chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: rash; shingles; hurts; This case was reported by a consumer and described the occurrence of rash in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included painful rash (experienced couple years before the reporting).   In June 2019, the patient received the 1st dose of Shingrix. In August 2019, between 2 and 3 months after receiving Shingrix, the patient experienced rash, shingles and pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir Hcl). On an unknown date, the outcome of the rash, shingles and pain were unknown.   It was unknown if the reporter considered the rash, shingles and pain to be related to Shingrix.  Additional information received were as follows: The patient started to experience rash on rear about 5 days ago from the reporting date. The patient blamed it on adult diaper rash because the patient had been outside sweating a lot on the weekends. On Wednesday, the patient decided to get 2nd dose of Shingrix. On Friday, on the reporting date, the patient finally went to the doctor and he looked at my rash.  The patient told him it did not itch, it hurts, and had something like this a couple years ago, which took about 3 or 4 weeks or more to heal, though did not go to the doctor for it years ago.  On the reporting date, the patient was diagnosed with Shingles. The patient was put on Valacyclovir HCl 1gm tablet, every 8 hours, for 7 days. The patient know that it is not supposed to get a Shingrix shot when you have Shingles. But the patient did not even know that the patient had Shingles. The patient asked that would being on the Valtrex (Valacyclovir), reduce the effectiveness of my second Shingrix shot. The patient asked whether do need to consider getting a third shot when the patient do not had Shingles.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Confusional state, Feeling jittery
Clinical narrative: 9 AM Flu Vaccine administered. 1015 AM In class at school - felt confused + jittery. Was in Math Class + couldn't answer question as he Normally would. Went to Nurses STation. BP slightly Elevated. Mom Took Home after 2 hrs. Felt Normal.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Contusion, Debridement, Pain, Ulcer
Clinical narrative: Bruising, severe pain, blisters and then subsequent ulcers that needed to be debrided.
Age: 30.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Employee had anaphylaxis reaction to the flu vaccine within 5 minutes of receiving dose. Treated with IM  EPI and taken to ER for further evaluation.
Age: 30.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea
Clinical narrative: Employee had anaphylaxis reaction to the flu vaccine within 5 minutes of receiving dose. Treated with IM  EPI and taken to ER for further evaluation.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 6 to 8 hours after the injection, the injection site and upper arm got raised and swollen, red  and hot to the touch   Patient said arm hurt at injection site
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site pain, Laboratory test, Malaise
Clinical narrative: Diagnosed with Shingles on 9/23/2019 by Dr.   Valtrex,  started on 9/21/2019.   Pamelor, Flomax started on 9/23/2019.    Lab work on 9/23/2019      Pain and soreness at injection site on 9/17/2019 No symptoms until 9/20/2019  Rash with blisters,  burning pain, Low grade fever, malaise--on right upper groin area, right flank, and right back.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Diagnosed with Shingles on 9/23/2019 by Dr.   Valtrex,  started on 9/21/2019.   Pamelor, Flomax started on 9/23/2019.    Lab work on 9/23/2019      Pain and soreness at injection site on 9/17/2019 No symptoms until 9/20/2019  Rash with blisters,  burning pain, Low grade fever, malaise--on right upper groin area, right flank, and right back.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Croup infectious, Dysphonia, Erythema, Pyrexia, Swelling
Clinical narrative: 09/11/2019 swelling and redness 09/12/2019 swelling and redness expanded 09/13/2019 swelling and redness expanded 09/13/2019 took him to urgent care. I  was told it was a skin reaction, not vaccine reaction.  He was prescribed Hydrocortisone Cream, 2.5% and Cetirizine Hydrochloride Oral Solution 1 mg/ml. Neither one seemed to reduce the swelling.  09/15/2019 took him again to urgent care. This time the Dr agreed that it may be a reaction to the vaccine, not skin allergy. 09/19/19 He broke into 101.9 fever 09/20/19 voice became hoarse and developed croup cough. Fever came back 101.3. 09/21/19 cough worsened. Tylenol reduced fever.  09/22/19 cough sounded more like whooping 09/23/19 took him back to facility. He was diagnosed with croup.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient has been experiencing a redness at the injection site, swelling, and hot to the touch sensation. she has used ibuprofen and ice but it has lasted about 2 days so far
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Dysphagia, Eye discharge, Ocular hyperaemia
Clinical narrative: Fever [temp 100.6], chills, sclerae reddened, purulent drainage from both eyes, lump in throat, difficulty swallowing, chest tightness.  Duration unknown.
