chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-MAY-2017 the patient (who was 1 year and 7 months old at the time) received the first dose in the two dose hepatitis A vaccination series with VAQTA injection 25/0.5 (lot#, expiration date, route of administration and dosing details were not reported), for prophylaxis. On 25-OCT-2017, the patient (who was 2 years old at the time) inadvertently received the second dose in the two dose hepatitis A vaccination series with VAQTA too early. No adverse were effects reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Musculoskeletal disorder, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician regarding a 19 year old (also reported as 20 years old) female patient. Her concurrent conditions included herpes type 1 positive (diagnosed in November 2016), herpes type 2 equivocal (diagnosed on 02-MAY-2017), and genital herpes. She did not have other medical history and concomitant medications. On 02-MAY-2017, the patient was vaccinated with first dose of GARDASIL 9 (lot # M042853, expiry 17-JUL-2019) in the left deltoid (dose and route unknown) for prophylaxis. On 02-MAY-2017, the patient complained of severe arm soreness described as "patient was unable to fully use her arm without pain". On the same day, the patient also complained of tenderness at the injection site (injection site pain) and aches. The patient did not receive treatment for the events. No lab diagnostics/studies were performed. The patient never received her second dose of GARDASIL 9. The outcome of pain in extremity, injection site pain and pain was unknown. Causality of the events was unknown with GARDASIL 9. This is one of three reports from the same physician (1804USA012047 and 1804USA012316).
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative regarding a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2016 the patient was vaccinated with first dose of GARDASIL (lot#, expiration date, route of administration and dosing details were not reported), for prophylaxis. On an unknown date in 2016 the patient was vaccinated with second dose of GARDASIL and it was unknown if the patient received the second dose at the recommended time interval as specified in the prescribing information. It was reported the patient has not received the third dose in the HPV series (inappropriate schedule of drug administration). No adverse effects were reported.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Incomplete course of vaccination, Nausea, Rash, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 18 year old female patient. Patient's pertinent medical history included, Herpes Type 1 positive, Genital Type 1 outbreaks recurrent, Bipolar and Migraine which were diagnosed on December 2016. Drug reactions/ allergies were reported as none. On 18-APR-2017 the patient was vaccinated with first dose of GARDASIL 9 (lot # M011117, expiry date 07-DEC -2017) intramuscularly in the right deltoid for the indication of age and risk. Concomitant therapies included ABILIFY, clonidine and vitamin d (unspecified). On 18-APR-2017, the patient developed very bad chest rash. On 21-APR-2017 the patient experienced nausea, diarrhoea and vomiting. The second dose of GARDASIL 9 was never received. Patient received an unspecified treatment for the events. No medical attention was sought for the events. Lab tests were reported as none. The outcome of rash, diarrhoea, vomiting and nausea was reported as recovered/resolved. Causality assessment was not provided. No product quality complaint was filed. This is one of the several reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 19-AUG-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 23-AUG-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 30-AUG-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 31-AUG-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant  medications were not reported. On 17-SEP-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 24-SEP-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 25-OCT-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 20-JUN-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 21-JUN-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 22-JUN-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 05-JUL-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 07-JUL-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 07-JUL-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 08-JUL-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 16-JUL-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from office manager refers to 28 year old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 29-JAN-2018, the patient was vaccinated with GARDASIL 9 (dose, units, route and frequency not reported) (lot # N019103 and expiration date: not reported) at the age of 28 years. No adverse effects reported. No product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 26-JAN-2016 and 03-APR-2017, the patient was vaccinated with VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 28-JAN-2016 and 04-APR-2017, the patient was vaccinated with Oka/Merck VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 09-MAR-2016 and 06-APR-2017, the patient was vaccinated with VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 16-MAR-2016 and 07-APR-2017, the patient was vaccinated with Oka/Merck VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 06-APR-2016 and 10-APR-2017, the patient was vaccinated with Oka/Merck VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 08-JUL-2016 and 10-APR-2017, the patient was Oka/Merck VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 11-JUL-2016 and 13-APR-2017, the patient was vaccinated with Oka/Merck VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 13-JUL-2016 and 13-APR-2017, the patient was vaccinated with VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 15-JUL-2016 and 13-APR-2017, the patient was vaccinated with VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Hypoaesthesia, Muscular weakness, Pain, Pain in extremity
