chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Confusional state, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Possible seizure. Prior history of seizures reported.  Diagnosed with syncopal episode. Pt described feeling dizzy. Patient was clammy and pale in color before syncopal episode occurred. Patient was unconscious for about 45 seconds, and confused after regaining consciousness for 15 seconds. Patient was fully alert and oriented afterwards.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Possible seizure. Prior history of seizures reported.  Diagnosed with syncopal episode. Pt described feeling dizzy. Patient was clammy and pale in color before syncopal episode occurred. Patient was unconscious for about 45 seconds, and confused after regaining consciousness for 15 seconds. Patient was fully alert and oriented afterwards.
Age: 23.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Burning sensation, Pain in extremity, Ultrasound scan
Clinical narrative: Extreme pain and burning sensation down left arm
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Erythema, Induration, Skin warm
Clinical narrative: 5-6 days of redness that was warm to touch and hard ("blister like").  Ibuprofen and ice pack helped area to resolve back to normal.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Chills, Dizziness, Erythema, Headache
Clinical narrative: Nausea, dizziness, headache, chills, severe swelling and redness of arm from elbow to top of shoulder and hot to touch, upper left back ache, throbbing pain in arm.  This was given Saturday morning and it is still hot and swollen today Tuesday.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Nausea, dizziness, headache, chills, severe swelling and redness of arm from elbow to top of shoulder and hot to touch, upper left back ache, throbbing pain in arm.  This was given Saturday morning and it is still hot and swollen today Tuesday.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: patient presented to ER for swelling of left arm following immunization. DX with Cellulitis
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Laboratory test, Rash
Clinical narrative: Rash on face waiting on test result Bumps indicative of hsv 1(no prior oubreaks) , shingles , impetigo
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site pain
Clinical narrative: Patient experienced excruciating pain at the injection site and shortness of breath on second day post administration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Rash, Skin discolouration, Tenderness
Clinical narrative: The Rash is described as flat and darkened. It began 4 days ago. The Rash is located left deltoid area. It occurs as an acute condition. The Rash is associated with mild pain with deep palpation, states it is really not bothering her; it is not associated with itch, myalgias/arthralgias or burning/stinging. states she first noticed it about 24 hours after getting shingrix. She had muscle tenderness for the first 24 hours and applied ice for about 20 minutes at a time several time the first 24 hours. States soreness went away and she first noticed the skin discoloration on night of 5/31.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Headache, Injection site erythema, Nausea
Clinical narrative: Fever 101.2° F-2 days, 99°-100.8° 2days Severe headache day one, moderate 3 days Body aches first day only  Red hot around vaccination site, very sore still Nausea since day 1, took Tylenol 1,000mg 3X daily for 3 days (no relief, no fever reduction)  I drank lots of water but couldn?t eat much, if at all because of nausea for 3 days Lost 3-4 lbs  Diahrrea all 4 days, drank electrolytes
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Vaccination site pain, Vaccination site warmth, Weight decreased
Clinical narrative: Fever 101.2° F-2 days, 99°-100.8° 2days Severe headache day one, moderate 3 days Body aches first day only  Red hot around vaccination site, very sore still Nausea since day 1, took Tylenol 1,000mg 3X daily for 3 days (no relief, no fever reduction)  I drank lots of water but couldn?t eat much, if at all because of nausea for 3 days Lost 3-4 lbs  Diahrrea all 4 days, drank electrolytes
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Seizure
Clinical narrative: I went into the room to explain to mom what shots both of her sons were due for . Mom agreed to the getting their shots and signed the paper . I put my gloves on and cleaned brother's arm and gave him the  vaccines he was due for  which was Dtap , Hep B and Hep A . After I finished his vaccines I asked mom would she like patient's vaccines  both in the same leg or one vaccine in each leg since he was under 20lbs . Mom stated that she wanted both in one leg which was patient's left leg. So i put my gloves on , and being to clean his left leg to  give him the vaccines he cried a little . They left the office around 2:30pm 07/30/2019 around 3:37pm mom called and stated patient was having a seziure and it was contuining . So she brung his in when mom got here we put them in a room called 911 . The child was still in a seziure at  3:48pm when peramedics arrived . We checked oxygen leave , pulse , child was a wake.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Axillary pain, C-reactive protein, Full blood count, Injection site pain, Pain
