chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Musculoskeletal stiffness, Skin discolouration
Clinical narrative: Could have begun previous night, we noticed when he woke 2 hours early 9/10/16.  He is experiencing lethargy and "green" look to skin tone.  Biggest issue is that site (leg) appears to be very stiff and sore.  He is limping and seems unable to bend the leg.  More stiff than sore.  Better word for limping probably, because it is that he is keeping the stiff leg completely straight while walking.  Administered ibuprofen. Still experiencing symptoms so appropriate event outcomes can't be checked at this time.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on thighs and spread to shoulders, chest and back.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Spotty rash, started on abdomen then expanded to rest of body.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: Soreness; limited movement; diminishing strength.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient experienced itching and redness on both arms and hands. We provided diphenhydramine and observed for an hour. Patient did not progress to anaphylaxis or get any worse.
Age: 23.0
Sex: F
Vaccine: DTAP
Symptoms: Loss of consciousness
Clinical narrative: Passed out in vehicle.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Oropharyngeal pain
Clinical narrative: Pt woke up and her arm near the injection site was red, swollen and hot to the touch. Pt felt sluggish/fatigued that day and had a sore throat.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Sluggishness
Clinical narrative: Pt woke up and her arm near the injection site was red, swollen and hot to the touch. Pt felt sluggish/fatigued that day and had a sore throat.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Redness near injection site & itching.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Area red and swollen.
Age: 71.0
Sex: F
Vaccine: FLUR3
Symptoms: Chills, Fatigue, Feeling abnormal, Hyperhidrosis, Pain
Clinical narrative: Patient states about 6 hours after vaccination she developed body aches not alleviated with Tylenol or ibuprofen, sweats and chills, fatigue and overall poor feeling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus generalised
Clinical narrative: 9/8/2016-VACCINE ADMINISTERED. 9/9/2016-PATIENT RETURNED TO PHARMACY. SHE HAD AN INJECTION SITE RASH..IRREGULAR SHAPE ABOUT 2-3 INCHES ACROSS.  EXPLAINED THIS WAS POSSIBLE SE. 9/10/2016-PATIENT RETURNED TO PHARMACY AGAIN.  CENTER OF RASH HAD DARKENED CONSIDERALBY AND SHE COMPLAINED OF GENERALIZED EXTREME ITCHING.  PROVIDED PATIENT WITH DIPHENHYDRAMINE AND INSTRUCTED HER TO CALL HER PCP.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Redness surrounding the injection site with a diameter of approximately 6 inches.   Patient said that it has been warm to the touch and has caused discomfort.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Irritability, Pyrexia, Rash generalised
Clinical narrative: Fever 101 degrees for 2 days, then diarrhea, lost appetite, drowsy, fussy and whole body rash that looked like measles on 09/10/2016 and 09/11/2016.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash morbilliform, Somnolence
Clinical narrative: Fever 101 degrees for 2 days, then diarrhea, lost appetite, drowsy, fussy and whole body rash that looked like measles on 09/10/2016 and 09/11/2016.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Pt reports chills and fever (99*F).
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Increasing redness and swelling at injection.
