chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: PT RECEIVED ZOSAVAX AT 12/8/17 AND DEVELOPED ITCHING AND RASHES SINCE 10 DAYS AGO ON NONINJECTION-SITE.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen skin surrounding injection site. Injection site was noticeable, with 2 rings around the site. Lighter red color closest to site then redder color ring surrounding first ring. Redness was very large, a little larger than a baseball.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Pt developed a 3 - 4 inch red ring around her arm about 1 -2 inches below injection site. She came in 2 days after vaccine to show me. It was red and warm to the touch. Pt stated it was getting better and that it was much worse day before.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site joint movement impairment, Loss of personal independence in daily activities, Musculoskeletal pain, X-ray limb
Clinical narrative: Pain in shoulder that has not improved over 2 months later, decreased range of motion of the left arm/shoulder. Difficulties carrying out normal tasks that I use the left arm for.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Gastrointestinal sounds abnormal, Headache, Nervousness
Clinical narrative: Within the hour I felt a shiver, started feeling shaky, my teeth chattered intermittently. I had an extreme headache all over my head and behind my left ear. I had body aches and pain - even in my feet. It hurt to turn over in bed.  My stomach was gurgling. No appetite - could not have tea or coffee - only water. The next day I was able to drink some ginger ale. All I wanted to do was lay down, sleep and sip water. The aches diminished as the days passed. Today, Sunday is the first day I felt well enough to go to pharmacy which is less than a half mile from my house.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Within the hour I felt a shiver, started feeling shaky, my teeth chattered intermittently. I had an extreme headache all over my head and behind my left ear. I had body aches and pain - even in my feet. It hurt to turn over in bed.  My stomach was gurgling. No appetite - could not have tea or coffee - only water. The next day I was able to drink some ginger ale. All I wanted to do was lay down, sleep and sip water. The aches diminished as the days passed. Today, Sunday is the first day I felt well enough to go to pharmacy which is less than a half mile from my house.
Age: 40.0
Sex: M
Vaccine: TTOX
Symptoms: Arthralgia, Muscle atrophy, Myalgia, Pain
Clinical narrative: Joint pain, muscle aches, pain. Deep, aching pain and muscle wasting in the upper arm(s). Elbow, Ligaments, no cartilage, Family Dr & Orthopedic.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Injection site erythema
Clinical narrative: He developed redness to left leg after vaccines. He was also admitted to hospital 2 days later, but that may be unrelated to vaccines.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Erythema, Pyrexia, Swelling
Clinical narrative: Fever, swelling, redness, bruising.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Muscle spasms, Nausea
Clinical narrative: Patient received Tdap booster in AM. Patient reports of acute, sudden onset of nausea, headache and neck spasm. Denies blurred vision, slurred speech, SOB, chest pain. Vitals: BP 108/75, P 78, RR 16. Pt was in offsite clinic at the time of immunization. Clinic activate EMS and pt was transferred to local ER for precaution. Pt recovered.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Hives, rash intermittently for at least 4 days. Rash began (1) day after Flu vaccine given. No other symptoms!
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash and ErythemaMultiform.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Headache, Pyrexia
Clinical narrative: Pt received vaccine on 7/8/16 and afterward experienced severe HA and fever approximately 101.5 for several days, unrelieved with ibuprofen or EXCEDRIN. Non N/V/D or neck stiffness. Hx migraine HAs. Pt called in for advice and was told to take sumatriptan and lie down. This resolved his HA. Pt also came in for arm redness assessment. He was going out of town and was given cephalexin in case of worsening redness to prevent soft tissue infection. Unclear whether he took it.
Age: 66.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Constant pain in shoulder, Limited range of motion.
