chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Urticaria
Clinical narrative: Started with hives on 12/11/2018 9pm, next morning, continued with hives, difficulty breathing and cough on 12/12/2018 sent to emergency department on 12/12/2018 at 10:00.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MENB, MNQ
Symptoms: Blood glucose normal, Dizziness, Fall, Loss of consciousness, Tremor
Clinical narrative: Pt reported felt dizzy and fell to the floor; lost consciousness for approximately 7 minutes. Upon coming to pt was shaking and nonverbal but tracking visually and breathing without difficulty. (classmate observed passing out). Paramedics called and transported to ER.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Dermatitis contact, Erythema, Peripheral swelling, Sensitive skin, Vaccination site discolouration
Clinical narrative: She received one anthrax vaccine that was administered on 28 Apr 2007. Other than slight arm redness and swelling she denied any problems with her immunization. About one year later she noted she would occasionally get some small bumps, similar to a pimple that would get dark around her vaccination site. The darkness persisted but would have episodes of a red ring of bumps surrounding area. Stated it looked like a ring worm but it was not. She reports a hx of sensitive skin and only uses natural products on her skin. She did report that she notices site irritation more when she has to take her fluconazole and sometimes ibuprofen. Suspect Systemic contact dermatitis. Symptoms: Rash and Oth Nonspec Skin Eruption (R21).
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Vaccination site irritation, Vaccination site rash
Clinical narrative: She received one anthrax vaccine that was administered on 28 Apr 2007. Other than slight arm redness and swelling she denied any problems with her immunization. About one year later she noted she would occasionally get some small bumps, similar to a pimple that would get dark around her vaccination site. The darkness persisted but would have episodes of a red ring of bumps surrounding area. Stated it looked like a ring worm but it was not. She reports a hx of sensitive skin and only uses natural products on her skin. She did report that she notices site irritation more when she has to take her fluconazole and sometimes ibuprofen. Suspect Systemic contact dermatitis. Symptoms: Rash and Oth Nonspec Skin Eruption (R21).
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Intensive care, Laboratory test
Clinical narrative: I received regular flu shot in sometime end of Sept from my employer facility. I am not sure from what clinic that they provided from or any main out source hospital.
Age: 24.0
Sex: M
Vaccine: HEPA
Symptoms: Inflammation, Pain, Paraesthesia
Clinical narrative: Inflammation and pain greater than expected. Tingling in arm from elbow down. Patient went to hospital and orthopedic doctor. The patient's sister says that the arm was too inflammed to do an MRI the day after receiving the vaccine and are going back to the orthopedic next week.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Erythema, Myalgia
Clinical narrative: Patient received SHINGRIX in the right deltoid and AFLURIA in the left deltoid on 10/1/2018. Per 10/2/2018 Primary Care note, patient reported generalized myalgias and dizziness 6 hours after receiving vaccines. Also has bilateral erythema and possible early cellulitis at both upper arms R greater than L. Given push fluids, TYLENOL PRN fever, and Z-PAK.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Pain at the injection site, muscle pain, tiredness, fever, headache, fatigue, shivering, nausea. Second dose on 12/6/18 at the same pharmacy and I had a worse reaction! I felt dizzy when I received the vaccine. My whole body hurts. I thought I would die.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Pain at the injection site, muscle pain, tiredness, fever, headache, fatigue, shivering, nausea. Second dose on 12/6/18 at the same pharmacy and I had a worse reaction! I felt dizzy when I received the vaccine. My whole body hurts. I thought I would die.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. The patient received PREVNAR 13 on an unspecified date in 2017. On an unknown date in 2017, the patient was vaccinated with first dose of PNEUMOVAX 23 intramuscularly (exact dose, lot number and expiration date were not reported) for prophylaxis. On 14-NOV-2018, the patient was vaccinated with second dose of PNEUMOVAX 23 lot # N027770, expiration date 02-FEB-2019, intramuscularly (exact dose was not reported) for prophylaxis. On 15-NOV-2018, the patient experienced arm being "very swollen with pain at injection site. No fever. Played racquetball last night". The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
