chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Flank pain, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: "Starting at 8:00pm same evening start felt like getting fever and developed some redness inch or 2 below injection site.  Drank glass of water every hour during night because so thirsty. Arm was aching underneath, couldn't raise arm and hurt down my side. Following day stayed in bed due to not feeling well. Nausea, slight headache, "just didn't feel good". Saturday morning still not better so went to urgent care and was told that her arm looked like it was cellulitis developing in arm. Was told very angry and red and having a bad reaction. given Prednisone but pt never took medication.  Today, 4/22/19, redness gone, no fever but still feels weak and feels groggy. "
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: "Starting at 8:00pm same evening start felt like getting fever and developed some redness inch or 2 below injection site.  Drank glass of water every hour during night because so thirsty. Arm was aching underneath, couldn't raise arm and hurt down my side. Following day stayed in bed due to not feeling well. Nausea, slight headache, "just didn't feel good". Saturday morning still not better so went to urgent care and was told that her arm looked like it was cellulitis developing in arm. Was told very angry and red and having a bad reaction. given Prednisone but pt never took medication.  Today, 4/22/19, redness gone, no fever but still feels weak and feels groggy. "
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Thirst
Clinical narrative: "Starting at 8:00pm same evening start felt like getting fever and developed some redness inch or 2 below injection site.  Drank glass of water every hour during night because so thirsty. Arm was aching underneath, couldn't raise arm and hurt down my side. Following day stayed in bed due to not feeling well. Nausea, slight headache, "just didn't feel good". Saturday morning still not better so went to urgent care and was told that her arm looked like it was cellulitis developing in arm. Was told very angry and red and having a bad reaction. given Prednisone but pt never took medication.  Today, 4/22/19, redness gone, no fever but still feels weak and feels groggy. "
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Local reaction, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Seen at Clinic on 4-20-19 (L) arm with induration approximately 4 cm below the vaccination site- surrounding erythema approximately 6 cm around site, right arm with induration about 2 cm below vaccination site, erythema about 2 cm around site, both areas red to touch.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Injection site erythema, Injection site pain, Injection site warmth, Metabolic function test normal
Clinical narrative: Redness, pain, warmth and swelling in L upper arm adjacent to injection site. Starting the day after administration, worsening, seen in ED on 4/21/2019 and started on Bactrim for concern of cellulitis. Returned to ED on 4/22/2019 for further eval.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Ultrasound scan
Clinical narrative: Redness, pain, warmth and swelling in L upper arm adjacent to injection site. Starting the day after administration, worsening, seen in ED on 4/21/2019 and started on Bactrim for concern of cellulitis. Returned to ED on 4/22/2019 for further eval.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). In September 2018, less than a year after receiving SHINGRIX, the patient experienced myalgia, fatigue and fever. On an unknown date, the outcome of the myalgia, fatigue and fever were recovered/resolved. It was unknown if the reporter considered the myalgia, fatigue and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The medical assistant had the patient that experienced myalgia, fever and fatigue. This occurred in September 2018, however, the vaccination date was unknown. The reactions resolved within 2-3 days. No additional details were available regarding dose number in the series. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Fatigue, Malaise, Pharyngitis, Rhinorrhoea
Clinical narrative: Pharyngitis, Enlarged Sub mandibular Salivary Glands, Rhinorrhea, Cough, Generalized Fatigue and Malaise
Age: 76.0
Sex: F
Vaccine: MMR
Symptoms: Sialoadenitis
Clinical narrative: Pharyngitis, Enlarged Sub mandibular Salivary Glands, Rhinorrhea, Cough, Generalized Fatigue and Malaise
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error
Clinical narrative: No concerns noted after the injection. Mom informed today of the of medication error. She denies concerns or side effects from the immunization.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Dizziness, Injection site erythema, Injection site mass
Clinical narrative: Day 1: erythema, tenderness, lump at injection site x 1 week w/ rash. Diameter of circular rash: 2.5cm. Day 2-day 5: general malaise, weakness, dizziness. Day 3: diarrhea through day 5.  Increased aches & pains. Symptoms started to decrease after day 5. Took TYLENOL arthritis 1300 mg. day 2-6 for some relief.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Malaise, Pain
Clinical narrative: Day 1: erythema, tenderness, lump at injection site x 1 week w/ rash. Diameter of circular rash: 2.5cm. Day 2-day 5: general malaise, weakness, dizziness. Day 3: diarrhea through day 5.  Increased aches & pains. Symptoms started to decrease after day 5. Took TYLENOL arthritis 1300 mg. day 2-6 for some relief.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site swelling, Skin discolouration, Tenderness
Clinical narrative: SHINGRIX received. 24 hours later patient noticed approx. 3in by 3in "bump" on portion of arm where vaccine was received. No itching and cool to the touch. Over night redness was gone and turned purple. Pt took ibuprofen 800 mg every 8 hours after 3 days bruise-like bump seemed to be healing. No longer purple but still tender on day 7.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Rash papular
Clinical narrative: Pt came in on 04/22/2019 with a bumpy rash on his left thigh and states he had this since Friday 04/19/2019 an hour after of vaccine. Informed pt we would get with provider and give her a call as soon as we are told what needs to get done.
