chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Exposure during pregnancy
Clinical narrative: Patient getting ready for entrance in to nursing school. Needed TdaP & varicella # 2, which were administered on 5/13/2019. Denied pregnancy at that time.  On 5/16/2019, grandmother called to notify that the client was pregnant now and was worried about effects on fetus.  Pregnancy history not available.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site swelling, Mobility decreased, Pain
Clinical narrative: Patient had pain in arm immediately after vaccine.  Patient thought the vaccine was given to high on arm.  Pain progressed that day.  Patient also developed golf-ball size lump and swelling at injection site.  Patient was unable to move arm by the end of day. Patient went to ER the next day.  2 days after the injection the swelling and pain had gone down but certain movements were still painful.  patient was contacted  12 days after immunization and arm was doing much better.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: patient woke up around 3am and his feet hurt, couldn't walk on them, compared it to having a broken ankle
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site warmth, Muscular weakness, Pain
Clinical narrative: Within hours of getting vaccinated, I developed warmth (several days) and ache (several months) at the injection site and have a residual ache at this time (with direct pressure only, such as when lying down).   The ache made me avoid sleeping on my left side for several weeks as pressure made the situation worse.  This ache did not appear to affect my range of motion so I assumed that the problem would resolve, took OTC antiinflammatory agents and avoided exercises that would irritate the muscle.  In the new year, I began a new exercise program and am surprised that I have weakness and some pain when lifting weights, or when in a position in which I am using my body weight (push up, plank).  I plan to seek a PT evaluation in hopes of resolving the weakness but want to document my problem in case this lot has caused problems with other persons. I am an NP, and can attest that the vaccine was administered properly by the pharmacist.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Blood test, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient had to receive a booster immunization because his levels were low based on blood work. On Wednesday, patient's left leg was becoming red, swollen and very sore. He would not put any weight on his left leg. We went to the pediatrician for a follow up. She drew a circle around it and said to follow up with her on Thursday. In the middle of the night, he had a fever of 103F and the redness was outside of the previous drawn circle. We went to the emergency room and then was admitted to the hospital for IV antibiotics.  (I would like to be anonymous in the reporting process)
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Ultrasound scan, Weight bearing difficulty
Clinical narrative: Patient had to receive a booster immunization because his levels were low based on blood work. On Wednesday, patient's left leg was becoming red, swollen and very sore. He would not put any weight on his left leg. We went to the pediatrician for a follow up. She drew a circle around it and said to follow up with her on Thursday. In the middle of the night, he had a fever of 103F and the redness was outside of the previous drawn circle. We went to the emergency room and then was admitted to the hospital for IV antibiotics.  (I would like to be anonymous in the reporting process)
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Middle insomnia
Clinical narrative: patient woke up at around 3am with extreme ankle pain felt like it was broken and it took a couple of hours before she could fall back asleep. she said it was very painful
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient reported that she has experienced left shoulder pain ever since receiving her vaccine. She reports that she can not move arm without it hurting. At rest there is no pain. Patient was seen by her primary care physician's office on 1/23 and the physician assistant's exam at that time showed no erythema, no ecchymosis, no joint effusion; patient had active range of motion, full range of motion; abduction was uncomfortable; shoulder was non-tender at rest and non-tender on palpation. Patient was advised by the physician assistant to apply moist heat, followed by stretching of the shoulder, followed by fifteen minutes of ice. She was advised to report back to the office if symptoms continued or worstened.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Following vaccine administration, patient experienced episode of syncope without loss of consciousness; patient monitored in clinic 20 min following episode until able to ambulate and drink water without difficulty. Vital signs checked to ensure stability, remained stable throughout event.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: pain in left arm, fever (100.6 in the a.m. Normal for me is 97.7 in the a.m.), aches, shivers
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Injection site pain, Pain
