chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest discomfort, Hypoaesthesia, Ocular hyperaemia, Pain in extremity, Photophobia
Clinical narrative: fever, shakiness, red eyes that are sensitive to light,  partial facial numbness above eye and nose, pt has high tolerance to pain and had severe pain in left arm, some slight tightness in chest  pt used proair and tightness stopped, fever recordings 99.4,100.7,101.4,101.8 @ 8pm ,101.5 @830pm pt took 2 extra strength Tylenols at 7pm. also added cold wash rag at 8pm.101.0
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia, Tremor
Clinical narrative: fever, shakiness, red eyes that are sensitive to light,  partial facial numbness above eye and nose, pt has high tolerance to pain and had severe pain in left arm, some slight tightness in chest  pt used proair and tightness stopped, fever recordings 99.4,100.7,101.4,101.8 @ 8pm ,101.5 @830pm pt took 2 extra strength Tylenols at 7pm. also added cold wash rag at 8pm.101.0
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Gait disturbance, Injection site pain, Injection site swelling
Clinical narrative: I have pictures, today is her eight day and her entire leg is swollen, in pain, has trouble walking
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: On 9/28/19 patient couldn't sleep because the area of the injection site (right deltoid) felt hot. On 9/29/19 and 9/30/19 the injection site continued to feel hot. Patient went to see his doctor on 9/30/19. On 10/1/19 patient returned to his doctor due to pain and swelling in arm from injection site extending down past the elbow to about the mid forearm.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Pyrexia, Staring, Tremor
Clinical narrative: About 2 hours after vaccination Mother noticed fever of 102F and administered 7.5ml of Motrin and Pt rested on the couch. after another hour and a half  the fever had not improved and Mom  gave 7.5ml of Tylenol. After the Tylenol mother noticed that the Pt was staring off into space and would not acknowledge his mothers presence. Mother also noted the Pt was shaking as though he was cold and decided to bring him upstairs to bed. Pt was also refusing water and mom tucked him in and watched him and believes that the fever reduced while the pt slept for 2-3 hours. Pt woke up and was  not happy until he was fed ice cream and his reheated dinner. At around 1030 pm pt went back to bed. Pt woke up at around 2AM and was given more 7.5ml Motrin due to another 102F fever and went back to bed. Pt woke up around 6 am and was given Tylenol preemptively and ate breakfast and seems to have recovered.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Chills, Dizziness, Hyperaesthesia teeth
Clinical narrative: 15-30 minutes of serious threat of fainting, perspiration then shivering.  Had to get to the floor several times.  Got through the worst of it after, maybe 30 minutes, but felt unsteady & weak for approx. 4+ hours.    Also, experienced extreme sensitivity to cold water/ice on upper left side of teeth.  No treatment, yet.  I think I've recovered, but only time will tell.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis
Clinical narrative: 15-30 minutes of serious threat of fainting, perspiration then shivering.  Had to get to the floor several times.  Got through the worst of it after, maybe 30 minutes, but felt unsteady & weak for approx. 4+ hours.    Also, experienced extreme sensitivity to cold water/ice on upper left side of teeth.  No treatment, yet.  I think I've recovered, but only time will tell.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Tingling and numbness in lips.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Immediate post-injection reaction, Nausea, Rash
Clinical narrative: Patient received Flu shot in Left Upper arm, immediately had sudden onset Back pain, nausea, lightheadedness, Red Rash on  chest up into her face.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Patient received Flu shot in Left Upper arm, immediately had sudden onset Back pain, nausea, lightheadedness, Red Rash on  chest up into her face.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Insomnia, Muscular weakness
Clinical narrative: 9/26/19: PAIN AT INJECTION SITE, SWELLING, SORENESS, HEADACHE.  LIMITED MOVEMENT OF LEFT SHOULDER JOINT. SEVERE PAIN WHEN RAISING ARM OR REACHING BEHIND. UNABLE TO SLEEP DUE TO PAIN. TREATED WITH NAPROXEN 220 mg. 9/27/19: CONTINUED LIMITED MOVEMENT OF LEFT SHOULDER JOINT. SEVERE PAIN WHEN RAISING ARM OR REACHING BEHIND. CONTINUED HEADACHE. RESTED ALL DAY AND DID NOT USE SHOULDER JOINT. NAPROXEN 220 mg. X 2 9/28/19 to PRESENT:  LIMITED MOVEMENT OF LEFT SHOULDER JOINT. CONTINUING PAIN WHEN RAISING ARM OR REACHING BEHIND. WEAKNESS IN LEFT ARM WHEN SHOULDER JOINT HAS ROLE IN TASK. TAKING NAPROXEN AND RESTRICTING MOVEMENT OF LEFT SHOULDER AS MUCH AS POSSIBLE
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Swelling
Clinical narrative: 9/26/19: PAIN AT INJECTION SITE, SWELLING, SORENESS, HEADACHE.  LIMITED MOVEMENT OF LEFT SHOULDER JOINT. SEVERE PAIN WHEN RAISING ARM OR REACHING BEHIND. UNABLE TO SLEEP DUE TO PAIN. TREATED WITH NAPROXEN 220 mg. 9/27/19: CONTINUED LIMITED MOVEMENT OF LEFT SHOULDER JOINT. SEVERE PAIN WHEN RAISING ARM OR REACHING BEHIND. CONTINUED HEADACHE. RESTED ALL DAY AND DID NOT USE SHOULDER JOINT. NAPROXEN 220 mg. X 2 9/28/19 to PRESENT:  LIMITED MOVEMENT OF LEFT SHOULDER JOINT. CONTINUING PAIN WHEN RAISING ARM OR REACHING BEHIND. WEAKNESS IN LEFT ARM WHEN SHOULDER JOINT HAS ROLE IN TASK. TAKING NAPROXEN AND RESTRICTING MOVEMENT OF LEFT SHOULDER AS MUCH AS POSSIBLE
