chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: I woke up in the middle of the night with a fever over 102, and pretty bad flu-like symptoms. Bad headache, aches and pains, dizziness. Only lasted 1 day
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Patient stated the day after she received the vaccine that she had violent shivering that occurred for about 30 minutes. She has since stated that she is ok now and has spoken to her md regarding this event.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient stated 4 -5 hours after vaccine seemed to have loss of range of motion of arm and pain for 1 day. Still soreness at times in arm today after 4 months.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: ~15 hours of fever with peak temperature of 101.5 degrees Headache, shivering, muscle soreness, soreness and redness around shot area.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: ~15 hours of fever with peak temperature of 101.5 degrees Headache, shivering, muscle soreness, soreness and redness around shot area.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptions: headache, body ache, ache in the joints, tiredness.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: Patient received shot on 8/21/2019. She reported to pharmacy two days later with complaint of itchy/sore arm and evident erythema at injection site. Patient was instructed that this can be a normal, mild reaction to vaccination, but to inform the pharmacist if it worsens or changes in the next few days.  Reaction has since resolved since first report.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Apparent life threatening event, Bacterial infection, Blood sodium decreased, Blood test, Erythema
Clinical narrative: High fever after 4 days; swollen and red arm; severe pain at site of injection.  When condition got worse went to see primary care on 11/15/2018; she told me I developed a severe life threatening infection due to bacteria on my arm.  Given Bactrim 160 mg. twice daily on 11/15/2018 for seven days.  Unknown to me, I was highly allergic to bactrium and ended up hospitalized with kidneys beginning to shut down because of Bactirum
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Peripheral swelling, Pyrexia, Renal impairment, Urine analysis
Clinical narrative: High fever after 4 days; swollen and red arm; severe pain at site of injection.  When condition got worse went to see primary care on 11/15/2018; she told me I developed a severe life threatening infection due to bacteria on my arm.  Given Bactrim 160 mg. twice daily on 11/15/2018 for seven days.  Unknown to me, I was highly allergic to bactrium and ended up hospitalized with kidneys beginning to shut down because of Bactirum
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Pyrexia
Clinical narrative: I had my first Shingrix vaccination in the early afternoon. Late evening/early morning I started presenting symptoms: low grade fever, persistent stomach pain, headache, slight chills. Stomach pain stopped but kept fever and mild headache through morning into afternoon. I took nothing for this as symptoms were bearable and I was concerned about more side effects! I have never has any adverse effects from a vaccination before and am filing this report on a family member?s (who is a health care professional) advice.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: HEADACHEAS, NAUSEA
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDDNESS BELOW INJECTION SITE, SWELLING
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Pt has red rash that is non-circular near site of injection, painful to the touch, not warm to the touch - roughly 2 inches long and wide. Just appeared this morning.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on torso and arm. went to urgent care on 8/21/19. Prescribed prednisone 20mg - 2 tabs daily for 5 days
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Rash
Clinical narrative: Patient had a mild rash 5 inches below the injection site. Area was not red, but felt hard. Patient does not present with any fever, and seems alert. This is probably just a minor reaction.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe pain in upper arm, difficulty moving arm for several days.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: When I had the first dosage (1/29/2019) I had severe muscular pain throughout my body.  It went  away in about a week.  The second dosage was similar but also included a stiff neck and headache (maybe due to anxiety).  Again, everything went away in about a week except for the stiff neck.  This has lessened, but remains in a annoying form.  Will it eventually go away?
