chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Hypertension, Hypotension, Loss of consciousness, Pain
Clinical narrative: Heavy bleeding, hemorrhaging, passing large blood clots, passing out, soreness, head aches, high blood pressure, low blood pressure, fever, chills, skin discoloration, nose bleeds, heart apnea, tachycardia, uti blood transfusion estrogen shots, anemia, sweats, room was 40 degrees and she was having hot flashes, dizziness, hit head twice as a result of passing out, no appetite.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Skin discolouration, Tachycardia, Thrombosis, Transfusion
Clinical narrative: Heavy bleeding, hemorrhaging, passing large blood clots, passing out, soreness, head aches, high blood pressure, low blood pressure, fever, chills, skin discoloration, nose bleeds, heart apnea, tachycardia, uti blood transfusion estrogen shots, anemia, sweats, room was 40 degrees and she was having hot flashes, dizziness, hit head twice as a result of passing out, no appetite.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Urinary tract infection
Clinical narrative: Heavy bleeding, hemorrhaging, passing large blood clots, passing out, soreness, head aches, high blood pressure, low blood pressure, fever, chills, skin discoloration, nose bleeds, heart apnea, tachycardia, uti blood transfusion estrogen shots, anemia, sweats, room was 40 degrees and she was having hot flashes, dizziness, hit head twice as a result of passing out, no appetite.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Pain and soreness; swelling; erythema; chills; fever (self reported. No documentation)
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Fine motor delay, Grip strength decreased, Hypoaesthesia, Injection site pain, Laboratory test normal
Clinical narrative: First noticed that it was difficult to hold can of soda and to hold pen right arm. Noticed injection site soreness in upper arm that progressed to forearm, hand, fingers, and palm of hand. Felt that hand motor control was delayed. Felt some numbness on right side of face and foot.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: First noticed that it was difficult to hold can of soda and to hold pen right arm. Noticed injection site soreness in upper arm that progressed to forearm, hand, fingers, and palm of hand. Felt that hand motor control was delayed. Felt some numbness on right side of face and foot.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: First am following injection quarter size swelling red warm welt. second am following injection painful swollen 3 inch diameter warm welt. possible fever-did not take but felt groggy and warm.  3rd day receding-expect to resolve soon.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Somnolence
Clinical narrative: First am following injection quarter size swelling red warm welt. second am following injection painful swollen 3 inch diameter warm welt. possible fever-did not take but felt groggy and warm.  3rd day receding-expect to resolve soon.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Red, itchy area 7cm x 5cm, warm to touch.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Headache, Rash, Restlessness
Clinical narrative: Patient reported getting a headache and rash in addition to restlessness at night and fatigue.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient states experiencing painful, warm, red area that is radiating to elbow. Patient states not experiencing blisters or fever, but thinks it is getting worse as of 09/23/2016 AM. Pharmacist recommended patient call primary doctor for evaluation.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Malaise, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Patient reported swelling and didn't feel well on 9/21/16. On 9/22/16, patient developed 103F fever, arm very red and painful.  Patient wen to ER and was admitted to the hospital for fluids and antibiotics.
Age: 21.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Pain
Clinical narrative: Patient stated that he still experienced pain and soreness in arm where he received the Td vaccine whenever he exercised and that it had been 4 days since he got vaccinated. Was examined by Dr. No pain during examination. Pain only occurring after exercising. Advised to not exercise for a few days. To return to clinic on Monday if pain persists. Patient referred to Vaccine Information Statement for Td that some pain is normal after Tetanus vaccine.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Feeling hot, Paraesthesia oral, Pharyngeal oedema, Pharyngeal paraesthesia
Clinical narrative: Weird taste in mouth, lips tingly, throat feels big and tingly, throat burns, body feels hot, employee called her PCP and was instructed to take ALLEGRA (which she did do).
