chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Influenza like illness, Injection site erythema, Pain
Clinical narrative: Pt was given PREVNAR 13 on 01/25/19 at about almost 1:00 pm. After the injection, pharmacist put ice pack on the site to prevent pain as usual for any patient. Pt complained about the pain and headache but it was not severe. Pt stayed at the pharmacy for avoer 30 minutes for pharmacist to observe and advised that pt should take some Tylenol or Advil. on 01/30/19, pt called back and complained about the pain continue, after 2 days of vaccination, he found the redness above the injection site, feeling fatigue, chills, pain in the joints, He also stated that he lost his appetite, only want to eat sour fruit, feeling like having flu. He reported that the pain went down  a bit compare to few days ago. (7 now  versus 10 before). Pharmacist contacted the manufacture Pfizer to report the issue. Pharmacist also advised patient to use ice pack, take NSAIDS and followed up with his PCP. However, pt.'s PCP office is closed today so pharmacist will follow up tomorrow. Pt is currently traveling out of state, pharmacist advised patient  to seek medical help if he feel uncomfortable.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Decreased appetite, Pain in extremity, Peripheral swelling
Clinical narrative: Pt was given PREVNAR 13 on 01/25/19 at about almost 1:00 pm. After the injection, pharmacist put ice pack on the site to prevent pain as usual for any patient. Pt complained about the pain and headache but it was not severe. Pt stayed at the pharmacy for avoer 30 minutes for pharmacist to observe and advised that pt should take some Tylenol or Advil. on 01/30/19, pt called back and complained about the pain continue, after 2 days of vaccination, he found the redness above the injection site, feeling fatigue, chills, pain in the joints, He also stated that he lost his appetite, only want to eat sour fruit, feeling like having flu. He reported that the pain went down  a bit compare to few days ago. (7 now  versus 10 before). Pharmacist contacted the manufacture Pfizer to report the issue. Pharmacist also advised patient to use ice pack, take NSAIDS and followed up with his PCP. However, pt.'s PCP office is closed today so pharmacist will follow up tomorrow. Pt is currently traveling out of state, pharmacist advised patient  to seek medical help if he feel uncomfortable.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient had a spike in blood pressure (per Epic BP was at 153/84 at ED) starting the next early morning after receiving vaccine as well as fever (100.6 F at ED). She went to ED for these symptoms and nausea, myalgia and headache.Provider that she saw was unable to find any other reason other than possibly the vaccine. Patient was not admitted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pyrexia
Clinical narrative: Patient states she felt very dizzy and could not lay down at night after receiving SHINGRIX vaccination in the morning. Patient also experienced fever.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Fatigue, Migraine, Muscle tightness
Clinical narrative: At first I got chilled to the bone. I had on layers of clothing and blankets, sitting in front of a fire - the indoor air temp was 71 degrees F - I was shivering uncontrollably. This lasted several hours. During that time I got a migraine (I have a history of these, so I don't know if it was related to the vaccination) - I took rizatriptan (10 mg) in response. Then there was severe nausea, achy body and fatigue. I took ZOFRAN, to prevent vomiting. The severe nausea lasted throughout the first day - it became a dull nausea, not so urgent, the second day. The achy body and fatigue lasted for 2 days. During the second day I had a tight sensation on both sides of my abdomen, up near the ribs, as if there was a tight band around me and it was pressing hard in those areas. This sensation moved down my abdomen as the day progressed, until it reached my lower abdomen. On the third day I was fine. On the fourth day I had severe nausea again. I took ZOFRAN- that cleared it up and the rest of the day I was fine. No symptoms since.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: At first I got chilled to the bone. I had on layers of clothing and blankets, sitting in front of a fire - the indoor air temp was 71 degrees F - I was shivering uncontrollably. This lasted several hours. During that time I got a migraine (I have a history of these, so I don't know if it was related to the vaccination) - I took rizatriptan (10 mg) in response. Then there was severe nausea, achy body and fatigue. I took ZOFRAN, to prevent vomiting. The severe nausea lasted throughout the first day - it became a dull nausea, not so urgent, the second day. The achy body and fatigue lasted for 2 days. During the second day I had a tight sensation on both sides of my abdomen, up near the ribs, as if there was a tight band around me and it was pressing hard in those areas. This sensation moved down my abdomen as the day progressed, until it reached my lower abdomen. On the third day I was fine. On the fourth day I had severe nausea again. I took ZOFRAN- that cleared it up and the rest of the day I was fine. No symptoms since.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Neck pain, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging heart, Ophthalmological examination normal