Clinical narrative: patient's left arm is very painful with shooting pains since his HPV injection 7/25/19. This was his 2nd HPV, first one didn't give any trouble. Mother notes that he complains of pain daily, this is unusual for him. Pain is at location of injection and in armpit. Using ibuprofen with good temporary relief. Doesn't feel like his pain is improving at all.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: patient's left arm is very painful with shooting pains since his HPV injection 7/25/19. This was his 2nd HPV, first one didn't give any trouble. Mother notes that he complains of pain daily, this is unusual for him. Pain is at location of injection and in armpit. Using ibuprofen with good temporary relief. Doesn't feel like his pain is improving at all.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Culture urine, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: Developed "trouble swallowing" later that evening.  Experienced shortness of breath and chest feeling heavy that evening.  Right arm is sore.  Right leg is weak.  Nauseous.  Dizzy.  Afebrile at 98.4.  Pt notified office of these symptoms 7-30-19.  Pt was advised to go to ER for further evaluation.  Pt went to local urgent care/walk-in clinic.  Was diagnosed with UTI.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Nausea, Pain in extremity, Pregnancy test urine negative, Protein urine present
Clinical narrative: Developed "trouble swallowing" later that evening.  Experienced shortness of breath and chest feeling heavy that evening.  Right arm is sore.  Right leg is weak.  Nauseous.  Dizzy.  Afebrile at 98.4.  Pt notified office of these symptoms 7-30-19.  Pt was advised to go to ER for further evaluation.  Pt went to local urgent care/walk-in clinic.  Was diagnosed with UTI.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Streptococcus test negative, Urinary tract infection, Urine leukocyte esterase positive
Clinical narrative: Developed "trouble swallowing" later that evening.  Experienced shortness of breath and chest feeling heavy that evening.  Right arm is sore.  Right leg is weak.  Nauseous.  Dizzy.  Afebrile at 98.4.  Pt notified office of these symptoms 7-30-19.  Pt was advised to go to ER for further evaluation.  Pt went to local urgent care/walk-in clinic.  Was diagnosed with UTI.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Neck pain, Pain
Clinical narrative: Patient states feeling  "drained" with no energy the next day.  She had a slight headache and wanted to lay down she felt so exhausted.  Her neck hurt and she ached all over.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Anxiety, Computerised tomogram head normal, Dizziness, Fall, Head injury
Clinical narrative: Pt had what appeared to be a vasovagal / syncope response after receiving vaccines today. Pt was sitting up in chair smiling and talking after receiving all three vaccines. Pt did not complain of feeling dizzy or unwell. Within minutes, pt suddenly tensed up and fell out of the chair and onto the floor hitting her forehead. Pt was alert and assisted to the exam table where vitals were assessed, an ice pack was applied, and a coke was given to drink. Vitals assessed: BP 110/73 and HR 92 @ 11:24 AM and BP 117/81 HR 93 @ 11:38 AM. Pt stated after the event that she felt a little dizzy "after the third shot" (HPV vaccine) but did not say anything at the time. Pt sister stated she had not had much to eat and was a little anxious about getting shots but has never reacted like this before. Pt was monitored for about 30 minutes sitting up on exam table until father arrived to pick her up. Pt stated she felt fine with the exception of her head hurting where she hit it on the floor. Pt had about 3x3 cm knot on forehead. Pt father stated he was going to take her the ER to be checked out.  Contacted patient's father to check on patient around 5:00 PM. Pt father stated he took her to the ER where they did a cat scan and everything checked out fine. Pt father stated pt is okay and appreciated the phone call.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Swelling face, Syncope, Tension
Clinical narrative: Pt had what appeared to be a vasovagal / syncope response after receiving vaccines today. Pt was sitting up in chair smiling and talking after receiving all three vaccines. Pt did not complain of feeling dizzy or unwell. Within minutes, pt suddenly tensed up and fell out of the chair and onto the floor hitting her forehead. Pt was alert and assisted to the exam table where vitals were assessed, an ice pack was applied, and a coke was given to drink. Vitals assessed: BP 110/73 and HR 92 @ 11:24 AM and BP 117/81 HR 93 @ 11:38 AM. Pt stated after the event that she felt a little dizzy "after the third shot" (HPV vaccine) but did not say anything at the time. Pt sister stated she had not had much to eat and was a little anxious about getting shots but has never reacted like this before. Pt was monitored for about 30 minutes sitting up on exam table until father arrived to pick her up. Pt stated she felt fine with the exception of her head hurting where she hit it on the floor. Pt had about 3x3 cm knot on forehead. Pt father stated he was going to take her the ER to be checked out.  Contacted patient's father to check on patient around 5:00 PM. Pt father stated he took her to the ER where they did a cat scan and everything checked out fine. Pt father stated pt is okay and appreciated the phone call.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity, Peripheral swelling, Tendonitis
