chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included anaphylaxis and allergic reaction (experienced a lot after numerous other unspecified vaccines). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist got this information from another registered pharmacist who administered the SHINGRIX to the patient. The age at vaccination was not reported. The healthcare professional was looking for information on one dose efficacy with SHINGRIX. The reporter did not speak to the patient, so did not have any other details. The reporter would have other pharmacist to call back with details of the adverse event.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a adult female patient who received Herpes zoster (Zoster vaccine) for prophylaxis. Co-suspect products included mepolizumab (Nucala) unknown for an unknown indication. On an unknown date, the patient received Zoster vaccine at an unknown dose. On 24th November 2017, the patient started Nucala 100 mg at an unknown frequency. On an unknown date, less than a year after receiving Zoster vaccine and Nucala, the patient experienced herpes zoster and back pain. The action taken with Nucala was unknown. On an unknown date, the outcome of the herpes zoster and back pain were unknown. It was unknown if the reporter considered the herpes zoster and back pain to be related to Zoster vaccine. The reporter considered the herpes zoster and back pain to be related to Nucala. Additional details were details updated as follow: The age at vaccination was not reported. The patient was vaccinated for zoster previously, received 6 doses of Nucala developed back pain which turned out to be shingles.  The healthcare professional (HCP) believes that this was related to the administration of Nucala.  The patient had to cancel next appointment on May 6th because of zoster infection. The patient followed up with physician in June.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Pyrexia
Clinical narrative: This case was reported by a non-health professional via other manufacturer and described the occurrence of exhaustion in a 16-year-old male patient who received MENVEO (batch number M17041, expiry date unknown) for prophylaxis. On 6th July 2018, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 6th July 2018, less than a day after receiving MENVEO, the patient experienced exhaustion (serious criteria other: per reporter) and fever (serious criteria other: as per reporter). On 14th July 2018, the outcome of the exhaustion and fever were recovered/resolved. It was unknown if the reporter considered the exhaustion and fever to be related to MENVEO. Additional information was reported as follows: The patient's medical history indicated that he was very healthy. The patient experienced extreme fatigue. The patient was not participating in any Novartis sponsored program. The reporter gave consent to be contacted if more information was needed for the report.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect product formulation administered
Clinical narrative: On 7/9/2018, client was given MENVEO vaccine, not reconstituted with the powder prior to immunization, so client only received vaccination against CWY strains and not the A strain. Upon reviewing the state registry, it was noted that the client recieved his Meningococcal vaccine on 5/22/2018 at a different location, so revaccination is not needed. Client's mother was informed of the situation.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Pt was given SHINGRIX vaccine 7/25/18, Pt came in 7/31/18 ~ 8:30pm reporting left arm redness, swelling, itching and slight fever. She went to walk in clinic where they wanted her to take benadryl and report incident to rx. Pt was given Benadryl otc packet.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia
Clinical narrative: Large muscle aches, chills (possible fever - no thermometer), loss of appetite, fatigue. Started in the morning after vaccination. No treatment. Expecting symptoms to go away in another day or two.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: LT. ARM SWOLLEN AND PAINFUL SOON AFTER SHOT WAS GIVEN. MOM GAVE TYLENOL 500 MG AT 5 PM ONLY. WOKE UP THIS AM STILL C/O PAIN IN LT. ARM AND COULD LIFT HIS ARM. CAME TO CLINIC ON 8/1/2018 AT 8.30 AM WAS SEEN BY ME. LT. ARM WAS MILDLY SWOLLEN AT INJECTION SITE, TENDER TO PALPATION 5/10 PAIN SCALE. NO ERYTHEMA/INDURATION/FLUCTUANCE/DISCHARGE NOTED. ABLE TO LIFT ARM UP TO 90 DEGREES. NO NUMBNESS/TINGLING IN LT ARM, HAND OR DIGITS.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Syncope
Clinical narrative: Patient was having her blood drawn for routine lab work after receiving both vaccines. While patient was having her blood drawn she fainted. She woke up immediately and was talking right away. Pt was given snacks and juice. Blood pressure was 116/72 and HR was 76, consistent with her vitals upon arrival as 106/70 and HR of 78. Upon further discussion with patient it came to light that she had not had anything to drink, nor had she eaten yet at this point in the day. After 30 mins of observation patient was able to leave the office. It is unclear what the true cause of fainting was.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Laboratory test, Nervous system disorder, Pyrexia, Seizure
