chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pain
Clinical narrative: Tenderness; redness; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago from day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site tenderness, injection site erythema and drug dose administration interval too long. On an unknown date, the outcome of the injection site tenderness, injection site erythema and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site tenderness and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient recently received her second injection late, which led to lengthening of vaccination schedule. The patient reported that with the second injection she experienced tenderness and redness at the injection site. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain/soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter reported multiple patients of unknown ages and gender who had received the Shingrix vaccine and had experienced pain and soreness at the injection site. The healthcare professional did not have a specific patient, he was mentioning in general how patients experienced pain and soreness at the injection site. The reporter consent to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling, Peripheral swelling, Rash
Clinical narrative: rash and swelling from the injection site to her wrist one week starting day of injection and lasting until one week later; rash and swelling from the injection site to her wrist one week starting day of injection and lasting until one week later; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender  received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) , via an unspecified route of administration on 23Oct2019 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that rash and swelling from the injection site to her wrist one week starting day of injection and lasting until one week later. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: Patient received vaccine that had temperature excursion; Patient received vaccine that had temperature excursion; This is a spontaneous report from a contactable nurse.  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: AA7116, expiration date: 31May2021), via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient's medical history and concomitant medications were not reported. Patient received vaccine that had temperature excursion. Product details of other lot of Prevnar 13: LOT#: AL3577; Expiration date: 30Jun2021, LOT#: X93780; Expiration date: 31Jan2021; LOT#: X93806; Expiration date: 31Jan2021.  Information on the batch number has been requested.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Asthenia, Breast pain, Chest pain, Dizziness
Clinical narrative: Patient said she fell asleep and woke up between 8 and 9 pm 11/8/19 and had dizziness, weakness, headache, fever of 102, runny nose, sore throat and pain in left breast/chest area, joint aches.  She said at around 3-4 am on 11/9/19 she had trouble breathing going down stairs.  She called her MD office 11/9/19  with symptoms still and and they wanted her to come in or go to ER/urgent care.  She said no she wouldn't and would treat the symptoms with zicam and aspirin, vitamin c, proair, tylenol.  She mentioned that the office told her to come in if things continued. She said that she got a call from the office for 3 days in a row to check in on her.  By Monday 11/11/19 she said she felt better and temp was down to 100 11/9 Saturday her temp  was 101.  Tuesday am 11/12/19 she was feeling back to normal.  Patient never went in to be seen regarding these symptoms at this time.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Dyspnoea, Headache, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Patient said she fell asleep and woke up between 8 and 9 pm 11/8/19 and had dizziness, weakness, headache, fever of 102, runny nose, sore throat and pain in left breast/chest area, joint aches.  She said at around 3-4 am on 11/9/19 she had trouble breathing going down stairs.  She called her MD office 11/9/19  with symptoms still and and they wanted her to come in or go to ER/urgent care.  She said no she wouldn't and would treat the symptoms with zicam and aspirin, vitamin c, proair, tylenol.  She mentioned that the office told her to come in if things continued. She said that she got a call from the office for 3 days in a row to check in on her.  By Monday 11/11/19 she said she felt better and temp was down to 100 11/9 Saturday her temp  was 101.  Tuesday am 11/12/19 she was feeling back to normal.  Patient never went in to be seen regarding these symptoms at this time.
Age: 14.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Tremor, Vomiting
Clinical narrative: patient passed out and became very sweaty and pale. When he came to he threw up. He was non responsive at first when he opened his eyes and very shaky. By the time he left the pharmacy he was ok. He walked away by himself and was responsive and talking when he left.
Age: 23.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site vesicles, Vaccination site warmth
Clinical narrative: 11/14/2019 employee developed a warm and reddened area on vaccine site given.  11/14/2019 developed a  0.5x0.5 diameter blister that popped  11/15/2019
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: In Pentacel it contains DTap, Polio and HIB. The diluent is DTap and Polio and the powder mix is HIB. I gave the Diluent only. I then Gave HIB on its own after I figured out that I made a mistake. There was no treatment needed, and the outcome was ok.
