chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Fall, Hypotension, Pallor
Clinical narrative: Approximately 15 mins post vaccination, patient returned to clinic with c/o feeling dizzy. Patient had gone to get food since he had not eaten. Patient was pale, skin was cold and clammy, he was instructed to lie down. Every time patient sat up he felt dizzy. Patient then stood up, took 2 steps and fainted, fell to floor but did not hit head. EMS was called. BP was low but steadily improved. 11:00 am BP=100/50, p=86, 11:15 am BP=102/50, 11:30 am BP=120/62. EMT asked him if he wanted to go to hospital and he said yes. Transported to Hospital by rescue. Doctor spoke with nurse later and he stated patient was doing fine.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Approximately 15 mins post vaccination, patient returned to clinic with c/o feeling dizzy. Patient had gone to get food since he had not eaten. Patient was pale, skin was cold and clammy, he was instructed to lie down. Every time patient sat up he felt dizzy. Patient then stood up, took 2 steps and fainted, fell to floor but did not hit head. EMS was called. BP was low but steadily improved. 11:00 am BP=100/50, p=86, 11:15 am BP=102/50, 11:30 am BP=120/62. EMT asked him if he wanted to go to hospital and he said yes. Transported to Hospital by rescue. Doctor spoke with nurse later and he stated patient was doing fine.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Patient reported Bell's palsy, as diagnosed at hospital ER.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called around 12:00pm on 10/7/18 to report redness, warmth, and swelling around injection site which started about 12 hours after initial injection. She has had reaction to flu vaccine approx. 10-15 years ago, but has not had any problems since then. Says reaction is not as severe as she had in the past. Past reaction resulted in her going to ER, but she does not feel this is necessary at this time. Was recommended that patient go to urgent care or ER to have vaccination site checked out, but she declined at this time. Patient will be taking ibuprofen to help with swelling and will report back with any changes.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: Patient reported getting a red spot below and off to the side of the injection site a couple of days after vaccination day. She reported that the spot was not painful but warm and got warmer after shower. No other symptoms reported.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache
Clinical narrative: Patient stated she experienced a headache the night of vaccine administration and on and off for a few days following administration. She states that she usually never gets headaches. The patient stated that the frequency and intensity of the headaches were decreasing with time. She did not seek medical care that we are aware of and just wanted to share her experience.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fall, Injection site nodule, Pain, Vertigo
Clinical narrative: PATIENT STATES SHE HAD A KNOT AT INJECTION SITE; RED ON THE WHOLE TOP OF HER ARM; ACHING ALL OVER; VERTIGO; ACTUALLY FELL DOWN INTO A CHAIR.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 6 days later I was diagnosed with shingles.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient came in the day after the imz and the area that was the imz site was raised and red. I suggested cold and ibuprofen. She later called her md and he suggested the ibuprofen and warm packs. Spoke to her today and she is fine.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Patient stated that a few days after the vaccine (approx. 3-4 days) his arm started to ache and it continued for over a month. He also developed a rash on his chin that he still has. He is not sure if the rash on his chin is related to the vaccine or not.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Woke up with severe headache(I never get headaches) -couldn't even get out of bed until 2 pm  Took TYLENOL around noon----much better by 6pm. Back to normal next morning.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Painful site of injection, all over muscle soreness and fatigue. Chills and fever in PM. Bed rest required on 2nd day.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Patient came in the store the following day showing her arm which was erythematous and warm to touch. The patient wanted to confirm this was an ADR to the vaccine since she had previously been immunized in the past with no issues. The area was large covering 3 to 4 inches in diameter and 2-3 inches in length. She stated that it did itch and took a BENADRYL that seemed to help. The patient also voiced concern about getting the vaccine the following year.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia, Visual impairment
Clinical narrative: Patient notified the Pharmacy of the situation on 10/7/18. She complained of vision changes and being sensitive to the lights at store, where she works. This started on 10/5/18 at around 8 pm. She left work early that day. It happened again on 10/6/18 at 8 pm and she left work early as well. She has no issues at home or anywhere else per patient.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema
Clinical narrative: REDNESS BELOW THE SHOT THAT PATIENT STATES SEEMS TO BE GROWING.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Pyrexia
Clinical narrative: Chills, headache, fever of 100.7, very tired. Took EXCEDRIN and slept a lot. Felt 100% by the following morning.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Mobility decreased, Pain in extremity, Rash
