chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Influenza virus test positive, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a child patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The office reported that the patient who received FLUARIX vaccine resulted positive for influenza. This case was considered as suspected vaccination failure case since the time to onset were unknown at the time reporting. The reporter did not agree to follow up from GlaxoSmithKline. This case was linked with US2019GSK000798 and US2019GSK000802, reported by the same reporter. Lab Comments: on an unknown date, the patient did laboratory test.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Influenza virus test positive, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a child patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The office reported that the patient who received FLUARIX vaccine resulted positive for influenza. This case was considered as suspected vaccination failure case since the time to onset were unknown at the time reporting. The reporter did not agree to follow up from GlaxoSmithKline. This case was linked with US2019GSK000801 and US2019GSK000798, reported by the same reporter. Lab Comments: On an unknown date, the patient did laboratory test.
Age: 67.0
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 67-year-old 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 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 patient received 1st dose 3 months prior to the 2nd dose. The patient had only 1 to 2 days of pain at the injection site. The patient had not yet seen her healthcare professional. The reporter did not consent to follow-up. The reporter stated it was related to patient. For tolerance to next dose, refer case US2019000455.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of muscle pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient experienced muscle pain after receiving a dose of SHINGRIX. The health care professional had no information regarding patient and vaccine. This case is linked to case US2019000441, reported by same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 78-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on unknown date). On 22nd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, 3 days after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a rash 3 to 5 days after the vaccination that would not go away. The patient was extremely convinced that it's shingles from the shot. The patient visited her dermatologist and was told that it should not be shingles, but the dermatologist believed that it looks like shingles. The rash was located in the lower extremities. The vaccine administration facility was the same as primary reporter.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site rash, Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date unknown) for prophylaxis. On 2nd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd October 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and rash. On an unknown date, the patient experienced shoulder pain. The patient was treated with Physical Therapy (Nos), Anti-Inflammatory and Pain Medication. On an unknown date, the outcome of the injection site pain and shoulder pain were not recovered/not resolved and the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the injection site pain and rash to be related to SHINGRIX. The reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient arm was sore at the injection site right after getting the shot and less than a day after receiving SHINGRIX, the patient developed a rash that went up about 1 to 2 inches above the injection site. Later, less than a year after receiving SHINGRIX, her right shoulder started being really sore. On 14th December 2018, the patient went to get the 2nd shot of SHINGRIX (batch number D9P5X) and her right shoulder was still very sore so she got it in her left arm instead. The shoulder pain had not gone away so the patient saw an orthopedist who said the pain was due to a reaction to SHINGRIX. The patient had been ordered physical therapy and was taking an anti-inflammatory and a pain medication. This was the potential legal case. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, 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 75-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Acetaminophen. On 7th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 8th September 2018, the patient experienced tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm, one day after vaccination, she experienced feeling tired. The patient planned to follow-up with her physician on an unknown date. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Movement disorder, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of knee pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 1st January 2019, the patient received the 1st dose of SHINGRIX. On 1st January 2019, less than an hour after receiving SHINGRIX, the patient experienced knee pain, leg pain and movement disorder. On an unknown date, the outcome of the knee pain, leg pain and movement disorder were recovering/resolving. It was unknown if the reporter considered the knee pain, leg pain and movement disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 70 years or 71 years. The patient received SHINGRIX on the right arm. Within an hour after receiving SHINGRIX, the patient developed severe pain in her left knee from the back of the knee and down her leg. It was difficult to raise her foot so for the last two days from the date of reporting, she had slid her foot along the floor. The pain did not subside when she sat or laid down. The patient could not take inflammatory medicines but used ice which provided temporary relief. When the patient woke up in the morning on the day of reporting, her leg and knee were much better and she could raise her knee to her waist level with only a twinge. The patient wanted to provide only her name.