Age: 40.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Limb discomfort, Pruritus
Clinical narrative: Rash around the  injection site extends down half way to the elbow. Painful  and warm to touch, sore arm. Itchy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Increased  redness and bruising to injection site (Right thigh)
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Swelling of the face started late Friday after dose was given, approximately 6-8 hours later. Swelling of face persisted still on Monday.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Peripheral swelling
Clinical narrative: Patients arm was swollen and couldn't move arm. Patient reported she couldn't move shoulder and her fingers were swollen. MD office prescribed 3 day course of Prednisone 10mg. I spoke to staff at presrcibers office and stated that patient took benadryl and felt better.
Age: 35.0
Sex: F
Vaccine: CHOL, FLUC4, HEPA
Symptoms: Dizziness, Hyperhidrosis, Insomnia, Malaise, Nausea
Clinical narrative: Difficulty sleeping.  General feeling of being unwell.  Morning 04/22/2019 5 am to 6 am drenched in sweat, nausea, vomiting and lightheadedness.
Age: 35.0
Sex: F
Vaccine: CHOL, FLUC4, HEPA
Symptoms: Vomiting
Clinical narrative: Difficulty sleeping.  General feeling of being unwell.  Morning 04/22/2019 5 am to 6 am drenched in sweat, nausea, vomiting and lightheadedness.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Joint range of motion decreased, Musculoskeletal pain, Pain, Product administered at inappropriate site
Clinical narrative: Patient had considerable pain on left shoulder and could not sleep. He had difficulty with the range of motion as well. He said the injection was given too high in the arm almost at the shoulder level. Patient had to go to urgent care due to pain and was told to apply ice and take Ibuprofen.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Symptoms are patient reported. Mother reports rash consistent with chickenpox comprised of 8 discrete lesions on the right upper trunk, neck and face. The rash occurred days after receiving vaccine and resolved completely by today.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site bruising, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient had severe right arm pain that significantly limited her ability to use her arm and had a very large bruise at the site of injection that took about 3 weeks to resolve.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria, Vertigo
Clinical narrative: SEVERE VERTIGO 6 DAYS POST VACCINATION; HIVES 8 DAYS POST VACCINATION.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Redness, painful, large parameter below the vaccine area.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymerase chain reaction, Varicella, Varicella virus test negative
Clinical narrative: Chicken pox.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Lethargy, Myalgia
Clinical narrative: Patient reports having flu-like symptoms (myalgia & lethargy) for approximately 5-6 days following vaccination. Patient received booster dose on 4/22/19 at same facility.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported that she developed a slight case of shingles approximately 4 weeks after receiving SHINGRIX dose #1. She stated she contacted her physician and was prescribed a course of "an antiviral".