Clinical narrative: Patient received both PNEUMOVAX 23 and FLUZONE HD on 10-4. On 10/7 patient notified pharmacy that she had a reaction that involved a rash on her arm that extended to her armpit as well as having a headache and chills. She also stated that her arm was so sore that she couldn't lift it.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: Patient came in on 10/7/2018 to get a flu vaccine and before I gave him the vaccine he asked that I be careful to not inject the vaccine to high on his shoulder because when he got the PNEUMOVAX 23 vaccine on 9/26/2018 he thought the injection was too high and close to the joint. He said that he could not raise his arm for two days and after that his shoulder was fine.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Patient experienced burning at injection site and a significant red area with a couple of blisters looked like a large bruise purple /red.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Mobility decreased, Pain in extremity, Rash
Clinical narrative: Patient received both PNEUMOVAX 23 and FLUZONE HD on 10-4. On 10/7 patient notified pharmacy that she had a reaction that involved a rash on her arm that extended to her armpit as well as having a headache and chills. She also stated that her arm was so sore that she couldn't lift it. She is taking Ibuprofen and applying a cool compress to the area.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient came in to pharmacy on Oct 7, 2018 at 4:30, her left arm is red, swollen at vaccination site & says it is warm. I suggested for her to take anti-itch tablet for itch and call MD if it worsens.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient was given the vaccine on 10/4/18. On 10/05/18 the patient states when she woke up that her arm was red and swollen around the injection site and she had some pain. The next day the redness and swelling had started to spread further on her arm and was still hot to touch. She states it was very painful to move her arm. Patient came in today 10/7/18 and I could visibly see the patient's arm was red and swollen at the injection site and spreading further around her arm from the elbow up on the backside of her arm. It was hot to touch. She said she was finally able to move her arm some today. I told the patient to apply a cool compress and she could take some TYLENOL for the pain. We will contact patient's PCP and be in contact with the patient for further instructions. She said that she took 2 BENADRYL on 10/05/18 and it did nothing for her. Patient states she has not had trouble breathing or any type of anaphylactic reaction.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersomnia, Influenza like illness, Night sweats
Clinical narrative: Headache began in evening; chills and sweats during night; swollen arm; low grade fever next day; flu-like symptoms for 2 days; slept most of the 2 days.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Headache began in evening; chills and sweats during night; swollen arm; low grade fever next day; flu-like symptoms for 2 days; slept most of the 2 days.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient came in the Tuesday following the immunization and complained of swelling, sorness, and redness at and around the injection site. She showed me the site and it was still visibly swollen and there was some redness a few inches below the injection site. She had been to the gym and done some lifting, so that may have contributed to the swelling somewhat.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation
Clinical narrative: Patient stated the next morning he felt a burning sensation in both arms that slowly fade as the day goes on.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chromaturia, Constipation, Headache, Mobility decreased, Pain
Clinical narrative: Pt reports within 2 hours that her arm was hurting worse than usual, to the point of not being able to use it to lift herself from the chair. She reports that the following day she started becoming incontinent (urination) and the color was unusually dark and stained the floor where she "leaked". She also reports that due to "routine bowel resections" she usually has frequent BMs of 10-12 times daily, but now is not going at all. Reports headaches, body aches as well as a low grade fever. This was reported to me on 10/7/18 (2 days after the vaccinations). She called a family member and wanted to go to urgent to be sure she was ok. I affirmed that this would be a good idea and to keep me posted. She then came to the pharmacy 4 hours later and reported that the clinic diagnosed her with a UTI possibly aggravated by the immunizations (treated with antibiotics and prednisone).
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Urinary incontinence, Urinary tract infection
Clinical narrative: Pt reports within 2 hours that her arm was hurting worse than usual, to the point of not being able to use it to lift herself from the chair. She reports that the following day she started becoming incontinent (urination) and the color was unusually dark and stained the floor where she "leaked". She also reports that due to "routine bowel resections" she usually has frequent BMs of 10-12 times daily, but now is not going at all. Reports headaches, body aches as well as a low grade fever. This was reported to me on 10/7/18 (2 days after the vaccinations). She called a family member and wanted to go to urgent to be sure she was ok. I affirmed that this would be a good idea and to keep me posted. She then came to the pharmacy 4 hours later and reported that the clinic diagnosed her with a UTI possibly aggravated by the immunizations (treated with antibiotics and prednisone).
