chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: opened Ipol vial that was exposed to a temperature excursion; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  It was linked with 2019SA130411, 2019SA130412 and 2019SA130377.  This case involves a 4 months old male patient who that was exposed to a temperature excursion, while he received 0.5 ml vaccine IPV (VERO) [IPOL] on 24-Apr-2019 (lot: P1A242M)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE (HIB) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was of actual medication error due to incorrect product storage. It was reported vaccine underwent the following elevated temperature excursion on 23 Apr 2019: at 1:05 pm the temperature was 46.4 degrees F, at 2:05 pm the temperature 46.7 degrees F, and by 2:35 pm it had returned to within range at 45.8 degrees F.  It was unknown whether adverse event was experienced.  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.  List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: temperature excursion on 23 Apr 2019:; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  It was linked with 2019SA130412, 2019SA130377 and 2019SA130410.  This case involves a 8 months old male patient who that was exposed to a temperature excursion, while he received 0.5 ml vaccine IPV (VERO) [IPOL] on 25-Apr-2019 (lot: P1A242M)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was of actual medication error due to incorrect product storage.  It was unknown whether adverse event was experienced.  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.  List of documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: elevated temperature excursion; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  It was linked with 2019SA130411, 2019SA130377 and 2019SA130410.  This case involves a 2 months old female patient who that was exposed to a temperature excursion, while he received 0.5 ml vaccine IPV (VERO) [IPOL] on 24-Apr-2019 (lot: P1A242M)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE (HIB) for Immunisation; and Prevnar for Immunisation.  It was of actual medication error due to incorrect product storage.  It was unknown whether adverse event was experienced.  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.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The Quadracel vaccine was given to a two-year old patient, no adverse event; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a two years old female patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5500CA) vaccine in right thigh on 01-Apr-2019   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); HEPATITIS B VACCINE (HEPATITIS B VACCINE); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It is an actual medication error due to Inappropriate age at vaccine administration.  It was reported that the Quadracel vaccine was given to a two-year old in the right thigh.  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.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: liquid portion of Pentacel given without reconstituting with the lypoholized HIB powder portion/ No reports of side effects; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 28 months old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history and family history were not provided. Concomitant vaccination included Hepatits A and MMR vaccines.   On 09-May-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (ACT-HIB) lot UJ108AA, expiry date 24-Jul-2020 via intramuscular route in right thigh (R vastus lateralis).  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that liquid portion of Pentacel given without reconstituting with the lypoholized HIB powder portion.  The patient did not experience any adverse reaction after the injection.   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.  List of documents held by sender- none.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: gave a ACT-HIB to an individual and it was reconstituted with sterile water instead of the appropriate diluent; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown demographic patient who was vaccinated with HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] lot number not reported via unknown route in unknown administration site on an unspecified date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong solution used in drug reconstitution. It was reported that someone who gave Act-HIB to an individual and it was reconstituted with sterile water instead of the appropriate diluent.  It was unknown whether the individual had any adverse event or not.  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.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: low grade fever for 6-7 days at 100 something-102 degrees; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an 18 years old female patient who experienced low grade fever for 6-7 days at 100 something-102 degrees, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-May-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  The patient developed a non-serious low grade fever for 6-7 days at 100 something-102 degrees (pyrexia) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  (Other relevant tests included No lab data.)  Final diagnosis was low grade fever for 6-7 days at 100 something-102 degrees.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for low grade fever for 6-7 days at 100 something-102 degrees.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Daptacel was mistakenly given to an 11 year-old child/ no AE; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 11 years old patient (gender unknown) who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 11-Apr-2019, the patient received a fifth dose in series of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5206AA, expiry date 17-May-2018 via intramuscular route in the right deltoid.  It was an actual medication error due to inappropriate age at vaccine administration. It was reported that Daptacel was mistakenly given to an 11 year-old child.  The patient did not experience any adverse reaction after the injection.   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.  List of documents held by sender- none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: lypholized powder portion of the pentacel was given with sterile water instead of liquid dtap ipv that is provided as diluent/dtap ivp liquid was not administered/ no adverse event; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17.5 months old female patient who received lypholized powder portion of the pentacel with sterile water instead of liquid dtap ipv that was provided as diluent/dtap ivp liquid was not administered/ no adverse event, while she received vaccine 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.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar) for Immunisation; and rotavirus vaccine live oral 1v (Rotarix) for Immunisation.  On 07-May-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (ActHIB Lyophilized Powder. Lot: C5542AA exp date: 09-Aug-2019 ) via unknown route in the right vastus lateralis.  It was a case of actual medication error due to inappropriate reconstitution technique.  There were no side effects.  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.  List of documents held by sender- none.