Clinical narrative: After patient was administered the second dose of TWINRIX, she began to have pain in her left arm. She stated that her arm was sore the same day and the pain began to move down her arm and to her elbow. She has been having pain and weakness in her left arm since the vaccination and states that she is not able to lift things with her left arm. She states that after sleeping, when she wakes up and tries to stretch her arm out, the pain is severe. She also states that her arm hurts constantly throughout the day, especially in her bicep to her elbow. She states that her arm tingles and is numb at times.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Paraesthesia
Clinical narrative: After patient was administered the second dose of TWINRIX, she began to have pain in her left arm. She stated that her arm was sore the same day and the pain began to move down her arm and to her elbow. She has been having pain and weakness in her left arm since the vaccination and states that she is not able to lift things with her left arm. She states that after sleeping, when she wakes up and tries to stretch her arm out, the pain is severe. She also states that her arm hurts constantly throughout the day, especially in her bicep to her elbow. She states that her arm tingles and is numb at times.
Age: 3.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given both Varicella and MMRV.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Hypoaesthesia, Peripheral swelling, Skin warm, Throat tightness
Clinical narrative: Face got red and hot. Fingers felt numb. Arms and hands swollen. Pt was given BENADRYL at strong hospital, 2 hours later her throat started to close, prednisone given. Discharged home.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Sore arm, muscle aches, fatigue, headache.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient developed pain, swelling, and increased redness below site of injection that lasted greater than 72 hrs.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash and erythema multiform.
Age: 39.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dizziness, Dyspnoea, Headache, Hypertension, Vomiting
Clinical narrative: Lightheaded with emesis & short of breath. Seen @ urgent care @ 3:15pm. Hypertensive on admission with headache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Headache, chills, weakness, severe dizziness, watery mouth and heavy perspiration.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Salivary hypersecretion
Clinical narrative: Headache, chills, weakness, severe dizziness, watery mouth and heavy perspiration.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, headache.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site pain, Myalgia, Nausea
Clinical narrative: Pain at injection site, Pain in muscles and joints, Flu like systems, nausea, Rash on trunk of body front and back.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pain at injection site, Pain in muscles and joints, Flu like systems, nausea, Rash on trunk of body front and back.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Tenderness
Clinical narrative: Patient received vaccine on the 16th and then on Thursday started feeling sensation of nerve pain, tenderness to cheek area. Pain increases and by Saturday night the pain woke up patient. On Sunday there were a few blisters and then it continued to accelerate and by Monday morning patient saw MD and was diagnosed with shingles on the side of his face.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Ear canal erythema, Erythema, Herpes zoster, Herpes zoster infection neurological
Clinical narrative: Patient received vaccine on the 16th and then on Thursday started feeling sensation of nerve pain, tenderness to cheek area. Pain increases and by Saturday night the pain woke up patient. On Sunday there were a few blisters and then it continued to accelerate and by Monday morning patient saw MD and was diagnosed with shingles on the side of his face.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mucosa vesicle, Pain, Paraesthesia, Rash, Rash papular
Clinical narrative: Patient received vaccine on the 16th and then on Thursday started feeling sensation of nerve pain, tenderness to cheek area. Pain increases and by Saturday night the pain woke up patient. On Sunday there were a few blisters and then it continued to accelerate and by Monday morning patient saw MD and was diagnosed with shingles on the side of his face.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Scab
