chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Posture abnormal, Respiratory rate increased, Seizure, Syncope, Tearfulness
Clinical narrative: Pt looked pale. She moved to chair next to chair that she was sitting in for vaccine. She was talking to RN and then slumped in chair. RN supported her weight while she was out. Pt then had a quick seizure and came to. She was confused and upset. The event happened less than 5 minutes after vaccines were given. She sat on her mom's lap and was tearful and breathing fast. RN ENC her to take slow deep breaths. Pt then walked to room next door and laid on exam table with legs elevated. RN put cool cloth on her head. RN gave her apple juice to sip on and fruit snacks. RN observed pt for about a half hr before pt left. Child reported that before she fainted she had blurry vision and felt really tired. Mom stated that child has never had a seizure before. RN ENC mom to take child to walk in or to her PCP today to be evaluated. Mom stopped at PCP's office and nurse there stated that if she had symptoms again to bring her in to be seen. She was not seen by nurse or PCP. RN called mom to CK in this afternoon. She reports that child threw up on the way home and reported feeling much better afterward.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Vision blurred, Vomiting
Clinical narrative: Pt looked pale. She moved to chair next to chair that she was sitting in for vaccine. She was talking to RN and then slumped in chair. RN supported her weight while she was out. Pt then had a quick seizure and came to. She was confused and upset. The event happened less than 5 minutes after vaccines were given. She sat on her mom's lap and was tearful and breathing fast. RN ENC her to take slow deep breaths. Pt then walked to room next door and laid on exam table with legs elevated. RN put cool cloth on her head. RN gave her apple juice to sip on and fruit snacks. RN observed pt for about a half hr before pt left. Child reported that before she fainted she had blurry vision and felt really tired. Mom stated that child has never had a seizure before. RN ENC mom to take child to walk in or to her PCP today to be evaluated. Mom stopped at PCP's office and nurse there stated that if she had symptoms again to bring her in to be seen. She was not seen by nurse or PCP. RN called mom to CK in this afternoon. She reports that child threw up on the way home and reported feeling much better afterward.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Hypoacusis, Syncope, Vision blurred
Clinical narrative: Pt's younger sister fainted after her vaccines today. Pt had blurry vision and muffled hearing. She states that she felt light headed. She laid down on the floor and elevated her legs. She did not faint. RN put a cool cloth on her head. RN observed pt for 15 minutes. RN called mom later this afternoon to CK in and mom states that both girls are doing fine.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: 08-17-17 am mom noticed a red area size of a dime on L thigh. Area warm to touch, raised, hard, no streaking, no fever. On 08-18-17 mom noticed the area to now be size of quarter. Patient seen in office 8-18-17 with 1.1 x 0.5 in slightly firm, erythematous, lump to L outer thigh, no streaking, does not appear TTP, no swelling surrounding site, area marked with pen, possible central punctum mark to center of cellulitis - treated with KEFLEX - mom aware of s/sx to call for re: worsening infection.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Feeling abnormal, Haematemesis
Clinical narrative: Patient contacted pharmacy 08/21/2017 at 2:33 pm and notified that she was experiencing vomiting with blood, diarrhea, cold chills, fever, body aches, nausea upset stomach since on Friday evening  after receiving the immunization in the afternoon. Patient stated she received a PHENERGAN injection and LEVAQUIN from Dr over the weekend to treat the symptoms. Patient states she has lost 11 pounds and is feeling progressively worse.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Pyrexia, Weight decreased
Clinical narrative: Patient contacted pharmacy 08/21/2017 at 2:33 pm and notified that she was experiencing vomiting with blood, diarrhea, cold chills, fever, body aches, nausea upset stomach since on Friday evening  after receiving the immunization in the afternoon. Patient stated she received a PHENERGAN injection and LEVAQUIN from Dr over the weekend to treat the symptoms. Patient states she has lost 11 pounds and is feeling progressively worse.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Extremely swollen left upper arm (quad area) and bright red (like a sunburn)... started 8/15 gone by 8/21.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever, nausea, fatigue, injection site redness and swelling.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient was given first one on May 19th 2016 and we gave another MENVEO on May 16 2017 because most vaccines were abstracted into the chart the day she got the MENVEO so we thought that if we gave the MENVEO she would be up to date on her vaccines, then on May 19th 2017 all her records were scanned in. The reason we are just catching the error is because she came back in for a vaccine update and pulled her old records, and found that not all old vaccines were abstracted into her chart.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Feeling abnormal, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient reported swelling and redness from a little below shoulder to a few inches above elbow starting the day after immunization was given. Also reported fever, and feeling "out of it". When patient came into the pharmacy 4 days later it had improved (red area had lessened in size and swelling had gone down) but was still warm to touch. Patient also said felt better.