Age: 35.0
Sex: F
Vaccine: ANTH, FLUC4, TYP
Symptoms: Feeling abnormal, Feeling cold, Flushing
Clinical narrative: 30-45 minutes post immunization/blood draw, pt c/o "not feeling good", "feeling cold", skin flushing. B/P taken. Reported - pt taken to urgent care. Pt left facility oriented. Ambulatory, alert and orientated.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Severe body pain.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Eye movement disorder, Face injury, Fall, Loss of consciousness, Muscle rigidity
Clinical narrative: 1046 Hep A vaccine given to pt with no distress noted. 1047 pt fell face first to floor with rigidity, stiffness noted, eyes rolled back in head, passed out, assisted to catch pt but pt hit face (R) side to floor. Within 5 sec pt turned over on back, legs shaky, rigidity diminished fever, no rigidity. Pt then alert and oriented x 3. Pt stated he was ok. Pt verbalized eating the same. No history fainting.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Musculoskeletal stiffness, Tremor
Clinical narrative: 1046 Hep A vaccine given to pt with no distress noted. 1047 pt fell face first to floor with rigidity, stiffness noted, eyes rolled back in head, passed out, assisted to catch pt but pt hit face (R) side to floor. Within 5 sec pt turned over on back, legs shaky, rigidity diminished fever, no rigidity. Pt then alert and oriented x 3. Pt stated he was ok. Pt verbalized eating the same. No history fainting.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Sleep apnoea syndrome
Clinical narrative: SAS.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Disorientation, Dizziness, Headache, Nausea
Clinical narrative: Patient claims 2 days after immunizations she became nauseous, extremely dizzy, disoriented, headache 911 called, transported to hospital (ER) overnite.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Full blood count, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid red, warm, swollen. Fever.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Left deltoid red, warm, swollen. Fever.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Muscle tightness, Neck pain, Pain in extremity
Clinical narrative: Pain at injection site, spreading to arm, shoulder, neck, tightening of muscles, pain down arm to hand and fingers that would not be reduced by pain relievers, still extremely painful after 3 weeks.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain at injection site, spreading to arm, shoulder, neck, tightening of muscles, pain down arm to hand and fingers that would not be reduced by pain relievers, still extremely painful after 3 weeks.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Muscle tightness, Neck pain, Pain in extremity
Clinical narrative: Pain radiating from injection site down to hand. Stiffness of neck area.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain radiating from injection site down to hand. Stiffness of neck area.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Vertigo
Clinical narrative: Soreness at injection site. Vertigo.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Localized erythema at injection site approximately 4cm diameter. No fever. No chills. No paresthesias.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Pyrexia
Clinical narrative: I woke up because of a fever very early in the morning. At that time it was low grade - about 99.9. As the day progressed my fever went up to 101, and it was 103 by 9:00 PM. 1000 mg of Tylenol helped control the fever early in the day, but by 9:00 PM it had no effect. Fever continued to by high throughout the night, but had fallen back down to 100.00 by morning.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Erythema, Hypoaesthesia, Neuralgia, Paraesthesia
Clinical narrative: I got one large blister on my left back flank, as well as 8 other areas of red spots on both sides of body, tingling and numbness down right leg and foot. On 9/2/16 I was placed on anti vaccine medicine Valacyclovir 1mg as well as Gabapentin 100mg. On 9/10/16 due to ongoing neuropathic pain down my left leg and foot, I was placed on Prednisone 20 MG and Hydrocodone 5-500mg.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Contusion, Hypoaesthesia, Malaise, Petechiae, Pyrexia
Clinical narrative: I got one large blister on my left back flank, as well as 8 other areas of red spots on both sides of body, tingling and numbness down right leg and foot. On 9/2/16 I was placed on anti vaccine medicine Valacyclovir 1mg as well as Gabapentin 100mg. On 9/10/16 due to ongoing neuropathic pain down my left leg and foot, I was placed on Prednisone 20 MG and Hydrocodone 5-500mg.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scab, Sensory loss, Varicella
Clinical narrative: I got one large blister on my left back flank, as well as 8 other areas of red spots on both sides of body, tingling and numbness down right leg and foot. On 9/2/16 I was placed on anti vaccine medicine Valacyclovir 1mg as well as Gabapentin 100mg. On 9/10/16 due to ongoing neuropathic pain down my left leg and foot, I was placed on Prednisone 20 MG and Hydrocodone 5-500mg.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Gait disturbance, Herpes zoster, Hypoaesthesia, Insomnia
Clinical narrative: I got one large blister on my left back flank, as well as 8 other areas of red spots on both sides of body, tingling and numbness down right leg and foot. On 9/2/16 I was placed on anti vaccine medicine Valacyclovir 1mg as well as Gabapentin 100mg. On 9/10/16 due to ongoing neuropathic pain down my left leg and foot, I was placed on Prednisone 20 MG and Hydrocodone 5-500mg.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: I got one large blister on my left back flank, as well as 8 other areas of red spots on both sides of body, tingling and numbness down right leg and foot. On 9/2/16 I was placed on anti vaccine medicine Valacyclovir 1mg as well as Gabapentin 100mg. On 9/10/16 due to ongoing neuropathic pain down my left leg and foot, I was placed on Prednisone 20 MG and Hydrocodone 5-500mg.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted moments after injecting Fluvirin IIV3 Trivalent vaccine. Recovered with stable vitals less than 2 minutes later. EMT personnel was dispatched as a precaution and found her to be normal and able to drive herself home.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Myalgia, Nausea, Paraesthesia
Clinical narrative: Pain in joints and muscles, tingling on all extremities, chills, fever over 100 F, tearing up, nausea.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tearfulness
Clinical narrative: Pain in joints and muscles, tingling on all extremities, chills, fever over 100 F, tearing up, nausea.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pyrexia, Rash, Rash pustular, Skin irritation
Clinical narrative: Fever of 102, pus and red irritated rash on feet and legs.
