chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: persistent strain of herpes zoster/severe herpes zoster or shingles; did not prevent shingles as intended; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported.  On an unknown date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance for the prevention of shingles. On an unknown date, the patient experienced herpes zoster and vaccination failure. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. She was treated at the hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result she had suffered and would continue to suffer significant medical expenses, and pain and suffering and other damages.  The outcome of the events was unknown. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Hypoxia, Urticaria, Urticarial vasculitis
Clinical narrative: angiodema; Urticarial Vasculitis; hypoxia; urticaria/hives; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 18-SEP-2013, the patient was inoculated in the clinic with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) as recommended for routine adult health maintenance for the prevention of shingles. From an unknown date, she was treated for urticarial/hives. Subsequently she was treated for angioedema in the emergency department. Subsequently, she was treated for urticarial vasculitis and hypoxia from unknown dates. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, she suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not provided.  The events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of angioedema, urticarial vasculitis and hypoxia were considered to be medically significant.; Sender's Comments:  US-009507513-1910USA005083: US-009507513-1910USA005082: US-009507513-1910USA005066: US-009507513-1910USA005084:
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Deafness
Clinical narrative: vision loss; hearing loss; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On 07-NOV-2017, the pt was inoculated with zoster vaccine live(ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) as recommended for routine adult health maintenance for the prevention of shingles, at the pharmacy. On an unknown date, the pt was treated at the physician's office for vision loss and hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The causality was related.  Upon internal review, the events of vision loss and hearing loss were determined to be medically significant.; Sender's Comments:  US-009507513-1910USA005081: US-009507513-1910USA005084:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: did not prevent shingles as intended; persistent strain of herpes zoster/ severe herpes zoster or shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  In 2016, the patient was inoculated in the medical center with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and she subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated by healthcare provider for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, she suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not reported.  The events were considered to be related to zoster vaccine live (ZOSTAVAX).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA005082: US-009507513-1910USA005081: US-009507513-1910USA005066: US-009507513-1910USA005083:
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle twitching
Clinical narrative: twitching in between thumb and index finger.
Age: 46.0
Sex: U
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The symptoms started on 6/28/2019.  Swelling, redness, hot, and painful to touch and to move at my upper left arm.  It was painful when lifted my arm up, down, reached front and back for a week.  Even though all the symptoms subsided after I applied ice packs couple of times a day, my upper left is still not the same.  I feel there is block at bellow the left deltoid muscle every time I lift or raise my arm, and reach front and back.  I feel I my left upper arm is going to break and  feel hurt  with all these activities above.    I waited until now to file a report because I thought my will get better in times but it has been 3 months, the pain is restricted me to move my arm freely.
Age: 46.0
Sex: U
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: The symptoms started on 6/28/2019.  Swelling, redness, hot, and painful to touch and to move at my upper left arm.  It was painful when lifted my arm up, down, reached front and back for a week.  Even though all the symptoms subsided after I applied ice packs couple of times a day, my upper left is still not the same.  I feel there is block at bellow the left deltoid muscle every time I lift or raise my arm, and reach front and back.  I feel I my left upper arm is going to break and  feel hurt  with all these activities above.    I waited until now to file a report because I thought my will get better in times but it has been 3 months, the pain is restricted me to move my arm freely.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Described as:  hives on the chest, neck and left shoulder where the injection site was.  Lasted until 10/4/19.  Person did not seek medical attention/assessment.  Treated self with Benadryl.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: patient was in our office with his wife. his wife was due for Tdap and patient was due for Flu vaccine. I had the vaccines laying on top of signed consents. I cleaned and dried patient's arm, and while having a conversation with the patient, I grabbed the wrong vaccine and administered Tdap vaccine rather than Flu vaccine.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Muscle swelling, Myalgia, Nasal congestion, Nasopharyngitis