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presents with red, swollen site area
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt noticed that he has a swollen spot on his arm the size of a peach that is warm to the touch and looks rashy.  It does not have any pain, just got swollen at injection site
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Skin warm
Clinical narrative: Inflamed,  hot to touch, size of a baseball
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Chiropractic, Exposure during pregnancy, Hypoaesthesia, Infection
Clinical narrative: During my pregnancy last August 2018, I was encouraged to get the Tdap vaccine prior to her birth. I was due on 8/28 and was checking in weekly. I was primarily healthy, and had no issues during the pregnancy. I had the vaccine upon arrival of my visit with our midwives clinic. Like most vaccines, I knew there would be some pain following the visit. After days upon weeks of numb pain, trouble sleeping on it, loss of feeling in my arm (tingling), I notified my doctors and midwives of the consistent pain. They all assured me that it could take some time to disappear. After giving birth to my daughter via cesarean, she was brought to their nicu with sepsis and was resuscitated after delivery. She was born at 6lb .4 oz. Following her stay, she has been a relatively normal baby. After her birth, I was still experiencing terrible pain, which was only increased after having surgery and an infection myself. I sought out the help of our midwives one more time for a check-up but with no help I went elsewhere. I was referred to a chiropractor who specialized in Active Release Technology and dry needling. He examined me and administered the dry needling upon our first visit. I did feel a sense of relief in my upper arm after our visit, but the pain soon came back. I visited the chiropractor several other visits and he said that he had never seen anyone with that type of muscle issue prior, and was concerned he may not be able to help and that I should seek a medical doctor. Feeling hopeless,  I gave up on finding a solution and continued on using self techniques such as roller balls and muscle rollers. My husband and I moved to another state in May, and I immediately set up an appointment to see a doctor as I was still having issues with everyday tasks and sleeping. The sleeping was the worst, as at the end of the day all of the pain and aches started to settle. I went in to establish care with a new primary doc, I told her about the issues with the shot and she said she would recommend reporting the issue to the CDC. She also gave me some in home therapies that I had already been aware of (such as the roller balls).
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Pain, Paraesthesia, Sensory loss, Surgery
Clinical narrative: During my pregnancy last August 2018, I was encouraged to get the Tdap vaccine prior to her birth. I was due on 8/28 and was checking in weekly. I was primarily healthy, and had no issues during the pregnancy. I had the vaccine upon arrival of my visit with our midwives clinic. Like most vaccines, I knew there would be some pain following the visit. After days upon weeks of numb pain, trouble sleeping on it, loss of feeling in my arm (tingling), I notified my doctors and midwives of the consistent pain. They all assured me that it could take some time to disappear. After giving birth to my daughter via cesarean, she was brought to their nicu with sepsis and was resuscitated after delivery. She was born at 6lb .4 oz. Following her stay, she has been a relatively normal baby. After her birth, I was still experiencing terrible pain, which was only increased after having surgery and an infection myself. I sought out the help of our midwives one more time for a check-up but with no help I went elsewhere. I was referred to a chiropractor who specialized in Active Release Technology and dry needling. He examined me and administered the dry needling upon our first visit. I did feel a sense of relief in my upper arm after our visit, but the pain soon came back. I visited the chiropractor several other visits and he said that he had never seen anyone with that type of muscle issue prior, and was concerned he may not be able to help and that I should seek a medical doctor. Feeling hopeless,  I gave up on finding a solution and continued on using self techniques such as roller balls and muscle rollers. My husband and I moved to another state in May, and I immediately set up an appointment to see a doctor as I was still having issues with everyday tasks and sleeping. The sleeping was the worst, as at the end of the day all of the pain and aches started to settle. I went in to establish care with a new primary doc, I told her about the issues with the shot and she said she would recommend reporting the issue to the CDC. She also gave me some in home therapies that I had already been aware of (such as the roller balls).