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurses gave an expired Daptacel vaccine/no adverse event; expired Daptacel Vaccine was given to 1 yr 7 mo old female/3rd dose the series/no adverse event; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 months old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 08-May-2019, the patient received 0.5 ml third dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in the leg.  It was of actual medication error case due to Inappropriate age at vaccine administration and Expired vaccine used.  It was reported that no adverse event was experienced.  Information on the batch number was requested  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.  List of documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Product container issue
Clinical narrative: This is a spontaneous case, initially received from a pharmacist on 29-Nov-2018, concerns a 50-year-old, adult male patient. It was reported that as the vial was being held upside down to withdraw doses, the vial leaked as the needle was removed. On 08-Oct-2018, the patient was administered FLUAD (TIV) from the leaking vial [dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: not reported] for unknown indication. 25-gauge needle and 3 mL size syringe were used. The user added air to the vial from the syringe. The leak was observed at the exit point of the needle. No adverse reactions reported after administration of the vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034039. Based on the QA investigation, the Investigation of the Batch Production Records and Manufacturing Systems involved in Batch 252234, found it to be unlikely that the Leaking Vial defect identified in this complaint was the result of the manufacturing process at the facility. It was concluded that, the complaints were reported after the vials had been punctured; during and after usage. FLUCELVAX was manufactured for multi-dose usage. Facility did not manufacture or supply the devices used for administration activities. Additionally, the technique used to administer the preceding doses from the complaint vial(s) could not be determined. No factors from within facility processing were found to have contributed to the reported complaints. This case is linked to case: 201806030 (same reporter). The reporter assessed this case as non-serious. Follow-up received from pharmacist on 21-Jan-2019: The patient's date of birth and other details (address, city, county, state, postal code and phone number) were added in the patient tab. Added reference number (Med info number: SEQ19-00381) in the additional information tab. No changes were done in the narrative. Reporter's Comments: A 50-year-old male patient was administered dose from the leaking multi-dose vial of FLUAD TIV. The company assessed the events as not related to the suspect vaccine due to the accidental nature of the event product leakage and incidental nature of the event drug administration error.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea, Faecal volume increased
Clinical narrative: patient developed large volume, non-bloody diarrhea  that started the evening of her first rota virus vaccine and has persisted since.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site swelling
Clinical narrative: -- after vaccination, the next day (05-14-2019), mother noted redness and swelling in left lateral thigh. Nurse believes this is where the varicella vaccine was given. Over the next two days, the swelling and redness worsened to perhaps 6-7 inches diameter. Mild discomfort only, no fever.  Benadryl and topical steroid given.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Pt experienced brief dizziness and palor that resolved with laying supine with an ice pack for several minutes and sips of water. Slowly sat up and dangled to standing with no difficulties.