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of muscle pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient experienced muscle pain after receiving a dose of SHINGRIX. The health care professional had no information regarding patient and vaccine. This case is linked to case US2019GSK001711, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Mobility decreased, 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 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received 3 months prior to the 2nd dose, refer case US2019GSK001214). In November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In November 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced mobility decreased and muscle pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the mobility decreased and muscle pain were unknown. It was unknown if the reporter considered the pain in arm, mobility decreased and muscle pain to be related to SHINGRIX. Additional details were provided as follows: After vaccination, the patient experienced severe pain in her arm but it was still continuing and had not improved. The patient was unable to raise her arm, could not lift anything and it was painful to lay on that side. The patient did not have any redness or swelling, it was just internal muscular pain. The patient had not yet seen her healthcare professional. The reporter stated it was related to patient. The reporter did not consent to follow-up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count abnormal, Haemoglobin decreased, Mean cell haemoglobin concentration decreased, Mean cell volume increased, Monocyte count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of complete blood count abnormal in a 71-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included knee arthritis, inflammation, tooth infection and dental cavity. On 17th December 2018, the patient received SHINGRIX. On 18th December 2018, 1 days after receiving SHINGRIX, the patient experienced complete blood count abnormal. On an unknown date, the outcome of the complete blood count abnormal was not recovered/not resolved. It was unknown if the reporter considered the complete blood count abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on right arm. On 18th December 2018, the patient had blood work performed. The patient's levels were within the normal range, but all levels were slightly out of normal range. White blood cells 12.3, red blood cell 4.36, mean corpuscular volume 98.2, mean corpuscular hemoglobin concentration 31.3, hemoglobin 13.4, neutrophils 8.67 and monocytes 1.02. The patient has arthritis in his knee that has some inflammation. The patient also mentioned the possibility that he has an infection in his tooth, although he thinks it was probably a cavity. These symptoms were present prior to the vaccination. The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Neutrophil count increased, Red blood cell count decreased, White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of complete blood count abnormal in a 71-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included knee arthritis, inflammation, tooth infection and dental cavity. On 17th December 2018, the patient received SHINGRIX. On 18th December 2018, 1 days after receiving SHINGRIX, the patient experienced complete blood count abnormal. On an unknown date, the outcome of the complete blood count abnormal was not recovered/not resolved. It was unknown if the reporter considered the complete blood count abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on right arm. On 18th December 2018, the patient had blood work performed. The patient's levels were within the normal range, but all levels were slightly out of normal range. White blood cells 12.3, red blood cell 4.36, mean corpuscular volume 98.2, mean corpuscular hemoglobin concentration 31.3, hemoglobin 13.4, neutrophils 8.67 and monocytes 1.02. The patient has arthritis in his knee that has some inflammation. The patient also mentioned the possibility that he has an infection in his tooth, although he thinks it was probably a cavity. These symptoms were present prior to the vaccination. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, 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 67-year-old female patient who received SHINGRIX (batch number 4FS5N, expiry date 18th March 2021) for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional information was provided as follows: The pharmacist reported that they administered the SHINGRIX to a patient in left arm and the patient experienced arm soreness with redness and pain. The patient came in the pharmacy a couple of days after the vaccination to report the reaction and she claims that the side effects lasted for 3 months. Consented to follow up was provided.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Scab, Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pimples in a 67-year-old male patient who received SHINGRIX (batch number 4ZF42, expiry date 30th April 2019) for prophylaxis. On 19th November 2018, the patient received SHINGRIX .5 ml. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pimples. On an unknown date, the patient experienced crust and skin discoloration. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the pimples, crust and skin discoloration were unknown. It was unknown if the reporter considered the pimples, crust and skin discoloration to be related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX in the left deltoid. After receiving SHINGRIX the patient got a pimple thing, like a white head about 4 inches above his wrist. After receiving SHINGRIX, less than a year after the patient experienced crust and skin discoloration. On the same arm where he got the injection. This happened within a week of getting the SHINGRIX injection. The patient tried to pop the pimple and used antibiotic to treat it locally but it did not heal for 3 or 4 days. It eventually fell off. The white crust fell off but he still had that pink thing on his arm. Consent to follow up was provided.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received KINRIX outside of recommended age range. No S/S of adverse event. Pt did not have to obtain any treatment due to administration error.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever, chills, aches followed by a rash around my neck and torso. The chills woke me up in the middle of the night. They were uncontrollable. My husband took my temperature (101) and gave me Advil.  The fever broke within an hour. The rash didn't appear until the following day. It lasted approximately 2 days. No itching, just a bright red rash. Within 24 hours I felt better but was very tired.