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Feeling abnormal, Nausea, Nervousness, Pain in extremity, Pyrexia
Clinical narrative: Patient was  nauseous (dry heaves), feverish , shaky, and right arm was super sore. Patient still felt lousy the next morning , but by 2:30pm on 8/25/2019 patient was feeling better and symptons were resolving.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Retching
Clinical narrative: Patient was  nauseous (dry heaves), feverish , shaky, and right arm was super sore. Patient still felt lousy the next morning , but by 2:30pm on 8/25/2019 patient was feeling better and symptons were resolving.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Inflammation, Urticaria
Clinical narrative: inflammed, blisters, hives lasting from 8/19/19-8/22/19
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Joint range of motion decreased, Lethargy, Neck pain, Pain in extremity
Clinical narrative: Per patient she had severe sore arm followed by lethargy on day 1 and day 2.  It became hot to the touch and sore all the way to shoulder.  Starting day 3 she lost some range of arm motion, got severe neck pain and left sided headache that lasted for several days.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Skin warm
Clinical narrative: Per patient she had severe sore arm followed by lethargy on day 1 and day 2.  It became hot to the touch and sore all the way to shoulder.  Starting day 3 she lost some range of arm motion, got severe neck pain and left sided headache that lasted for several days.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: PATIENT BEGAN EXPERIENCING PAIN IN THE LEFT ARM, SHOULDER AND NECK ABOUT 2 WEEKS AFTER THE IMMUNIZATION. STATES THAT SHE IS HAVING DIFFICULTY RAISING THE ARM.  UNSURE IF RELATED TO THE IMMUNIZATION. ADVISED PATIENT TO FOLLOW UP WITH PRIMARY CARE PHYSICIAN.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Raised  red area in area of vaccination approximately  2 inch by 3 inch. warm to touch. itchy.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash, Skin warm
Clinical narrative: 08/24/2019: Patient reported to pharmacist of redness, warmth, itchy patch below where shot was injected, appeared on 08/23/2019. Treatment: Ice, Hydrocortisone cream and Benadryl as needed for itching or discomfort. 08/25/2019: Patient reports rash is resolving with benadryl
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Face got puffy and swollen
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Heart rate increased, Hyperhidrosis
Clinical narrative: Patient reports increased heart rate per watch during sleep, about 4 hours of continued increased heart rate. Patient also reports sweating and chills.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: LIGHT HEADED  AFTER RECEIVING FLU VACCINE. AFTER SITTING FOR 15 TO 20  MINUTES PATIENT SAID HE IS OK AND WENT HOME
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: He told his mother he had a bug bite on his left arm this morning.  A few hours later she noticed the left deltoid region had some redness and swelling. His vital signs were normal.  No red streaks.  CMS intact distally.  Full ROM of left shoulder.  No lip/mouth/throat swelling/lesions. Lungs: CTAB.  Heart: RRR. Advised to use an OTC non-drowsy antihistamine and a cool pack.  Area is marked with a sterile skin marker.   She is asked to have a recheck in 2 days, sooner with spreading of the area of redness, difficulty in moving joint or any systemic symptoms-headache, body aches, fever, fatigue, lethargy.  She is advised to call 911 with ANY swallowing or breathing difficulties, lip/mouth swelling, red streaks or ANY worsening or concerning symptoms.  She agrees and understands.  I called pt's mother again this evening and he is doing well; area of redness is the same. Mother gave an antihistamine and cool pack.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Injection site pain, Laboratory test, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: day 1 sore arm, pain at injection site, very stiff arm. day 2- pain in right leg, unable to walk or apply any pressure. lasted about 1 month
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Extreme tiredness, slept most of the day.  One day only.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: PATIENT STATED THAT SHE FELT ITCHING ALL OVER THE DAY AFTER RECIEVING A SINGLE DOSE OF PREVNAR 13.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT SAID HIS ARM WAS RED, SWOLLEN AND PAINFUL
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Pt called 1 day after receiving vaccines and said she had broke out in hives on her right arm by her tatoo. Pt states a history of hives and they alway occur on her tatoo. Normal redness, swelling and pain noted at injection site (left deltoid). She took 3 doses of Benadryl and hives went away.  She wonders if she should take the 2nd dose of Shingrix. I advised her to continue with Benadryl if hives perssist, monitor and speak with MD about second dose. Because she has a history of hives its difficult to tell if it was a cause. I am unsure if she called an ER or went to the ER.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pyrexia, Rash, Tremor
Clinical narrative: Fever, headache, dizziness, rash moving down the arm, tremor. The patient has taken acetaminophen and diphenhydramine.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: severe site reaction, swollen and red about 8 inches in diameter
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Pt reported a know on arm, reported back with red arm , warm to the touch.  no problems with movement.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: 30 hours after injection: chills, headache, muscle aches, body rash, diarrhea, tiredness
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 30 hours after injection: chills, headache, muscle aches, body rash, diarrhea, tiredness
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood test, Computerised tomogram abdomen normal, Headache, Mobility decreased