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyskinesia, Presyncope
Clinical narrative: Pt. jerked arm while giving SHINGRIX, resulted in partial administration of vaccine and had to be re-administered after 7 days. Patient also felt dizzy afterwards and suffered near-syncopal event.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Irritability, Pyrexia, Rash generalised, Respiratory tract congestion
Clinical narrative: High fever irritability. Fever got worse. Called doctor. Doctor said no worries. She got worse. Took her to walk in clinic. They said to see her doctor if it hasn?t improved as they saw no reasons why she was ill. Started having a cough and congestion Saturday the 20th. Had a rash all over her belly, back and privates the 21st.  Rash spread to face, neck, and legs on the 22nd. Called to request follow up appointment today. They will see her tomorrow.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Peripheral swelling
Clinical narrative: Received SHINGRIX 50 mg/0.5 m injection on Tues. April 2. Arm swelled and hurt right away. Came down with shingles April 6, 2019. Saw dermatologist April 8, 2019 who confirmed shingles. The new SHINGRIX 50mg/0.5 m injection was to prevent shingles. I came down with shingles 5 days later and had to be treated with Valacyclovir by dermatologist.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Sleep disorder, Swelling face
Clinical narrative: Patient got the first SHINGRIX vaccine and reports swelling on the left side of the face 24 hours after injection (also on the left side). Patient took BENADRYL and iced that side of her face to help with the swelling. Reports swelling has gone down 48 hours post injection but it is still there. Also took ADVIL 48 hours post injection (uses for arthritis as needed). Does not reports a rash, difficulty breathing, swelling of the tongue or throat. Her sleep has been disrupted as she was anxious about something happening to her at night. Did not go to urgent care or ER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Asthenia, Chills, Diarrhoea
Clinical narrative: Thought it would be useful to report these side effects from the second SHINGRIX shot, which surprised me by being worse than the first. The first time I just felt pain and swelling at the site and headache-y and tired. After the second shot, I also had flu-like symptoms: generalized muscle aches, extreme tiredness/weakness, belly pain, diarrhea, headache, upset stomach, chills. Worst of the symptoms passed after about 24 hours. Received the shot on April 18.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Thought it would be useful to report these side effects from the second SHINGRIX shot, which surprised me by being worse than the first. The first time I just felt pain and swelling at the site and headache-y and tired. After the second shot, I also had flu-like symptoms: generalized muscle aches, extreme tiredness/weakness, belly pain, diarrhea, headache, upset stomach, chills. Worst of the symptoms passed after about 24 hours. Received the shot on April 18.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Dizziness, Headache, Influenza like illness, Injection site swelling
Clinical narrative: Fever, vomiting, dehydration, flu-like muscle pain, headache, dizziness, swelling of upper (L) arm and pain.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, dehydration, flu-like muscle pain, headache, dizziness, swelling of upper (L) arm and pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema 4 inches around injection site along with swelling and warmth.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever (102), chills, headache, severe arm pain and erythema at site.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Oedema
Clinical narrative: Redness, swelling & pain @ RUE extends from top of shoulder down to just above the elbow. Ultrasound to rule out cellulitis or abcess. Mild subcutaneous edema & discomfort. Tx: cold compress & otc pain relievers. No underlying fluid collection.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan
Clinical narrative: Redness, swelling & pain @ RUE extends from top of shoulder down to just above the elbow. Ultrasound to rule out cellulitis or abcess. Mild subcutaneous edema & discomfort. Tx: cold compress & otc pain relievers. No underlying fluid collection.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Muscle rigidity, Pallor, Seizure
Clinical narrative: Mom states when driving home, child was white and rigid. Mom took child to hospital was told child had seizure.