Age: 42.0
Sex: F
Vaccine: FLU4, HEPAB, TDAP
Symptoms: Bronchiolitis, Oral mucosal eruption, Paraesthesia, Peripheral swelling, Rash pruritic
Clinical narrative: 1/6/19 at 18:00, small patches of itchy rash on extremities. No treatment. 1/7/19 at 01:00, extremely  itchy, tingling rash/hives wrapping around entire trunk, all extremities and back of scalp, but no rash on face. Minor swelling of extremities. Also, small lumps (not painful, just raised bumps) in mouth. No actual difficulty breathing, but presence of slightly irritated sensation in bronchioles when breathing. Treatment beginning 1/7/19, diphenhydramine HCl at approx 01:20, 50 mg; 03:30 additional 25 mg; 08:00, 50 mg; 12:30, 50 mg; 15:20, 25mg; 18:30, 50 mg; 22:30, 50 mg. Patches of rash still present on trunk and extremities, somewhat less itchy. 1/8/2019, diphenhydramine HCl at 02:00, 50 mg, 07:00 50 mg. Minor rash throughout, getting less itchy. Bronchioles no longer feel irritated and small bumps in mouth have gone away.
Age: 42.0
Sex: F
Vaccine: FLU4, HEPAB, TDAP
Symptoms: Urticaria
Clinical narrative: 1/6/19 at 18:00, small patches of itchy rash on extremities. No treatment. 1/7/19 at 01:00, extremely  itchy, tingling rash/hives wrapping around entire trunk, all extremities and back of scalp, but no rash on face. Minor swelling of extremities. Also, small lumps (not painful, just raised bumps) in mouth. No actual difficulty breathing, but presence of slightly irritated sensation in bronchioles when breathing. Treatment beginning 1/7/19, diphenhydramine HCl at approx 01:20, 50 mg; 03:30 additional 25 mg; 08:00, 50 mg; 12:30, 50 mg; 15:20, 25mg; 18:30, 50 mg; 22:30, 50 mg. Patches of rash still present on trunk and extremities, somewhat less itchy. 1/8/2019, diphenhydramine HCl at 02:00, 50 mg, 07:00 50 mg. Minor rash throughout, getting less itchy. Bronchioles no longer feel irritated and small bumps in mouth have gone away.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SWELLING AND REDNESS AND PAIN ON LEFT SQ ARM.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided. On 11-DEC-2018, the patient was vaccinated with a dose of improperly stored VAQTA (dose not provided, lot # R009799, expiration date 02-JUN-2019) intramuscularly for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the multiple temperature excursions from 32 up to 35 (34.79) degrees Fahrenheit in a time frame of 6 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1901USA000392.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAY-2012, the patient was inoculated by a pharmacist with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. On or about 22-DEC-2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with an incorrectly stored dose of PROQUAD injection, lot # R017799 with expiration on 13-DEC-2019 (dose, and route of administration were not reported) for prophylaxis, reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (strength, dose, frequency, route of administration, lot number, expiration date and indication were not reported). On unknown dates, the vaccine underwent a temperature excursion of -14 to -10 degrees Celsius over the period of 19 minutes. Digital Data logger was not involved in the recording of the excursion.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a pharmacist via patient support programs and described the occurrence of spaced out in a 74-year-old male patient who received SHINGRIX (batch number 77PL3, expiry date 18th April 2021) for prophylaxis. On 19th December 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced spaced out and activities of daily living impaired. On an unknown date, the outcome of the spaced out and activities of daily living impaired were unknown. It was unknown if the reporter considered the spaced out and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient was felt out and could not get himself dressed and went to the emergency room where the medical team equated it to the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included spondylosis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shoulder pain and pain in arm. On an unknown date, the outcome of the shoulder pain and pain in arm were unknown. It was unknown if the reporter considered the shoulder pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's shoulder and arm hurts terrible after taking SHINGRIX injection. The reporter did not gave consent to follow-up. This case has been linked with US2019000153, reported for same patient.