Age: 8.0
Sex: M
Vaccine: RAB
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt has red, pinpoint, non-raised rash on chest area- started after day zero rabies PEP and worsened after day 3 imovax received on 8/20/2017.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site pain, Injection site reaction, Rash pruritic
Clinical narrative: Patient's mother reported that beginning the day after vaccination patient had some pain and developed an itchy rash at the injection site. She took the patient to the doctor who told the mother it was some form of cellulitis. As of last contact patient's condition was slowly improving.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Local redness and pain with swelling. Pain throughout upper arm.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Cystogram, Electroencephalogram, Nuclear magnetic resonance imaging brain, Retinogram, Ultrasound urinary system
Clinical narrative: 4/20/16 - Upper respiratory infection. 4/27/16 - Urinary tract infection/urinary reflux. 5/6/16 - Ultrasound urinary reflux. 5/9/16 - Infantile spasms and epilepsy.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Upper respiratory tract infection, Urinary tract infection, Vesicoureteric reflux, Visual evoked potentials, X-ray
Clinical narrative: 4/20/16 - Upper respiratory infection. 4/27/16 - Urinary tract infection/urinary reflux. 5/6/16 - Ultrasound urinary reflux. 5/9/16 - Infantile spasms and epilepsy.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to two patients of unknown demographics. On 15-AUG-2017 the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N011305, expiry date: 20-JAN-2019) for prophylaxis. The doses of PNEUMOVAX 23 were stored at a temperature of 47 degree Fahrenheit (F) to 77 F for time frame of 19 days. No adverse effects reported. No Product Quality complaint (PQC) was involved. This case is cross-referenced with 1708USA007541 (Same Reporter link). Sender's Comments: US-009507513-1708USA007541.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Localized reaction- Redness and warmth around injection site.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Anaemia, Chills, Full blood count normal, Mononucleosis heterophile test negative, Night sweats
Clinical narrative: Onset of fever approximately 2 hrs after administration in healthy 17 YO male. Cyclical fever over the next 11 days, spiking to as high as 103.7  at night, breaking in the am. Patient experienced night sweats and chills also. CBC on 6/19/17 was normal and monospot test negative. Another bout of unexplained fever 7/11/17  through 7/17/17, also cyclical with fever highest at night, with chills and night sweats. CBC on 7/14/17 showed slight anemia but no indication of infection.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Pyrexia, Red blood cell count decreased, West Nile virus test negative
Clinical narrative: Onset of fever approximately 2 hrs after administration in healthy 17 YO male. Cyclical fever over the next 11 days, spiking to as high as 103.7  at night, breaking in the am. Patient experienced night sweats and chills also. CBC on 6/19/17 was normal and monospot test negative. Another bout of unexplained fever 7/11/17  through 7/17/17, also cyclical with fever highest at night, with chills and night sweats. CBC on 7/14/17 showed slight anemia but no indication of infection.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Patient was okay immediately following the vaccine, but after standing up and trying to leave he got very hot and sweaty and light headed. He sat down for a period of time and was supplied with an ice pack and cold water and everything subsided.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Underneath arm (from armpit to elbow is red, swollen and warm to touch).