Clinical narrative: The patient complained on 7/30/19 that she had a sore arm with some swelling the day after receiving the Shingrix. She stated the the swelling went away within a couple of days but arm pain and restricted range of motion continued till the present day. She stated that her physician said she has tendinitis from the Shringrix vaccine and she is seeking physical therapy.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: PATIENT WAS SITTING UPRIGHT ON EXAM TABLE, I GAVE HIS TRUMENBA VACCINE IN RIGHT DELTOID. I THEN PROCEDED TO LEFT ARM AND GAVE HIM THE HPV9 VACCINE, HE IMMEDIATELY HAD SYNCOPE EPISODE. I HELPED HIS MOM LIE HIM DOWN ON THE EXAM TABLE, MOM SAID SHE THOUGHT HE WAS HAVING A SIEZURE BECAUSE HIS BODY JERKED ONE TIME WHEN HE WAS  HAVING SYNCOPE EPISODE. HE WAS "OUT" FOR 10-15 SECONDS. I WENT OUT OF ROOM AND GOT DR AND SHE CAME RIGHT IN EXAM ROOM. WE THEN RAISED THE TABLE SO THAT HIS LEGS WERE ELEVATED ABOVE HEART LEVEL. HE WAS TALKING AND RESPONDING TO HIS SURROUNDINGS. MOM SAID PATIENT HAS  FAINTED  SEVERAL TIMES BEFORE. PATIENT SAID HE WAS FINE. HE WAS OBSERVED FOR FEW MORE MINUTES BEFORE LEAVING THE OFFICE.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Myalgia, Neuralgia, Nodule, Pain
Clinical narrative: Numbness, sharp shooting pain when arm is rotated or lifted from fingers to jaw, muscle and nerve pain, knot in arm, four months and still has no relief
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: Numbness, sharp shooting pain when arm is rotated or lifted from fingers to jaw, muscle and nerve pain, knot in arm, four months and still has no relief
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Injection site pain, Neuralgia, Pain in extremity
Clinical narrative: Numbness, sharp shooting pain when arm is rotated or lifted from fingers to jaw, muscle and nerve pain, knot in arm, four months and still has no relief
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia
Clinical narrative: patient called pharmacy to report that she felt numb all over her body, and the symptoms started "about" a week after she got the Td shot.  She went to urgent care to try and get checked out, they gave told her to take Benadryl, which didn't help.  She was further advised to see her PCP for further evaluation.  She states she is looking for one and will make an apt to see her pcp soon.  By further talking with pt to get a better picture, she states that she called her mom and her mom told her she had the same problem when she got the tetanus shot, and advises her to "wait it out".   At our last conversation, pt stated that her symptoms are getting better by the day but still not feeling like herself before getting the shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: patient started experiencing redness and swelling to the injection site that moved to his neck.
Age: 33.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Heart rate decreased, Loss of consciousness, Pallor
Clinical narrative: Initially no physical exam done, but I examined pt just after pt passed out. Color was pale and pulse dropped to 50's BP stayed low normal. P slowed improved once lying flat and given cup of coffee. No seizure activity, she had no incontinence. Pt rechecked and ultimately at 1346 hrs she left with boyfriend improved.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Insomnia, Peripheral swelling, Skin warm
Clinical narrative: Patient stated at night, arm was swollen and red and warm to touch.  She said could not sleep on that side of bed last night and continued this morning so called her allergist.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Rash erythematous, Skin warm
Clinical narrative: pain redness at injection site. pt reports "fist-sized" rash and it is still red and hot to the touch today 7/30 (3 days later). currently taking Tylenol for pain, I recommended ibuprofen. Pt also put in a call to her md
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Chills, Consciousness fluctuating, Electrocardiogram normal, Fatigue
Clinical narrative: First, hives across breasts and headache (same day as shot). Next day I had fever, chills, nausea, headache, extreme tiredness, total body aching, pain at injection site, my  lips swelled and went numb, I was in and out of awake state and was rushed back to hospital. Given benedryl and pepcid in IV form and monitored. Took 2 doses of benedryl after I was home until symptoms cleared up. Could not get vaccine info details from hospital when I called 7/30/19; they said they were too busy.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia oral, Injection site pain, Lip swelling, Nausea
Clinical narrative: First, hives across breasts and headache (same day as shot). Next day I had fever, chills, nausea, headache, extreme tiredness, total body aching, pain at injection site, my  lips swelled and went numb, I was in and out of awake state and was rushed back to hospital. Given benedryl and pepcid in IV form and monitored. Took 2 doses of benedryl after I was home until symptoms cleared up. Could not get vaccine info details from hospital when I called 7/30/19; they said they were too busy.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Urticaria, Vaccination complication