Age: 0.33
Sex: M
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Irritability, Overdose
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of irritability in a 4-month-old male patient who received PEDIARIX (batch number XT73A, expiry date unknown) for prophylaxis. Co-suspect products included INFANRIX (batch number 2N43Z, expiry date 4th December 2020) for prophylaxis. On 31st December 2018, the patient received PEDIARIX .5 ml and INFANRIX. On 31st December 2018, unknown after receiving PEDIARIX and INFANRIX, the patient experienced overdose. On 1st January 2019, the patient experienced irritability. On an unknown date, the outcome of the irritability and overdose were unknown. It was unknown if the reporter considered the irritability to be related to PEDIARIX and INFANRIX. Additional details were provided as follows: The physician said the patient was a healthy 4 month old as far as any medical history. Mother of the patient reported that the patient received a PEDIARIX dose as well as a INFANRIX on the same day, which led to an overdose of DTaP component. On 1st January 2019, 1 day after receiving PEDIARIX and INFANRIX, the patient experienced irritability. The physician called back on 4th January 2019 and stated that he followed up with the mother of the patient and the patient did experience some irritability the next day.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Oral herpes, Pain in extremity, Therapeutic response unexpected, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of musculoskeletal pain (first dose, for tolerance of 1st dose refer case US2019GSK001258). Concurrent medical conditions included spondylosis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shoulder pain, pain in arm, cold sores and unexpected therapeutic effect. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shoulder pain, pain in arm, cold sores and unexpected therapeutic effect were unknown. It was unknown if the reporter considered the shoulder pain, pain in arm, cold sores and unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient has not had cold sores ever since, but after 2nd dose of SHINGRIX he had worst one. The patient's shoulder and arm hurts terrible after taking SHINGRIX injection. His spondylosis went away after second shot of SHINGRIX, it was an unexpected positive result of vaccine. The reporter did not give consent to follow-up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
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. On 31st December 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced chills and pain. On an unknown date, the outcome of the chills and pain were recovering/resolving. It was unknown if the reporter considered the chills and pain to be related to SHINGRIX. Additional details were provided as follows: The patient, who was a consumer reported that she experienced chills and achiness that has gotten better but still continues today. The patient asked the question before but want to double check that could she be with her granddaughter aged 8 months as the patient experienced a reaction of chills and body aches. All of a sudden, the patient could no longer hear the caller and the call was disconnected. The patient did not report the reactions to the vaccine to GSK before as she did not think they were serious enough. Actually she read just about reporting them from this site just now. The patient did actually report it to the pharmacy where she got the vaccine. The patient was agree to contact to her physician. No further information was available.
Sex: U
Vaccine: FLUA3, PNC13
Symptoms: Pruritus generalised
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. A patient of an unspecified age and gender received, on an unknown date, PREVNAR 13 at single dose and FLUAD; both for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccinations, the patient experienced 'itching all over'. Clinical outcome was unknown at time of this report. The information on the lot number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Diet refusal
Clinical narrative: This is a spontaneous report from a non-contactable consumer (mother). An infant patient (less of 6 months old) of unspecified gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient stopped breast feeding on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Defiant behaviour, Dizziness, Dysstasia, Mood altered
Clinical narrative: Wed. 10/3/2018-approx. 5:30 AM-patient became dizzy, lightheaded, could not stand alone-called "911" for aid. Paramedics took him to hosp, not certain as to what caused this problem. Patient also had "3" very itchy marks on area of right hip, first thought to be "bug bites", however probably "hives" I'm not sure, MDs were not sure, as well. Patient also had "mood change"? He was defiant, rebellious, toward nursing staff. This is not "patient'.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Wed. 10/3/2018-approx. 5:30 AM-patient became dizzy, lightheaded, could not stand alone-called "911" for aid. Paramedics took him to hosp, not certain as to what caused this problem. Patient also had "3" very itchy marks on area of right hip, first thought to be "bug bites", however probably "hives" I'm not sure, MDs were not sure, as well. Patient also had "mood change"? He was defiant, rebellious, toward nursing staff. This is not "patient'.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Headache, Influenza like illness, Nausea
Clinical narrative: Initial dose received June 5, 2018. Flu like symptoms, headache, body aches began the next day and lasted 2 days. Second dose received January 3, 2019. Due to shortage had to wait for the supply to come in. Same symptoms as first time, except much worse. More severe headache, nausea, no appetite, severe body aches and fever. Most lasted 2 days, nausea lasted 3 days, ending with diarrhea.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Initial dose received June 5, 2018. Flu like symptoms, headache, body aches began the next day and lasted 2 days. Second dose received January 3, 2019. Due to shortage had to wait for the supply to come in. Same symptoms as first time, except much worse. More severe headache, nausea, no appetite, severe body aches and fever. Most lasted 2 days, nausea lasted 3 days, ending with diarrhea.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Limb discomfort, Mobility decreased
Clinical narrative: Localized redness, swelling/lump, discomfort experienced for a duration of 1 month. Pt. stated that she had difficulty using arm to lift bowling ball/heavy objects d/t discomfort, but otherwise unaffected. Denied weakness, numbness of extremity. Symptoms resolved on its own w/o intervention.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Ear pain, Feeding disorder, Headache, Immediate post-injection reaction
Clinical narrative: Pt states arm pain began as soon as the injection started on 1/3/19. It radiated down arm and to back, head, ear, & mouth. Pt states pain hasn't stopped since injection and can not eat. I advised her to see her doctor. Pt said she couldn't until Monday. I advised her to see an urgent care or ER.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Oral pain, Pain, Pain in extremity
Clinical narrative: Pt states arm pain began as soon as the injection started on 1/3/19. It radiated down arm and to back, head, ear, & mouth. Pt states pain hasn't stopped since injection and can not eat. I advised her to see her doctor. Pt said she couldn't until Monday. I advised her to see an urgent care or ER.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient got a fever and chills.