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT ARM WAS RED AND SWOLLEN. 2 DAYS LATER STILL RED AND SWOLLEN BUT SLOWLY SUBSIDING.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Left arm is swolen, red, and warm to touch. Patient states left deltoid is tender to the touch.
Age: 51.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Heart rate increased, Hypotension, Injection site rash, Pyrexia, Swelling
Clinical narrative: Patient stated that starting about 2 hours after receiving the vaccine he had the following symptoms: Fever (99.6), Increased heart rate (122 bpm) lowered BP (systolic was 100 when he usually runs 140); he also had a rash at site of injection and swelling along his Right Axilla and up into his neck/down right side of torso.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood culture, Sepsis
Clinical narrative: Patient was hospitalized with sepsis.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising, Injection site joint discomfort
Clinical narrative: Patient returned to the pharmacy on 10/7/2018 to report an adverse reaction to his vaccination received 9/23/2018. He reported short term joint discomfort lasting 24-48 hours. He also reported a dark purple bruise at the injection site that has persisted. The presence of the bruise was confirmed on 10/7/18. It is on his left upper deltoid and slightly larger than the size of a quarter, circular in shape. The patient reported there has been little to no change in the size or color of the bruise since it appeared. He states no other signs (pain, warm to the touch, swelling, redness, etc) are present.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Cough, Myalgia, Pain, Pruritus generalised
Clinical narrative: Moderate muscle and whole body aches. Mild to moderate itching from head to toe. This lasted through the night. The next morning I felt a little better. Then developed a moderate cough, mild chest pains and sinus.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Sinus pain
Clinical narrative: Moderate muscle and whole body aches. Mild to moderate itching from head to toe. This lasted through the night. The next morning I felt a little better. Then developed a moderate cough, mild chest pains and sinus.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, pain, and swelling on right arm in approximate area of injection site on 10/4/18. She saw her primary care physician that day and was prescribed triamcinolone 0.1% cream twice daily, azithromycin 250mg 5 day dose pak, and tramadol 50mg twice daily.
Age: 71.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Extreme soreness at site and up and left down arm, chills and fever, muscle soreness entire body, headache, fatigue. Symptoms began within several hours of vaccine administration. Shingles vaccine was given in the left arm, flu vaccine in right arm. Shingles vaccine symptoms, except for soreness, lasted around 18 hours. Soreness lasted for 2 1/2 days. Soreness from flu vaccine was minimal.
Age: 71.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Extreme soreness at site and up and left down arm, chills and fever, muscle soreness entire body, headache, fatigue. Symptoms began within several hours of vaccine administration. Shingles vaccine was given in the left arm, flu vaccine in right arm. Shingles vaccine symptoms, except for soreness, lasted around 18 hours. Soreness lasted for 2 1/2 days. Soreness from flu vaccine was minimal.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Malaise, Urticaria
Clinical narrative: After 1st vaccine my arm was sore and tingling within two hours. The next day I couldn't move my arm at all and had an overall sick feeling. I called in sick to work. After 2nd vaccine my arm was not so sore but two days later I had (still have) hives on the same arm as the vaccine was injected into. I have no other hives but again this time, feel ill. I also have lightheadedness this time.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever, chills, flu-like symptoms (congestion, cough, aches).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory tract congestion
Clinical narrative: Fever, chills, flu-like symptoms (congestion, cough, aches).
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Heart rate increased, Tremor
Clinical narrative: HE SAID THE NEXT MORNING HE HAD SHAKING AND CHILLS. THEY CALLED THE AMBULANCE AND ALL THAT THEY COULD FIND WAS AN INCREASED HEART RATE OF 114 BBM. THE SHAKING AND CHILLS HAD STOPPED. HE DID NOT FOLLOW UP WITH ANY OTHER HEALTH CARE PROVIDER.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Influenza like illness, Injection site inflammation, Pain
Clinical narrative: Flu like symptoms, soreness, inflammation spreading around site area approximately 6 inches in area. I have been applying ice to the area. Taking Ibuprofen and started BENADRYL after redness was still spreading on the 5th day.