Age: 83.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Discomfort, Erythema, Feeling hot
Clinical narrative: Redness, discomfort, heat start day of vaccination, report to pharmacy 3 days later. Pt had not removed band-aid yet. Third day, pt seen in ER dx cellulitis received antibiotic rx.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash on Chest, back and Arms.  Red speckled rash in groin area.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Large, red, itchy welt around injection site.  About 3x4 inches.  Rough outline.  A lot of heat emanating from it.  I don't know the exact time it started but the vaccine was given between 5 & 7 pm.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Nodule, Swelling
Clinical narrative: Golf-ball sized knot, localized heat, swelling.  No fever, no limited joint movement, no infection.
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Blister, Herpes zoster, Injection site pain, Injection site vesicles, Polymerase chain reaction positive
Clinical narrative: Vesicle along with fever started on right ankle and then enlarged and spread up toward his thigh. Was painful. Seen by dermatology who diagnosed on 8/25/2016 shingles confirmed by PCR (Herpes zoster infection). Treated with acyclovir for 7 days.
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Pyrexia, Viral test positive
Clinical narrative: Vesicle along with fever started on right ankle and then enlarged and spread up toward his thigh. Was painful. Seen by dermatology who diagnosed on 8/25/2016 shingles confirmed by PCR (Herpes zoster infection). Treated with acyclovir for 7 days.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm
Clinical narrative: Pt is having warmth in injection arm, and pain in the arm.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: RED RASH ON ARMS THAT HAS SPREAD TO LEGS, BACK, AND BUTTOCKS THAT STARTED DAY OF VACCINATION. PATIENT IS TAKING BENADRYL OTC TO HELP. STILL ONGOING. PATIENT HAS INSTRUCTIONS TO SEEK MEDICAL CARE IF CONDITION WORSENS.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Skin swelling
Clinical narrative: 10Sept2016; 12:35 PM; Complained of itching on her body and on her head. Noticeable bump/raised skin on member left wrist. Denies any issues/complications with her breathing/ respiratory, or any swelling of tongue/ lips. Member instructed to immediately go to the local Urgent Care. She has also been instructed to submit documentation from the Urgent Care to the medical office as soon as possible.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Back pain, Epistaxis, Fatigue, Injection site erythema
Clinical narrative: Fever 101, body aches, swollen arm, red circle around injection site, stamach pain, nausea and vomiting mucus, tirdness, sore skin, nose bleeding when I blow it, severe lower back pain.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pain of skin, Peripheral swelling, Pyrexia
Clinical narrative: Fever 101, body aches, swollen arm, red circle around injection site, stamach pain, nausea and vomiting mucus, tirdness, sore skin, nose bleeding when I blow it, severe lower back pain.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Fever 101, body aches, swollen arm, red circle around injection site, stamach pain, nausea and vomiting mucus, tirdness, sore skin, nose bleeding when I blow it, severe lower back pain.