Age: 23.0
Sex: M
Vaccine: JEV1, RAB
Symptoms: Chills, Dizziness, Headache, Malaise, Pain
Clinical narrative: Feverish feeling, chills, malaise, headache, dizziness, body aches
Age: 23.0
Sex: M
Vaccine: JEV1, RAB
Symptoms: Pyrexia
Clinical narrative: Feverish feeling, chills, malaise, headache, dizziness, body aches
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Diarrhoea, Dyskinesia, Electroencephalogram, Vomiting
Clinical narrative: vomiting, diarrhea, and arm/leg jerdking
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Death, Sneezing
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 3-year-old male patient with Wiedemann-Steiner syndrome (captured as short stature, developmental delay, muscle hypotonia, facial dysmorphism and hairy elbow syndrome). No other information regarding his pertinent medical history, drug reactions or allergies and concomitant medications was reported. On 12-MAR-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # R025297 has been verified to be a valid lot number, expiration date 08-JUN-2020) (exact dose, route of administration and injection site were not provided) as immunization for the prevention of pneumococcal disease. On 13-MAR-2019, he began to experience coughing and sneezing. The patient did not seek medical treatment for the events. On 14-MAR-2019, the patient died. The cause of death was unknown. It was unknown what medical intervention was sought or performed on 14-MAR-2019 or if an autopsy was performed. The outcome of the coughing and sneezing was unknown. The relatedness between the events and the suspect vaccine was not provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect; patient recieved MMRII and VARIVAX via intramuscular route; This spontaneous report was received from a health professional (nurse) refers to a patient of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. The concomitant therapies included sterile diluent (STERILE DILUENT). On 13-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency and anatomical location were unknown) (lot # R014689,expiry date 23-MAY-2020) via intramuscular route for prophylaxis, varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency and anatomical location were unknown) (lot # R031626,expiry date 01-NOV-2020) via intramuscular route for prophylaxis.( incorrect route of product administration). No adverse effects reported. No product quality complaint (PQC) reported for this case.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Patient administered an improperly stored dose of VARIVAX; This spontaneous report was received from an other healthcare professional (medical assistant) regarding a patient of unknown age and gender. The patient's concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reaction and drug allergies were unknown. On 07-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # N035941 and expiry date: 18-DEC-2019 (strength, dose and route) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) for 26 hours. Previously vaccine underwent temperature excursion of 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for 5 hours. The call was due to digital data logger. No adverse symptoms reported (no adverse event). Product quality complaint was not involved.
Age: 60.0
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Vaccination site swelling
Clinical narrative: Adult hepatitis A vaccine administered at 90 degree angle with 1-inch, 25 gauge needle. Immediately following vaccination, a bump approximately the size of a nickel formed at the site of vaccination. Patient did not complain of pain following vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: swollen, red, hot to touch, sore to the bone! Dr. said do not get the second shot but I am still having the same symptoms, almost as bad,  and tomorrow is ONE WEEK. It seemed like it was better on Tuesday but seems to have flared up again????
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Cough, Endoscopy, Fatigue, Laryngitis
Clinical narrative: Rash on arm, 101.3 Temperature 04/27/2019,   Laryngitis 04/30/2019,  Sore throat, white sores and inflammation at back of throat, Tired, chronic cough 04/30/2019.  Symptoms lasted until 05/14/2019
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Rash, Streptococcus test negative, Throat irritation, Throat lesion
Clinical narrative: Rash on arm, 101.3 Temperature 04/27/2019,   Laryngitis 04/30/2019,  Sore throat, white sores and inflammation at back of throat, Tired, chronic cough 04/30/2019.  Symptoms lasted until 05/14/2019
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin discolouration, Skin irritation
Clinical narrative: Patient has 3" by 6" purple area of left side of upper mid back that had started the day after receiving the vaccine on 2/8/19 and still continuing on 5/16/19. She says it fluctuates to achy to irritated to painful.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Cough, Decreased appetite, Myalgia, Nausea