Age: 7.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Rash
Clinical narrative: White Rash located on the client's face, arms, and stomach.  Client's caregiver states that the sites where the rash appears does not itch. Also, the rash appeared on the face and has begun to spread throughout the last few days to rest of the body.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient did not received HIB. Called parent to schedule vaccine to be given.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Headache, Myalgia, Pyrexia
Clinical narrative: Morning after vaccine woke up at 5 am with 101.4 temp oral, at 11am fever at 101.5 oral with loss of appetite, muscle aches, headache and spent most of day in bed. Next day temp up to 99.1 oral in evening and spend all day doing little and having little energy. Did start to eat. Next day temp normal at 97.1 oral and still feeling with little energy but went outside and raked some leaves and went to Mass at noon.. Next day got up at usual time 6 am to go to Mass and feeling better.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Morning after vaccine woke up at 5 am with 101.4 temp oral, at 11am fever at 101.5 oral with loss of appetite, muscle aches, headache and spent most of day in bed. Next day temp up to 99.1 oral in evening and spend all day doing little and having little energy. Did start to eat. Next day temp normal at 97.1 oral and still feeling with little energy but went outside and raked some leaves and went to Mass at noon.. Next day got up at usual time 6 am to go to Mass and feeling better.
Age: 64.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shingles vaccine site swelled and turned red, and was hot to touch. Swelling and redness lasted 8 days; heat lasted 3 days.
Age: 4.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Blood immunoglobulin M, Rash, Varicella virus test
Clinical narrative: Rash lasting 5-6 days
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt mother reports noticing the reaction to arm the day after injection 11/8/19 around 7 pm. Pt was seen at local ER around 8pm. ER notes document a 3" red round circle at site of flu vaccine injection and pt was c/o itching. Pt mother reports that the red area was hot to touch.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness
Clinical narrative: After getting Pneumovax 23, the patient became dizzy.  She said she had never had that happen after getting a vaccine.  I asked the patient to stay seated until she felt better.  I also asked her husband to escort her, supporting her while walking to their car, to minimize the risk of a fall.  I called the patient to check on her later in the day, but was unable to reach her.  I also notified the doctor who had prescribed the Rx for Pneumovax 23 of the adverse event.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Muscle spasms, Pallor
Clinical narrative: Directly after receiving the last vaccination (HPV-9) the patient became pale with complaint of dizziness. Patient was place in supine position with legs raised on exam table. At this time I observed slight left leg spasms. Patient remained A&O x4, conversing appropriately,  dizziness resolved, denied nausea & s.o.b.  No other complaints noted by patient. Patient self noticed left leg spasms asked when it will go away, mom was asked if the leg spasms have happened with previous vaccinations. Mom stated no.  Patient remained supine with cold packs to forehead, and bilateral armpits.  Patient left facility with slight muscle spasms to left leg remaining. Patient was escorted to vehicle. Mom advised that if condition remains or worsens seek medical attention at local ER. Mom stated understanding.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: as of this date patient experiencing pain at site of injection, radiating/vibrating all the way down to finger tips/hand
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: The patient experienced injection site redness after receiving the ZOSTA VAX vaccine 5 years ago; for shingles; This spontaneous report was received from a female patient of unknown age referring to herself. Information about medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was not provided.  On an unknown date in 2014 (reported as five years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (one single shot, route of administration, lot# and expiration date were not reported) for shingles (product use in unapproved indication), and in approximately 2014 after receiving zoster vaccine live (ZOSTAVAX), the patient experienced injection site redness. The redness went away within a couple of days. The causality between the event and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: pain in his left arm which shot up to left side of his neck; pain in his left arm which shot up to left side of his neck; trouble lifting his arm; This spontaneous report was received from a pharmacist referring to a male patient of 67 years-old. The patient's current conditions included prostate cancer, diabetes mellitus and high cholesterol. The patient's medical history was not reported. Concomitant therapies included treatment for prostate cancer (it was unspecified if it was completed or currently continued), unspecified cholesterol medicine and metformin. On 10-OCT-2018, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, anatomical location, route and lot number with expiration date were not reported) for prophylaxis. On 05-NOV-2019, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly in the left arm (dose not reported) (lot number S005857 with expiration date of 03-DEC-2020) for prophylaxis. On the evening of 05-NOV-2019, the patient developed pain in his left arm (pain in extremity) which shot up the left side of his neck (neck pain). The patient also complained of trouble lifting his arm to remove his shirt (Injected limb mobility decreased). The patient visited the pharmacist on 06-NOV-2019 and reported these events. The pharmacist did not show that whether patient ever had Prevnar 13. The events did not recover. The patient did not receive any treatment for the events. Causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swelling under armpit; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm. The patient had swelling under armpit on the same arm where the injection was given. The patient enquired whether this was normal side effect. The reporter requesting consent to follow up.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Burning sensation, Injection site bruising, Injection site pain, Paraesthesia