Age: 63.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE BECAME RED, SWOLLEN, INFLAMED AND HOT TO THE TOUCH. SHE SAID A KNOT CAME UP. SHE DID NOT REPORT TO US UNTIL 9/11 BUT SHE SAID IT IS MUCH BETTER.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness and tenderness and swelling around injection site, low grade fever.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient report severe redness, pain, and warmth at the site of her Zostavax injection.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site paraesthesia, Musculoskeletal pain, Neck pain
Clinical narrative: TINGLE OR PAIN AT INJECTION SITE THAT CONTINUES TO PRESENT, MILD PAIN PROGRESSING FROM SHOULDER UP NECK. HAS NOT SOUGHT MED TREATMENT, AS IT IS A MILD AGGRAVATING PAIN. ANTI-INFLAMMATORY TAKEN WHEN NEEDED.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Diplopia
Clinical narrative: Double vision.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: VIth nerve paralysis
Clinical narrative: Double vision.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Electroencephalogram, Loss of consciousness, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Suddenly pass out and seizure occurs within 3-5 minutes.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Electroencephalogram, Fear, Heart rate abnormal, Loss of consciousness, Nuclear magnetic resonance imaging
Clinical narrative: Suddenly pass out and seizure occurs within 3-5 minutes.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Seizure, Staring, Syncope
Clinical narrative: Suddenly pass out and seizure occurs within 3-5 minutes.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Cough, Rhinorrhoea
Clinical narrative: Blisters, running nose, and cough.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Hypophagia, Retching, Speech disorder developmental, Vomiting
Clinical narrative: He was eating baby food (cereal, fruits and vegetables) great before his 6 month vaccines.  We started him on baby food about a month before he got his vaccines and he loved it.  The day he got his vaccines, he wouldn't eat anything. When we would try to put food in his mouth, he would gag and throw it up. We could not get him to eat anything for 8 months.  He would only breastfeed.  After 8 months, he gradually started eating, but mostly mushy foods. It took several months for him to eat more chunky solid food.  We called the Pediatrician the day he got vaccinated to report that something was not right and he wasn't acting himself.  They said to give it a few days that sometimes they can feel sick/sore for a few days after a vaccine.  When we would take him for his checkups and told the doctor he was still not eating, they kept saying he probably developed a gag reflex.  He never had a gag reflex before and this all started the day he was vaccinated so I think it was related to the vaccines.  He is eating fine now.  He is having speech delays so not sure if that is related as well.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Left arm sore, red, and swollen with a knot in that area.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of GARDASIL 9. No adverse effect reported. The temperature excursion details included exposure to temperature of 47 Fahrenheit for 8 hours. No previous temperature excursions reported. No additional doses have been administered. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II (rHA, lot # L012482, expiration date 10-APR-2017, rHA, lot # L043704, expiration date 01-NOV-2017; dose was unknown). The vaccines were stored at 7.5 Fahrenheit degree for 2 hours and 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a medical assistant referring to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates from 2005 to 2006, the patient was vaccinated with three doses of RECOMBIVAX HB (strength, lot#, expiration date and route were not reported), at the recommended 0, 1 and 6 month dosing schedule. On an unknown date, the patient had negative titers after receiving all the three doses in the series. It was reported that no treatment was given. The outcome of the event was reported as not recovered. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-JUL-2016 the patient received an improperly stored dose of VARIVAX (lot # L031066, expiry date: 13-JAN-2017). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Pt had welts/swelling on arm with fever for 3 days- she did consult her Dr. He did not give her anything but said he would monitor reaction and see her in two weeks.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Irritability, Vomiting
Clinical narrative: Very fussy, vomiting, diarrhea.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction/raised red mark appearing about 24 hrs after administration and so far clearing up on its own without treatment.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: On 9/17/16 I administered PNEUMOVAX 23 to patient. After the vaccination she informed me that she already received the two pneumonia vaccines. No harm was done. I informed her she didn't need this vaccine that I just gave her. No reports of adverse reactions.
Age: 61.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: After 1day =shot site Right Deltoid (PNEUMOVAX) felt like "hard knot" by 9/9/16 = shot site hot, red, painful, can't lift arm-worried called pharmacy - was taking Ibuprofen/BENADRYL. 9/10/16 = swollen 4 inches/hot/painful -> went to urgent care Rx CEPHALAXIN to treat cellulitis -> MD treating symptoms of...- 9-11-16 will see regular MD for follow up visit.