Clinical narrative: Patient received vaccine on the 16th and then on Thursday started feeling sensation of nerve pain, tenderness to cheek area. Pain increases and by Saturday night the pain woke up patient. On Sunday there were a few blisters and then it continued to accelerate and by Monday morning patient saw MD and was diagnosed with shingles on the side of his face.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an 18 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 08-MAR-2018, the patient was administered an improperly stored PROQUAD (lot: N025928, expiry date: 18-MAR-2019) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours, 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter. Sender's Comments: US-009507513-1804USA004755.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 4 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 13-MAR-2018, the patient was administered an improperly stored Oka-Merck PROQUAD (lot: N025928, expiry date: 18-MAR-2019) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours, 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter. Sender's Comments: US-009507513-1804USA004755.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 6 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored PROQUAD (lot: N025928, expiry date: 18-MAR-2019) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours, 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter. Sender's Comments: US-009507513-1804USA004755.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 2 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 13-MAR-2018, the patient was administered an improperly stored PROQUAD (lot: N025928, expiry date: 18-MAR-2019) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours, 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter. Sender's Comments: US-009507513-1804USA004755.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient given Zoster vaccine instead of the Varicella vaccine she had requested. No adverse reactions noted and followed up with appropriate dose of VAR one month later.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Vaccines given approximately at 2:10 PM, pt. sent to lobby to await discharge when mother noticed rash started. Brought back to room, evaluated by provider. Dx with red rash to torso and face. Pt. was calm but warm to touch, no fever, no wheezing, lungs clear.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Noticed it a week ago from vaccine redness, swelling and rash down to elbow took BENADRYL, went to urgent care and got seen and received antibiotic it has cleared up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Multiple red lines started appearing on her neck on both sides, and 2 red lines on her face but no discomfort or itchiness. Subsided within a few minutes and almost disappeared.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea started day after vaccination. Vomiting with each bottle feed, diarrhea was non-bloody and 3-4 x per day. Symptoms lasted for 5 days.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Erythema, Peripheral swelling, Swelling
Clinical narrative: Patient walked in Monday complaining of redness and swelling at arm and chest area and shortness of breath.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Hypoaesthesia, Mental status changes, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of stroke in a adult patient who received SHINGRIX. 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 stroke (serious criteria GSK medically significant), numbness, tingling, mental status changes, blurred vision and fever. On an unknown date, the outcome of the stroke, numbness, tingling, mental status changes, blurred vision and fever were unknown. It was unknown if the reporter considered the stroke, numbness, tingling, mental status changes, blurred vision and fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced significant stroke like side effects including numbness, tingling, altered mental status, blurred vision and fever after receiving a dose of SHINGRIX, significant enough to warrant an Emergency department visit. The reporter was still in the process of gathering and validating information but he wanted to reach out to see if GlaxoSmithKline had received any reports of stroke like symptoms after SHINGRIX administration occurring elsewhere.
Sex: U
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of stroke in a adult patient who received SHINGRIX. 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 stroke (serious criteria GSK medically significant), numbness, tingling, mental status changes, blurred vision and fever. On an unknown date, the outcome of the stroke, numbness, tingling, mental status changes, blurred vision and fever were unknown. It was unknown if the reporter considered the stroke, numbness, tingling, mental status changes, blurred vision and fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced significant stroke like side effects including numbness, tingling, altered mental status, blurred vision and fever after receiving a dose of SHINGRIX, significant enough to warrant an Emergency department visit. The reporter was still in the process of gathering and validating information but he wanted to reach out to see if GlaxoSmithKline had received any reports of stroke like symptoms after SHINGRIX administration occurring elsewhere.