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Purulent discharge, Pyrexia, Sensation of foreign body
Clinical narrative: Fever [temp 100.6], chills, sclerae reddened, purulent drainage from both eyes, lump in throat, difficulty swallowing, chest tightness.  Duration unknown.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fall, Fatigue, Limb discomfort, Limb injury
Clinical narrative: That day patient prescribed Cipro for urinary tract infection; doctor said vaccine was ok to receive as long as there was no fever.   Tetanus received at ER in hospital maybe within last month.    Patient took antibiotics around 5pm and arm felt funny.  Patient started to get chills and shaking and could not control it.  Patient fell down when tried to move to get blanket and scraped arm on table on the way down. Patient wet herself, sat down for a while.  Finally got up and went to bed; not sure at what time this was.   On Sunday, did not feel the best went got up, spent afternoon with kids. On Monday felt like got tired easily.  Today feels chills and aches but feels better now.  Patient called pharmacist today, VAERS number given, and encouraged to follow-up with doctor; will not go to the doctor since doesn't feel as bad now.   Patient at 80% recovery.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain, Tremor, Urinary incontinence
Clinical narrative: That day patient prescribed Cipro for urinary tract infection; doctor said vaccine was ok to receive as long as there was no fever.   Tetanus received at ER in hospital maybe within last month.    Patient took antibiotics around 5pm and arm felt funny.  Patient started to get chills and shaking and could not control it.  Patient fell down when tried to move to get blanket and scraped arm on table on the way down. Patient wet herself, sat down for a while.  Finally got up and went to bed; not sure at what time this was.   On Sunday, did not feel the best went got up, spent afternoon with kids. On Monday felt like got tired easily.  Today feels chills and aches but feels better now.  Patient called pharmacist today, VAERS number given, and encouraged to follow-up with doctor; will not go to the doctor since doesn't feel as bad now.   Patient at 80% recovery.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Erythema, Mobility decreased, Pain, Swelling
Clinical narrative: red swollen area with pain and cant raise arm much behind her and cant reach behind you and pain is radiating
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt had a sore arm night of 9/21 and had flu like symptoms on 9/22. She started feeling better by Monday 9/23, however by the evening of Tuesday 9/24 her arm was more sore. She took Tylenol and went to bed but woke up at 2am Wed 9/25 with an extremely painful arm. Her arm is extremely painful with any movement and she has limited mobility in the arm. She also reports shooting pain with any sudden movements and is concerned about nerve issues. Patient reports her arm is tender to touch above the injection site, but states there is no swelling/bump/redness. She does have RA, which has manifested with the same symptoms, and she thinks that it may have been triggered by the shot but we are not sure at this point. I counseled patient to take some more Tylenol and recommended she go to an urgent care or see her physician so that they can take a look at her arm more closely.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on forehead; This case was reported by a physician via sales rep and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). 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 details were provided as follows: The patient experienced shingles within one week of receiving Shingrix. The patient received Valtrex as a treatment for herpes zoster on forehead and not in eye. This case has been linked with cases US2019AMR167873, US2018GSK096361 and US2019AMR084177 reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). 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 details were provided as follows: The patient experienced shingles within one week of receiving Shingrix. The patient received Valtrex as a treatment for herpes zoster on forehead and not in eye. This case has been linked with cases US2019AMR167862, US2018GSK096361 and US2019AMR084177 reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Chicken pox outbreak; This case was reported by a consumer and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 12 days after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was not recovered/not resolved.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient broke out with Chickenpox after receiving Shingrix vaccine.  The patient trying to ascertain if it's contagious. The patient had approximately 40-50 pox sores at various degrees or healing and still breaking out with new pox places daily. Initially started breaking out 12 days after the vaccination. The reporter asked if was there any treatment other the over the counter meds such as antihistamines and asked how long can expect this to continue.