Age: 61.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Injection site warmth
Clinical narrative: After 1day =shot site Right Deltoid (PNEUMOVAX) felt like "hard knot" by 9/9/16 = shot site hot, red, painful, can't lift arm-worried called pharmacy - was taking Ibuprofen/BENADRYL. 9/10/16 = swollen 4 inches/hot/painful -> went to urgent care Rx CEPHALAXIN to treat cellulitis -> MD treating symptoms of...- 9-11-16 will see regular MD for follow up visit.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Musculoskeletal pain, Somnolence
Clinical narrative: Patient reported severe aches (muscle and skeletal), diarrhea and drowsiness for remainder of day till 24 hr after shot.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Injection site remains tender.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MENB
Symptoms: Erythema, Injected limb mobility decreased, Pain, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 16-year-old female patient who received BEXSERO. On 17th August 2016, the patient received the 1st dose of BEXSERO. In August 2016, less than a week after receiving BEXSERO, the patient experienced injection site pain, injection site redness, raised rash and injected limb mobility decreased. On 22nd August 2016, the outcome of the injection site pain, injection site redness, raised rash and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site redness, raised rash and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a health department. the age at vaccination was not reported. On 17th August 2016, at 16 pm, the patient received 1st dose of BEXSERO and on 19th August 2016, at 16:35 pm, the patient's grandmother called the physician's office and stated that her granddaughter's left arm was very sore at the injection site and she could barely move her arm. Also, a red, raised rash the size of a half dollar had developed below the injection site. On 19th August 2016, the patient was evaluated at the office and told that this was a reaction to the BEXSERO and she should take CLARITIN right before her next dose of BEXSERO. the all symptoms had resolved by 22md August 2016. the field representative stated that the information he provided was sent to him via email on the evening of 29th August 2016. He was unable to provide any further details. He did say that this was the first time he had reported these adverse events although he thought it was reported to adverse event reporting system by the health department. the field representative also stated unknown to the causality question although he did stated that the email indicated that the patient was told at the evaluation on 19th August 2016 that it was a reaction to the BEXSERO.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 16-year-old female patient who received BEXSERO. On 17th August 2016, the patient received the 1st dose of BEXSERO. In August 2016, less than a week after receiving BEXSERO, the patient experienced injection site pain, injection site redness, raised rash and injected limb mobility decreased. On 22nd August 2016, the outcome of the injection site pain, injection site redness, raised rash and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site redness, raised rash and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a health department. the age at vaccination was not reported. On 17th August 2016, at 16 pm, the patient received 1st dose of BEXSERO and on 19th August 2016, at 16:35 pm, the patient's grandmother called the physician's office and stated that her granddaughter's left arm was very sore at the injection site and she could barely move her arm. Also, a red, raised rash the size of a half dollar had developed below the injection site. On 19th August 2016, the patient was evaluated at the office and told that this was a reaction to the BEXSERO and she should take CLARITIN right before her next dose of BEXSERO. the all symptoms had resolved by 22md August 2016. the field representative stated that the information he provided was sent to him via email on the evening of 29th August 2016. He was unable to provide any further details. He did say that this was the first time he had reported these adverse events although he thought it was reported to adverse event reporting system by the health department. the field representative also stated unknown to the causality question although he did stated that the email indicated that the patient was told at the evaluation on 19th August 2016 that it was a reaction to the BEXSERO.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient was in the store and I asked how she was and she showed me the injection site.  It was raised.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: On 9/8/2016 recd a Flu vaccination and Pneumonia booster (PPSV23) on same day. Mild headache afternoon of 9/8. The next day (9/9) woke w/headache, nausea, no appetite, no energy. Noticed vaccination spot on arm was now 2 red sore spots. (9/10) Felt somewhat better, but still a headache and feeling tired, no appetite and the vaccination spot on arm, still sore.  (9/11) Better but still a continuing headache and feeling tired. (9/12) Middle of night woke up to another headache.  Feeling better - hoping that feeling like this is over.  I've RARELY had headaches and now since this I do hope it's not something I have to deal with on a daily basis.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Blood calcium decreased, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal
