reported. The patient experienced severe pain and tingling for several days. The patient would not get the second dose of BEXSERO because of the side effects she experienced. The reporter thought it had something to do with receiving this BEXSERO vaccine and MENACTRA previously. The reporter agreed to be followed up. It was unknown if the reporter considered the severe pain and tingling to be related to MENACTRA as well. This case has been linked to the US2018GSK140943, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Depressed mood, Erythema, Headache, Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included hypertension. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, myalgia, shivering, headache, feeling down, erythema, tenderness and swelling. On an unknown date, the outcome of the influenza-like symptoms, fever, myalgia, shivering and headache were unknown and the outcome of the feeling down, erythema, tenderness and swelling were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, myalgia, shivering, headache, feeling down, erythema, tenderness and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 67 or 68 years. The patient received 1st dose at retail and not at the reporting nurse's clinic. The exact date of vaccination was not reported. The patient experienced flu like symptoms consisting of fever, myalgia, shivering and headache and was being down for a week. The patient also experienced local redness, tenderness and swelling lasting a few days. The nurse did not agree to follow up from GlaxoSmithKline. This case has been linked with the case US2018GSK139588, reported for patient's wife.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Swelling, Tenderness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included hypertension. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, myalgia, shivering, headache, feeling down, erythema, tenderness and swelling. On an unknown date, the outcome of the influenza-like symptoms, fever, myalgia, shivering and headache were unknown and the outcome of the feeling down, erythema, tenderness and swelling were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, myalgia, shivering, headache, feeling down, erythema, tenderness and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 67 or 68 years. The patient received 1st dose at retail and not at the reporting nurse's clinic. The exact date of vaccination was not reported. The patient experienced flu like symptoms consisting of fever, myalgia, shivering and headache and was being down for a week. The patient also experienced local redness, tenderness and swelling lasting a few days. The nurse did not agree to follow up from GlaxoSmithKline. This case has been linked with the case US2018GSK139588, reported for patient's wife.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Depressed mood, Erythema, Headache, Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included mastectomy and breast cancer (the patient was 2 years status post mastectomy only no chemotherapy for breast cancer). In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, myalgia, shivering, headache, feeling down, erythema, tenderness and swelling. On an unknown date, the outcome of the influenza-like symptoms, fever, myalgia, shivering and headache were unknown and the outcome of the feeling down, erythema, tenderness and swelling were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, myalgia, shivering, headache, feeling down, erythema, tenderness and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 69 or 70 years. The patient received 1st dose at retail and not at the reporting nurse's clinic. The exact date of vaccination was not reported. The patient experienced flu like symptoms consisting of fever, myalgia, shivering and headache and was being down for a week. The patient also experienced local redness, tenderness and swelling lasting a few days. The patient did not want to return for the 2nd dose of SHINGRIX. The nurse did not agree to follow up from GlaxoSmithKline. This case has been linked with the case US2018GSK135816, reported for patient's husband.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Swelling, Tenderness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included mastectomy and breast cancer (the patient was 2 years status post mastectomy only no chemotherapy for breast cancer). In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, myalgia, shivering, headache, feeling down, erythema, tenderness and swelling. On an unknown date, the outcome of the influenza-like symptoms, fever, myalgia, shivering and headache were unknown and the outcome of the feeling down, erythema, tenderness and swelling were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, myalgia, shivering, headache, feeling down, erythema, tenderness and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 69 or 70 years. The patient received 1st dose at retail and not at the reporting nurse's clinic. The exact date of vaccination was not reported. The patient experienced flu like symptoms consisting of fever, myalgia, shivering and headache and was being down for a week. The patient also experienced local redness, tenderness and swelling lasting a few days. The patient did not want to return for the 2nd dose of SHINGRIX. The nurse did not agree to follow up from GlaxoSmithKline. This case has been linked with the case US2018GSK135816, reported for patient's husband.