chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a five months old male patient and reported that 5 months, received 0.25 ml of FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Sep-2018, the patient received a 0.25 ml dose of suspect FLUZONE QUADRIVALENT (lot number: UT6262MA and expiry date: 30-June-2019) (dose in series was not reported) via intramuscular route in the left thigh. This was the case of actual medication error due to inappropriate age at vaccine administration. No reported symptoms. 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. List of documents held by sender: none.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four months old male patient who was vaccinated with a 0.5 ml third dose of PENTACEL (lot number: C5408AA (liquid) (lot number: C5543AA) (cartoon); expiry date:08-Sep-2019) (route of administration was not reported) in the left thigh on 13-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients concomitant medications included ROTATEQ for Immunisation; and PREVNAR 13 for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse reactions have been reported. 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: 61.0
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Vaccinated on 9/18/2018 and on 9/20/2018 reports that the injection area is red, warm, no itchiness, hardening. Referred to doctor.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever and swelling at injection site.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Haemorrhage, Injection site bruising
Clinical narrative: Patient presented with a bruising at injection site. She said the injection felt different than it normally has felt in the past. She said she felt as if she could feel the vaccine being injected. Her bleeding was more than normal and the pharmacist had to put on several band aids to stop the bleeding.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Headache, Injection site pain, Malaise, Myalgia
Clinical narrative: High fever, chills, malaise, headache, muscle aches, injection site soreness.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pyrexia
Clinical narrative: High fever, chills, malaise, headache, muscle aches, injection site soreness.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient received the vaccine in the Right Arm on Monday. On Tuesday, patient developed a rash on his right arm that spread to his right trunk area.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Injection site swelling and redness continues to expand, mild muscle tenderness and pain at the injection site is about the same - it improves slightly for about an hour with application of a cooling muscle rub. Arm hurts to lift or flex.
Age: 91.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red rash ocurred. Visiting nurse outlined with a pen and it grew larger the next day.
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Adverse reaction included redness, warmth, and pain at site. Treatment alternate OTC TYLENOL and MOTRIN use cold compresses to alleviate pain and warmth.
Age: 33.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received ZPSTAVAX, should have received VARIVAX per patient age and request - needed 2 shot series to immunize against chicken pox for school requirements.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt reported rash around injection site which has progressively gotten better.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Mild Localized reaction to the right thigh at injection site.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Injection site bruising, Injection site erythema, Pyrexia
Clinical narrative: Fever of 102.9 started on 9/19/18; Bruising and redness at injection site (Left thigh); Still having fever of 102.4 as of 9/20/18.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Noticed redness/swelling to injection site; went away with no type of treatment.
Age: 53.0
Sex: M
Vaccine: FLUC4, PPV, TDAP
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Pain
Clinical narrative: Patient called pharmacy specifying that as of 9/19/18 he has dizziness, headaches, body aches, shivers and shortness of breath. We recommended a doctor visit.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt thigh swelling, redness and warm.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccine at 10 AM on 9/20/18. Began to experience itching at site at 1:30 PM and by 2:00 PM injection site was swollen, red and warm. Sent to the ED for further evaluation and treatment.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Low grade fever (99.5-100.5), headache, nausea, fatigue, sore and swollen arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Low grade fever (99.5-100.5), headache, nausea, fatigue, sore and swollen arm.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Large red painful rash. Appeared night after injection and was large for 24 hours then began to subside. Patient took antihistamines and ibuprofen and used a cold compress.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swollen red arm.