Clinical narrative: Patient received MCV4 and PPD around 8:50AM. She was not seen for a visit. After receiving her vaccine and PPD, she remained seated >5 minutes and then collapsed hitting the occipital portion of her skull. 911 was called and parents were notified. Initially her pulse and respirations were steady so no CPR was indicated. We administered 6L O2 by bag mask and connected the AED which advised no shock. She remained unconscious for >10 minutes prior to the arrival of the Fire Dept and ambulance and continued to be unconscious during a portion of her transport. Her vitals remained stable P 70, B/P 130/72, Spo2 100%, R 14, slow, deep, regular. Paramedics from Denver Health took over at 9:13 AM. Pt was transported by ambulance in a C-Collar and Backboard. Contacted Dr to give report. Pt departed by ambulance to  at 9:20 AM still unconscious.  She had awakened by the time she arrived at the ED. Her diagnosis was s/p syncopal ground level fall with + LOC with small right frontal hemorrhagic contusion.  Treatment includes following concussion protocol with multiple visits until patient has progressed through Return to Play. No surgical intervention indicated.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Computerised tomogram head abnormal, Contusion
Clinical narrative: Patient received MCV4 and PPD around 8:50AM. She was not seen for a visit. After receiving her vaccine and PPD, she remained seated >5 minutes and then collapsed hitting the occipital portion of her skull. 911 was called and parents were notified. Initially her pulse and respirations were steady so no CPR was indicated. We administered 6L O2 by bag mask and connected the AED which advised no shock. She remained unconscious for >10 minutes prior to the arrival of the Fire Dept and ambulance and continued to be unconscious during a portion of her transport. Her vitals remained stable P 70, B/P 130/72, Spo2 100%, R 14, slow, deep, regular. Paramedics from Denver Health took over at 9:13 AM. Pt was transported by ambulance in a C-Collar and Backboard. Contacted Dr to give report. Pt departed by ambulance to  at 9:20 AM still unconscious.  She had awakened by the time she arrived at the ED. Her diagnosis was s/p syncopal ground level fall with + LOC with small right frontal hemorrhagic contusion.  Treatment includes following concussion protocol with multiple visits until patient has progressed through Return to Play. No surgical intervention indicated.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Fall, Haematocrit normal, Haemoglobin normal, Head injury, Loss of consciousness
Clinical narrative: Patient received MCV4 and PPD around 8:50AM. She was not seen for a visit. After receiving her vaccine and PPD, she remained seated >5 minutes and then collapsed hitting the occipital portion of her skull. 911 was called and parents were notified. Initially her pulse and respirations were steady so no CPR was indicated. We administered 6L O2 by bag mask and connected the AED which advised no shock. She remained unconscious for >10 minutes prior to the arrival of the Fire Dept and ambulance and continued to be unconscious during a portion of her transport. Her vitals remained stable P 70, B/P 130/72, Spo2 100%, R 14, slow, deep, regular. Paramedics from Denver Health took over at 9:13 AM. Pt was transported by ambulance in a C-Collar and Backboard. Contacted Dr to give report. Pt departed by ambulance to  at 9:20 AM still unconscious.  She had awakened by the time she arrived at the ED. Her diagnosis was s/p syncopal ground level fall with + LOC with small right frontal hemorrhagic contusion.  Treatment includes following concussion protocol with multiple visits until patient has progressed through Return to Play. No surgical intervention indicated.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Platelet count normal, Syncope, White blood cell count normal
Clinical narrative: Patient received MCV4 and PPD around 8:50AM. She was not seen for a visit. After receiving her vaccine and PPD, she remained seated >5 minutes and then collapsed hitting the occipital portion of her skull. 911 was called and parents were notified. Initially her pulse and respirations were steady so no CPR was indicated. We administered 6L O2 by bag mask and connected the AED which advised no shock. She remained unconscious for >10 minutes prior to the arrival of the Fire Dept and ambulance and continued to be unconscious during a portion of her transport. Her vitals remained stable P 70, B/P 130/72, Spo2 100%, R 14, slow, deep, regular. Paramedics from Denver Health took over at 9:13 AM. Pt was transported by ambulance in a C-Collar and Backboard. Contacted Dr to give report. Pt departed by ambulance to  at 9:20 AM still unconscious.  She had awakened by the time she arrived at the ED. Her diagnosis was s/p syncopal ground level fall with + LOC with small right frontal hemorrhagic contusion.  Treatment includes following concussion protocol with multiple visits until patient has progressed through Return to Play. No surgical intervention indicated.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Constipation, Diarrhoea, Pyrexia