Clinical narrative: Cough, joint pain, muscle pain, loss of appetite, nausea, fever
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Cough, joint pain, muscle pain, loss of appetite, nausea, fever
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Anxiety, Dizziness, Injection site pain
Clinical narrative: Apprx. 30 mins after MMR vaccine, EE C/O feeling dizzy, soreness at site of injection, anxious. VSS
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Headaches, Fever, Nausea, malaise 3 hours after admin. Sent to ER by ambulance.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Cerebellar ataxia, Fall, Gait disturbance, Immunisation reaction, Irritability
Clinical narrative: walking and overcompensating on right side,  Losing balance and falling.  Hypersensitive to light this morning.  More lethargic, more needy, more cranky.    Starting at 36 hrs, had tendency to veer left. That is still present at 48 hrs  1. Cerebellar ataxia  2. Post-immunization reaction, initial encounter  Treatment: Close Observation
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Lethargy, Photophobia
Clinical narrative: walking and overcompensating on right side,  Losing balance and falling.  Hypersensitive to light this morning.  More lethargic, more needy, more cranky.    Starting at 36 hrs, had tendency to veer left. That is still present at 48 hrs  1. Cerebellar ataxia  2. Post-immunization reaction, initial encounter  Treatment: Close Observation
Age: 18.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Blood pressure normal, Cold sweat, Hyperhidrosis, Incomplete course of vaccination, Pallor
Clinical narrative: Pt in clinic for immunizations. NKDA. Denies any previous reactions to immunizations. Consent signed. Handouts given: State copy of 121 form and vaccination personal record sheet.  Varicella and  HPV administered using aseptic technique. Educated parents and pt on vaccines, s/sx of adverse reactions, and when to seek medical attention. Client started getting clammy and sweaty. Color turned pale. Ice packs applied to forehead and layed client down with legs up. BP 100/58 P 50. Client states is very "scared of needles". Did not administer Menactra or Hep A after this incident. 15 min later BP 110/62 P 68, color came back and client was ok. Monitored for 30 minutes before client left HD.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Crying, Discomfort, Irritability, Opisthotonus, Screaming
Clinical narrative: Mom stated that patient has been fussy and that last night patient woke up crying/screaming and arching back. Mom giving tylenol to help with discomfort, advised mom keep an eye on patient today and if it happens again to come in and be seen in office. First two vaccine sets mom stated patient was fussy, but no other reactions.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Chest X-ray, Cough, Decreased appetite, Injection site erythema, Irritability
Clinical narrative: Child began with redness at the site of injection on right arm on 5/10/19 started with a fever tmax 102 on 5/12/19, irritability,  decreased appetite  cough and congestion at time of injection has not worsened
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Child began with redness at the site of injection on right arm on 5/10/19 started with a fever tmax 102 on 5/12/19, irritability,  decreased appetite  cough and congestion at time of injection has not worsened
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Influenza like illness, Injection site pain, Migraine, Ophthalmological examination
Clinical narrative: Continued Double Vision, migrane for 4 days afterward, flu-like symptoms, injection site (arm) VERY painful for days afterward.
Age: 67.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth, pain
Age: 9.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had redness, pain and swelling at injection site
Age: 20.0
Sex: M
Vaccine: HEPA, MMR, TD
Symptoms: Confusional state, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: VASOVAGAL SYNCOPE IMMEDIATELY AFTER GETTING ALL THREE VACCINES, CAME TO IN MOMENTS AND RECORDED CONFUSION AND PALENESS TO SKIN ( MAINLY FACE), MONITORED VITALS AND RELEASED AFTER 30MINS.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: the patient was inadverently administered a dose of MMR II by intramuscular injection instead of subcutaneous injection; No adverse effects were reported; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender.      The patient's pertinent medical history and drug reaction or allergies were not reported.  On 05-MAY-2019, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # R036583, expiration date reported as 17-FEB-2020, but upon internal validation established as 17-DEC-2020 for prophylaxis (dosage was not reported) by intramuscular injection instead of subcutaneous injection (incorrect route of product administration). No adverse effects were reported. Vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (M-M-R II) was reconstituted with sterile diluent.