Clinical narrative: Fever and onset of seizures with severe neurological disease, which initially was thought to be ADEM. Work-up is ongoing.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: GARDASIL was the third injection. Almost immediately patient reported it was itching and it turned red. MD notified. Ice applied. No respiratory distress or further urticaria. When I interviewed patient's mother in the afternoon I enquired about possible latex allergy as a number of years ago I had a patient who mentioned that GARDASIL vial had latex in membrane. Patient had no further swelling, itching, and the redness was resolving.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Report on 07/25/18 at office visit: Pt noticed on 07/24/18 early morning that she had stomach pain and diarrhea. She then noticed redness to site of injection from 07/23/18. Pt was seen by provider for another concern, but they did draw circle around redness. This redness has now spread past the lines drawn. The redness is warm to the touch. Pt reports that she has had a fever 100.8 and also checked again and it was 100.1 yesterday. Today in the office was 98.4. This is likely a local injection site reaction. These usually resolve in under 96 hours. Patient does have some TTP. There is warmth, erythema and swelling has spread from injection site to the volar, distal upper left arm. Recommended ice and ibuprofen for treatment. Will have her back for a NV on Friday. If symptoms are not improved will treat with antibiotic. 07/27/18:Area looked much improved. Barely any redness or swelling remains. Still minimal pain. This was definitely a vaccine reaction and not cellulitis.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Pyrexia, Tenderness
Clinical narrative: Report on 07/25/18 at office visit: Pt noticed on 07/24/18 early morning that she had stomach pain and diarrhea. She then noticed redness to site of injection from 07/23/18. Pt was seen by provider for another concern, but they did draw circle around redness. This redness has now spread past the lines drawn. The redness is warm to the touch. Pt reports that she has had a fever 100.8 and also checked again and it was 100.1 yesterday. Today in the office was 98.4. This is likely a local injection site reaction. These usually resolve in under 96 hours. Patient does have some TTP. There is warmth, erythema and swelling has spread from injection site to the volar, distal upper left arm. Recommended ice and ibuprofen for treatment. Will have her back for a NV on Friday. If symptoms are not improved will treat with antibiotic. 07/27/18:Area looked much improved. Barely any redness or swelling remains. Still minimal pain. This was definitely a vaccine reaction and not cellulitis.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac stress test normal, Chest pain, Electrocardiogram normal, Headache, Injection site pain
Clinical narrative: I was seen at Urgent Care as a result of left-side chest pain. An EKG was conducted at Urgent Care. I was advised by the MD at Urgent Care to go to Medical Center for further work-up. I was admitted for observation, given an additional EKG followed by a stress test the following day. I was advised that there was nothing wrong with my heart and I was discharge home. I have been experiencing ongoing pain in my chest, throbbing headaches, and pain at the injection site to this day.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test
Clinical narrative: I was seen at Urgent Care as a result of left-side chest pain. An EKG was conducted at Urgent Care. I was advised by the MD at Urgent Care to go to Medical Center for further work-up. I was admitted for observation, given an additional EKG followed by a stress test the following day. I was advised that there was nothing wrong with my heart and I was discharge home. I have been experiencing ongoing pain in my chest, throbbing headaches, and pain at the injection site to this day.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Headache, Pain in extremity
Clinical narrative: I was seen at Urgent Care as a result of left-side chest pain. An EKG was conducted at Urgent Care. I was advised by the MD at Urgent Care to go to Medical Center for further work-up. I was admitted for observation, given an additional EKG followed by a stress test the following day. I was advised that there was nothing wrong with my heart and I was discharge home. I have been experiencing ongoing pain in my chest, throbbing headaches, and pain at the injection site to this day.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Pain in the area of shot and up and down the arm, low-grade fever (99.5 F) pain in arm started night of the shot. Fever noticed around 3:00 pm, Aug 1.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm noted to be swollen, red, warm to touch, within 24 hours after vaccine given, patient mom denied fever, no dizziness, no headache. Tx to include bactrim DS x 10 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Erythema at injection site requiring ER visit.