Clinical narrative: Tingling feeling in the left arm; Burning feeling in the left arm; Bubble bruise at the injection site; Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 55-year-old male patient who received HAB (Twinrix adult) (batch number H4A37, expiry date 18th October 2021) for prophylaxis.   On 15th September 2019, the patient received the 3rd dose of Twinrix adult (intramuscular) .5 ml. On 15th September 2019, less than a day after receiving Twinrix adult, the patient experienced injection site bruising and injection site pain. On 29th September 2019, the patient experienced tingling of extremity and burning sensation. On 29th September 2019, the outcome of the injection site bruising and injection site pain were recovered/resolved. On an unknown date, the outcome of the tingling of extremity and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, injection site pain, tingling of extremity and burning sensation to be related to Twinrix adult.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient developed a sore arm and bubble bruise at the injection site that lasted for two weeks. 14 days after vaccination, the patient then developed a tingling burning feeling in the left arm that still persists at the time of reporting. The reporter did not consent to follow up. As per sales data sheet reported batch number was changed from H4A3 to H4A37.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number J352N, expiry date 11th December 2021) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix. On 5th August 2019, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The patient experienced shingles 5 days after receiving dose of Shingrix . The reporter consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Flank pain, Headache, Migraine
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th August 2019).   On 10th November 2019, the patient received the 2nd dose of Shingrix. On 11th November 2019, 1 days after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were not recovered/not resolved.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The healthcare professional did not have the vaccine lot number and expiry date. The patient experienced migraine headache, chills, myalgia, arthralgia, sensitive skin, and flank pain. These events were ongoing at the time of reporting. The reporter consented to follow up. In the XML document outcome of events was reported as recovering, but its mentioned as not recovered, so kept as reported.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Sensitive skin
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th August 2019).   On 10th November 2019, the patient received the 2nd dose of Shingrix. On 11th November 2019, 1 days after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were not recovered/not resolved.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The healthcare professional did not have the vaccine lot number and expiry date. The patient experienced migraine headache, chills, myalgia, arthralgia, sensitive skin, and flank pain. These events were ongoing at the time of reporting. The reporter consented to follow up. In the XML document outcome of events was reported as recovering, but its mentioned as not recovered, so kept as reported.
Age: 75.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient received Shingrix on 10/4/19 and Flublok Quad on 10/21/19. She had no major issues after either injection until 11/11/19 when she developed pain in both her arms at the site of injections. The left arm where she received the Shingrix vaccine in noticeably more sore than her right arm where she received the flu shot. She had no noticeable relief with her daily use of Acetaminophen or Celecoxib. She had some relief after applying heat to the area. The pain doesn't appear to be getting worse at this time, however it doesn't appear to be improving either.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Peripheral swelling
Clinical narrative: Pt presented to the pharmacy on 11/15 @ 10 am. Pt states that her arm was swollen and inflamed and that it started swelling 2-3 days after administration of vaccine. It is swollen to about the size of half a golf ball, and Pt states that she saw a nurse  practitioner 11/14, about a different reason, and they told her to put some neosporin on it. I counseled the pt on Ibuprofen and Benadryl and to ice the area.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Asthenia, Chills, Feeling cold, Hallucination
Clinical narrative: 7 hours after shot  got the chills and felt weak. Went to be early. Chills got worse I was so cold I piled blankets on    Got so weak I could hardly move  By about 10:00 P.M. hallucination started and lasted for about 5 hours I was so weak I could not call for help if I wanted to.  First reaction ever to a vaccine
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Crying, Dizziness, Headache, Irritability
Clinical narrative: Crying, irritable, headache, dizziness, nauseous, stomach ache.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Nausea
Clinical narrative: Crying, irritable, headache, dizziness, nauseous, stomach ache.
