chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Hypophagia, Hypotonia, Insomnia, Malaise, Mania
Clinical narrative: The night of 11/20/19, patient received his first flu vaccine. After flu clinic, patient was hyperactive, seemed to have difficulty with focusing, with rapid eye movements; seemed almost manic to the parents and agitated. He seemed unable to get comfortable when held but was not crying as if in pain. His tongue was protruding as if it was numb and seemed limp. His grip was weak; he was unable to hold onto his toys or hold his pacifier to his mouth or keep it in his mouth. He was inconsolable for more than four hours with rapid respirations. He was thrashing in his sleep, sweaty and clammy; he barely slept, only about two hours total overnight. He had decreased oral intake; refused a bottle from 2100 to 0500 -- which is unusual for him. Parents gave him Tylenol and ibuprofen but neither seemed to help. He was returning to baseline the following day; simply seemed like he didn't feel well. Mother reports that patient bumped his head four days prior, but seemed normal afterward. Grandmother wondered about possibility of concussion symptoms being delayed.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Poor sucking reflex, Protrusion tongue, Psychomotor hyperactivity, Respiratory rate increased
Clinical narrative: The night of 11/20/19, patient received his first flu vaccine. After flu clinic, patient was hyperactive, seemed to have difficulty with focusing, with rapid eye movements; seemed almost manic to the parents and agitated. He seemed unable to get comfortable when held but was not crying as if in pain. His tongue was protruding as if it was numb and seemed limp. His grip was weak; he was unable to hold onto his toys or hold his pacifier to his mouth or keep it in his mouth. He was inconsolable for more than four hours with rapid respirations. He was thrashing in his sleep, sweaty and clammy; he barely slept, only about two hours total overnight. He had decreased oral intake; refused a bottle from 2100 to 0500 -- which is unusual for him. Parents gave him Tylenol and ibuprofen but neither seemed to help. He was returning to baseline the following day; simply seemed like he didn't feel well. Mother reports that patient bumped his head four days prior, but seemed normal afterward. Grandmother wondered about possibility of concussion symptoms being delayed.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: 8 cm x 5 cm red, hard, warm to touch, blistered area surrounding injection site. Observation, patient instructed to call clinic if area worsens or other symptoms develop.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Brain natriuretic peptide normal, Chest X-ray normal, Dyspnoea, Echocardiogram normal, Wheezing
Clinical narrative: Severe wheezing and difficulty in breathing/shortness of breath lasting several days. Intense use of albuterol (2 inhalations every 4 hours) plus famotidine (20 mg/bid) was required before office visits to primary care physician, pulmonologist, and cardiologist. I was prescribed Symbicort (165/4.5 mg - 2 inhalations bid) and famotidine (40 mg bid). I am currently on that regimen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Tenderness
Clinical narrative: Large area of redness and tender even at 9 days after vaccine
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red, warm rash on right arm roughly 2 inches below injection site. Initially occurred roughly 72 hours following vaccination. Over the following 24 hours it grew to roughly baseball size, and has since remained about the same size. It is reported to be tender to the touch with a burning sensation from clothing.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Heart rate increased, Malaise, Myalgia, Urticaria
Clinical narrative: 11/18/2019:   from 8:30 pm till about 8:30 am the next morning I experienced a very rapid heartbeat, extreme muscle and joint pain and just an overall feeling of being "unwell".  I was confined to bed most of the day 11/19/2019.  Feeling slightly better on 11/20/2019 I was able to perform my duties.  However on 11/21/2019 while showering I scratched an area on my right shoulder that turned out to be Hives.  I have a picture.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Pt reports fever, severe chills, body aches, nausea and vomiting  starting 12 hours after vaccine and lasting about 24 hours
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Heart rate increased, Tinnitus
Clinical narrative: Severe chills, weakness, dizziness, fast heartbeat, ringing in the ears,  Severe for 2 days, still dizzy on third day
Age: 19.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Body temperature increased, Headache, Hyperhidrosis, Rash
Clinical narrative: Nov 17, 2019: Client reports headache, Nov 19, 2019: Client reports elevated temperature and sweating, but she has never measured her temperature. Nov 21, 2019: Client reports rash started and has spread to hands, abdomen and back. Nov 22, 2019: Client's mother calls to report these symptoms,.  Client denies any joint pain, states that the head ache is gone, and that she is feeling somewhat better although she still has the rash.  This has been reported to our facilities physician, who has recommended treatment for signs and symptoms, such as tylenol. Client has been taught that if her symptoms worsen that she should seek additional treatment and has been given contact information for the Clinics.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Arm swelling day after recieving Pneumovax 23. Left arm & MD prescribed Bactrim to treat possible bacterial skin infection.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Ear pain, Full blood count normal, Headache, Influenza virus test negative