Age: 89.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: The patient noted the next day she had a rash come up around the injection site. She did not report it, and it continued to grow throughout the week. Her daughter came to visit her today and she told her daughter about the rash. The daughter called the pharmacy and was advised to bring her to the pharmacy or urgent care clinic across from us. The daughter brought her mom into the pharmacy to see if it was something I thought could be treated topically or if she needed to take her to the Dr. I told her after seeing her definitely the doctor. They came back later with a prescription for an oral antibiotic.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient had large red patch that started near the immunization site and continuted down the arm. It was warm to the touch and itchy. The reaction started about one day following the immunization. She came to the pharmacy four day after the vaccniation and the red area was continuing to spread. She has followed up with urgent care yesterday (10/6/18) and again today (10/7/18) and was put on antibiotics and a steriod. The red area is decreasing in size and the area does not feel as warm.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient's arm was swelling, and painful. She was developing a fever. For treatment she was taking TYLENOL, icing the arm, and BENADRYL at night to help with the swelling.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased
Clinical narrative: The patient said that the area was red and it was difficult to fold her arm. I suggested she take TYLENOL (because she didn't want to take ibuprofen) and to alternate cold and warm packs. I called her after a few hours and she said that she was doing better. We will follow up with her doctor in the morning.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid oedema
Clinical narrative: Severe swelling of both right and left eyelids. Had to take 6 doses of BENADRYL ALLERGY liquid gel caps 25mg. each.
Age: 86.0
Sex: F
Vaccine: FLUX
Symptoms: Cerumen removal, Ear pain, Neck pain
Clinical narrative: Got flu shot at Dr.'s office on Tuesday. Tuesday night, started having severe pain around right ear area (NOT in the ear - around the ear) and neck area behind ear. Went back to Dr.'s on Thur with pain complaint - they said must be allergies, but cleaned out wax in both ears. Said take aspirin. Went back to Dr.'s office on Saturday. They have prescription for general antibiotic, said to come back on Oct. 10th if still pain. My mother NEVER complains of pain. She has been in severe pain since flu shot given. Aspirin is NOT helping. She does NOT have allergies.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Pneumonia
Clinical narrative: Patient's husband came in today stating that the patient developed pneumonia symptoms two days after receiving vaccine (9/18/2018). He said they had to visit the hospital (he didn't have the name of the hospital) and was discharged over the past couple of days. Patient was prescribed augmentin for their pneumonia on 10/4/2018 for 2 days (previous therapy was administered in hospital). Patient's husband states they are taking her into urgent care today because she's still not feeling well.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Swollen tongue
Clinical narrative: Pt received FLUZONE HIGH DOSE vaccine morning of 10/07/2018. Pt called pharmacy at around 4:30PM same day to report adverse event experienced with flu shot. Pt tongue was swollen and she gave herself an epinephrine shot at around 4:00PM. Pt stated she has not gotten worse after given herself the epinephrine shot. Pt just turned 65 this August and therefore was given the high dose flu vaccine. Pt stated not allergic to latex or egg. Unclear what might have caused the allergic reaction. Pt was encouraged to call 911 if condition worsen or having trouble breathing.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient's arm swelled up immediately after injection. Became very tender, swollen, and hard in a one inch radius around the injection site. Patient did not feel dizzy, could breathe fine, and overall felt in general health. I had the patient sit in the sitting room for five minutes under observation, then in the waiting room for 15 minutes. After 15 minutes, I checked on the patient to monitor for changes, and the swelling and hardness had stopped progressing. He still felt "the way he usually feels", so I instructed his son to continue to monitor him and seek medical attention if he started to worsen or show signs of anaphylaxis.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever and severe pain in left arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Impaired work ability, Injection site pain, Injection site reaction
Clinical narrative: Chills, fever lasting from 4:30 am 10/6 through 12:30 pm 10/7, headache, painful muscles over entire body, painful at injection site and unable to raise arm without pain, unable to work due to fever, now an itchy rash is developing around injection site. Same symptoms occurred with first injection except for itchy rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Rash pruritic
Clinical narrative: Chills, fever lasting from 4:30 am 10/6 through 12:30 pm 10/7, headache, painful muscles over entire body, painful at injection site and unable to raise arm without pain, unable to work due to fever, now an itchy rash is developing around injection site. Same symptoms occurred with first injection except for itchy rash.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Feeling hot
Clinical narrative: During the afternoon of 9/11, approximately 20 hours after the vaccination, began feeling warm. My temperature was 99.7. I took 2 ADVIL & rested at home from 4-7pm. I felt fine from there on.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Aggression, Condition aggravated, Confusional state, Focal dyscognitive seizures, Laboratory test normal
Clinical narrative: Patient had a partial complex seizure that started 90 minutes after administration. She was unresponsive for 5 minutes followed by her most severe postictal state ever. She was completely confused, combative: hitting, kicking, screaming.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Postictal state, Screaming, Unresponsive to stimuli