Age: 33.0
Sex: F
Vaccine: FLUC4, HEP, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: c/o pain warm to touch ichchy, redness, raised at he varicella site that started n two days
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Mouth gums became red + sensitive, Got worse next day. Then, some sores erupted. Then entire lower gums burst into puss/white blisters. Saw doc + she gave me Valacyclovir 500 mg.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gingival blister, Gingival erythema, Gingival pain, Noninfective gingivitis, Rash pustular
Clinical narrative: Mouth gums became red + sensitive, Got worse next day. Then, some sores erupted. Then entire lower gums burst into puss/white blisters. Saw doc + she gave me Valacyclovir 500 mg.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Left under arm pain hours after vaccine, then 2 weeks later pain in right arm and now uppers arms and forearms as well.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Axillary pain, Injection site pain, Pain in extremity
Clinical narrative: Left under arm pain hours after vaccine, then 2 weeks later pain in right arm and now uppers arms and forearms as well.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Inflammation, Injection site pain, Joint noise, Muscle tightness
Clinical narrative: Left under arm pain hours after vaccine, then 2 weeks later pain in right arm and now uppers arms and forearms as well.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Myalgia, Neck pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Left under arm pain hours after vaccine, then 2 weeks later pain in right arm and now uppers arms and forearms as well.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Poor quality sleep, Rheumatoid arthritis, Rotator cuff syndrome, Sjogren's syndrome
Clinical narrative: Left under arm pain hours after vaccine, then 2 weeks later pain in right arm and now uppers arms and forearms as well.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Spinal X-ray, Ultrasound scan, X-ray limb normal
Clinical narrative: Left under arm pain hours after vaccine, then 2 weeks later pain in right arm and now uppers arms and forearms as well.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: 1 month after the initial vaccine I came down with a mild case of shingles - I read the adverse effects and this was not one that was stated.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: Received vaccine approximately 3:15pm on 4/19/2019 and was extremely tired at dinner at 7:30pm with left arm sore, Woke up next day at 7:30am 4/20/2019 with headache, extremely sore arm, shivering, muscle aches on entire body, cough, and difficulty breathing. I could not perform any activities of daily living and went back to bed. Slept all day, woke for 2 hours and went back to bed until 7:00am the next morning. Felt better this morning 4/21 but not 100% until morning of 4/22.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain in extremity, Somnolence
Clinical narrative: Received vaccine approximately 3:15pm on 4/19/2019 and was extremely tired at dinner at 7:30pm with left arm sore, Woke up next day at 7:30am 4/20/2019 with headache, extremely sore arm, shivering, muscle aches on entire body, cough, and difficulty breathing. I could not perform any activities of daily living and went back to bed. Slept all day, woke for 2 hours and went back to bed until 7:00am the next morning. Felt better this morning 4/21 but not 100% until morning of 4/22.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: Severe headache, fatigue, body ache, muscle pain, soreness at injection site - lasting 24 hour.
Age: 0.0
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; dose of Rotateq was administered to 2 week old unspecified patient; This spontaneous report was received from a registered nurse and refers to a 2-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-MAR-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose, orally for prophylaxis (lot # and expiration date were not reported.) It was reported, that there was no product confusion. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; 12 month old pitent was administered a properly stored but expired dose of VAQTA; Information has been received from a medical assistant referring to a 12-month-old patient (gender unknown).  Information about concurrent condition, concomitant medication and medical history was not provided.  On 02-APR-2019, the patient was vaccinated with a properly stored but expired dose of hepatitis A vaccine, inactivated (VAQTA) (lot # R010368, expired date: 25-MAR-2019) (strength and route were not reported) for prophylaxis. No adverse events reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness and swelling at the injection site; pain, redness and swelling at the injection site; pain, redness and swelling at the injection site; used for COPD; This spontaneous report was received from an adult male pharmacist in mid of his 50 years referring to himself. Information about medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose detail, lot # and expiration date were not reported), intramuscularly for COPD (chronic obstructive pulmonary disease) (product use in unapproved indication). On unknown dates, the patient experienced pain, redness and swelling at the injection site following the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of pain, redness and swelling at the injection site was reported as recovered. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Lump in the area they received the vaccine; swollen arm; the patients complain of hot to the touch in the area they received the vaccine; painful in the area they received the vaccine; red in the area they received the vaccine; is the patient pregnant: yes; This spontaneous report was received from a physician's officer manager and refers to three female patients of unknown age. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported.   On unknown date in April 2019, the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R033079 with expiration date on 06-JUN-2020 for prophylaxis (strength, dose #, anatomical site and route of administration were not provided).   