chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE; expired vaccine administered; This spontaneous report was received from a physician and refers to a 73-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 15-OCT-2020, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R034248, expiry date 07-AUG-2020 (also reported as 08-AUG-2020) (dose, route of administration and anatomical location were not provided) for prophylaxis. There was no temperature excursion. No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R034248; expirationdate: 07-AUG-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: herpes zoster with ophthalmic complications; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On or about 150DEC-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by the physician assistant for herpes zoster with ophthalmic complications. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.  Upon internal review, the event of herpes zoster with ophthalmic complications was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: rash underside of same arm / sore and itchy rash on the underside of same arm; very sore underside of the arm that I received the vaccine; chicken pox sore on the other arm.; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult 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 itchy rash, painful rash and vesicular rash. On an unknown date, the outcome of the itchy rash, painful rash and vesicular rash were recovered/resolved.   It was unknown if the reporter considered the itchy rash, painful rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient had reported the event for himself/herself. The patient received 1st dose of shingrix. The patient experienced very sore and itchy rash on the underside of the arm that the patient received vaccine and also what looked like a chicken pox sore on the other arm. For the tolerance of 2nd dose of shingrix link case US2020AMR206588.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206588:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Product preparation issue
Clinical narrative: Headache; Pain; Administrated a first dose of Shingrix only the adjuvant without the powder; Administrated a first dose of Shingrix only the adjuvant without the powder; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, less than a day after receiving Shingrix, the patient experienced headache, pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the headache, pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the headache and pain to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported that the patient administrated a 1st dose of Shingrix only the adjuvant without the powder which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The patient reported pain and headache. The reporter consented to follow up. Pharmacist didn't know who she gave just the adjuvant. The case had been linked with US2020203921 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203921:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: pneumonia; Initial information was received on 14-Oct-2020 regarding an unsolicited valid serious social media case from a consumer.  This case involves a patient of unknown demographics who experienced pneumonia, when received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiration date were not reported) via an unknown route and administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia, unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.; Sender's Comments: This case involves a patient with unknown demography who got pneumonia after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out predisposing etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: R deltoid with 5 x 5 cm red area, no tenderness, no warmth
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site, worsening over time causing pain to the Rt arm.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: pt presents to pharmacy 10/23/20 complaining of 2 months of shoulder pain/limited movement in left shoulder. pt notes pain is worse at night/when lying down/performing certain motions (twisting a light switch, putting arm in pocket and pulling out). highest pain leve 7-8/10 - lasts for 10 seconds.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: red, hot, hard and itchy arm, the size of an adult hand.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Per patient after 1 day got fever and spreading rash.  Had MD visit via on-line,  and MD had patient start Claritin.
Age: 74.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Burning sensation, Erythema, Herpes zoster, Pain, Tenderness
Clinical narrative: Beginning 10/18, tenderness to touch on right side of back around waist, on 10/19 tenderness continued, red spot noted next to spine of right side, pain and burning extended from spine to front  umbilical area,  on 10/20 pinpoint spots  waist area on right side.  Pain and burning increased.  Skin very sensitive to touch.  10/ 21 area on back larger, spots on side increased in number.  sought medical attention.  Shingles confirmed and started on treatment of Valtrex, 1 g 3x day for one week, Gabapentin, 100 mg  3x day.  Pain and tenderness has continued.  No further outbreak as of today's date.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Patient has severe hives on the torso and between thighs and rectum.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Bone pain, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache within the hour recieved, chills/shivers, fevor, all over body aches both muscle and bone. That same night by 7:00 pm