Clinical narrative: Patient had a partial complex seizure that started 90 minutes after administration. She was unresponsive for 5 minutes followed by her most severe postictal state ever. She was completely confused, combative: hitting, kicking, screaming.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient stated that after she recieved the PNEUMOVAX 23 on 10/06/18 at 2:40pm, she noticed that her left arm started to swell, redness, very itchy, but no reports of pain or feeling lightheadedness/ dizziness. Pt noticed this event at night sometime and told her daughter about it. Pt came into pharmacy the next day at 1:10pm and informed and showed me (pharmacist) this adverse event. Pt was given to use BENADRYL cream OTC to help with the itching and will inform her Oncologist as well. I informed pt that I will follow up with her in a couple of days to ensure she is doing okay as well inform her MD.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune disorder, Biopsy kidney abnormal, Blood urine present, DNA antibody positive, Protein urine present
Clinical narrative: In late November 2015 she developed a UTI.  After treatment from antibiotics follow up urine tests indicated large amounts of blood and protein in urine. We were referred to urology in January 2016 and finally nephrology by May 2016.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Renal disorder, Urinary tract infection
Clinical narrative: In late November 2015 she developed a UTI.  After treatment from antibiotics follow up urine tests indicated large amounts of blood and protein in urine. We were referred to urology in January 2016 and finally nephrology by May 2016.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Inflammation of injection site with erythema onset 24 h post injection. Pt treating with BENADRYL and cold compress.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy skin, Biopsy skin abnormal, Burning sensation, Hypersensitivity vasculitis, Rash
Clinical narrative: This is a serious literature case, initially received on 01-Oct-2018 and concerns an 82-year-old, elderly, male patient. On an unspecified date (reported as 2 weeks prior), the patient was administered Influenza Vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On an unspecified date (reported as one week prior), after the vaccination (reported as following influenza vaccination), the patient developed pruritic and burning rash. Dermatological examination revealed an erythematous maculopapular rash involving the neck, chest and bilateral upper extremities. Histological examination of punch biopsies from the medial and lateral left shoulder revealed a neutrophilic infiltrate involving the vessels of the superficial vascular plexus, extravasation of erythrocytes into the surrounding dermis, and extensive nuclear debris. The endothelial cells within the affected vessels appeared enlarged and damaged. Subsequently, the patient was diagnosed with leucocytoclastic vasculitis. At the time of this report, the outcome of the events was not reported. The development of various types of vasculitides occurring in timely association with influenza vaccination had been rarely reported.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: This is a serious literature case, initially received on 01-Oct-2018 and concerns an 82-year-old, elderly, male patient. On an unspecified date (reported as 2 weeks prior), the patient was administered Influenza Vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On an unspecified date (reported as one week prior), after the vaccination (reported as following influenza vaccination), the patient developed pruritic and burning rash. Dermatological examination revealed an erythematous maculopapular rash involving the neck, chest and bilateral upper extremities. Histological examination of punch biopsies from the medial and lateral left shoulder revealed a neutrophilic infiltrate involving the vessels of the superficial vascular plexus, extravasation of erythrocytes into the surrounding dermis, and extensive nuclear debris. The endothelial cells within the affected vessels appeared enlarged and damaged. Subsequently, the patient was diagnosed with leucocytoclastic vasculitis. At the time of this report, the outcome of the events was not reported. The development of various types of vasculitides occurring in timely association with influenza vaccination had been rarely reported.
Age: 60.0
Sex: U
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Patient called today 10/7 to say she was C/O pain and had swelling on arm to collar bone and back to shoulder blade. Also said very painful. I recommended a walk in clinic visit.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyskinesia, Pain, Tremor
Clinical narrative: Had shot Fri evening, woke up achy Sat AM took ADVIL and felt fine rest of day. When she went to bed she had tremor and jerky movements begin from her knees up to her shoulders and it was uncontrollable. Event lasted about 30 min and has not reoccurred.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Lethargy, Rash generalised
Clinical narrative: Pt. had rash on entire body, felt hot and lethargic for a few days.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Excessive eye blinking, Hyperhidrosis, Influenza like illness
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Shingrix (batch number Z9RR4, expiry date unknown) for prophylaxis. On 15th June 2018, the patient received Shingrix. In June 2018, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was not reported. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient suffered flu-like symptoms after receiving the vaccine.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Shingrix (batch number Z9RR4, expiry date unknown) for prophylaxis. On 15th June 2018, the patient received Shingrix. In June 2018, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was not reported. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient suffered flu-like symptoms after receiving the vaccine.