Clinical narrative: I was sleepy and achy all day Sunday; which did not have me concerned until Monday when I noticed my left trapezius muscle was very sore, I then noticed it had swelled to 3 times the size of the other side, then swelling was progressing toward the front of my neck around the clavicle. I took ibuprofen for a headache I woke with, the swelling started to subside as a result of it. The pain was mostly gone by evening. Last night I was getting stuffy, I still feel like I have a bit of a cold; achy, mucous forming mostly in my left nostril along with sore throat. This is the first reaction I have had to a flu shot, although last year I had a strong reaction to my 2nd dose of the Shingrex; with severe chills and shaking.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea, Secretion discharge, Somnolence
Clinical narrative: I was sleepy and achy all day Sunday; which did not have me concerned until Monday when I noticed my left trapezius muscle was very sore, I then noticed it had swelled to 3 times the size of the other side, then swelling was progressing toward the front of my neck around the clavicle. I took ibuprofen for a headache I woke with, the swelling started to subside as a result of it. The pain was mostly gone by evening. Last night I was getting stuffy, I still feel like I have a bit of a cold; achy, mucous forming mostly in my left nostril along with sore throat. This is the first reaction I have had to a flu shot, although last year I had a strong reaction to my 2nd dose of the Shingrex; with severe chills and shaking.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Erythema, Injection site pain, Pain in extremity
Clinical narrative: Evening of injection, red spot on arm, soreness in arm.  Over past week, soreness traveled up left arm to left shoulder to left back, the area between backbone and shoulder.  Nagging pain has been worst in this upper left back area over past 4-5 days.  Have taken advil 3 times/day and used topical rubs and ice packs during this time with only temporary results
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Developmental delay, Emotional distress, Food allergy, Screaming, Seizure
Clinical narrative: Screaming, inconsolable, food allergies, developmental delays, seizure
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is red, swollen, and warm to touch.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient called and said she received the Fluzone HD yesterday and woke up this morning being very dizzy no other side effects. She also claimed she had a concussion in August 2016 and she was given meclizine for dizziness. Apologized to the patient about what happened and advised the patient to go see a doctor which she made an appoitment for tomorrow. Also, advised patient to go to urgent care or ER if she needs. Also advised patient to eat and hydrate herself and she can also get meclizine OTC if she needs. The patient did not want us to check up on her and she said if she needs her son can get her some meclizine or go to the urgent care or ER.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Agitation, Erythema, Hyperhidrosis, Irritability, Pruritus
Clinical narrative: Vaccines above given at 1530. Dad was waiting around for the discharge summary. Dad had taken Patient to the bathroom. At 1600 Dad informed our MA that Patient was itching and red. The M.A. then informed Dr. and myself about Patient symptoms. Me and Dr. walked to the room, where Patient was sitting with his Dad. Patient was very irritable, agitated, copios oral secretions with vomiting and very diaphoretic. At 1615, Dr. assessed and ordered EPI PEN 0.15MG and 25MG BENADRYL. EPI and BENADRYL given as ordered by patient did not tolerate the BENADRYL. He spit out the BENADRYL. Breath sounds were cleared. Pt didn't tolerate placing the CR monitor or Pulse OX on him. 1630, BS remained  clear but remained agitated diaphoretic and continue to present with hive. At this time Dr. informed me to call 911 while she called Hospital to give report. At 1645, 911 arrived and was taken to Hospital.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Salivary hypersecretion, Urticaria, Vomiting
Clinical narrative: Vaccines above given at 1530. Dad was waiting around for the discharge summary. Dad had taken Patient to the bathroom. At 1600 Dad informed our MA that Patient was itching and red. The M.A. then informed Dr. and myself about Patient symptoms. Me and Dr. walked to the room, where Patient was sitting with his Dad. Patient was very irritable, agitated, copios oral secretions with vomiting and very diaphoretic. At 1615, Dr. assessed and ordered EPI PEN 0.15MG and 25MG BENADRYL. EPI and BENADRYL given as ordered by patient did not tolerate the BENADRYL. He spit out the BENADRYL. Breath sounds were cleared. Pt didn't tolerate placing the CR monitor or Pulse OX on him. 1630, BS remained  clear but remained agitated diaphoretic and continue to present with hive. At this time Dr. informed me to call 911 while she called Hospital to give report. At 1645, 911 arrived and was taken to Hospital.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Peripheral swelling, Tenderness
Clinical narrative: Developed redness + swelling of (R) arm noticed morning after vaccination by parents. (+) tenderness. Area of redness & induration spread over next 24 hours @ which time was seen in office by MD.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Exposure via eye contact, Exposure via skin contact, Product container issue
Clinical narrative: While administering the vaccine to gthe patient, the vial burst and vaccine liquid was splashed all over the patient face, including into her eyes.