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Vomiting projectile
Clinical narrative: I had the vaccine at 3:45 on 10/20. At 10 pm  I woke up and projectile vomited, had very bad diarrheah.  was dizzy and weak. The next day 10/21 I stayed in bed all day, feeling  very dizzy and had no appetite. One 10/22 I got up and showered, but still felt dizzy and had little appetite. Today,  10/23, I am still dizzy  and  have no appetite. I would not trust myself to drive. I have written an email to Dr and talked to the nurse today to get vaccine info for this report. I have not been back to clinic.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood potassium increased, Crying, Electrocardiogram normal, Electroencephalogram normal, Eye movement disorder
Clinical narrative: On the ride home after receiving the vaccination, the patients mother noted his pulse ox to be low (88%). She reports that he had a weak cry, looked purple, and was limp. She also notes that his eyes rolled to the back of his head. The mother did not notice any abnormal body movements associated with the episode. The mother took the patient out of the car seat and his coloration improved. She brought him to the ER.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Hypotonia, Oxygen saturation decreased, Skin discolouration, White blood cell count normal
Clinical narrative: On the ride home after receiving the vaccination, the patients mother noted his pulse ox to be low (88%). She reports that he had a weak cry, looked purple, and was limp. She also notes that his eyes rolled to the back of his head. The mother did not notice any abnormal body movements associated with the episode. The mother took the patient out of the car seat and his coloration improved. She brought him to the ER.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Her left arm was red and swollen, started with 24 hr of vaccine. It lasted for couple of days. Some redness was still there today.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Initially sore at site of injection.  Over time, pain moved posteriorly to back of shoulder.  At times feels pain radiating into arm
Age: 75.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site scab
Clinical narrative: Patient received Pneumovax 23 in Left Deltoid on 10/15/20. Patient came back to clinic 10/23/20 stating she had a sore at the site of the injection. Seen by FNP-C. Upon examination, pt had a scabbed over area at injection site that was 1cm across. Under scab, hardened tissue was felt and measured to be 2cm across. No drainage was noted. Patient prescribed bactroban ointment to apply topically and instructed to return to clinic for follow up in 1 week or sooner if site worsens.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: vasovagal syncope
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Crying, Disability, Fear, Gait inability
Clinical narrative: Incapacitated; Felt like she had the flu; Thought she was going to die; This frightened her; Unable to walk; Even trying to move around hurt so much that she cried; Even trying to move around hurt so much that she cried; Unable to eat a lot during this time; Feels very weak; Very nauseated; Headache; Very sick; This spontaneous case was received on 16-Oct-2020 from other non-health professional via Med Communications (reference number: SEQW20-03816) and concerned an 80-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient received a flu vaccine, but never experienced side effects.   On 13-Oct-2020, in the morning, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular; anatomical location: left deltoid) as protection against seasonal influenza. The batch number was not reported. It was confirmed that it was 2020-2021 formulation.  On the same day, after receiving Fluad Quadrivalent, around 3 pm, the patient developed a headache that continued to get worse and worse as the day progressed. By the end of the day the patient was very sick and 'thought she was going to die'. The patient lived alone and that frightened her. She stated it got to the point where she felt like she had the flu, was unable to walk and that even trying to move around hurt so much that she cried and was incapacitated. The patient was very nauseated, unable to eat a lot during this time and also felt very weak. No corrective treatment was applied for events.  At the time of initial reporting on 16-Oct-2020, the patient was recovering from events, as until that date the patient did not see some of these issues started to lessen and she still felt very weak and was still nauseated, but it was not as bad as it was from 13-Oct 2020 to 15-Oct-2020.  The reporter did not provide a causality assessment.  The event of 'disability' and 'flu' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: Disability, influenza, fear of death, fear, gait inability, pain, crying, feeding disorder, asthenia, nausea, headache and malaise were associated with the use of the suspect product - Fluad Quadrivalent. Chronology seems very suggestive and possibly related for influenza, gait inability, pain, feeding disorder, asthenia, nausea, headache and malaise and unrelated for fear of death, fear and crying.; Sender's Comments: Disability, influenza, fear of death, fear, gait inability, pain, crying, feeding disorder, asthenia, nausea, headache and malaise were associated with the use of the suspect product - Fluad Quadrivalent. Chronology seems very suggestive and possibly related for influenza, gait inability, pain, feeding disorder, asthenia, nausea, headache and malaise and unrelated for fear of death, fear and crying.