Clinical narrative: BODY ACHES, CHILLS (DAY 5 & 6 AFTER), BODY ACHES, CHILLS, HEADACHES, MOUTH FULL OF SORES (DAY 7-9), DR VISIT ON DAY 9, FLU TEST & STREP TEST NEGATIVE, CBC NORMAL, TERRADOL INJECTION, LIDOCAINE MOUTHWASH, CONTINUE IBUPROPHEN & TYLENOL, STILL HAVING BODY ACHES AND SORE MOUTH FROM DAY 10-14, BODY ACHES LIGHTENING UP, MOUTH SORES STARTED SUBSIDING ON DAY 18, STILL HAVE SOME SORE GLANDS CAUSING EAR PAIN IN BOTH EARS AND MUCH REDUCED MOUTH ON DAY 20 AS I WRITE THIS.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Lymph node pain, Oral pain, Pain, Stomatitis, Streptococcus test negative
Clinical narrative: BODY ACHES, CHILLS (DAY 5 & 6 AFTER), BODY ACHES, CHILLS, HEADACHES, MOUTH FULL OF SORES (DAY 7-9), DR VISIT ON DAY 9, FLU TEST & STREP TEST NEGATIVE, CBC NORMAL, TERRADOL INJECTION, LIDOCAINE MOUTHWASH, CONTINUE IBUPROPHEN & TYLENOL, STILL HAVING BODY ACHES AND SORE MOUTH FROM DAY 10-14, BODY ACHES LIGHTENING UP, MOUTH SORES STARTED SUBSIDING ON DAY 18, STILL HAVE SOME SORE GLANDS CAUSING EAR PAIN IN BOTH EARS AND MUCH REDUCED MOUTH ON DAY 20 AS I WRITE THIS.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Magnetic resonance imaging, Pain in extremity
Clinical narrative: My left arm is very sore and I have limited range of motion and can barely move my arm
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: My left arm is very sore and I have limited range of motion and can barely move my arm
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Magnetic resonance imaging, Pain in extremity
Clinical narrative: Patient complained days after vaccine of pain, swelling and trouble moving arm.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Patient complained days after vaccine of pain, swelling and trouble moving arm.
Age: 1.83
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Hepatitis A administered today, mother called in stating pt. had 1 vomit episode after the shot, mother denies any other concern or symptom at this time, advice to keep pt. under observation, if vomit persist or any other symptom, to call back or take pt. to the urgent care for medical evaluation, mother agreed and instructions verbally understood.
Age: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: The patient has complaint of soreness in his shoulder that has persisted from time of injection. It is worse in the morning and gets better throughout the day. He has been using a pain cream, and that has helped. He also said that when he wakes the pain is on both sides and then subsides to his right shoulder. The patient denies any arthritis, and his doctor ruled that out as well.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid injury, Fall, Loss of consciousness, Syncope
Clinical narrative: 3-4 minutes post vaccination, patient had a syncopal episode x45 seconds and incurred a fall injury. Patient lost consciousness and fell forward into a wall while still in the clinical area. She had a soft tissue injury to her eyelid but had no other residual sx after regaining consciousness. After evaluation from a medical provider, she was referred to the ER/Urgent care to have her eyelid repaired. The soft tissue injury could possibly leave a permanent scar on eyelid.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Erythema, Feeling hot, Hyperhidrosis, Wheezing
Clinical narrative: Within 2-3 minutes after the injection, he turned bright red from the neck up.  Patient stated that his face felt hot.  His hands were sweaty.  He complained of chest tightness.  The physician assistant who examined the patient heard wheezing in the patient's chest.  Patient states that he is a smoker. Symptoms stated to resolve within 10 mins and when patient left the office 30 minutes later, he stated that he was symptom free.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Irritability, Pallor, Presyncope
Clinical narrative: 3 minutes post vaccination, patient had a vasovagal reaction while picking out a sticker. Child fell backwards and may have hit his head. The child regained consciousness immediately but was pale/irritable x5-10 minutes while placed in recumbent position w/ feet elevated. Child had no residual or additional symptoms- patient was evaluated by pediatrician and released.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: as reported by parent: Generalized rash starting on 11/18/201 at approximately 7:00 PM, On 11/19/2019 Zyrtec given by parent and rash went away.  11/20/2019 rash and itching returned in the evening.  11/21/2019 she was taken to clinic and seen by employee and parent was told it was a reaction to the influenza vaccine.  Was prescribed steroid pack and Zyrtec.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cardiac failure, Chromaturia, Echocardiogram abnormal, Hepatic enzyme increased, Magnetic resonance cholangiopancreatography