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Fatigue, Injection site mass, Injection site warmth, Pain
Clinical narrative: Left arm (flu shot) had walnut sized lump, warm to touch for a week. Now is the size of mosquito bite. Was exhausted and achy for 3 days.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Nasal congestion, Nausea
Clinical narrative: Had dizziness, nausea, headache. I had to lie down for most of the day. By the next day I felt better but still had some symptoms.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Pt developed full body rash including fine sandpaper rash as well as multiple hives within ~ 24 hours of flu vaccine. Hives controlled now with Benadryl (PO & topical), but hives reappear as Benadryl wears off. He was also taking a magnesium supplement when he received the vaccine, so he discontinued that when he saw the hives.
Age: 25.0
Sex: F
Vaccine: FLUA3
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, Product container issue
Clinical narrative: While administering the vaccine to the patient, the vial burst and vaccine liquid was splashed all over my face (I am the Pharmacist), including into my eyes.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Pain
Clinical narrative: Bruised arm, soreness for last 2 weeks
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling hot, Malaise, Tremor
Clinical narrative: I started to feel very sick, I felt very hot, my teeth started to chatter, I started tremble all over my body.  I needed to lie down.   I fell asleep for a few hours.  When I woke I was feeling better.  By nighttime, I was back to normal.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Injection site pain, Muscle spasms, Pain
Clinical narrative: Major site pain at Lt deltoid, started on 9/20/19 and went away approx. 2-3 days after, rated pain as 6/10 at most intense level.   Major Rt hip pain, started on 9/25/19, painful to sit, bear weight on it when laying on R side, and moving it in certain positions due to it freezing up. Lower back pain with spasms and cramping intermittently while sitting or lying down, similar to childbirth spasms and cramping.   Right hip & lower back pain symptoms resolved spontaneously around 4 days after 9/25/19.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Weight bearing difficulty
Clinical narrative: Major site pain at Lt deltoid, started on 9/20/19 and went away approx. 2-3 days after, rated pain as 6/10 at most intense level.   Major Rt hip pain, started on 9/25/19, painful to sit, bear weight on it when laying on R side, and moving it in certain positions due to it freezing up. Lower back pain with spasms and cramping intermittently while sitting or lying down, similar to childbirth spasms and cramping.   Right hip & lower back pain symptoms resolved spontaneously around 4 days after 9/25/19.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient presents with a red, warm, swollen rash on his right arm, in the area around the vaccination (about 6" in diameter) which was first noticed on 10/08/2019 at appx. 6:30 a.m. Patient denies any fever or systemic symptoms, and has not taken any treatment for the rash/reaction. Instructed the patient to take Benadryl by mouth (25mg-50mg) prn, along with Tylenol as needed for pain/inflammation.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: The patient presented with redness, swelling, and heat several inches below the injection site 2 days following immunization with Fluzone HD. We told the patient to take Benadryl and referred her to her physician.  The physician diagnosed her with a local reaction to the flu shot and gave her a prescription for dexamethasone, which he stated should cause her symptoms to fully resolve.