On unknown date in April 2019, the patients called the doctor's office complaining of swollen arm (peripheral swelling), red (injection site erythema), hot to the touch (injection site warmth), painful (injection site pain) and lump (injection site mass) in the area they received the vaccine. The office manger stated that the physician had requested a lot check.  It was reported that the patients were pregnant (exposure during pregnancy). Neither the patients' date of last menstrual period nor the due date were specified at the moment of this report.  No information regarding the pregnancy (outcome pending) and fetal outcome was provided. The outcome of peripheral swelling, injection site erythema, injection site warmth, injection site pain and injection site mass were not reported.   The relatedness between the adverse events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided by the reported.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Lump in the area they received the vaccine; swollen arm; the patients complain of hot to the touch in the area they received the vaccine; painful in the area they received the vaccine; red in the area they received the vaccine; is the patient pregnant: yes; This spontaneous report was received from a physician's officer manager and refers to three female patients of unknown age. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported.   On unknown date in April 2019, the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R033079 with expiration date on 06-JUN-2020 for prophylaxis (strength, dose #, anatomical site and route of administration were not provided).   On unknown date in April 2019, the patients called the doctor's office complaining of swollen arm (peripheral swelling), red (injection site erythema), hot to the touch (injection site warmth), painful (injection site pain) and lump (injection site mass) in the area they received the vaccine. The office manger stated that the physician had requested a lot check.  It was reported that the patients were pregnant (exposure during pregnancy). Neither the patients' date of last menstrual period nor the due date were specified at the moment of this report.  No information regarding the pregnancy (outcome pending) and fetal outcome was provided. The outcome of peripheral swelling, injection site erythema, injection site warmth, injection site pain and injection site mass were not reported.   The relatedness between the adverse events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided by the reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye pain, Headache, Herpes ophthalmic, Herpes zoster
Clinical narrative: This spontaneous report was received from the consumer's husband and refers to a 64 year old female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date in approximately 2017 (reported as 2 years ago), the patient was vaccinated with zoster vaccine live (manufacture unknown) for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). On 10-APR-2019 (reported as two days ago), the patient developed shingles (Herpes ophthalmic). It was reported that within the last two days, the patient experienced, very hard and difficult headache, running into the top of her left eye. Patient also felt a knot come above her head and it was inflamed red. The patient's physician stated that there was a possibility that patient could lose her vision. The patient sought for medical attention. The outcome of herpes ophthalmic was unknown. At the time of the report, the causality between the aforementioned events and zoster vaccine live (manufacture unknown) was not provided. Upon internal review the event Herpes ophthalmic was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Nodule
Clinical narrative: This spontaneous report was received from the consumer's husband and refers to a 64 year old female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date in approximately 2017 (reported as 2 years ago), the patient was vaccinated with zoster vaccine live (manufacture unknown) for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). On 10-APR-2019 (reported as two days ago), the patient developed shingles (Herpes ophthalmic). It was reported that within the last two days, the patient experienced, very hard and difficult headache, running into the top of her left eye. Patient also felt a knot come above her head and it was inflamed red. The patient's physician stated that there was a possibility that patient could lose her vision. The patient sought for medical attention. The outcome of herpes ophthalmic was unknown. At the time of the report, the causality between the aforementioned events and zoster vaccine live (manufacture unknown) was not provided. Upon internal review the event Herpes ophthalmic was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No adverse effects noted; expired dose was administered to one patient; This spontaneous report was received from a nurse and refers to a 12 month old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 15-APR-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA ) intramuscularly, lot # R010369, expiration date 25-MAR-2019 (vaccination site and dose were not provided), for prophylaxis.
Sex: U
Vaccine: RV5
Symptoms: Exposure via skin contact, No adverse event