Age: 66.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Insomnia, Mobility decreased, Pain
Clinical narrative: Constant pain in shoulder, Limited range of motion.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV1
Symptoms: Ear swelling, Rash, Urticaria
Clinical narrative: Rash and hives over mouth, neck chest, belly, diaper area, arms, back. Swollen right ear.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called the pharmacy stating her right arm was red, swollen and sore around the injection site. I referred her to be seen by a physician in the case that it was cellulitis. Patient was seen in the ER with dx of cellulitis and given a 7 day course of doxycycline.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin warm
Clinical narrative: Diffuse rash, warm to the touch surrounding adjacent area of injection.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Itchy feeling in arm, large red circle around injection site, hot to touch, skin is firm.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Developed fever 103+ and whole body rash.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Patient said arm was really red and also back and chest area. Itching very bad. Told patient to continue taking BENADRYL, could use some hydrocortisone, AVEENO oatmeal bath or baking soda bath to soothe. Patient said they might use calamine lotion too. Told him he may need to go to dr for prednisone taper if gets worse.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Extreme swelling, itching, redness, and pain at injection site. Took BENADRYL and acetaminophen for 3 days. Lump at injection site remained approximately a month.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Redness Swelling Warmth all the way around arm. Spoke with patient on Monday and her arm is doing much better. Also on Friday evening she could not raise her arm up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Computerised tomogram normal, Confusional state, Cryptococcus test, Disorientation
Clinical narrative: Patient was encouraged to undergo Serogroup B Meningococcal Vaccination per CDC recommendation following two confirmed cases of Meningitis B at the University. After a week post vaccination characterized by general malaise (chills early, then predominantly tiredness), in the PM of Friday Dec 8 the patient suffered a series of Generalized Tonic-Clonic seizures in her dorm, accompanied by disorientation, confusion and possibly/eventually unconsciousness. Leading to an 9-1-1 call, ambulance transport to local hospital then immediately to the ER, where she was hospitalized in the Dept. of Neurology until discharge 4 days later.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Electroencephalogram abnormal, Encephalitis, Fatigue, Generalised tonic-clonic seizure, Herpes simplex test negative
Clinical narrative: Patient was encouraged to undergo Serogroup B Meningococcal Vaccination per CDC recommendation following two confirmed cases of Meningitis B at the University. After a week post vaccination characterized by general malaise (chills early, then predominantly tiredness), in the PM of Friday Dec 8 the patient suffered a series of Generalized Tonic-Clonic seizures in her dorm, accompanied by disorientation, confusion and possibly/eventually unconsciousness. Leading to an 9-1-1 call, ambulance transport to local hospital then immediately to the ER, where she was hospitalized in the Dept. of Neurology until discharge 4 days later.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Lumbar puncture abnormal, Malaise, Nervous system disorder, Nuclear magnetic resonance imaging normal, Treponema test negative
Clinical narrative: Patient was encouraged to undergo Serogroup B Meningococcal Vaccination per CDC recommendation following two confirmed cases of Meningitis B at the University. After a week post vaccination characterized by general malaise (chills early, then predominantly tiredness), in the PM of Friday Dec 8 the patient suffered a series of Generalized Tonic-Clonic seizures in her dorm, accompanied by disorientation, confusion and possibly/eventually unconsciousness. Leading to an 9-1-1 call, ambulance transport to local hospital then immediately to the ER, where she was hospitalized in the Dept. of Neurology until discharge 4 days later.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Varicella virus test negative
Clinical narrative: Patient was encouraged to undergo Serogroup B Meningococcal Vaccination per CDC recommendation following two confirmed cases of Meningitis B at the University. After a week post vaccination characterized by general malaise (chills early, then predominantly tiredness), in the PM of Friday Dec 8 the patient suffered a series of Generalized Tonic-Clonic seizures in her dorm, accompanied by disorientation, confusion and possibly/eventually unconsciousness. Leading to an 9-1-1 call, ambulance transport to local hospital then immediately to the ER, where she was hospitalized in the Dept. of Neurology until discharge 4 days later.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Eye movement disorder, Syncope
Clinical narrative: THE PATIENT WAS FAINTING WITH HER EYES ROLLING BACK IN HER HEAD. WE AWOKE HER - MADE HER ALERT AND GAVE HER WATER AT FIRST. SHE THEN SAID SHE WANTED A SODA. SHE STARTED GOING OUT AGAIN, AND  GOT A SODA AND SHE DRANK THAT. SHE HAS HAD A HISTORY OF FAINTING AT SIGHT OF NEEDLES. SHE RESTED AND AFTER ABOUT 15 MINUTES LEFT THE STORE.