Clinical narrative: As previously stated, I received the Pneumovax vaccination on June 6, 2017.  That night, I awoke in the early hours of the morning with an urge to use the bathroom. I could not understand why the muscles in my entire body were so sore and painful when I moved or walked. I thought perhaps I caught a bug.    Unable to move, I remained in bed for two days and had to use a commode.  It was during that time, I realized my urine had changed color, resembling that of black coffee. As a nurse, I became worried and knew this was not just a bug and needed to go to the hospital.   On the third day, my husband and I arrived at the Emergency Room of Hospital, where I was admitted and given IVs throughout the day.  The soreness and muscle pain subsided gradually, and I had expected to be released, however they admitted me and remained at the hospital for a total of five days.   The doctors were extremely concerned regarding my liver enzymes which were elevated. I have never had any medical issue with my liver before and the doctors were trying to find the cause. The medical terms used during my stay were: ? Myositis? inflammation of muscles and muscle damage Transaminitis - refers to unusually high levels of a family of enzymes called transaminases. Myalgia ? mild to sever muscle pain   At the end of five days I was discharged and advised to see Doctor at the same hospital.  I saw him go through my records and requested that I go to the lab again and have blood drawn to check my liver enzymes.  The doctor ordered my blood drawn at regular intervals after that to continue to monitor my liver enzymes.    Over months my liver enzymes eventually stabilized and I was extremely relieved.  He gave me the news over the phone as he had since retired.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Magnetic resonance imaging abdominal normal, Micturition urgency, Middle insomnia, Mobility decreased, Myalgia
Clinical narrative: As previously stated, I received the Pneumovax vaccination on June 6, 2017.  That night, I awoke in the early hours of the morning with an urge to use the bathroom. I could not understand why the muscles in my entire body were so sore and painful when I moved or walked. I thought perhaps I caught a bug.    Unable to move, I remained in bed for two days and had to use a commode.  It was during that time, I realized my urine had changed color, resembling that of black coffee. As a nurse, I became worried and knew this was not just a bug and needed to go to the hospital.   On the third day, my husband and I arrived at the Emergency Room of Hospital, where I was admitted and given IVs throughout the day.  The soreness and muscle pain subsided gradually, and I had expected to be released, however they admitted me and remained at the hospital for a total of five days.   The doctors were extremely concerned regarding my liver enzymes which were elevated. I have never had any medical issue with my liver before and the doctors were trying to find the cause. The medical terms used during my stay were: ? Myositis? inflammation of muscles and muscle damage Transaminitis - refers to unusually high levels of a family of enzymes called transaminases. Myalgia ? mild to sever muscle pain   At the end of five days I was discharged and advised to see Doctor at the same hospital.  I saw him go through my records and requested that I go to the lab again and have blood drawn to check my liver enzymes.  The doctor ordered my blood drawn at regular intervals after that to continue to monitor my liver enzymes.    Over months my liver enzymes eventually stabilized and I was extremely relieved.  He gave me the news over the phone as he had since retired.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Myositis, Pain, Transaminases increased, Ultrasound scan normal
Clinical narrative: As previously stated, I received the Pneumovax vaccination on June 6, 2017.  That night, I awoke in the early hours of the morning with an urge to use the bathroom. I could not understand why the muscles in my entire body were so sore and painful when I moved or walked. I thought perhaps I caught a bug.    Unable to move, I remained in bed for two days and had to use a commode.  It was during that time, I realized my urine had changed color, resembling that of black coffee. As a nurse, I became worried and knew this was not just a bug and needed to go to the hospital.   On the third day, my husband and I arrived at the Emergency Room of Hospital, where I was admitted and given IVs throughout the day.  The soreness and muscle pain subsided gradually, and I had expected to be released, however they admitted me and remained at the hospital for a total of five days.   The doctors were extremely concerned regarding my liver enzymes which were elevated. I have never had any medical issue with my liver before and the doctors were trying to find the cause. The medical terms used during my stay were: ? Myositis? inflammation of muscles and muscle damage Transaminitis - refers to unusually high levels of a family of enzymes called transaminases. Myalgia ? mild to sever muscle pain   At the end of five days I was discharged and advised to see Doctor at the same hospital.  I saw him go through my records and requested that I go to the lab again and have blood drawn to check my liver enzymes.  The doctor ordered my blood drawn at regular intervals after that to continue to monitor my liver enzymes.    Over months my liver enzymes eventually stabilized and I was extremely relieved.  He gave me the news over the phone as he had since retired.