Clinical narrative: "dribbled some of the vaccine onto chin"; No adveser effects; This spontaneous report has been received from a nurse referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported.      On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral (indication, strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. During administration "dribbled some of the vaccine onto chin". No adverse effects were reported.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern, referring to a 16 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On 02-OCT-2018, the patient received the first dose of GARDASIL 9 lot # R010596 (expiration date: 11-DEC-2020) for prophylaxis (strength, frequency and route of administration were not reported). Then on 30-MAR-2019, approximately 6 months apart from the first dose the patient received the second of GARDASIL 9, for prophylaxis (strength, frequency, route of administration, lot number and expiration date were not reported)(inappropriate schedule of vaccine administered). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist (the patient's father) referring to a female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date the patient started having rashes (described as "generalized, all over her body"). It could not be further clarified when this event occurred relative to the patient's vaccine GARDASIL 9 dosing schedule. It was unknown if treatment was given or lab diagnostics/studies were performed. The patient sought medical attention. The outcome of rash generalised was unknown. The causality assessment was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects reported; inadverently administered an expired dose of MMRII; This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. The patient's medical history, concurrent conditions, drug allergies or reactions and concomitant therapies were not reported. On 17-APR-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expired product administered) therapy type as rHA (recombinant human albumin), lot # N009799, expiration date 24-MAR-2019 via a subcutaneous route(dose, dose number were not provided) for prophylaxis. There were no adverse effects. There were no temperature excursion. The outcome of expired product administered and no adverse event were unknown.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 15 year old female patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date in November 2017, 15-SEP-2018 and 29-OCT-2018, the patient was vaccinated with GARDASIL 9 injection, an received 3 doses via intramuscular route (strength, lot # and expiry date unspecified) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Cellulitis, Condition aggravated, Deafness neurosensory, Vertigo
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was received regarding medical history, concurrent conditions, or concomitant medications. On or around 15-APR-2013, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered exacerbation of congestive heart failure, cellulitis, vertigo, and sensorineural hearing loss. As a direct and proximate of the Company's defective ZOSTAVAX vaccine, the patient's symptoms resulted in physical limitations not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not resolved. Causality assessment was related. The lawyer considered exacerbation of congestive heart failure, cellulitis, vertigo, and sensorineural hearing loss to be disabling. Upon internal review, exacerbation of congestive heart failure, cellulitis, and sensorineural hearing loss were considered to be medically significant events. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EFFECT; the patient was administered an expired dose of MMR II; This spontaneous report was received from physician assistant regarding a patient of unknown demographics.  There was no information regarding concurrent condition, pertinent medical history and drug allergies or reactions.     On 18-APR-2019, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N009800, expiration date: 24-MAR-2019, subcutaneous for prophylaxis (expired product administered). Concomitant therapies included sterile diluent. No adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Oral herpes
Clinical narrative: fever blisters; This spontaneous report was received from a pharmacist refers to a 56 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 07-FEB-2019 (Thursday), the patient was vaccinated pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route of administration not given) (lot# R018735 and expiry date: 06-APR-2020) for an prophylaxis. On the same day, the patient was also vaccinated with some flu vaccine (details unspecified). On 08-FEB-2019 (Friday), the patient experienced reaction which was fever blister on her mouth which she had never before. The outcome of the event fever blister was unknown. The reporter considered fever blister to be not related with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the flu vaccine. The reporter further added that the patient had never received (PREVNAR 13) and it was that topical cream which caused the fever blisters.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: patient received an expired VARIVAX; This spontaneous report was received from a nurse regarding a 4-year-old female (child) patient. There was no information about concomitant medication, pertinent medical history and drug allergies or reactions.   On 17-APR-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot# unknown) which got expired on 16-APR-2019 for prophylaxis (expired product administered).
Sex: U
Vaccine: FLU4
Symptoms: Drug hypersensitivity
Clinical narrative: drug allergy; This case was reported by a physician via other manufacturer and described the occurrence of drug allergy in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown.   It was unknown if the reporter considered the drug allergy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by the physician who prescribed the suspect product.  The age at vaccination was not reported. The patient had a drug allergy to Adhesive contact dermatitis, Codeine,  Fish derived products, Peanut containing drug products, Ppd tuberculin purified protein derivative, Shellfish derived products, Gabapentin, Influenza Vaccine Split Quad, Latex, Methadone, Other, Ace Inhibitors and Bactrim.