Clinical narrative: Employee complains of pain in left deltoid preventing movement without pain. Was evaluated by a MD at local health works location on 1/27/2020  who stated there is no noted adverse affect apparent on examination. Employee described vaccination injection point, as well as process and MD stated she reassured her all was done correct. MD did recommend modified duty x2 week (no lifting more than 5 lbs and no overhead lifting) and followup at the 2week mark
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever, fatigue, headache.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: SYmptoms:  Rash & UrticariaPruritus  Treatment: Diphenhydramine 25 mg once ,hydrocortisone 1 application GM ONCE one application to injection site
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site bruising, Injection site pain
Clinical narrative: erythema, pain and bruising at site of injection. Symptoms began with in 6 hrs of injection. Cool compress and analysis.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Erythema, Fatigue, Gastric disorder
Clinical narrative: Woman, 58 years old, in excellent health, 5'5" 130 lbs. Had second Shingrix vaccine on 1/18/20. Had mild side effects upon awakening the next morning which were helped with Advil. Was very tired during the day and continued to need Advil to mitigate the symptoms. The following nights about 30 hrs after the vaccine was administered, I experienced gastric discomfort, body aches, nausea, chills and had difficulty sleeping due to the discomfort I was experiencing. On the third day after the injection I got a rash on my Left wrist, right side of my neck and on my face. On day four I am not noticing any new rash developing but at the existing rash sites my skin is red, swollen, blistered and feels like it was burned.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Pain, Pain of skin, Rash
Clinical narrative: Woman, 58 years old, in excellent health, 5'5" 130 lbs. Had second Shingrix vaccine on 1/18/20. Had mild side effects upon awakening the next morning which were helped with Advil. Was very tired during the day and continued to need Advil to mitigate the symptoms. The following nights about 30 hrs after the vaccine was administered, I experienced gastric discomfort, body aches, nausea, chills and had difficulty sleeping due to the discomfort I was experiencing. On the third day after the injection I got a rash on my Left wrist, right side of my neck and on my face. On day four I am not noticing any new rash developing but at the existing rash sites my skin is red, swollen, blistered and feels like it was burned.
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling
Clinical narrative: Woman, 58 years old, in excellent health, 5'5" 130 lbs. Had second Shingrix vaccine on 1/18/20. Had mild side effects upon awakening the next morning which were helped with Advil. Was very tired during the day and continued to need Advil to mitigate the symptoms. The following nights about 30 hrs after the vaccine was administered, I experienced gastric discomfort, body aches, nausea, chills and had difficulty sleeping due to the discomfort I was experiencing. On the third day after the injection I got a rash on my Left wrist, right side of my neck and on my face. On day four I am not noticing any new rash developing but at the existing rash sites my skin is red, swollen, blistered and feels like it was burned.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: I got the vaccine for hpv and then caught hpv.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 64-year-old male patient. Medical history, concurrent conditions and concomitant medications were not provided.   On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 28-MAY-2015, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration and lot # were not provided). On unknown dates, the patient suffered the following injuries as a result of zoster vaccine live (ZOSTAVAX): herpes zoster and post herpetic neuralgia. The patient claimed damages as a result of: injury to themselves, loss of services and economic losses. The outcome of the events was not provided.   The lawyer felt the events were related to zoster vaccine live (ZOSTAVAX).
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse effect; 15 yr old patient received an adult dose of VAQTA; This spontaneous report was received from a nurse referring to a 15-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 24-JAN-2020, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) injection 50/1.0 units per milliliter (U/mL) (dose #, schedule and route were not reported) lot # S018772 and expiry date 07-JUL-2020 for prophylaxis (incorrect dose administered). No additional adverse effects reported.
Sex: U
Vaccine: MENB
Symptoms: Chills, Exposure to extreme temperature
Clinical narrative: 46-year-old patient received the meningococcal group b rlp2086 vaccine by mistake; shivers; cold temperatures; This is a spontaneous report from a contactable pharmacist.  A 46-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date at a single dose for immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the 46-year-old patient received the meningococcal group b rlp2086 vaccine by mistake and afterwards experienced shivers and cold temperatures. The clinical outcomes of shivers and cold temperatures were unknown.   The batch/lot numbers for the vaccine, meningococcal group b rlp2086, were not provided and will be requested during follow up.