Clinical narrative: Patient had dizziness and severe pain in arm and neck that was radiating down spine. This started a few hours after her vaccine which occurred in the evening. She said she couldn't move and felt paralyzed. She says she guesses she fell asleep and did not wake up for like 12 hours. She said the pain continued and blurriness was in her eyes for like 4 days, She went to her doctor and he did an MRI and MRA. She had an eye exam. All were clear. She states she still has some arm soreness.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paralysis, Spinal pain, Vision blurred
Clinical narrative: Patient had dizziness and severe pain in arm and neck that was radiating down spine. This started a few hours after her vaccine which occurred in the evening. She said she couldn't move and felt paralyzed. She says she guesses she fell asleep and did not wake up for like 12 hours. She said the pain continued and blurriness was in her eyes for like 4 days, She went to her doctor and he did an MRI and MRA. She had an eye exam. All were clear. She states she still has some arm soreness.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Child sitting in IZ chair. Mother with child throughout visit. After giving Flu shot child bent over in chair and appeared to lose consciousness for approx. 5-10 seconds. No injury. Child recovered quickly and was answering questions and talking. Child appeared pale for approx. 1 minute. Legs elevated. Child stayed in Clinic with mother for approximately 1/2 hour. Upon leaving Clinic, child stated she felt fine.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Disturbance in attention, Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 4-5" area around injection site developed: swelling, redness and heat. Patient felt "fuzzy and out of it" with "difficulty focusing".
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: The patient had arm pain in the shoulder and still does. Has had cortisone shots that alleviate the pain but the pain comes back. This developed following the first shot of the SHINGRIX series.  Pharmacy notified of this 1/30/2019.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: "2 days of my arm feeling hot and like it had taken a few hard slugs" "upper arm  still has a reddish hive splotches and is somewhat swollen".
Age: 19.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after getting the TDAP and HPV vaccines. She came to very quickly and was checked by a provider before leaving the clinic. Vitals were stable and patient was given juice and crackers.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Hypersomnia, Influenza like illness
Clinical narrative: I experienced flu-like symptoms that began around 6 pm day of shot and lasted throughout the night and into the next day. Had headache, chills, back pain and ended up sleeping over 12 hours.  I don't know if I had a fever as I did not have a thermometer.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, soreness starting about day after and lasting about 4 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Cough, Dyspnoea, Headache, Injection site erythema
Clinical narrative: Acute Pain, swelling and redness/rash  at injection site. Acute pain lasted 48 hrs, rash and redness with itching are ongoing; moderate body aches, tingling in arms and legs; headache  lasting  48 hrs, chest pains, cough, shortness of breath, sore throat, runny nose. Body ache, cough and sore throat are ongoing as of today. No treatment yet. I am considering seeing my doctor if the rash does not resolve.  I am not planning to have the second shot/booster.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Oropharyngeal pain
Clinical narrative: Acute Pain, swelling and redness/rash  at injection site. Acute pain lasted 48 hrs, rash and redness with itching are ongoing; moderate body aches, tingling in arms and legs; headache  lasting  48 hrs, chest pains, cough, shortness of breath, sore throat, runny nose. Body ache, cough and sore throat are ongoing as of today. No treatment yet. I am considering seeing my doctor if the rash does not resolve.  I am not planning to have the second shot/booster.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Rhinorrhoea