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Weird taste in mouth, lips tingly, throat feels big and tingly, throat burns, body feels hot, employee called her PCP and was instructed to take ALLEGRA (which she did do).
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: Woke up to very swollen arm and a red patch rash that was about 3 inches by 3 inches - got worse during day & iced and took MOTRIN & TYLENOL. Slight fever that night. Lasted for several days.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: Swollen hard red bump, hot to touch, itches, and soreness. Started shortly after injection and has continued through current time period.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Red, golf ball size lump at site.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Diarrhoea, Nausea
Clinical narrative: PATIENT REPORTED FEELING NAUSEATED, CLAMMY, AND HAD DIARRHEA WITHIN IN 30 MINUTES OF THE SHOT. WAS TOLD TO GO TO URGENT CARE BUT SHE REPORTED FEELING BETTER WITHIN THE NEXT 30 MINUTES.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Nodule, Pain, Pruritus, Skin warm
Clinical narrative: INITIALLY EXP SORENESS, TENDERNESS, REDNESS, WARMTH. NEXT COUPLE DAYS EXP ADDITIONAL ITCHINESS AND A KNOT AND SPREADING OF REDNESS. WEDNESDAY RED IMPROVED BUT ITCHING WORSENED.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Tenderness
Clinical narrative: INITIALLY EXP SORENESS, TENDERNESS, REDNESS, WARMTH. NEXT COUPLE DAYS EXP ADDITIONAL ITCHINESS AND A KNOT AND SPREADING OF REDNESS. WEDNESDAY RED IMPROVED BUT ITCHING WORSENED.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Single dose Vial was administered as well as Kinrix.  So DTAP was doubled up by giving both Pediarix and Kinrix.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Axillary pain, Dyspnoea, Lymphadenopathy, Paraesthesia, Ultrasound scan
Clinical narrative: Pt went to the ER with tingling pain under arm and short of breath. Dx with swollen lymph nodes. Using cold presses and IBU.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain in extremity, Skin warm
Clinical narrative: While trying to go to sleep my arm was very painful to lie on and is very hot to the touch.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Patient started having chills, left arm pain and fever.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Migraine, Myalgia
Clinical narrative: Pt presented to the ER with a migraine that she could not control. She has chills and myalgia since the injections. She was treated with IV medications and given an rx for IMITREX.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Induration, Mass, Skin warm, Swelling
Clinical narrative: Hot to touch swollen hard lump that grew over 2 days to three times the size.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Skin warm
Clinical narrative: The patient called 9/23/16 with complaints of swelling of the arm from the injection site to the elbow. She also mentioned her arm being warm to the touch.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Dyskinesia, Fatigue, Gait disturbance, Myalgia
Clinical narrative: Started with chills. Progressed to also include fatigue and muscle soreness around 10:00 AM. At 10:30 AM, visible involuntary movement of muscles, trouble walking. Took Advil at 10:45 AM, symptoms started to gradually disappear.
Age: 1.08
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Day after receiving injection, my arm was sore (as expected). However, soreness has gotten worse. Pain has travelled up into shoulder area, difficulty in lifting arm, entire left arm is in throbbing pain. Difficulty in extending elbow completely out, and pain traveling up my neck.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Sleep disorder
Clinical narrative: Day after receiving injection, my arm was sore (as expected). However, soreness has gotten worse. Pain has travelled up into shoulder area, difficulty in lifting arm, entire left arm is in throbbing pain. Difficulty in extending elbow completely out, and pain traveling up my neck.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Day after receiving injection, my arm was sore (as expected). However, soreness has gotten worse. Pain has travelled up into shoulder area, difficulty in lifting arm, entire left arm is in throbbing pain. Difficulty in extending elbow completely out, and pain traveling up my neck.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Pt received flu shot at renal clinic and developed tremors 5 min after flu shot. BG 211. Pt denied neurologic disorders. Was sent to ED for monitoring. Symptoms dissipated after 2 hours. Discharged home with follow up in 2-4 days.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: Tennis ball size in diameter, raised welt, red.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Sleep disorder, Tremor
Clinical narrative: Patient complained of significant left arm pain at site of injection night of 9/22/16 and could not sleep, and shakiness.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Limb discomfort, Peripheral swelling, Pyrexia
Clinical narrative: Injection site reactions (severe pain, redness), fever, chills, severe arm swelling and arm heaviness. All signs/symptoms lasted approximately 5 days, which then later lead to skin peeling.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Skin exfoliation
Clinical narrative: Injection site reactions (severe pain, redness), fever, chills, severe arm swelling and arm heaviness. All signs/symptoms lasted approximately 5 days, which then later lead to skin peeling.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Myalgia
Clinical narrative: PT DEVELOPED FLU-LIKE SYMPTOMS MAINLY MUSCLE. PAIN/SORENESS, NO FEVER THOUGH. PT TOOK TYLENOL PERIODICALLY AND FULLY RECOVERED NEXT DAY.