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: The patient woke up the morning after the vaccination not feeling well. By 11 am he felt bad enough that he went back to bed and stayed in bed all day. He was "down" about 13 hours. He had a fever of 101 F, achy, and chills. The following day he felt okay (day 2 after vaccine). Soreness at the site remained for several days.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: No problems noted except slight soreness at shot site. Next morning I went to aerobics exercise class, 1 hour, as usual, feeling okay. As class began I began ... feeling bad? And fatigued. Got home from class feeling really rotten, and took two-hour nap, followed by another two-hour nap. Feeling much better afterwards. At about 4 pm, I had a mild diarrhea-like attack, although not very severe, which was followed by a second one about two hours later. End of symptoms and feeling just fine today. My lady friend had an identical shot, same place, same time, and except for a bit of swelling at the shot site, had no reactions at all.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Syncopal episode without loss of consciousness. Was anxious before receiving injections. Immediately after last injected became very light-headed. We had him lie down and the symptoms went away. We put him in a sitting position at 10:16 am (BP normal 130/66, and standing position 10:17 BP normal 128/78 with no further symptoms. Left ambulatory to car with parent accompanied by a nurse with no further problems.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt in office for well child exam and vaccines, pt fainted within 2 mins after being injected with MENACTRA and Tdap vaccines. Recovered within 15 mins. No complaints/symptoms when patient left office.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Pallor, Vomiting
Clinical narrative: Within 1-2 minutes of receiving the Hep B injection, the patient became pale and vomited twice into the trash. Patient was given a few sips of water to rinse her mouth. Patient was monitored for further changes for about 15 minutes. Prior to walking out of the clinic, patients color was pink and she was acting normal per patients mother. Patient's mother was contacted approx. 8 hours after incident to check on the child. It was reported that the child appeared to be at baseline per mom. Mom did say that the child had vomited 4 times within 5 minutes after receving  the MMR vaccine on 6/21/2018 also.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Nodule
Clinical narrative: Patient has knot 3 days post injection and has not gone away.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Loss of consciousness, Muscle twitching, Pallor, Seizure
Clinical narrative: HPV was administered to right arm, and within minutes she passed out, fell to the floor and started twitching, as if having a seizure, was pale, white in color, provider was called to evaluate pt, she was on the floor with her head on mother's knee, getting fanned, EMS was called, was in the upper 90s in O2 and 80s in pulse..EMS arrived she was put on a stretcher and evaluated, she was coherent, speaking and texting, and was put in ambulance and taken to ER.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: There is moderate induration, erythema or warmth to left lateral arm with some gravitational dependent swelling to the lateral mid arm. No ascending cellulitis. No crepitance. No other distal rash..  Claritin Tablet, Start Keflex Capsule, 500 MG, 1 capsule, Orally, tid, 07 days, 21 Capsule, Refills 0.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Before the vaccination I had complete rangle of motion in  my right arm. Now I do not. I have continung pain.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Chest pain, Dyspnoea, Fall, Feeling abnormal, Pallor
Clinical narrative: 3:40PM--Patient received vaccination without any adverse symptoms. 3:42PM--Patient report SOB with chest pain and feeling uneasy. He then slumped against the wall and slid to the floor still awake and coherent, just slightly groggy. 3:43PM--Patient was promptly helped to Room 5 and sat into chair. Provider was notified and began to evaluate patient by listening to his heartbeat and observing his breathing pattern. He was immediately placed on an O2 sensor and his BP was checked. Patient looked pale and his vitals were: Pulse: 56, BP: 86/44. 3:53PM--Patient was rechecked for vital signs. His appearance has pinked up and he is acting "normally" per mom. He reports he is feeling normal again. His vitals were: Pulse: 62 and BP: 93/55. We informed patient he would be monitored for 10 more minutes. 4:15PM--Patient was rechecked for vital signs. He is now joking with his sister and playing with the vital machines. His vitals were: Pulse: 66 and BP 104/60. Mom was given the emergency number to call Dr if he had any further symptoms and educated on what to look for if further symptoms occur. Patient was ready to go and appeared to have recovered from his brief symptoms.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Somnolence