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, concomitant medications and drug reactions or allergies were not reported. On 10-DEC-2018, when the patient was 14-year-old, was vaccinated with the first dose of with GARDASIL 9 injection (exact dose, strength, frequency and lot# with expiration date were not reported) for prophylaxis. On 17-SEP-2018, when the patient was 18-year-old, was vaccinated with the second dose of GARDASIL 9 injection, lot# N025428 with expiry date 19-JUN-2020 (exact dose, strength, frequency and lot# with expiration date were not reported) for prophylaxis. No adverse events were reported. The outcome of inappropriate schedule of product administration and no adverse event was unknown. This case was considered non-valid due to lack of the patient's identifiers.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer regarding his wife of 53 years old. The patient's medical history, concurrent conditions were not reported. The patient's concomitant medications included unspecified menopause medications. On an unknown date in June 2018, the patient was vaccinated with ZOSTAVAX, 1 injection (strength, frequency, route, lot# and expiry were not reported) for prevention of shingles. On an unknown date in June 2018, the patient developed a bump that is several inches long underneath the injection site (vaccination site mass). Patient sought medical attention from doctor. No laboratory diagnostics or studies were performed. Outcome of the event vaccination site mass was reported as not recovered. Causality assessment was not reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, the patient's healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, 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 include 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. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-DEC-2018, the patient was vaccinated with expired VAQTA intramuscularly (dose was not reported, lot # N016805, expiration date 04-SEP-2018) for prophylaxis. The vaccine was stored properly. No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-DEC-2018, the patient was vaccinated with an expired dose of PROQUAD, lot # N008826, expiry date 12-SEP-2018, subcutaneously for prophylaxis. No adverse effects were reported.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Nausea, Peripheral swelling
Clinical narrative: Major swelling of entire upper arm ---more than twice normal size---, nausea, stomach ache.  Treatment: patient used BENADRYL and ADVIL. Next day swelling reduced by 50 %. Nausea and stomach gone.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Borrelia test, C-reactive protein, Dizziness, Electromyogram
Clinical narrative: Patient reported increased dizziness, vertigo symptoms to her primary care provider on 11/9/2018 then presented to Emergency Room on 12/5/2018 with sudden onset weakness and numbness and hyponatremia. Diagnosed with GBS and treated with IVIG and plasma exchange. As of 12/12/2018 pt remains hospitalized with parasthesia.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Hyponatraemia, Immunoglobulin therapy, Immunology test
Clinical narrative: Patient reported increased dizziness, vertigo symptoms to her primary care provider on 11/9/2018 then presented to Emergency Room on 12/5/2018 with sudden onset weakness and numbness and hyponatremia. Diagnosed with GBS and treated with IVIG and plasma exchange. As of 12/12/2018 pt remains hospitalized with parasthesia.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Paraesthesia, Plasmapheresis, Vertigo
Clinical narrative: Patient reported increased dizziness, vertigo symptoms to her primary care provider on 11/9/2018 then presented to Emergency Room on 12/5/2018 with sudden onset weakness and numbness and hyponatremia. Diagnosed with GBS and treated with IVIG and plasma exchange. As of 12/12/2018 pt remains hospitalized with parasthesia.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Viral infection
Clinical narrative: Patient reported increased dizziness, vertigo symptoms to her primary care provider on 11/9/2018 then presented to Emergency Room on 12/5/2018 with sudden onset weakness and numbness and hyponatremia. Diagnosed with GBS and treated with IVIG and plasma exchange. As of 12/12/2018 pt remains hospitalized with parasthesia.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeding disorder, Headache
Clinical narrative: First of all, I do not know the drug company or lot number for this vaccine that was administered. I had the vaccine about 2 pm and around midnight, I woke up with feeling weak, shivering, and chills, which seemed to go a long time. When I woke up in the morning I was very weak and had a very bad headache that was above my eyes, forehead and back of the head and neck area. This lasted all day, along with the continued weakness. I vomited two times, and could not eat, but did drink water. Then I woke up this morning with continued headache and now have a really red rash around my eyes, and on most of my face, neck, and chest. It is now 11:30 am, and finally the headache has gone away, but I still have the rash and am tired.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Vomiting
Clinical narrative: First of all, I do not know the drug company or lot number for this vaccine that was administered. I had the vaccine about 2 pm and around midnight, I woke up with feeling weak, shivering, and chills, which seemed to go a long time. When I woke up in the morning I was very weak and had a very bad headache that was above my eyes, forehead and back of the head and neck area. This lasted all day, along with the continued weakness. I vomited two times, and could not eat, but did drink water. Then I woke up this morning with continued headache and now have a really red rash around my eyes, and on most of my face, neck, and chest. It is now 11:30 am, and finally the headache has gone away, but I still have the rash and am tired.