Clinical narrative: Acute Pain, swelling and redness/rash  at injection site. Acute pain lasted 48 hrs, rash and redness with itching are ongoing; moderate body aches, tingling in arms and legs; headache  lasting  48 hrs, chest pains, cough, shortness of breath, sore throat, runny nose. Body ache, cough and sore throat are ongoing as of today. No treatment yet. I am considering seeing my doctor if the rash does not resolve.  I am not planning to have the second shot/booster.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Saturday evening on right side between eye and nose, above eye, on forehead and in scalp started red and itchy used topical diphenhydamine the next morning the redness had become blistery. Started acyclovir Tuesday 1/29/19.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Low-grade fever, fatigue, malaise, general body aches.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal disorder, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Injection site extremely high on arm right below shoulder bone that comes out from clavicle. Injection time after insertion of needle was very long, about 10 seconds. Within an hour extreme pain, unable to use arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Feeling hot, Headache
Clinical narrative: At first very sore arm, painful at site and can't lift without pain. Then the next morning, I felt flulike symptoms like chills, then hot, achy all over and later in day, headache. Also, stomach feels weird, not much appetite. I just feel like I am getting the flu. Fever was 99.9 F.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: At first very sore arm, painful at site and can't lift without pain. Then the next morning, I felt flulike symptoms like chills, then hot, achy all over and later in day, headache. Also, stomach feels weird, not much appetite. I just feel like I am getting the flu. Fever was 99.9 F.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test, Henoch-Schonlein purpura, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: My daughter had a reaction after all these shots given at her 12 months. She had a high fever after 103. Then severely broke out in red bumps all over body and began vomiting. She was diagnosed with Henoch-Schonlein Purpura once taken to her Pediatrician and got blood work.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: My daughter had a reaction after all these shots given at her 12 months. She had a high fever after 103. Then severely broke out in red bumps all over body and began vomiting. She was diagnosed with Henoch-Schonlein Purpura once taken to her Pediatrician and got blood work.
Age: 36.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Developed rash/redness at injection site. Went to Urgent Care, was given BENADRYL 25MG and released. We are unable to obtain further information from her.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Infection, Lymphadenopathy, Pyrexia
Clinical narrative: Pt report: discomfort in chest/breathing at time of injection, 2 days later fever, swollen lymph nodes in multiple areas. Pt states MD diagnosed as secondary infection since issues are occurring in right side of body. Currently treated by AUGMENTIN.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: Patient received second RZV dose 1/7/19 at approx. 2pm. Patient called the next day to report the following: Patient with possible shingles injection reaction from yesterday. He had a really bad headache last pm getting slowly better today. Still rates h/a a 6. He is sweating and his arm is sore. His stomach is upset but no vomiting. He has no appetite and he doesn't feel like doing anything but lay on the couch. I will send this note for PCP for recs.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Headache, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Patient received RZV and seasonal influenza vaccine on 1-9-19. Patient called the following morning and reported the following: Patient called to report nausea and headache this AM. He had a shingles injection yesterday. His arm is slight warm and red at the site. He will take TYLENOL for his headache, ice to his arm and report any worsening symptoms, concerns or seek care.
Age: 74.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient with possible reaction to Shingles/tetanus injection left arm last week. States arm is sore/painful/very little redness but now pain goes down to left hand that is slightly swollen. He states entire arm is very sore and sore to move. Dr. notified and patient instructed to use ice and TYLENOL prn and call/ seek care with worsening of symptoms or no improvement 3-5 days. He will call back with problems/concerns.