Clinical narrative: 3:40PM--Patient received vaccination without any adverse symptoms. 3:42PM--Patient report SOB with chest pain and feeling uneasy. He then slumped against the wall and slid to the floor still awake and coherent, just slightly groggy. 3:43PM--Patient was promptly helped to Room 5 and sat into chair. Provider was notified and began to evaluate patient by listening to his heartbeat and observing his breathing pattern. He was immediately placed on an O2 sensor and his BP was checked. Patient looked pale and his vitals were: Pulse: 56, BP: 86/44. 3:53PM--Patient was rechecked for vital signs. His appearance has pinked up and he is acting "normally" per mom. He reports he is feeling normal again. His vitals were: Pulse: 62 and BP: 93/55. We informed patient he would be monitored for 10 more minutes. 4:15PM--Patient was rechecked for vital signs. He is now joking with his sister and playing with the vital machines. His vitals were: Pulse: 66 and BP 104/60. Mom was given the emergency number to call Dr if he had any further symptoms and educated on what to look for if further symptoms occur. Patient was ready to go and appeared to have recovered from his brief symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Patient called 7/31/18 to report she has a bright, brilliant, blotchy rash on her trunk and under her arms. She stated that it doesn't itch and she feels fine otherwise - she can everything that she usually does. She said that she forgot to tell pharmacist when she got the second shot that she had a reaction to the first shot she received 3/15/18. Her neck and trunk were red and 2 days after shot she had a full body rash that itched. She said that her current rash does not currently itch. Last time her injection side was sore, it is not this time. I told her to contact us and her doctor if her symptoms worsen or do not go away after a few days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Feeling abnormal, Hyperhidrosis, Pallor
Clinical narrative: Right after received vaccines, pt stood up. Within 45 seconds, pt reported feeling funny and was swaying back and forth. Pt was directed back into the chair, where she began to get lightheaded, clammy, pale and sweating. Her head was lowered to between her legs. Cold clothes applied to her and head and neck. BP was also monitored at this time. After about 10 minutes, pt reported to feel better. Blood pressure had came up, pt returned to normal color and was more coherent and cognitive. Pt instructed to remain sitting for 10 more minutes and was then instructed she could get up and move around if she felt well enough. Pt did.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Chills, Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: Subjective fever, chills, headache, lightheadedness, one episode of emesis a few hours after administration today. His father, also a Physician, contacted our office and tells me his son is feeling better after episode of emesis.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Dysstasia
Clinical narrative: Patient became very weak and unable to stand after receiving vaccine.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Aphasia, Asthenia, Autism spectrum disorder, Condition aggravated, Developmental regression
Clinical narrative: Developed Inflammation in Head, GERD, Feeding problems, weakness, Development regressed, lost speech, ability to function. Learning disabled, cannot tolerate any foods except organic raw plant based foods. Very low functioning. Diagnosed with Autism on 10/6/2015. Now I have two boys both injured by Hep B shot and I have to provide lifelong care. Who is going to pay for this? Everyone profiting from the sale and administration of these vaccines is immune. Can you please send me the safety studies on HepB vaccine that HHS has submitted to congress Please? Child has mercury and Aluminum poisoning sysmptoms. Why is no one accountable?
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Gastrooesophageal reflux disease, Inflammation, Learning disability, Loss of personal independence in daily activities, Metal poisoning
Clinical narrative: Developed Inflammation in Head, GERD, Feeding problems, weakness, Development regressed, lost speech, ability to function. Learning disabled, cannot tolerate any foods except organic raw plant based foods. Very low functioning. Diagnosed with Autism on 10/6/2015. Now I have two boys both injured by Hep B shot and I have to provide lifelong care. Who is going to pay for this? Everyone profiting from the sale and administration of these vaccines is immune. Can you please send me the safety studies on HepB vaccine that HHS has submitted to congress Please? Child has mercury and Aluminum poisoning sysmptoms. Why is no one accountable?
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Noninfective encephalitis, Poor feeding infant
Clinical narrative: Developed Inflammation in Head, GERD, Feeding problems, weakness, Development regressed, lost speech, ability to function. Learning disabled, cannot tolerate any foods except organic raw plant based foods. Very low functioning. Diagnosed with Autism on 10/6/2015. Now I have two boys both injured by Hep B shot and I have to provide lifelong care. Who is going to pay for this? Everyone profiting from the sale and administration of these vaccines is immune. Can you please send me the safety studies on HepB vaccine that HHS has submitted to congress Please? Child has mercury and Aluminum poisoning sysmptoms. Why is no one accountable?