Age: 59.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood test, Hepatitis B surface antibody positive, Hepatitis B virus test positive
Clinical narrative: positive hepatitis B test; This case was reported by a consumer via call center representative and described the occurrence of hepatitis b test positive in a 59-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Hepatitis B vaccine (unknown hepatitis B vaccine received 10-15 years before the date of reporting).   On 11th June 2019, the patient received the 1st dose of Twinrix adult (intramuscular). On 14th June 2019, 3 days after receiving Twinrix adult, the patient experienced hepatitis b test positive. On an unknown date, the outcome of the hepatitis b test positive was unknown.   It was unknown if the reporter considered the hepatitis b test positive to be related to Twinrix adult.  Additional details were provided as follows: The had blood work done. It was reported that, the patient tested positive for Hepatitis B, however, the health department believed it was detected in his blood due to him receiving the vaccine 3 days prior to testing.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling
Clinical narrative: swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient experienced swelling at the injection site to about the size of an orange.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced rash. The patient was treated with prednisone. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The pharmacist called to report that the patient has rash. The patient was scheduled for 2nd dose of Shingrix. Doctor gave Shingrix and prednisone for the rash.  The reporter stated that she did not have Shingles.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Pain; Myalgia; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients 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 pain, myalgia and fatigue. On an unknown date, the outcome of the pain, myalgia and fatigue were unknown.   It was unknown if the reporter considered the pain, myalgia and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The reporter did not reported a specific number of patients, did not have information regarding lot or expiry date or patient specific details. The reporter reported pain, fatigue, myalgia from Medical Information requested for a different inquiry, from lot of patients. The reporter denied permission to follow up.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Site of injection is very swollen (3-4 inches in diameter), red, raised, and warm/hot to the touch. It is very painful for patient to lift her arm. Symptoms began last night and remain unresolved with ice and ibuprofen.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis
Clinical narrative: cellulitis
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Middle insomnia, Paraesthesia, Pruritus
Clinical narrative: My left hand started itching so much that it woke me repeatedly during the night. It continued to itch throughout the day after the vaccination. In addition to itching, there was a burning sensation and sometimes a tingling.  The itching has subsided, but tingly sensation persists a little.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Employee has previously received a three shot series of the Hepatitis B vaccine in 2009. Employee received first injection of  Hepislav-B on 9/23/2019 by trained staff. Employee states that she had only a slight headache when she received the vaccination. Roughly 8 hours after receiving the vaccination employee noted the injection site was sore, raised, red and warm to the touch. Roughly 12 hours after the shot employee states that she had a migraine, itching at the injection site, tingling in the right arm, nausea, fatigued, loss of appetite, and with chills. Employee took Excedrin Migraine and baclofen.  Employee presented to work to complete form. States that the injection site pain has stopped. The tingling in her arm and stopped but the redness remains. Employee now denies nausea and loss of appetite. Employee continues to complain of chills and  fatigue.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Employee has previously received a three shot series of the Hepatitis B vaccine in 2009. Employee received first injection of  Hepislav-B on 9/23/2019 by trained staff. Employee states that she had only a slight headache when she received the vaccination. Roughly 8 hours after receiving the vaccination employee noted the injection site was sore, raised, red and warm to the touch. Roughly 12 hours after the shot employee states that she had a migraine, itching at the injection site, tingling in the right arm, nausea, fatigued, loss of appetite, and with chills. Employee took Excedrin Migraine and baclofen.  Employee presented to work to complete form. States that the injection site pain has stopped. The tingling in her arm and stopped but the redness remains. Employee now denies nausea and loss of appetite. Employee continues to complain of chills and  fatigue.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Migraine, Nausea, Paraesthesia
Clinical narrative: Employee has previously received a three shot series of the Hepatitis B vaccine in 2009. Employee received first injection of  Hepislav-B on 9/23/2019 by trained staff. Employee states that she had only a slight headache when she received the vaccination. Roughly 8 hours after receiving the vaccination employee noted the injection site was sore, raised, red and warm to the touch. Roughly 12 hours after the shot employee states that she had a migraine, itching at the injection site, tingling in the right arm, nausea, fatigued, loss of appetite, and with chills. Employee took Excedrin Migraine and baclofen.  Employee presented to work to complete form. States that the injection site pain has stopped. The tingling in her arm and stopped but the redness remains. Employee now denies nausea and loss of appetite. Employee continues to complain of chills and  fatigue.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test, Full blood count, Induration, Local reaction
Clinical narrative: Severe local reaction measuring 2.5 inches in diameter of induration.  Prescription for Pramoxine-Hydrocortisone 2.5-1% cream prescribed.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Migraine
Clinical narrative: Right arm very sore from shoulder to elbow for 3 days (8/26-8/28/2019).  For 4 days migraine headaches (8/29-9/1/2019).