Sex: M
Vaccine: RAB, UNK
Symptoms: Chest X-ray, Cough
Clinical narrative: cough; Initial information received on 02-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 46 years old male patient who experienced cough, while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and while treated with HUMAN RABIES IMMUNOGLOBULIN [IMOGAM RABIES-HT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.   On 23-Nov-2019, the patient started taking IMOGAM RABIES-HT (HUMAN RABIES IMMUNOGLOBULIN) dosage unknown route unknown (with an unknown batch number) for Immunisation.  On 23-Nov-2019, the patient received a first dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site and 2 other doses were administered on unknown dates for suspect RABIES (HDC) VACCINE.  Patient stated that he is received the Imogam and Imovax because he found a bat in his house.  On an unknown date, the patient developed a non-serious cough (Unknown latency) following intake of HUMAN RABIES IMMUNOGLOBULIN and unknown latency following the administration of RABIES (HDC) VACCINE.  Patient stated that he saw on some paperwork that Xrays may interact with Imovax Rabies or Imogam, and asked for any information on that. Patient had 2 chest Xrays after Imovax Rabies and Imogam, due to a cough.  (Other relevant tests included no laboratory data.)  Final diagnosis was cough.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for cough.  There will be no information available on the batch number for this case (patient did not have it).
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a 15 month female patient received only the DTaP component of the Pentacel/No AE; Initial information received on 21-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who only received the DTAP component of the HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ230AA, expiry date: 04-APR-2021 via unknown route in unknown administration site on an unknown date.  Medical history, concomitant, medical treatment, vaccination and family history were not provided.   It was an actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: I received the Shingrix vaccine on 1/24/20 in the am at my primary care physicians. It was properly administered to the upper left arm in the muscle. I had significant soreness at the injection site (sore to the touch) persisting through 1/26/20 in the evening. On 1/25/20, I developed chills, fever of 101.2, headache, muscle aches, and fatigue. These persisted through the night but was resolved by the morning of 1/26/20 with the exception of the muscle soreness.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I received the Shingrix vaccine on 1/24/20 in the am at my primary care physicians. It was properly administered to the upper left arm in the muscle. I had significant soreness at the injection site (sore to the touch) persisting through 1/26/20 in the evening. On 1/25/20, I developed chills, fever of 101.2, headache, muscle aches, and fatigue. These persisted through the night but was resolved by the morning of 1/26/20 with the exception of the muscle soreness.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pyrexia, Vaccination complication
Clinical narrative: My husband had a Shingrix vaccination on 1/24/2020 and got very sick with fever headache and extreme fatigue 1/25/20. He is still very sick today 1/26/20. He is the third person I know who has had very severe reactions to the Shingrix vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Musculoskeletal disorder, Pain, Pain in extremity
Clinical narrative: Patient received her 2nd Shingrix shot. She had no adverse reactions to her first shot. Later that night she had severe pain in her arm. She could not sleep in her bed so she attempted to sleep in a chair but was unable to because of pain and was unable to use her arm at all. The next day she still was unable to use her arm. There was slight improvement on the 3rd day. She was able to use her arm but with some pain still. She said that she is slowly improving now and asked us to report for her.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Morbillivirus test positive, Polymerase chain reaction positive, Pyrexia, Rash
Clinical narrative: Patient received an MMR vaccine on 12/06/19. Patient developed rash and fever. The nasopharyngeal swab came back positive for measles vaccine strain RNA by real time PCR. By the time the result came back, the child was almost back to normal. No harm to the child.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever of 100.4 degrees F 10 hours after booster dose of Shingrix. Fever lasted about 8 hours.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Induration, Injection site pain, Malaise
Clinical narrative: I received an injection Sanofi Pasteur Fluzone high dose, lot UJ27 488 in my left upper biceps. Two days later I awoke to a 10 + cm area of blanching erythema and induration that was painful and tender. I also had severe malaise and fatigue, and a low grade fever of 100 F. I was bedbound for 3 days. The injection site is now tender but all other sx have resolved.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pallor, Pyrexia, Tenderness
Clinical narrative: I received an injection Sanofi Pasteur Fluzone high dose, lot UJ27 488 in my left upper biceps. Two days later I awoke to a 10 + cm area of blanching erythema and induration that was painful and tender. I also had severe malaise and fatigue, and a low grade fever of 100 F. I was bedbound for 3 days. The injection site is now tender but all other sx have resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: received the second Shingrix shot in April. Got three cases of shingles in at 6 week intervals. Hope I don't continue to sffer from these recurrences.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Muscle swelling, Myosclerosis
Clinical narrative: Headahce, swollen, bicept, painful, redness overall fatigued, hard bicepts
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Headahce, swollen, bicept, painful, redness overall fatigued, hard bicepts
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M increased, Pyrexia, Rash, Vaccination complication
Clinical narrative: The child received an MMR vaccine. Two weeks after the vaccine, the child developed rash and fever. Mother brought the patient to the doctor's office and some lab tests were performed. Measles IgG was negative and IgM was positive, suggesting reaction to the vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Consciousness fluctuating, Mobility decreased, Pain, Pyrexia