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia
Clinical narrative: temporary numbness in the deltoid region of her arm on an unspecified date which resolved "within a month"; third dose of GARDASIL 9 was administered by subcutaneous injection; This spontaneous report was received from a physician and refers to a 34-year-old female patient. The patient did not have pertinent medical history and drug reactions or allergies. The patient did not take any concomitant medications.  On an unknown dates, the patient was vaccinated intramuscularly with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, lot number and expiration date were not reported) for prophylaxis.   On an unknown date, after the patient's second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, she experienced temporary numbness in the deltoid region of her arm which resolved within a month. There was no lab diagnostic performed and no treatment given for the adverse event.  On an unknown date in 2018 (reported as "sometime late last year"), the patient's third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered by subcutaneous injection (incorrect route of product administration) (exact dose, lot number and expiration date were not reported). No adverse effects were reported after the third injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The relatedness between temporary numbness in the deltoid region of patient's arm and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects; patient received two (2) doses of PNEUMOVAX 23 on 5/10/2019; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported.  On 10-MAY-2019, the patient was vaccinated with two doses of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot# R022249, expiration date 16-APR-2020 (exact doses and site of administration were not reported) for prophylaxis. No adverse effects were reported.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: redness, a little bit of soreness, swelling, and small lump directly at injection site; redness, a little bit of soreness, swelling, and small lump directly at injection site; redness, a little bit of soreness, swelling, and small lump directly at injection site; redness, a little bit of soreness, swelling, and small lump directly at injection site; the patient was administered an expired dose on PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a 68-year-old female patient. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 10-MAY-2019, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 dose 0.5 milliliter, lot # N025656, expiration date 19-APR-2019, intramuscularly in the right deltoid (strength and dose number were not reported) for prevention of pneumonia. On 11-MAY-2019, the patient developed redness, a little bit of soreness, swelling and small lump directly at injection site. The outcome of the events was reported as recovering.  The causality assessment between the suspect therapy and the events was not provided.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Face oedema, Genital rash, Injection site erythema, Penile oedema, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythema induratum in a 68-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (injection received years before). On 29th April 2019, the patient received SHINGRIX. On 29th April 2019, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema. On 1st May 2019, the patient experienced erythema induratum (serious criteria GSK medically significant), genital eruption male and rash. On an unknown date, the outcome of the erythema induratum, injection site erythema, genital eruption male and rash were unknown. It was unknown if the reporter considered the erythema induratum, injection site erythema, genital eruption male and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on left arm. The patient experienced redness at the injection site. On 1st May 2019, the physician noted that the patient has a 10 cm area of indurate erythema on the left lower tricep where it meets the deltoid. The physician also reports the patient had edematous areas about 1.5 cm in area around the right cheek and area of the penis. The reporter consented to follow up. The physician gave permission to contact him for any further specifics. The patient was not given the injection of SHINGRIX at this physician's office.