Age: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Patient reported ringing in ears following her immunization.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Musculoskeletal pain
Clinical narrative: Extreme fatigue for 36 hours after inoculation. Shoulder soreness for 24 hours. Upper arm redness for four days.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Arthropod bite, Injection site erythema, Injection site pain, Injection site warmth, Scab
Clinical narrative: Right shoulder erythematous, TTP, warm down to elbow, a few crusted insect bites on right back and right arm, tiny pustule at site of vaccine administration, no fluctuance.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Vaccination site pustule
Clinical narrative: Right shoulder erythematous, TTP, warm down to elbow, a few crusted insect bites on right back and right arm, tiny pustule at site of vaccine administration, no fluctuance.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 18-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 13-DEC-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other related complications. On or about 07-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 27-JUN-2008,  the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 16-NOV-2016, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: Arm is beat red, had high fever for 24 hours, red arm does not hurt, just red.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash, Vaccination site rash
Clinical narrative: Small outbreak of a rash on the child's Right Thigh at vaccination site, side of face (left), both arms towards the wrist, on upper chest and lower back.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Feeling cold, Headache, Myalgia
Clinical narrative: Headache, fatigue, muscle aches, diahrrea, chills.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Pyrexia
Clinical narrative: Chills - Fever.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: Hives - 10 welts developed over 24 hours - 4 on right side of face (under eye, jaw, neck and ear), 2 on right arm, 1 on left arm, 3 on left thigh. Several hours apart from 7:30 AM 9/19 - 7:30 AM 9/20. Large raised circular red welts ranging from size of a dime-quarter. Eye and neck 7:30 AM at home. Jaw- 11 AM; right arm - 1 PM; left thigh 3 PM and 6 PM; left arm 10 PM; right ear 7 AM. Treated with hydro-cortisone (6 PM 9/29) and ALLEGRA (9:30 AM 9/20).
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage, approximately 8 weeks pregnant.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood folate normal, Blood heavy metal normal, Blood thyroid stimulating hormone normal, Burning sensation, Condition aggravated
Clinical narrative: Metallic taste in mouth, facial and eye burning, facial flushing, fatigue worse.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysgeusia, Epstein-Barr virus test negative, Eye burns, Fatigue, Flushing
Clinical narrative: Metallic taste in mouth, facial and eye burning, facial flushing, fatigue worse.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count normal, Laboratory test normal, Metabolic function test normal, Vitamin B12 normal
Clinical narrative: Metallic taste in mouth, facial and eye burning, facial flushing, fatigue worse.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient stated he developed rashes around groin area on the same day - Sep 19th (about 4 hours later after getting flu vaccination). He started to take BENADRYL 1 tablet every 4 to 6 hours for rash. And next morning (on 9/20), pt developed more rashes on different areas (on armpits). Per patient, BENADRYL has been helping rashes, but not cleared completely yet. Patient has been receiving flu shot every year (except last year), he is not allergic to eggs. He has finished taking antibiotics (BACTRIM DS) about 2 days before getting vaccinations and had CAT SCAN.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Pain
Clinical narrative: Full body aches, chills, weakness, fatigue.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Decreased appetite, Influenza virus test negative, Irritability, Pyrexia, Urine odour abnormal
Clinical narrative: Mom called and reported that child had loss of appetite and irritable within a couple of hours after receiving the HIB vaccine 0n 9-11-18. Mom called today (9-20-18) because she had to pick up child at daycare with a fever of 102.4. Child was seen at Pediatrics and was tested negative for flu. Mom reports that fever has gone down after TYLENOL but child is lethargic. Mom also reports that child's urine has a strong odor. Mom told me that the Dr. she saw today at Peds told her that reactions usually occur with a couple of days but Mom is still concerned because she thought it was her first dose of HIB. I, told Mom that according to our records she had previously had a first dose of HIB. I instructed Mom to take child to ER if fever spikes again.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: Upper arm red and swollen, some pain, no treatment, 3 days. Right shin and ankle pink and itchy on 4th day, became a rash on shin. Treated with Clobetasol, moisturizing cream. Itch stopped in one day, rash gradually disappeared. About 4 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Musculoskeletal chest pain, Myalgia, Nausea
Clinical narrative: Patient reports having pain around right rib cage, emanating from spine, vertigo, nausea, headache, joint pain and muscle soreness beginning a few hours after vaccine and continuing for about 36 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain, Vertigo
Clinical narrative: Patient reports having pain around right rib cage, emanating from spine, vertigo, nausea, headache, joint pain and muscle soreness beginning a few hours after vaccine and continuing for about 36 hours.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Muscle aches and pains, headache, weakness, dizziness, fever, chills.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle aches and pains, headache, weakness, dizziness, fever, chills.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Facial pain, Rash
Clinical narrative: Rash covering chest and pain in the face.