Clinical narrative: Severe back pain began within about 5 hours of receiving vaccine.  Back pain and left side pain continued overnight.  Felt unable to move in the morning, severe head- and neck- ache which took about six hours to mostly resolve.  Side and lessened back pain continued for approximately a week; emergency room visit on 8-18-19, CT abdominal scan showed nothing; normal WBC count, not a recurring UTI.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Urine analysis, White blood cell count normal
Clinical narrative: Severe back pain began within about 5 hours of receiving vaccine.  Back pain and left side pain continued overnight.  Felt unable to move in the morning, severe head- and neck- ache which took about six hours to mostly resolve.  Side and lessened back pain continued for approximately a week; emergency room visit on 8-18-19, CT abdominal scan showed nothing; normal WBC count, not a recurring UTI.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hypoacusis, Visual impairment
Clinical narrative: pt became light headed and she stated that she could not see or hear for about 30 seconds. after 30 seconds or a minute she said that everything returned to normal. this happened about 5 minutes after administration. 911 was called and pt was checked out. all vitals were fine and pt remained with her parents.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Pruritus, Wheezing
Clinical narrative: Patient stated that she first started itching.  She began to wheeze and have difficulty breathing so she called a doctor on call service and they told her to go to ER immediately.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Anion gap, Basophil count normal, Basophil percentage, Blood calcium normal, Blood chloride normal
Clinical narrative: Began having vague fatigue and nausea 8/21/19. Fever up to 102F began 8/23/19. Seen in urgent care 8/25/19. Sore throat, no rhinorrhea, cough or congestion. No sick contacts. No other members of family ill. CBC WNL.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium decreased, Blood urea normal
Clinical narrative: Began having vague fatigue and nausea 8/21/19. Fever up to 102F began 8/23/19. Seen in urgent care 8/25/19. Sore throat, no rhinorrhea, cough or congestion. No sick contacts. No other members of family ill. CBC WNL.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Carbon dioxide normal, Eosinophil count decreased, Eosinophil percentage, Fatigue, Haematocrit normal
Clinical narrative: Began having vague fatigue and nausea 8/21/19. Fever up to 102F began 8/23/19. Seen in urgent care 8/25/19. Sore throat, no rhinorrhea, cough or congestion. No sick contacts. No other members of family ill. CBC WNL.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Haemoglobin normal, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Began having vague fatigue and nausea 8/21/19. Fever up to 102F began 8/23/19. Seen in urgent care 8/25/19. Sore throat, no rhinorrhea, cough or congestion. No sick contacts. No other members of family ill. CBC WNL.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Mean cell volume normal, Mean platelet volume decreased, Monocyte count increased, Monocyte percentage increased, Nausea
Clinical narrative: Began having vague fatigue and nausea 8/21/19. Fever up to 102F began 8/23/19. Seen in urgent care 8/25/19. Sore throat, no rhinorrhea, cough or congestion. No sick contacts. No other members of family ill. CBC WNL.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Neutrophil count normal, Neutrophil percentage, Oropharyngeal pain, Platelet count normal, Pyrexia
Clinical narrative: Began having vague fatigue and nausea 8/21/19. Fever up to 102F began 8/23/19. Seen in urgent care 8/25/19. Sore throat, no rhinorrhea, cough or congestion. No sick contacts. No other members of family ill. CBC WNL.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Red blood cell count normal, Red cell distribution width normal, White blood cell count normal
Clinical narrative: Began having vague fatigue and nausea 8/21/19. Fever up to 102F began 8/23/19. Seen in urgent care 8/25/19. Sore throat, no rhinorrhea, cough or congestion. No sick contacts. No other members of family ill. CBC WNL.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram ST segment elevation, Myocarditis, Nuclear magnetic resonance imaging heart, Troponin increased
Clinical narrative: Myopericarditis
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm,: 4 days;  fever of 99.6: 2 days; whole body aching : 2 days; severe headache for 2 days. Treated with 2 extra strength Tylenol every 6 hours for 2 days
Age: 0.5
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Amblyopia, Tremor
Clinical narrative: Baby developed a tremor. It has occurred every day for the past 6 months. She is currently age 12 months. She also developed a lazy eye. She DID NOT display either of these symptoms prior to this set of vaccinations.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Woke up feeling fine.  Started suspecting about 11:00am that a mild reaction had started.  By 12:00 noon I was sure .  Had body aches and headache and fever of over 100.  I don't think I had a fever with the first dose but I had chills,shivers & shakes that I did not have this time.  I went to bed still not feeling well and got to sleep about 2:00am.  Woke up next morning feeling great.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Woke up feeling fine.  Started suspecting about 11:00am that a mild reaction had started.  By 12:00 noon I was sure .  Had body aches and headache and fever of over 100.  I don't think I had a fever with the first dose but I had chills,shivers & shakes that I did not have this time.  I went to bed still not feeling well and got to sleep about 2:00am.  Woke up next morning feeling great.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain in extremity, Pruritus
Clinical narrative: Patient said that she got blisters with pain and itching on arm starting 8/3/19. She reported this on 8/22/19. She still had 1 blister. She used "Listerine" on affected area and said it helps. She sent picture to Dr and was told not to get 2nd shot. Dr. was contacted by pharmacy on 8/4/19 to report incident.