Age: 22.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Dizziness, Lymphadenopathy, Pain, Pallor, Peripheral swelling
Clinical narrative: Fever lymph node swelling arm pit with extreme pain body aches dizzy lightheaded pale. By the next day arm swollen. Collar bone lymph nodes swollen still has fevers body aches tearful.
Age: 22.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pyrexia, Tearfulness
Clinical narrative: Fever lymph node swelling arm pit with extreme pain body aches dizzy lightheaded pale. By the next day arm swollen. Collar bone lymph nodes swollen still has fevers body aches tearful.
Age: 57.0
Sex: F
Vaccine: FLUX, TD, VARZOS
Symptoms: Chills, Erythema, Swelling, Tenderness
Clinical narrative: RED spot, swelling, tenderness, chills.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Local swelling, Pain, Skin warm
Clinical narrative: Redness, Pain, Local Swelling, Heat, Firm to touch.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Activities of daily living impaired, Dyspnoea, Dysstasia, Eye movement disorder, Immediate post-injection reaction
Clinical narrative: Pain in hands immediately following.  2 Days later facial twitching and gasping.  4 days later seizure like movements, eyes rolling back, stopping breathing.  Taken to ER.  3 weeks later removed from school for seizure like movements, unable to stand up, involuntary shrieking and gasping and sneezing.  Can no longer attend school.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Muscle twitching, Pain in extremity, Respiratory arrest, Screaming, Seizure like phenomena
Clinical narrative: Pain in hands immediately following.  2 Days later facial twitching and gasping.  4 days later seizure like movements, eyes rolling back, stopping breathing.  Taken to ER.  3 weeks later removed from school for seizure like movements, unable to stand up, involuntary shrieking and gasping and sneezing.  Can no longer attend school.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Sneezing
Clinical narrative: Pain in hands immediately following.  2 Days later facial twitching and gasping.  4 days later seizure like movements, eyes rolling back, stopping breathing.  Taken to ER.  3 weeks later removed from school for seizure like movements, unable to stand up, involuntary shrieking and gasping and sneezing.  Can no longer attend school.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Altered state of consciousness, Extremity contracture, Sneezing, Tic
Clinical narrative: Pain in hands immediately following.  2 Days later facial twitching and gasping.  4 days later seizure like movements, eyes rolling back, stopping breathing.  Taken to ER.  3 weeks later removed from school for seizure like movements, unable to stand up, involuntary shrieking and gasping and sneezing.  Can no longer attend school.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypersensitivity, Photophobia, Vomiting
Clinical narrative: Vomiting profusely, dizzy to the point of not being able to stand, extreme sensitivity to light and noise.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to right arm at injection site, prescribed antibiotics for cellulitis.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Nausea, Retching, Vertigo
Clinical narrative: Patient reported nausea and dry heaves, as well as diarrhea and some vertigo.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Diarrhoea, Eye pain, Injection site erythema, Injection site pain
Clinical narrative: Pain, swelling, redness at injection site.  Nausea, vomiting, diarrhea.  Sharp pains down legs and arms.change in kidney function. eyes hurting--Went to ER on 9/23/16 diagnosed with cellulitis and given septra ds and voltaren.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling, Nausea, Pain, Pain in extremity, Renal impairment
Clinical narrative: Pain, swelling, redness at injection site.  Nausea, vomiting, diarrhea.  Sharp pains down legs and arms.change in kidney function. eyes hurting--Went to ER on 9/23/16 diagnosed with cellulitis and given septra ds and voltaren.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vomiting