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: The following day after receiving flulaval injection, patient started to get a red welt around the injection site. It was also very warm to touch. Over the next few days, the area of redness spread and then started to turn purple like a bruise. The area, which patient states took up most of her upper arm, was also still very warm to touch. Skin discoloration is fading but you can still see some residual today 3 weeks later.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: The following day after receiving flulaval injection, patient started to get a red welt around the injection site. It was also very warm to touch. Over the next few days, the area of redness spread and then started to turn purple like a bruise. The area, which patient states took up most of her upper arm, was also still very warm to touch. Skin discoloration is fading but you can still see some residual today 3 weeks later.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed a few hives (urticaria) 8 hours after vaccination and more generalized urticaria involving trunk the next morning
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: patient as administered 1 dose of improperly stored MMR II; no adverse effects reported; This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 10-JUL-2019, the patient was vaccinated with the first dose of an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R015165 exp date 29-MAY-2020) (route not reported) which was reconstituted with properly stored sterile diluent. A data logger issue was reported. The temperature of excursion was 50 °F for 4 hours. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the administration of one dose of an improperly stored vaccine, VAQTA, to one patient; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Information on pertinent medical history and drug reactions/allergies was not reported.   On 12-SEP-2019, the patient was vaccinated with an improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) (dose, dose number, route of administration and location of administration were not reported) (lot # S005723, expiration date 10-JUL-2020), administered for prophylaxis.   The vaccine was exposed to a temperature of 0.24 degree Celsius multiple times for a time frame of 5 hours and 30 minutes as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; One dose of an improperly stored vaccine, VAQTA, to one patient; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 09-SEP-2019, the patient was vaccinated with an improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) injection, for prophylaxis, lot number S005723 with expiration date in 10-JUL-2020 (strength and anatomical location  were not reported).  The hepatitis a vaccine, inactivated (VAQTA) was stored at a temperature of 0.24 Celsius (°C) (reported as multiple) for the time frame of 5 hours and 30 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; A patient was administered improperly stored PROQUAD; Information has been received from a medical assistant regarding a 4-year-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 05-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, for prophylaxis, lot number S009759 with expiration date in 27-SEP-2020 which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (dose, strength and anatomical location were not reported).  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F (17.6 F) for the time frame of 56 hours and 40 minutes. A previous temperature excursion was reported of 6 °F to 14 °F (6.2 °F) for 10 minutes. The call was not because of a data logger.  No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain from the injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years 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 information received were as follows: The age at vaccination was not reported. The pharmacy student stated that her mom experienced pain from the injection when she received Shingrix.  The reporter consented to follow up. Additional details not provided at the time of this call, but pharmacy student granted permission to follow up.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain; radiating pain; This case was reported by a nurse via call center representative and described the occurrence of shoulder pain in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA12AZ, expiry date 28th February 2021) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of musculoskeletal pain (1st dose received on 3rd August 2018, refer linked case US2019148696).   On 9th August 2019, the patient received the 2nd dose of Bexsero. In August 2019, less than a week after receiving Bexsero, the patient experienced shoulder pain and radiating pain. In August 2019, the outcome of the shoulder pain and radiating pain were recovered/resolved.   It was unknown if the reporter considered the shoulder pain and radiating pain to be related to Bexsero.  Additional information received were as follows: The registered nurse called to report a Bexsero adverse event. The patient received vaccine in left deltoid. The patient had the same reaction as he had to the 1st dose, significant shoulder pain that radiated to the back. The reporter reported that the pain lasted a while as she spoke to the patient's mother, 4 days after the 2nd dose. The reporter consented to follow up. This case had been linked to the case US2019148696, reported for same patient by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Bad side effects; This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient was having bad side affects after receiving Shingrix.