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Dehydration, Dysphonia, Gastroenteritis, Injection site rash, Laboratory test
Clinical narrative: Child with significant medical history rec'd Flu,MMR,VZV vaccines. He became ill with presumed gastroenteritis, parents also report respiratory symptoms of congestion and hoarse voice. Child refused oral feeds and became dehydrated resulting in a hospital admission from 10/19-11/4/19 at Medical Ctr.   Hospitalization appears secondary to child's chronic medical issues and viral syndrome, however family concerned d/t timing from vaccination Child developed a rash at the injection of site of his flu vaccine, which remains present 4 weeks later
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Nasal congestion
Clinical narrative: Child with significant medical history rec'd Flu,MMR,VZV vaccines. He became ill with presumed gastroenteritis, parents also report respiratory symptoms of congestion and hoarse voice. Child refused oral feeds and became dehydrated resulting in a hospital admission from 10/19-11/4/19 at Medical Ctr.   Hospitalization appears secondary to child's chronic medical issues and viral syndrome, however family concerned d/t timing from vaccination Child developed a rash at the injection of site of his flu vaccine, which remains present 4 weeks later
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC13, RV5
Symptoms: Immunisation, No adverse event, Product preparation issue
Clinical narrative: No adverse harm - had to give patient 1 extra poke to administer Hib separately as did not mix Pentacel correctly.  Only Dtap/IPV portion of pentacel given, and Hib given as Pedvax Hib.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Oedema, Pain, Pain in extremity, Swelling
Clinical narrative: Pain localized to thigh, developed swelling, edema and later erythema. Pain to walk. Treated with local ice pack, gave Benadryl every 6 hours for next 48 hours and Tylenol for pain. Monitor at home and via phone call.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: When the patient wake on 11/13/19 there was swelling under his left eye and his feet were swollen and there was redness and swelling at the injection site.The swelling in his feet went down that day but eye and arm remained swollen. On the morning of 11/14/2019 there was swelling under his right eye. As of today 11/15/2019 there was still swelling under both eyes and arm was swollen about 2 inches around the injection site.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Injection site pain, Malaise, Pyrexia, X-ray
Clinical narrative: low grade fever, progressive pain in the arm from injection site to the elbow; loss of appetite, general feeling of illness for about a week and a half. Tx: steroids, tramadol, aleve, icing
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, VARCEL
Symptoms: Injection site reaction, Petechiae, Platelet count decreased
Clinical narrative: 36hrs later she developed diffuse petechial rash including mucosal involvement as well as large local reactions at the sites of injection. Platelet count was 2.  Evaluated by Hematology.
Age: 24.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Nausea, Syncope
Clinical narrative: Syncope episode addressed with patient remaining seated, cold compress, and water to drink.  Afterward patient complained of nausea and that he sometimes has hypoglycemic episodes - a small snack was provided.  Patient remained in chair entire time and was observed for 20 minutes.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Patient had swelling and red rash around injection site that was warm to the touch.  She went an urgent care clinic on 11/15/2019 and was perscribed cephalexin
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Migraine, Pain, Pyrexia
Clinical narrative: Migraine 1 day, chills 2 days, body aches 5 days so far,, low grade fever  1 day, I took ibuprofen
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pruritus, Pyrexia, Rash
Clinical narrative: The patient/employee presented with a rash covering her face, all extremeties, and trunk on the morning of 11/12/2019.  She reported the rash and associated itching, low grade fever, and headache started around 6 pm on 11/11/2019.  A visit to the local Occupational Health provider for our office was recommended, but the employee refused.  Instead, she stated she had started taking Benadryl at onset of symptoms with slight relief.  She continued to have the rash and itching for three more days, but the fever and headache subsided by the second day.  The employee reported that she was still taking Benadryl at night, but plans to stop now that the rash resolved.  She never saw a physician for the problem, just myself, who is an RN in charge of our in-house occupational health, including administration of the annual flu vaccines and associated monitoring of potential side effects/reactions.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: redness and swelling reported on 11/12/19.  Employee evaluated on 11/14/19.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Patient developed cellulitis at site and left upper arm with fever
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain, won't go away
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus
Clinical narrative: Itching at the injection site for 4 days
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Bone contusion, Cough, Ear pain, Headache, Pyrexia
Clinical narrative: fever 103 for 3days. Severe headaches. earaches. Dry cough to the point of bruised ribs
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Employee complained of breaking out in itchy hives on upper body one day after flu vaccine administration.  Employee saw her doctor for symptoms.  MD was not sure if hives were related to flu vaccine or not.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Vaccination site pain
Clinical narrative: Initial rash, very pruritic. Then prolonged pain involving left arm, where vaccination was given.