Clinical narrative: First, hives across breasts and headache (same day as shot). Next day I had fever, chills, nausea, headache, extreme tiredness, total body aching, pain at injection site, my  lips swelled and went numb, I was in and out of awake state and was rushed back to hospital. Given benedryl and pepcid in IV form and monitored. Took 2 doses of benedryl after I was home until symptoms cleared up. Could not get vaccine info details from hospital when I called 7/30/19; they said they were too busy.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: swelling at injection site, red-pinkness in color, warm area--warmer than her other arm, area was bigger than a quarter, itchy area.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Eyelid function disorder, Immediate post-injection reaction, Pallor, Posture abnormal, Restlessness
Clinical narrative: Immediately after the shot patient screamed land all of sudden stop screaming like a light switch. And she got super pale. At 200pm patient Right side of face swelled. From cheek bone to eye.  She couldn?t open her right eye all the way. Not because it was swollen but it wouldn?t open.  4 days and nights following: extreme restlessness especially at night. Also seemed like she couldn?t hold her head up as she did prior
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Screaming, Swelling face
Clinical narrative: Immediately after the shot patient screamed land all of sudden stop screaming like a light switch. And she got super pale. At 200pm patient Right side of face swelled. From cheek bone to eye.  She couldn?t open her right eye all the way. Not because it was swollen but it wouldn?t open.  4 days and nights following: extreme restlessness especially at night. Also seemed like she couldn?t hold her head up as she did prior
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe muscle pain at the site of injection.  Chills.  Impaired movement of the arm.  Headache.  Redness & swelling.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Severe muscle pain at the site of injection.  Chills.  Impaired movement of the arm.  Headache.  Redness & swelling.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: The patient reported immediately after the vaccine was administered that it stung. The pain in his shoulder and radiated from the shoulder into his chest and neck. That pain has subsided but his shoulder is very stiff and now swollen and red. He has never had a reaction to a vaccine like this before. This was reported to me 7.30.19.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: The patient reported immediately after the vaccine was administered that it stung. The pain in his shoulder and radiated from the shoulder into his chest and neck. That pain has subsided but his shoulder is very stiff and now swollen and red. He has never had a reaction to a vaccine like this before. This was reported to me 7.30.19.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Patient had swelling, erythema, and bruising about 2 inches above her left elbow
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Poor quality sleep, Skin warm
Clinical narrative: Patient reported pain at injection site that started at around 9 PM (approximately 8 hours after immunization occurred) with heat radiating down the length of the arm. She woke up at around 12 midnight with restless sleep throughout the night and into the morning. She did not take any pain medication. Upon reporting this to the pharmacy she was advised to inform her primary care physician to determine course of action including any pain medication she can take.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient felt pain in her arm for a few days, and her back started to hurt. No fever or joint pain. On 7/30/19, patient came into the pharmacy and showed her arm to the pharmacist. She did get an injection site reaction and there was redness and a little swelling around the injection site  (about 6 inches long and 3 inches wide). She did not complain of itchiness or severe pain. Pharmacist suggested cold compresses and a benadryl. Advised her to wait a few days to see if the injection site got better. It it doesn't get better, advised her to see her doctor.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Foaming at mouth, Loss of consciousness, Road traffic accident, Seizure like phenomena
Clinical narrative: Patient was given shingrix vaccine around 11:55 AM, and she waited in the waiting area  for 15 minutes without complaints or symptoms. Around 12:25  store manager came and report the patient had an accident while she reversing her car. When I went to check the patient she was unconscious but breathing ,also noticed some frothy secretions from her mouth. It appeared more like seizure activity. 911 was called. by the time EMS arrived patient was little bit more responsive. I am not sure it is from vaccine or car accident.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Migraine, Nausea
Clinical narrative: Patient experienced redness & swelling @ the injection site, a severe migraine with nausea.  She had redness and swelling with the first dose of the series but no migraine or nausea.  She presented to ER overnight the night of the injection due to the severe migraine & nausea.  She stated she was treated with IV Benadryl, IV fluids and another IV medication but she was unsure of what it was.  No steroids were given at her request.  She is very sensitive to medications and has had many different reactions with many medications in the past but never a reaction to a vaccine until she received Shingrix.  She said the reaction resolved quickly after she was treated in the ER and has no issues now.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Grip strength decreased, Injection site pain, Injection site swelling, Limb discomfort, Pain in extremity