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Hypophagia, Influenza like illness, Malaise, Nausea
Clinical narrative: Incapacitated; Felt like she had the flu; Thought she was going to die; This frightened her; Unable to walk; Even trying to move around hurt so much that she cried; Even trying to move around hurt so much that she cried; Unable to eat a lot during this time; Feels very weak; Very nauseated; Headache; Very sick; This spontaneous case was received on 16-Oct-2020 from other non-health professional via Med Communications (reference number: SEQW20-03816) and concerned an 80-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient received a flu vaccine, but never experienced side effects.   On 13-Oct-2020, in the morning, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular; anatomical location: left deltoid) as protection against seasonal influenza. The batch number was not reported. It was confirmed that it was 2020-2021 formulation.  On the same day, after receiving Fluad Quadrivalent, around 3 pm, the patient developed a headache that continued to get worse and worse as the day progressed. By the end of the day the patient was very sick and 'thought she was going to die'. The patient lived alone and that frightened her. She stated it got to the point where she felt like she had the flu, was unable to walk and that even trying to move around hurt so much that she cried and was incapacitated. The patient was very nauseated, unable to eat a lot during this time and also felt very weak. No corrective treatment was applied for events.  At the time of initial reporting on 16-Oct-2020, the patient was recovering from events, as until that date the patient did not see some of these issues started to lessen and she still felt very weak and was still nauseated, but it was not as bad as it was from 13-Oct 2020 to 15-Oct-2020.  The reporter did not provide a causality assessment.  The event of 'disability' and 'flu' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: Disability, influenza, fear of death, fear, gait inability, pain, crying, feeding disorder, asthenia, nausea, headache and malaise were associated with the use of the suspect product - Fluad Quadrivalent. Chronology seems very suggestive and possibly related for influenza, gait inability, pain, feeding disorder, asthenia, nausea, headache and malaise and unrelated for fear of death, fear and crying.; Sender's Comments: Disability, influenza, fear of death, fear, gait inability, pain, crying, feeding disorder, asthenia, nausea, headache and malaise were associated with the use of the suspect product - Fluad Quadrivalent. Chronology seems very suggestive and possibly related for influenza, gait inability, pain, feeding disorder, asthenia, nausea, headache and malaise and unrelated for fear of death, fear and crying.
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain
Clinical narrative: Incapacitated; Felt like she had the flu; Thought she was going to die; This frightened her; Unable to walk; Even trying to move around hurt so much that she cried; Even trying to move around hurt so much that she cried; Unable to eat a lot during this time; Feels very weak; Very nauseated; Headache; Very sick; This spontaneous case was received on 16-Oct-2020 from other non-health professional via Med Communications (reference number: SEQW20-03816) and concerned an 80-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient received a flu vaccine, but never experienced side effects.   On 13-Oct-2020, in the morning, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular; anatomical location: left deltoid) as protection against seasonal influenza. The batch number was not reported. It was confirmed that it was 2020-2021 formulation.  On the same day, after receiving Fluad Quadrivalent, around 3 pm, the patient developed a headache that continued to get worse and worse as the day progressed. By the end of the day the patient was very sick and 'thought she was going to die'. The patient lived alone and that frightened her. She stated it got to the point where she felt like she had the flu, was unable to walk and that even trying to move around hurt so much that she cried and was incapacitated. The patient was very nauseated, unable to eat a lot during this time and also felt very weak. No corrective treatment was applied for events.  At the time of initial reporting on 16-Oct-2020, the patient was recovering from events, as until that date the patient did not see some of these issues started to lessen and she still felt very weak and was still nauseated, but it was not as bad as it was from 13-Oct 2020 to 15-Oct-2020.  The reporter did not provide a causality assessment.  