Sex: U
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: Injection Site Redness; Discomfort at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Quadrivalent .5 ml. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema and injection site discomfort. On an unknown date, the outcome of the injection site erythema and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema and injection site discomfort to be related to FluLaval Quadrivalent.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced redness and discomfort at injection site. The reporter consented to follow up. This is 1 of the 5 linked cases reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: Discomfort at injection site; Injection Site Redness; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Quadrivalent .5 ml. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema and injection site discomfort. On an unknown date, the outcome of the injection site erythema and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema and injection site discomfort to be related to FluLaval Quadrivalent.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced redness and discomfort at injection site. The reporter consented to follow up. This is 1 of the 5 linked cases reported by the same reporter.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Hurt arm; Tiredness for a couple of days; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient reported after 1st dose of Shingrix in August 2019, experienced tiredness for a couple of days and arm hurt. The reporter did not consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Suspected shingles after SHingrix; This case was reported by a other health professional via call center representative and described the occurrence of suspected shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date unknown) for prophylaxis.   On 20th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 7 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 information received were as follows: The patient experienced a suspected case of shingles. The reporter did not consent to follow-up. The caller refused to give any further details.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: swollen, hard and red at injection site
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This was my 2nd dose of Shingrix Vial Kit . 1st shot no problems, this one when I woke up day after shot had: chills, a fever of 100.6, achy, feeling tired, headache really horrible. Left work early went home & slept for 2.5 hours, on a bright & sunny day! Was feeling better by Wednesday morning. (shot received late afternoon on Monday)
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: vomiting, fever, tightness in chest, body ache, heavy breathing, numbing in face
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: vomiting, fever, tightness in chest, body ache, heavy breathing, numbing in face
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Influenza like illness, Malaise
Clinical narrative: Received the first shot for Shingrix. I got quite sick in the evening, with flu-like symptoms, vomited 4 times, diarrhea,  shivers, sweats.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Received the first shot for Shingrix. I got quite sick in the evening, with flu-like symptoms, vomited 4 times, diarrhea,  shivers, sweats.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Cough, Diarrhoea, Discomfort, Fatigue
Clinical narrative: rapid heartbeat, weakness, tired/fatigue, sinus symptoms such as facial pressure around the eyes, sneezing, cough (at bedtime) and diarrhea.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate increased, Sinus disorder, Sneezing
Clinical narrative: rapid heartbeat, weakness, tired/fatigue, sinus symptoms such as facial pressure around the eyes, sneezing, cough (at bedtime) and diarrhea.
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 61-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, 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 Flu vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced soreness at the injection site following previous flu shots. The caller did not provide any additional details. The reporter denied permission to follow up. This was 1 of the 3 cases reported by same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient experienced pain, swelling, redness in left arm at injection site. Approximately 14 hours post injection, also experienced nausea. These symptoms lasted 48 hours, except for nausea.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hangover, Headache, Influenza
Clinical narrative: Received the vaccine shot in the morning, about 12 hours later started experiencing typical flu symptoms - achy,  shivering, pain in joints, headache.   Went to bed shivering.  Woke up not shivering, but still achy all over.   Like I have a hang over.    No nausea associated.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Received the vaccine shot in the morning, about 12 hours later started experiencing typical flu symptoms - achy,  shivering, pain in joints, headache.   Went to bed shivering.  Woke up not shivering, but still achy all over.   Like I have a hang over.    No nausea associated.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: NAUSEA, PAIN AND SWELLING AT INJECTION SITE, HEADACHE
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Myalgia, Rash macular, Vomiting
Clinical narrative: Patient developed vomiting shortly after receiving injection on 9/27/19, 2 days post vaccine developed muscle aches which continued to worsen. 4 days after vaccine, muscle pains continued along with red blotchy areas to back and face.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, chills, violent shivering,  headache
Sex: M
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered chronic inflammatory demyelinating polyneuropathy.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided. In or around 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).  On an unknown date, reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)", the pt suffered chronic inflammatory demyelinating polyneuropathy.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitations not present prior to using it. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX). Chronic inflammatory demyelinating polyneuropathy as disabling event, due to the pt's permanent and incurable injuries. Upon internal review, chronic inflammatory demyelinating polyneuropathy was determined to be a medically significant event.