Age: 3.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Ear infection, Febrile convulsion, Pyrexia
Clinical narrative: Per telephone call from Mom to pediatrician office on 10/27/18--Patient had a fever of 103 yesterday afternoon and he did end up having a febrile seizure. He was taken by ambulance to hospital where he was diagnosed with a simple febrile seizure. Today patient is afebrile and no more seizures. Mom is giving ibuprofen q 6 hours and TYLENOL prn if fever breaks through while on ibuprofen. Patient did have the start of an ear infx so he is on antibiotics now. Mom concerned because patient's brother had a febrile seizure yesterday morning too. Neither child has ever had a seizure before and patient has had fevers in the past. Mom concerned it could be something more than coincidence and wants to know if any testing needs to be done. ED was not concerned. Any testing you suggest? Mom aware we will call back Monday. Note: I am comfortable watching and supportive care for both. If recurrent or nonfebrile seizures then recommend more testing.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Rash/redness in arm (large area) pain in arm. 1/24/19 to 1/29/19.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient got vaccines at clinic at 9:45AM on 1/15/19. Our clinic does not carry VFC vaccines. Then at about 12pm on 1/15/10, patient was complaining of itchiness of the right thigh. Mother also noticed the right thigh was red and swollen. She called clinic which advised her to call primary doctor, our clinic.
Sex: U
Vaccine: IPV
Symptoms: Product lot number issue
Clinical narrative: One of our ambulatory clinics reported that the lot number on the box differs from the lot number on the vial. This has created some issues with decrementing inventory and confusion about which lot number to record in patient chart. The clinic said that this has been an issue for a while, at least a year and a half. Unclear why some vaccines have the lot number on vial matching the box but this one does not match.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I miss read vaccine records and thought she had not had her Meningococcal. Age of patient at time of event: 11 years 4 months. Type of Event: Wrong timing/interval.
Age: 70.0
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: The client came into immunization clinic for his second Hepatitis B vaccine (ENGERIX-B) and after the second dose was administered and documented in both the clinic's EMR system and immunization registry was it discovered that client's first Hepatitis B vaccine was the new HEPLISAV-B. Therefore the second (and final dose when using HEPLISAV-B) should have been HEPLISAV-B as it is not interchangeable with ENGERIX-B or RECOMBIVAX. The error was revealed when the client produced a copy of his printed immunization registry record he obtained after the first HEPLISAV-B vaccine was administered and on the paper copy was hand-written adjustments to the dosing schedule and brand name. Immunization registry and the clinic's EMR have HEPLISAV-B in their inventory systems but for whatever reason, immunization registry has not adjusted it's dosing schedule nor indicates the brand name on the general viewing screen as it does for ENGERIX-B, etc. The clinic is aware of the error and encouraged to obtain second HEPLISAV-B vaccine 16 weeks from receiving the first HEPLISAV-B vaccine to achieve optimal protection, per CDC guidelines.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient was given expired vaccine. Age of patient at time of event: 4 years.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient had already had two HPV 9 vaccines. Received third on accident.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: Patient received PPSV23 at age 67 years, despite having received both the PCV13 and PPSV23 at age 65 and 66 respectively. Therefore, patient received an unnecessary extra dose of PPSV23. Pharmacy student intern provided this most recent vaccination, and did not look into patient's file to see that he had already completed the pneumococcal vaccination series. Patient received this extra vaccination because he could not recall that he had already completed the vaccine series.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: A 1 mL dose of Hepatitis B vaccine was given to a patient who was indicated for a 0.5 mL dose to complete the 3rd dose of a 3 dose series. Age of patient at time of event: 19 years 5 months.
Age: 0.16
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pt was given both PEDIARIX and PENTACEL today at appointment. Instead of HIB grabbed PENTACEL.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: .25ml dose given to 3 year old instead of .5ml dose.
Age: 40.0
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Our pharmacy accidently ordered the pediatric dose and used it for several adults. Age of patient at time of event: 40 years.
