chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Next day arm was swollen/red/itchy, Pt went to Dr who said it was a local skin reaction because the site was only the injection arm, received an antibiotic cephalexin and few days later swelling went down and pt said only still a little itchy.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Erythema, Local reaction, Peripheral swelling, Pruritus
Clinical narrative: Next day arm was swollen/red/itchy, Pt went to Dr who said it was a local skin reaction because the site was only the injection arm, received an antibiotic cephalexin and few days later swelling went down and pt said only still a little itchy.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Ear pain, Gingival bleeding, Head banging, Irritability, Mouth ulceration
Clinical narrative: Had high fever of 104 for 6 consecutive days. Then the fever subsided followed by head banging, ear and neck pain, heavily bleeding gums, cold sores and mouth ulcers. Crankiness and fussiness with hitting her head on the floor.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Oral herpes, Pyrexia
Clinical narrative: Had high fever of 104 for 6 consecutive days. Then the fever subsided followed by head banging, ear and neck pain, heavily bleeding gums, cold sores and mouth ulcers. Crankiness and fussiness with hitting her head on the floor.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Fever, nausea, trembling.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Middle insomnia, Myalgia
Clinical narrative: Approximately 10 hrs after injection, woke-up with significant aching muscle pain in hips/groin, shoulders, elbows and wrists. Was unable to go back to sleep until after 1000mg tylenol  took effect. Muscle aches continued throughout the day on 11/4, and continue now on 11/5. Pain is managed alternating 1000mg tylenol and 500mg ibuprofen. Continuing ADLs, but with some discomfort.
Age: 16.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events. Patient was administered wrong vaccination for age.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-OCT-2018 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot# N001007 and expiration date 19-SEP-2018) (dose, units, route and frequency unknown. No adverse effects were reported.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via company employee and refers to a 17-year-old male patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not reported. On 03-OCT-2018, the patient was vaccinated with first dose of GARDASIL 9 lot # R001263, expiration date 10-NOV-2020 (dose, route of administration were not reported) for prevention of human papilloma virus (hpv). On the same day, the patient experienced an episode of syncope while being at the office. No treatment was given for the adverse event. The outcome of the event was reported as recovered on an unknown date in October 2018. The relatedness between the event and GARDASIL 9 was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 18-OCT-2018, the patient inadvertently received an expired dose of PNEUMOVAX 23 (strength, dose and route of administration were not provided) (lot # M039060 and expiration date: 22-MAY-2018) for prophylaxis (expired product administered). No adverse effects were reported. The medical assistant enquired when the patient could be revaccinated. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a 32 years old female social worker referring to herself. The patient had no concurrent condition, pertinent medical history, drug reactions/allergies or concomitant medication. On an unknown date the patient was vaccinated with an unspecified number of M-M-R II (strength, dose, frequency, route, lot # and expiration date were not reported) for routine vaccination. On an unknown date in September 2018 (reported as last month), the patient's blood work result stated she did not have immunity to measles. It also reported that the patient didn't have lab diagnostics/studies performed. She didn't seek medical attention. No treatment was given to the patient. The outcome of therapy was reported as not recovered. The causality between the event and suspected therapy was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Eye injury, Herpes zoster, Herpes zoster oticus, Ophthalmic herpes zoster, Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a physician, recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about OCTOBER 2007, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) (by an unspecified healthcare provider/professional). The patient was inoculated with the ZOSTAVAX to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 20-JUL-2008, the patient was treated by a physician and also by another physician (ophthalmologist) for shingles on the face, scalp, ear, and eye and other zoster related vision and eye injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the 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 (not further specified); lost wages; loss of earnings capacity; and other losses and damages as a result of shingles and other zoster-related injuries. The outcome of the events was considered to be not recovered. Upon internal review, the event of Shingles on eye and other zoster related vision and eye injuries was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender.The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 08-SEP-2016, 20-MAR-2017 and 13-AUG-2018 the patient received the three GARDASIL 9 or GARDASIL because it was unknown which vaccine was administered (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. On 26-OCT-2018, the patient was vaccinated with GARDASIL 9 as a fourth dose after 3 previous HPV vaccinations. No adverse effects were reported