Sex: F
Vaccine: UNK
Symptoms: Blister, Injection site erythema, Injection site pruritus, Injection site warmth, Scar
Clinical narrative: Scar; Large blister; Red Injection Site; Warm Injection Site; Itchy; This case was reported by a consumer via call center representative and described the occurrence of blister in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine 2017-2018 season) for prophylaxis.   In October 2017, the patient received Influenza vaccine 2017-2018 season. In October 2017, less than a day after receiving Influenza vaccine 2017-2018 season, the patient experienced blister, injection site erythema and injection site itching. On an unknown date, the patient experienced injection site warmth and scar. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the blister, injection site erythema, injection site warmth and injection site itching were recovered/resolved and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the blister, injection site erythema, injection site warmth, injection site itching and scar to be related to Influenza vaccine 2017-2018 season.  Additional details were received as follows: The age at vaccination was not reported.  The patient received flu vaccine in October of 2017. She states that within 1-2 hours she developed a large blister that led to a scar after it resolved in 2.5 weeks. she states she also developed itching (resolved in 48-72 hours after taking benadryl)and a red, warm injection site, both of which resolved within one week. The reporter consented to follow up. Consumer does not know or declined to provide any further information at this time, consents to HCP follow up. Received the injectioN. She does not know the name or manufacturer of the flu vaccine.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: rash/rash on shoulder, back and chest; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 21-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, couple of hours after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were received as follows: The patient experienced rash on shoulder, back and chest a few hours after receiving the vaccine. The reporter did not consented to follow up.  The reporter notesdshe was unable to locate the lot and expiration date since RN did not enter it on the paperwork
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus
Clinical narrative: Patient described and intense burning and itching  that radiated down the whole arm. Symptoms began approximately 24 hours after injection and occurred mainly in the evening. Symptoms where treated by patient's physician with Gabapentin and resolved in about 12 days.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Malaise, Myalgia, Neck pain
Clinical narrative: Patient felt minor pain the day of the vaccination. The next day, the patient noticed fever and chills and more severe pain. The patient noted muscle pain as well as neck pain. The patient also noted difficulty breathing on the day after administration, causing her to use her inhalers more frequently. The patient went in to see her primary care physician and was examined. Four days after vaccine administration, the patient still reports general malaise, but no specific side effects like described above.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Patient felt minor pain the day of the vaccination. The next day, the patient noticed fever and chills and more severe pain. The patient noted muscle pain as well as neck pain. The patient also noted difficulty breathing on the day after administration, causing her to use her inhalers more frequently. The patient went in to see her primary care physician and was examined. Four days after vaccine administration, the patient still reports general malaise, but no specific side effects like described above.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: Possibly cellulitis, was given cephalexin by urgent care provider.   On Sept 27th, pt stated symptoms improving
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Patient described a bursitis like feeling beginning the morning following vaccination. Shoulder and upper arm of the left side were stiff and achy. Symptoms were intense for a few days but became progressively milder over time. Patient stated that her partner is a physician and expressed the opinion that the vaccine administration site may have been too high on the shoulder and caused irritation to the tendon or bursa.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Pyrexia
Clinical narrative: Patient husband called concerning his wife and her symptoms post immunization.  Last night she developed fever, chills, diarrhea, upset stomach, etc.  All side effects mentioned by husband are listed as potential side effects of shingrix.  Patient received shingrix and flu shot at visit.  Advised OTC pain reliever for fever and to follow up with physician if symptoms do not diminish.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Swelling face
Clinical narrative: When patient woke up day after vaccine administartion, one side of his face/cheek was swollen. Patient is concerned it may have something to do with the flu shot.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Vaccination complication
Clinical narrative: Monday 9/30/19 at 8pm arm was red and swollen, applied cool compresses. Tuesday 10/1/19 at 4pm when the child returned from school arm had increased redness, pain, and swelling.  Applied cool compresses, circled the area to check for increasing redness and swelling, and gave benadryl.  Wednesday 10/3/19 the redness had spread outside the line, brought  to walk-in clinic  and was diagnosed with a reaction to the flu vaccine
Age: 44.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal stiffness
Clinical narrative: After about 1 hour noted mild numbness of face. Started on right. Transitioned to entire face. Lasted about 20 hours leaving a mild stiffness in the cheek/facial area. Right arm injection site is sore.