Clinical narrative: Pain, swelling, redness at injection site.  Nausea, vomiting, diarrhea.  Sharp pains down legs and arms.change in kidney function. eyes hurting--Went to ER on 9/23/16 diagnosed with cellulitis and given septra ds and voltaren.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: The patient experienced hives on her arms and her back.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient described a large, circular red mark at the site of the injection. Patient complains injection site is hard, swollen, painful and warm to the touch, unlike any immunization she has received in the past.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, soreness, & swelling below the immunization site.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Patient experienced redness throughout body.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: Shoulders and back hurt like I'd been hit with a hammer, for about 36 hours. Took Aleve, did not help.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Autism spectrum disorder, Confusional state, Dyskinesia, Pyrexia, Seizure like phenomena
Clinical narrative: High fever, confusion, waving hands in the air, body going tense seizure like movements.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Speech disorder, Tension, Tic
Clinical narrative: High fever, confusion, waving hands in the air, body going tense seizure like movements.
Age: 3.0
Sex: M
Vaccine: DTPIHI
Symptoms: Abdominal pain upper, Malaise, Muscle twitching, Pyrexia, Vomiting
Clinical narrative: High fever up to 104, muscle twitching, vomiting, stomach pain, general malase.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Peripheral swelling, Tenderness
Clinical narrative: Patient report arm swelling and tenderness/pain at site of injection. Patient went to seek medical attention.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash generalised, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 52 year old female via a company representative. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (lot#, expiration date, strength, dose and route of administration were not reported). Patient's concomitant medication was not provided. On an unknown date, within 12 days after receipt of the vaccine, the patient experienced a "varicella like rash" at the injection site. On 15-SEP-2016, the patient was seen in the office and the previously reported "varicella like rash" was diagnosed as chickenpox (varicella) and was found to be more widespread. At the reporting time, the outcome of varicella was unknown. The reporter did not provide the relationship between varicella and VARIVAX. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Autoimmune disorder, Systemic lupus erythematosus
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to multiple unspecified number of patients of unknown age and gender. The physician learned of the events from unspecified media reports. The patients' medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with GARDASIL 9 (dose, frequency and route of administration were unknown). Following administration some patients developed lupus (systemic lupus erythematosus) and others developed autoimmune disease. The outcome of the events was unknown. Causality assessment was not provided. Product quality complaint (PQC) was not involved. Upon internal review, the events were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose and route unknown) from lot # M023380 with expiry date of 11-MAY-2018. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Urticaria
Clinical narrative: Hives on left leg - seen in office - treating with BENADRYL.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Diarrhoea, Injection site erythema, Injection site swelling
Clinical narrative: Left shoulder and upper arm swelling. Upper arm bright red.  Chills, diarrhea, loss of energy.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Patient-received (PENTACEL and HIB). so-patient received 2 doses of HIB.