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-OCT-2018, the patient was vaccinated with a dose of VARIVAX (lot # N017394, expiration date: 07-JUN-2019) and PROQUAD (lot # R006218, expiration date: 28-AUG-2019) (dose and route of administration were not provided for both) for prophylaxis which was considered to be an medication error. Both vaccines were reconstituted with a sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, past drug reactions, allergies, and medical history were not provided. The patient's concomitant therapies included sterile diluent. On 26-OCT-2018, the patient was vaccinated with an improperly stored dose of PROQUAD reported lot number R012416, expiration date: 28-OCT-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -9 Celsius degrees to 8 Celsius degrees (-6.09 Celsius (C)) for 1 hour and 36 minutes as recorded by a data logger. The vaccines had not had any previous temperature excursions. There were no adverse effects reported. No product quality complaint was filed. Sender's Comments: US-009507513-1811USA001081.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 30-OCT-2018, the pharmacist inadvertently administered to the patient a dose of M-M-R II intramuscularly rather than subcutaneously, for prophylaxis (strength, lot 3 and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-OCT-2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a health care provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about October 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about an unknown date later in 2013, 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 the 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 4 month old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 31-OCT-2018 the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # R007986, expiration date 13-OCT-2019, for prophylaxis (strength, dose, and frequency were not reported). The temperature excursion was of 9 Centigrade degrees (°C) (9°C to 25°C), during 20 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 29 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On unknown dates, (reported as "when she was a child"), the patient received two doses of M-M-R II as vaccination (strengths, doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported). On an unknown date, an unspecified test was performed and showed low titers. The outcome of the patient's antibody test negative and its causal relationship between therapy with M-M-R II were not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history and concurrent conditions. Concomitant therapies included sterile diluent. On 01-NOV-2018, the patient was vaccinated with improperly stored PROQUAD lot # R013127 (expiration date: 04-NOV-2019) for prophylaxis (strength, dose, frequency, route of administration were not reported). Temperature excursion was 15°F to 46°F and time frame was approximately 5 hours and 55 minutes, as recorded by a data logger. No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, past drug reactions, allergies, and medical history were not provided. The patient's concomitant therapies included sterile diluent. On 28-OCT-2018, the patient was vaccinated with an improperly stored dose of PROQUAD reported lot number R012415, expiration date 28-OCT-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -9 Celsius degrees to 8 Celsius degrees (-6.09 Celsius (C)) for 1 hour and 36 minutes as recorded by a data logger. The vaccines had not had any previous temperature excursions. There were no adverse effects reported. No product quality complaint was filed. Sender's Comments: US-009507513-1810USA013853.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Hypoaesthesia, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Localized swelling and soreness at injection site. Headache began at noon on Sunday, aches and fever began around 4pm Sunday. Discovered purple ring around injection site around 5pm and redness extending through shoulder and bicep. Took TYLENOL. Sunday evening and morning was experiencing numbness in my fingertips and left hand. Stiff/swollen/sore shoulder, stiff elbow, stiff hands, and headache continue as of 11/5/2018 8:45am.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Musculoskeletal pain, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Localized swelling and soreness at injection site. Headache began at noon on Sunday, aches and fever began around 4pm Sunday. Discovered purple ring around injection site around 5pm and redness extending through shoulder and bicep. Took TYLENOL. Sunday evening and morning was experiencing numbness in my fingertips and left hand. Stiff/swollen/sore shoulder, stiff elbow, stiff hands, and headache continue as of 11/5/2018 8:45am.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Localized swelling and soreness at injection site. Headache began at noon on Sunday, aches and fever began around 4pm Sunday. Discovered purple ring around injection site around 5pm and redness extending through shoulder and bicep. Took TYLENOL. Sunday evening and morning was experiencing numbness in my fingertips and left hand. Stiff/swollen/sore shoulder, stiff elbow, stiff hands, and headache continue as of 11/5/2018 8:45am.
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Limb discomfort, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: Arm soreness/ pain did not go away after 1 week. Arm swollen, weak, difficult to raise arm.