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Agitation, Circumstance or information capable of leading to medication error, Screaming
Clinical narrative: Patient was extremely agitated. Kicking and screaming. Several people holding pt while trying to administer injection. Pt pushed injection back out of lt thigh.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Middle insomnia, Pain in extremity
Clinical narrative: Patient reported residual arm pain believed to be caused from vaccination. Pain has lasted longer than 1 month. States that the arm pain wakes her up throughout the night time. Pain resides a bit throughout the day. Has seen a doctor twice since vaccination. States she is waiting for a follow up from a specialist.
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unable to walk in a elderly male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unable to walk. On an unknown date, the outcome of the unable to walk was unknown. It was unknown if the reporter considered the unable to walk to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported the adverse event for his grandfather. The patient stated that the patient was given SHINGRIX, and since the injection, the patient had had lost the ability to walk on his own (a man who walked 2 miles a day prior to the injection). The reporter was curious if the company had any way to help them since it was this product that caused the issues. This case has been linked with case US2018GSK219943, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 20th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received both doses of SHINGRIX. Approximately 1 month after 1st dose the patient had a shingles outbreak. This was diagnosed at emergency room. This was the 4th episode of shingles the patient had experienced in her lifetime. She received her 2nd of SHINGRIX in September.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood heavy metal normal, Blood test normal, Computerised tomogram normal, Decreased appetite, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included neuropathy peripheral. Previously administered products included Shingles and SHINGRIX with an associated reaction of pyrexia (1st dose received on 16th Feberuary 2018, refer case US2018213937). On 16th April 2018, the patient received the 2nd dose of SHINGRIX. On 16th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 17th April 2018, the patient experienced nausea, lethargy and fatigue. On an unknown date, the patient experienced weight loss and appetite lost. On 17th April 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the weight loss, appetite lost, nausea, lethargy and fatigue were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, weight loss, appetite lost, nausea, lethargy and fatigue to be related to SHINGRIX. Additional details were reported as follows: A patient reported that he had already submitted to VAERS. The patient only experienced a sore arm, which resolved the next day of vaccination. The patient reported that patient only experienced a sore arm, which resolved the next day. The patient reports that the next day, he began to feel lethargic, and needed to sit for several hours. The patient then began to feel nausea and fatigue. The patient went to the doctor in May, and had blood work which was normal. The patient went to urgent care with fatigue and nausea in June, and was ordered a series of scans, including an MRI, CT scan, and lumbar puncture. All were normal. The patient saw a neurologist as well and was checked for heavy metals, which was negative. The patient still feels the symptoms and the fatigue and nausea are still present. The patient also lost 24 pounds and needs to force himself to eat 3 meals a day.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Lumbar puncture normal, Nausea, Nuclear magnetic resonance imaging normal, 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 70-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included neuropathy peripheral. Previously administered products included Shingles and SHINGRIX with an associated reaction of pyrexia (1st dose received on 16th Feberuary 2018, refer case US2018213937). On 16th April 2018, the patient received the 2nd dose of SHINGRIX. On 16th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 17th April 2018, the patient experienced nausea, lethargy and fatigue. On an unknown date, the patient experienced weight loss and appetite lost. On 17th April 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the weight loss, appetite lost, nausea, lethargy and fatigue were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, weight loss, appetite lost, nausea, lethargy and fatigue to be related to SHINGRIX. Additional details were reported as follows: A patient reported that he had already submitted to VAERS. The patient only experienced a sore arm, which resolved the next day of vaccination. The patient reported that patient only experienced a sore arm, which resolved the next day. The patient reports that the next day, he began to feel lethargic, and needed to sit for several hours. The patient then began to feel nausea and fatigue. The patient went to the doctor in May, and had blood work which was normal. The patient went to urgent care with fatigue and nausea in June, and was ordered a series of scans, including an MRI, CT scan, and lumbar puncture. All were normal. The patient saw a neurologist as well and was checked for heavy metals, which was negative. The patient still feels the symptoms and the fatigue and nausea are still present. The patient also lost 24 pounds and needs to force himself to eat 3 meals a day.