Age: 70.0
Sex: M
Vaccine: TD
Symptoms: Rash, Urticaria
Clinical narrative: Symptoms: Skin Rash and hives. Treatment: Diphenhydramine
Sex: U
Vaccine: HEPA, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 10-JUL-2016 to 09-SEP-2016 the patients were vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # L044475, expiry date: 12-MAY-2017), which was stored at a temperature of 25 degree Fahrenheit, for a time frame of 4 days 1 hour 45 minutes there was no previous temperature excursions reported, (lot # M020103, expiry date: 15-FEB-2018), which was stored at a temperature of 25 degree Fahrenheit for a time frame of 15 minutes. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to 4 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB, 0.5 ml (batch #M020101, expiry date 07-MAR-2019) (dose and route not reported). The vaccine was exposed to temperature of 61 Fahrenheit for 3 hours. No previous temperature excursion was reported. No adverse effects and no product quality complaints (PQC) were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Blood pressure decreased, Cold sweat, Unresponsive to stimuli
Clinical narrative: Decreased BP, clammy, "feels like passing out" then became unresponsive for 5-10 sec.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Emotional distress, Fatigue, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Pt had fever but also extreme irritability, inconsolable x 7 1/2 hrs and seemed to be in pain esp both legs even with light touch. He was admitted for obs and D/C'd after 1 day fully recovered. Pt came into the office yesterday for 6 month well visit and received ROTA/PENTACEL/PVC has been very fussy since with fever and leg swelling to both legs; slept x 3 hrs after shots and then fussy throughout the day but inconsolable since 9PM last night; still drinking and wetting; no diarrhea; emesis sm amt x 1; TYLENOL helps with fever - TMAX 102 but not with fussiness; no rash. He presented with fever. It is described as acute. The symptom is sudden in onset. The symptom started 7 hours ago. The temperature is 102 degrees (maximum temperature). The frequency of episodes is daily. Episodes occur upon awakening. Important triggers include no known associated factors. The symptom is alleviated by TYLENOL. Pertinent findings include fatigue, denies abdominal pain, denies constipation, denies cough, denies nausea, denies vertigo and denies vomiting.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt had fever but also extreme irritability, inconsolable x 7 1/2 hrs and seemed to be in pain esp both legs even with light touch. He was admitted for obs and D/C'd after 1 day fully recovered. Pt came into the office yesterday for 6 month well visit and received ROTA/PENTACEL/PVC has been very fussy since with fever and leg swelling to both legs; slept x 3 hrs after shots and then fussy throughout the day but inconsolable since 9PM last night; still drinking and wetting; no diarrhea; emesis sm amt x 1; TYLENOL helps with fever - TMAX 102 but not with fussiness; no rash. He presented with fever. It is described as acute. The symptom is sudden in onset. The symptom started 7 hours ago. The temperature is 102 degrees (maximum temperature). The frequency of episodes is daily. Episodes occur upon awakening. Important triggers include no known associated factors. The symptom is alleviated by TYLENOL. Pertinent findings include fatigue, denies abdominal pain, denies constipation, denies cough, denies nausea, denies vertigo and denies vomiting.
Age: 44.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Discomfort, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Can't move right arm. Numbness down arm. Pressure deep in axilla. Can't lift arm above head-still 2 days later. Supportive care.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, arthralgia, myalgia, fatigue, chills. Low grade fever.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: Headache, arthralgia, myalgia, fatigue, chills. Low grade fever.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Autopsy, Sudden infant death syndrome, Toxicologic test
Clinical narrative: 3 days after 2 month immunizations baby suddenly died.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient received the vaccine (FLUARIX QUAD 2016-2017) intramuscularly from pharmacy on 8/20/2016 and came back complaining of a sore arm almost a month after on 9/18/2016. There was no sign of swelling or redness.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Tongue discomfort
Clinical narrative: Within 10 to 15 minutes of getting the Flu shot started getting itchy and then tongue felt funny. Was given BENADRYL and symptoms improved. Took BENADRYL over night. Now feels itchy again but denies any problems with her tongue. Will continue with BENADRYL as needed and seek further medical care if needed.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient had FLUZONE HD on 9/20/16. She developed hematoma (bruises) on the upper arm on 9/22/16. She came to pharmacy today. Patient didn't complain any pain or swelling. The bruise started to fade as of 9/23. Per pt. the bruise didn't get bigger comparing to yesterday.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Administration site pain
Clinical narrative: Pain at administration site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: None stated.