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Arrhythmia, Chills, Feeling hot, Influenza like illness, Injection site erythema
Clinical narrative: Body aches, fever, arrhythmias, chills, heat, redness, and  swelling at injection site, flu-like symptoms.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Body aches, fever, arrhythmias, chills, heat, redness, and  swelling at injection site, flu-like symptoms.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Anxiety, Feeling hot, Headache, Loss of consciousness, Vision blurred
Clinical narrative: Approximately 3-5 minutes after vaccination administration the patient lost consciousness. Approximately 5-10 seconds later the patient regained consciousness. Patient complained of feeling warm, blurred vision, and headache. Emergency medical staff arrived at scene approximately 7-10 minutes later in order to evaluate. Upon further evaluation they concluded nothing was wrong with patient and probably was a psychological (anxiety) reaction to getting a vaccination.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient reported that her arm swelled up and became really hot the same day of the injection. She reported the event two days later, reporting that it did get better after applying ice and taking TYLENOL, however, it still remained a bit swollen.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Localized redness and swelling and induration on right leg at site of either varicella or hep A.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Patient has lesions on her legs, hands and arms. Patient was seen today 8/21/17 in the office and her primary care doctor diagnosed her with Varicella without complication.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Blood test, Dizziness, Heart rate irregular, Hyperhidrosis
Clinical narrative: High fever (101), sweating, aches and pains in joints, dizziness, nauseous, irregular heartbeat, & ringing in ears!! Most symptoms still exist!!
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pyrexia, Tinnitus
Clinical narrative: High fever (101), sweating, aches and pains in joints, dizziness, nauseous, irregular heartbeat, & ringing in ears!! Most symptoms still exist!!
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Viral upper respiratory tract infection
Clinical narrative: Not true adverse event more like cold symptoms.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called on 8/21/2017 and reported that he had pain in his arm, forearm and middle of his hand of the arm he got the flu shot in. No numbness, fever or rash. He said it has gotten progressively worse since he had the shot. CDC call suggested he see his MD to get the site checked out, we advised that to the patient.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypoaesthesia
Clinical narrative: The patient is experiencing numbness in the lower left arm.
Age: 46.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Administration site swelling, Administration site warmth, Chills, Pain, Pyrexia
Clinical narrative: Warm and swollen arm at administration site, fever, chills, pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed a large red mark at injection site that was raised and itchy. There was no swelling, hives or other rash, fever, or trouble breathing.
Age: 1.75
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Abnormal behaviour, Blood culture, Blood test normal, Clumsiness, Crying
Clinical narrative: On day 9 after vaccines was given he had a large raised red hot to the touch bump / nodule on his right thigh at the injection site with a high temp, low fever of 100. Was seen at the ER and was released the same day without treatment diagnosed as febrile illness immunization rxn. On day 10 his fever spiked to 104.6 and we returned to the ER where we ran blood work for illnesses which came back clear. Fever was treated and we were sent home and advised to follow up with his pediatrician. I immediately made an apt for today Monday August 21st. While at school today his teacher noted he was crying all day and was biting himself. This is not like him. We went to his Dr apt and was turned away, they said they could no longer see us. I called our insurance company and was able to be reassigned to another pediatrician in which we have now scheduled a follow up apt with for tomorrow afternoon. We are still monitoring him around the clock and noting everything that seems unusual for him which are as follows, clumsiness, loss of appetite, interrupted sleep, soreness at injection site, redness, itching, low to high fever, biting himself and crying on and off.
Age: 1.75
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Decreased appetite, Erythema, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: On day 9 after vaccines was given he had a large raised red hot to the touch bump / nodule on his right thigh at the injection site with a high temp, low fever of 100. Was seen at the ER and was released the same day without treatment diagnosed as febrile illness immunization rxn. On day 10 his fever spiked to 104.6 and we returned to the ER where we ran blood work for illnesses which came back clear. Fever was treated and we were sent home and advised to follow up with his pediatrician. I immediately made an apt for today Monday August 21st. While at school today his teacher noted he was crying all day and was biting himself. This is not like him. We went to his Dr apt and was turned away, they said they could no longer see us. I called our insurance company and was able to be reassigned to another pediatrician in which we have now scheduled a follow up apt with for tomorrow afternoon. We are still monitoring him around the clock and noting everything that seems unusual for him which are as follows, clumsiness, loss of appetite, interrupted sleep, soreness at injection site, redness, itching, low to high fever, biting himself and crying on and off.