Sex: M
Vaccine: VARZOS
Symptoms: Arterial fibrosis, Cardiac failure, Dizziness, Dyspnoea, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cardiac insufficiency in a 65-year-old male patient who received ROTARIX (batch number ROT001, expiry date 31st December 2018). Co-suspect products included SHINGRIX (batch number SHG001, expiry date 30th August 2020), TWINRIX (batch number TWIN001, expiry date 13th September 2018), BREATHE RIGHT NASAL STRIPS ADVANCED (batch number BREATH01, expiry date 1st January 2022) for snoring and ADVAIR inhalation powder (batch number ADV003, expiry date 1st June 2018) for chronic obstructive pulmonary disease. On 15th December 2017, the patient received the 1st dose of ROTARIX (catheter) 10 mcg/mg. On 1st March 2018, the patient received the 1st dose of SHINGRIX (injection) 50 mg. On 27th February 2018, the patient received the 1st dose of TWINRIX (injection) 33 mcg/mg. On 25th February 2018, the patient started BREATHE RIGHT NASAL STRIPS ADVANCED. On 20th February 2018, the patient started ADVAIR (inhaled) 100 mcg/mg once daily. On 1st March 2018, 76 days after receiving ROTARIX, an unknown time after receiving SHINGRIX, 2 days after receiving TWINRIX, 4 days after starting BREATHE RIGHT NASAL STRIPS ADVANCED and 9 days after starting ADVAIR, the patient experienced cardiac insufficiency (serious criteria hospitalization and GSK medically significant). On 2nd March 2018, the patient experienced arterial fibrosis and nausea. On 3rd March 2018, the patient experienced felt faint. On 4th March 2018, the patient experienced shortness of breath. ROTARIX was continued with no change. SHINGRIX was continued with no change. TWINRIX was discontinued. ADVAIR was discontinued on 2nd March 2018. On 2nd March 2018, the outcome of the arterial fibrosis was recovered/resolved. On 5th March 2018, the outcome of the cardiac insufficiency was recovered/resolved. On an unknown date, the outcome of the nausea, felt faint and shortness of breath were unknown. It was unknown if the reporter considered the cardiac insufficiency, arterial fibrosis, nausea, felt faint and shortness of breath to be related to ROTARIX, SHINGRIX, TWINRIX, BREATHE RIGHT NASAL STRIPS ADVANCED and ADVAIR. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Seizure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of convulsion in a 17-year-old male patient who received BEXSERO. On 20th November 2017, the patient received the 1st dose of BEXSERO. On 20th November 2017, 2 hrs after receiving BEXSERO, the patient experienced fever. On 22nd November 2017, the patient experienced convulsion (serious criteria GSK medically significant). On an unknown date, the outcome of the convulsion and fever were unknown. It was unknown if the reporter considered the convulsion and fever to be related to BEXSERO. Additional details were provided as follows: The reporter stated that patient's body temperature recorded was 101.89 degrees. The patient was recommended to go to an emergency room but the patient did not go to the emergency department. All questions were asked but GlaxoSmithKline representative provided limited information.
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Disorientation, Dizziness, Loss of consciousness, Product quality issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of passed out in a 22-year-old male patient who received HAVRIX (batch number TB995, expiry date 25th October 2020). On 20th April 2018, the patient received the 1st dose of HAVRIX 1 ml. On 20th April 2018, less than a minute after receiving HAVRIX, the patient experienced passed out (serious criteria GSK medically significant), disorientation and dizziness. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the passed out, disorientation and dizziness were recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the passed out, disorientation and dizziness to be related to HAVRIX. Additional details were provided as follows: This case was associated with pharmaceutical product complaint. At 3:15 pm, the patient received HAVRIX in left deltoid. The nurse reported that the patient was scared to get the HAVRIX vaccine and within a few seconds of the vaccination, the patient felt dizzy and passed out. This lasted for a couple of seconds and then resolved. the patient was out cold and was slightly disoriented after passing out but resolved quickly. The reporter insisted that the adverse event experienced was related to the lot of the HAVRIX product and insisted that a quality assurance (QA) report be filed.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Conjunctivitis, Dermatitis, Erythema, Feeling hot