The event of 'disability' and 'flu' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: Disability, influenza, fear of death, fear, gait inability, pain, crying, feeding disorder, asthenia, nausea, headache and malaise were associated with the use of the suspect product - Fluad Quadrivalent. Chronology seems very suggestive and possibly related for influenza, gait inability, pain, feeding disorder, asthenia, nausea, headache and malaise and unrelated for fear of death, fear and crying.; Sender's Comments: Disability, influenza, fear of death, fear, gait inability, pain, crying, feeding disorder, asthenia, nausea, headache and malaise were associated with the use of the suspect product - Fluad Quadrivalent. Chronology seems very suggestive and possibly related for influenza, gait inability, pain, feeding disorder, asthenia, nausea, headache and malaise and unrelated for fear of death, fear and crying.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient called at 5:30 she explained she received the flu shot on 10/21/2020, she had concerns about injection site pain and redness. I explained to her that it could be a common side effect. She later explained that the injection site is now like a rash and has went from a quarter size to now the size of her palm. She explained that she will be going in to see the doctor. She was concerned of a possible allergic reaction to the vaccine.   Followed up, patient went to a clinic to be seen, was told it was an allergic reaction to the vaccine and was given Benadryl and zofran. Rash has gone down and patient is now feeling fine.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Patient had Flublok administered on 9/30/20.  On 10/5/20 she called into our clinical triage department and was given a same day appointment at our facility due to neck shoulder, & arm pain that began after the flu vaccine was administered.  She was given medications for the pain and referred to physical therapy.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Concussion, Electrocardiogram normal, Migraine, Neurological examination normal
Clinical narrative: Syncope with tonic-clonic movements, short-term memory loss (temporary), concussion, migraine
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Syncope with tonic-clonic movements, short-term memory loss (temporary), concussion, migraine
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: At approximately 9:30 AM of 10/23/2020, I started to feel nauseous and light-headed.   Notes from Nurse Manager: At around 10 AM, I was notified of the employee's condition. Went to see her at the clinic, she was in the room with the provider and patient. She came out and she advised me that she drank water and feels a little better. At around 11 AM, she verbalized that she's no longer lightheaded since she's sitting. Employee declined the other supervisor's offer to seek medical consult. I advised the employee to call me ASAP if symptoms persist or worsen. She verbalized understanding and that she had my direct number.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: C/o left shoulder pain with range of motion.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Anal incontinence, Dehydration, Dizziness, Fatigue, Headache
Clinical narrative: Extreme muscle pain with limited arm use, headache, extreme tiredness, feeling dizzy and then fainting, loss of bowel control  resulting in messing bathroom floor, dehydration
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Syncope
Clinical narrative: Extreme muscle pain with limited arm use, headache, extreme tiredness, feeling dizzy and then fainting, loss of bowel control  resulting in messing bathroom floor, dehydration
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Fatigue, Lymphadenopathy, Tenderness
Clinical narrative: That night experienced severe fatigue. Then woke up next morning and axillary lymph nodes on the same side (left) were enlarged and was about the size of a fist. Was also severely tender. As of 10/23 still tender and enlarged but no longer quite as large as it was on 10/22
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 10x10 cm area erythema with slight swelling, slight warmth at vaccine site
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Pyrexia, Vaccination site bruising, Vaccination site swelling, Vaccination site warmth
Clinical narrative: LEFT UPPER ARM SWELLING WITH REDNESS DEVELOPED ON 10/20/2020 AT SITE OF ONE VACCINATION. AREA IS WARM TO THE TOUCH. MOTHER STATES SWELLING IS THE SIZE OF A SOFTBALL AND IS STILL THAT SIZE. BRUISING TO LEFT ARM WHERE ONE OF THE VACCINATIONS WAS GIVEN. MOTHER REPORTS CHILD HAVING A FEVER OF 101.2-101.4 ON 10/20/2020, BUT DENIES FEVER AT THIS TIME. MOTHER REPORTS NO MEDICATIONS WERE GIVEN. ICE PACK WAS USED AT SITE OF SWELLING; SWELLING HAS GONE DOWN A LITTLE AND REDNESS HAS LIGHTENED. CHILD IS NOT COMPLAINING OF PAIN. MOTHER DENIES PUS, RASH, OR RED STEAKS AT SITE OF SWELLING.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Immediately after administering the vaccine child experienced vasovagal syncope. Time of unconsciousness less than 10 seconds. Child confused upon awakening. Vital signs taken immediately following event and periodically after. All VS stable. Child laid on exam table with feet elevated for nearly an hour. Discharged from clinic in wheelchair due to dizziness. Mom declined to take child to ER at that time and elected to take child home to be monitored by mom. Mom with child throughout entire event.