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included neuropathy peripheral. Previously administered products included Shingles and SHINGRIX with an associated reaction of pyrexia (1st dose received on 16th Feberuary 2018, refer case US2018213937). On 16th April 2018, the patient received the 2nd dose of SHINGRIX. On 16th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 17th April 2018, the patient experienced nausea, lethargy and fatigue. On an unknown date, the patient experienced weight loss and appetite lost. On 17th April 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the weight loss, appetite lost, nausea, lethargy and fatigue were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, weight loss, appetite lost, nausea, lethargy and fatigue to be related to SHINGRIX. Additional details were reported as follows: A patient reported that he had already submitted to VAERS. The patient only experienced a sore arm, which resolved the next day of vaccination. The patient reported that patient only experienced a sore arm, which resolved the next day. The patient reports that the next day, he began to feel lethargic, and needed to sit for several hours. The patient then began to feel nausea and fatigue. The patient went to the doctor in May, and had blood work which was normal. The patient went to urgent care with fatigue and nausea in June, and was ordered a series of scans, including an MRI, CT scan, and lumbar puncture. All were normal. The patient saw a neurologist as well and was checked for heavy metals, which was negative. The patient still feels the symptoms and the fatigue and nausea are still present. The patient also lost 24 pounds and needs to force himself to eat 3 meals a day.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX (batch number XN24S, expiry date 29th November 2020) for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.  It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had an immediate sharp pain at the injection site after receiving a dose of SHINGRIX. The pain was still noted when the patient reaches for something or stretches her arm. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX (batch number XN24S, expiry date 29th November 2020) for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.  It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had an immediate sharp pain at the injection site after receiving a dose of SHINGRIX. The pain was still noted when the patient reaches for something or stretches her arm. The reporter consented to follow up.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A, Hepatitis A virus test positive
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis a in a 42-year-old female patient who received HAVRIX for prophylaxis. On 9th November 2018, the patient received the 1st dose of HAVRIX. On 4th December 2018, 25 days after receiving HAVRIX, the patient experienced hepatitis A. On an unknown date, the outcome of the hepatitis A was unknown. It was unknown if the reporter considered the hepatitis a to be related to HAVRIX. Additional information received as follows: On 4th December 2018, the patient was informed of a positive blood test for Hepatitis A. The reporter gave consent to follow up. The pharmacist did not have access to product details as the vaccine was administered at a different site.
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis.  On 15th November 2018, the patient received SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 16th November 2018, 1 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. The reporter considered the fever to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. About 3 weeks before the time of reporting, the patient received SHINGRIX and Flu vaccine on the same day. The fever was lasted on and off for several days. The patient required emergency room visit. The physician had other questions concerning about the SHINGRIX, so the physician was warm transferred to medical information for further information. The reporter did not give consent to follow-up.
Age: 8.0
Sex: U
Vaccine: FLUR4
Symptoms: Wrong product administered
Clinical narrative: Based on information received on 05-Dec-2018, the report previously considered as non-valid became valid: [as age of patient was updated]. Initial information received on 12-Nov-2018 regarding an unsolicited non-valid non-serious case received from a nurse. This case involves a 8 years old patient of unknown gender, he/she received vaccine FLUBLOK QIV. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were given. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was reported that multiple patients received Flublok that were under 18. Medical errors due to packaging looking similar for Fluzone and Flublok. There was no adverse reaction. 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. Follow up information received on 05-Dec-2018 regarding an unsolicited non-valid non-serious case received from a nurse. Case updated to valid as patient age was updated. Documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Initial and follow up information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse with live follow-up on same date. This case involves an eight years old female patient who received a 0.5 ml dose of MENACTRA, (lot number, expiry date, dose in series, route and site of administration was not reported) on 27-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Patient received no other vaccines concomitantly. It was a case of actual medication error due to inappropriate age at vaccine administration. 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: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Erythema, Feeling abnormal, Feeling hot, Injection site pain