Age: 1.75
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Intentional self-injury, Pruritus, Pyrexia
Clinical narrative: On day 9 after vaccines was given he had a large raised red hot to the touch bump / nodule on his right thigh at the injection site with a high temp, low fever of 100. Was seen at the ER and was released the same day without treatment diagnosed as febrile illness immunization rxn. On day 10 his fever spiked to 104.6 and we returned to the ER where we ran blood work for illnesses which came back clear. Fever was treated and we were sent home and advised to follow up with his pediatrician. I immediately made an apt for today Monday August 21st. While at school today his teacher noted he was crying all day and was biting himself. This is not like him. We went to his Dr apt and was turned away, they said they could no longer see us. I called our insurance company and was able to be reassigned to another pediatrician in which we have now scheduled a follow up apt with for tomorrow afternoon. We are still monitoring him around the clock and noting everything that seems unusual for him which are as follows, clumsiness, loss of appetite, interrupted sleep, soreness at injection site, redness, itching, low to high fever, biting himself and crying on and off.
Age: 1.75
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Sleep disorder, Vaccination complication
Clinical narrative: On day 9 after vaccines was given he had a large raised red hot to the touch bump / nodule on his right thigh at the injection site with a high temp, low fever of 100. Was seen at the ER and was released the same day without treatment diagnosed as febrile illness immunization rxn. On day 10 his fever spiked to 104.6 and we returned to the ER where we ran blood work for illnesses which came back clear. Fever was treated and we were sent home and advised to follow up with his pediatrician. I immediately made an apt for today Monday August 21st. While at school today his teacher noted he was crying all day and was biting himself. This is not like him. We went to his Dr apt and was turned away, they said they could no longer see us. I called our insurance company and was able to be reassigned to another pediatrician in which we have now scheduled a follow up apt with for tomorrow afternoon. We are still monitoring him around the clock and noting everything that seems unusual for him which are as follows, clumsiness, loss of appetite, interrupted sleep, soreness at injection site, redness, itching, low to high fever, biting himself and crying on and off.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Limb injury, Pallor, Syncope
Clinical narrative: Patient received all three vaccines and as nurse turned her back fainted and fell off exam table. Immediately came to and color returned after resting a few minutes, hit arm and head on floor.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient has significant pain in the shoulder and immobility 10 days after immunization.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Patient presented with redness, hives, itching, and swelling on right side of face and near injection site after receiving the vaccine 1 hour prior.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Patient presented with redness, hives, itching, and swelling on right side of face and near injection site after receiving the vaccine 1 hour prior.
Age: 47.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Local reaction, Vaccination site warmth
Clinical narrative: Next day, patient's arm became red and warm to the touch a few inches below the vaccinations. Arm was not painful and fever not established. Patient had insisted both vaccinations given in right arm. Immunizing pharmacist agreed. Patient went to a walk-in clinic on the day following the immunization who said it was most likely a local site reaction but will treat with a methylprednisone 6 day pack and cephalexin to treat possible cellulitis.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: According to patient within about 1 and 1/2 hrs of receiving PNEUMOVAX 23 her entire left arm became red, swollen and very sore. The next day I examined her arm and could find no evidence of redness. Both arms appeared somewhat "puffy" and fingers edematous, but were that way before vaccine was given. Fingers on left hand appeared slightly more swollen than on right hand. She took TYLENOL and MOTRIN for the pain. Since then the pain is lessening but arm is still somewhat sore.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: According to patient within about 1 and 1/2 hrs of receiving PNEUMOVAX 23 her entire left arm became red, swollen and very sore. The next day I examined her arm and could find no evidence of redness. Both arms appeared somewhat "puffy" and fingers edematous, but were that way before vaccine was given. Fingers on left hand appeared slightly more swollen than on right hand. She took TYLENOL and MOTRIN for the pain. Since then the pain is lessening but arm is still somewhat sore.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Heart rate increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to our pharmacy on 08/21/17 to report that she had adverse reaction on her right arm following the PREVNAR 13 shot she had in our pharmacy on 08/18/2017. She said she had swelling, redness and hot/warm around the injection site. She also said her heart rate increased to 80 to 90. She said she then started taking BENADRYL pills and her condition had improved.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity, Pain, Peripheral swelling
Clinical narrative: My child had an allergic reaction. Her arm swoll up, she was in pain, and the clinic is not sure what they gave her. They think because their clinic had one more of this and one less shot of that, that is what my daughter received.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Autoimmune disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of autoimmune disorder in a 18-year-old male patient who received FLUARIX TETRA (batch number 2J2EC, expiry date May 2018). Concurrent medical conditions included Crohn's disease. Concomitant products included Mesalamine. On 9th August 2017, the patient received FLUARIX TETRA (intramuscular) .5 ml. On 11th August 2017, 2 days after receiving FLUARIX TETRA, the patient experienced autoimmune disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the autoimmune disorder was unknown. It was unknown if the reporter considered the autoimmune disorder to be related to FLUARIX TETRA. Additional details were reported as follows: On 9th August 2017 at 12:00, the patient received FLUARIX QIV vaccine on left deltoid. It was reported to pharmacist that a patient experienced an auto-immune reaction that was not related to Crohn's disease.