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Feeling abnormal, Impaired work ability, Irritable bowel syndrome, Migraine
Clinical narrative: muscle aches; bone aches; nausea; vomiting; fever; massive migraines; felt bad; irritable bowel syndrome; This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine.   In March 2019, the patient received the 1st dose of Shingrix. In March 2019, 21 days after receiving Shingrix, the patient experienced irritable bowel syndrome. On an unknown date, the patient experienced muscle pain, bone pain, nausea, vomiting, fever, migraine and feeling bad. On an unknown date, the outcome of the muscle pain, bone pain, nausea, vomiting, fever, migraine, irritable bowel syndrome and feeling bad were recovered/resolved.   It was unknown if the reporter considered the muscle pain, bone pain, nausea, vomiting, fever, migraine, irritable bowel syndrome and feeling bad to be related to Shingrix.  Additional details were provided as follows: The nurse reported these adverse events were experienced by herself. The age at vaccination was not reported. Two months ago (from the date of reporting), the patient received 1st dose of the vaccine.  About 3 weeks later, the patient developed irritable bowel syndrome (IBS).  The patient had parasite testing as well as abdominal and pelvic ultrasound done. All results returned normal. Less than a year after receiving the 1st dose, the patient experienced muscle and bone aches, nausea with vomiting, fever and massive migraines and she felt bad. The patient remarked that she was very hesitant to get 2nd dose, but followed through with receiving it as she was a registered nurse and recognizes the importance of completing the series.  After receiving 2nd dose, the patient felt so bad as the first time and that she had to take a day off of work, for tolerance refer case US2019GSK086655.   The patient also commented that pharmacist really needs to highlight the horrible side effects of the vaccine.  No other details provided.      Lab Comments: On an unknown date, parasitic test, abdominal and pelvic ultrasound was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Parasitic blood test negative, Pyrexia, Ultrasound abdomen normal
Clinical narrative: muscle aches; bone aches; nausea; vomiting; fever; massive migraines; felt bad; irritable bowel syndrome; This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine.   In March 2019, the patient received the 1st dose of Shingrix. In March 2019, 21 days after receiving Shingrix, the patient experienced irritable bowel syndrome. On an unknown date, the patient experienced muscle pain, bone pain, nausea, vomiting, fever, migraine and feeling bad. On an unknown date, the outcome of the muscle pain, bone pain, nausea, vomiting, fever, migraine, irritable bowel syndrome and feeling bad were recovered/resolved.   It was unknown if the reporter considered the muscle pain, bone pain, nausea, vomiting, fever, migraine, irritable bowel syndrome and feeling bad to be related to Shingrix.  Additional details were provided as follows: The nurse reported these adverse events were experienced by herself. The age at vaccination was not reported. Two months ago (from the date of reporting), the patient received 1st dose of the vaccine.  About 3 weeks later, the patient developed irritable bowel syndrome (IBS).  The patient had parasite testing as well as abdominal and pelvic ultrasound done. All results returned normal. Less than a year after receiving the 1st dose, the patient experienced muscle and bone aches, nausea with vomiting, fever and massive migraines and she felt bad. The patient remarked that she was very hesitant to get 2nd dose, but followed through with receiving it as she was a registered nurse and recognizes the importance of completing the series.  After receiving 2nd dose, the patient felt so bad as the first time and that she had to take a day off of work, for tolerance refer case US2019GSK086655.   The patient also commented that pharmacist really needs to highlight the horrible side effects of the vaccine.  No other details provided.      Lab Comments: On an unknown date, parasitic test, abdominal and pelvic ultrasound was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound pelvis normal, Vomiting
Clinical narrative: muscle aches; bone aches; nausea; vomiting; fever; massive migraines; felt bad; irritable bowel syndrome; This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine.   In March 2019, the patient received the 1st dose of Shingrix. In March 2019, 21 days after receiving Shingrix, the patient experienced irritable bowel syndrome. On an unknown date, the patient experienced muscle pain, bone pain, nausea, vomiting, fever, migraine and feeling bad. On an unknown date, the outcome of the muscle pain, bone pain, nausea, vomiting, fever, migraine, irritable bowel syndrome and feeling bad were recovered/resolved.   It was unknown if the reporter considered the muscle pain, bone pain, nausea, vomiting, fever, migraine, irritable bowel syndrome and feeling bad to be related to Shingrix.  Additional details were provided as follows: The nurse reported these adverse events were experienced by herself. The age at vaccination was not reported. Two months ago (from the date of reporting), the patient received 1st dose of the vaccine.  