Clinical narrative: High temperature - didn't know anything. Chills, Ached all over. Couldn't get out  of bed without help. Believe first day I was  in and out of consciousness. I was by myself 1st  2 days.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt  came in to get her last dose of Pneumonia. Pt claims she has redness and swelling on her arm after getting Pnumovax 23 vaccine. I felt for the correct muscle administered the shot. Pt has no adverse reaction when after wards. It was only after 6-7 hours later did she complain of, redness, soreness and said her arm was swollen. MD called in abx for her and when she came the next day, I couldn't see any swelling but just redness near the injection site (which was in the deltoid muscle) Pt states she thinks I injected her at shoulder blade, even though there was no redness there.  Pt is fine now, taking abx just has soreness. Not redness except by injection side and surrounding areas.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Cyanosis, Hypotonia, Unresponsive to stimuli
Clinical narrative: After the 1st injection, patient started to inhale. The 2nd 2 injections were given and patient made a slight noise as if he were trying to cry. MA instructed parents to pick him up and blow on his face to try to get him to cry and start breathing on his own. Mother picked up him and he was limp in her arms and his face had started turning purple. His eyes were closed but he did respond to being rubbed on the head. MA ran to get MD from her office 3 feet away and when MD first arrived, patient was limp and purplish and apneic in mother's arms. We placed him on the exam table and he started having spontaneous respiratory effort. A pulse ox showed SpO2 96%, HR 140. MD listened to heart and lungs and by this time his color had improved and he was breathing on his own. The apneic/limp period lasted for possibly 40 seconds at most.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling hot, Headache, Myalgia, Nausea
Clinical narrative: Same as described on "possible side effects" list with brochure.  Nausea, fever, cycle between chills/shivering then feeling hot every 20-30 minutes, muscle ache, headache. Note:  This was my second round of the vaccine (first was previous June 16, 2019).  I do not recall any adverse symptoms with my first injection of the vaccine.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Same as described on "possible side effects" list with brochure.  Nausea, fever, cycle between chills/shivering then feeling hot every 20-30 minutes, muscle ache, headache. Note:  This was my second round of the vaccine (first was previous June 16, 2019).  I do not recall any adverse symptoms with my first injection of the vaccine.
Age: 20.0
Sex: F
Vaccine: HEPA, MENB, TD
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediatric dose of Hep A given when it should have been Hep A adult dose.  No adverse reactions noted
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Patient reports she felt normal for the remainder of the day on 1/21/2020 after receiving the vaccine at about 2:30pm. The following morning on 1/22/2020 the patient reports she woke up in the morning and her arm was red with some swelling. Patient reports that her arm felt tender from the elbow to the shoulder and more on the inner side of her arm (under armpit to inner elbow).  The patient denied broken skin or blistering. The patient also denied shortness of breath. Patient contacted  us on 1/23/2020 to report the reaction, she noted that the redness and swelling were improving, and she denied any itching.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: HIVES
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Tinnitus, Weight bearing difficulty
Clinical narrative: On 12/10/19 I saw my family doctor for a check-up.  She strongly suggested I have the pneumonia vaccine.   I was administered PNEUMOCOCCAL CONJUGATE 13-VALENT at this visit.  The following evening, I went to get up from a desk chair and could not bear weight on my right leg.  I also could not weight bear much on my left leg.  The pain was excruciating.  Over the course of the next few days, I continued to have difficulty ambulating.   Just when I thought the symptoms were subsiding, they would flare.  I contacted my health provider several weeks after the injection to inform her what  happened..  Although it has been over a month since this injection, I continue with some strange symptoms I did not have prior to the injection to include a continual buzzing type sound in my ears.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Anti-cyclic citrullinated peptide antibody, Antibody test, Arthralgia, Chills, Chlamydia test
Clinical narrative: Left deltoid pain (site of injection); fever, chills, body aches which lasted 3 days; as these resolved, the right ankle began swollen and painful to the point he had difficulty bearing weight, now the left ankle is swollen.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Full blood count, Injection site pain, Joint swelling, Metabolic function test, Pain
Clinical narrative: Left deltoid pain (site of injection); fever, chills, body aches which lasted 3 days; as these resolved, the right ankle began swollen and painful to the point he had difficulty bearing weight, now the left ankle is swollen.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Red blood cell sedimentation rate, Rheumatoid factor, Urine analysis, Weight bearing difficulty
Clinical narrative: Left deltoid pain (site of injection); fever, chills, body aches which lasted 3 days; as these resolved, the right ankle began swollen and painful to the point he had difficulty bearing weight, now the left ankle is swollen.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus
Clinical narrative: Less than 30 minutes after receiving the vaccine she developed itching and redness on her neck, upper chest, and on her right ear lobe.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site rash
Clinical narrative: RASH ON VACCINE SITE , LEFT ARM
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Grandparent stated patient is having fevers of 103 degrees, on and off since last night.  She gave him Motrin yesterday and then Tylenol this morning.  The medication doesn't seem to be helping the fever.  Only goes down to 100 degrees then back up.  The current temp is at 100.8 degrees. Grandmother was offered a same day appt, but she declined. She states pt is feeling better. I advised grandmother to keep monitoring pt, and if he is not feeling better tomorrow to call us back so we can schedule him for an appt. Grandmother verbalized understanding.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: About 3 hours after shot patient presented with fever 100 F even with taking tylenol. Also reported chills very sore arm insomnia and severe headache in the front portion of her head. Patient said symptoms lasted a full 24 hour period before resolving.