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt had no symptoms/reactions
Age: 63.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Injection site erythema, Pain in extremity
Clinical narrative: Patient states stomach upset and chills started 10/4/19.  Progressed to redness of left arm below injection site and soreness of arm on 10/5/19.  States she developed diarrhea on 10/7/19.  Symptoms first reported to pharmacy on 10/7/19.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: During screening client and father denied any difficulties with vaccines in the past 0940 Client received 4 IM vaccinations; pale appearing; given glass of water 0955 Dad stated that he needed to return to work and client denied dizziness and stated felt well. 1000 Client fainted after walking out of office and Dad caught her-no fall or injuries; given cool cloth, more water and snack
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Eye swelling, Headache, Lip swelling
Clinical narrative: Very short of breath, wheezing, scratchy throat, scratch body, swollen eyes, swollen lips, bloodshot eyes, body aches, head ache, severe congestion, very dizzy/
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Pain, Pruritus, Respiratory tract congestion, Throat irritation
Clinical narrative: Very short of breath, wheezing, scratchy throat, scratch body, swollen eyes, swollen lips, bloodshot eyes, body aches, head ache, severe congestion, very dizzy/
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Very short of breath, wheezing, scratchy throat, scratch body, swollen eyes, swollen lips, bloodshot eyes, body aches, head ache, severe congestion, very dizzy/
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Imaging procedure, Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient reported sore shoulder, unable to raise arm. Reported to Pharmacy on 9/28/2019 treated with tylenol and ice. Patient staed doctor advised to use claritin until visit to doctor on 10/01/19. Patient was examined received prednisone. Patient reported arm feeling much better on Monday and Doctor could not find any injury, swelling or inflamation. Patient also received imaging which was inconclusive. Follow up call was held with patient on 10/02/19 patient reported arm feeling much better and doctor could not determine what was cause of shoulder pain.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Presyncope, Seizure like phenomena
Clinical narrative: seizure like activity for 5-10 seconds; Vasovagal episode with seizures; This spontaneous report was received from a registered nurse and refers to a 17-year-old female patient. The patient's medical history included fainting with other unspecified immunizations. The patient did not have any concomitant medications, drug reactions or allergies. On 30-SEP-2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2019, one dose, intramuscularly prevent cancer.  On the same day after the patient received injection, she experienced vasovagal episode with seizure like activity for 5-10 seconds and nausea. The patient sought medical attention and received cool compress to the her head and laid down while having her vital signs monitored. None lab diagnostics/ studies were performed. The outcome of the events was reported as recovered. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. Upon internal review, seizure like activity was determined to be medically significant.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Night sweats, Pain in extremity, Rash
Clinical narrative: Localized rash, headache, night sweats pain in arm significantly more severe than after previous flu shots. Symptoms started around 6 to 7 pm and resolved overnight
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Dysgeusia, Fatigue
Clinical narrative: Metal taste in mouth - strong Fatigue
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash
Clinical narrative: Got flu shot on 9/25/19, went home & started developing rashes on neck then spread to chest & breasts. 0 difficulty w/breathing, no SOB, no confusion or numbness, no tingling on face/extremities, no fever or chills. Advised to go to ER but pt, she is fine at that time so will Follow up with PCP.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Swelling of lower lip - Pt described Prednisone taper
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Left arm still sore. Headaches Body Aches
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Had blood and mucus in stool the day after he got the vaccines for 1 to 2 days, then resolved.  1 week after his 2 month vaccines which were Pentacel, Rotateq, Hep B, and Prevnar he had blood in his stool for 1 day. Both times he was not fussy and ate normal.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: after flu shot administration patient reported pain that was radiating to his fingers and he said it was getting better.  He later called back saying he was still experiencing pain and he spoke to his primary doctor.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: redness to injections site, warmth, swelling longer than 6 days; nausea, chills, body aches x 6 days; Treated with warm compress/ ice packs, covered with clindamycin for possible infectious area to injection site.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: redness to injections site, warmth, swelling longer than 6 days; nausea, chills, body aches x 6 days; Treated with warm compress/ ice packs, covered with clindamycin for possible infectious area to injection site.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Peripheral swelling, Skin warm
Clinical narrative: flu shot given in right deltoid, 1/2 dollar size redness surrounding injection site, no streak, no ooze, no breathing difficulty, arm swollen, warm to touch