Age: 0.25
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was signed up for a flu clinic by his parents and was administered a shot, though he is below the minimum age.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness, Heart rate increased, Nausea, Pyrexia
Clinical narrative: Chills with severe shaking, nausea, light fever, and dizziness.  Had a rapid heart rate increase up to 205, which stayed in the 185 to 200 range for approximately 2 hours.  The heart rate gradually came down after 6/7 hours.  Was still at 115 at midnight and was 85 in the morning.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Chills with severe shaking, nausea, light fever, and dizziness.  Had a rapid heart rate increase up to 205, which stayed in the 185 to 200 range for approximately 2 hours.  The heart rate gradually came down after 6/7 hours.  Was still at 115 at midnight and was 85 in the morning.
Age: 11.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Brief syncopal episode, lasted 5-10 seconds then slowly awakened and returned to baseline within a few minutes.  Provided a bottle of water and Jolly Rancher once he was fully awake and drinking well.  He did not remember passing out and thought he was coherent the whole time.  He was held up by his mother and lowered to a chair by myself and his mother at which point he began awakening.  By 15 minutes he had completed drinking his bottle of water and was feeling normal, no residual effects.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: pt states "red hot lump"
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Injection site haematoma, Injection site pain
Clinical narrative: pt called on 10/23/20 to report that she has been diagnosed with a hematoma at the injection site and stated that the pain and difficulty in using the arm started approx. 1 week after injection (received vaccine on 10/1/2020)
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Musculoskeletal stiffness, Swelling
Clinical narrative: Swollen, redness, muscles feels stiff
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Malaise, Pallor
Clinical narrative: Pt received flu vaccine without incident.  After approx 5 minutes she was standing with mom talking with a friend and she said she didn't feel well and felt dizzy.  She was clammy and pale and was lowered to the ground. No LOC.  She had eaten before the clinic and was not overly nervous during her vaccination.  She was given a drink and applesause.   vitals BP 92/46, P 80. vitals remained stable. She recovered and went home with mom.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Occasional numbness or tingling in arm with shot. Comes and goes. Spoke with client originally at 11:15 over phone. PT spoke with doctor over phone. Called back at 230. Symptoms improving. no further care requested.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash vesicular
Clinical narrative: Patient experienced shortly after receiving vaccine itching and redness on injection site . By day 3 the area appeared to be a blister like rash  and grew in size from day 1.  Patient reported these reactions to his Doctor who told him not to proceed with getting dose 2.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Painful red rash and swelling of upper arm x 5 days. Treated with cephalexin TID x 7 days
Age: 46.0
Sex: F
Vaccine: FLUA4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site warmth, Pain, Sleep disorder
Clinical narrative: Patient felt pain with the injection and immediately afterward. It was reported as shooting pain at the site and "and a sort of painful heat sensation right after". Since then, she experienced shooting pain between her left shoulder and elbow and had pain upon movement of that arm. The pain was significant enough to interfere with sleep. Patient sought medical attention at urgent care on 10/22/20. She was given injection of Toradol and told to alternate between Tylenol and ibuprofen. Patient is feeling much better today, 10/23/20, and is able to move her arm with little discomfort.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Pain in arm, radiates up and down  at times into neck and forearm.  Started 3 days after receiving vaccine, has gotten progressively worse each day since.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anaesthesia, CSF protein, CSF white blood cell count, Central nervous system lesion, Hypoaesthesia
Clinical narrative: Transverse myelitis. Weakness and numbness in legs and feet, saddle anesthesia, developing over 30 hours.  Treatment: 1,000 mg/day methylprednisolone for 3 days, followed by IVIG. After hospitalization of 10 days, transfer to inpatient rehab for 7 days. Five days after discharge from rehab, recurring leg weakness, numbness in hands and fingers, Lhermitte's sign. Hospitalized another five days. Treatment: 1,000 mg/day methylprednisolone for 3 days, followed by plasmapheresis. Outpatient physical therapy has begun and is continuing