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Dyskinesia
Clinical narrative: Patient's sister phoned office 11/19/2019 to report that patient's leg was jerking like he was about to have a seizure. Sister was told to call 911.
Sex: U
Vaccine: FLU3, HEPA
Symptoms: Product storage error
Clinical narrative: The nurse is reporting that the patient received improperly stored vaccine; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On 30-SEP-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) in the right thigh for prophylaxis (lot number: S007770, expiration date: 24-JUL-2020) (exact dose and route of administration was not reported) and with one dose of influenza virus whole virion 3v vaccine inactivated (FLUZONE) in the left thigh with lot number: 06653BD (exact dose, route of administration, indication and expiration date were not reported). It was reported that the patient received previously 1 dose of hepatitis a vaccine, inactivated (VAQTA) and 1 dose of influenza virus whole virion 3v vaccine inactivated (FLUZONE) on an unknown dates.  The hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion of 1.4 degree Celsius for 20 minutes. Previous temperature excursion was 10.5 degree Celsius for 56 minutes. The digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; one improperly stored dose of PROQUAD administered to to patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.           On 25-OCT-2019, the patient was vaccinated improperly stored dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S006828, expiration date 02-SEP-2020, dosage detail, route and strength were not provided ) for prophylaxis.  Administered doses of vaccine experienced temperature excursion from -14 degrees Celsius (C) to -10 C for 8 hours 40 mintues. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; multiple outbrakes of herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers a female patient of an unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the pt was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster -related conditions. On an unknown date, the pt was administered zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) by a pharmacy team member. The pt suffered the following injuries and was diagnosed on an unspecified dates as a result of the zoster vaccine live (ZOSTAVAX) vaccine: multiple outbreaks of herpes zoster and post herpetic neuralgia. The outcome of the events was unknown. The causality was related.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored dose of PEDVAX and ROTATEQ; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reaction/ allergies and concomitant medications were not reported. On 18-NOV-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S006470 expiration date reported as 15-JAN-2021, but upon internal validation established as 15-JAN-2022) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# R029818, expiry date: 09-JUL-2020 (product storage error) (strength, formulating, dose/frequency, route were unknown) for prophylaxis. The vaccines were stored at a temperature of 10.1 degree Celsius for 1hour. There was previous temperature excursion at 10.6 degree Celsius for 15 minutes. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: ran titers and from the serotypes covered by Prevnar 13, there were no immunity concentration levels; This is a spontaneous report from contactable physician via Pfizer Sales Representative.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  They ran titers and from the serotypes covered by Prevnar 13, there were no immunity concentration levels  on an unspecified date with outcome of unknown.    The information on the batch number has been requested
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: Patient had allergic reaction when Prevnar was administered; This is a spontaneous report from a non-contactable consumer based on the information received by Pfizer from Merck & Co., Inc. (Case number: 01394376). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient had allergic reaction when prevnar was administered on an unspecified date with outcome of unknown.    No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin irritation
Clinical narrative: developed redness, itching and irritation about 3 inches away from the injection site; developed redness, itching and irritation about 3 inches away from the injection site; developed redness, itching and irritation about 3 inches away from the injection site; This is a spontaneous report from a contactable Pharmacist based on information received by Pfizer from Merck & Co. Inc. (Case Number: 01395915).  A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient developed redness, itching and irritation about 3 inches away from the injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: arm began swelling; warm to the touch; redness; rash; This is a spontaneous report from a contactable nurse via Pfizer sales representative.  A 65-year-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included omeprazole. On an unspecified date, the patient experienced arm began swelling, warm to the touch, redness, rash. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: ordered to receive Pediarix and ActHIB but the consumer received Pentacel and Pediarix, no AE; ordered to receive Pediarix and ActHIB but the consumer received Pentacel and Pediarix, no AE; that the consumer is behind on their vaccine schedule, no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 months old female patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency once) (lot number: UJ129AAA, expiry date: 03-Nov-2020 via intramuscular route in the right thigh on 22-Oct-2019 and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] lot number not reported via unknown route in unknown administration site on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to extra dose administered, and wrong vaccine administered and Inappropriate schedule of vaccine administered. It was reported that the patient ordered to receive Pediarix and ActHIB but the consumer received Pentacel and Pediarix. The nurse reported that the consumer received a double dose of the Dtap-IPV component on the day of the injections due to the Pentacel and Pediarix contain those components; that the medication error occurred on 22Oct2019. The consumer is behind on their vaccine schedule.  