Age: 47.0
Sex: F
Vaccine: ANTH, IPV, MMR, TYP
Symptoms: Antibody test, Pyrexia, Swelling face, Vaccination site pain
Clinical narrative: Patient states that she reported to a emergency room with a fever, jaw line swelling and soreness at the vaccine site.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain in extremity, Post herpetic neuralgia, Rash pustular
Clinical narrative: ...ABOUT 10 DAYS AFTER INJECTION SITE SORENESS &  MILD "FLU-LIKE" SYMPTOMS, VERY SEVERE RIGHT LEG PAIN (SCIATIC NERVE DISTRIBUTION) BEGAN. I HAVE NEEDED HIGH DOSES OF TYLENOL & IBUPROFEN TO  KEEP ME FUNCTIONAL. MY INTERNIST THINKS IT IS VERY MUCH LIKE "POST-HERPETIC NEURALGIA, BUT WITH ONLY A FEW POX-LIKE SKIN ERUPTIONS IN THE SCIATIC NERVE AREA. THE PAIN CONTINUES NOW INTO THE 3RD MONTH POST SHINGRIX. PEOPLE SHOULD BE WARNED THAT THIS CAN HAPPEN...
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram head, Facial paralysis
Clinical narrative: Bells Palsy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received vaccines on 10/31 and mom notice on 11/1 that patient had redness and swelling on left lateral upper arm. Patient was seen by MD on 11/2 and MD prescribed Diphenhydramine 12.5 mg (Hcl 12.5 mg/5ml) every 6 hours as needed.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient was given the influenza vaccine subcutaneously instead of intramuscularly. The patient experienced a localized swelling (up to golf ball sized), redness, and tenderness to touch. This condition self-resolved over the next 48 hours. The patient did not require any hospitalization or further interventions.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Stated she has fainted in the past after getting an injection. Immediately after receiving flu vaccine, patient fainted. Remained in chair. Feet were elevated. Patient responded in less than 40 seconds. Remained seated for 15 minutes. Was alert and cooperative.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Pt had tingling going down to her fingers.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Computerised tomogram thorax abnormal, Hyperhidrosis, Hypersomnia, Injection site pain
Clinical narrative: Besides the normal pain at injection site I began shivering badly at 5 am on Nov 1st (shot taken Oct 31st 12 noon. slept most of day heavy sweating. woke at 3pm shivering badly. Went to emergency Dept. Chest CT with contrast showed lymph nodes in arm pits right axilla to be 3.6X1.5X1.7 cm in size. left armpit and throat lymph's were only slightly swollen.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Scan with contrast abnormal
Clinical narrative: Besides the normal pain at injection site I began shivering badly at 5 am on Nov 1st (shot taken Oct 31st 12 noon. slept most of day heavy sweating. woke at 3pm shivering badly. Went to emergency Dept. Chest CT with contrast showed lymph nodes in arm pits right axilla to be 3.6X1.5X1.7 cm in size. left armpit and throat lymph's were only slightly swollen.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient reported to corporate that she could not lift her arm above her shoulder.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site infection
Clinical narrative: PATIENT HAD A YELLOWISH/GREY AREA ON THE RIGHT DELTOID MUSCLE WHERE THE SHOT WAS ADMINISTERED. SHE WENT TO SEE HER PCP ABOUT THE REACTION WHO ORDERED AN ANTIBIOTIC KEFLEX AND PREDNISONE.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Infection, Pain, Skin warm
Clinical narrative: Patient said warm pain infection Dr called in Keflex.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Approximately 4 hrs. after the injections started to get chills and a fever that went up 102.9. This lasted approximately 5 hours.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Approximately 4 hrs. after the injections started to get chills and a fever that went up 102.9. This lasted approximately 5 hours.