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Patient was given the vaccination and within minutes she developed a large knot or bump just above the injection.  The raised area was the size of a half dollar and was painful to the patient.  Ice was placed on the arm immediately and the arm was monitored.  Patient remained seated with the ice on her arm for about 10 minutes.  She then decided that she would rather go home and place ice on it and take a diphenhydramine that she had at home.  At about 10:45 am, I called the patient to check up on her.  She said the area was warm to the touch and the raised area was hard to the touch, but she felt okay.  I called her again at 5:20 pm and she said she was doing okay, but still concerned and the area was very sore.  I spoke to her the next morning and she said it was still swollen, red and tender to the touch and it looked as though it was bruising.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient was given the vaccination and within minutes she developed a large knot or bump just above the injection.  The raised area was the size of a half dollar and was painful to the patient.  Ice was placed on the arm immediately and the arm was monitored.  Patient remained seated with the ice on her arm for about 10 minutes.  She then decided that she would rather go home and place ice on it and take a diphenhydramine that she had at home.  At about 10:45 am, I called the patient to check up on her.  She said the area was warm to the touch and the raised area was hard to the touch, but she felt okay.  I called her again at 5:20 pm and she said she was doing okay, but still concerned and the area was very sore.  I spoke to her the next morning and she said it was still swollen, red and tender to the touch and it looked as though it was bruising.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Cellulitis, Erythema
Clinical narrative: patient reported of redness of shoulder and went to emergency room and diagnosed with cellulitis
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient described developing a rash after receiving the vaccine.  The rash extended from her upper arm down to her elbow.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Miliaria, Swelling
Clinical narrative: Pt experienced severe swelling, redness, heat rash, and induration from deltoid muscle to base of elbow
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Ear pain, Influenza, Vertigo
Clinical narrative: Patient reported 2 days after received vaccine, she experienced throbbing in her left ear, then vertigo the day after, and flu symptoms on the 4th day after vaccine.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms
Clinical narrative: severe muscle spasms lasting 2 1/2 hours.none
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Patient received vaccines on 07/30/2019,  the next day mother reported to  the the on-call pediatrician , that all immunizations  were given on 07/30/19 in the same arm and the child's arm was red , hot and swollen and had a knot. The on call pediatrician told mother that was normal but to call back in 2 days if it did not go away. Mom stated it did go away within the day and she did not call back. However on 09/20/2019 the mom called the clinic and spoke with staff nurse and told the entire story and now she says the child recently had some intermittent red spots on arm that were not raised or itching.  Mom states she talked to pediatrician again and was told he had a reaction to the vaccines and is being sent to an allergist.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Rash, Swelling
Clinical narrative: Headache rash, and swelling
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Product administered at inappropriate site, Swelling
Clinical narrative: 10/1/19 849 AM  flu vaccine given into the sub-acromial space.  10/1/19 346 PM patient called office complaining of pain. Ibuprofen and ice prescribed to patient  10/2/19 patient came into office due to continued pain and swelling. Could not move arm. Provider prescribed steroids, heat and gentle motion of arm.  10/7/19- patient called back stating that she had continued pain, but swelling went down. Provider recommended she go to the Ortho Urgent Care. Patient did and provider wanted patient to continue on the steroids, prescribed Naproxen and  recommended 3 weeks of physical therapy. if does not in 3 weeks, patient to have MRI.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Blister, Induration, Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: Pt had severe swelling, red hot rash, induration from shoulder to elbow. With a large blister developed in the middle of compound rash area
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Continuous positive airway pressure, Seizure
Clinical narrative: Infant started having apparent seizures at 2330 on 10/3/19, apnea noted at 0345 on 10/4 which responded to tactile stimulation. Another episode of apnea and seizure activity at 0514 on 10/4 which required PPV .   No more seizures or apnea noted at the vaccination facility after phenobarbital . unaware of what happened after infant was transferred to Medical Center