Age: 44.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: After about 1 hour noted mild numbness of face. Started on right. Transitioned to entire face. Lasted about 20 hours leaving a mild stiffness in the cheek/facial area. Right arm injection site is sore.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Aggression, Blood glucose normal, Cold sweat, Computerised tomogram head normal, Dyskinesia
Clinical narrative: PT WAS ANXIOUS AT TIME OF ENTERING FACILITY, COMPLAINS OF FEAR OF NEEDLES.  WAS CLAMMY INITIALLY AFTER INJECTION.  HAD PT LIE DOWN WITH FEET UP AND  GAVE HIM A  SUCKER. COOL WET COMPRESS TO FOREHEAD. AFTER QUESTIONING PT STATES NO BREAKFAST JUST A SMALL COOKIE. PT FEELING BETTER REPEATEDLY STATES I'M OK. OFFERED WATER, PT DECLINED.  AFTER APPROX 10 MINUTES ALLOWED PT TO LEAVE WITH PARENT STATING ALSO, SHE FELT OK LEAVING WITH HIM.  AFTER GETTING OUTSIDE ANOTHER PERSON CAME INTO CLINIC STATING PT WAS OUTSIDE HAVING A "SEIZURE". ANOTHER STAFF MEMBER CALLING 911. FOUND PT ON GROUND WITH JERKING MOVEMENTS TO EXTREMITIES, EYES ROLLED BACK, BITING LIP. AFTER COUPLE MINUTES ( APPROX) PT CAME AROUND IN VIOLENT MANNER. PT STATES HE COULD NOT OPEN HIS EYES, DID NOT HEAR WHAT WAS GOING ON AROUND HIM. STATES HE "COULD FEEL HIS HEART" AND ALL  HIS MEMORIES WERE FLASHING. NO APPARENT INJURIES NOTED, NO LOSS OF B&B AMBULANCE ARRIVED AND TRANSFERRED PT TO LOCAL HOSPITAL. PT REFUSED IV IN AMBULANCE. UPON ARRIVAL AT HOSPITAL PT REFUSED TO HAVE GLUCOSE FINGER STICK. LABS DONE AND WNL GLUCOSE NOTED TO BE 98. CT OF HEAD PERFORMED AND WAS NEGATIVE FOR ACUTE ABNORMALITIES. EKG DONE IN SINUS BRADYCARDIA.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Electrocardiogram abnormal, Eye movement disorder, Eyelid function disorder, Hypoacusis, Lip injury
Clinical narrative: PT WAS ANXIOUS AT TIME OF ENTERING FACILITY, COMPLAINS OF FEAR OF NEEDLES.  WAS CLAMMY INITIALLY AFTER INJECTION.  HAD PT LIE DOWN WITH FEET UP AND  GAVE HIM A  SUCKER. COOL WET COMPRESS TO FOREHEAD. AFTER QUESTIONING PT STATES NO BREAKFAST JUST A SMALL COOKIE. PT FEELING BETTER REPEATEDLY STATES I'M OK. OFFERED WATER, PT DECLINED.  AFTER APPROX 10 MINUTES ALLOWED PT TO LEAVE WITH PARENT STATING ALSO, SHE FELT OK LEAVING WITH HIM.  AFTER GETTING OUTSIDE ANOTHER PERSON CAME INTO CLINIC STATING PT WAS OUTSIDE HAVING A "SEIZURE". ANOTHER STAFF MEMBER CALLING 911. FOUND PT ON GROUND WITH JERKING MOVEMENTS TO EXTREMITIES, EYES ROLLED BACK, BITING LIP. AFTER COUPLE MINUTES ( APPROX) PT CAME AROUND IN VIOLENT MANNER. PT STATES HE COULD NOT OPEN HIS EYES, DID NOT HEAR WHAT WAS GOING ON AROUND HIM. STATES HE "COULD FEEL HIS HEART" AND ALL  HIS MEMORIES WERE FLASHING. NO APPARENT INJURIES NOTED, NO LOSS OF B&B AMBULANCE ARRIVED AND TRANSFERRED PT TO LOCAL HOSPITAL. PT REFUSED IV IN AMBULANCE. UPON ARRIVAL AT HOSPITAL PT REFUSED TO HAVE GLUCOSE FINGER STICK. LABS DONE AND WNL GLUCOSE NOTED TO BE 98. CT OF HEAD PERFORMED AND WAS NEGATIVE FOR ACUTE ABNORMALITIES. EKG DONE IN SINUS BRADYCARDIA.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Seizure, Sinus bradycardia