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immunoglobulin therapy, Laboratory test, Lhermitte's sign, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal abnormal
Clinical narrative: Transverse myelitis. Weakness and numbness in legs and feet, saddle anesthesia, developing over 30 hours.  Treatment: 1,000 mg/day methylprednisolone for 3 days, followed by IVIG. After hospitalization of 10 days, transfer to inpatient rehab for 7 days. Five days after discharge from rehab, recurring leg weakness, numbness in hands and fingers, Lhermitte's sign. Hospitalized another five days. Treatment: 1,000 mg/day methylprednisolone for 3 days, followed by plasmapheresis. Outpatient physical therapy has begun and is continuing
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Myelitis transverse, Plasmapheresis
Clinical narrative: Transverse myelitis. Weakness and numbness in legs and feet, saddle anesthesia, developing over 30 hours.  Treatment: 1,000 mg/day methylprednisolone for 3 days, followed by IVIG. After hospitalization of 10 days, transfer to inpatient rehab for 7 days. Five days after discharge from rehab, recurring leg weakness, numbness in hands and fingers, Lhermitte's sign. Hospitalized another five days. Treatment: 1,000 mg/day methylprednisolone for 3 days, followed by plasmapheresis. Outpatient physical therapy has begun and is continuing
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Magnetic resonance imaging spinal, Muscular weakness, Myelitis transverse, Plasmapheresis
Clinical narrative: Transverse myelitis. Weakness and numbness in legs and feet, saddle anesthesia, developing over 30 hours.  Treatment: 1,000 mg/day methylprednisolone for 3 days, followed by IVIG. After hospitalization of 10 days, transfer to inpatient rehab for 7 days. Five days after discharge from rehab, recurring leg weakness, numbness in hands and fingers, Lhermitte's sign. Hospitalized another five days. Treatment: 1,000 mg/day methylprednisolone for 3 days, followed by plasmapheresis. Outpatient physical therapy has begun and is continuing
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: red, raised rash around injection site. The patient showed me the rash and said it hasn't been bothering her at all, but just wanted to make sure it was ok. I recommended taking Benadryl to help with the rash and to let us know or her doctor's office know if it seems to get larger.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm swelling, redness, heat, itching
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint noise, Musculoskeletal discomfort, Pain
Clinical narrative: Pt reports that she got her flu shot at 6am on 10/7/2020. Pt notes that there was intense pain on insertion of the needle of her flu shot on the L arm.  She also reports that she feels as though the injection was placed very high on her shoulder. She notes that she awoke that evening with intense L shoulder discomfort and reduced range of motion and now reports that she can feel her shoulder clicking. She reports heavily reduced ROM for the first few days which has gradually improved, however, she still notes waking up regularly at night with pain in her shoulder. Pain is well-localized and non-radiating and she still reports reduced ROM with overhead reaching. Pain, which she describes as a catching sensation, and ROM improve with increased activity. Once she is moving she can be pain free but overnight she awakens with up to 5/10 pain. Pain also improves with neutral positioning.  Treatment is conservative at this time. The patient first sought care on 10/23/2020.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Product administered at inappropriate site, Sleep disorder
Clinical narrative: Pt reports that she got her flu shot at 6am on 10/7/2020. Pt notes that there was intense pain on insertion of the needle of her flu shot on the L arm.  She also reports that she feels as though the injection was placed very high on her shoulder. She notes that she awoke that evening with intense L shoulder discomfort and reduced range of motion and now reports that she can feel her shoulder clicking. She reports heavily reduced ROM for the first few days which has gradually improved, however, she still notes waking up regularly at night with pain in her shoulder. Pain is well-localized and non-radiating and she still reports reduced ROM with overhead reaching. Pain, which she describes as a catching sensation, and ROM improve with increased activity. Once she is moving she can be pain free but overnight she awakens with up to 5/10 pain. Pain also improves with neutral positioning.  Treatment is conservative at this time. The patient first sought care on 10/23/2020.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Asthenia, Blood glucose normal, Dizziness
Clinical narrative: Patient felt weak and dizzy a few minutes post vaccination. Patient was examined by MD- vital signs were stable. Patient discharged home with ER precautions.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Myalgia, Pruritus