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I over looking her vaccine record and thought I saw she had not had her TDAP.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, Neutropenia, Pancreatitis
Clinical narrative: Patient was given her first dose of flu vaccine on 9/11/18 in clinic. Second dose was to be given on her next clinic visit 10/23/18. Per CDC guidelines the flu vaccine should be given at least 4 weeks (at least 21 days is also acceptable) apart. However, patient was admitted from 9/24-9/27 for pancreatitis and neutropenia. On the day of discharge she was administered the flu vaccine. This was given 2 weeks after her first dose. Per PH if the 2nd dose is given too soon, then another dose should be repeated at least 21 days after the first dose. Advisory Committee allows a 4 day grace period with most vaccines. So the patient got her third flu vaccine in clinic today.
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: On 11.7.18 staff inadvertently administered Tdap instead of Dtap. Age of patient at time of event: 11 years 1 months.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient received MMRV instead of MMR and Varicella vaccines. MMRV is only approved for 12mon-12yrs according to FDA and CDC. 13 and over should received MMR and Varicella individual vaccines.
Age: 0.17
Sex: U
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient ordered to receive Dtap, Hep B, IPV combination vaccine. Dtap (INFANRIX) administered instead of combination vaccine (PEDIARIX). Age of patient at time of event: 2 months.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Immunisation, Product preparation issue
Clinical narrative: Nursing staff prepared MENVEO using the incorrect or corresponding conjugate component, vaccine had to be repeated as recommended per manufacturer. The manufacturer also has now provided us with little bands that connect the powder and diluent bottles together in the box. Nursing staff was also re-educated on preparation for MENVEO. Vaccine was re-administered to Pt. and prepared appropriately.
Age: 0.0
Sex: U
Vaccine: FLU4, HEP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Newborn infant had Hep B Vaccine ordered, but was given Flu vaccine.
Age: 0.17
Sex: U
Vaccine: FLU3
Symptoms: Drug dispensed to wrong patient
Clinical narrative: Medical assist preparing more than one patient's vaccinations at the same time. All vaccines were lying on same desk near one another. Medical assistant picked up high dose influenza and gave to the wrong patient in error. PCP notified and error discussed with patient's mother.
Age: 14.0
Sex: U
Vaccine: HEPA, MEN, TDAP, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Patient is 14 years old and was receiving 4 vaccines including TDaP, varicella, meningococcal, and hepatitis A. Patient was mistakenly given adult dose of hepatitis A vaccination. Family made aware of mistake.
Age: 26.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Flu dose given on 9/28/18 and 10/12/18 on a 26 y/o.
Age: 14.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Administered VARIVAX and PROQUAD together to patient due for MMR and Varicella vaccination. Did not realize the error until the medications were entered into computer. Age of patient at time of event: 14 years 10 months.
Age: 92.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Lethargy
Clinical narrative: I don't know if it has been reported. My 92 y/o mother was given 5cc of the flu vaccine instead of 0.5cc in her arm. She has been lethargic since and now is on comfort measures. This was reported to me by staff at the nursing home.
Age: 17.0
Sex: U
Vaccine: FLUX
Symptoms: Product administered to patient of inappropriate age, Product packaging confusion, Wrong product administered
Clinical narrative: FLUBLOK and FLUZONE QUAD packaging are VERY similar. FLUBLOK is not indicated under 18 and is preferred product in those over age 50. The identical packaging of these products results in confusion when pulling an appropriate product since they are indicated for different age ranges.
Age: 1.25
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Age of patient at time of event: 15 months. Wrong timing/interval (e.g., interval too short).
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A high dose vaccine was accidentally given to a 44 year old woman. This occurred during an offsite clinic where we forgot to bring the portal we use to scan in vaccines. If we would have had this, the error would have been caught before being given to the patient.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: We gave a 4 month old PENTACEL that was expired by 7 days during an off site clinic.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient improperly given PREVNAR vaccination before age 65 with no immunocompromising conditions. Patient then given PNEUMOVAX vaccination 6 months later. PREVNAR was then most recently and incorrectly provided with a second PREVNAR dose after age 65. Age of patient at time of event: 65 years 20 days.