Age: 18.0
Sex: F
Vaccine: IPV, MENB
Symptoms: Cellulitis
Clinical narrative: Diagnosed with cellulitis.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Contusion, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient experienced swelling of injection site and upper arm. Significant redness of the area soreness of arm, and a large bruise, and fever/chills. Patient treated reaction with BENADRYL and all symptoms resolved within a few days.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient experienced swelling of injection site and upper arm. Significant redness of the area soreness of arm, and a large bruise, and fever/chills. Patient treated reaction with BENADRYL and all symptoms resolved within a few days.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Rhinorrhoea
Clinical narrative: Rectal temp to 100.3 am after vaccines. Mild runny nose.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Bedridden, Chills, Contusion, Dizziness, Fall
Clinical narrative: Dizziness, chills, patient walked in to a door and feel and bruised. Was bedridden for 3 days.
Sex: U
Vaccine: IPV, MENB
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site cellulitis in a adult patient who received BEXSERO. Concomitant products included IPOL. On an unknown date, the patient received the 2nd dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site cellulitis and injection site erythema. The patient was treated with antibiotics. On an unknown date, the outcome of the injection site cellulitis and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site cellulitis and injection site erythema to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient received BEXSERO on left arm. The patient was also given separately but sequentially on the same day the polio vaccine called IPOL in the same left arm. The reporting physician neither administered the vaccines nor seen the vaccines being administered. It was unknown which vaccine was administered first or the specific timeline for vaccine administration or timeline regarding how soon the left arm redness and cellulitis developed following the administration of the vaccines. The patient went to a walk-in urgent care clinic and was given and took an unknown antibiotic for the left arm redness and cellulitis. The patient was fine at the time of reporting. The immunization clinic had already reported to VAERS but they wanted GlaxoSmithKline to also be aware. It was currently not known which one of the two vaccines might have caused the left arm redness and cellulitis and no further information was provided. The physician gave consent to contact for any further related questions.
Age: 12.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMRV
Symptoms: Erythema, Pallor, Urticaria
Clinical narrative: 1:30 pm immunizations given. 1:35 wheals noted on right sore arm, called NP to room. Noted 3 wheals in succession ranging in size from 8 mm to 20 mm, surrounded by erythema and blanching. 1:45 pm HR 88, B/P 111/72, T 98.3. 25 mg BENADRYL given at 1:37 by NP. 1:45 Heart RSR/RRR, normal S1, S2, no murmurs; Lungs: Clear to auscultation bilaterally, patient positioned on exam table/bed at 45 degrees HOB elevated. Alert and oriented X 3.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Persistent local site of injection pain.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Injection site bruising, Injection site pain
Clinical narrative: Pt felt weird feeling when she got the flu shot. Later she mentioned it's very painful and got blackish bruise on that area.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Syncopal episode greater than 5 min after administration.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Syncopal episode greater than 5 min after administration.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Rash
Clinical narrative: Woke up with rash morning after vaccine on stomach, slight red, lacey, and bumpy.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Full blood count, Injection site rash
Clinical narrative: Rash at injection site - left vastus lateralis.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Pt report pain (plus) fever like S/S on Saturday one after shot. Redness, tenderness all around vaccine site. Temp 98.9.