Clinical narrative: Low grade fever and diarrhea; Fever lasted for 3 days; followed by constipation and diarrhea ongoing for 2+ weeks.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 61 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-APR-2016, the patient received dose of improperly stored ZOSTAVAX lot number L035283, expiry date: 15-DEC-2016; (the dose, dosage number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients received improperly stored doses of PNEUMOVAX 23 (dose and route of administration were not provided) (lot number: K022886, expiration date: 09-JUN-2016; K010523, expiration date: 25-FEB-2016; L001311, expiration date: 06-JUL-2016). 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: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse referring to a 23 year old female patient. The patient had no drug reactions/allergies. Information regarding concomitant medication and medical history were unknown. On 23-AUG-2016, the patient was vaccinated with 2 doses of RECOMBIVAX HB (10 microgram x 3 doses) (lot # M023892 with expiration date 17-SEP-2017, intramuscular) (inappropriate schedule of vaccine administered). On an unknown date in August 2016, the patient experienced redness and swelling at the injection site. The patient didn't sought medical attention. No treatment was given for the events and no lab diagnostics studies were performed. At the reporting time, the patient was recovering from the events. The causality between the events and the vaccine was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Back pain, Chest pain, Injection site erythema, Injection site pain
Clinical narrative: Swelling and pain in Left shoulder, entire deltoid extending to mid chest, mid back and axilla. Erythema deltoid to mid humerus. Sling, ice, ibuprofen for treatment severe pain with movement or touch.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Local swelling, Pain
Clinical narrative: Swelling and pain in Left shoulder, entire deltoid extending to mid chest, mid back and axilla. Erythema deltoid to mid humerus. Sling, ice, ibuprofen for treatment severe pain with movement or touch.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 02-Sep-2016. This case involves a 72-year-old female patient who was vaccinated with a dose of FLUZONE HD via intramuscular route (batch number: UI659AB, expiry date: 29-Mar-2017) (dose and dose in series not reported) in left deltoid on 29-Aug-2016. Patient's illness at time of vaccination was reported as no. It was also reported that pre-existing physician diagnosed allergies: eggs and birth defects, medical conditions are not reported. Concomitant medications were not reported. On 29-Aug-2016 by the evening, same day following the vaccination, the patient experienced had redness and warmth at the injection site, left deltoid. It was also reported that swelling was larger than the size of a softball. It was also reported that patient had Fluzone last year and had not experienced a reaction. Patient required ER/Doctor visit. Lab test and corrective treatment were not reported. Outcome of the events were reported as unknown. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Blindness, Fatigue, Pyrexia, Visual impairment
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of loss of vision in a 17-year-old female patient who received MENVEO. Co-suspect products included TRUMENBA. On an unknown date, the patient received MENVEO at an unknown dose and TRUMENBA at an unknown dose. On an unknown date, less than a day after receiving MENVEO, the patient experienced loss of vision (serious criteria GSK medically significant), fever and fatigue. On an unknown date, the outcome of the loss of vision, fever and fatigue were recovering/resolving. It was unknown if the reporter considered the loss of vision, fever and fatigue to be related to MENVEO. Additional details were provided as follows: This case was reported by a Pfizer sales representative. The patient's medical history was unknown. The patient received MENVEO and TRUMENBA vaccine on the same day and the patient ended up having fever, fatigue, loss of vision, everything get black with spot. The events were improved after 24 hours. As per reporting sales representative, the doctor initiated about adverse events and medical assistant provided further information. The reporting sales representative mentioned that the physician was surprised that it happened with TRUMENBA and MENVEO together because they had given TRUMENBA separately as well, but did not see anything so they were concerned with certain things and they were wondering if it was because they have given them together. The reporting sales representative had limited information and did not have any email address of Physician. This case was not associated with product complaint and there was no medical information request.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Blindness, Fatigue, Pyrexia, Visual impairment
Clinical narrative: This is a spontaneous report from a contactable physician and a contactable medical assistant via a Pfizer sales representative. These physician and medical assistant reported similar events for two patients. This is the first of two reports. This case is serious, the other case is non serious. A 17 year-old female patient of an unspecified ethnicity received TRUMENBA at 0.5 ml single and MENVEO at 1 dosage from (DF) single, the same day, on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced loss of vision/everything got black with spot, fever and fatigue on an unspecified date. The patient was recovering, symptoms improved after 24 hours. The reporters were kind of surprised that these events occurred with the two vaccines together because they had given TRUMENBA separately as well but they did not see anything so they were concerned with certain things and they were wondering if it was because they have given them together.
Age: 48.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Arm burning, pain, and redness around injection site approximately 3 hours after injection.  Also patient had a fever.