Clinical narrative: PT WAS ANXIOUS AT TIME OF ENTERING FACILITY, COMPLAINS OF FEAR OF NEEDLES.  WAS CLAMMY INITIALLY AFTER INJECTION.  HAD PT LIE DOWN WITH FEET UP AND  GAVE HIM A  SUCKER. COOL WET COMPRESS TO FOREHEAD. AFTER QUESTIONING PT STATES NO BREAKFAST JUST A SMALL COOKIE. PT FEELING BETTER REPEATEDLY STATES I'M OK. OFFERED WATER, PT DECLINED.  AFTER APPROX 10 MINUTES ALLOWED PT TO LEAVE WITH PARENT STATING ALSO, SHE FELT OK LEAVING WITH HIM.  AFTER GETTING OUTSIDE ANOTHER PERSON CAME INTO CLINIC STATING PT WAS OUTSIDE HAVING A "SEIZURE". ANOTHER STAFF MEMBER CALLING 911. FOUND PT ON GROUND WITH JERKING MOVEMENTS TO EXTREMITIES, EYES ROLLED BACK, BITING LIP. AFTER COUPLE MINUTES ( APPROX) PT CAME AROUND IN VIOLENT MANNER. PT STATES HE COULD NOT OPEN HIS EYES, DID NOT HEAR WHAT WAS GOING ON AROUND HIM. STATES HE "COULD FEEL HIS HEART" AND ALL  HIS MEMORIES WERE FLASHING. NO APPARENT INJURIES NOTED, NO LOSS OF B&B AMBULANCE ARRIVED AND TRANSFERRED PT TO LOCAL HOSPITAL. PT REFUSED IV IN AMBULANCE. UPON ARRIVAL AT HOSPITAL PT REFUSED TO HAVE GLUCOSE FINGER STICK. LABS DONE AND WNL GLUCOSE NOTED TO BE 98. CT OF HEAD PERFORMED AND WAS NEGATIVE FOR ACUTE ABNORMALITIES. EKG DONE IN SINUS BRADYCARDIA.
Age: 60.0
Sex: F
Vaccine: FLUC4, UNK
Symptoms: Discomfort, Pruritus, Tachycardia
Clinical narrative: Per pt., started to experience extreme itchiness and tachycardia around 8 PM. No other changes to diet or routine besides Influenza vaccine and TB test administered a couple of hours earlier. Pt. had to take a Benadryl around 8:15 PM d/t uncomfortable feeling of itchiness. Pt. called employee health nurse to report reaction on 10/2 @ 9:50 AM. Informed pt. that employee health nurse would be making a VAERS report in which she verbalized understanding. Pt. states that she does have seasonal allergies, and does take Zyrtec for tx. Pt. continues to report some itchiness this morning, but somewhat better than last night. No c/o of SOB, throat closure, etc. Informed pt. to consult PCP in regards to reaction to Influenza vaccine, and to go to ER if she starts experiencing s/s of anaphylaxis reaction in which she verbalized understanding. At this time, pt. states that she feels like she does not need to see her PCP unless s/s worsen, and will inform PCP about Influenza vaccine on scheduled appt. on 10/13.