Clinical narrative: Pt complained of injecting hurting when given, then around 7pm her right arm started to swell up.  The right arm swelled up from the shoulder to the fingers, pt c/o not being able to hold a pen.  The arm was painful and warm to the touch.  The incident was reported 7/30/19 around 1pm. Pt also contacted her Dr. and left a message Pt was directed to take her oxycodone for pain, keep her arm elevated and to apply the diclofenac gel to her arm.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pt complained of injecting hurting when given, then around 7pm her right arm started to swell up.  The right arm swelled up from the shoulder to the fingers, pt c/o not being able to hold a pen.  The arm was painful and warm to the touch.  The incident was reported 7/30/19 around 1pm. Pt also contacted her Dr. and left a message Pt was directed to take her oxycodone for pain, keep her arm elevated and to apply the diclofenac gel to her arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient had a 5 cm red injection site reaction which has lasted for 7 days--it is improving.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Loss of consciousness
Clinical narrative: PATIENT SAID HE HAD FLU LIKE SYMPTOMS AND PASSED OUT FOR A FEW SECONDS ON THE 3RD DAY AFTER VACCINATION
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Muscle spasms, Pain
Clinical narrative: 5 days of diarrhea, fatigue, aches, cramps and chills
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Rash
Clinical narrative: Patient came in to pharmacy with concearns of a adverse reaction. Patients left arm is in pain and has developed a rash.  Patient was advised to take Benadryl and Advil to help with reaction and pain.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Hep B Vaccine administered on 07/15/2019 was invalid as it expired on 07/03/2019. No Adverse Reaction occurred.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient came in with a local reaction to the injection. Left arm revealed a large black section where the injection was given, with redness on the outside and further out, was yellow. Patient did not have any pain, but the area did have minimal swelling. The discoloration was of most concern to her. She said it was better, but reaction started after the injection was originally given. Patient was recommended to seek attention from a medical doctor as soon as possible.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Rash At Injection Site And Below Site; Elbow Area; Around Neck. Took CIPROFLOXACIN HCL 500 MG For 7 days. Applied Betamethasone VA 0.1% Cream. 5/21/19 Had Penumonia Shot at Pharmacy. Prevnar 13. Reaction was a rash on arm Viisited Dr. on May 29, 2019, prescribed Ciprofloxacin for seven days and betamethasone Cream for rash. (5/29/19) 6/26/19 Saw Dr. Rash continues and spreading. Continue using cream. Dr. suggested I see a Dermatology Doctor.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: 35 weeks Gestation for Tdap Client called reports that has Knot came up on Left arm about size dime and is about same size today. It is red and itchy today. Encouraged her to apply cool compress and notify her OB/Gyn for further instructions due to Pregnancy.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: DTAP/IPV QUADRACEL given IM left thigh on 7/22/2019. Swelling extends to knee on 7/24/2019.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt came in on 7/29/19 and spoke with employee. She had a baseball size (3 inch area) of red + hot to touch skin where injection was given. It protruded (swollen) about 1/4" from skin. Employee recommended Tylenol, ice + call DR!
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: On 7/23/19, the patient experienced a fever of 104 degrees and swelling in her arm. She went to her physician and the physician suspected a respiratory issue and did chest x-ray and bloodwork. Patient was started on Amox-Clav and Benzonatate. Physician ruled out bacterial infection. As of today, 7/30/19, patient is still experiencing feeling of nausea and believes the vaccination to be the cause. She had no adverse reaction to the first dose of Shingrix.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory disorder
Clinical narrative: On 7/23/19, the patient experienced a fever of 104 degrees and swelling in her arm. She went to her physician and the physician suspected a respiratory issue and did chest x-ray and bloodwork. Patient was started on Amox-Clav and Benzonatate. Physician ruled out bacterial infection. As of today, 7/30/19, patient is still experiencing feeling of nausea and believes the vaccination to be the cause. She had no adverse reaction to the first dose of Shingrix.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient called on 7/29/19 complaining of inject site pain and inflammation "swollen and egg size lump". I asked if patient tried used tylenol or advil, she had not. Asked patient to try tylenol or advil and ice if needed. If site continues to get worse then call doctor.