It was reported that the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: 2-month-old female received the DTap/IPV component; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old female patient who received only DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Lot # U6216AB, exp date 10Oct2020) via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pentacel being administered to a 5 year old/No AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 5 year old patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of potential medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: received the ActHib component out of the Pentacel vaccine, reconstituted with the diluent out of an ActHib box (0.4 percent saline).; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Infant patient who received the HIB component out of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and, reconstituted with the diluent out of box (0.4 percent saline) of vaccines HIB (PRP/T) VACCINE [ACT-HIB].  ActHib component taken from the Pentacel box and used was UJ020AAA expiration 09 Oct 2020; diluent that was used to reconstitute, from the ActHib box, was U6338AA expiration 21 Aug 2020; ActHib vial that was not used (but whose diluent was used) was UJ075AA expiration 27 Nov 2020; and Pentacel diluent that was not used (but whose ActHib vial was used) was U6215AA expiration 09 Oct 2020  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to wrong technique in product usage process.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was administered on 28Oct2019 and had expired on 23Oct2019, no AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 months old male patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5307AA via intramuscular route in the left thigh on 28-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used. It was reported that the vaccine was administered on 28-Oct-2019 and had expired on 23-Oct-2019.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Vaccination site inflammation
Clinical narrative: injection site was red and swollen; injection site was swollen; injection site was red; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from Consumer/Non-HCP (Medical assistant).  This case involves a 6 years old patient who experienced the injection site swollen and redness (Vaccination site swelling), (Vaccination site erythema) and (Vaccination site inflammation), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The medical history, medical treatments, vaccinations and family history were not provided.  On 10-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6645LA Expiry date: 30-JUN-2020) via intramuscular route in the right arm.  On unknown date, the patient developed a non-serious injection site swollen and redness (vaccination site swelling), (vaccination site erythema) and (vaccination site inflammation) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 12-Nov-2019, patient visited to physician for the follow up of laceration of foot.  Other relevant tests included No lab data.  Final diagnosis was the injection site swollen and redness.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown for all events.
Sex: F
Vaccine: RAB
Symptoms: Neuralgia
Clinical narrative: nerve pain; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old female patient who experienced nerve pain, while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Oct-2019, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious nerve pain (neuralgia) unknown latency following the administration of RABIES (HDC) VACCINE.  It was reported that patient has been two weeks can not lift anything since receiving the shot.   Other relevant tests were not reported.  Final diagnosis was nerve pain.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Injection site pruritus, Injection site urticaria, Nodule
Clinical narrative: big knot under arm, it hurt; shot spot has a scab on it, is still red around it, about the size of a dime. Right below the shot site, pain starts about the size of a soft ball; itchy spot, hives on arm around injection site; itchy spot around injection site; shot spot has a scab on it; shot spot has a scab on it, is still red around it, about the size of a dime. Right below the shot site, pain starts about the size of a soft ball; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 68 old female patient who experienced big knot under arm, it hurt (nodule), shot spot has a scab on it, is still red around it, about the size of a dime, right below the shot site, pain starts about the size of a soft ball (inflammation), (vaccination site reaction), hives on arm around injection site (vaccination site urticaria), itchy spot around injection site (vaccination site pruritus) and shot spot has a scab on it (vaccination site scab), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2019 (or as reported 27-Oct-2019), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a non-serious hives on arm around injection site (vaccination site urticaria), itchy spot around injection site (vaccination site pruritus) after about a week or more following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious big knot under arm, it hurt (nodule), shot spot has a scab on it, is still red around it, about the size of a dime. right below the shot site, pain starts about the size of a soft ball (inflammation), (vaccination site reaction) and shot spot has a scab on it (vaccination site scab) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was shot spot has a scab on it, is still red around it, about the size of a dime, right below the shot site, pain starts about the size of a soft ball, shot spot has a scab on it, itchy spot, hives on arm around injection site and big knot under arm, it hurt.  The patient was treated with (Benadryl [Diphenhydramine Hydrochloride]) and Ibuprofen for Product used for unknown indication.  The outcome of the event was Unknown for all the events.