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The first night I had chills, uncontrollable shaking, body aches and slight fever (100.3), The site of the injection was red, swollen, painful and warm to the touch. Day 2 - body aches, fatigue, continued redness, swelling, pain, and heat at the injection site, Day 3 - (today) body aches, rash on torso - which I always get when I have something viral - and continued redness, pain, swelling and heat at the injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia, Rash, Tremor
Clinical narrative: The first night I had chills, uncontrollable shaking, body aches and slight fever (100.3), The site of the injection was red, swollen, painful and warm to the touch. Day 2 - body aches, fatigue, continued redness, swelling, pain, and heat at the injection site, Day 3 - (today) body aches, rash on torso - which I always get when I have something viral - and continued redness, pain, swelling and heat at the injection site.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pruritus
Clinical narrative: Patient received routine vaccines and a Band-Aid was placed on each arm (site of injection); about 1 - 2 minutes later the patient began to pat her arms at the site, complaining of itching. I immediately removed the Band-Aids and rubbed each area with alcohol, under supervision of the nurse practitioner. The areas were not inflamed or bleeding. Nurse practitioner reported to the nurse on the unit to observe patient and to report to her if symptoms worsened; a verbal order for BENADRYL was also given.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Fatigue, Headache, Influenza like illness, Lymphadenopathy
Clinical narrative: Pt reported of having flu-like symptoms on the same day the vaccine was given (ie., slight fever, headache), but did not take any medication to alleviate the fever. The following day, she was more tired and couldn't lift up her arm. She also noticed bruises on left breast and left under arm and swollen lymph nodes and they lasted for 6-7 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: Pt reported of having flu-like symptoms on the same day the vaccine was given (ie., slight fever, headache), but did not take any medication to alleviate the fever. The following day, she was more tired and couldn't lift up her arm. She also noticed bruises on left breast and left under arm and swollen lymph nodes and they lasted for 6-7 days.
Age: 1.08
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Crying, Rash, Somnolence, Staring, Unresponsive to stimuli
Clinical narrative: On Saturday 28th 10 pm the client cried uncontrollably for 15 min then fell asleep. She could not be awaken for 5 minutes. Then when she awakened and had a blank stare on her face and would not respond for 30 min then recovered. A rash was noted on Sunday  on face that was flat and about the size of a pencil eraser.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Blood glucose decreased, Disturbance in attention, Dizziness, Headache
Clinical narrative: Dizziness, low blood sugar, concentration issues and headache.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Patient reported spots of itchiness at various sites of body (legs, back, torso) beginning 24 hours after vaccination. Patient contacted PCP (at clinic) and was still waiting for a response at the time he visited the pharmacy on 8/1/18. Recommended for patient to get in touch with PCP as soon as possible and take antihistamines in the meantime to alleviate the itchiness.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood test, Cyanosis, Decreased activity, Decreased appetite, Dysstasia
Clinical narrative: He started acting super lethargic, screaming, wouldn't eat or drink fluids, had trouble standing, would not play or interact. He got a fever the next day and started slowing down and showing all of these symptoms the day after the shot. Gave Tylenol and Motrin for fever. Had febrile seizure 2 days after. Took by ambulance to the hospital. He was foaming out of his nose and mouth, arched back, seizing, unresponsive, turned blue for about 3-5 mins.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Foaming at mouth, Lethargy, Opisthotonus, Pyrexia
Clinical narrative: He started acting super lethargic, screaming, wouldn't eat or drink fluids, had trouble standing, would not play or interact. He got a fever the next day and started slowing down and showing all of these symptoms the day after the shot. Gave Tylenol and Motrin for fever. Had febrile seizure 2 days after. Took by ambulance to the hospital. He was foaming out of his nose and mouth, arched back, seizing, unresponsive, turned blue for about 3-5 mins.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Screaming, Seizure, Unresponsive to stimuli
Clinical narrative: He started acting super lethargic, screaming, wouldn't eat or drink fluids, had trouble standing, would not play or interact. He got a fever the next day and started slowing down and showing all of these symptoms the day after the shot. Gave Tylenol and Motrin for fever. Had febrile seizure 2 days after. Took by ambulance to the hospital. He was foaming out of his nose and mouth, arched back, seizing, unresponsive, turned blue for about 3-5 mins.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Heart rate increased, Injection site pain
Clinical narrative: Very sore arm around injection site;  high heart rate (95+) even at rest.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Somnolence
Clinical narrative: Patients wife reports that pt has been sleeping all day and has no appetite.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Local redness about 9cm x 9cm circular on injection site. Better than it was yesterday.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: Patient was accidentally given HIB vaccine, should have been given KINRIX.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local swelling and redness to left arm where received shot. Swelling and redness has increased with each day and is not covering from her shoulder to her elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood test normal, Cardiac function test normal, Heart rate increased, Pain
Clinical narrative: Patient's husband contacted the pharmacy and noted that patient had to visit the ER on the morning of 7/31/18 due to heart palpitations. The ER ran a blood panel and heart function tests but could not attribute the increase in BP and HR to anything. She was then discharged from the ER since nothing conclusive was gained from the tests. The patient was recommended bed rest and TYLENOL for the fever and pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia
Clinical narrative: Patient's husband contacted the pharmacy and noted that patient had to visit the ER on the morning of 7/31/18 due to heart palpitations. The ER ran a blood panel and heart function tests but could not attribute the increase in BP and HR to anything. She was then discharged from the ER since nothing conclusive was gained from the tests. The patient was recommended bed rest and TYLENOL for the fever and pain.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Seizure
Clinical narrative: According the father who was next to patient, he had seizures.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: On 7/31/2018 Child was here for his Kindergarten Physical. He received KINRIX to cover his 5th DTaP, and 4th IPV intramuscularly to his right deltoid, and PROQUAD to his left arm. On 08/01/2018, his mother brought the child in for a swollen, warm, red right arm where the injection site occurred. She noted that it started 07/31/2018, and doubled in size from yesterday to today. She denies fever, pain or itching. Upon exam, the area of redness was oval in shape, approximately 4x5 inches, with an area of firmness and heat approximately 2-3 inches in diameter near the injection site. The child denied pain or itchiness, he noted it just feels "hot".