Sex: F
Vaccine: SMALL
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Hives & mild shortness of breath within 24 hrs of vaccination seen in ER
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injection site erythema, Malaise, Neck pain, Pain
Clinical narrative: Shooting pains into neck on injection side and malaise and then next day 2 cm redness around injection site
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, blue - bruise around area of injection site on day of injection. Everything cleared out after about 2 weeks. Patient did not do anything to treat the area.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Severe swelling at injection site and entire upper arm.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Dehydration, Full blood count, Pyrexia
Clinical narrative: High fever up to 104 degrees for 4 days after receiving injection. Required IV therapy for dehydration
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chills, Full blood count, Hypersensitivity, Infection, Laboratory test normal
Clinical narrative: 6/30/17, CBC; 7/1/17, Chemistry all within normal limits; fever, chills. Infectious disease dx allergic reaction to one of the vaccines, no active infection; fever, chills. Infectious disease dx allergic reaction to one of the vaccines, no active infection; fever, chills. Infectious disease dx allergic reaction to one of the vaccines, no active infection; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (702485). This spontaneous report refers to an 18-years-old male patient. The patient's current illnesses, medical history, prior vaccinations and other medications were not reported.  On 29-JUN-2017, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number M042853) administered intramuscularly in the left arm for prophylaxis. Other suspect vaccine included meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) (lot number 158501C) also administered intramuscularly in the right arm (administered doses and dose numbers in vaccines series were unknown).  On 29-JUN-2017, the same day, the patient presented to the emergency department (ED) with fever and chills (pyrexia). Also, an infectious disease was present and an allergic reaction to one of the vaccines was diagnosed (hypersensitivity), with no active infection. On 30-JUN-2017 (onset reported as "29-JUN-2017") the patient underwent a complete blood count (CBC); however, the results were not reported (full blood count reported as event). On 01-JUL-2017 (onset reported as "29-JUN-2017"), the patient underwent an unspecified chemistry test , which resulted all within normal limits (laboratory test normal reported as event).  The outcome of all the reported events was reported as resolved. The causality assessment was not provided by the agency. The agency considered the events to be serious due to hospitalization. The hospitalization date was not provided.   Follow-up information was received from the a registered nurse, through the Regulatory Authority (702485) on 15-APR-2019. It was confirmed that the patient did not have any chronic or long standing health conditions nor illnesses at the time of vaccination, other than allergy to lactose. It was also reported that the patient had not suffered from any adverse events on previous vaccination. The nurse confirmed that the patient received 0.5 milliliters (ml) of meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) in the right deltoid; and 0.5 ml of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left deltoid.  Follow up information has been received on 26-JUL-2019. All telephone attempts to obtain follow up information have been unsuccessful.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: 6/30/17, CBC; 7/1/17, Chemistry all within normal limits; fever, chills. Infectious disease dx allergic reaction to one of the vaccines, no active infection; fever, chills. Infectious disease dx allergic reaction to one of the vaccines, no active infection; fever, chills. Infectious disease dx allergic reaction to one of the vaccines, no active infection; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (702485). This spontaneous report refers to an 18-years-old male patient. The patient's current illnesses, medical history, prior vaccinations and other medications were not reported.  On 29-JUN-2017, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number M042853) administered intramuscularly in the left arm for prophylaxis. Other suspect vaccine included meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) (lot number 158501C) also administered intramuscularly in the right arm (administered doses and dose numbers in vaccines series were unknown).  On 29-JUN-2017, the same day, the patient presented to the emergency department (ED) with fever and chills (pyrexia). Also, an infectious disease was present and an allergic reaction to one of the vaccines was diagnosed (hypersensitivity), with no active infection. On 30-JUN-2017 (onset reported as "29-JUN-2017") the patient underwent a complete blood count (CBC); however, the results were not reported (full blood count reported as event). On 01-JUL-2017 (onset reported as "29-JUN-2017"), the patient underwent an unspecified chemistry test , which resulted all within normal limits (laboratory test normal reported as event).  The outcome of all the reported events was reported as resolved. The causality assessment was not provided by the agency. The agency considered the events to be serious due to hospitalization. The hospitalization date was not provided.   