Age: 82.0
Sex: M
Vaccine: FLUA3
Symptoms: Contusion
Clinical narrative: pt states that he woke up the next morning with bruising between ring and pinkie finger on palm of right hand. Hand did have bruising about 1 inch in diameter on the palm between 4th and 5th fingers
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Chills, Cold sweat, Cough, Ear discomfort
Clinical narrative: I want to report that I had a serious adverse event produced by the Shingrix vaccine. I have never had an allergic response to a vaccine. After the injection on Monday August 26th, I felt little discompfort at the site of injection but dry cough appeared after 3-days. The symptoms continued with rhinitis, sinusitis, headacke, blocked ear drums, chills, cold sweat that made me go to the Emergency room.  X rays were clean but CRP level  was 105 mg/L. Monocytes were 10.5% with 1.08*10^9. All other cell types and levels were within normal range. They treated me with paracetamol IV and polaramine im. I stayed for over 3hrs and they let me go with bilastine 20 mg qd. When returned home visited the Drs. office and was treated with amoxicillin and Flonase .  I also visited an ENT due to the ear blockade.  She told me it will take sometime to clear up (ears were ok but my hearing was decreased).Today, October 2nd, I am still with ear drum blockade but no headache or pain. FYI I had chicken pox when I was a child and was vaccinated with Zostavax approximately 3 years ago.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hypoacusis, Injection site discomfort, Monocyte count increased, Monocyte percentage increased
Clinical narrative: I want to report that I had a serious adverse event produced by the Shingrix vaccine. I have never had an allergic response to a vaccine. After the injection on Monday August 26th, I felt little discompfort at the site of injection but dry cough appeared after 3-days. The symptoms continued with rhinitis, sinusitis, headacke, blocked ear drums, chills, cold sweat that made me go to the Emergency room.  X rays were clean but CRP level  was 105 mg/L. Monocytes were 10.5% with 1.08*10^9. All other cell types and levels were within normal range. They treated me with paracetamol IV and polaramine im. I stayed for over 3hrs and they let me go with bilastine 20 mg qd. When returned home visited the Drs. office and was treated with amoxicillin and Flonase .  I also visited an ENT due to the ear blockade.  She told me it will take sometime to clear up (ears were ok but my hearing was decreased).Today, October 2nd, I am still with ear drum blockade but no headache or pain. FYI I had chicken pox when I was a child and was vaccinated with Zostavax approximately 3 years ago.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rhinitis, Sinusitis, X-ray normal
Clinical narrative: I want to report that I had a serious adverse event produced by the Shingrix vaccine. I have never had an allergic response to a vaccine. After the injection on Monday August 26th, I felt little discompfort at the site of injection but dry cough appeared after 3-days. The symptoms continued with rhinitis, sinusitis, headacke, blocked ear drums, chills, cold sweat that made me go to the Emergency room.  X rays were clean but CRP level  was 105 mg/L. Monocytes were 10.5% with 1.08*10^9. All other cell types and levels were within normal range. They treated me with paracetamol IV and polaramine im. I stayed for over 3hrs and they let me go with bilastine 20 mg qd. When returned home visited the Drs. office and was treated with amoxicillin and Flonase .  I also visited an ENT due to the ear blockade.  She told me it will take sometime to clear up (ears were ok but my hearing was decreased).Today, October 2nd, I am still with ear drum blockade but no headache or pain. FYI I had chicken pox when I was a child and was vaccinated with Zostavax approximately 3 years ago.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: The day after the injection - 10/2/19, i developed severe fatigue and body aches from head to toe.  Approximately 24 hours after vaccination, I developed (2) areas approximately 3 inches by 2 inches, that were firm red and warm, 3 inches below the injection in the left arm and a similar area on the right shoulder. I took Benadryl 10/2/19.  By the next morning 10/3/19, the aches have subsided and the area on the opposite shoulder has started to subside but the area beneath the injection site is still firm, warm and red.  I took Loratidine this morning.  No other treatment sought.  My Doctor was notified.
Age: 71.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient called the office the day after immunizations stating his right arm was very painful and he was unable to lift his arm up because of the pain. He denies any redness, rash, or swelling.