Sex: U
Vaccine: FLU4, HEPAB, FLU4, HEPAB
Symptoms: Dizziness, Fatigue, Injection site pain, Joint injury, Laboratory test normal
Clinical narrative: This case was reported by a consumer and described the occurrence of fainting in a patient who received TWINRIX for prophylaxis. Co-suspect products included FLUZONE QUADRIVALENT for prophylaxis. On 11th August 2018, the patient received TWINRIX and FLUZONE QUADRIVALENT. On an unknown date, less than a week after receiving TWINRIX, the patient experienced fainting (serious criteria hospitalization), dizziness, back injury and bruising of hand. On an unknown date, the outcome of the fainting, dizziness, back injury and bruising of hand were unknown. It was unknown if the reporter considered the fainting, dizziness, back injury and bruising of hand to be related to TWINRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient received two vaccinations, TWINRIX and FLUZONE and felt dizzy, fainted and patient sustained injury to back and right contusion. The patient sent to hospital via ambulance. It was unknown if the reporter considered the fainting, dizziness, back injury and bruising of hand to be related to FLUZONE QUADRIVALENT.
Sex: U
Vaccine: FLU4, HEPAB, FLU4, HEPAB
Symptoms: Syncope, Tremor
Clinical narrative: This case was reported by a consumer and described the occurrence of fainting in a patient who received TWINRIX for prophylaxis. Co-suspect products included FLUZONE QUADRIVALENT for prophylaxis. On 11th August 2018, the patient received TWINRIX and FLUZONE QUADRIVALENT. On an unknown date, less than a week after receiving TWINRIX, the patient experienced fainting (serious criteria hospitalization), dizziness, back injury and bruising of hand. On an unknown date, the outcome of the fainting, dizziness, back injury and bruising of hand were unknown. It was unknown if the reporter considered the fainting, dizziness, back injury and bruising of hand to be related to TWINRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient received two vaccinations, TWINRIX and FLUZONE and felt dizzy, fainted and patient sustained injury to back and right contusion. The patient sent to hospital via ambulance. It was unknown if the reporter considered the fainting, dizziness, back injury and bruising of hand to be related to FLUZONE QUADRIVALENT.
Sex: U
Vaccine: FLU4, HEPAB, FLU4, HEPAB
Symptoms: Back injury, Contusion, Dizziness, Syncope
Clinical narrative: This case was reported by a consumer and described the occurrence of fainting in a patient who received TWINRIX for prophylaxis. Co-suspect products included FLUZONE QUADRIVALENT for prophylaxis. On 11th August 2018, the patient received TWINRIX and FLUZONE QUADRIVALENT. On an unknown date, less than a week after receiving TWINRIX, the patient experienced fainting (serious criteria hospitalization), dizziness, back injury and bruising of hand. On an unknown date, the outcome of the fainting, dizziness, back injury and bruising of hand were unknown. It was unknown if the reporter considered the fainting, dizziness, back injury and bruising of hand to be related to TWINRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient received two vaccinations, TWINRIX and FLUZONE and felt dizzy, fainted and patient sustained injury to back and right contusion. The patient sent to hospital via ambulance. It was unknown if the reporter considered the fainting, dizziness, back injury and bruising of hand to be related to FLUZONE QUADRIVALENT.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: This spontaneous report was received from a nurse and refers to a 1 year old female patient. The patient had no relevant medical history, conurrent conditions nor was taking concomitant medicatios. No allergies were reported. On 10-SEP-2018, the patient was vaccinated with VARIVAX subcutaneously, for prophylaxis, lot # R011809 and expiration date 23-APR-2020 (dose, stength and frequency were unknown). On the same date, the patient was also vaccinated with M-M-R II for prophylaxis; dose, strength, route of administration, frequency, lot# and expiration date were unknown. Vaccines were reconstituted with sterile diluent (Merck Sharp & Dohme). On 18-SEP-2018, the patient developed an elevated temperature and on 20-SEP-2018 the patient developed a rash. The outcome of body temperature increased and rash was reported as recovering. Causal relationship between the suspect therapies and the mentioned events was unknown.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Body temperature increased, Rash