Age: 55.0
Sex: F
Vaccine: FLUR4, MMR
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Left arm pain, swelling, Itching, since vaccine administration. Symptoms worsened > 2 wks after administration of vaccine. Also with stiff (L) shoulder, neck + radiation of pain down volar surface of left arm to palm
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Oedema peripheral
Clinical narrative: Swelling under left arm pit and swelling in left clavicle glands.
Age: 48.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a Ped Hep B. Called IR, per IR not enough antigens in vaccine, OK to give adult dose of Hep B same day.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms; the patient was vaccinated with M-M-R II and VARIVAX on 07/24/2019 and PROQUAD on 9/4/2019; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 24-JUL-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number, expiration date, dose and route of administration were not provided) and the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number, expiration date, dose and route of administration were not provided). On 04-SEP-2019, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot number, expiration date, dose and route of administration were not provided) (inappropriate schedule of vaccine administered). No adverse symptoms were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse effect; administered a dose or improperly stored VARIVAX; This spontaneous report was received from a medical assistant regarding a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-NOV-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number: S021925, expiration date: 15-JUL-2021 (exact dose, strength, route of administration and anatomical location were unknown) for prophylaxis (product storage error). A properly stored sterile diluent was used to reconstitute the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX). The vaccine underwent temperature excursion from 6 degree Fahrenheit to 14 degree Fahrenheit (14 F) for a duration of 5 hours and from 15 degree Fahrenheit to 46 degree Fahrenheit (15.3 F) for a duration of 1 hour and 15 minutes. There was no previous temperature excursion. A data logger was involved. No product quality complaints were involved.   This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004359:
Sex: M
Vaccine: FLUN3
Symptoms: Death
Clinical narrative: DIED FROM FLUMIST; A spontaneous report has been received from a consumer concerning a 3 year old male patient.    No medical history was reported. No concomitant products were reported.    On an unknown date, the patient started receiving a treatment with Flumist (influenza vaccine (live, attenuated)), via nasal route.     It was reported that nephew died from the Flumist (Preferred term: death). He was 3. They gave him the mist when he had slight cold like symptoms (cough and runny nose) He died within 36 hours of receiving the mist. It was not known whether an autopsy was performed. The cause of death was unknown.    It was unknown if any action was taken with Flumist (influenza vaccine (live, attenuated)).     The event was considered serious (death) by the reporter.    The reporter considered the following event(s) related to treatment with Flumist (influenza vaccine (live, attenuated)): died from Flumist.; Sender's Comments: The report concerns a 3 years old male patient, who died while on treatment with Q/LAIV (Flumist), the cause of death was not further specified. Due to limited information, relevant medical history, drug details, concurrent diseases, concomitant medication, circumstances leading to death, date and autopsy report it is not possible to make a conclusive assessment of the causal relationship of the event and suspect drug.  ; Reported Cause(s) of Death: DIED FROM FLUMIST
Sex: F
Vaccine: HEPA
Symptoms: Blood immunoglobulin M increased, Hepatitis A, Vaccination failure
Clinical narrative: Suspected vaccination failure; Hepatitis A; positive IgM; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a female patient who received HAV (Havrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Havrix. On 5th November 2019, 139 days after receiving Havrix, the patient experienced vaccination failure (serious criteria GSK medically significant), hepatitis a and immunoglobulin m increased. On an unknown date, the outcome of the vaccination failure, hepatitis a and immunoglobulin m increased were unknown.   It was unknown if the reporter considered the vaccination failure, hepatitis a and immunoglobulin m increased to be related to Havrix.  Additional details were provided as follows: This case was reported by the public health nurse. The age at vaccination was not reported. The patient received Havrix and lab work was showing a positive IgM and the facility was classifying her as a Hepatitis A case.  The reporter stated that the patient had no symptoms to constitute that this was a Hepatitis A case.  The reporter stated that, it was always IV drug use, they were in prison with these patients and they receive the vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre (GBS) Syndrome; This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter had patient with a history of Guillain-Barr syndrome following an influenza vaccination.  The patient received Shingrix on 13th November 2019. The reporter asked was it safe for this patient to receive the Shingrix vaccine. The reporter was consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Breast swelling, Peripheral swelling
Clinical narrative: Swelling on the arms; Swelling on the breast; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received HAV (Havrix) (batch number E9G4E, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced swelling arm and breast swelling. On an unknown date, the outcome of the swelling arm and breast swelling were unknown.   It was unknown if the reporter considered the swelling arm and breast swelling to be related to Havrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Havrix and experienced swelling in the arms and breast. The reporter provided all patient identifiers and batch number but no expiration date, as it was not available.