Age: 32.0
Sex: M
Vaccine: ANTH, IPV, MMR
Symptoms: Acne, Erythema, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: Right arm was swollen and itching 2 days after. Then Sunday morning, my back was broke out in a raised red rash with pimples. Took BENADRYL and redness went away.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4, FLUX, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 13 year old, non-pregnant, female patient. The patient had a drug reaction or allergy to penicillin (unspecified). On 17-FEB-2017, the patient was vaccinated with first dose of GARDASIL 9 lot # M041212 with expiration date on 21-JUN-2018. During the same visit, the patient also received an an unspecified flu vaccine. Immediately after administration, the patient had a syncope event with tonic-clonic movements in both hands. The physician assistant immediately laid the patient down as treatment, the patient woke right. The physician assistant proceeded to observe the patient for an additional 1 hour and 30 minutes from administration to check if nothing else would occur. The outcome of the events was reported as recovered. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of tonic-clonic movements in both hands was considered to be medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4, FLUX, HPV9
Symptoms: Immediate post-injection reaction, Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 13 year old, non-pregnant, female patient. The patient had a drug reaction or allergy to penicillin (unspecified). On 17-FEB-2017, the patient was vaccinated with first dose of GARDASIL 9 lot # M041212 with expiration date on 21-JUN-2018. During the same visit, the patient also received an an unspecified flu vaccine. Immediately after administration, the patient had a syncope event with tonic-clonic movements in both hands. The physician assistant immediately laid the patient down as treatment, the patient woke right. The physician assistant proceeded to observe the patient for an additional 1 hour and 30 minutes from administration to check if nothing else would occur. The outcome of the events was reported as recovered. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of tonic-clonic movements in both hands was considered to be medically significant. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Staring
Clinical narrative: This is a spontaneous report from a contactable nurse. A 2-month-old female patient of unknown race/ethnicity received on 14Jun2017 15:47 the first dose of PREVNAR 13 (lot number R48402, expiration date 30Apr2018, NDC number 0005-1971-02) at 0.5 ml single dose intramuscular in the right thigh for routine 2 month vaccinations. In the same date, the patient received also first dose of PENTACEL (Sanofi, lot number C5316AA, expiration date 13Feb2018, NDC number 49281-510-05) at 0.5 ml single dose intramuscular in the right thigh and first dose of ROTATEQ (Manufacturer: Merck, lot number M035456, expiration date 01May2018, NDC number 0006-4047-41) at 2 ml single dose orally, both for routine 2 month vaccinations. Medical history was none. On 16May2017 the patient received second dose of hepatitis B vaccine (Manufacturer: Merck, lot number M034894) intramuscular for immunization. On 14Jun2017 the patient experienced intermittent episodes of gazing off and mom was unable to break the stare that recovered on the same date. No lab data performed. Reaction was reported as follows: The patient was brought back for 4 month immunizations and mom reported a reaction the day of her 2 month immunizations. For several hours after they went home, the patient was having intermittent episodes lasting up to 10 minutes per episode, of gazing off and mom was unable to break the stare. Depending on neuro exam the patient had a temporary stop of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid. Second doses of pneumococcal 13-val conj vac (dipht crm197 protein) and rotavirus vaccine live reassort oral 5v were administered on 14Aug2017 during 4-month visit.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR13 may have contributed to the occurrence of the reported event of the episodes of gazing off / the stare considering the close time association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3
Symptoms: Myalgia, Pyrexia, Tinnitus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 65-year-old male patient who received BOOSTRIX (batch number 7Z9Z5, expiry date 31st May 2019). Concomitant products included meloxicam, FLUAD, PREVNAR 13 and ZOSTAVAX. On 14th August 2017, the patient received BOOSTRIX .5 ml. On 15th August 2017, 1 days after receiving BOOSTRIX, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved. The reporter considered the tinnitus to be unrelated to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in left arm. The FLUAD vaccine was manufactured by Seqirus. The PREVNAR vaccine was manufactured by Pfizer and the ZOSTAVAX vaccine was manufactured by Merck. Concomitant products included FLUAD vaccine (batch number 178303, expiry date 30th April 2018) received on 14th August 2017 on left arm, PREVNAR 13 vaccine (batch number R70446, expiry date 30th April 2018) received on 14th August 2017 on right arm and ZOSTAVAX vaccine (batch number L025375, expiry date 18th Jan 2018) received on 14th August 2017 on right arm.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3