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 73 years old female patient who had intermittent redness and rash on her upper chest, tightness in her neck, generalized warm sensations, tachycardia, tremors, nerve pain, heat sensation in her right eye, electrical activity in her head and soreness at the injection site, lips are tingling and so are her legs while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included hypothyroid, hand tremors, nerve pain and heat sensation in her Right eye prior to the FLUZONE HD. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 29-Nov-2018, the patient received a 0.5 ml dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (lot number: LUI981AA and expiry date: 16-Mar-2019) (dose in series and site of administration was not reported) via intramuscular route. On an unknown date, following the vaccination the patient experienced soreness at the injection site, intermittent redness and rash on her upper chest. Patient had tachycardia on Monday night. Patient had gone to see her HCP x2 since the FLUZONE HD. On an unspecified date, patient had tightness in her neck, lips are tingling and so are her legs, electrical activity in her head and generalized warm  sensations. Patient was diagnosed with hand tremors prior to the FLUZONE HD and her hand tremors seem worse now. She has had nerve pain prior to the FLUZONE HD and now that seems worse, had a heat sensation in her Right eye prior to the FLUZONE HD and that may be a little more now. (Other relevant tests included no lab data.) Final diagnosis was rash, erythema, neck tightness, feeling of warmth, tachycardia, tremor, nerve pain, warmness in eyes, head banging and vaccination site pain hand tremors, lips are tingling and so are her legs and heat sensation in her Right eye. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Neuralgia, Paraesthesia, Paraesthesia oral, Rash
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 73 years old female patient who had intermittent redness and rash on her upper chest, tightness in her neck, generalized warm sensations, tachycardia, tremors, nerve pain, heat sensation in her right eye, electrical activity in her head and soreness at the injection site, lips are tingling and so are her legs while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included hypothyroid, hand tremors, nerve pain and heat sensation in her Right eye prior to the FLUZONE HD. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 29-Nov-2018, the patient received a 0.5 ml dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (lot number: LUI981AA and expiry date: 16-Mar-2019) (dose in series and site of administration was not reported) via intramuscular route. On an unknown date, following the vaccination the patient experienced soreness at the injection site, intermittent redness and rash on her upper chest. Patient had tachycardia on Monday night. Patient had gone to see her HCP x2 since the FLUZONE HD. On an unspecified date, patient had tightness in her neck, lips are tingling and so are her legs, electrical activity in her head and generalized warm  sensations. Patient was diagnosed with hand tremors prior to the FLUZONE HD and her hand tremors seem worse now. She has had nerve pain prior to the FLUZONE HD and now that seems worse, had a heat sensation in her Right eye prior to the FLUZONE HD and that may be a little more now. (Other relevant tests included no lab data.) Final diagnosis was rash, erythema, neck tightness, feeling of warmth, tachycardia, tremor, nerve pain, warmness in eyes, head banging and vaccination site pain hand tremors, lips are tingling and so are her legs and heat sensation in her Right eye. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Tremor
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 73 years old female patient who had intermittent redness and rash on her upper chest, tightness in her neck, generalized warm sensations, tachycardia, tremors, nerve pain, heat sensation in her right eye, electrical activity in her head and soreness at the injection site, lips are tingling and so are her legs while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included hypothyroid, hand tremors, nerve pain and heat sensation in her Right eye prior to the FLUZONE HD. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 29-Nov-2018, the patient received a 0.5 ml dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (lot number: LUI981AA and expiry date: 16-Mar-2019) (dose in series and site of administration was not reported) via intramuscular route. On an unknown date, following the vaccination the patient experienced soreness at the injection site, intermittent redness and rash on her upper chest. Patient had tachycardia on Monday night. Patient had gone to see her HCP x2 since the FLUZONE HD. On an unspecified date, patient had tightness in her neck, lips are tingling and so are her legs, electrical activity in her head and generalized warm  sensations. Patient was diagnosed with hand tremors prior to the FLUZONE HD and her hand tremors seem worse now. She has had nerve pain prior to the FLUZONE HD and now that seems worse, had a heat sensation in her Right eye prior to the FLUZONE HD and that may be a little more now. (Other relevant tests included no lab data.) Final diagnosis was rash, erythema, neck tightness, feeling of warmth, tachycardia, tremor, nerve pain, warmness in eyes, head banging and vaccination site pain hand tremors, lips are tingling and so are her legs and heat sensation in her Right eye. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from health professional. This case involves a male patient (age at time of reporting was 13 months old) who was vaccinated with QUADRACEL at 04th month of age (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. At two months of age patient had received his first DAPTACEL at 2 months and PENTACEL at 6 months. It was an actual medication error due to Inappropriate schedule of vaccine administered & Inappropriate age at vaccine administration. It was unknown if patient had adverse event. 