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Father of child states no problems at this time
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Complained of pain and swelling to left arm and headache.
Age: 66.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Body temperature increased, Chills, Tremor
Clinical narrative: 1-21-20 at 9:30p (Start time) Pt had sudden severe chill, weakness, trembling, blood pressure 150/100, heart rate upper 80's, and temperature between 103.1F-104.8F. Pt reports symptoms stopped at 1/22/20 at 4-5am
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient stated that her arm swelled up from Shingrix shot, it appeared the size of a softball at first. Her arm was hot, big and had red circles. She had a fever + Headache. Her Neck was hot. Patient had full Range of motion with arm and neck though. Arm swollenness went Down. Her arm swelled w/1st shot but Not like this. As of 1/27 @ 1130 a, pt feels completely betteR.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient stated that her arm swelled up from Shingrix shot, it appeared the size of a softball at first. Her arm was hot, big and had red circles. She had a fever + Headache. Her Neck was hot. Patient had full Range of motion with arm and neck though. Arm swollenness went Down. Her arm swelled w/1st shot but Not like this. As of 1/27 @ 1130 a, pt feels completely betteR.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Patient stated that her arm swelled up from Shingrix shot, it appeared the size of a softball at first. Her arm was hot, big and had red circles. She had a fever + Headache. Her Neck was hot. Patient had full Range of motion with arm and neck though. Arm swollenness went Down. Her arm swelled w/1st shot but Not like this. As of 1/27 @ 1130 a, pt feels completely betteR.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; A medical assistant states that on 01/21/2020 GARDASIL 9 was administered to a 5 monfu old child; This spontaneous report has been received from a medical assistant, referring to a patient of 5 months old. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drugs reactions or allergies were not provided.  On 21-JAN-2020, the patient was vaccinated (product administered to patient of inappropriate age) with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), injection, lot number 1621929 and expiration date 06-DEC-2021 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not reported). No adverse effects reported.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscle twitching, Syringe issue
Clinical narrative: Had the vaccine ready and as I was injecting and the needle in his muscle , his muscle twitched and most of the dose came out of the syringe and started dripping . Not sure If he ended up getting any drops or not but it seems that most if not all the vaccine was lost . Thinking it is probably a bad syringe .
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Immediate post-injection reaction, Muscle spasms
Clinical narrative: Had the vaccine ready and as I was injecting and the needle in his muscle , his muscle twitched and most of the dose came out of the syringe and started dripping . Not sure If he ended up getting any drops or not but it seems that most if not all the vaccine was lost . Thinking it is probably a bad syringe .