Clinical narrative: The patient is a previously healthy 23-year-old male primary vaccinee who has been traveling to training via bus and received SPV vaccine 13 March 2018 = 13 days ago (Lot number the VVO4-003A) ; while midtrip he developed a generalized macular papular erythematous pruretic urticarial dermatitis which was treated with BENADRYL which has continued to evolve during today's evaluation. He has lesions to hands including palms, arms bilateral, chest, feet and legs. He has no shortness of breath, oral face throat tongue swelling, flushing although feels hot, chest pain, conjunctivitis, rhinorrhea, nausea or vomiting. He has no fever chills malaise, but does complain of headache.   As of this filing patient has recovered
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Headache, Nausea, Pruritus, Rash maculo-papular, Rhinorrhoea
Clinical narrative: The patient is a previously healthy 23-year-old male primary vaccinee who has been traveling to training via bus and received SPV vaccine 13 March 2018 = 13 days ago (Lot number the VVO4-003A) ; while midtrip he developed a generalized macular papular erythematous pruretic urticarial dermatitis which was treated with BENADRYL which has continued to evolve during today's evaluation. He has lesions to hands including palms, arms bilateral, chest, feet and legs. He has no shortness of breath, oral face throat tongue swelling, flushing although feels hot, chest pain, conjunctivitis, rhinorrhea, nausea or vomiting. He has no fever chills malaise, but does complain of headache.   As of this filing patient has recovered
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion, Urticaria, Vomiting
Clinical narrative: The patient is a previously healthy 23-year-old male primary vaccinee who has been traveling to training via bus and received SPV vaccine 13 March 2018 = 13 days ago (Lot number the VVO4-003A) ; while midtrip he developed a generalized macular papular erythematous pruretic urticarial dermatitis which was treated with BENADRYL which has continued to evolve during today's evaluation. He has lesions to hands including palms, arms bilateral, chest, feet and legs. He has no shortness of breath, oral face throat tongue swelling, flushing although feels hot, chest pain, conjunctivitis, rhinorrhea, nausea or vomiting. He has no fever chills malaise, but does complain of headache.   As of this filing patient has recovered
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Tinnitus
Clinical narrative: A few minutes after immunizations, felt ringing in her ears and dizzy, fell forward. Monitored for 15 minutes afterward and given juice and crackers. Stable vital signs. Dizziness and ringing resolved approximately 10 minutes after falling.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea and Diarrhea, Diarrhea-about 6 times a day, started 4/28/18 in the evening. No blood in stool, no fever.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Malaise, Pruritus, Pyrexia, Rash, Skin lesion
Clinical narrative: Patient complaining of rash that developed approximately 1 week after SPV. Patient now 30 days out from SPV but rash is persistent. Previously evaluated and treated by PCM for arthropod insult with Rx of hydrocortisone. Describes lesions on extremities and trunk to include groin area that are pruritic in nature. Previously also noted to be painful. Lesions are NOT pustules r draining. Otherwise patient is well and non-toxic. He denies any chest pain, shortness of breath, arthralgias, myalgias or other systemic symptoms. He did have a low-grade fever and mild "illness" at peak immune response of vaccine at 7-10 days s/p vaccination. All those symptoms have since resolved.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a 2-year-old male patient. His medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 29-MAR-2018, the patient was vaccinated with a dose of VARIVAX (dose, route and site of administration, lot number and expiration date were not reported) that was reconstituted with an improperly stored sterile diluent (dose, route and site of administration were not reported, lot # M009799, expiration date: 11-SEP-2018). The sterile diluent was stored in temperature below 32 Fahrenheit degrees (F) (-11 F) for 120 hours. There was a previous temperature excursion of 32 F up to 35 F (34.5 F) for 45 minutes. Temperature excursion occurred as a result of a reading from a Digital Data Logger. It was confirmed that VARIVAX had no temperature excursion prior to being administered. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1804USA013048: US-009507513-1804USA013049.