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site mass, Peripheral swelling
Clinical narrative: Big swollen bump on her arm right away; Lump immediately formed; This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# AL3605, Exp date Jul2021, NDC 0005197102), via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. Medical history included high cholesterol and type 2 diabetes mellitus. Concomitant medications were not reported. The patient previously took Pneumovax for immunisation and experienced mass and peripheral swelling. The patient experienced big swollen bump on her arm right away and lump immediately formed both on an unspecified date immediately after vaccination. Outcome of the events was unknown. It was reported that same happened with Pneumovax but not so soon after giving it.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, HIBV, IPV, RV, UNK, UNK
Symptoms: Intestinal obstruction, Intussusception, Vomiting
Clinical narrative: Intussusception; Vomiting; Information has been downloaded from Regulatory Authority (US-SP-U1999-00591).  This spontaneous report was received from a physician concerning to a 4 month-old female patient. The patient's medical history and concurrent conditions were reported as unknown; the patient's concomitant medications was not reported.      On 16-JUN-1999, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency, route of administration, anatomical site of vaccination  and indication were not provided) (Lot number 0878H is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate). Other suspect vaccines included diphtheria toxoid (+) pertussis acellular biken vaccine (+) tetanus toxoid (TRIPEDIA) lot number 738981A, poliovirus vaccine inactivated (vero) (IPOL) lot number N1033, rotavirus g1 g2 g3 g4 reassortant vaccine live (human-rhesus) (ROTASHIELD) orally (lot number 4988094), poliovirus vaccine inactivated (unspecified) (IPV-VIRELON), diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (ACELLUVAX DTP) and hib conj vaccine (unspecified carrier)    On an unknown date, the patient experienced intussusception (intestinal obstruction) and vomiting, the patient was admitted due to the events on an unspecified date.   The outcome of intestinal obstruction and vomiting and the causality assessment between suspect vaccines and the aforementioned events, were both unknown.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient broke out in severe hives that covered 98 percent of his body.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Skin laceration
Clinical narrative: Skin tear noted at midnight, roughly 9 hours after receiving the injection.  Felt pain at the site, took off her bandage (slowly) and saw skin off of her arm.  No bleeding.  Didn't notice the swelling or redness until just prior to visit.  Skin tear was concerning to the patient, and states that it did not occur when removing the bandage.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Glossodynia, Oropharyngeal pain, Swelling of eyelid, Swollen tongue
Clinical narrative: Tongue and eye lids and surrounding tissue swelling, difficulty swallowing.  Two days after the event, the tissue under my tongue and throat are sore.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Angiogram, Angiogram normal, Chest X-ray normal, Condition aggravated, Electrocardiogram normal
Clinical narrative: pleurisy severe flare-up of transient global amnesia
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pleurisy, Transient global amnesia, Troponin normal
Clinical narrative: pleurisy severe flare-up of transient global amnesia
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Body temperature increased, Drooling, Influenza virus test negative, Mouth breathing, Protrusion tongue
Clinical narrative: Approximately 8p, patient had a temperature of 100.4 and had been receiving Tylenol for vaccines. she began with her tongue sticking out and drooling. She began panting about one hour later. She did sleep OK and wake to nurse but by the morning, she had an increased resp rate, worsening panting, drooling. Mother took her to the ED and was diagnosed with possible epiglotittis. She was given a dose of steroids and monitored. She did have some improvement after steroids. Symptoms gradually improved but didn't resolve until Wednesday. She had no cold symptoms prior to or after vaccination.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Respiratory rate increased, X-ray normal
Clinical narrative: Approximately 8p, patient had a temperature of 100.4 and had been receiving Tylenol for vaccines. she began with her tongue sticking out and drooling. She began panting about one hour later. She did sleep OK and wake to nurse but by the morning, she had an increased resp rate, worsening panting, drooling. Mother took her to the ED and was diagnosed with possible epiglotittis. She was given a dose of steroids and monitored. She did have some improvement after steroids. Symptoms gradually improved but didn't resolve until Wednesday. She had no cold symptoms prior to or after vaccination.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Electrocardiogram, Local reaction, Loss of consciousness, Pain in extremity