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Peripheral coldness
Clinical narrative: Overall body aches, shivering, cold extremities, headache, tired feeling, fever.  Shivering began about eight hours after I received the vaccine.  It lasted about two hours.  Cold extremities and low-grade fever continued to 48 hours after the vaccine.  Took 600 mg at time of shivering/headache/body aches and 800mg of Advil about 42 hours in.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Overall body aches, shivering, cold extremities, headache, tired feeling, fever.  Shivering began about eight hours after I received the vaccine.  It lasted about two hours.  Cold extremities and low-grade fever continued to 48 hours after the vaccine.  Took 600 mg at time of shivering/headache/body aches and 800mg of Advil about 42 hours in.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Swelling, Swelling face, Urticaria
Clinical narrative: Patient was here for vaccinations and Physical today. About 15 min after  vaccinations, while still in waiting room, mom noticed extreme redness, hives  and swelling on face, cheeks, neck and back. Patient was brought to exam room,  Vital Signs and Oxygen level were assessed. O2 level was 99% and no difficulty  breathing, Benadryl IM given x1 per protocol. Patient tolerated well. Vital Signs monitored  throughout. O2 level maintained above 95% on Room air. Patient was assessed by  Dr. and patient started returning to baseline skin color. Patient was  monitored for an additional 30 min and we discussed with mom the need to just  watch for additional symptoms today. Advised to return to ER or MD if needed,  but no further evaluation needed unless additional symptoms occur. Mom  verbalized understanding and states she is comfortable now bringing him home at  this time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia, Tremor
Clinical narrative: About 10 hours after the injection, I woke up with fever, extreme shaking, muscle pain and bad headache.   The fever and chills lasted until the middle of the next day.  The muscle pain lasted 2 days, and the headache lasted 3 days.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Syncope
Clinical narrative: Patient arrived at the pharmacy to get IMZ with her husband. Pt received Fluzone HD, Prevnar, and Shingrix as requested. Pt was instructed to wait 10-15mins after IMZ administration in order to assess the occurrence of any ADRs. The pt did not comply. The pt collapsed in the Pharmacy Store Parking lot. EMS was contacted and she was taken to the ER for evaluation.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Location of vaccine presented with a red, raised, hot to touch bump larger than a half dollar. Pt reported that it was painful to the touch. Pt also stated he was unable to lift his arm the night after obtaining the vaccine
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin discomfort
Clinical narrative: Patient stated she developed rash of red itchy bumps all over her body today (1/28/20) after getting flu vaccination yesterday (1/27/20). No fever or other symptoms besides topical discomfort.  Counseled patient to take benadyl for the time being to alleviate the itchiness and rash and to see medical professional advise if symptoms worsen. Pharmacy will follow-up with patient in the morning
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: pt fainted to the ground.  no other adverse events reported once he got up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm pain, nausea, fever as high as 100.6, headache. Felt lousy and stayed in bed all day 1/18, felt a little better 1/19 but occasional nausea, headache continued for 2-3 days, arm tenderness continued almost a week. I had a negative reaction (similar) to the first shot in the series, but this was definitely worse.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Arm pain, nausea, fever as high as 100.6, headache. Felt lousy and stayed in bed all day 1/18, felt a little better 1/19 but occasional nausea, headache continued for 2-3 days, arm tenderness continued almost a week. I had a negative reaction (similar) to the first shot in the series, but this was definitely worse.
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt came to pharmacy on the evening of  1/27/20 complained left shoulder pain that it's difficult for him to put on his shirt. He stated he didn't have any fever, swelling, or any side effects after the injection.  The pain appeared 1 week after the vaccination and persists till now.  Pt dd not take any medication for the symptom. Pt will see his primary care soon.  Advised pt to take Aleve with food.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Feeling hot, Vaccination complication
Clinical narrative: The patient had an adverse reaction after the flu shot was given. She felt warm and was having difficulty breathing. She was administered an Epipen and monitored. The pharmacist called 911 as a precaution.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant, Pain in extremity, Surgery, Vaccination site mass
Clinical narrative: PATIENT CALLED  ABOUT MONTH AFTER VACCINATION AND INFORMED US THAT HER ARM WAS STILL REALY SORE. SHE WAS GOING TO SEE HER DOCTOR. SHE CALLED TODAY (01/28/2020), ABOUT 5 MONTHS AFTER IMMUNIZATION TO INFORM US THAT HER MD REFERRED HER TO A SURGEON, WHO REFERRED HER TO AN ONCOLOGIST AND THAT A SURGERY WAS PERFORMED FOR CANCEROUS MASS AT THE SPOT OF VACCINATION OF HER LEFT ARM.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Extreme nausea and fatigue, vomiting approximately every 30 minutes, cannot retain fluids