Age: 53.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 53 year old patient of unknown gender. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported. On 24-APR-2018, the patient was inadvertently vaccinated with a dose of Oka-Merck) PROQUAD lot # M044020, expiry date 01-MAY-2018, intramuscularly for prophylaxis, instead of (wistar ra 27-3) M-M-R II (lot# and expiry date were not reported). Concomitant therapies included sterile diluent (lot# and expiry date were not reported). No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a 4-year-old female patient. Her medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-APR-2018, the patient was vaccinated with a dose of VARIVAX (dose, route and site of administration, lot number and expiration date were not reported) that was reconstituted with an improperly stored sterile diluent (dose, route and site of administration were not reported, lot # M009799, expiration date: 11-SEP-2018). The sterile diluent was stored in temperature below 32 Fahrenheit degrees (F) (-11 F) for 120 hours. There was a previous temperature excursion of 32 F up to 35 F (34.5 F) for 45 minutes. Temperature excursion occurred as a result of a reading from a Digital Data Logger. It was confirmed that VARIVAX had no temperature excursion prior to being administered. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1804USA004764: US-009507513-1804USA013049.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a 5-year-old female patient. Her medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 04-APR-2018, the patient was vaccinated with a dose of Oka/Merck VARIVAX (dose, route and site of administration, lot number and expiration date were not reported) that was reconstituted with an improperly stored sterile diluent (dose, route and site of administration were not reported, lot # M009799, expiration date: 11-SEP-2018). The sterile diluent was stored in temperature below 32 Fahrenheit degrees (F) (-11 F) for 120 hours. There was a previous temperature excursion of 32 F up to 35 F (34.5 F) for 45 minutes. Temperature excursion occurred as a result of a reading from a Digital Data Logger. It was confirmed that Oka/Merck VARIVAX had no temperature excursion prior to being administered. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1804USA004764: US-009507513-1804USA013048.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt complaining of red visible rash spreading around injection site. Area is red, swollen, warm to touch, itching. Pt advised to try BENADRYL and cold compress at this time.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Pt complaining of red visible rash spreading around injection site. Area is red, swollen, warm to touch, itching. Pt advised to try BENADRYL and cold compress at this time.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: Patient received the first dose of SHINGRIX vaccine on Friday, April 27. She had some injection site pain when the vaccine was going in. Patient reports that on Sunday morning, she noticed a rash on her neck and face. She has a history of unexplained neck rash, but said that it has not previously been this bad.. and usually is not on her face. She went to Clinic and was given a steroid shot, steroid pack, and steroid cream. We will follow up with patient to make sure she is okay, and needs no further assistance or treatment. We will also notify the physician who authorized the vaccine to let him know.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash, Rash generalised
Clinical narrative: Patient reports swelling in arm that injection was received the next day. A progressive body rash has occurred along with a rash on the face started to occur the day following the vaccination and is still ongoing. It is scaling now and has not gone away as of yet.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Left lateral upper arm - erythematous circular patch at the injection site, warm and slightly tender to touch, site induration of 2x2.5cm, symptom started 10days ago.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain
Clinical narrative: Persistent muscular pain with abduction and external rotation of arm. Now going on 3 weeks. No site reaction, however.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient was given SHINGRIX dose without proper mixing. Patient received only adjuvant, without antigen being properly added. Patient noted she did have soreness at injection site. Per manufacturer, proper dose was given 3 days later in opposite arm and patient was counseled.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Pt complained of her right arm/shoulder being sore, red and swollen.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Localized, well demarcated erythema of L shoulder w/induration. Spread laterally down arm - 10 cm x 11 cm. Lt. shoulder arthralgia and stiffness. Subjective patient fever.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Localized, well demarcated erythema of L shoulder w/induration. Spread laterally down arm - 10 cm x 11 cm. Lt. shoulder arthralgia and stiffness. Subjective patient fever.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Pain, Peripheral swelling, Pruritus
Clinical narrative: Whole arm swollen, red itchy, mobility. Neck immobilized. Severe pain.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Pyrexia, Rash erythematous, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Client states that pain in arm began approximately 4-5 hours she received both PPSV23 and Tetanus vaccine (not sure of the brand). By the next evening, client noticed a red, hot rash that started a few inches lower than site of vaccine on right arm. Rash did not extend to forearm. Red was raised but not itchy. Today (4/30), rash is still visible but not as red, still raised, and warm to the touch. States had a fever from 4/26 until possibly 4/28 but does not know how high because didn't take temp.