Sex: F
Vaccine: FLU3
Symptoms: Pain, Scab
Clinical narrative: big knot under arm, it hurt; shot spot has a scab on it, is still red around it, about the size of a dime. Right below the shot site, pain starts about the size of a soft ball; itchy spot, hives on arm around injection site; itchy spot around injection site; shot spot has a scab on it; shot spot has a scab on it, is still red around it, about the size of a dime. Right below the shot site, pain starts about the size of a soft ball; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 68 old female patient who experienced big knot under arm, it hurt (nodule), shot spot has a scab on it, is still red around it, about the size of a dime, right below the shot site, pain starts about the size of a soft ball (inflammation), (vaccination site reaction), hives on arm around injection site (vaccination site urticaria), itchy spot around injection site (vaccination site pruritus) and shot spot has a scab on it (vaccination site scab), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2019 (or as reported 27-Oct-2019), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a non-serious hives on arm around injection site (vaccination site urticaria), itchy spot around injection site (vaccination site pruritus) after about a week or more following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious big knot under arm, it hurt (nodule), shot spot has a scab on it, is still red around it, about the size of a dime. right below the shot site, pain starts about the size of a soft ball (inflammation), (vaccination site reaction) and shot spot has a scab on it (vaccination site scab) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was shot spot has a scab on it, is still red around it, about the size of a dime, right below the shot site, pain starts about the size of a soft ball, shot spot has a scab on it, itchy spot, hives on arm around injection site and big knot under arm, it hurt.  The patient was treated with (Benadryl [Diphenhydramine Hydrochloride]) and Ibuprofen for Product used for unknown indication.  The outcome of the event was Unknown for all the events.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Reaction on left leg, redness and bumps around site of vaccine, Rash (bumps) did spread throughout both legs, no other parts affected.  Benadryl/Diphenhydramine 2.5ml po given at 1130, and Dexamethasone 0.5ml po at 1150.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Copied from the student's  Primary Care visit at Health Service on 11/21/2019  "22 year old patient with c.o. of redness at injection site. Patient was seen on 11/13/2019 for immunization visit. Vaccinated with Tdap in L deltoid. Injection site became swollen that even. Patient noticed redness over the weekend + Pain-rates pain 4/10. Notice increase in pain-though today is better. +itching. +warm to touch Denies treating pain or itchiness with medication On Exam: Visible redness (16cm x 7.5cm). Tender and warm to touch
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Rash, Rash erythematous
Clinical narrative: big red circle on upper (L) arm, 4" diameter.  Lasted for about a week.  Also a rash - red dots all the way from upper (L) arm to wrist.  Lasted about 2 days.  Pain at site of injection.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Pollakiuria, Pyrexia
Clinical narrative: Patient came in on 11-21-19 for Low grade fever and frequent urinating. Flu shot was administered on Left arm Yesterday. Mother states that patient got high fever @ home. Patient came in the next day 11-22-19 with 104.1 fever.
Age: 1.25
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Rash erythematous
Clinical narrative: Red rash on back. Redness at injection site
Age: 52.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Injection site swelling, Peripheral swelling, Pyrexia
Clinical narrative: fever, swelling L arm, shoulder S.O.B given epinephrine 1:1000 0.3u SubQ & Kenelog 40mg IM with improvement
Age: 77.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Fall, Injection site pain, Pain, Pain in extremity
Clinical narrative: Reaction To Shindrix - Have never reacted to any vaccine. Had Shingles Vaccine 15 YRS ago. EXTReme shooting pain in arm - shoulder To hand - Pain scale 10. Took 800 mg Ibuprofen brought IT down to a 6 - Last for hours. Weakness - needed help getting out of bed. Fell in Bathrm. Tremors in legs. Rapid Resp BP + HR. NoRmal.