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Myalgia, Pain, Urticaria
Clinical narrative: Soreness, hives, arm numbness, muscle pain up arm into neck.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: DNA antibody positive, Dry eye, Dry mouth, Food intolerance
Clinical narrative: Dry mouth with extreme sensitivity to spicy, citric, vinegary, minty foods. Dry eyes.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, soreness, fever at site of injection.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Ocular discomfort, Pain, Pyrexia, Sinus congestion
Clinical narrative: Patient reported severe body aches, fever, headache (pressure behind eyes), wheezing, and sinus congestion. Patient stated the symptoms lasted about 2 weeks. Spoke with Dr. on his next office visit and the doctor suggested he not receive the 2nd dose of SHINGRIX. Patient's symptoms have resolved and reported his event to the pharmacist during a phone conversation on 8/1/18. Patient requested his adverse event be reported to VAERS.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: Patient reported severe body aches, fever, headache (pressure behind eyes), wheezing, and sinus congestion. Patient stated the symptoms lasted about 2 weeks. Spoke with Dr. on his next office visit and the doctor suggested he not receive the 2nd dose of SHINGRIX. Patient's symptoms have resolved and reported his event to the pharmacist during a phone conversation on 8/1/18. Patient requested his adverse event be reported to VAERS.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Erythema, Headache
Clinical narrative: Redness, pain, itching, flu like symptoms, headache, dizziness, nausea, chills and joint pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain, Pruritus
Clinical narrative: Redness, pain, itching, flu like symptoms, headache, dizziness, nausea, chills and joint pain.
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Irritability, Pyrexia, Seizure, Skin warm
Clinical narrative: "The onset was just prior to arrival. The course/duration of symptoms is constant. Associated symptoms: fussiness. Temperature is subjective. Risk factors consist of none. Prior episodes: occasional. Therapy today: none. 17-month-old boy with no significant past medical history who is vaccinated presents after a seizure at home. It lasted 30 seconds and resolved spontaneously. Prior to that mother noted that he felt very hot and was developing a fever. Patient is fully vaccinated he had no viral prodrome over the last 1-2 days. No ill contacts or recent travel. "
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever about lasted 24-48 hours, soreness around inject site.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak left arm, side, shoulder.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Balance disorder, Dizziness, Hyporesponsive to stimuli, Malaise, Pallor
Clinical narrative: Pt received the Pediatric Hep A vaccine. I stepped away from imz booth to fill out form for mom and when I returned, mom said he isn't feeling well. Pt looked pale, head was hanging down, and eyes closed. I shook pt, called his name, and asked if he could hear me and only nodded his head. He was not very responsive. Checked his breathing and pulse, both were fine. After talking to him a little longer and he was still responding poorly, I decided to move pt to the floor and so I could prop up his legs. During this time I had pharmacy tech go get water for him and a pillow to put pt's head on. Mom also went to get a sugary soda. We also placed a cold rag on his forehead. After laying there a few more minutes and sipping some soda and water, pt became more responsive and talking more. Mom wanted to get him up, so I help stand him up and he seemed a little unsteady but able to walk. I advised for them to stay longer, but mom thought he was okay, just had become a little light headed. I told them if he did not continue to get better and got worse, to go to ER. So with Mom walking at his side, they left the store. I followed up with mom a couple of hours later and said pt was playing video games and doing well. She also said she was checking on him frequently.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Posture abnormal