Sex: M
Vaccine: MENB
Symptoms: Back pain, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received BEXSERO (batch number 154101A, expiry date May 2017). Previously administered products included BEXSERO (1st dose received on an unknown date without experiencing any an adverse event). On 12th September 2016, the patient received the 2nd dose of BEXSERO. In September 2016, less than a week after receiving BEXSERO, the patient experienced injection site pain, low back pain and fever. On an unknown date, the outcome of the injection site pain, low back pain and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, low back pain and fever to be related to BEXSERO. Additional details were provided as follows: Age at vaccination was not reported. the patient's date of birth was reported as 29th June (healthcare professional refused to give year of birth). the patient experienced injection site pain (arm), lower back pain and low grade fever after receiving 2nd dose of BEXSERO.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Swelling, heat, redness, pain. Spoke with physician and started BENADRYL 50mg.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Rash, Skin warm, Swelling
Clinical narrative: Rash on upper arm, above elbow, red, swelling and pt. fill heat. May be cellulitis.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV, DTAP, FLU4, MMRV
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vomiting in a 4-year-old male patient who received FLUARIX Quadrivalent (batch number 29PD2, expiry date 30th June 2017). Concurrent medical conditions included developmental delay. Concomitant products included PROQUAD. On 15th September 2016, the patient received the 1st dose of FLUARIX Quadrivalent. On 15th September 2016, 50 min after receiving FLUARIX Quadrivalent, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to FLUARIX Quadrivalent. Additional details were provided as follows: On 15th September 2016, at 9 hours, the patient received FLUARIX Quadrivalent in left deltoid and at 9.50 hours, he vomited right after given the flu shot. On the same day, the patient also received PROQUAD in left deltoid concomitantly. The reported lot number (29PZ2) for FLUARIX did not exist and was updated to 29PD2 as per the sales database.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 52-year-old male patient who received FLULAVAL QUADRIVALENT (batch number AE735, expiry date May 2017). On 8th September 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 8th September 2016, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site warmth and injection site erythema were recovering/resolving. The reporter considered the injection site warmth and injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The patient received the vaccine on left arm. On 10th September 2016, the patient informed pharmacist about an injection site reaction. One inch below the site of injection, the patient had redness radiating to the underside of the arm all the way to the elbow, and arm hot to the touch. The reporter referred the patient to healthcare provider, the pharmacy declined reporters offer to email the PI.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pallor
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of leg pain in a 16-year-old male patient who received BEXSERO (batch number 15C601, expiry date 31st October 2017). Concomitant products included bupropion SR and topiramate. On 13th September 2016, the patient received the 2nd dose of BEXSERO. On 13th September 2016, less than an hour after receiving BEXSERO, the patient experienced leg pain, chills, pallor, headache and nausea. On 13th September 2016, the outcome of the leg pain was recovered/resolved. On an unknown date, the outcome of the chills, pallor, headache and nausea were not recovered/not resolved. It was unknown if the reporter considered the leg pain and headache to be related to BEXSERO. The reporter considered the chills, pallor and nausea to be possibly related to BEXSERO. Additional details were reported as follows: The concomitant medication included topiramate (25mg which patient took on the day of vaccination in morning) and bupropion SR (100mg but did not take on the day of reporting). The health care professional stated that patient had no reaction to first dose of BEXSERO. The patient received the vaccine and then left the physician's office. The patient came back 30 mins later stating about pain in the leg that traveled up body to head. The reporter stated that blood pressure was normal.