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Headache, Injection site pain, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: Injection site pain on 9/20/19 (2 days after injection) which caused a Rt sided headache which became intolerable and had to leave work to go home.  Headache was managed with ibuprofen.  Severe back pain on 9/23/19 (4-5 days post injection).  Intially dull and "achey," rated pain as 5-6/10, relieved with ibuprofen and heat pack as needed.  On 9/27/19, unable to sit for a morning meeting and had to stand due to back ache.  On 10/2/19, back pain increased to 7-8/10.  On 10/3/19 increased ibuprofen amount and used acetaminophen intermittently.  Called in sick from work on 10/4/19 due to back spasms.  Back pain tolerable 10/7/19 with medication and intermittent standing instead of sitting.  Leg pain started 9/20/19 (2 days post vaccination), which starts from lower back down to back of thighs.  Dull and achey pain, hurts when walking and when sitting for prolonged period of time.  Changes positions from sitting to standing and vice versa when pain is noticeable.  Still with back pain 10/7/19 that go down to back of thighs, but improving.  Taking ibuprofen and acetaminophen when need to.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Injection site pain on 9/20/19 (2 days after injection) which caused a Rt sided headache which became intolerable and had to leave work to go home.  Headache was managed with ibuprofen.  Severe back pain on 9/23/19 (4-5 days post injection).  Intially dull and "achey," rated pain as 5-6/10, relieved with ibuprofen and heat pack as needed.  On 9/27/19, unable to sit for a morning meeting and had to stand due to back ache.  On 10/2/19, back pain increased to 7-8/10.  On 10/3/19 increased ibuprofen amount and used acetaminophen intermittently.  Called in sick from work on 10/4/19 due to back spasms.  Back pain tolerable 10/7/19 with medication and intermittent standing instead of sitting.  Leg pain started 9/20/19 (2 days post vaccination), which starts from lower back down to back of thighs.  Dull and achey pain, hurts when walking and when sitting for prolonged period of time.  Changes positions from sitting to standing and vice versa when pain is noticeable.  Still with back pain 10/7/19 that go down to back of thighs, but improving.  Taking ibuprofen and acetaminophen when need to.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Ill-defined disorder, Local reaction, Malaise
Clinical narrative: Localized reaction, malaise and illness for over 48 hours
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of control of legs, Nausea
Clinical narrative: Patient collapsed in the morning after the shot. Patient states feeling dizzy, nauseous  and her legs "buckled" spontaneously.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Seizure
Clinical narrative: Patient said 2 hours after the shot she got nauseous and developed a fever (ranging form 101-103 degrees).  She said the next day she developed a seizure (not a grand mal) but lasting about 15 minutes of shaking.  Her md said because of this reaction...no more vaccines for her.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: bumps/bites on both armas
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Altered state of consciousness, Arthralgia, Chills, Dizziness
Clinical narrative: When I received the first shingles vaccine last month, I was  pretty sick the next few days  with extreme flu-like symptoms.  I told the pharmacist what happened with the first shot and she told me that people who have a bad reaction with the first shot are usually good with the second.  So I went ahead and got the second shot.  I got very sick that evening, and 4 days later, I still don't feel well.  My reaction was fever, chills, extreme sweating, body aches, joint soreness, headache, nausea, stomach cramps, dizziness.  I couldn't even stand up the day after the second shot without feeling like I was going to pass out.  I notified the pharmacist and my doctor as soon as possible about the whole incident.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hyperhidrosis, Malaise, Nausea, Pain
Clinical narrative: When I received the first shingles vaccine last month, I was  pretty sick the next few days  with extreme flu-like symptoms.  I told the pharmacist what happened with the first shot and she told me that people who have a bad reaction with the first shot are usually good with the second.  So I went ahead and got the second shot.  I got very sick that evening, and 4 days later, I still don't feel well.  My reaction was fever, chills, extreme sweating, body aches, joint soreness, headache, nausea, stomach cramps, dizziness.  I couldn't even stand up the day after the second shot without feeling like I was going to pass out.  I notified the pharmacist and my doctor as soon as possible about the whole incident.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: When I received the first shingles vaccine last month, I was  pretty sick the next few days  with extreme flu-like symptoms.  I told the pharmacist what happened with the first shot and she told me that people who have a bad reaction with the first shot are usually good with the second.  So I went ahead and got the second shot.  I got very sick that evening, and 4 days later, I still don't feel well.  My reaction was fever, chills, extreme sweating, body aches, joint soreness, headache, nausea, stomach cramps, dizziness.  I couldn't even stand up the day after the second shot without feeling like I was going to pass out.  I notified the pharmacist and my doctor as soon as possible about the whole incident.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysgeusia, Muscle spasms, Myalgia, Nausea
Clinical narrative: When I received the first shingles vaccine last month, I was  pretty sick the next few days  with extreme flu-like symptoms.  I told the pharmacist what happened with the first shot and she told me that people who have a bad reaction with the first shot are usually good with the second.  So I went ahead and got the second shot.  I got very sick that evening, and 4 days later, I still don't feel well.  My reaction was fever, chills, extreme sweating, body aches, joint soreness, headache, nausea, stomach cramps, dizziness.  I couldn't even stand up the day after the second shot without feeling like I was going to pass out.  I notified the pharmacist and my doctor as soon as possible about the whole incident.