Sex: F
Vaccine: PPV
Symptoms: Infection, Periarthritis
Clinical narrative: Give me a cellulite Infection, frozen shoulder.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site hypoaesthesia, Injection site nodule, Injection site pain
Clinical narrative: redness at injection site; bruise at injection site; sore arm; arm feels numb and tingly; arm feels numb and tingly; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 28th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site bruising, pain in arm, numbness of upper extremities and tingling of extremity. On an unknown date, the outcome of the injection site erythema, injection site bruising, pain in arm, numbness of upper extremities and tingling of extremity were unknown.   It was unknown if the reporter considered the injection site erythema, injection site bruising, pain in arm, numbness of upper extremities and tingling of extremity to be related to Shingrix.  Additional case details were reported as follows: The patient experienced redness and bruise at injection site, arm was sore and felt numb and tingly. The reporter gave permission to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injection site bruising, Injection site erythema, Pain in extremity, Paraesthesia
Clinical narrative: redness at injection site; bruise at injection site; sore arm; arm feels numb and tingly; arm feels numb and tingly; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 28th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site bruising, pain in arm, numbness of upper extremities and tingling of extremity. On an unknown date, the outcome of the injection site erythema, injection site bruising, pain in arm, numbness of upper extremities and tingling of extremity were unknown.   It was unknown if the reporter considered the injection site erythema, injection site bruising, pain in arm, numbness of upper extremities and tingling of extremity to be related to Shingrix.  Additional case details were reported as follows: The patient experienced redness and bruise at injection site, arm was sore and felt numb and tingly. The reporter gave permission to follow up.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: The patient had a positive HPV test, negative for types 16 & 18, and apparently the HPV test tested out the other HPV types; Information has been received from a physician via company representative, concerning a 24-year-old female patient. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On an unknown date in 2007, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection as prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). It was unknown how many doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) did the patient received.  On an unknown date, the patient had a positive human papilloma virus (HPV) test, however negative for types 16 and 18, and apparently test tested out other HPV types. At the time of this report, the outcome of the event human papilloma virus test positive was unknown.  The causal relationship between the positive HPV and the therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.  It has been determined that the case # US-009507513-1908USA005643 was sent to distribution with an incorrect initial aware date. Therefore, the case # US-009507513-1908USA005643 is being deleted from our files and the case # US-009507513-1908USA008561 was created to capture the correct initial aware date.  This is an amended report. The aware date was changed from 13-AUG-2019 to 12-AUG-2019.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: Shingrix vaccine was reconstituted with sterile diluent, not the adjuvant diluent that was provided with the vaccine. The patient did not report any adverse effects or outcomes but did require a repeat injection for the first dose of the series on 8/20/19
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immunisation, No adverse event, Product preparation error
Clinical narrative: Shingrix vaccine was reconstituted with sterile diluent, not the adjuvant diluent that was provided with the vaccine. The patient did not report any adverse effects or outcomes but did require a repeat injection for the first dose of the series on 8/20/19
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: Shingrix vaccine was reconstituted with sterile diluent, not the adjuvant diluent that was provided with the vaccine. The patient did not report any adverse effects or outcomes but did require a repeat injection for the first dose of the series on 8/20/19
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immunisation, No adverse event, Product preparation error
Clinical narrative: Shingrix vaccine was reconstituted with sterile diluent, not the adjuvant diluent that was provided with the vaccine. The patient did not report any adverse effects or outcomes but did require a repeat injection for the first dose of the series on 8/20/19
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Conjunctivitis, Cough, Eye swelling, Ocular hyperaemia
Clinical narrative: Oculorespiratory syndrome- conjunctivitis in both eyes, eyes swollen and red, cough, feeling like something in throat, chest tightness lasted about 6 hours
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Oculorespiratory syndrome, Sensation of foreign body
Clinical narrative: Oculorespiratory syndrome- conjunctivitis in both eyes, eyes swollen and red, cough, feeling like something in throat, chest tightness lasted about 6 hours