Age: 0.33
Sex: F
Vaccine: RVX
Symptoms: Haematochezia
Clinical narrative: Bloody stool.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt is reporting arm pain after immunization, is especially worried about higher site (containing FLUZONE HB, PNEUMOVAX 23 was below it), and reported it to pharmacy after reading report on the internet about possible joint damage. Encouraged pt to ice arm for 20 minute intervals and try keep using arm to help work out the stiffness more quickly. Will follow up to see how pt's arm pain is improving. Will encourage a visit with physician if not improving.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Antibody test abnormal, Injection site pain, Injection site reaction, Myositis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Focal area of severe pain and evidence of myositis at injection site. Assessment and Recommendations: Agree with CBC with diff, ESR, CPK, CRP - consider blood cultures (could have SBE with locus minoris resistentiae - seeding of muscle). Consider ortho and/or rheum consult and biopsy of affected muscle region with culture and histology. I reviewed the MRI with the attending radiologist - clearly inflammation in the muscle, differential includes arthrus reaction (type III hypersensitivity -> patients already with high levels of antibody to antigen, get antigen-antibody  complex) and delayed hypersensitivity (Type IV) reaction - infectious etiology unlikely given focal persistence without further muscle body involvement or abscess formation.  These type of reactions seem quite rare, but would be reportable to national database as vaccine complication and also potentially publishable as case report. Myositis of the deltoid has also been reported due to delayed type hypersensitivity and bacterial infection myositis and sterile abscess formation, and calcifying dermatomyositis following tetanus vaccination. Necrotizing fasciitis due to S. aureus has also been reported after vaccination (BCG & varicella, though not with influenza that I can see). Generalized polymyositis has also been associated in one reported case with hepatitis B immunization.   Texted Dr. Bittleman to make him aware of recommendations. Contact me with  questions: Office x2585, Pager 858-347-1666, Cell 858-504-1517.  David J. Looney, MD #A05925 Pager: 347-1666
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Focal area of severe pain and evidence of myositis at injection site. Assessment and Recommendations: Agree with CBC with diff, ESR, CPK, CRP - consider blood cultures (could have SBE with locus minoris resistentiae - seeding of muscle). Consider ortho and/or rheum consult and biopsy of affected muscle region with culture and histology. I reviewed the MRI with the attending radiologist - clearly inflammation in the muscle, differential includes arthrus reaction (type III hypersensitivity -> patients already with high levels of antibody to antigen, get antigen-antibody  complex) and delayed hypersensitivity (Type IV) reaction - infectious etiology unlikely given focal persistence without further muscle body involvement or abscess formation.  These type of reactions seem quite rare, but would be reportable to national database as vaccine complication and also potentially publishable as case report. Myositis of the deltoid has also been reported due to delayed type hypersensitivity and bacterial infection myositis and sterile abscess formation, and calcifying dermatomyositis following tetanus vaccination. Necrotizing fasciitis due to S. aureus has also been reported after vaccination (BCG & varicella, though not with influenza that I can see). Generalized polymyositis has also been associated in one reported case with hepatitis B immunization.   Texted Dr. Bittleman to make him aware of recommendations. Contact me with  questions: Office x2585, Pager 858-347-1666, Cell 858-504-1517.  David J. Looney, MD #A05925 Pager: 347-1666
Age: 45.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Eyelid ptosis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of ptosis in a 45-year-old male patient who received FLUARIX QUADRIVALENT (batch number 3L9FJ, expiry date unknown). Co-suspect products included MENVEO (batch number M16123, expiry date unknown). Concurrent medical conditions included drug allergy. Concomitant products included Albuterol Sulfate, Allopurinol, CRESTOR, Vitamin D3, ZYRTEC, LEVSIN and lisinopril. On 18th December 2017, the patient received FLUARIX QUADRIVALENT .5 ml and MENVEO .5 ML. On 20th December 2017, 2 days after receiving FLUARIX QUADRIVALENT and MENVEO, the patient experienced ptosis (serious criteria other: as per reporter). On an unknown date, the outcome of the ptosis was not recovered/not resolved. It was unknown if the reporter considered the ptosis to be related to FLUARIX QUADRIVALENT and MENVEO. Additional details were reported as follows: The patient received FLUARIX QUADRIVALENT in right deltoid and MENVEO in left deltoid. The patient developed ptosis in the right eye and went to the doctor's office on 22nd December 2017. The patient saw both an optometrist and an ophthalmologist and the latter ordered laboratory tests and a magnetic resonance imaging for Friday of the reporting week. The reported lot number (3L9FG) for FLUARIX QUADRIVALENT did not exist and was updated to 3L9FJ, according to the sales database.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Shoulder pain constantly, 2 months after injection and decreased range of motion. It hurts to move my right arm, it started the day I got the flu vaccine. I think it was given too high, right into my shoulder joint instead of the muscle.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Facial paralysis, Headache, Herpes zoster, Herpes zoster oticus