Age: 22.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyspnoea, Headache, Throat tightness
Clinical narrative: 9/18/18, approximately 4:45 PM: vaccine administered; approximately 11 PM: pulsing headache, throat tightening, difficulty breathing. Patient reports not taking any medication for the issues, nor seeking medical attention. He went to bed, slept soundly, and woke up about 10 AM on 9/19/18. He came to pharmacy where vaccination given at 2:30 PM on 9/19/18 reporting these issues. Patient's head felt better, but his throat still felt "funny," like it was slightly closing in. Patient drove self to pharmacy and felt well enough to drive back home, so didn't want any treatment in store. He was given diphenhydramine and instructed to take 50 mg upon arriving home and repeat in 4 hours. He was instructed to go to the emergency room if he had difficulty breathing again. At about 4:20 PM, pharmacist called patient's grandparents' home (where patient was staying at the time) to check on patient; patient's grandfather reported patient said he felt fine and had been napping.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Myalgia, Pain
Clinical narrative: Soreness for one day. Joint and muscle aches and pains throughout body, shivers and fever Day following injection. Redness at injection site for one week.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness for one day. Joint and muscle aches and pains throughout body, shivers and fever Day following injection. Redness at injection site for one week.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red swollen and hot.
Age: 33.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site paraesthesia, Malaise, Paraesthesia, Peripheral coldness, Swelling
Clinical narrative: Due to known allergy to eggs, patient was offered the egg-free recombinant vaccine, FLUBLOK. Despite having an egg-free vaccine, patient had tingling in the entire arm down to the fingers and up to her neck on the side of the injection. This occurred within minutes of the vaccination. She also began to feel swollen in her neck and had some tingling in the other arm after a few minutes. Provider examined her and found that her hands were cold, but no other significant issues. Patient then took 50 mg of BENADRYL. Patient rested reclined for several minutes, but was talking. Patient reports that she was later was referred by provider to go to the ER since she was still not feeling well. Patient reports that she received epinephrine in the ER, and received prescriptions for Hydroxyzine and Prednisone.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dry skin, Injection site indentation, Injection site reaction, Pallor
Clinical narrative: Patient stated when she removed her bandage later on the day she received the vaccine, the skin was white and felt "rough" to touch. She denied any unusual pain, fever, swelling, or redness. She said the white patch has gotten bigger since Sunday and it appeared to me to be depressed. She has received the flu shot previously and never had a reaction. She received a PNEUMOVAX in her right arm on the same day and had no local reaction. I advised her to seek medical attention from her physician as soon as possible since I was unfamiliar with this kind of skin reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient reported small rash spots around both upper arms/chest/shoulder.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: No rash or blisters BUT extreme pain to the touch around my whole midriff; doctors described it as shingles like symptoms and I am still suffering although with my new medication IT IS BETTER.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Crying, Decreased appetite, Ear pain, Headache, Oropharyngeal pain