Age: 33.0
Sex: M
Vaccine: UNK
Symptoms: Blood test, Pain in extremity
Clinical narrative: Very sore arm
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: patient reported "painful rash" getting larger over last few days
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count, Haematocrit decreased, Haemoglobin decreased, Palpable purpura, Rash
Clinical narrative: Received high dose flu vaccine 9/19/19. Urgent care visit 9/27/19 w rash/vasculitis LE feet to upper calf areas, palpable purpura, decreased hgb and hct
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Vasculitis
Clinical narrative: Received high dose flu vaccine 9/19/19. Urgent care visit 9/27/19 w rash/vasculitis LE feet to upper calf areas, palpable purpura, decreased hgb and hct
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site was swollen, red, warm, and extremely tender for 3 days after shot.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Allergy test positive, Blood test, Chest discomfort, Cough, Lip swelling
Clinical narrative: Hives all over my body from the tip of my toes to the tip of my scalp Swelling on lips and inside my mouth Chest pressure Paleness Occasional Cough
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Mouth swelling, Pallor, Urticaria
Clinical narrative: Hives all over my body from the tip of my toes to the tip of my scalp Swelling on lips and inside my mouth Chest pressure Paleness Occasional Cough
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Tremor
Clinical narrative: Pt reported "shaking and shivering" evening after being vaccinated and feeling extremely tired the following day (today).
Age: 92.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site pain, Injection site reaction, Pain, Pain in extremity
Clinical narrative: RASH Headache Pain in arm Welt in L arm @ injection site (pain) Itchy throat Fever of 101 degrees ACHY feeling Symptoms started about 6:00pm I did take Benadryl and tylenol was taken upon my arrival home. Symptoms continued to 9/24/19. Additional benadryl taken and symptoms resolved 9/25/19
Age: 92.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Rash, Throat irritation, Urticaria
Clinical narrative: RASH Headache Pain in arm Welt in L arm @ injection site (pain) Itchy throat Fever of 101 degrees ACHY feeling Symptoms started about 6:00pm I did take Benadryl and tylenol was taken upon my arrival home. Symptoms continued to 9/24/19. Additional benadryl taken and symptoms resolved 9/25/19
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Headache, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Body Ache, sore Throat, High Fever, Shivering Headache, Dizziness, Pain on site of Injection, Ichy & Bumpy for few days. Off work for 2 days - Treated with cold meds, Advil.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Body Ache, sore Throat, High Fever, Shivering Headache, Dizziness, Pain on site of Injection, Ichy & Bumpy for few days. Off work for 2 days - Treated with cold meds, Advil.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; A dose of expired but properly stored PNEUMOVAX 23 was inadvertently was administered to one patient; This spontaneous information has been received from a registered nurse regarding a 70 year-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 03-OCT-2019, the patient was vaccinated with a expired but properly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot number: R000692 with expiration date on 09-SEP-2019) (strength, route of administration and anatomical location not reported) (expired vaccine administered).  No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effect; intramuscular route rather than subcutaneous; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, drug reaction/allergies or concomitant medications were not reported.  On 07-OCT-2019, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX)  intramuscular route rather than subcutaneous route for prophylaxis(dose number, dose, frequency, anatomical location, lot number and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The physician is reporting that the patient recieved improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On unknown date, the patient was vaccinated with an improperly dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) one dose, lot number S007075, expiration date 06-SEP-2020 (route of administration was not reported). Administered dose of vaccine experienced the temperature excursion of 32.5 degrees Fahrenheit (°F) for 8 hours. Data logger was involved. There were no previous excursions reported.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Symptoms rash on elbows, knees and other areas lasted for ~24 hrs Then some rashes came back. Used cortisone cream
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, body ache, headache, pain in Arm Symptoms went away the next day, however I had a mild fever around 3pm the next day.