Clinical narrative: As a condition of my employment every new employee is required to get a Influenza shot before they can start work. Well. I this is what I thought I got until I was diagnosed with Shingles in the ear in Dec. 2017. Up to this point, about two weeks to 30 days I got a rash on my stomach. I thought maybe it was something I was allergic to so I just bought antifungal cream from the store. The second rash about maybe two a month later showed up on my chest below my collar bone but above my chest. This lasted a while and then the third rash sometime in Sept. 2017 on the back of my neck around my hair line. When I look at my chart it shows that I had a varicella zoster vaccination instead of a influenza vaccination. So now it is all adding up. Just looking back on the symptoms; rashes, dizzy spells, headaches, and muscle aches I can conclude that I've had Shingles for some time now. It just progressed until it ended. The second vaccination I got in Nov. I'm not sure if that was the wrong vaccination or not. I have requested my records. Well, due to having Shingles, the pain and inflammation my nerves on my right side of my face are paralyzed. I believe I am sick because I was administered the wrong vaccination., I was not scheduled to have a varicella zoster shot it was supposed to be the influenza shot. Considering I've never had chicken pox before this shot should not have been administered without my consent. I was told I was getting an influenza. Now I'm not feeling well and my face on one side does not work because I was given the wrong vaccination in error.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Laboratory test normal, Malaise, Myalgia, Pain
Clinical narrative: As a condition of my employment every new employee is required to get a Influenza shot before they can start work. Well. I this is what I thought I got until I was diagnosed with Shingles in the ear in Dec. 2017. Up to this point, about two weeks to 30 days I got a rash on my stomach. I thought maybe it was something I was allergic to so I just bought antifungal cream from the store. The second rash about maybe two a month later showed up on my chest below my collar bone but above my chest. This lasted a while and then the third rash sometime in Sept. 2017 on the back of my neck around my hair line. When I look at my chart it shows that I had a varicella zoster vaccination instead of a influenza vaccination. So now it is all adding up. Just looking back on the symptoms; rashes, dizzy spells, headaches, and muscle aches I can conclude that I've had Shingles for some time now. It just progressed until it ended. The second vaccination I got in Nov. I'm not sure if that was the wrong vaccination or not. I have requested my records. Well, due to having Shingles, the pain and inflammation my nerves on my right side of my face are paralyzed. I believe I am sick because I was administered the wrong vaccination., I was not scheduled to have a varicella zoster shot it was supposed to be the influenza shot. Considering I've never had chicken pox before this shot should not have been administered without my consent. I was told I was getting an influenza. Now I'm not feeling well and my face on one side does not work because I was given the wrong vaccination in error.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Wrong drug administered
Clinical narrative: As a condition of my employment every new employee is required to get a Influenza shot before they can start work. Well. I this is what I thought I got until I was diagnosed with Shingles in the ear in Dec. 2017. Up to this point, about two weeks to 30 days I got a rash on my stomach. I thought maybe it was something I was allergic to so I just bought antifungal cream from the store. The second rash about maybe two a month later showed up on my chest below my collar bone but above my chest. This lasted a while and then the third rash sometime in Sept. 2017 on the back of my neck around my hair line. When I look at my chart it shows that I had a varicella zoster vaccination instead of a influenza vaccination. So now it is all adding up. Just looking back on the symptoms; rashes, dizzy spells, headaches, and muscle aches I can conclude that I've had Shingles for some time now. It just progressed until it ended. The second vaccination I got in Nov. I'm not sure if that was the wrong vaccination or not. I have requested my records. Well, due to having Shingles, the pain and inflammation my nerves on my right side of my face are paralyzed. I believe I am sick because I was administered the wrong vaccination., I was not scheduled to have a varicella zoster shot it was supposed to be the influenza shot. Considering I've never had chicken pox before this shot should not have been administered without my consent. I was told I was getting an influenza. Now I'm not feeling well and my face on one side does not work because I was given the wrong vaccination in error.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, referring to an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-SEP-2017, the patient was administered VAQTA 25/0.5 injection, for prophylaxis. Lot number was N012324 and expiration date 05-APR-2018 (route of administration and anatomical location were not provided). The reporter stated that on the day of the vaccination, the patient received two pediatric doses of VAQTA and that no adverse effects were reported after the administration.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from medical assistant concerning to a 4 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 30-NOV-2017, the patient was vaccinated with one improperly stored dose of VARIVAX from lot number reported as N201582 with expiration date 09-AUG-2019, or lot number N014632 with expiration date 11-MAY-2019, or lot number N019131 with expiration date 22-JUN-2019, or lot number N019839 with expiration date 13-JUL-2019, or lot number reported as N019397 with expiration date 07-JUN-2019, or lot number N021317 with expiration date 07-AUG-2019 (route of administration and anatomical location were not provided); for prophylaxis. The VARIVAX was reconstituted with properly stored sterile diluent (MERCK) (lot # and expiration date were unknown). There was no previous temperature excursion and the data logger was no involved. The vaccines were exposed to temperatures between 47 F (Fahrenheit) to 77 F (Fahrenheit) during 10 hours and 18 minutes. No adverse effects were reported. Lot number N201582 is an invalid lot number for varicella virus vaccine live (oka/merck). Lot number N019397 is an invalid lot number for varicella virus vaccine live (oka/merck).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-NOV-2017, the patient was inadvertently vaccinated with VARIVAX (dose, route of administration, lot number and expiration date were not reported) instead of ZOSTAVAX for prophylaxis. At the time of this report, no adverse effects were reported in the patient.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Biopsy skin, Blister, Herpes zoster, Papule, Rash