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: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional and an additional information was received on 05-Dec-2018 from the same reporter. This case was linked with 2018SA336905 (same reporter). This case involves a 54 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (lot UJ046AB) in the shoulder nos. on an unknown date at 07:42 AM (reported as yesterday) that was exposed to 11 F. 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 product storage error and deteriorated drug administered. It was not reported if the patient experienced 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: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two months old male patient who was vaccinated with a dose of 0.5 ml expired vaccine ACT-HIB (powder expired) lot UI820AA and Exp. Date 18 Nov 2018(for powder) via intramuscular route in the left thigh on 06-Dec-2018. It was reported that, Diluent lot U5962AA and Exp. date: 05 Jan 2019. The patients medical history not reported and concomitant medications included PREVNAR 13; ROTATEQ; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and POLIO VACCINE INACT (IPV) for Immunization. It was an actual medication error case due to expired vaccine used. It was unknown whether the patient experienced any adverse event. 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: 67.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 67 years old male patient who received vaccines ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE HIGH DOSE for Immunisation. On an unknown date, the patient received 0.5 mL dose of suspect ADACEL lot U6128AA, expiry date: 20-NOV-2020 in the right arm. On an unknown date, the patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6014AB, expiry date: 20-JUL-2020 via intramuscular route in the right deltoid. It was a case of actual medication error due to extra dose administered. It was reported that 67 years old male who received ADACEL & TENIVAC vaccination due to a misunderstanding by the MA for routine Tetanus and Diphtheria vaccination. Both were given in the same arm. It was unknown if any adverse event was 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 and Module VI of the 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.
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a six months old female patient who was vaccinated with a 0.5 ml third dose of vaccine PENTACEL (lot C5408AB and Exp. Date 06-OCT-2019) via intramuscular route in the left thigh on 04-Dec-2018. The patients' medical history not reported and concomitant vaccinations included PREVNAR and Rotavirus Vaccine for Immunization on 04-Dec-2018. It was reported that, the patient was accidentally injected with the DTAP/IVP liquid portion of the dose to the patient, however did not mix in the powder portion of the ACTHIB portion of the injection. It was an actual medication error case due to inappropriate reconstitution technique. There was no Adverse event noted at the time of the event. 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: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-NOV-2018, the patient was vaccinated with expired dose of VAQTA (dose, units and frequency unknown) (lot # N028743 and expiration date 23-NOV-2018). No symptoms were reported. No product quality issue (PQC) was present. This is one of the several reports received from same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of back pain in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received original shingles virus vaccine two years or more before the date of reporting). On 26th October 2018, the patient received the 1st dose of SHINGRIX. In November 2018, 30 days after receiving SHINGRIX, the patient experienced back pain, muscle pain and general body pain. On an unknown date, the outcome of the back pain, muscle pain and general body pain were recovering/resolving. It was unknown if the reporter considered the back pain, muscle pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The reporter asked Could he or she be suffering from a side effect one month after receiving vaccine. For the past week from the date of reporting, the patient experienced severe lower back pain, left side muscle pain, whole back pain, not as severe and other numerous body aches and pains which started about the same time. A day or two before the date of reporting, the events started getting slightly better.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis.  On 27th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and myalgia. The patient was treated with analgesic, NOS. On an unknown date, the outcome of the injection site pain and myalgia were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient reported pain at injection site and on the same day the patient reported pain in right arm (injection arm) as her arm hurts bad and myalgia. The reporter wanted to know the side effects of SHINGRIX vaccine. The reporter confirmed she had taken an analgesic for the pain and referred her to the health care professional for additional medical advice and questions.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad experience after vaccination. The patient was unable to get out of bed for 2 days each time. Felt like the flu or something. The patient said that if she knew it would be that bad she would have been better off getting shingles. The patient's physician was charging  her a lot of money, The patient wanted to know was there any reimbursement or he would be going public about this.