Sex: M
Vaccine: MENB
Symptoms: Chills, Injection site pain, Lethargy, Myalgia, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sinus infection in a male patient who received BEXSERO. On 24th July 2016, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced sinus infection (serious criteria other: as per reporter), muscle pain (serious criteria other: as per reporter), chills (serious criteria other: as per reporter), injection site pain (serious criteria other: as per reporter), throat swelling (serious criteria other: as per reporter), sore throat (serious criteria other: as per reporter) and lethargy (serious criteria other: as per reporter). On an unknown date, the outcome of the sinus infection, muscle pain, chills, injection site pain, throat swelling, sore throat and lethargy were unknown. It was unknown if the reporter considered the sinus infection, muscle pain, chills, injection site pain, throat swelling, sore throat and lethargy to be related to BEXSERO. Additional details were provided as follows: The case was reported by patient's mother. Concomitant medication included antibiotics. The age at vaccination was not provided. The patient required physician's visit and emergency room visit for the events. This case was previously reported to the doctor. The caller declined to answer questions for safety report and vaccination healthcare professional office was not available.
Sex: M
Vaccine: MENB
Symptoms: Pharyngeal oedema, Sinusitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sinus infection in a male patient who received BEXSERO. On 24th July 2016, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced sinus infection (serious criteria other: as per reporter), muscle pain (serious criteria other: as per reporter), chills (serious criteria other: as per reporter), injection site pain (serious criteria other: as per reporter), throat swelling (serious criteria other: as per reporter), sore throat (serious criteria other: as per reporter) and lethargy (serious criteria other: as per reporter). On an unknown date, the outcome of the sinus infection, muscle pain, chills, injection site pain, throat swelling, sore throat and lethargy were unknown. It was unknown if the reporter considered the sinus infection, muscle pain, chills, injection site pain, throat swelling, sore throat and lethargy to be related to BEXSERO. Additional details were provided as follows: The case was reported by patient's mother. Concomitant medication included antibiotics. The age at vaccination was not provided. The patient required physician's visit and emergency room visit for the events. This case was previously reported to the doctor. The caller declined to answer questions for safety report and vaccination healthcare professional office was not available.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Malaise, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old male patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included blood cholesterol increased and arthritis. Concomitant products included biotin, Rosuvastatin, Turmeric and zinc. In October 2015, the patient received influenza vaccine Quadrivalent (intramuscular). On 15th December 2015, 61 days after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant), sickness and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the sickness and influenza were recovered/resolved. It was unknown if the reporter considered the vaccination failure, sickness and influenza to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The patient reported that around end of October 2015, he received 4 strain flu shot. The reporter did not know what brand it was. On 15 December 2015, approximately 2 months after vaccination, the patient got sick, possibly with the flu (suspected vaccination failure), but might be something else. The patient felt sick for several days, but did not have the full flu symptoms. The patient was a professional Santa, so he was exposed to many germs in the fall leading up to Christmas, so he always got sick with something. This case was considered as suspected vaccination failure as the target disease of flu was not confirmed and also no laboratory confirmation was provided.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Bacterial test negative, Injected limb mobility decreased, Injection site pain, Muscle contractions involuntary, Muscle spasms
Clinical narrative: A contactable consumer reporting on behalf of her mother reported that a 82-year-old female patient received PREVNAR 13 on 21Dec2015, in right arm, at single dose. Medical history included heart problem. The patient concomitant medications were not reported. the patient experienced immobile right arm on 21Dec2015 with outcome of not recovered, could not move her arm past her head on 21Dec2015 with outcome of not recovered, she occasionally had spasms on an unspecified date with outcome of unknown, swollen arm on 21Dec2015 with outcome of not recovered, muscle contraction on an  unspecified date with outcome of not recovered, did not have any feeling in her right arm on an unspecified date with outcome of unknown, she could not use her right arm since then on 21Dec2015 with outcome of not recovered. She was still having pain at injection site since 21Dec2015. Treatment received included BENADRYL 75 mg  tablet, steroids, pain medications, muscle relaxers. the pain medication and muscle relaxers were not doing any good. Some fluid was withdrawn twice out of the big knot (swelled part) but did not find any bacteria in that. the patient went back to the doctor who gave the vaccine. She had also been to the orthopaedic doctor and cardiologist.