Clinical narrative: Information has been received from the patient's mother, concerning a 6 year old male patient. The patient's concurrent condition and concomitant medications were not provided and there was reported that the patient did not experienced chickenpox, herpes zoster or herpes zoster ophthalmic as a medical history. The patient had recent exposure to chickenpox from another patient case (MARRS #1712USA014554). On 29-NOV-2012, the patient was vaccinated with two separates doses of VARIVAX (dose, frequency, route of administration, lot number and expiration date were not provided) for prevent chicken pox.  Furthermore, the patient was also vaccinated on 17-NOV-2016 with PROQUAD (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. On 28-NOV-2017 (also reported as 29-NOV-2017), the patient developed a rash on one side of his body, left upper torso wrapping to under arm 5-6 varicose clostridium and 2 individuals spots on right side after diagnosis. On 29-NOV-2017, the patient was taken to a doctor and was diagnosed with shingles. A sample was collected on 05-DEC-2017 and showed skin vesicle lesion, papule, rubbed skin cells from rash area. The outcome of shingles was reported as still has rash (not recovered). The causal relationship between the adverse events and the therapies was not assessed. This is one of two report received from the same reporter. ; Sender's Comments: US-009507513-1712USA014554:
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a healthcare worker concerning 2 adult patients of unknown genders. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, both patients were vaccinated with PNEUMOVAX 23 lot # N022650 and expiration date of 01-MAR-2019 for prophylaxis (dose and route of administration were not reported). On unknown dates, patients experienced reactions (adverse reaction) to PNEUMOVAX 23. The outcome of the event adverse reaction and the causal relationship between the event and therapy with PNEUMOVAX 23 were not reported. The reporter wanted to inquire that there were no issues with the lot that was reported.
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant referring to a currently 71 year old female patient. The patient had no relevant medical history or concomitant medications. Information about concurrent condition was not reported. On an unknown date (reported as "April"), the patient was vaccinated with PNEUMOVAX 23 (lot# M036728, expiration date: 20-MAY-2018; dose, route were not reported) for prophylaxis. Other suspect therapies included PREVNAR 13 (dose, frequency, route , lot # and expiration date were not reported) for prophylaxis. On 14-DEC-2017, the patient came into the office again. When they looked at her chart, they were not able to tell if she had gotten the PNEUMOVAX 23 that was ordered or if she received PREVNAR 13 inadvertently (Wrong drug administered). It was unknown if there was relevant lab work. As of 14-DEC-2017, it's unknown if the patient would receive PNEUMOVAX 23 again and the outcome of possibly getting PREVNAR 13 inadvertently was unknown.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV9, TDAP
Symptoms: Urticaria
Clinical narrative: Urticarial facial rash on 12/11/17 at about 4 pm. Patient given BENADRYL, rash returned 4 hours later. Patient taken to ER given BENADRYL and Prednisolone. Rash. Last knew rash was 12/10/17 at 10 pm. Pt seen and examined in office, recommended ZYRTEC and continue Prednisolone for a total of 5 days.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Initial insomnia, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Entire right arm hurts to the point that it's hard to fall asleep. It's hard to lift it up. It slows me down from carrying out my daily activities. It aches and sometimes I feel a burning sensation. I used blue ice analgesic on it but it didn't work.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, MNQ, TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and parasthesia to left hand and forearm for less than 3 days.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Crepitations, Injection site pain, Pain
Clinical narrative: Patient states that he has pain in his left upper arm since receiving the vaccine at the Employee Health Clinic. He did not report this until 12-21-2017. Pt. presents to clinic stating that his left upper arm has hurt ever since he received the flu shot in October. Date of influenza vaccine was 10/26/2017 in the afternoon. He was also in a cast for a fractured wrist prior to this and undergoing PT while complaining of the pain in his left deltoid area. He states that he has sharp pain in the deltoid muscle area of the left arm with range of motion and also especially with abduction of upper extremity and supination of forearm/wrist. Has good radial/ulnar pulses on left, no palpable masses or tenderness of deltoid muscle on left. FROM of left upper extremity but is painful to patient. Some crepitus palpated with abduction to 90 degrees. States that he has been doing band exercises in PT with arms flexed at elbow at 90 degrees and extension laterally which may also be causing some inflammation to area.