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt states after receiving vaccine, she is unable to lift her arm up, area is painful to the touch and she does not have any fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Back pain, Chills, Dysstasia
Clinical narrative: Yesterday morning when I received the vaccine around 8:00, within an hour, my left arm where the vaccine was administered, my wrists and gradually back muscles started to feel very achy like the flu.  My left arm and both armpits started to feel painful and sensitive.  In the afternoon, I started to develop chills and a fever.  Around 5:00 yesterday afternoon, I started shaking uncontrollable for about a half hour until I drank some hot tea to help the shaking stop.  The achy feeling, chills and fever got worse during the night and my head started hurting as well.  I could not sleep on my left side because it was too painful.  I took an Aleve PM to help with pain and to help me sleep.  When I woke up this morning around 5:00 am, I felt nauseated and could not stand for any length of time before having to lie back down.  I started to feel gradually better around 10:00 a.m.  and through the afternoon.  It is 7:00 right now and I am feeling tired and am still feeling soreness on my left arm and both armpits especially when I lift up my arms.   I have had flu shots every year for the past 20 years and have never had a reaction like this to any of those vaccines.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Insomnia, Nausea
Clinical narrative: Yesterday morning when I received the vaccine around 8:00, within an hour, my left arm where the vaccine was administered, my wrists and gradually back muscles started to feel very achy like the flu.  My left arm and both armpits started to feel painful and sensitive.  In the afternoon, I started to develop chills and a fever.  Around 5:00 yesterday afternoon, I started shaking uncontrollable for about a half hour until I drank some hot tea to help the shaking stop.  The achy feeling, chills and fever got worse during the night and my head started hurting as well.  I could not sleep on my left side because it was too painful.  I took an Aleve PM to help with pain and to help me sleep.  When I woke up this morning around 5:00 am, I felt nauseated and could not stand for any length of time before having to lie back down.  I started to feel gradually better around 10:00 a.m.  and through the afternoon.  It is 7:00 right now and I am feeling tired and am still feeling soreness on my left arm and both armpits especially when I lift up my arms.   I have had flu shots every year for the past 20 years and have never had a reaction like this to any of those vaccines.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Yesterday morning when I received the vaccine around 8:00, within an hour, my left arm where the vaccine was administered, my wrists and gradually back muscles started to feel very achy like the flu.  My left arm and both armpits started to feel painful and sensitive.  In the afternoon, I started to develop chills and a fever.  Around 5:00 yesterday afternoon, I started shaking uncontrollable for about a half hour until I drank some hot tea to help the shaking stop.  The achy feeling, chills and fever got worse during the night and my head started hurting as well.  I could not sleep on my left side because it was too painful.  I took an Aleve PM to help with pain and to help me sleep.  When I woke up this morning around 5:00 am, I felt nauseated and could not stand for any length of time before having to lie back down.  I started to feel gradually better around 10:00 a.m.  and through the afternoon.  It is 7:00 right now and I am feeling tired and am still feeling soreness on my left arm and both armpits especially when I lift up my arms.   I have had flu shots every year for the past 20 years and have never had a reaction like this to any of those vaccines.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial test positive, Balance disorder, Canalith repositioning procedure, Chest X-ray, Electrocardiogram
Clinical narrative: Pt reported that she started having adverse effects starting the morning after receiving the flu shot (10/28). She started having changes in her vision and needed to blink multiple times to focus. That day she went to pick up her meds from her regular pharmacy and then went to choir practice. She was still having vision issues and then developed a headache, for which she took Tylenol to help with the pain, and then went home. When she was home her eyes started to dart side to side. She notes that she slept well that night but the following day had felt worse. On the morning of 10/29 she still had trouble with focusing and then felt unsteady. On 10/30 she said that she was feeling a little worse. She still had trouble with her eyes darting and her balance was getting worse, however she also had vomited once in the day. On 10/31 she stated that she couldn?t focus completely, had bad balance and had to stagger to throw out her trash. When she came back inside her house her eyes were still darting and felt like she was going to fall so she sat down and called the EMTs. They came about 5 minutes after her call and took her vitals, which were fine, and then they took her to Hospital. While at the ER, a chest x-ray, EKG and MRI of her head and neck were done, however she was not told of the results. The hospital also ran a urinalysis on the patient, which she states had tested positive for bacteria. A Rhomberg test and Epley test were administered in which she had trouble balancing and was leaning to the right. Due to this she spent the night at the hospital for observation and was given Zofran, but this had no good response for her. On 11/1 the patient was discharged to rehabilitation where she stayed for 11 days to work on her balance. The patient states that the nystagmus had slowly started to resolve and her balance had slowly gotten better during this time, however it is not completely back to normal. On 11/13 she was discharged to her primary doctor, who she saw on the Monday following her discharge. Since then the patient had home visits with physical therapy, who helped her with exercises to help her balance and to help her walk with a walker and then a cane. The patient has recently been able to visit the site for these appointments and her last appointment will be next week. Pt has appointment with Dr. on 1/30/20.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Eye movement disorder, Gait disturbance, Headache, Magnetic resonance imaging brain, Magnetic resonance imaging neck