Clinical narrative: This spontaneous report was received from a nurse and refers to a 1 year old female patient. The patient had no relevant medical history, conurrent conditions nor was taking concomitant medicatios. No allergies were reported. On 10-SEP-2018, the patient was vaccinated with VARIVAX subcutaneously, for prophylaxis, lot # R011809 and expiration date 23-APR-2020 (dose, stength and frequency were unknown). On the same date, the patient was also vaccinated with M-M-R II for prophylaxis; dose, strength, route of administration, frequency, lot# and expiration date were unknown. Vaccines were reconstituted with sterile diluent (Merck Sharp & Dohme). On 18-SEP-2018, the patient developed an elevated temperature and on 20-SEP-2018 the patient developed a rash. The outcome of body temperature increased and rash was reported as recovering. Causal relationship between the suspect therapies and the mentioned events was unknown.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a nurse referring to a 1 year old male patient. Information about concomitant medication, medical history and drug reactions/allergies was not provided. On 11-SEP-2018, the patient was vaccinated with VARIVAX (lot # R011809, expired date 23-APR-2020) subcutaneously, M-M-R II and sterile diluent (MERCK STERILE DILUENT) for prophylaxis. On the same day, the patient received purified protein derivative (PPD) skin test. On 20-SEP-2018, the patient experienced rash. At the reporting time, the outcome of rash was reported as recovering. The causality was not provided.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a nurse referring to a 1 year old male patient. Information about concomitant medication, medical history and drug reactions/allergies was not provided. On 11-SEP-2018, the patient was vaccinated with VARIVAX (lot # R011809, expired date 23-APR-2020) subcutaneously, M-M-R II and sterile diluent (MERCK STERILE DILUENT) for prophylaxis. On the same day, the patient received purified protein derivative (PPD) skin test. On 20-SEP-2018, the patient experienced rash. At the reporting time, the outcome of rash was reported as recovering. The causality was not provided.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt went to ER 9/18/18 with bilateral facial weakness, distal extremity paresthesias, areflexia, elevated protein on LP. Diagnosis of Guillain-Barre.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Areflexia, CSF immunoglobulin increased, CSF protein increased, Facial paresis, Guillain-Barre syndrome
Clinical narrative: Pt went to ER 9/18/18 with bilateral facial weakness, distal extremity paresthesias, areflexia, elevated protein on LP. Diagnosis of Guillain-Barre.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia
Clinical narrative: Pt went to ER 9/18/18 with bilateral facial weakness, distal extremity paresthesias, areflexia, elevated protein on LP. Diagnosis of Guillain-Barre.
Age: 90.0
Sex: U
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: This case was reported by a other health professional via other manufacturer and described the occurrence of atrial fibrillation in a 90-year-old patient who received SHINGRIX for prophylaxis.  Co-suspect products included FLUZONE HD for prophylaxis. On an unknown date, the patient received SHINGRIX and FLUZONE HD. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant) and drug administration error. On an unknown date, the outcome of the atrial fibrillation was recovered/resolved and the outcome of the drug administration error was unknown. It was unknown if the reporter considered the atrial fibrillation to be related to SHINGRIX. Additional information received as follows: The past weekend from the reporting date, the reporter had the patient that experienced the adverse events with concomitant administration of FLUZONE HD and SHINGRIX. The patient insisted on getting both shots administered in the same arm, which led to drug administration error. According to her physician, the patient was then thrown into Atrial Fibrillation. They were able to correct this and the patient was stable at the time of reporting. The reporter was wondering if there was any data where this had happened before so that the reporter might advised his or her pharmacist on how to deal with situations like this. The reporter was asking if GlaxoSmithKline could have somebody from their team, contact reporter when they got a chance in regarded to this manner, the reporter would appreciate it. No additional information was provided. The reporter allowed to contact directly for additional information.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Vaccine positive rechallenge
Clinical narrative: Extreme fatigue, headache, body aches the day after the injection. First dose caused same reaction. Was fine after that one day.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient concurrent conditions, concomitant medications and medical history were not provided. On an unknown dates, the patient was vaccinated with improperly stored VARIVAX (lot# R002056, expiration date: 22-JAN-2020, lot# N034553 expiration date: 05-DEC-2019, lot# N031004, expiration date: 03-NOV-2019 and lot# N027000, expiration date: 28-SEP-2019) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT MRK) (lot# and expiration date were not reported). Dose and route of administration for all vaccines were not provided. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 9 Celsius degrees to 8 Celsius degrees for 5 hours 30 minutes. Data logger was involved. There were no previous excursions reported. No additional information has been provided. Follow up information was received from the certified medical assistant (C.M.A) on 28-SEP-2018. On 28-SEP-2018, a call was placed to the CMA. The CMA stated she would have her supervisor fax the requested patient identifiers and dates of vaccination.