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Burning sensation, Dizziness, Injection site reaction
Clinical narrative: Employee reported burning sensation at the site of IM injection Left Deltoid immediately after administration at 1555 on 09/23/2019.  Employee started to complain of feeling "dizzy" at 1600 Blood pressure obtained 104/70mmHg , HR 89bpm , regular respiration rate , no signs of respiratory compromise  or distress noted. Employee stated she had nothing to eat today 09/23/19. Employee provided with cheese crackers x6 and 12 ounces of electrolyte fluid. Employee remained in office #2 for observation , at 1618 employee now reports abdominal cramping rates a 9 out of 10  on a 0-10 scale with 10 being the most pain. At 1620 Blood pressure obtained 100/67 mmHg and HR 87bpm , no changes in respiration pattern. No signs of anaphylatic reaction ,no facial swelling, no hives, no swelling throat noted, employee denies difficulty breathing. Employee states "dizziness feeling is only when she lifts her head up and not when my head is lying down "Employee reports no other symptoms experienced and no changes in intensity for symptoms of dizziness, abdominal cramping. employee requested ibuprofen for pain for abdominal cramps employee and reports no changes with cramping with food and fluid. employee did consume all of the crackers and electrolyte drink provided . Employee did stated burning sensation to left arm at IM site stopped . 1630 after re-evaluation of employee's response to treatment the employee took medication two 200 mg tablets of Ibuprofen by mouth provided from first aid kit .  Employee remains under MSA /MCS observation post administration of Hepatitis B  vaccine.  1720 BP 98/61 mmHg HR 84 bpm Respiratory rate 20 breaths per minute. employee remains awake and alert.  No redness or swelling noted to site.  CMD notified and stated for employee to transfer to the hospital.  911 dispatched at 1750. 1755 EMS arrived, employee walked independently to ambulance with paramedic to go to Hospital ED.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain, Laboratory test, Pain
Clinical narrative: Starting 2 days after injection the arm became very sore from injection site all the way to tips of fingers. Fingers became numb and couldn't hold things. Very severe body pain at night that is lingering. Skin on middle fingers is sore to touch. Gradually able to grasp things again after 2 weeks.  Primary care physician appointment 9/9/19.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain of skin
Clinical narrative: Starting 2 days after injection the arm became very sore from injection site all the way to tips of fingers. Fingers became numb and couldn't hold things. Very severe body pain at night that is lingering. Skin on middle fingers is sore to touch. Gradually able to grasp things again after 2 weeks.  Primary care physician appointment 9/9/19.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain, Urticaria
Clinical narrative: hives and neck pain
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: The vaccines were administered on 9/23. On 9/25, pt came in with a rash on his arm.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Extreme itching and rash over entire body began day after injection and lasted at least 5 days
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Swollen left arm from shoulder to elbow area
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Pain in extremity, Paraesthesia
Clinical narrative: Pain and tingling throughout arm, cellulitis
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Tachycardia
Clinical narrative: tachycardia flu like symptoms
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Vision blurred
Clinical narrative: Menveo brand by GlaxoSmithKline is given as the second dose. 17 year old male discharged from appointment in pediatrics. Nurse alert called to outside front lobby. Patient was found to be lying on ground with purse under his head and mother by his side. Per mother, as he left our clinic, he walked outdoors and verbalized that it was blurry and bright to see and passed out immediately. When nurse arrives, patient was found alert, oriented to place, person and time. Initial vital signs while supine at 1145 am, B/P 110/74, AHR 59, blood chemstix 85, pulse oximetry 99% on room air. He was closely monitored for the next 15 minutes outdoors then transferred back to the pediatric treatment room at noon via wheelchair. The primary care provider was notified of incident immediately. It was noted that he had received his meningococcal vaccine prior to leaving his appointment and had not had anything to eat or drink before his visit today.  He was monitored until 1230 pm as vital signs remained stable. He was also given apple juice, crackers and 24 ounces of water while being monitored. Dr. (PCP) evaluated him and  was cleared to be discharged home. Nurse accompanies him by walking him outside as mother had car pulled up and escorted to car. He denied any further symptoms upon discharge.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Cold sweat, Discomfort, Disturbance in attention