Age: 6.0
Sex: M
Vaccine: MMR, UNK
Symptoms: Inappropriate schedule of product administration, Measles antibody negative
Clinical narrative: titer was 0. 7 EIA which is negative per the laboratory report; One dose on an unspecified date in 2007 and another dose on an unspecified date in 2018; This spontaneous report was received from a medical assistant, referring to an 18-years-old male patient. His pertinent medical history, concomitant medications, drug reactions and allergies were not reported.   In 2007 and 2018, respectively, the patient was vaccinated with the first and second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) "to catch up immunization" (inappropriate schedule of product administration); which were reconstituted with Merck sterile diluent injection (vaccine scheme frequency, route and anatomical location of vaccinations, lot numbers and expiration dates were not reported).   On an unknown date, the  immigration department required that the patient was performed a titer level. According to the reporter, the patient's enzyme immunoassay (EIA) titer resulted in "0.7" (units not provided) which was negative per the laboratory report (measles antibody negative). The reporter mentioned that a third measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose would be administered to the patient if negative or equivocal titer resulted; however, by reporting time, further information about this action was not provided.     The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the Merck sterile diluent administration, and the occurred event, as well as the patient's outcome from it, were not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: she had been administering PROQUAD to an unspecified number of patients aged 12 years through 18 years of age since an unspecified date; she had been administering PROQUAD to an unspecified number of patients aged 12 years through 18 years of age since an unspecified date; No adverse effects; This spontaneous report has been received from a nurse via a company representative referring to an unspecified number of adolescent patients. The patients' concurrent conditions, medical history, concomitant medications, drug reactions/allergies were not reported.  The nurse reported she had been administering  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, route, lot# and expiration date were not reported) to the patients since an unspecified date (product administered to patient of inappropriate age and product use in unapproved population). No adverse effects were reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-51294589-1908USA001356:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; the patient was inadvertently administered a dose of ROTATEQ, on 01-AUG-2019, that was improperly stored/Temperature: 10.5 °C; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information according the patient's current conditions, medical history, previously past drugs or allergies, and concomitant therapies were not provided.   On 01-AUG-2019, the patient was vaccinated with an improperly dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, as prophylaxis (strength, formulation, dose number, dose, and  anatomical site injection were not reported; lot number reported as S004400; expiration date 14-NOV-2020).   The temperature was of 10.5 degrees Celsius, for a time frame of 5 hours, with a previous temperature excursion. A digital data logger was not used. No adverse effect reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission
Clinical narrative: patient missed their second dose of GARDASIL 9; first dose was administered on 2/8/2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 08-FEB-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602284 (verified to be a valid lot number), expiration date reported and established as 26-SEP-2021, for prophylaxis.         On an unknown date, the patient missed their second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse affects were reported.
Sex: F
Vaccine: PPV
Symptoms: Rash, Skin warm, Tenderness
Clinical narrative: the patient said the rash was warm and tender to touch; the patient said the rash was warm and tender to touch; one female patient had a rash developed on her left arm leading to her lymph nodes; This spontaneous report was received from a pharmacist referring to a 61 year old, non-pregnant female patient. The patient's medical history included a previous breast cancer and her current conditions included diabetes. The patient was also allergic to nitrofurantoin (MACROBID).  On 11-AUG-2019, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, with lot number reported as S0045647 and expiration date on 12-AUG-2020, for prophylaxis (dose number and anatomical injection site were not reported). On the same date, after the administration of the vaccine, the patient had a rash developed on her left arm and in her armpit leading to her lymph nodes. The patient stated that the rash was warm and tender to touch (skin warm and tenderness). The patient went back to the pharmacy, but she did not received any treatment. No diagnostic laboratories or studies were performed.  At the time of the report, the patient had not recovered from the events. The causality assessment between rash, skin warm and tenderness with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Lot number S0045647 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent).