Clinical narrative: On 9-18-18 client was seen in clinic and given IPV & Hib on the R thigh. Client's mother called on 9-20-18 to report the child has had fever X2day ranging between 100- 102, she has been giving the child TYLENOL q3hr. Mother stated child has also not wanted to eat, and has had soar throat, headache, and ear pain, has been laying around crying. Clinic Nurse advise mother to take child into the ER to have a doctor evaluate her, and to follow the TYLENOL guidelines of q4hr, unless otherwise told by a doctor.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: On 9-18-18 client was seen in clinic and given IPV & Hib on the R thigh. Client's mother called on 9-20-18 to report the child has had fever X2day ranging between 100- 102, she has been giving the child TYLENOL q3hr. Mother stated child has also not wanted to eat, and has had soar throat, headache, and ear pain, has been laying around crying. Clinic Nurse advise mother to take child into the ER to have a doctor evaluate her, and to follow the TYLENOL guidelines of q4hr, unless otherwise told by a doctor.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Patient reported tingling in the vaccinated arm that would come and go. She states this did not happen in the other arm and began day of injection. The arm tingling has since resolved. Patient is now feeling tingling in her legs. The feeling comes and goes and alternates legs. She reports no muscle involvement or loss of function.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Alien limb syndrome, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Evaluated by Dr. on 9/20/18, determined patient was experiencing Alien Hand Syndrome (AHS). Physician associated disorder with previous influenza immunization, FLUZONE QUAD. Patients symptoms are subsiding at present time.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Migraine, Urticaria
Clinical narrative: Patient's sister reported patient was experiencing shortness of breath, hives, and severe migraines within an hour and a half of receiving the vaccine. Patient was admitted to the emergency room for treatment shortly after and was discharged that same evening. It should be noted that the patient had taken her initial dose of MACROBID during the period between receiving the vaccine and developing symptoms. The MACROBID was new for the patient. Upon followup the next day, the patient had recovered but was still experiencing some migraines, though not as severe.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: Chills & fever, exhausted - slept from 11pm - 1pm next day (14hrs). Felt much better upon waking.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site erythema, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Patient states intermittent fevers and body aches and pains starting to occur Tuesday morning and most pronounced by noon-time 9/18. States intermittent fevers lasted throughout Wed. night 9/19 and reported to be as high as 104 degrees F. She was sick enough with body aches and pains and high fever to miss work for three days. No fever reported 9/20 but patient was still taking TYLENOL for a sore arm. She had erythema surrounding the site of injection as well as projecting down her left deltoid, but not expandiing past the elbow joint. It was warm to the touch and possibly slightly raised.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient states intermittent fevers and body aches and pains starting to occur Tuesday morning and most pronounced by noon-time 9/18. States intermittent fevers lasted throughout Wed. night 9/19 and reported to be as high as 104 degrees F. She was sick enough with body aches and pains and high fever to miss work for three days. No fever reported 9/20 but patient was still taking TYLENOL for a sore arm. She had erythema surrounding the site of injection as well as projecting down her left deltoid, but not expandiing past the elbow joint. It was warm to the touch and possibly slightly raised.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Oedema
Clinical narrative: Headache, watery diarrhea, constant nausea, fever, severe fatigue, sneezing, clear runny nose, edema, itching, hives on torso.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Pyrexia, Rhinorrhoea, Sneezing, Urticaria
Clinical narrative: Headache, watery diarrhea, constant nausea, fever, severe fatigue, sneezing, clear runny nose, edema, itching, hives on torso.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm
Clinical narrative: Pt stated his arm was painful, red and hot starting the day after vaccination and Dr. confirmed cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Pt stated that her husband had a bad reaction to the flu shot and he went to the Dr. the Dr. confirmed cellulitis and asked to see her arm as well. Dr. then told her she also had cellulitis and gave oral and topical antibiotic.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Pt came to pharmacy and said she was experiencing pain and rash at injection site so pharmacist on duty recommended BENADRYL and ibuprofen over the counter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Discomfort, Fatigue