Clinical narrative: Redness, firm and swelling on just about the entire upper arm, at injection.  Itches constantly.  1st 2 days muscle aches on my entire right side,  only.  Redness and itching did not go away until 10/23.2020
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: measles like rash developed 10 days later no fever no other symptoms
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral embolism, Thrombosis
Clinical narrative: Patient lower leg pain and clot which hospitalized him with large bilateral PE.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Borrelia test negative, C-reactive protein normal, Differential white blood cell count normal, Dizziness, Full blood count normal
Clinical narrative: My arm usually gets sore within a few hours of getting a flu shot, but after this one, the left side of my face from my lower cheek to my eyebrow became slightly numb at the same time. Within five days, slight numbness/tingling began to gradually spread to other parts of my body, particularly the left arm, left leg from the knee down, and eventually forehead, around my lips/mouth/eye sockets, and right forearm/hand, right ankle/top of foot, along with sporadic feelings in other places. Also experienced some lightheadness/vision feeling slightly off first few weeks of October.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Human herpes virus 6 serology negative, Hypoaesthesia, Magnetic resonance imaging brain normal, Magnetic resonance imaging neck, Magnetic resonance imaging normal
Clinical narrative: My arm usually gets sore within a few hours of getting a flu shot, but after this one, the left side of my face from my lower cheek to my eyebrow became slightly numb at the same time. Within five days, slight numbness/tingling began to gradually spread to other parts of my body, particularly the left arm, left leg from the knee down, and eventually forehead, around my lips/mouth/eye sockets, and right forearm/hand, right ankle/top of foot, along with sporadic feelings in other places. Also experienced some lightheadness/vision feeling slightly off first few weeks of October.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging thoracic normal, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate normal, Visual impairment
Clinical narrative: My arm usually gets sore within a few hours of getting a flu shot, but after this one, the left side of my face from my lower cheek to my eyebrow became slightly numb at the same time. Within five days, slight numbness/tingling began to gradually spread to other parts of my body, particularly the left arm, left leg from the knee down, and eventually forehead, around my lips/mouth/eye sockets, and right forearm/hand, right ankle/top of foot, along with sporadic feelings in other places. Also experienced some lightheadness/vision feeling slightly off first few weeks of October.
Age: 50.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: The patient is stating that her arm continues to hurt even after the injection. The patient is also stating there is some numbness along the arm that has not subsided and has continued since the shot.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: local swelling/erythema/pruritus/warmth Treated with IM steroid, OTC NSAIDS Last evaluation (10/23/20) above signs had decreased about 70%
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Crying, Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 10/20/2020 Child presents to parents upon waking with localized swelling and bruised right upper arm following vaccination the previous afternoon. Reports her ?arm really hurts? rates pain 6/10 using Wong-Baker FACES scale. Child is guarded with arm, and cries when being dressed. Body temperature 97.8 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. 200mg Ibuprofen administered PO Q6h for pain.  10/21/2020 Bruising is diminished, but erythema and edema (1+) are present at injection site and immediately surrounding tissue. Firmness detected in deltoid muscle not present on opposite non-injected arm. Pain reported at 4/10. Child remains guarded with arm, will not allow parents to dress her. Winces when raising affected arm above shoulder level. Body temperature 98.1 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. 200mg ibuprofen administered Q6 h for pain. 10/22/2020 Erythema and edema (1+) extending from shoulder to elbow. Firmness in deltoid has increased, and is visible from a profile view. Swelling visible and noticeable without close inspection. Pain not reported, but child will still not allow parents to assist in dressing. Winces when arm is touched, or raised above shoulder level. Body temperature 98.1 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally.  10/23/20 Erythema and edema (1+) extend from shoulder to elbow, erythema splotchy v. contiguous in nature. Firmness in deltoid has increased further. Child does not want to move arm above shoulder level, says ?it pinches.? Denies pain. Body temperature 97.9F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. Pediatrician notified. Will continue to monitor for signs of infection and range of motion.