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, Swelling, Tenderness, Local Temperature elevation, Bruising at the injection site.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Pruritus, Rash pruritic, Urticaria
Clinical narrative: Face, neck and chest had raised, itchy rash for 3 days. The rest of my body was itchy as well, but did not have a visible rash. 1 hive on left knee area. Headache x 3 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: After waiting 10 minutes in the exam room after immunizations were administered, patient and mother left to schedule a follow up appointment. Upon reaching the front desk patient passed out once and regained consciousness, patient proceeded to take a seat and passed out one more time. Patient regained consciousness 1-2 minutes after passing out. Doctor examined her and patient was advised to sit in lobby for 10 minutes and if she did not pass out again she could leave. Patient proceeded to leave after 10 minutes.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Haemorrhage, Skin mass
Clinical narrative: Patient arm bleed more that usual for her (reported by patient) and a knot appeared under the skin.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms including sweatiness, chills, nausea, headache for 6 hours.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Diarrhoea, Fatigue, Muscular weakness, Nausea
Clinical narrative: Weakness in arms and hands (first symptom). Mild weakness in feet. Fatigue/Exhaustion. Jaw pain. Diarrhea. Nausea. Cold sweats.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in jaw
Clinical narrative: Weakness in arms and hands (first symptom). Mild weakness in feet. Fatigue/Exhaustion. Jaw pain. Diarrhea. Nausea. Cold sweats.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram, Blood test, Eyelid ptosis, Mydriasis, Nuclear magnetic resonance imaging
Clinical narrative: Drooping of left eyelid and mild pupil dialation. Mild swelling on left cheek around orbit and below.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Ophthalmological examination, Periorbital swelling, Swelling face
Clinical narrative: Drooping of left eyelid and mild pupil dialation. Mild swelling on left cheek around orbit and below.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated he typically runs fever after flu vaccine. Morning after his arm was very sore and became red and swollen.  Second day after since it was no better, he decided to go to urgent care to have it checked. Received rx for Keflex as precaution.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: 6 days after both the 1st dose (given in May) and after the 2nd dose I developed hives that spread very rapidly. In May they lasted  2 days. They just started (following the 2nd dose) today. I have never had hives except these two times.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Urticaria, Vaccine positive rechallenge
Clinical narrative: 6 days after both the 1st dose (given in May) and after the 2nd dose I developed hives that spread very rapidly. In May they lasted  2 days. They just started (following the 2nd dose) today. I have never had hives except these two times.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Burning sensation, Neuralgia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Pt. states she had nerve pain following injection. Unsure when it started but it did cause her to "go to the hospital doctor" who told her it was not an allergic reaction but a neuropathy. Patient pointed to right forearm when asked the location of the pain. She decribed it as burning and tingling and lasted "about a week."
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Radiculopathy, Spinal myelogram normal
Clinical narrative: Severe neck pain with features of radiculopathy in the L side, seen in office on 10/23/18; ED visit 10/22/18 for the same symptoms.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Lymph node pain
Clinical narrative: Red, warm, swollen and very itchy at site. 11/3/18 I noticed the Lymph node in my right armpit was swollen, sore and painful to touch. Swelling at site of injection went down by 11/4/18 and Lymph node in right armpit is still swollen and painful to touch.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Red, warm, swollen and very itchy at site. 11/3/18 I noticed the Lymph node in my right armpit was swollen, sore and painful to touch. Swelling at site of injection went down by 11/4/18 and Lymph node in right armpit is still swollen and painful to touch.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt had vaccine 10/31/18 on 11/01/18 seen at office for c/o redness, warmth, tender to touch at injection site, had not taken anything for reaction or pain per pt.  Area measures 2.5 cm x 1.25 cm slight raised patch of erythema.  Instructed to use ice on the area, can take Benadryl and should call if noting any worsening ssx.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Condition aggravated, Dermatitis atopic, Eczema, Peripheral swelling
Clinical narrative: According to the Urgent Doctor, I had an adverse reaction to the flu shot given on 11/1 which activated my eczema which in turn I developed a topical dermatitis. I developed rash on my back, cheeks, hands, arms, and thighs. It was itchy, red and angry. My face and right hand only swelled up. I was prescribed 7 days of oral pill Prednisone.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic, Swelling face
Clinical narrative: According to the Urgent Doctor, I had an adverse reaction to the flu shot given on 11/1 which activated my eczema which in turn I developed a topical dermatitis. I developed rash on my back, cheeks, hands, arms, and thighs. It was itchy, red and angry. My face and right hand only swelled up. I was prescribed 7 days of oral pill Prednisone.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Explorative laparotomy, Internal hernia, Intestinal obstruction, Lethargy, Postoperative adhesion
Clinical narrative: Starting at midnight 2 days after vaccines he developed progressive vomiting which became bilious and associated lethargy.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Starting at midnight 2 days after vaccines he developed progressive vomiting which became bilious and associated lethargy.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2015, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 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 the 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 19-NOV-2014, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-OCT-2015, the patient was treated by a health care provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Discomfort, Headache, Infection