Clinical narrative: Pt became nauseaus around 7:00p on 9/18/18 and had a lighter than normal dinner because she was not hungry. Around 9pm she began feeling more tired than normal and had difficulty falling asleep because she felt uncomfortable. Around midnight she began experiencing full body aches and joint pain followed by shivering/shaking around 2am. She slept all morning and felt better around 1pm 9/19/18. She did take ibuprofen 200mg 1 tablet at 2am 9/18/18, 8am 9/19/18 and 1pm 9/19/18. Pt did not see a physician.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Pain, Tremor
Clinical narrative: Pt became nauseaus around 7:00p on 9/18/18 and had a lighter than normal dinner because she was not hungry. Around 9pm she began feeling more tired than normal and had difficulty falling asleep because she felt uncomfortable. Around midnight she began experiencing full body aches and joint pain followed by shivering/shaking around 2am. She slept all morning and felt better around 1pm 9/19/18. She did take ibuprofen 200mg 1 tablet at 2am 9/18/18, 8am 9/19/18 and 1pm 9/19/18. Pt did not see a physician.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral coldness, Urticaria
Clinical narrative: Pt has a quarter-sized welt. Pink, upraised. Cool to touch. Advised ice and BENADRYL and monitoring. Asked to verify allergies equals none. Asked if had flu vaccines in past equals yes.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: The next day after the vaccination I felt fluish. A lot of pain at the injection site. I could barely move arm. I was slightly dizzy, very tired, weak, slightly nauseous and a nagging headache. These symptoms were pronounced for 2 days and lessened on the 3rd and 4th days. I felt poorly for 4 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site pain, Mobility decreased, Nausea
Clinical narrative: The next day after the vaccination I felt fluish. A lot of pain at the injection site. I could barely move arm. I was slightly dizzy, very tired, weak, slightly nauseous and a nagging headache. These symptoms were pronounced for 2 days and lessened on the 3rd and 4th days. I felt poorly for 4 days.
Age: 63.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Pyrexia
Clinical narrative: By patient's request both vaccines were given on left deltoid. After vaccines were given patient reported a fever of 101.5 F and felt better the day after without any treatment.
Age: 71.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pruritus, Swelling, Vaccination site induration
Clinical narrative: Developed swelling and redness with itching next day of vaccinations. Seen on 6th day, now red erythema on Left arm 8x5 cm and induration 4.5x3cm at the vaccination site. Advised to apply ice, Ibuprofen 3 times daily and CLARITIN daily x 1 week.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Pt said he felt really sick and ended up in emergency room. He is better now, but just wanted to bring it under our attention.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine given before it was due. Dose #1 given 7/9/18. Dose #2 given 8/7/18. Dose #3 given 9/20/18.
Age: 65.0
Sex: M
Vaccine: FLUR4, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: (L) arm swelling, redness, pain and itching.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. reports localized red, swollen, raised, warm and tender arm at injection site. Pt. took oral BENADRYL and all improved but kept returning. Tenderness and warmth w/low gr. fever (100) at time of 2nd visit, treated for mild cellulitis w/BACTRIM po and ZYRTEC po.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient saw doctor 9 days after administration with sore arm. Dr told her the vaccine was administered too high up on arm.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin reaction
Clinical narrative: PNEUMOVAX 23 and FLUZONE HIGH DOSE were administered on 9/19/2018 on the same arm at 2 different injection sites separated about 1 inch apart. Patient came back on 9/20/2018 and her whole arm was red and swollen.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Injection site pain, Myalgia
Clinical narrative: 9/19/18 early AM (less than 24 hours after immunization)=soreness at site, chills, muscle aches, diaphoretic and severe headache.