Symptoms: Tinnitus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 65-year-old male patient who received BOOSTRIX (batch number 7Z9Z5, expiry date 31st May 2019). Concomitant products included meloxicam, FLUAD, PREVNAR 13 and ZOSTAVAX. On 14th August 2017, the patient received BOOSTRIX .5 ml. On 15th August 2017, 1 days after receiving BOOSTRIX, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved. The reporter considered the tinnitus to be unrelated to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in left arm. The FLUAD vaccine was manufactured by Seqirus. The PREVNAR vaccine was manufactured by Pfizer and the ZOSTAVAX vaccine was manufactured by Merck. Concomitant products included FLUAD vaccine (batch number 178303, expiry date 30th April 2018) received on 14th August 2017 on left arm, PREVNAR 13 vaccine (batch number R70446, expiry date 30th April 2018) received on 14th August 2017 on right arm and ZOSTAVAX vaccine (batch number L025375, expiry date 18th Jan 2018) received on 14th August 2017 on right arm.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3
Symptoms: Headache, Injection site pain, Pyrexia, Tinnitus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 65-year-old male patient who received BOOSTRIX (batch number 7Z9Z5, expiry date 31st May 2019). Concomitant products included meloxicam, FLUAD, PREVNAR 13 and ZOSTAVAX. On 14th August 2017, the patient received BOOSTRIX .5 ml. On 15th August 2017, 1 days after receiving BOOSTRIX, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved. The reporter considered the tinnitus to be unrelated to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in left arm. The FLUAD vaccine was manufactured by Seqirus. The PREVNAR vaccine was manufactured by Pfizer and the ZOSTAVAX vaccine was manufactured by Merck. Concomitant products included FLUAD vaccine (batch number 178303, expiry date 30th April 2018) received on 14th August 2017 on left arm, PREVNAR 13 vaccine (batch number R70446, expiry date 30th April 2018) received on 14th August 2017 on right arm and ZOSTAVAX vaccine (batch number L025375, expiry date 18th Jan 2018) received on 14th August 2017 on right arm.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Burning sensation, Fatigue, Headache, Hypoaesthesia
Clinical narrative: One hour after shot (left arm by nurse record, right arm according to patient), he described tingling and numbness of hands, purple color of right index finger, then tingling of toes. That night he got body aches all over, headache, fatigue and slight fever at 100F. 2 days later on July 5 he had worse pains of left arm, elbow and hand and malaise. Burning and tingling of hands and feet continued for weeks. On July 23 left foot was more painful, left big toe and right index finger turned purple.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: One hour after shot (left arm by nurse record, right arm according to patient), he described tingling and numbness of hands, purple color of right index finger, then tingling of toes. That night he got body aches all over, headache, fatigue and slight fever at 100F. 2 days later on July 5 he had worse pains of left arm, elbow and hand and malaise. Burning and tingling of hands and feet continued for weeks. On July 23 left foot was more painful, left big toe and right index finger turned purple.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Skin discolouration
Clinical narrative: One hour after shot (left arm by nurse record, right arm according to patient), he described tingling and numbness of hands, purple color of right index finger, then tingling of toes. That night he got body aches all over, headache, fatigue and slight fever at 100F. 2 days later on July 5 he had worse pains of left arm, elbow and hand and malaise. Burning and tingling of hands and feet continued for weeks. On July 23 left foot was more painful, left big toe and right index finger turned purple.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Steven-Johnson's syndrome