Clinical narrative: Pt reported that she started having adverse effects starting the morning after receiving the flu shot (10/28). She started having changes in her vision and needed to blink multiple times to focus. That day she went to pick up her meds from her regular pharmacy and then went to choir practice. She was still having vision issues and then developed a headache, for which she took Tylenol to help with the pain, and then went home. When she was home her eyes started to dart side to side. She notes that she slept well that night but the following day had felt worse. On the morning of 10/29 she still had trouble with focusing and then felt unsteady. On 10/30 she said that she was feeling a little worse. She still had trouble with her eyes darting and her balance was getting worse, however she also had vomited once in the day. On 10/31 she stated that she couldn?t focus completely, had bad balance and had to stagger to throw out her trash. When she came back inside her house her eyes were still darting and felt like she was going to fall so she sat down and called the EMTs. They came about 5 minutes after her call and took her vitals, which were fine, and then they took her to Hospital. While at the ER, a chest x-ray, EKG and MRI of her head and neck were done, however she was not told of the results. The hospital also ran a urinalysis on the patient, which she states had tested positive for bacteria. A Rhomberg test and Epley test were administered in which she had trouble balancing and was leaning to the right. Due to this she spent the night at the hospital for observation and was given Zofran, but this had no good response for her. On 11/1 the patient was discharged to rehabilitation where she stayed for 11 days to work on her balance. The patient states that the nystagmus had slowly started to resolve and her balance had slowly gotten better during this time, however it is not completely back to normal. On 11/13 she was discharged to her primary doctor, who she saw on the Monday following her discharge. Since then the patient had home visits with physical therapy, who helped her with exercises to help her balance and to help her walk with a walker and then a cane. The patient has recently been able to visit the site for these appointments and her last appointment will be next week. Pt has appointment with Dr. on 1/30/20.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Nystagmus, Romberg test positive, Vision blurred, Visual impairment, Vomiting
Clinical narrative: Pt reported that she started having adverse effects starting the morning after receiving the flu shot (10/28). She started having changes in her vision and needed to blink multiple times to focus. That day she went to pick up her meds from her regular pharmacy and then went to choir practice. She was still having vision issues and then developed a headache, for which she took Tylenol to help with the pain, and then went home. When she was home her eyes started to dart side to side. She notes that she slept well that night but the following day had felt worse. On the morning of 10/29 she still had trouble with focusing and then felt unsteady. On 10/30 she said that she was feeling a little worse. She still had trouble with her eyes darting and her balance was getting worse, however she also had vomited once in the day. On 10/31 she stated that she couldn?t focus completely, had bad balance and had to stagger to throw out her trash. When she came back inside her house her eyes were still darting and felt like she was going to fall so she sat down and called the EMTs. They came about 5 minutes after her call and took her vitals, which were fine, and then they took her to Hospital. While at the ER, a chest x-ray, EKG and MRI of her head and neck were done, however she was not told of the results. The hospital also ran a urinalysis on the patient, which she states had tested positive for bacteria. A Rhomberg test and Epley test were administered in which she had trouble balancing and was leaning to the right. Due to this she spent the night at the hospital for observation and was given Zofran, but this had no good response for her. On 11/1 the patient was discharged to rehabilitation where she stayed for 11 days to work on her balance. The patient states that the nystagmus had slowly started to resolve and her balance had slowly gotten better during this time, however it is not completely back to normal. On 11/13 she was discharged to her primary doctor, who she saw on the Monday following her discharge. Since then the patient had home visits with physical therapy, who helped her with exercises to help her balance and to help her walk with a walker and then a cane. The patient has recently been able to visit the site for these appointments and her last appointment will be next week. Pt has appointment with Dr. on 1/30/20.