Age: 7.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: DAPTACEL given to 7 YO. Age of patient at time of event: 7 years.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 4 y/o received adult dose of VAQTA.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: PPSV23 ordered, PCV13 given. Age of patient at time of event: 65 years.
Age: 26.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: 26 y/o given pediatric/adolescent dose of HAVRIX.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: 19 y/o received the pediatric/adolescent dose of VAQTA.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Accidental exposure to product
Clinical narrative: HPV testing ordered on pap smear specimen, staff misunderstood and gave HPV vaccine to a 32 y/o.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PROQUAD given to 16 y/o.
Sex: U
Vaccine: FLU3
Symptoms: Contusion, Product administered at inappropriate site
Clinical narrative: Patient states flu shot given in incorrect area and showed staff bruise from injection which was about 8 inches lower than the deltoid area.
Age: 33.0
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High dose flu given to 33 y/o.
Age: 28.0
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: On 10/19/2018, client report to facility for completion of TWINRIX vaccine series. Client assessed and reports that he only needed the Hepatitis B vaccine according to his University. Client was provided one dose of ENGERIX (Hepatitis B) vaccine, he did not complete the TWINRIX dose for the addition of the Hepatitis A vaccine. It has not been reported that the client had any reaction post receiving the Hepatitis B vaccine, instead of the combination of TWINRIX (Hepatitis A/B). Supervising staff notified post vaccination. TWINRIX vaccine added above, however client did not receive the vaccine. Age of patient at time of event: 28 years.
Age: 63.0
Sex: U
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient was given PREVNAR 13, should have received Pneumo Poly 23 based on chronic conditions. Age of patient at time of event: 63 years.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Flu vaccine was ordered, but we did not double check patient's chart to verify if he had it placed already.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Immunisation, Product preparation issue
Clinical narrative: Medical assistant drew partial of the MCV vaccine, did not constitute it properly and administered diluent only. Re-drew the vaccine and second proper dose was administered. Age of patient at time of event: 16 years.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: I administered a .25 FLUZONE to a 3yr old on 09/24/2018. Pt mom is aware of this.
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Administered VARIVAX 0.5 ml and PROQUAD 0.5 ml. Patient got a double dose notified mother of what happened and explained if fever became uncontrollable to take patient to ER and that patient would have leg pain.
Age: 3.0
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was a 3 year old and the provider ordered for them to receive the Influenza Vaccine but the nurse administered a Tdap vaccine instead.
Age: 35.0
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient presented to office for apt and provider ordered Flu vaccine for pt and children of pt. I checked lot numbers and expiration date of all vaccines and labeled all caps with vaccine and pt name. Tdap and Flu are stored next to each other and both green in color. Even with double checking label it was missed that the Tdap was given until after vaccine was given to pt instead of flu. The clinic manager and pt were both notified as soon as I realized the mistake was made. The patient was not upset and understanding to the error.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Patient came in for meningococcal vaccine and was given HPV by mistake.