Age: 15.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: I don't know which flu vaccine it was.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient got a shot in right arm.  She said the immunizer was standing over her while she was sitting. Her arm hurt after shot. She thought after two weeks of pain that the pain should have gone away by now. She emailed her MD. Dr told her to put on warm compresses on the site and take motrin.  Any heat/signs of infection/fever/swelling/redness to get evaluated. She came in today still in pain. She is going to make an appointment with her MD.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: After administering the last injection, the patient lost consciousness and fell onto the floor from the chair he was sitting on, hitting his head on the floor. The patient was turned over onto his mother's lap, started regaining consciousness and and ammonia inhalant was used. The patient's mental status and pupil dilation were assessed, alert and oriented and pupils were small, round and reactive. Patient remained laying on floor for approximately 15 minutes, emergency response services activated. Patient denied visual changes, tingling of upper and lower extremities. After paramedics arrived they continued to assess patient and it was determined it was safe for his mother to take him home and continue to evaluate. Signs and symptoms of concussion and additional warning signs were reviewed with mother. She was instructed her to follow up in Emergency Room or dial 911 for any warning signs.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Evening after immunization patient experience pain starting at injection site, going up arm, along shoulder and neck to base of skull.  Pain was very severe.  She used ibuprofen , I suggested she also  use ice, and contact her provider as well.   she was going to call her provider immediately after our conversation.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient received second series of Shingrix and complains of pain and not being able to lift arm up.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Generalised vaccinia, Lymphadenopathy, Malaise, Skin lesion
Clinical narrative: Generalized Vaccinia, lesions on abdomen, back, bilateral arms, face, neck and head appeared 10 days after vaccination, also swollen left axilla lymph nodes, no pruritus. No history of skin conditions. Had chills and feeling sick a couple days after vaccination but has resolved. No treatment, usually self limiting. Placed on 72 hr quarters and provided infection control precautions. Patient to follow up if signs of infection.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Chills, Delirium, Fatigue, Injection site pain
Clinical narrative: The name of the vaccine was Trivalent High-Dose 2:00 (ish) - flu shot Ate a light lunch (1/2 sandwich) around 3:00 Had 1/2 beer and some almonds around 5:15 5:45 - stabbing pain in upper abdomen, nausea (no vomiting) 6:15 (ish) - pain seemingly moving from injection site to right side of body, exhausted, had to lie down. Chills, low fever (99.5). Couldn't move to get more blankets. Heart starts racing (could have been a panic attack), took 1/4 mg of xanax . Mild  delirium. For the next 8 hours, imagined the pain as a video game board that I was 'clearing' - the pain in the area would lessen each time I 'cleared' it.  2:30 AM - finally able to fall asleep, fever at 100.5 5:00 AM - fever breaks, able to get up for water 6:00 - 11:00 AM  - sleep, listless and fatigued the rest of the day
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Listless, Mobility decreased, Nausea, Pain, Palpitations
Clinical narrative: The name of the vaccine was Trivalent High-Dose 2:00 (ish) - flu shot Ate a light lunch (1/2 sandwich) around 3:00 Had 1/2 beer and some almonds around 5:15 5:45 - stabbing pain in upper abdomen, nausea (no vomiting) 6:15 (ish) - pain seemingly moving from injection site to right side of body, exhausted, had to lie down. Chills, low fever (99.5). Couldn't move to get more blankets. Heart starts racing (could have been a panic attack), took 1/4 mg of xanax . Mild  delirium. For the next 8 hours, imagined the pain as a video game board that I was 'clearing' - the pain in the area would lessen each time I 'cleared' it.  2:30 AM - finally able to fall asleep, fever at 100.5 5:00 AM - fever breaks, able to get up for water 6:00 - 11:00 AM  - sleep, listless and fatigued the rest of the day
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: The name of the vaccine was Trivalent High-Dose 2:00 (ish) - flu shot Ate a light lunch (1/2 sandwich) around 3:00 Had 1/2 beer and some almonds around 5:15 5:45 - stabbing pain in upper abdomen, nausea (no vomiting) 6:15 (ish) - pain seemingly moving from injection site to right side of body, exhausted, had to lie down. Chills, low fever (99.5). Couldn't move to get more blankets. Heart starts racing (could have been a panic attack), took 1/4 mg of xanax . Mild  delirium. For the next 8 hours, imagined the pain as a video game board that I was 'clearing' - the pain in the area would lessen each time I 'cleared' it.  2:30 AM - finally able to fall asleep, fever at 100.5 5:00 AM - fever breaks, able to get up for water 6:00 - 11:00 AM  - sleep, listless and fatigued the rest of the day
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Staff member spoke with Infection Prevention on 10/2/2019 at 1105 am to report that she developed a rash on her chest and that she had an itching sensation on her face starting around 5 pm on 10/1/2019 after receiving the flu vaccine.  No respiratory concerns reported, no medications taken for rash per report.  Advised to contact her health care provider to document the event and to seek medical care if condition worsens.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: redness to site 3 days later after vaccine
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle aches started first on 9/30 pm then on 10/1 pm fever started, 10/1 6 pm chills (had to use 3 blankets and gloves to get relief).  Fever 100.3.  Fever at 100.0 at 1 a.m. 10/2 and fever broke before 5 a.m.  Started taking 2 acetaminophen tablets every 4 hours 10/1 - 10/2.  Today is 10/2 and just feel tired and nauseous. Had flu shot at same time but different arm.  Was unsure which flu vaccine to list above so just chose 1st one.