Clinical narrative: Patient had a localized reaction within an hour of getting the flu shot; her arm was hurting bad, was swollen and hot. At 3:20 pm she was taken to the school nurse to assess. She got blurry and passed out for 3-4 seconds shortly after. She was given a cold pack to put on her arm. The ambulance was called when she passed out and the EMTs did vitals and her father was on scene at that time. Patient was not transported, but went home with her dad and reported being tired. Her parents opted to have her seen on 11/08/2019. She was seen and evaluated by PA-C. An EKG was done to check for heart irregularities. Patient was improving by the time she was seen at the clinic and was fully recovered on 11/10/2019. On 11/08/2019 she developed a bruise.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin warm, Vision blurred
Clinical narrative: Patient had a localized reaction within an hour of getting the flu shot; her arm was hurting bad, was swollen and hot. At 3:20 pm she was taken to the school nurse to assess. She got blurry and passed out for 3-4 seconds shortly after. She was given a cold pack to put on her arm. The ambulance was called when she passed out and the EMTs did vitals and her father was on scene at that time. Patient was not transported, but went home with her dad and reported being tired. Her parents opted to have her seen on 11/08/2019. She was seen and evaluated by PA-C. An EKG was done to check for heart irregularities. Patient was improving by the time she was seen at the clinic and was fully recovered on 11/10/2019. On 11/08/2019 she developed a bruise.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: After administration of 1st Shingles shot developed the following - headache joint pain/body-aches fever localized swelling and warm welt developed at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: After administration of 1st Shingles shot developed the following - headache joint pain/body-aches fever localized swelling and warm welt developed at injection site.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Patient reports getting flu-like symptoms the day after getting the 2nd Shingrix dose which lasted for a few days. But the pain and soreness in his arm is still present 2 months after getting the vaccine.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Autism spectrum disorder, Decreased eye contact, Developmental delay, Laboratory test, Pica
Clinical narrative: Patient was sick when it was time for his first set of shots, so when it came time for his second the doctor doubled up so that he would be up to date on his vaccinations. The date they were administered maybe entered incorrectly as I have been waiting for a call back from the doctor but it was his initial immunization that caused the change in patient.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Psychomotor hyperactivity, Schizotypal personality disorder
Clinical narrative: Patient was sick when it was time for his first set of shots, so when it came time for his second the doctor doubled up so that he would be up to date on his vaccinations. The date they were administered maybe entered incorrectly as I have been waiting for a call back from the doctor but it was his initial immunization that caused the change in patient.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Right deltoid pain for 2 days, warm at site
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Erythema, Swelling
Clinical narrative: red/swelling - going to a doctor to be examined
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: Exaggerated local response, 8 cm in diameter on right thigh
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acoustic stimulation tests, Burning sensation, Headache, Injection site pain, Oral herpes
Clinical narrative: My arm was extremely sore for a week at the injection site, I developed an itchy and burning rash localized on  the right side of my spine, I developed a fever blister on my right lip, I had a very painful headache for 1 1/2 weeks, and worst of all I developed constant tinnitus.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Tinnitus
Clinical narrative: My arm was extremely sore for a week at the injection site, I developed an itchy and burning rash localized on  the right side of my spine, I developed a fever blister on my right lip, I had a very painful headache for 1 1/2 weeks, and worst of all I developed constant tinnitus.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: My arm was extremely sore for a week at the injection site, I developed an itchy and burning rash localized on  the right side of my spine, I developed a fever blister on my right lip, I had a very painful headache for 1 1/2 weeks, and worst of all I developed constant tinnitus.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Rash pruritic, Rash vesicular, Scratch, Tinnitus
Clinical narrative: My arm was extremely sore for a week at the injection site, I developed an itchy and burning rash localized on  the right side of my spine, I developed a fever blister on my right lip, I had a very painful headache for 1 1/2 weeks, and worst of all I developed constant tinnitus.
Age: 79.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Gingival pain, Injection site erythema, Injection site pain, Pain
Clinical narrative: The patient reported having pain and tenderness in her gums the following day after administration of vaccines and until 11/14/19 (still tender but not quite as tender). The tenderness was to the point where the patient could not eat hard foods or brush her teeth with a toothbrush. She also reported arm redness and soreness in her left arm (where Prevnar was administered) for several days following adminitration. The soreness was to the point where she could not raise her arm above her head. By 11/14/19 when this was reported to me, she said the redness had gone away and the soreness had subsided.