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Product preparation issue
Clinical narrative: During vaccine prep I accidentally put rota diluent into the hep B vial.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Malaise, Myalgia
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves an unknown age female patient who experienced myalgia, malaise/ didn't feel right, severe hand pain/ foot pain/finger pain, pain in her wrist, patient experienced her heart racing, dizziness and pain when flossing her teeth, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Rheumatoid arthritis in JUN-2017 and Osteoarthritis. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 31-Oct-2017, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious myalgia, malaise/ didn't feel right (malaise) , hand pain/ foot pain/finger pain (pain in extremity) , pain in her wrist (arthralgia), heart racing (palpitations) , dizziness and pain when flossing her teeth (teething) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Final diagnosis was pain when flossing her teeth, dizziness, patient experienced her heart racing, pain in her wrist, severe hand pain/ foot pain/finger pain, malaise/ didn't feel right and myalgia. The patient was treated with METHOTREXATE (METHOTREXATE) for Osteoarthritis and PREDNISONE (PREDNISONE). The event outcome was reported as Unknown. List of documents held by sender: none
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Palpitations, Toothache
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves an unknown age female patient who experienced myalgia, malaise/ didn't feel right, severe hand pain/ foot pain/finger pain, pain in her wrist, patient experienced her heart racing, dizziness and pain when flossing her teeth, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Rheumatoid arthritis in JUN-2017 and Osteoarthritis. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 31-Oct-2017, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious myalgia, malaise/ didn't feel right (malaise) , hand pain/ foot pain/finger pain (pain in extremity) , pain in her wrist (arthralgia), heart racing (palpitations) , dizziness and pain when flossing her teeth (teething) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Final diagnosis was pain when flossing her teeth, dizziness, patient experienced her heart racing, pain in her wrist, severe hand pain/ foot pain/finger pain, malaise/ didn't feel right and myalgia. The patient was treated with METHOTREXATE (METHOTREXATE) for Osteoarthritis and PREDNISONE (PREDNISONE). The event outcome was reported as Unknown. List of documents held by sender: none
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, concerning seven unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, lot # R007693 with expiration date on 14-MAR-2020 and lot # R009411 with expiration date on 29-MAR-2020, for prophylaxis (dose, route of administration and anatomical location were not reported). The administered doses of the vaccine experienced a temperature excursion of 15 to 46 (14.5) degrees Fahrenheit (°F) for 50 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is a non-valid report due to lack of patient identifiers. As of 28-JAN-2019, all telephone attempts to obtain follow-up information have been unsuccessful.
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 4 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 18-JAN-2019, the patient inadvertently was vaccinated with GARDASIL 9 for prophylaxis lot #158675 and expiration date 16-FEB-2021 (product administered to patient of inappropriate age) (strength, dose, frequency and route of administration was not reported), instead of  PROQUAD (vaccine not administered) (wrong product administered) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Age: 1.42
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 17-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 22-JAN-2019, the patient was inadvertently vaccinated with PROQUAD lot# R021232, expiration date 21-JAN-2020 (exact dose, route and site of administration were not reported), instead of intended M-M-R II concomitantly with VARIVAX lot# R022117, expiration date 02-AUG-2020 (exact dose, route and site of administration were not reported). Concomitant therapy included sterile diluent. The nurse reported the provider who administered the doses confused PROQUAD with M-M-R II because the vials were the same color, so he thought they were the same vaccine. No adverse effect reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 23-JAN-2019 the patient was vaccinated with a dose of GARDASIL 9 (strength, dose and frequency were not reported) lot # R025155 expiration date 23-MAY-2021, intramuscularly for prophylaxis in the (right ventrogluteal region" (Vaccine administered at inappropriate site). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age. and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 28-JAN-2019, the patient was vaccinated with PROQUAD 0.5 ml, once, lot# R015744, expiration date 12-FEB-2019, subcutaneously, for prophylaxis (strength was not reported) reconstituted with an expired dose of sterile diluent subcutaneously, lot # N008378 and 08-JUN-2018 (strength, dose, frequency and indication were not reported). No adverse effects were reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Blood pressure increased, Dizziness, Gait disturbance, Heart rate irregular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 11th May 2018, the patient experienced generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on the right arm. On 11th May 2018, 7 days after receiving SHINGRIX, the patient experienced, pain at injection site, rash on body, hives on body, swelling on wrist, ganglion cyst on wrist, hair falling out, unable to use right hand, irregular heartbeat, thyroid issues (up and down), difficulty seeing, difficulty walking and psoriasis on back. The patient was planned to follow-up with her physician on an unknown date. The emergency room visit required. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injected limb mobility decreased, Injection site pain, Joint swelling, Psoriasis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 11th May 2018, the patient experienced generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on the right arm. On 11th May 2018, 7 days after receiving SHINGRIX, the patient experienced, pain at injection site, rash on body, hives on body, swelling on wrist, ganglion cyst on wrist, hair falling out, unable to use right hand, irregular heartbeat, thyroid issues (up and down), difficulty seeing, difficulty walking and psoriasis on back. The patient was planned to follow-up with her physician on an unknown date. The emergency room visit required. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Synovial cyst, Thyroid disorder, Urticaria, Visual impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 11th May 2018, the patient experienced generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on the right arm. On 11th May 2018, 7 days after receiving SHINGRIX, the patient experienced, pain at injection site, rash on body, hives on body, swelling on wrist, ganglion cyst on wrist, hair falling out, unable to use right hand, irregular heartbeat, thyroid issues (up and down), difficulty seeing, difficulty walking and psoriasis on back. The patient was planned to follow-up with her physician on an unknown date. The emergency room visit required. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site pain, Pain, Respiratory tract congestion
Clinical narrative: Injection site soreness within two hours. Approx. 12 hours after injection, congestion, general body aches, and temperature of 99.8 upon arising.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP
Symptoms: CSF culture negative, Culture urine negative, Electroencephalogram normal, Febrile convulsion, Laboratory test
Clinical narrative: Infant had fever afternoon following vaccine administration. She had what is believed to be a seizure. Presented to ED and was admitted for observation overnight. Infectious workup was negative. EEG was negative. Did not undergo MRI. She was seen by neurology and diagnosed with an atypical febrile seizure felt to be secondary to fever following vaccination. She was observed in the hospital overnight without any further episodes.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP
Symptoms: Leukocytosis, Pyrexia, Seizure, Septic screen, White blood cell count increased
Clinical narrative: Infant had fever afternoon following vaccine administration. She had what is believed to be a seizure. Presented to ED and was admitted for observation overnight. Infectious workup was negative. EEG was negative. Did not undergo MRI. She was seen by neurology and diagnosed with an atypical febrile seizure felt to be secondary to fever following vaccination. She was observed in the hospital overnight without any further episodes.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP
Symptoms: Febrile convulsion
Clinical narrative: Infant had fever afternoon following vaccine administration. She had what is believed to be a seizure. Presented to ED and was admitted for observation overnight. Infectious workup was negative. EEG was negative. Did not undergo MRI. She was seen by neurology and diagnosed with an atypical febrile seizure felt to be secondary to fever following vaccination. She was observed in the hospital overnight without any further episodes.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Impaired work ability, Injection site pain
Clinical narrative: 2 hours after injection, soreness in left arm around site that continued for 5 days (lessening each day). Evening of injection: headache, muscle aches, fever. In the morning, took 2 Extra Strength Tylenol. Symptoms abated, but felt tired for rest of day. 4 days later (Tuesday): Woke up with diarrhea; had to stay home from work. Tired for entire day. Treated with 3 doses of Pepto Bismol and symptoms abated.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: 2 hours after injection, soreness in left arm around site that continued for 5 days (lessening each day). Evening of injection: headache, muscle aches, fever. In the morning, took 2 Extra Strength Tylenol. Symptoms abated, but felt tired for rest of day. 4 days later (Tuesday): Woke up with diarrhea; had to stay home from work. Tired for entire day. Treated with 3 doses of Pepto Bismol and symptoms abated.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site pruritus
Clinical narrative: Dime sized spot of discolored skin with continued itching since injection at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cardiac flutter, Dizziness, Erythema, Feeling hot, Flushing
Clinical narrative: Patient experienced flushing, feeling hot, flutter in heartbeat, lightheaded, dark vision, erythema.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Visual impairment
Clinical narrative: Patient experienced flushing, feeling hot, flutter in heartbeat, lightheaded, dark vision, erythema.
Age: 73.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Joint range of motion decreased, Pain in extremity, Tenderness
Clinical narrative: Pain the left arm rated 10/10, loss of range of motion, tender to touch.