Age: 77.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Respiratory rate increased, Tremor
Clinical narrative: Reaction To Shindrix - Have never reacted to any vaccine. Had Shingles Vaccine 15 YRS ago. EXTReme shooting pain in arm - shoulder To hand - Pain scale 10. Took 800 mg Ibuprofen brought IT down to a 6 - Last for hours. Weakness - needed help getting out of bed. Fell in Bathrm. Tremors in legs. Rapid Resp BP + HR. NoRmal.
Age: 46.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Anxiety, Burning sensation, Electromyogram, Migraine, Pain in extremity
Clinical narrative: Pain Right arm, Burning, tingling. severe armpain caused anxiety and migraine
Age: 46.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Paraesthesia, X-ray
Clinical narrative: Pain Right arm, Burning, tingling. severe armpain caused anxiety and migraine
Age: 46.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Feeling cold, Insomnia, Nerve conduction studies, Pain, Skin warm
Clinical narrative: Pain Right arm, Burning, tingling. severe armpain caused anxiety and migraine
Age: 46.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: X-ray
Clinical narrative: Pain Right arm, Burning, tingling. severe armpain caused anxiety and migraine
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Inflammation, Muscle twitching, Myalgia
Clinical narrative: as i was giving the pneumovax-23, patient stated that her muscle twitched. next morning, she woke up and it really hurt. during the day, it started to get very red and inflammed and it hurt. saturday morning (11-16) she stated her arm was all red and swollen from her shoulder to down past her elbow. she went to urgent care where the doctor diagnosed her as having cellulitis/staph infection. they put her on bactrim ds. she is feeling much better now.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Staphylococcal infection
Clinical narrative: as i was giving the pneumovax-23, patient stated that her muscle twitched. next morning, she woke up and it really hurt. during the day, it started to get very red and inflammed and it hurt. saturday morning (11-16) she stated her arm was all red and swollen from her shoulder to down past her elbow. she went to urgent care where the doctor diagnosed her as having cellulitis/staph infection. they put her on bactrim ds. she is feeling much better now.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis staphylococcal, Muscle twitching, Pain, Peripheral swelling, Tenderness
Clinical narrative: as i was giving the pneumovax-23, patient stated that her muscle twitched. next morning, she woke up and it really hurt. during the day, it started to get very red and inflammed and it hurt. saturday morning (11-16) she stated her arm was all red and swollen from her shoulder to down past her elbow. she went to urgent care where the doctor diagnosed her as having cellulitis/staph infection. they put her on bactrim ds. she is feeling much better now.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Gait inability, Inflammation, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Upon awakening on 10/10/19 she was unable to move or walk for 7 hours due to severe inflammation of the lumbar region (L5 and S1 - where pinched nerve was previously diagnosed). Symptoms continued to worsen and by 10/14 she was unable to walk. Bedridden on 10/14 and 15. Pain was severe. 10/16 she went to hospital and was released on 10/20. Symptoms gradually improved after corticosteroid treatment. Patient was discharged and required a walker until 11/11. Patient was able to return to work without a walker on 11/12. Symptoms have improved but are not completely resolved.  Treatment included oral corticosteroids, oxycodone for severe pain in initial stages, and then injectible corticosteroids and gabapentin on 10/28 for moderate pain .
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Walking aid user, X-ray
Clinical narrative: Upon awakening on 10/10/19 she was unable to move or walk for 7 hours due to severe inflammation of the lumbar region (L5 and S1 - where pinched nerve was previously diagnosed). Symptoms continued to worsen and by 10/14 she was unable to walk. Bedridden on 10/14 and 15. Pain was severe. 10/16 she went to hospital and was released on 10/20. Symptoms gradually improved after corticosteroid treatment. Patient was discharged and required a walker until 11/11. Patient was able to return to work without a walker on 11/12. Symptoms have improved but are not completely resolved.  Treatment included oral corticosteroids, oxycodone for severe pain in initial stages, and then injectible corticosteroids and gabapentin on 10/28 for moderate pain .
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dysstasia, Fall, Gait disturbance, Lip swelling
Clinical narrative: Severe weakness. Could barely walk and stand up for an entire day. That night when getting up to use the bathroom, I fell on the floor and could not get up. My husband helped me get back to bed. Next day I was better, but not normal, and had a severely swollen upper lip.