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vomiting in a 4-year-old male patient who received FLUARIX Quadrivalent (batch number 29PD2, expiry date 30th June 2017). Concurrent medical conditions included developmental delay. Concomitant products included PROQUAD. On 15th September 2016, the patient received the 1st dose of FLUARIX Quadrivalent. On 15th September 2016, 5 min after receiving FLUARIX Quadrivalent, the patient experienced vomiting. On 15th September 2016, the outcome of the vomiting was recovered/resolved. It was unknown if the reporter considered the vomiting to be related to FLUARIX Quadrivalent. Additional details were provided as follows: The patient received concomitant vaccine PROQUAD on left deltoid. On 15th September 2016, at 9:15 hours, the patient received FLUARIX Quadrivalent on left deltoid. At 9:20 hours, right after the vaccination the patient experienced vomiting. The reported lot number (29PZ2) for FLUARIX Quadrivalent was not exist and was updated to 29PD2, according to sales database.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male patient who received FLULAVAL TETRA (batch number H9HZ7, expiry date 31st March 2017). On 13th September 2016, the patient received FLULAVAL TETRA .5 ml. In September 2016, less than a week after receiving FLULAVAL TETRA, the patient experienced extensive swelling of vaccinated limb at injection site redness. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site redness were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site redness to be related to FLULAVAL TETRA. Additional details were provided as follows: The patient experienced redness at the injection site, which continued to worsen. The patient presented to the clinic to see the doctor on reporting date morning with worsening swelling, redness from his shoulder down to his elbow on the arm where he received the FLULAVAL vaccine.
Sex: M
Vaccine: MENB
Symptoms: Back pain, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a male patient who received BEXSERO (batch number 154101A, expiry date May 2017). Previously administered products included BEXSERO (1st dose, the patient did not experience an adverse events). In September 2016, the patient received the 2nd dose of BEXSERO. On 12th September 2016, less than a week after receiving BEXSERO, the patient experienced injection site pain, fever and low back pain. On an unknown date, the outcome of the injection site pain, fever and low back pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever and low back pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not provided. The patient experienced unresolved pain in the arm (at the injection site), pain in the lower back, and a low grade fever after receiving the second dose of BEXSERO 2 days ago. The patient's date of birth, health care professional refused to give the year.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Injected limb mobility decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injected limb mobility decreased in a 49-year-old female patient who received TWINRIX (batch number 7C4Z3, expiry date 6th May 2018). Concomitant products included CRESTOR. On 26th April 2016, the patient received the 2nd dose of TWINRIX (intramuscular) 1 ml. In May 2016, 14 days after receiving TWINRIX, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was not recovered/not resolved. The reporter considered the injected limb mobility decreased to be unrelated to TWINRIX. Additional details were provided as follows: The patient received TWINRIX on the left arm. The patient started experiencing a decreased range of motion in her left arm 2 weeks after receiving a TWINRIX vaccination and the patient cannot lift her arm above her head. At the time of reporting, the patient was seen for an evaluation, and this information was reported.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 45-year-old female patient who received FLULAVAL QUADRIVALENT. On 13th September 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular). On an unknown date, less than a week after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The patient was the employee. The patient experienced a grade 1 injection site pain reaction. The patient declined to provide date of birth. Due to time constraints, the patient had to end call prior to asking seriousness criteria questions. The patient could be contacted at later time for further information.