Age: 35.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Altered state of consciousness, Feeling hot, Malaise
Clinical narrative: Patient given Hep A shot in left deltoid, patient and this RN were discussing the schedule for the Oral Typhoid and weather the patient wanted to get her Hep B shot as well when patient stated she was feeling hot and not well, patient stated that she felt like she would pass out, this RN asked if she needed to lay down in a room with a bed, patient stated she would just lay on the floor of the RN's clinic room where patient went from sitting in the chair to laying on the floor, patient's mother was asked to watch patient for a moment while this RN got the vitals machine, cold pack and another RN to assist. Blood pressure 13:57 78/56, HR 48, patient's legs were elevated to assist in bringing up Blood pressure, cold compress was placed on patient's forehead, patient never lost consciousness and was able to answer the RN appropriately. Vitals were taken again at 16:08 B/P 105/65, HR 72, patient stated she was feeling better and then sat up in the chair with the assistance of the RN's, patient stated she was feeling much better and that she would like to take her Hep B shot. This RN asked if she was sure that she wanted to and that if she did then we would take precautions and lay her down in another room in the event she started feeling the same way again. Hepatitis B shot was given with no reactions.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a non dialysis patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 19-DEC-2017, the patient was inadvertently vaccinated with a dialysis dose of RECOMBIVAX HB (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. No causality assessment was provided by the reporter.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-DEC-2017, the patient was inadvertently vaccinated with a dose of ZOSTAVAX, lot# N020943 and expiration date: 26-OCT-2018 (dose and route of administration were not reported). There were no adverse effects reported.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Dime sized red area on L thigh at site of imm. firm to touch not painful. Afebrile.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal distension, Constipation, Crying, Influenza, Influenza B virus test positive
Clinical narrative: Received vaccines on 12/14/17. The case had 2 bowel movements on 12/15/17 and then did not have a bowel movement  for the next  6 days. Mother reports that the baby is breast fed and normally has 4-5 stools per day. The baby became distended and cried when abdomen was touched. Mother did not report any vomiting. The baby resumed  having bowel movements on 12/22/17.The baby did not receive any special treatment for the decrease in stool. Mother did not note blood in the stool after he resumed having bowel movements. Symptoms disappeared.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: Severe soreness from the elbow to the shoulder, even to the back of the arm. I could not lift more than 6 inches or so from my body. Dressing and sleeping were difficult. Bruising at shot site. 4 days later and I am better but upper arm still sore for lifting arm over the head.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Injection site pain
Clinical narrative: Pain in upper left arm has continued and has become increasingly more uncomfortable. It feels as if the shot somehow damaged something in my arm.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, RVX
Symptoms: Dystonia, Electroencephalogram, Lethargy, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Seizure like activity, dystonia like activity, fever, lethargic, visually not responsive x 4 days.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, RVX
Symptoms: Pyrexia, Seizure like phenomena, Unresponsive to stimuli, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Seizure like activity, dystonia like activity, fever, lethargic, visually not responsive x 4 days.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Arthralgia, Blood thyroid stimulating hormone normal, C-reactive protein normal, Dizziness
Clinical narrative: 4 days following the vaccine patient had developed headache, abdominal pain, knee and ankle pain without swelling, lightheadedness, fatigue and blurred vision which lasted several since. Since, the patient has had same sx every 2-4 weeks. Also hair seems more brittle and curly. Once with ~ 2hours of hives. No other rashes.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Full blood count normal, Hair texture abnormal, Headache, Red blood cell sedimentation rate normal
Clinical narrative: 4 days following the vaccine patient had developed headache, abdominal pain, knee and ankle pain without swelling, lightheadedness, fatigue and blurred vision which lasted several since. Since, the patient has had same sx every 2-4 weeks. Also hair seems more brittle and curly. Once with ~ 2hours of hives. No other rashes.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Serum ferritin decreased, Trichorrhexis, Urticaria, Vision blurred, Vitamin B12 normal
Clinical narrative: 4 days following the vaccine patient had developed headache, abdominal pain, knee and ankle pain without swelling, lightheadedness, fatigue and blurred vision which lasted several since. Since, the patient has had same sx every 2-4 weeks. Also hair seems more brittle and curly. Once with ~ 2hours of hives. No other rashes.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Vitamin D
Clinical narrative: 4 days following the vaccine patient had developed headache, abdominal pain, knee and ankle pain without swelling, lightheadedness, fatigue and blurred vision which lasted several since. Since, the patient has had same sx every 2-4 weeks. Also hair seems more brittle and curly. Once with ~ 2hours of hives. No other rashes.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Left arm was red, tender, warm to touch with 1.5inch by 2.5 inch reddened and swollen area.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Left shoulder very painful, swollen, red, sore shoulder joint for over one week, stiff. Hard to sleep on left shoulder for one week. I talked to my pharmacist about my reaction she told me pneumococcal conjugate vaccine (PCV13) is only given every 5 years. My Dr. gave me the same injection 6-14-16. Just because I have seasonal asthma Dr. said I need this every year. Please look into this injection and actually how often is it required. The office staff injected too close to my shoulder joint.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Sleep disorder
Clinical narrative: Left shoulder very painful, swollen, red, sore shoulder joint for over one week, stiff. Hard to sleep on left shoulder for one week. I talked to my pharmacist about my reaction she told me pneumococcal conjugate vaccine (PCV13) is only given every 5 years. My Dr. gave me the same injection 6-14-16. Just because I have seasonal asthma Dr. said I need this every year. Please look into this injection and actually how often is it required. The office staff injected too close to my shoulder joint.