Sex: U
Vaccine: HEPA, HIBV, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB for prophylaxis, lot #N024572 and expiration date 02-MAY-2020 and lot #R000877 and expiration date 24-SEP-2020 (strength, dose, frequency and route of administration were not reported); with improperly stored PNEUMOVAX 23 for prophylaxis, lot #N030987 and expiration date 15-MAY-2019 (strength, dose, frequency and route of administration were not reported); with improperly stored ROTATEQ orally for prophylaxis, lot #N034401 and expiration date 09-MAY-2019 (strength, dose, frequency were not reported) and with improperly stored VAQTA for prophylaxis, lot #R002086 and expiration date 22-APR-2019 (strength, dose, frequency and route of administration were not reported). The temperature of excursion was reported as 33° degrees Fahrenheit (°F) to 35°F (32°F) during a time frame of 39 hours. No previous temperature of excursion was reported. There was a digital data logger involved. Follow up information has been received on 04-OCT-2018. A phone call was placed to medical assistant in regards to product storage issue involving LIQUID PEDVAXHIB, PNEUMOVAX 23, ROTATEQ and VAQTA. The practice manager answered the call. She explained those vaccines were "VFC-owned, vaccines for children, and they would have to able to release that information. Tons of children were vaccinated with them.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report has received from a pharmacist referring to a 72 years old female patient. The patient had none, medical history, concomitant therapy drug reactions or allergies. Information about concurrent condition was unknown. On 12-SEP-2018, the patient received a dose of PNEUMOVAX 23 (lot # N025656, expire date 19-APR-2019) intramuscularly for prophylaxis. On the same day, after receiving received vaccine 2 hours later, the patient couldn't lift arm with severe pain which persisted to 14-SEP-2018. The patient received no treatment. There was no lab diagnostic or study performed. The pharmacist reported that "she recommended that patient call physician and apply cold compress to injection site". The outcome of the event was not recovered. Causality assessment was not provided.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a female nurse of unknown age via a company representative referring to herself. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (route, strength, dose, batch/lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had redness and a rash near the injection site. The outcome of the events was unknown.The causality between the event and PNEUMOVAX 23)was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, pertinent medical history, drug reactions or allergies provided. On 30-JUL-2018, the patient was vaccinated with the first dose of VAQTA injection, lot # R006346, expiration date 31-JAN-2021 (also reported as 21-APR-2019), (dose and route of administration were not provided) for prophylaxis. On 13-SEP-2018, the patient was vaccinated with the second dose of VAQTA injection, lot # R002487, expiration date 21-APR-2019 (dose and route of administration were not provided) for prophylaxis. No adverse event was reported.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Back pain, Blood alkaline phosphatase normal, Culture urine negative
Clinical narrative: This spontaneous report was received from a physician regarding a 17 year old male patient. The patient's pertinent medical conditions and concomitant medications were not reported. On 18-JUN-2018, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly, lot # N028567, expiry date: 17-MAY-2020 for prophylaxis. Approximately on 28-JUN-2018, 10 days after vaccination, the patient experienced fever, malaise, gross hematuria and back pain. On an unknown date in 2018, the patient's white blood cell count was dropped from 6.7 to 2.1 (unknown units) and liver enzymes were elevated. On an unknown date in 2018, the patient underwent Epstein-Barr count, urine culture and urologic imaging which was negative, and alanine transaminase was 78, aspartate transaminase was 48 and alkaline phosphatase was 73 (unknown units). The event fever was resolved on 01-JUL-2018 (reported as 3 days after) and on an unknown date in 2018, the liver enzymes returned to normal. On 31-JUL-2018, the white blood cell count was 5 (unknown units). Outcome of the other events was considered to be recovered (reported as patient was doing fine) on an unknown date in 2018. Causality assessment was not provided. No product quality complaint was involved.