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves adult male patient who experienced feeling unwell, infection NOS and a swollen lymph node located around the right axillary, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a dose of suspect INFLUENZA VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in right arm. On an unknown date, patient developed a non-serious feeling unwell unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious infection NOS unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious a swollen lymph node located around the right axillary unknown latency following the administration of INFLUENZA VACCINE. Both happened in the same arm (right arm). On an unknown date, patient developed a non-serious a little bit of pain where I received the vaccine unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious feeling weak unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious discomfort unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious fever unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious back pain unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious headache unknown latency following the administration of INFLUENZA VACCINE. Final diagnosis was a swollen lymph node located around the right axillary, infection NOS and feeling unwell, little bit of pain where I received the vaccine, feeling weak, discomfort, fever, back pain, headache. Lab data was not reported. The patient was treated with oral antibiotics of CLEOCIN HCL 300 mg. The event were resolving at the time of reporting. List of documents held by sender: none. Follow up information received on 22-Oct-2018. Event was updated. Site and side of administration of vaccine was updated. Event details was updated. Corrective treatment was updated.
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Lymphadenopathy, Malaise
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves adult male patient who experienced feeling unwell, infection NOS and a swollen lymph node located around the right axillary, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a dose of suspect INFLUENZA VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in right arm. On an unknown date, patient developed a non-serious feeling unwell unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious infection NOS unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious a swollen lymph node located around the right axillary unknown latency following the administration of INFLUENZA VACCINE. Both happened in the same arm (right arm). On an unknown date, patient developed a non-serious a little bit of pain where I received the vaccine unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious feeling weak unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious discomfort unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious fever unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious back pain unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious headache unknown latency following the administration of INFLUENZA VACCINE. Final diagnosis was a swollen lymph node located around the right axillary, infection NOS and feeling unwell, little bit of pain where I received the vaccine, feeling weak, discomfort, fever, back pain, headache. Lab data was not reported. The patient was treated with oral antibiotics of CLEOCIN HCL 300 mg. The event were resolving at the time of reporting. List of documents held by sender: none. Follow up information received on 22-Oct-2018. Event was updated. Site and side of administration of vaccine was updated. Event details was updated. Corrective treatment was updated.
Sex: M
Vaccine: FLU3
Symptoms: Product distribution issue, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299809, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299814, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 65 years old male patient (height: 75, weight: 225) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no 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: F
Vaccine: FLU3
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299809, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 72 years old female patient (height: 63, weight: 185 lbs) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no 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: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 45 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI998AD, expiration date: 30-Jun-2019, route: intramuscular and site of administration: left deltoid) on 29-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (Fluzone Quad MDV left at room temperature over the weekend). It was accidentally given to a patient this morning. It was unknown whether patient experienced any adverse event following vaccination. 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: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 85 years old female patient who experienced extensive pain in the arm and unable to raise her arm or dress herself, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered. On 01-Oct-2018, the patient received a once 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AB; expiration date- 05-May-2019 via intramuscular route in the left deltoid. On an unknown date patient developed a non-serious extensive pain in the arm  and was unable to raise her arm  or dress herself following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also reported there was no swelling or redness at the injection site. (Other relevant tests included No lab test.) Final diagnosis was unable to raise her arm or dress herself and extensive pain in the arm.  It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for extensive pain in the arm and as Unknown for unable to raise her arm.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four residents of nursing facility received expired doses of vaccine FLUZONE HIGH DOSE (expiration date: April 2018, batch number, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used (four residents of nursing facility received expired doses of Fluzone High dose). It was unknown whether patient experienced any adverse event following vaccination. 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.