Age: 58.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swollen big as baseball ball redness stay that way for 5 days and hurts when arm was used. Some of information don't know as my doctor at clinic.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: C/O left upper arm swelling, itching, painful, red, at injection site given on 12/20/2017 increased swelling today.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Left upper arm muscle has been hurting for 2 months when it is moved in very specific ways (taking off a sweater, etc.). I was waiting for it to wear off but it hasn't. This is the first time in 10 plus years of flu shots that the pain has lingered.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Dysphonia, Dyspnoea, Headache, Influenza virus test negative
Clinical narrative: I got this shot about 10;00 am and by 5:00 pm started having bad aching in left arm. Also bad headache in back right side of head. as the evening progressed I had body aches, sore throat, scratchy voice and lungs feeling like they were tight and harder to breath. Next day I started coughing a hard tight cough. If I had a fever it was slight. I also experience stiff sore neck mussels. These symptoms lasted for the best part of four days at which time I returned to the doctor to see what went wrong. He thought most of it was a coincidental viral infection. The worst part was the headache that lasted for 4 days. Tylenol helped reduce the ache but not completely.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Lung disorder, Musculoskeletal stiffness, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: I got this shot about 10;00 am and by 5:00 pm started having bad aching in left arm. Also bad headache in back right side of head. as the evening progressed I had body aches, sore throat, scratchy voice and lungs feeling like they were tight and harder to breath. Next day I started coughing a hard tight cough. If I had a fever it was slight. I also experience stiff sore neck mussels. These symptoms lasted for the best part of four days at which time I returned to the doctor to see what went wrong. He thought most of it was a coincidental viral infection. The worst part was the headache that lasted for 4 days. Tylenol helped reduce the ache but not completely.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I got this shot about 10;00 am and by 5:00 pm started having bad aching in left arm. Also bad headache in back right side of head. as the evening progressed I had body aches, sore throat, scratchy voice and lungs feeling like they were tight and harder to breath. Next day I started coughing a hard tight cough. If I had a fever it was slight. I also experience stiff sore neck mussels. These symptoms lasted for the best part of four days at which time I returned to the doctor to see what went wrong. He thought most of it was a coincidental viral infection. The worst part was the headache that lasted for 4 days. Tylenol helped reduce the ache but not completely.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Injection site swelling, Pain, Puncture site pain
Clinical narrative: Donor received Tetanus vaccine 12/29/17 at 1600 the next morning at 12/30/17 at approx. 0830 donor noticed left arm had become swollen, tender and pain at the puncture site. Donor states later that night 12/30/17 he developed chills, low grade fever and body aches. Donor denies seeking care for symptoms just rested and symptoms resolved. Upon examination of donors arm today 1/2/18 left bicep moderately swollen BP 118/82 Pulse 78 Temp 98.2.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Puncture site swelling, Pyrexia
Clinical narrative: Donor received Tetanus vaccine 12/29/17 at 1600 the next morning at 12/30/17 at approx. 0830 donor noticed left arm had become swollen, tender and pain at the puncture site. Donor states later that night 12/30/17 he developed chills, low grade fever and body aches. Donor denies seeking care for symptoms just rested and symptoms resolved. Upon examination of donors arm today 1/2/18 left bicep moderately swollen BP 118/82 Pulse 78 Temp 98.2.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash macular, Rash pruritic
Clinical narrative: Pruritic rash developed 30 min after vaccination, scattered macular rash on neck, trunk, and back area. 5mls of BENADRYL given to patient at the office. Itchiness and rash improved in 15min. Patient and mother left office without anaphylactic reactions. Mother was advised to bring patient back to the office if symptom worsened.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness
Clinical narrative: On 01/02/2018 the patient reported loss of vision after leaving the pharmacy after receiving a high-dose flu vaccine on 12/8/17. Her and her husband went to gamble then left because she couldn't see. They arrived at their home roughly 90-120 minutes after receiving the vaccine and by that time her vision had fully returned. She has had no further problems with her vision since the date of the vaccine.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PNEUMOVAX 23 inj. in left upper arm; 4-6 hrs. later severe swelling, site warm and light red; "hard" muscle to touch and pain in upper arm. Symptoms were still present 12/23 with swelling of entire upper left arm/warmth/light red. 12/24/17 still pain at inj. site and inner upper arm still swollen.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Gave patient PNEUMOVAX 23 shot IM in right deltoid
Sex: M
Vaccine: HEPA
Symptoms: Allergy to metals, Biopsy skin abnormal, Dermatitis, Dry skin, Injection site dermatitis
Clinical narrative: This literature marketed report was received from the authors of the published article. A 4-year-old boy presented with a 1-month history of three soft, pruritic, subcutaneous, 1-cm mobile nodules on the anterior left and right thighs with overlying hypopigmentation, excoriated dermatitis, and moderate xerosis. The patient had a history of persistent cervical lymphadenopathy of the right anterior and lateral neck, eczema on the flanks and upper buttock, and keratosis pilaris on the posterior bilateral arms. Viral studies were unremarkable except for detectible immunoglobulin G antibodies to EpsteinBarr virus indicating a previous infection. The patient's family first observed the nodules after he had received a hepatitis A vaccine (manufacturer unknown) in the left thigh 1 month before. The patient received six vaccinations: three doses of the diphtheria, tetanus, pertussis, polio vaccine  Haemophilus influenzae type b conjugate vaccine and three doses of the pneumococcal vaccine. There was no record of where on the patient these vaccines were administered. His scheduled vaccination program was continued after he and his family moved. A punch biopsy of a nodule on the left anterior thigh was performed for histopathologic examination. A punch biopsy specimen demonstrated lobular panniculitis with a dense infiltrate composed of lymphocytes, histiocytes, plasma cells, numerous eosinophils, and clusters of dendritic Langerhans cells. Stains for microorganisms were unrevealing. The patient underwent patch testing and at 96 hours had a 2+ positive reaction to 2.0% aluminum chloride hexahydrate. In the months after, the patient developed diffuse hypopigmented patches on his trunk and overlying the thigh nodules. The patient was diagnosed with aluminum hypersensitivity. The outcome of events was unknown. The authors considered the events to be related to aluminium salts used as adjuvants in vaccines, including hepatitis A vaccine (manufacturer unknown).
Sex: M
Vaccine: HEPA
Symptoms: Injection site discolouration, Injection site erosion, Injection site nodule, Injection site pruritus, Injection site reaction
Clinical narrative: This literature marketed report was received from the authors of the published article. A 4-year-old boy presented with a 1-month history of three soft, pruritic, subcutaneous, 1-cm mobile nodules on the anterior left and right thighs with overlying hypopigmentation, excoriated dermatitis, and moderate xerosis. The patient had a history of persistent cervical lymphadenopathy of the right anterior and lateral neck, eczema on the flanks and upper buttock, and keratosis pilaris on the posterior bilateral arms. Viral studies were unremarkable except for detectible immunoglobulin G antibodies to EpsteinBarr virus indicating a previous infection. The patient's family first observed the nodules after he had received a hepatitis A vaccine (manufacturer unknown) in the left thigh 1 month before. The patient received six vaccinations: three doses of the diphtheria, tetanus, pertussis, polio vaccine  Haemophilus influenzae type b conjugate vaccine and three doses of the pneumococcal vaccine. There was no record of where on the patient these vaccines were administered. His scheduled vaccination program was continued after he and his family moved. A punch biopsy of a nodule on the left anterior thigh was performed for histopathologic examination. A punch biopsy specimen demonstrated lobular panniculitis with a dense infiltrate composed of lymphocytes, histiocytes, plasma cells, numerous eosinophils, and clusters of dendritic Langerhans cells. Stains for microorganisms were unrevealing. The patient underwent patch testing and at 96 hours had a 2+ positive reaction to 2.0% aluminum chloride hexahydrate. In the months after, the patient developed diffuse hypopigmented patches on his trunk and overlying the thigh nodules. The patient was diagnosed with aluminum hypersensitivity. The outcome of events was unknown. The authors considered the events to be related to aluminium salts used as adjuvants in vaccines, including hepatitis A vaccine (manufacturer unknown).