Clinical narrative: My left upper arm turned red and swollen at the/from the site of the injection  to my elbow all the way around the entire circumference of my upper left arm. It became very hot and remained so for at least 4 to 5 days with the swelling continuing to this day; it has slowly improved along with the redness but both symptoms still linger. At about the 3rd day post-injection I was awoken from sleep with a deep pain in my elbow and upper & lower arm -- my arm was black and blue, especially at the vein areas and now the arm was swollen. This went into the second week and though it has improved I am still in moderate discomfort. I had/have difficulty lifting my arm during time and still have the same problem. Along with the above I have felt sick: breaking out in chills and cold sweats and shaking, very tired and trouble concentrating. The cold sweats began about a week post injection and still continue (at just over 2 weeks). And, now my left leg is having vein pain/discomfort same as my left arm. I am still tired, my left arm still hurts and I have been to the doctor and may need to go ahead. I am trying to avoid the Emergency Room, if at all possible.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Full blood count normal, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: My left upper arm turned red and swollen at the/from the site of the injection  to my elbow all the way around the entire circumference of my upper left arm. It became very hot and remained so for at least 4 to 5 days with the swelling continuing to this day; it has slowly improved along with the redness but both symptoms still linger. At about the 3rd day post-injection I was awoken from sleep with a deep pain in my elbow and upper & lower arm -- my arm was black and blue, especially at the vein areas and now the arm was swollen. This went into the second week and though it has improved I am still in moderate discomfort. I had/have difficulty lifting my arm during time and still have the same problem. Along with the above I have felt sick: breaking out in chills and cold sweats and shaking, very tired and trouble concentrating. The cold sweats began about a week post injection and still continue (at just over 2 weeks). And, now my left leg is having vein pain/discomfort same as my left arm. I am still tired, my left arm still hurts and I have been to the doctor and may need to go ahead. I am trying to avoid the Emergency Room, if at all possible.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Malaise, Middle insomnia, Pain in extremity
Clinical narrative: My left upper arm turned red and swollen at the/from the site of the injection  to my elbow all the way around the entire circumference of my upper left arm. It became very hot and remained so for at least 4 to 5 days with the swelling continuing to this day; it has slowly improved along with the redness but both symptoms still linger. At about the 3rd day post-injection I was awoken from sleep with a deep pain in my elbow and upper & lower arm -- my arm was black and blue, especially at the vein areas and now the arm was swollen. This went into the second week and though it has improved I am still in moderate discomfort. I had/have difficulty lifting my arm during time and still have the same problem. Along with the above I have felt sick: breaking out in chills and cold sweats and shaking, very tired and trouble concentrating. The cold sweats began about a week post injection and still continue (at just over 2 weeks). And, now my left leg is having vein pain/discomfort same as my left arm. I am still tired, my left arm still hurts and I have been to the doctor and may need to go ahead. I am trying to avoid the Emergency Room, if at all possible.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration, Tremor, Vascular pain