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Burning sensation, Chills, Decreased appetite, Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 59-year-old female patient who received SHINGRIX (batch number GG2GA, expiry date 16th April 2021) for prophylaxis. Concurrent medical conditions included diabetes. On 16th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced shivering, gastrointestinal upset, injection site erythema, burning sensation, increased skin sensitivity, pain localized, tiredness, appetite lost and lymph node tenderness. On an unknown date, the outcome of the shivering, gastrointestinal upset, injection site erythema, burning sensation, increased skin sensitivity, pain localized, tiredness, appetite lost and lymph node tenderness were recovered/resolved. It was unknown if the reporter considered the shivering, gastrointestinal upset, injection site erythema, burning sensation, increased skin sensitivity, pain localized, tiredness, appetite lost and lymph node tenderness to be related to SHINGRIX. Additional deails were reported as follows: The patient received SHINGRIX vaccine on left arm. In 2019, the patient experienced shivering, upset stomach, injection site redness, burning and sensitive skin at the waist, pain at the waist, tender lymph glands under the arms, loss of appetite and tiredness after receiving SHINGRIX vaccine. The patient reported that she was seen by a physician because of these issues, but they resolved one month after receiving the vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site erythema, Lymph node pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 59-year-old female patient who received SHINGRIX (batch number GG2GA, expiry date 16th April 2021) for prophylaxis. Concurrent medical conditions included diabetes. On 16th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced shivering, gastrointestinal upset, injection site erythema, burning sensation, increased skin sensitivity, pain localized, tiredness, appetite lost and lymph node tenderness. On an unknown date, the outcome of the shivering, gastrointestinal upset, injection site erythema, burning sensation, increased skin sensitivity, pain localized, tiredness, appetite lost and lymph node tenderness were recovered/resolved. It was unknown if the reporter considered the shivering, gastrointestinal upset, injection site erythema, burning sensation, increased skin sensitivity, pain localized, tiredness, appetite lost and lymph node tenderness to be related to SHINGRIX. Additional deails were reported as follows: The patient received SHINGRIX vaccine on left arm. In 2019, the patient experienced shivering, upset stomach, injection site redness, burning and sensitive skin at the waist, pain at the waist, tender lymph glands under the arms, loss of appetite and tiredness after receiving SHINGRIX vaccine. The patient reported that she was seen by a physician because of these issues, but they resolved one month after receiving the vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Autopsy, Death, Respiratory tract oedema, Tryptase increased
Clinical narrative: Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111401, 2019SA111422, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446  (same literature). Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 43 years old female patient who experienced anaphylactic reaction, while she received vaccines INFLUENZA VACCINE (QUADRIVALENT). The patient's past medical history included hypertension; depression; patient had no hypersensitivities. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown site of administration. On an unknown date, within one day the patient developed a serious anaphylactic reaction with symptoms patches of urticaria, airway swelling increased (Respiratory tract oedema) and serum tryptase level increased following the administration of INFLUENZA VACCINE, (QUADRIVALENT). The event anaphylactic reaction was leading to death. Lab test included increased serum tryptase level. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. Autopsy was performed and the cause of death was reported as anaphylactic reaction. Outcome for all the events was fatal. List of document held: none; Sender's Comments: This case is from a literature article concerning a 43-year-old female patient who died due to Anaphylactic Reaction followed by patches of urticaria and airway swelling following Morning after vaccination with INFLUENZA VACCINE (QUADRIVALENT). Time to onset is compatible. Past medical history included hypertension; depression but no hypersensitivities. Autopsy results confirming the cause of death was due to Anaphylactic Reaction. Further information with patient's medical condition at time of vaccination, clinical course of the events, laboratory results, concomitant therapy, family history including respiratory allergies, such as asthma and drug allergies are needed to reassess the role of vaccine.; Reported Cause(s) of Death: Anaphylactic reaction.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111401, 2019SA111422, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446  (same literature). Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 43 years old female patient who experienced anaphylactic reaction, while she received vaccines INFLUENZA VACCINE (QUADRIVALENT). The patient's past medical history included hypertension; depression; patient had no hypersensitivities. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown site of administration. On an unknown date, within one day the patient developed a serious anaphylactic reaction with symptoms patches of urticaria, airway swelling increased (Respiratory tract oedema) and serum tryptase level increased following the administration of INFLUENZA VACCINE, (QUADRIVALENT). The event anaphylactic reaction was leading to death. Lab test included increased serum tryptase level. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. Autopsy was performed and the cause of death was reported as anaphylactic reaction. Outcome for all the events was fatal. List of document held: none; Sender's Comments: This case is from a literature article concerning a 43-year-old female patient who died due to Anaphylactic Reaction followed by patches of urticaria and airway swelling following Morning after vaccination with INFLUENZA VACCINE (QUADRIVALENT). Time to onset is compatible. Past medical history included hypertension; depression but no hypersensitivities. Autopsy results confirming the cause of death was due to Anaphylactic Reaction. Further information with patient's medical condition at time of vaccination, clinical course of the events, laboratory results, concomitant therapy, family history including respiratory allergies, such as asthma and drug allergies are needed to reassess the role of vaccine.; Reported Cause(s) of Death: Anaphylactic reaction.