Age: 25.0
Sex: M
Vaccine: FLUX
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Death, Incoherent, Lethargy, Speech disorder
Clinical narrative: Pt. presented to clinic (Urgent Care) with mom on 10/1/19 at approx. 1945. He was lathargic, responsive to sternal rub, nonverbal and incoherent. 911 was called, pt. was taken by ambulance to the ED. Pt passed away on the evening of 10/1/19.
Age: 91.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Patient had a large swollen area on her arm - warm to touch, went to ER and was given antibiotics for oral use
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Ear discomfort, Ear pruritus, Eye pruritus, Eye swelling, Hypersensitivity
Clinical narrative: C/o allergic reaction to influenza vaccine at 3:20 pm 10/7/19. S/s right ear burning and itching, right eye itching and swollen and lower bottom of face itching. C/o wheezing.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Vaccination complication, Wheezing
Clinical narrative: C/o allergic reaction to influenza vaccine at 3:20 pm 10/7/19. S/s right ear burning and itching, right eye itching and swollen and lower bottom of face itching. C/o wheezing.
Age: 80.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Arthralgia, Asthenia, Nervousness, Pyrexia
Clinical narrative: Adverse Effects began next morning after vaccination for patient, She began feeling weak, feverish, increased arthritic pain, nervous.  She stated symptoms lasted for 3-4 days until feeling better.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt.'s mother calling to report approx. 2 1/2" red, swollen, warm area to injection site ( (L) arm). Pt c/o itching and burning at site. C/O headache and low grade fever.  Pt developed red, flat, lesion,  with whitish center, approx. 1" in diameter, to (L) outer breast region  the next day. Headache ongoing along with low grade of 100.1.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Skin lesion
Clinical narrative: Pt.'s mother calling to report approx. 2 1/2" red, swollen, warm area to injection site ( (L) arm). Pt c/o itching and burning at site. C/O headache and low grade fever.  Pt developed red, flat, lesion,  with whitish center, approx. 1" in diameter, to (L) outer breast region  the next day. Headache ongoing along with low grade of 100.1.
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2.25 inch erythematous indurated site reaction. No symptoms of anaphylaxis.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pharyngeal swelling
Clinical narrative: Patient had swelling to throat and eyes were bright red
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Paraesthesia
Clinical narrative: Patient reported feeling tingling in arm and lump under the skin that was oblong and 4-5 inches to the lower, left of where the shot was given. Patient continuing to feel lump and has redness on the surface of the skin. Patient followed up with another healthcare provider who advised her to come back to the pharmacy to have it evaluated.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Angiogram, Blood creatine phosphokinase, C-reactive protein, Computerised tomogram head, Full blood count
Clinical narrative: Patient was given HPV vaccine.  Within a few minutes, parent came out of room and advised that child was not responsive.  When provider and staff entered room,  patient was listless.  911 was called. Pt was sent to Hospital and transferred to Medical Center.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Listless, Metabolic function test, Unresponsive to stimuli
Clinical narrative: Patient was given HPV vaccine.  Within a few minutes, parent came out of room and advised that child was not responsive.  When provider and staff entered room,  patient was listless.  911 was called. Pt was sent to Hospital and transferred to Medical Center.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza like illness, Myalgia, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Flu like symptoms two hours after shot:  congestion, coughing, sore throat, fever, mussel aches and red eyes.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Flu like symptoms two hours after shot:  congestion, coughing, sore throat, fever, mussel aches and red eyes.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV, VARCEL
Symptoms: Crying, Pollakiuria, Pyrexia, Thirst, Type 1 diabetes mellitus
Clinical narrative: Fever, crying, thirst, constant urination.  Diagnosed with Type 1 diabetes mellitus one week later on 4/6/2018