Clinical narrative: My left upper arm turned red and swollen at the/from the site of the injection  to my elbow all the way around the entire circumference of my upper left arm. It became very hot and remained so for at least 4 to 5 days with the swelling continuing to this day; it has slowly improved along with the redness but both symptoms still linger. At about the 3rd day post-injection I was awoken from sleep with a deep pain in my elbow and upper & lower arm -- my arm was black and blue, especially at the vein areas and now the arm was swollen. This went into the second week and though it has improved I am still in moderate discomfort. I had/have difficulty lifting my arm during time and still have the same problem. Along with the above I have felt sick: breaking out in chills and cold sweats and shaking, very tired and trouble concentrating. The cold sweats began about a week post injection and still continue (at just over 2 weeks). And, now my left leg is having vein pain/discomfort same as my left arm. I am still tired, my left arm still hurts and I have been to the doctor and may need to go ahead. I am trying to avoid the Emergency Room, if at all possible.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dizziness, Injection site pain, Pain in extremity, Vision blurred
Clinical narrative: Patient felt stinging in injection area which progressed to pain in left arm. Patient also began to feel faint and dizzy. Vision became blurred momentarily. Nurse from facility's urgent care came to take vitals. Vitals were normal. Gave patient water and allowed her to sit and let the reaction wear off. Patient waiting about 20 minutes before becoming mobile again. No further treatment was given and patient felt okay to go home, but still was too anxious to walk back to car on her own. Husband wheeled her out.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Localized redness and pain
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Rash erythematous, Skin warm
Clinical narrative: red rash, warm to touch and inflammed
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Body aches, fever as high as 102 by 9/21/2019 - 8 PM.  Significant lack of energy. Took over the counter medication to combat fever and body aches. Symptoms subsided by 2 PM on 9/22/2019.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: hives
Age: 1.5
Sex: F
Vaccine: DTAP, FLU4, HEPA
Symptoms: Chest X-ray abnormal, Cyanosis, Hypotonia, Lung opacity, Syncope
Clinical narrative: About 7 hours post-immunization, child was getting out of a warm bath when her legs collapsed and she slide face down into the water. Mother immediately scooped her up and noted her to have a blue-grey appearance and that she was limp in parents arms.  EMS called and child returning to baseline on their arrival, MOC estimated event lasted about 8 minutes.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: About 3 inches below the injections site, pt presented with redness and slight swelling of the skin on his arm. It started the day after he received the vaccine. He didn't experience any pain, fever, or body aches. He was told if it gets any worse or doesn't improve to contact his dr. He was also told to place ice on the site.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Reddiness around shot area. Itching  times 4 days. No treatment was necessary.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient stated they had arm pain the day of the injection.  The pain continued to last and the patient went to the doctor's office today complaining of the pain and shoulder/joint pain.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: diffuse welt-like rash, erythematous. Sporadic body sites/locations
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Hyperhidrosis, Peripheral swelling, Rash
Clinical narrative: Patient came in 1 week after receiving both vaccines in the same arm approximately 2 inches apart. She reports a raw rash on the posterior arm and swelling on the entire arm and fingers on the right side. She also reported a similar rash under her breast. Patient also stated that she started sweating profusely after the vaccines were administered. No reports of any pain or redness at the injection site. Patient states that she receives the flu vaccine yearly with no reaction therefore she thinks that this reaction is from the boostrix vaccine
Age: 53.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: During a flu clinic at a local business a patient was administered a pneumovax and fluzone. The pharmacist. The patient requested that he get a pneumonia shot because he had revieved one in 2014 and needed another  and when the pharmacist asked if he was over 65, the technician that was helping out and going over patient questionaires with the pharmacist  at the flu clinic said 66. The pharmacist then administered the pneumovax and fluzone to the patient thinking the patient was over 65.  The prescriber and patient was then notified of the error.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient experienced significant pain in the right arm and could not raise arm. Patient was advised to take any pain medication she normally is allowed to take by primary care physician. Pain subsided over several days.