Age: 1.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: To my knowledge there was no adverse effect on this patient. She was 28weeks gestation and delivered at 38weeks gestation a 5lb, 11.5oz baby boy.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Delivery, Exposure during pregnancy, No adverse event
Clinical narrative: To my knowledge there was no adverse effect on this patient. She was 28weeks gestation and delivered at 38weeks gestation a 5lb, 11.5oz baby boy.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Accidental exposure to product, Delivery, Exposure during pregnancy
Clinical narrative: To my knowledge there was no adverse effect on this patient. She was 28weeks gestation and delivered at 38weeks gestation a 5lb, 11.5oz baby boy.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash maculo-papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 81-year-old male patient who received Shingrix (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 4th June 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced papular rash. Shingrix was discontinued. On an unknown date, the outcome of the papular rash was recovering/resolving. It was unknown if the reporter considered the papular rash to be related to Shingrix. Additional details were provided as follows: The patient emailed the pictures of a reaction that he experienced on Shingrix. As per the pharmacist from the pictures it looked like a macropapular rash on his chest, left arm and right arm. The patient required a visit to his dermatologist. The only time pharmacist saw the patient was on 2nd September 2018 and patient was recovering. The patient had been advised to not get the 2nd shot of the Shingrix vaccine.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash maculo-papular, Rash papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 81-year-old male patient who received Shingrix (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 4th June 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced papular rash. Shingrix was discontinued. On an unknown date, the outcome of the papular rash was recovering/resolving. It was unknown if the reporter considered the papular rash to be related to Shingrix. Additional details were provided as follows: The patient emailed the pictures of a reaction that he experienced on Shingrix. As per the pharmacist from the pictures it looked like a macropapular rash on his chest, left arm and right arm. The patient required a visit to his dermatologist. The only time pharmacist saw the patient was on 2nd September 2018 and patient was recovering. The patient had been advised to not get the 2nd shot of the Shingrix vaccine.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 25th July 2018 11:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on right deltoid. After receiving the vaccination, within 2 days the patient experienced shingles. The patient saw his primary care physician and it was confirmed that he had shingles. The patient was treated with valacyclovir for approximately one week. It was reported that, the shingles was lasted for four weeks.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 25th July 2018 11:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on right deltoid. After receiving the vaccination, within 2 days the patient experienced shingles. The patient saw his primary care physician and it was confirmed that he had shingles. The patient was treated with valacyclovir for approximately one week. It was reported that, the shingles was lasted for four weeks.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Feeling abnormal, Myalgia, Ocular hyperaemia, Oropharyngeal pain, Pyrexia
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid serious case received from other health professional. This case involves a 59 years old female patient who experienced anaphylactic reaction with blood shot weeping eyes and flu like syndrome, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLU VACCINE with she stated that she has been receiving the flu vaccine for over thirty years. The patient's past medical history, medical treatment(s) and family history were not provided. On 06-Sep-2018 at 12:45 PM, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI996AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a serious anaphylactic reaction with blood shot weeping eyes with the symptoms shortness of breath, throat swelling, heart rate of 125 with hypertension and fever, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. On 06-Sep-2018 at 05:00 PM, the patient developed a non-serious flu like syndrome with the symptoms of red eyes and sore throat, four hours 15-minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant laboratory tests were not reported. Final diagnosis was flu like syndrome and anaphylactic reaction with blood shot weeping eyes. The patient was treated with PREDNISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC) and ONDANSETRON HYDROCHLORIDE (ZOFRAN). On an unknown date, the patient was recovered from the events. Documents held by sender: none.; Sender's Comments: This case involves a 59 years old patient who presented with anaphylactic reaction with blood shot weeping eyes and flu like syndrome post vaccination with FLUZONE QUADRIVALENT. Time to onset is unknown for anaphylactic reaction. Anaphylactic reaction and flu like syndrome are expected after FLUZONE vaccination. However, addition information including patient's medical history, medical condition at the time of vaccination, allergic history, previous vaccination and its tolerance and laboratory investigations excluding other etiology are needed to fully assess this case. Based on available information role of a vaccine cannot be assessed.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Hypertension, Influenza like illness, Lacrimation increased