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ, lot # M041184, M043836, M040267, M041770, M046008, N000175 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1708USA007446: US-009507513-1708USA007447:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 07-AUG-2017,  the patient was vaccinated with a dose of improperly stored VAQTA (strength, dose, frequency and route unknown, lot # N005605, expiration date 08-APR-2018). The vaccine was stored at 47 to 77 degrees Fahrenheit for 15 minutes. There was no previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of GARDASIL 9 lot# M009173 (lot# M009173 is an invalid lot number for GARDASIL 9) with expiration date 20-NOV-2019, or lot# N009801 with expiration date 20-NOV-2017 (dose number, route of administration and anatomical location were not reported) were administered to the patients. The doses were stored in temperatures from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 5 minutes. Digital data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007202: US-009507513-1708USA007201:
Age: 47.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old male patient with white blood cell count decreased and multiple sclerosis. On an unknown date in April 2013, the patient was vaccinated with VARIVAX for "prevention of chickenpox". Concomitant therapies included sterile diluent. On an unknown date in 2017, the patient experienced "varicella titer" negative. The outcome of antibody test negative was reported as not recovered/not resolved. The causality assessment was not provided.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Loss of consciousness, Tunnel vision
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a 14 year old male patient.  The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies.  On 07-AUG-2017, the patient was vaccinated with his first dose of GARDASIL 9, 0.5 ml, intramuscular for prevention of Human Papilloma Virus (HPV) (lot# and expiration date were not reported). On the same day, 5 minutes after receiving the immunization, the patient "had tunnel vision and passed out ". The physician did check the patient's blood pressure and blood sugars and "they were normal", the patient's blood pressure was 107/70. No treatment was given for the events. At the time of the report, the outcome of events was recovered. Upon internal review, tunnel vision was determined to be medically significant.
Age: 26.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an adult patient of unknown exact age. On 01-AUG-2017, the patient was vaccinated with PROQUAD lot # M022402 for prophylaxis. Concomitant therapies included STERILE DILUENT. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to 40 unspecified patients of unknown gender and age. No information regarding the patients' concomitant medications, pertinent medical histories and drug reactions or allergies was provided. On unknown dates, 40 unspecified patients were vaccinated with improperly stored doses of M-M-R II (albumin status of recombinant human albumin (rHA)) lot # M042846, expiration date 21-OCT-2018 and lot # M045392, expiration date: 14-NOV-2018 (dose and route of administration were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature of 12.2 Celsius degrees for a time frame of 37 minutes. The temperature excursion was recorded by a digital data logger and the previous excursion was reported as 9.3 Celsius degrees for 16 minutes for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007367: US-009507513-1708USA008139: US-009507513-1708USA008140: US-009507513-1708USA008141.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Injection site vesicles, Lip and/or oral cavity cancer
Clinical narrative: This spontaneous report was received from a Nurse concerning a female patient of unknown age. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. It was unknown if the patient had any drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (route: unspecified injection) (dose number, dose, unit, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (indication, route, dose, frequency, lot# and expiration date were not reported). On an unknown date, several days after vaccination, one vesicle appeared at the patient's injection site and resolved on an unknown date. Later, the patient was diagnosed with oral cancer (death and medically significant). It was unknown if the patient received treatment. It was unknown if the patient sought medical attention. Approximately on an unspecified date in 2007 (10 years ago) the patient died. The cause of the death was oral cancer. It was unknown if autopsy was done. No product quality complaint was involved. Causality for the events was not reported. Upon internal review, the event oral cancer was determined to be medically significant.; Reported Cause(s) of Death: Oral cancer.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, strength, lot # and expiry date not reported) for prophylaxis. Concomitant therapies included sterile diluent. The pharmacist reported that the patient received 2 doses of ZOSTAVAX, each dose on a different unspecified date (extra dose administered). No adverse effects reported. This is one of the 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-AUG-2017 the patient was vaccinated with a dose of RECOMBIVAX HB lot # L026598 that had expired on 26-JUN-2017, 0.5 ml, intramuscular for prophylaxis. No adverse event was reported.  Additional information has been requested.