Sex: M
Vaccine: RV1
Symptoms: Crying, Enema administration, Fatigue, Intussusception, Pain
Clinical narrative: Intussusception- crying, pain, fatigue
Sex: M
Vaccine: RV1
Symptoms: Ultrasound scan
Clinical narrative: Intussusception- crying, pain, fatigue
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Patient reports right should and area around the injection site got itchy and she got a few hives within a couple hours of the injection. Pt states that she took Benadryl and went to bed, and when she woke this morning, it was fine.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warmth spreading down her arm past her elbow
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient has redness and swelling radiating down left arm
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Influenza
Clinical narrative: Feels like I have a really bad case of the Flu - fever, chills, aches, tired, dizzy, bad headache  - arm only hurts a little so that is not an issue.  Day after vaccine was the worse and I had to leave work - on day two now and much better but still really tired and have a slight headache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Feels like I have a really bad case of the Flu - fever, chills, aches, tired, dizzy, bad headache  - arm only hurts a little so that is not an issue.  Day after vaccine was the worse and I had to leave work - on day two now and much better but still really tired and have a slight headache.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous report as received from a registered nurse refers to a 27 year old female patient.    The patient's pertinent medical history, drug reactions, allergies or concomitant medications were not provided.  On 04-JUN-2019, the 27 year old patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot# and expiration date were not provided) (product administered to patient of inappropriate age). On 17-SEP-2019, the patient went back to receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; patient was administered an expired VAQTA; This spontaneous report was received from a consumer and office manager refers 26 month old patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 21-SEP-2019, the patient was administered an expired hepatitis a vaccine, inactivated (VAQTA) (expired product administered) for prophylaxis (lot # R018935, Expiry date: 05-SEP-2019). No adverse effect reported. No PQC involved. No additional information provided.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Injection site erythema, Injection site swelling
Clinical narrative: 3 year old girl came into ED -Emergency Department on 9/1/19 due to right upper thigh swelling and redness for the past 3 days.  Prior to coming into our ED, the girl was also seen in urgent care  for the same swelling and started on antibiotic- Cephalexin.   Mother stated that her daughter received flu vaccination in pediatrician's office 3 days ago (on 8/29/19).      Swelling involved anterior right thigh, circle of erythema, and additional symptoms also include abdominal pain. Patient was admitted to our pediatric unit for IV antibiotic and close observation.    Patient rec'd IV fluid,  Rocephin IVPB,  oral Benadryl,    Patient discharged the following day on 9/2/19  and to follow up with her pediatrician Dr.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Pallor, Seizure like phenomena, Syncope
Clinical narrative: Became dizzy, pale, diaphoretic and fainted within minutes of receiving injection.  Seizure like arm movements for 3-5 seconds after. Opened eyes right after seizure like movement.  Placed head between knees x5 minutes. Drank 2 glasses apple juice and ate crackers.  Then placed on stretcher to lie flat for 10 minutes. Gradually and incrementally raised HOB to sitting position. Pt remained without further dizziness.  VS remained stable throughout.  Pt states that she didn't eat breakfast.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Headache.  Muscle ache.  Sore throat. Tired.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: about 12 hours after injection, patients upper arm became very sore/painful. Swelled, turned red, and was hot to the touch. She used ice packs over next 2 days until symptoms subsided. She did not require additional treatment and only reported it upon a return trip to pharmacy on 9/25/19. Area was still slightly red but for most part all symptoms resolved
Age: 1.0
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received dose of IPV 11/28/18, 02/01/2019, 6/24/19 and 09/25/2019.  Received dose on 9/25/19 when not due.  Currently no documented adverse reactions.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Impaired driving ability, Tremor
Clinical narrative: Onset tremor, cold sweat and dizziness at 1645 after receiving injection at 1215.   Ate breakfast and had a bagel w cream cheese and sweet drink at 12:45, so unlikely to be intake related, no history of DM or hypoglycemia.....   Tried eating snack but dizziness persisted such that I have to lie down and couldn?t drive to pick up my kids
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: The patient called the pharmacy on 9/19/19 and told me he had a rash of small bumps that itched over most of his body - more concentrated in the trunk area of his body along his beltline and sock line. He said these bumps were also on his scalp. I instructed the patient to take Benadryl throughout the day and at bedtime as directed on the bottle and to go to the ER if any signs of anaphylaxis - difficulty breathing, swelling of face/mouth. I also advised him to call us or the doctor with any questions. I told him I would call him back to check in. 9/25/19 - I called back and the patient said his rash has improved but is not entirely gone - but he feels better and is still taking the Benadryl every day. He said he would call me back in a few days for another update.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: patient stated that upper arm is swollen. This is 5 hours after vaccination