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: 10/20/2020 Child presents to parents upon waking with localized swelling and bruised right upper arm following vaccination the previous afternoon. Reports her ?arm really hurts? rates pain 6/10 using Wong-Baker FACES scale. Child is guarded with arm, and cries when being dressed. Body temperature 97.8 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. 200mg Ibuprofen administered PO Q6h for pain.  10/21/2020 Bruising is diminished, but erythema and edema (1+) are present at injection site and immediately surrounding tissue. Firmness detected in deltoid muscle not present on opposite non-injected arm. Pain reported at 4/10. Child remains guarded with arm, will not allow parents to dress her. Winces when raising affected arm above shoulder level. Body temperature 98.1 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. 200mg ibuprofen administered Q6 h for pain. 10/22/2020 Erythema and edema (1+) extending from shoulder to elbow. Firmness in deltoid has increased, and is visible from a profile view. Swelling visible and noticeable without close inspection. Pain not reported, but child will still not allow parents to assist in dressing. Winces when arm is touched, or raised above shoulder level. Body temperature 98.1 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally.  10/23/20 Erythema and edema (1+) extend from shoulder to elbow, erythema splotchy v. contiguous in nature. Firmness in deltoid has increased further. Child does not want to move arm above shoulder level, says ?it pinches.? Denies pain. Body temperature 97.9F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. Pediatrician notified. Will continue to monitor for signs of infection and range of motion.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: 10/20/2020 Child presents to parents upon waking with localized swelling and bruised right upper arm following vaccination the previous afternoon. Reports her ?arm really hurts? rates pain 6/10 using Wong-Baker FACES scale. Child is guarded with arm, and cries when being dressed. Body temperature 97.8 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. 200mg Ibuprofen administered PO Q6h for pain.  10/21/2020 Bruising is diminished, but erythema and edema (1+) are present at injection site and immediately surrounding tissue. Firmness detected in deltoid muscle not present on opposite non-injected arm. Pain reported at 4/10. Child remains guarded with arm, will not allow parents to dress her. Winces when raising affected arm above shoulder level. Body temperature 98.1 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. 200mg ibuprofen administered Q6 h for pain. 10/22/2020 Erythema and edema (1+) extending from shoulder to elbow. Firmness in deltoid has increased, and is visible from a profile view. Swelling visible and noticeable without close inspection. Pain not reported, but child will still not allow parents to assist in dressing. Winces when arm is touched, or raised above shoulder level. Body temperature 98.1 F, BP and pulse within normal range. Radial pulse strong and equal bilaterally.  10/23/20 Erythema and edema (1+) extend from shoulder to elbow, erythema splotchy v. contiguous in nature. Firmness in deltoid has increased further. Child does not want to move arm above shoulder level, says ?it pinches.? Denies pain. Body temperature 97.9F, BP and pulse within normal range. Radial pulse strong and equal bilaterally. Pediatrician notified. Will continue to monitor for signs of infection and range of motion.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Crying, Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Per mom she woke up the next day with redness and a swollen arm to the elbow and per mom she can raise her arm. We told her to massage, take benadryl and use warm compresses. Also to call us back if she need her to be seen or if any other problems over the weekend to go ahead and go to ER
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Per mom she woke up the next day with redness and a swollen arm to the elbow and per mom she can raise her arm. We told her to massage, take benadryl and use warm compresses. Also to call us back if she need her to be seen or if any other problems over the weekend to go ahead and go to ER
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Per mom she woke up the next day with redness and a swollen arm to the elbow and per mom she can raise her arm. We told her to massage, take benadryl and use warm compresses. Also to call us back if she need her to be seen or if any other problems over the weekend to go ahead and go to ER