Follow-up information was received from the a registered nurse, through the Regulatory Authority (702485) on 15-APR-2019. It was confirmed that the patient did not have any chronic or long standing health conditions nor illnesses at the time of vaccination, other than allergy to lactose. It was also reported that the patient had not suffered from any adverse events on previous vaccination. The nurse confirmed that the patient received 0.5 milliliters (ml) of meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) in the right deltoid; and 0.5 ml of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left deltoid.  Follow up information has been received on 26-JUL-2019. All telephone attempts to obtain follow up information have been unsuccessful.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Diplopia, Headache, Idiopathic intracranial hypertension, Lumbar puncture, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Strabismus; Diplopia; Headache; Vision blurred; Idiopathic intracranial hypertension; Lumbar puncture; Nuclear magnetic resonance Imagmg abnormal; Papilloedema; This report was identified from a line listing obtained on request by the Company from the FDA (Agency # 709531) under the Freedom of Information Act.  This report was referring to a 11-year-old female patient. Information about her concurrent conditions, concomitant medications, prior vaccinations and medical history were not provided. The patient had no other medications.   On 07-AUG-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N012093, expiration date 13-JAN-2020; dose was unknown) intramuscularly in the right arm for prophylaxis.  Other suspect therapies included diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) ( lot # 7Y29Z) in the left arm and meningococcal acyw conj vaccine (crm197) (MENVEO) (lot # A16133) in the right arm, received on the same day, intramuscularly for unknown indication. On 10-AUG-2017, the patient experienced vision blurred and headache. On 12-AUG-2017, the patient experienced diplopia (positive). On 13-AUG-2017, the right eye (O.D.) turned inward (strabismus). On unknown date in August 2017, the patient went to the emergency room and was admitted for 2 days and the patient was diagnosed with idiopathic intracranial hypertension. On an unknown date in August 2017, the patient performed lumbar puncture (LP) in the hospital and she also performed magnetic resonance imaging (MRI) which showed bilat papilledema dilated tortuous optic nerve sheaths and partially empty sella (nuclear magnetic resonance imaging abnormal and papilledema). The patient was treated with acetazolamide (DIAMOX) 250 mg twice a day orally for three days and then turned to 500 mg. The outcome of the events was reported as recovered/resolved approximately on an unknown date in August 2017. The agency did not give the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  Follow up information has been received from a registered nurse via FDA (primary reporter was updated) on 15-APR-2019. The vaccine administration information was updated. The date of vaccination of  first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was updated as 07-AUG-2017 at 14:30 (pm). The onset date of vision blurred and headache was updated as 10-AUG-2017 at 08:00 (am).  As on 26-JUL-2019, all telephone attempts to obtain follow-up information have been unsuccessful.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Optic nerve disorder, Papilloedema, Strabismus, Vision blurred
Clinical narrative: Strabismus; Diplopia; Headache; Vision blurred; Idiopathic intracranial hypertension; Lumbar puncture; Nuclear magnetic resonance Imagmg abnormal; Papilloedema; This report was identified from a line listing obtained on request by the Company from the FDA (Agency # 709531) under the Freedom of Information Act.  This report was referring to a 11-year-old female patient. Information about her concurrent conditions, concomitant medications, prior vaccinations and medical history were not provided. The patient had no other medications.   On 07-AUG-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N012093, expiration date 13-JAN-2020; dose was unknown) intramuscularly in the right arm for prophylaxis.  Other suspect therapies included diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) ( lot # 7Y29Z) in the left arm and meningococcal acyw conj vaccine (crm197) (MENVEO) (lot # A16133) in the right arm, received on the same day, intramuscularly for unknown indication. On 10-AUG-2017, the patient experienced vision blurred and headache. On 12-AUG-2017, the patient experienced diplopia (positive). On 13-AUG-2017, the right eye (O.D.) turned inward (strabismus). On unknown date in August 2017, the patient went to the emergency room and was admitted for 2 days and the patient was diagnosed with idiopathic intracranial hypertension. On an unknown date in August 2017, the patient performed lumbar puncture (LP) in the hospital and she also performed magnetic resonance imaging (MRI) which showed bilat papilledema dilated tortuous optic nerve sheaths and partially empty sella (nuclear magnetic resonance imaging abnormal and papilledema). The patient was treated with acetazolamide (DIAMOX) 250 mg twice a day orally for three days and then turned to 500 mg. The outcome of the events was reported as recovered/resolved approximately on an unknown date in August 2017. The agency did not give the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  Follow up information has been received from a registered nurse via FDA (primary reporter was updated) on 15-APR-2019. The vaccine administration information was updated. The date of vaccination of  first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was updated as 07-AUG-2017 at 14:30 (pm). The onset date of vision blurred and headache was updated as 10-AUG-2017 at 08:00 (am).  As on 26-JUL-2019, all telephone attempts to obtain follow-up information have been unsuccessful.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abdominal pain upper, Blood glucose normal, Fatigue, Feeling abnormal, Laboratory test normal