Clinical narrative: Pt received the Pediatric Hep A vaccine. I stepped away from imz booth to fill out form for mom and when I returned, mom said he isn't feeling well. Pt looked pale, head was hanging down, and eyes closed. I shook pt, called his name, and asked if he could hear me and only nodded his head. He was not very responsive. Checked his breathing and pulse, both were fine. After talking to him a little longer and he was still responding poorly, I decided to move pt to the floor and so I could prop up his legs. During this time I had pharmacy tech go get water for him and a pillow to put pt's head on. Mom also went to get a sugary soda. We also placed a cold rag on his forehead. After laying there a few more minutes and sipping some soda and water, pt became more responsive and talking more. Mom wanted to get him up, so I help stand him up and he seemed a little unsteady but able to walk. I advised for them to stay longer, but mom thought he was okay, just had become a little light headed. I told them if he did not continue to get better and got worse, to go to ER. So with Mom walking at his side, they left the store. I followed up with mom a couple of hours later and said pt was playing video games and doing well. She also said she was checking on him frequently.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of a raised red bump, warm to the touch and itchy in the area of the injection site, starting within minutes of the immunization. Patient self-monitored condition over next 2 days, states condition has improved as of 8-1-18. Unknown if patient used any medication to treat condition.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Pyrexia
Clinical narrative: Fever 100.1. Headache.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Fall, Loss of consciousness
Clinical narrative: After receiving the vaccine, patient was standing in the line to pay for his purchases. He suddenly fall down on his back. He was unconscious, breathing normally, no swelling in lips or face, no hives, no sweating, no obvious injuries. 911 was called. He positioned on his back. His legs was raised above heart level until the ambulance arrived.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Feeling cold, Feeling hot
Clinical narrative: Sore arm at point of injection, stomach/bowel discomfort, diarrhea (started on 8/1, 7:00am), hot/cold feeling all day 8/1/2018, tired/sleepy.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Somnolence
Clinical narrative: Sore arm at point of injection, stomach/bowel discomfort, diarrhea (started on 8/1, 7:00am), hot/cold feeling all day 8/1/2018, tired/sleepy.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pyrexia, Swelling
Clinical narrative: Larger lump with redness. Fever 2 1/2 days of 99 degrees.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash generalised
Clinical narrative: Pt received 2 month vaccines. Came in the following day with a rash all over his body. -Called mother on July 26th, Mother stated baby is better and no longer has a rash.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever (intermittent) for 72 hours with high of 102 degrees. Head to toe rash (hive like) 48 hours out. Rash remains present 7 days out. Mom monitored and reported to Imm. Clinic. Consult made with Local Pharmacist and CDC consult. on 7-31-18.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Right after administration of ROTATEQ orally, the patient vomited it right up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling cold, Palpitations
Clinical narrative: On provider's note, pt had SHINGRIX vaccine 5/25/18. Pt was home when he got up to urinate and while returning to bed he felt a "massive cold shot through my entire body". Pt verbalized "I felt like I dive into a very cold pool". This was accompanied by his heart racing and dyspnea, resolved after lying in bed for about 15 mins. This had never happened before and has not happened since. He feels fine now.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Injection site erythema, Injection site pruritus, Pain, Skin warm
Clinical narrative: Redness measured 1.5in x 1.25in diameter around injection site. Felt warm for couple days. Had pain about 4 days per mom. Hard to touch. States arm still itching as of today.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient presents for rash to left arm. Pt describes as itchy and red. Associated symptoms included: erythema and pruritus. Had PCV 13 vaccine 7/26/18, noticed on Saturday 7/28/18 arm rash, had fever day 1 and 2, took TYLENOL with fever relief. No fever today. Pt marked rash, improving. Tx: rec cool compress, elevation of arm, Rx: KEFLEX.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain, Peripheral swelling, Tenderness
Clinical narrative: Patient experienced pain and swelling on left upper arm. Arm was swollen and tender. Patient complained of pain to touch. Patient took MOTRIN OTC and was advised to use an ice pack.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Decreased appetite, Dizziness, Lip injury, Pupils unequal
Clinical narrative: Woke up with inside of lip busted. Went to take seizure meds and he was a little busy. Complaining of stomach pain and not wanting to eat this morning. Mom did get him to take seizure medication this morning but mentioned that pupils are not evenly dilated and he is little dizzy. Told mom to take patient to ER and she said he has a neurologist. Told mom to get him seen by someone, either neurologist or ER. Mom stated understanding and will call the neurologist to see what they say. Patient was eventually admitted. Mom feels this was the result of the vaccines administered as he had been doing ok prior to this.