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; Expired vaccine used; Information has been received from a company representative referring to a 15 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 05-AUG-2019, the patient received one dose of expired Hepatitis A Vaccine, Inactivated (VAQTA) Hepatitis A Vaccine, Inactivated (VAQTA) (lot # R013859, expiration date: 14-JUN-2019, strength, dose, frequency and route were unknown) inadvertently (expired vaccine used) for prophylaxis. No adverse effects were reported.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Duodenal ulcer, Endoscopy upper gastrointestinal tract abnormal, Helicobacter test negative, Human papilloma virus test positive
Clinical narrative: Adjuvant quadrivalent HPV vaccine series was also adminstered /  ESOPHAGEAL SQUAMOUS PAPILLOMA in the pediatric population;   This literature marketed report was received from the authors of a published article and concerns to a 14 year old female patient.      On an unknown date, the 14 year-old female presented with with chronic abdominal pain and vomiting and initial upper endoscopy revealed Helicobacter pylori negative duodenal ulcer and due to it she was treated with proton pump inhibitors (PPI) therapy and follow up upper endoscopy revealed an isolated papilloma in the proximal esophagus, which was removed by biopsy forceps; immunohistochemistry confirmed Human Papillomavirus subtype 16/18. The patient had Esophageal Squamous Papilloma.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), dose reported as "series", (strength, frequency, route, anatomical location, lot number, and expired date were not reported), as adjuvant therapy for the Esophageal Squamous Papilloma (product drug use for unapproved indication). No other suspect or concomitant therapies were administered.     On an unknown date, reported as "6 months follow up", the patient showed normal esophageal mucosa on upper endoscopy.  This is one of two reports from the same literature article (MARRS CASE # 1908USA009206).    Sender's Comments:  US-009507513-1908USA009206:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immunohistochemistry, Oesophageal papilloma, Vomiting
Clinical narrative: Adjuvant quadrivalent HPV vaccine series was also adminstered /  ESOPHAGEAL SQUAMOUS PAPILLOMA in the pediatric population;   This literature marketed report was received from the authors of a published article and concerns to a 14 year old female patient.      On an unknown date, the 14 year-old female presented with with chronic abdominal pain and vomiting and initial upper endoscopy revealed Helicobacter pylori negative duodenal ulcer and due to it she was treated with proton pump inhibitors (PPI) therapy and follow up upper endoscopy revealed an isolated papilloma in the proximal esophagus, which was removed by biopsy forceps; immunohistochemistry confirmed Human Papillomavirus subtype 16/18. The patient had Esophageal Squamous Papilloma.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), dose reported as "series", (strength, frequency, route, anatomical location, lot number, and expired date were not reported), as adjuvant therapy for the Esophageal Squamous Papilloma (product drug use for unapproved indication). No other suspect or concomitant therapies were administered.     On an unknown date, reported as "6 months follow up", the patient showed normal esophageal mucosa on upper endoscopy.  This is one of two reports from the same literature article (MARRS CASE # 1908USA009206).    Sender's Comments:  US-009507513-1908USA009206:
Sex: F
Vaccine: HEP, MMR, UNK, VARCEL
Symptoms: Therapy non-responder, Viral titre decreased
Clinical narrative: tbe patient did not seroconvert for measles or hepatitis B, and had low varicella titers; tbe patient did not seroconvert for measles or hepatitis B, and had low varicella titers; the patient did not seroconvert for measles or hepatitis B, and had low varicella titers; This spontaneous report has been received from a nurse practitioner via a company representative reporting on a female patient around 21-year-old. The patient had no pertinent medical history. The patient's concurrent conditions and drug reactions/ allergies were not unknown by the reporter.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) diluted with sterile diluend, Hepatitis B Vaccine (Recombinant) (manufacturer unknown), and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (doses, routes of administration, lot numbers and expiration dates were not reported).  On an unknown date, the patient had her titers done; the patient's titers showed that the patient did not seroconvert for measles or hepatitis B, and had low varicella titers. It was unknown if treatment was given to the patient due to the adverse events.  It was unknown the present status of the patient by the reporter. The causal relationship between the events and the suspect therapies were not reported.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV9, MNQ, MNQ, HPVX, MNQ, TDAP