Clinical narrative: Tingling in arms and back; Migraine; Fogginess; Fatigue; Stomach ache; This is a spontaneous report from a contactable nurse.  An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number AL8468, Expiration Date Feb2021), at her 18 years old via an unspecified route of administration in arm left on 18Jul2019 at single dose for immunization.  There was no medical history or concomitant medications. The patient experienced migraine, fogginess, fatigue on 18Jul2019, tingling in arms and back on 19Jul2019, stomach ache in Jul2019. The patient underwent lab tests and procedures on 19Jul2019 which included blood glucose: 93, molecular DNA: negative, strep test: normal. The outcome of event migraine, stomach ache, fogginess, fatigue was recovered on 22Jul2019, for tingling in arms and back was recovered on 19Jul2019.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Migraine, Paraesthesia, Streptococcus test negative
Clinical narrative: Tingling in arms and back; Migraine; Fogginess; Fatigue; Stomach ache; This is a spontaneous report from a contactable nurse.  An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number AL8468, Expiration Date Feb2021), at her 18 years old via an unspecified route of administration in arm left on 18Jul2019 at single dose for immunization.  There was no medical history or concomitant medications. The patient experienced migraine, fogginess, fatigue on 18Jul2019, tingling in arms and back on 19Jul2019, stomach ache in Jul2019. The patient underwent lab tests and procedures on 19Jul2019 which included blood glucose: 93, molecular DNA: negative, strep test: normal. The outcome of event migraine, stomach ache, fogginess, fatigue was recovered on 22Jul2019, for tingling in arms and back was recovered on 19Jul2019.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abdominal pain upper, Blood glucose normal, DNA antibody negative, Fatigue, Feeling abnormal
Clinical narrative: Tingling in arms and back; Migraine; Fogginess; Fatigue; Stomach ache; This is a spontaneous report from a contactable nurse.  An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number AL8468, Expiration Date Feb2021), at her 18 years old via an unspecified route of administration in arm left on 18Jul2019 at single dose for immunization.  There was no medical history or concomitant medications. The patient experienced migraine, fogginess, fatigue on 18Jul2019, tingling in arms and back on 19Jul2019, stomach ache in Jul2019. The patient underwent lab tests and procedures on 19Jul2019 which included blood glucose: 93, molecular DNA: negative, strep test: normal. The outcome of event migraine, stomach ache, fogginess, fatigue was recovered on 22Jul2019, for tingling in arms and back was recovered on 19Jul2019.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chest X-ray abnormal, Chills
Clinical narrative: Injection in left arm slight pain. Pain dissipated in two days. Six days after getting shot I woke with very severe pneumonia like symptoms. All my joints, back, neck ache with pain. Constantly running fever (104), eyes hurt. I periodically sweat a lot, then shiver for hours. This has been going on from July 26 to present. On July 29, 2019 I visited my PCP. He stated symptoms were very serious & I needed to go to Emergency room. My wife immediately drove me to emergency  room at Hospital. I was having a hard time standing & walking, I was extremely weak. I was asked by several healthcare persons if I had recently had a flu shot etc. I told them on July 20 I had taken the Shingrix shot none seemed to know anything about Shingrix  (I explained to them what it was for). I told healthcare persons I did not have much of an appetite since getting the Shingrix shot. I told them I felt that if I ate I would vomit. I have been trying to avoid that at all cost. I can only imagine what the pressure if vomiting would be like on my aching head & body. They diagnosed me with pneumonia. I told them that before the shot & after I had not been around large groups of people with the exception of being in grocery store to get the shot. I truly believe that the Shingrix vaccine was the cause of this. I have not been sick in years. Bad diarrhea started on 7/31/2019. Entered emergency room on 7/29/2019 - 6:00 PM Released on 7/30/2019 - 5:00 PM
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Dysstasia, Eye pain, Gait disturbance
Clinical narrative: Injection in left arm slight pain. Pain dissipated in two days. Six days after getting shot I woke with very severe pneumonia like symptoms. All my joints, back, neck ache with pain. Constantly running fever (104), eyes hurt. I periodically sweat a lot, then shiver for hours. This has been going on from July 26 to present. On July 29, 2019 I visited my PCP. He stated symptoms were very serious & I needed to go to Emergency room. My wife immediately drove me to emergency  room at Hospital. I was having a hard time standing & walking, I was extremely weak. I was asked by several healthcare persons if I had recently had a flu shot etc. I told them on July 20 I had taken the Shingrix shot none seemed to know anything about Shingrix  (I explained to them what it was for). I told healthcare persons I did not have much of an appetite since getting the Shingrix shot. I told them I felt that if I ate I would vomit. I have been trying to avoid that at all cost. I can only imagine what the pressure if vomiting would be like on my aching head & body. They diagnosed me with pneumonia. I told them that before the shot & after I had not been around large groups of people with the exception of being in grocery store to get the shot. I truly believe that the Shingrix vaccine was the cause of this. I have not been sick in years. Bad diarrhea started on 7/31/2019. Entered emergency room on 7/29/2019 - 6:00 PM Released on 7/30/2019 - 5:00 PM