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pruritus, Pyrexia
Clinical narrative: AROUND 11 am ON 9/25/19, pt called said that he have sore on his shoulder the day after his shot,  we ask him how is it site of injection, he said it was fine except muscle sore on shouders, so i told pt to take some tylenol but he said he as ibuprofen, so he took ibu. I told him to call me back in afternoon for follow up. At 1p.m, pt called and said that he felt itchy and had fever. I ask him   was he just  itching  or felt  any difficult of breathing or tounge swelling, he said he just itched. So i told him to  take benadryl ( he got nightime benadryl) and tylenol, and i will call to check on him about lucnh. I also told him if he cant breathe, he has to go to hospital. after 2pm, i called him back he said he was ok ( but still had sores on shoulders)
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Decreased appetite, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: Patient developed malaise, extreme fatigue, myalgias, headache, lack of appetite, and nausea approximately 12 hours after receiving the Shingrix and PPV 23 vaccinations. Patient received vaccinations on 9/23 and was reevaluated on 9/25 due to symptoms thought to be related to an adverse reaction to vaccinations. Patient symptoms have been improved and were abating by late morning on 9/25. No anaphylaxis or angioedema reported. There were no rashes/hives.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyskinesia
Clinical narrative: After about five minutes of receiving Tdap and MCV patient began to have violent movements of arms and legs for a few seconds.  The patient was placed on a bed with her legs upright for fifteen minutes. When the fifteen minutes had past the patient was doing well and answering all questions.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Cyanosis, Diet refusal, Gait inability, Gastric dilatation, Hypersomnia
Clinical narrative: The night of the vaccination patient threw up and ran a fever of 103.4. The vomitting continued through the next 2 days along with extreme lethargy and the inability to walk. For the next week patient would not/could not hold her head upright, she was sleeping for 20hours a day and when she was awake she stared into space. She refuse to eat. She could not walk or climb which she had been doing for the last 4 months at that point. I took patient to the hospital about a week and a half after vaccination due to episodes of hypothermia, cyanosis, and the extreme lethargy. She also began having stomach distention shortly after discharge which continued for a month along with the cyanosis. The lethargy lifted after 2 weeks she began holding her head up again and slowly walking again. We began noticing personality trait differences as well. Increased appetite and mood swings which have not gone away
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Hypothermia, Increased appetite, Lethargy, Lumbar puncture, Mood swings
Clinical narrative: The night of the vaccination patient threw up and ran a fever of 103.4. The vomitting continued through the next 2 days along with extreme lethargy and the inability to walk. For the next week patient would not/could not hold her head upright, she was sleeping for 20hours a day and when she was awake she stared into space. She refuse to eat. She could not walk or climb which she had been doing for the last 4 months at that point. I took patient to the hospital about a week and a half after vaccination due to episodes of hypothermia, cyanosis, and the extreme lethargy. She also began having stomach distention shortly after discharge which continued for a month along with the cyanosis. The lethargy lifted after 2 weeks she began holding her head up again and slowly walking again. We began noticing personality trait differences as well. Increased appetite and mood swings which have not gone away
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Personality disorder, Posture abnormal, Pyrexia, Vomiting, X-ray limb
Clinical narrative: The night of the vaccination patient threw up and ran a fever of 103.4. The vomitting continued through the next 2 days along with extreme lethargy and the inability to walk. For the next week patient would not/could not hold her head upright, she was sleeping for 20hours a day and when she was awake she stared into space. She refuse to eat. She could not walk or climb which she had been doing for the last 4 months at that point. I took patient to the hospital about a week and a half after vaccination due to episodes of hypothermia, cyanosis, and the extreme lethargy. She also began having stomach distention shortly after discharge which continued for a month along with the cyanosis. The lethargy lifted after 2 weeks she began holding her head up again and slowly walking again. We began noticing personality trait differences as well. Increased appetite and mood swings which have not gone away
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever (102), chills, aches
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Feeling cold, Taste disorder
Clinical narrative: PATIENT RETURNED TO PHARMACY AFTER RECEIVING VACCINE APPROX 5 MINUTES PRIOR STATING SHE FELT LIGHT HEADED AND HAD AN UNUSUAL TASTE/COLDNESS IN HER MOUTH.  SHE SAT DOWN FOR 10-15 MINUTES UNTIL THE FEELING SUBSIDED THEN LEFT.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Soon after immunization was administered pt's arm swelled at injection site. redness and swelling. pt did not complain of any pain. I called RN into exam room to examine site. Ice pack was placed on site to help with swelling, vitals were rechecked and pt was monitored by myself and RN until provider came into exam room. Pt complained of lightheadedness/feeling faint and sob. prior to injection pt complained of anxiety that was addressed in office visit wtih provider.