Symptoms: Dyspnoea, Swelling face, Urticaria
Clinical narrative: The patient returned to the clinic on on 15-AUG-2018, because "the urticaria had returned".; The patient experienced "worsening urticaria, facial swelling, and difficulty breathing"; The patient experienced "worsening urticaria, facial swelling, and difficulty breathing".; The patient returned to the clinic on 14-AUG-2019,, complaining of "globalized urticaria"/The patient experienced "worsening urticaria, facial swelling, and difficulty breathing".; This spontaneous report was received from a medical assistant, referring a 12-year-old female patient. It was reported that the patient did not have any concurrent conditions, medical history or concomitant medications.  On 14-AUG-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (strength, dose number, dose, route of administration, and anatomical location vaccination were not reported; lot number 1602281 has been verified to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(; expiration date 21-JUL-2019). Also, the patient was vaccinated with a dose of meningococcal ACYW conj vaccine (carrier unspecified) and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (strengths, formulations, dose numbers, doses, routes of administration and indications were not reported for both therapies).  Consequently, on the same day, the patient returned to the clinic the patient experienced " globalized urticarial" therefore received Benadryl 25mg orally (unspecified) and intramuscular decadron 4mg (unspecified). It was reported that the patient experienced worsening urticaria (urticaria), facial swelling (swelling face), and difficulty breathing (dyspnoea) and received epinephrine 0.3 miligram (mg).  On 15-AUG-2019 the patient came back to the clinic because  the urticaria had returned, to sought medical attention. The patient received an epinephrine pen to use as needed, cetirizine, at a dose of 10 milligram orally; ranitidine hel capsule, at a dose of 50 milligram, twice a day, orally,  and montelukast sodium (SINGULAIR). On 16-AUG-2019, the patient was recovered from the events urticaria, swelling face, and dyspnoea. The relatedness between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned events were not provided. The events swelling face, dyspnoea, and urticaria were determined to be medically significant and life threatening events.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV9, MNQ, MNQ, HPVX, MNQ, TDAP
Symptoms: Swelling face, Urticaria
Clinical narrative: The patient returned to the clinic on on 15-AUG-2018, because "the urticaria had returned".; The patient experienced "worsening urticaria, facial swelling, and difficulty breathing"; The patient experienced "worsening urticaria, facial swelling, and difficulty breathing".; The patient returned to the clinic on 14-AUG-2019,, complaining of "globalized urticaria"/The patient experienced "worsening urticaria, facial swelling, and difficulty breathing".; This spontaneous report was received from a medical assistant, referring a 12-year-old female patient. It was reported that the patient did not have any concurrent conditions, medical history or concomitant medications.  On 14-AUG-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (strength, dose number, dose, route of administration, and anatomical location vaccination were not reported; lot number 1602281 has been verified to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(; expiration date 21-JUL-2019). Also, the patient was vaccinated with a dose of meningococcal ACYW conj vaccine (carrier unspecified) and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (strengths, formulations, dose numbers, doses, routes of administration and indications were not reported for both therapies).  Consequently, on the same day, the patient returned to the clinic the patient experienced " globalized urticarial" therefore received Benadryl 25mg orally (unspecified) and intramuscular decadron 4mg (unspecified). It was reported that the patient experienced worsening urticaria (urticaria), facial swelling (swelling face), and difficulty breathing (dyspnoea) and received epinephrine 0.3 miligram (mg).  On 15-AUG-2019 the patient came back to the clinic because  the urticaria had returned, to sought medical attention. The patient received an epinephrine pen to use as needed, cetirizine, at a dose of 10 milligram orally; ranitidine hel capsule, at a dose of 50 milligram, twice a day, orally,  and montelukast sodium (SINGULAIR). On 16-AUG-2019, the patient was recovered from the events urticaria, swelling face, and dyspnoea. The relatedness between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned events were not provided. The events swelling face, dyspnoea, and urticaria were determined to be medically significant and life threatening events.