Sex: M
Vaccine: FLUX
Symptoms: Acute disseminated encephalomyelitis, Anti-VGCC antibody negative, Anti-ganglioside antibody negative, Anti-muscle specific kinase antibody negative, Antinuclear antibody negative
Clinical narrative: This literature report, initially received on 23-Jul-2018, was reported by other health professional and concerns a 65-year-old, elderly, male patient. The patient's current conditions included human immunodeficiency virus (HIV) infection (CD4 count 533/uL), hypertension, diabetes mellitus type II and blindness (since an unspecified date). On an unspecified date, the patient was administered Influenza Vaccine (dose, route of administration, batch number, anatomical location and expiry date, manufacturer and trade name: not reported). On an unspecified date, 03 days after vaccination, the patient was admitted to the hospital for acute weakness of all extremities. Initial laboratory workup was performed and showed elevated protein in cerebrospinal fluid and no evidence of infection was noted. Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. The patient was treated with intravenous immunoglobulin and steroids for possible Guillan-Barre Syndrome, however his condition deteriorated, and he developed respiratory failure which required mechanical ventilation. The patient also experienced complete quadriplegia, nystagmus and multilobar pneumonia. Electromyography (EMG) showed a severe diffuse demyelinating pattern. On 16th day of hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On 17th day of hospitalization, the patient died and permission for autopsy was granted. The autopsy was performed and neuropathologic examination showed multiple soft lesions with tan discoloration throughout the brain and spinal cord, predominantly involving periventricular white matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons, medulla and upper cervical spinal cord. Microscopic examination showed discrete areas of demyelination surrounding vessels, with patchy macrophage aggregation, sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In a few of the lesions, the infiltrate was composed of neutrophils. Inflammation was perivascular or in the brain parenchyma and did not involve the vessel wall. No hemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated loss of myelin within the lesions. Neurofilament Immunohistochemical stain highlighted relative preservation of axons, although spheroids and axonal disruption were also present. The findings were more consistent with diagnosis of acute disseminated encephalomyelitis (ADEM). The outcome of the events respiratory failure, multilobar pneumonia and symptoms of ADEM (acute weakness of all extremities, complete quadriplegia, nystagmus, elevated protein in cerebrospinal fluid and severe diffuse demyelinating pattern) was not reported. The reporter assessed this case as serious (death and hospitalization).
Sex: M
Vaccine: FLUX
Symptoms: Autopsy, CD4 lymphocytes decreased, CSF protein increased, Central nervous system lesion, Death
Clinical narrative: This literature report, initially received on 23-Jul-2018, was reported by other health professional and concerns a 65-year-old, elderly, male patient. The patient's current conditions included human immunodeficiency virus (HIV) infection (CD4 count 533/uL), hypertension, diabetes mellitus type II and blindness (since an unspecified date). On an unspecified date, the patient was administered Influenza Vaccine (dose, route of administration, batch number, anatomical location and expiry date, manufacturer and trade name: not reported). On an unspecified date, 03 days after vaccination, the patient was admitted to the hospital for acute weakness of all extremities. Initial laboratory workup was performed and showed elevated protein in cerebrospinal fluid and no evidence of infection was noted. Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. The patient was treated with intravenous immunoglobulin and steroids for possible Guillan-Barre Syndrome, however his condition deteriorated, and he developed respiratory failure which required mechanical ventilation. The patient also experienced complete quadriplegia, nystagmus and multilobar pneumonia. Electromyography (EMG) showed a severe diffuse demyelinating pattern. On 16th day of hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On 17th day of hospitalization, the patient died and permission for autopsy was granted. The autopsy was performed and neuropathologic examination showed multiple soft lesions with tan discoloration throughout the brain and spinal cord, predominantly involving periventricular white matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons, medulla and upper cervical spinal cord. Microscopic examination showed discrete areas of demyelination surrounding vessels, with patchy macrophage aggregation, sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In a few of the lesions, the infiltrate was composed of neutrophils. Inflammation was perivascular or in the brain parenchyma and did not involve the vessel wall. No hemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated loss of myelin within the lesions. Neurofilament Immunohistochemical stain highlighted relative preservation of axons, although spheroids and axonal disruption were also present. The findings were more consistent with diagnosis of acute disseminated encephalomyelitis (ADEM). The outcome of the events respiratory failure, multilobar pneumonia and symptoms of ADEM (acute weakness of all extremities, complete quadriplegia, nystagmus, elevated protein in cerebrospinal fluid and severe diffuse demyelinating pattern) was not reported. The reporter assessed this case as serious (death and hospitalization).