Age: 32.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: About 5 minutes after both vaccines were administered, the potential new Volunteer started to look pale in his face and stated he felt "a little lightheaded", also started sweating on his forehead. Monitored for over 20 minutes for his safety with another Employee at the time and also gave him some water. Potential new volunteer refused to lie down or be taken to Emergency dept. upstairs. After 20 min, he stated he felt fine. Possible vasovagal episode.
Age: 1.25
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Nasopharyngitis, Seizure
Clinical narrative: 2 weeks later she came down with a cold followed by a seizure.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Patient reported that within one week of SHINGRIX vaccine she began having significant muscle pain. Beginning in low back and progressing to "all over" especially knees, legs and joints. She has seen her PCP and found no reason for sudden onset of muscle/joint pain has been found. Patient is attributing the pain to vaccine.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Upon internal review significant amendment was done on 08-Jan-2018 to add narrative. Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 35 years old female patient who experienced when she touches it she feels pain, while she received vaccine FLUZONE QUADRIVALENT, suspension of injection. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Aug-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UI986AB) in the left arm. On an unknown date, the patient developed a non-serious when she touches it she feels pain (vaccination site pain) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Final diagnosis was when she touches it she feels pain. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for vaccination site pain. List of document held by sender: none. Addendum: 08-Jan-2018. The narrative was added.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves Infant patient who received only diluent of ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine lot number not reported via unknown route. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 years old female patient who had FLUBLOK QIV lot QFAA1833 in left arm on 31-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Inappropriate age at vaccine administration. The patient outcome is reported as Not Applicable for flublok vaccine was administered to a 6 year old. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PPV, VARCEL
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case involves a 12 months old female patient who received vaccine PENTACEL. The patient's past medical history and family history were not provided. Concomitant medications included Hep A, Hep B, MMR, PCV 13 and Varicella on 18-Dec-2018. On 18-Dec-2018, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5545AA, expiry date 06-Oct-2019 via intramuscular route in the right leg. It was an actual medication error due to inappropriate reconstitution technique. It was reported that patient was given the DTaP-IPV portion of PENTACEL and not the ACTHIB portion. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2019SA004554 (same reporter). This case involves a six-year old male patient who was vaccinated with a single dose of FLUBLOK QIV (lot QFAA1804 via intramuscular route in the left thigh on 14-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Saw primary care Dr. 11/20/18 severe shoulder pain (left). Visit to Orthopedic Dr. for injection shoulder. Prescribed anti-inflammatory medicine 11/30/2018. Told me I was 5th person, same situation.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse manager. This case involves a 4 months old male patient who received expired vaccine PENTACEL. The patients past medical history, concomitant medication and family history were not provided. On 02-Jan-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5449AA, expiry date 07-Dec-2018 via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used, as patient received expired PENTACEL. PENTAVEL box and the lyophilized powder were mixed from components from same box and 0.5 mL dose given. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA004466. This case involves a 18 years old female patient who received double dose of vaccine FLUZONE QUADRIVALENT (lot number: UJ009AA, expiry date: 30-Jun-2019) via intramuscular route in right deltoid on 02-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to overdose because the patient received a 1ml instead of a 0.5ml FLUZONE QUADRIVALENT. There were no side effects after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2019SA004547. This case involves a 11 years old female patient who received 0.5 ml of vaccine FLUBLOK QIV (lot number: QFAA1804, expiry date: 06-Jan-2019) via intramuscular route in left deltoid on 14-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. This was a case of actual medication error due to inappropriate age at vaccine administered. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.