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of headache in a 16-year-old female patient who received MENVEO. On an unknown date, the patient received MENVEO. On an unknown date, 1 day after receiving MENVEO, the patient experienced headache, joint pain and fever. On an unknown date, the outcome of the headache, joint pain and fever were recovered/resolved. It was unknown if the reporter considered the headache, joint pain and fever to be related to MENVEO. Additional details were reported as follows: No further information was available or reported regarding the event. The patient attended the Emergency room or doctor visit.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose and route were unknown; lot # M019706 with expiration date 24-OCT-2017 and lot # reported as L036694 with expiration date 16-JUN-2017). The vaccines were exposed under temperature of 46.9 degrees Fahrenheit for 10 minutes. The previous temperature excursions were 47.2 degrees Fahrenheit for 10 minutes, 47.3 degrees Fahrenheit for 10 minutes and 46.9 degrees Fahrenheit for 10 minutes. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been requested from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (dose and route were unknown) lot # M023380 with expiration date 11-MAY-2018, lot # M014309 with expiration date 21-MAR-2018, lot # M009745 (an invalid lot number) with expiration date 23-AUG-2017 and lot # M001152 (an invalid lot number) with expiration date 05-JUL-2017. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test positive
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 21-JUL-2016, the patient was vaccinated with a dose of VARIVAX (dose, route and lot # not reported). The pharmacist reported that the patient had a varicella antibody titers drawn on 25-AUG-2016 and the titer results showed high levels of positive antibodies. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Erythema, Rash macular, Skin discolouration
Clinical narrative: Within approx. 3 min after receiving injections pt bilat ankles and feet developed macular rash and a band of redness developed around each ankle. Bottom of feet turned purple. Resolved on its own within approx. 15 minutes with treatment.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Vaccine 8/18/2016 - Area of 6 cm swelling next day. Over next week, develops 7 x 11 cm area of redness. Started to improve 8/25/2016.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Local swelling, Rash vesicular
Clinical narrative: 2/3 of rear of arm inflamed-large (3cm) raised area with appearance of several potential "Pox resembling" lesions within last 48hrs.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: Patient was given 2nd GARDASIL injection. Patient was fine while getting the injection. Patient went to get off of the table and felt dizzy then nauseated. Patients grandfather helped her sit down in the chair and patient slumped over. I left the room to get the doctor. Doctor came in the room and got patient to lay down on the bed. Patient felt, dizzy, faint and nauseated. Patient was given time to feel better before leaving. Time span of 20 min.
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles, Pruritus generalised
Clinical narrative: 2x2 1/2 raised erythemic blistering lesion increasing in size over (R) upper thigh pruritic with generalized developing pruritis all over body.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Bright red area on back of left triceps area.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient started to experience pain around injection site the evening after receiving the vaccination. By the next morning it was red around the injection site and firm to the touch. He could not lift his arm even to shoulder level due to the pain.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Tongue dry
Clinical narrative: Patient started feeling itchy on hands - then tongue was dry. Gave patient water and patient took OTC BENADRYL approximately 50 mg liquid. Patient was with husband and stayed in store approximately 30 min. Patient left saying "I feel better" and left with husband.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to herself as a female patient of unknown age. No pertinent medical history and drug reactions/allergies were reported. On an unknown date of 2011 (reports as about 5 years ago) the patient was vaccinated with ZOSTAVAX (lot and expiration date was not reported) for one time. No concomitant medications were reported. On an unknown date January 2016 (reported as about 9 months ago) the patient experienced an internal itch down her arms and back. The outcome of the event pruritus was unknown. The causality assessment was not provided by the reporter. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 03-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Pharmacy Technician (CPhT), refers to the two unspecified patients of unknown age and gender. No information on the patients' concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the two patients were vaccinated with doses of improperly stored RECOMBIVAX HB injection, strength: 10/1.0 microgram/ml, lot # L048848, expiration date: 09-AUG-2018 (route of administration was not reported). There were no adverse effects reported. Additional information is not expected because there was no consent for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern referring to unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates since 07-JUL-2016, the patients were vaccinated with improperly stored doses of VARIVAX which had lot# K020758 with expiry date: 31-OCT-2016 (dosing details not provided). The vaccine was exposed to a temperature of 36 degree Fahrenheit for 22 hours. The vaccine had no previous temperature excursion. The call was due to data logger. No adverse effects and no product quality complaint (PQC) involved. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of an unknown age and gender. the patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with first dose of GARDASIL 9 injection (lot number/expiry date and dosage not reported). On an unknown date, the patients were late in receiving the second dose of GARDASIL 9 injection (lot number/expiry date and dosage not reported). No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.