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid serious case received from other health professional. This case involves a 59 years old female patient who experienced anaphylactic reaction with blood shot weeping eyes and flu like syndrome, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLU VACCINE with she stated that she has been receiving the flu vaccine for over thirty years. The patient's past medical history, medical treatment(s) and family history were not provided. On 06-Sep-2018 at 12:45 PM, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI996AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a serious anaphylactic reaction with blood shot weeping eyes with the symptoms shortness of breath, throat swelling, heart rate of 125 with hypertension and fever, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. On 06-Sep-2018 at 05:00 PM, the patient developed a non-serious flu like syndrome with the symptoms of red eyes and sore throat, four hours 15-minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant laboratory tests were not reported. Final diagnosis was flu like syndrome and anaphylactic reaction with blood shot weeping eyes. The patient was treated with PREDNISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC) and ONDANSETRON HYDROCHLORIDE (ZOFRAN). On an unknown date, the patient was recovered from the events. Documents held by sender: none.; Sender's Comments: This case involves a 59 years old patient who presented with anaphylactic reaction with blood shot weeping eyes and flu like syndrome post vaccination with FLUZONE QUADRIVALENT. Time to onset is unknown for anaphylactic reaction. Anaphylactic reaction and flu like syndrome are expected after FLUZONE vaccination. However, addition information including patient's medical history, medical condition at the time of vaccination, allergic history, previous vaccination and its tolerance and laboratory investigations excluding other etiology are needed to fully assess this case. Based on available information role of a vaccine cannot be assessed.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid serious case received from other health professional. This case involves a 59 years old female patient who experienced anaphylactic reaction with blood shot weeping eyes and flu like syndrome, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLU VACCINE with she stated that she has been receiving the flu vaccine for over thirty years. The patient's past medical history, medical treatment(s) and family history were not provided. On 06-Sep-2018 at 12:45 PM, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI996AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a serious anaphylactic reaction with blood shot weeping eyes with the symptoms shortness of breath, throat swelling, heart rate of 125 with hypertension and fever, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. On 06-Sep-2018 at 05:00 PM, the patient developed a non-serious flu like syndrome with the symptoms of red eyes and sore throat, four hours 15-minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant laboratory tests were not reported. Final diagnosis was flu like syndrome and anaphylactic reaction with blood shot weeping eyes. The patient was treated with PREDNISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC) and ONDANSETRON HYDROCHLORIDE (ZOFRAN). On an unknown date, the patient was recovered from the events. Documents held by sender: none.; Sender's Comments: This case involves a 59 years old patient who presented with anaphylactic reaction with blood shot weeping eyes and flu like syndrome post vaccination with FLUZONE QUADRIVALENT. Time to onset is unknown for anaphylactic reaction. Anaphylactic reaction and flu like syndrome are expected after FLUZONE vaccination. However, addition information including patient's medical history, medical condition at the time of vaccination, allergic history, previous vaccination and its tolerance and laboratory investigations excluding other etiology are needed to fully assess this case. Based on available information role of a vaccine cannot be assessed.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date unknown) for prophylaxis. On 19th June 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than 3 months after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient developed a rash. The patient went to the doctor office and was told the rash probably happened due to the SHINGRIX. The rash resolved in couple weeks. The rash was on the patient's abdomen.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Breast pain, Chills, Decreased appetite, Differential white blood cell count
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 2nd dose of SHINGRIX. On 7th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On 8th September 2018, 2 days after receiving SHINGRIX, the patient experienced swelling, erythema and skin warm. In September 2018, several days after receiving SHINGRIX, the patient experienced fever, axillary lump and chills. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant) and fatigue. The patient was treated with Amoxicillin. On an unknown date, the outcome of the cellulitis was unknown and the outcome of the pain, swelling, axillary lump, chills, fatigue, erythema and skin warm were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the cellulitis, pain, swelling, fever, axillary lump, chills, fatigue, erythema and skin warm to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The patient experienced knot under her arm. The patient was prescribed Amoxicillin by the primary care physician (PCP) for possible cellulitis after observation.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 2nd dose of SHINGRIX. On 7th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On 8th September 2018, 2 days after receiving SHINGRIX, the patient experienced swelling, erythema and skin warm. In September 2018, several days after receiving SHINGRIX, the patient experienced fever, axillary lump and chills. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant) and fatigue. The patient was treated with Amoxicillin. On an unknown date, the outcome of the cellulitis was unknown and the outcome of the pain, swelling, axillary lump, chills, fatigue, erythema and skin warm were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the cellulitis, pain, swelling, fever, axillary lump, chills, fatigue, erythema and skin warm to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The patient experienced knot under her arm. The patient was prescribed Amoxicillin by the primary care physician (PCP) for possible cellulitis after observation.