About 3 weeks later, the patient developed irritable bowel syndrome (IBS).  The patient had parasite testing as well as abdominal and pelvic ultrasound done. All results returned normal. Less than a year after receiving the 1st dose, the patient experienced muscle and bone aches, nausea with vomiting, fever and massive migraines and she felt bad. The patient remarked that she was very hesitant to get 2nd dose, but followed through with receiving it as she was a registered nurse and recognizes the importance of completing the series.  After receiving 2nd dose, the patient felt so bad as the first time and that she had to take a day off of work, for tolerance refer case US2019GSK086655.   The patient also commented that pharmacist really needs to highlight the horrible side effects of the vaccine.  No other details provided.      Lab Comments: On an unknown date, parasitic test, abdominal and pelvic ultrasound was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Constipation, Diarrhoea, Gastrointestinal disorder, Headache, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of gastrointestinal disturbance in a female patient who received SHINGRIX for prophylaxis.  Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced gastrointestinal disturbance (serious criteria GSK medically significant), constipation, diarrhea, vomiting, general body pain, headache, drug dose administration interval too short and off label use. On an unknown date, the outcome of the gastrointestinal disturbance, constipation, diarrhea, vomiting, general body pain, headache, drug dose administration interval too short and off label use were unknown. It was unknown if the reporter considered the gastrointestinal disturbance, constipation, diarrhea, vomiting, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The case was reported for the reporter's friend. The age at vaccination was not reported. The batch number for SHINGRIX was not provided. It was reported that patient was advised by her doctor to receive the 2nd dose of SHINGRIX one week after receiving the 1st dose, which led to shortening of vaccination schedule and might lead to off label use. The patient subsequently experienced headache, body aches, vomiting, diarrhea, constipation and digestive blocking. It was reported that the patient might be vulnerable to the vaccine reaction. It was reported that this was an anecdotal event and she did not have other details.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of gastrointestinal disturbance in a female patient who received SHINGRIX for prophylaxis.  Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced gastrointestinal disturbance (serious criteria GSK medically significant), constipation, diarrhea, vomiting, general body pain, headache, drug dose administration interval too short and off label use. On an unknown date, the outcome of the gastrointestinal disturbance, constipation, diarrhea, vomiting, general body pain, headache, drug dose administration interval too short and off label use were unknown. It was unknown if the reporter considered the gastrointestinal disturbance, constipation, diarrhea, vomiting, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The case was reported for the reporter's friend. The age at vaccination was not reported. The batch number for SHINGRIX was not provided. It was reported that patient was advised by her doctor to receive the 2nd dose of SHINGRIX one week after receiving the 1st dose, which led to shortening of vaccination schedule and might lead to off label use. The patient subsequently experienced headache, body aches, vomiting, diarrhea, constipation and digestive blocking. It was reported that the patient might be vulnerable to the vaccine reaction. It was reported that this was an anecdotal event and she did not have other details.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Chest pain, Dyspnoea, Speech disorder
Clinical narrative: 10 minutes after receiving YF vaccine, patient developed sharp chest pain which then proceeded to shortness of breath to the point where he could not speak. Patient was taken back to the clinic where a rapid response team was contacted. Member received Epi and Benadryl prior to transport to a civilian emergency room for further evaluation and treatment. Pt received solumedrol and Pepcid IV. He was observed for 3 hours and then discharged with home prescription for prednisone, Pepcid, and epi pen.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Blood potassium decreased, Chest pain, Flushing, Full blood count, Laboratory test
Clinical narrative: MMR given subcutaneously right deltoid area. Within 3 minutes became flushed, chest pain, tachycardia. Taken to ER for treatment. Was hospitalized overnight, released next day with no restrictions.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Tachycardia, Troponin increased
Clinical narrative: MMR given subcutaneously right deltoid area. Within 3 minutes became flushed, chest pain, tachycardia. Taken to ER for treatment. Was hospitalized overnight, released next day with no restrictions.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Influenza like illness, Peripheral swelling
Clinical narrative: shaking, headache, flu like symptoms, feeling cold, shivering, swollen arm
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: shaking, headache, flu like symptoms, feeling cold, shivering, swollen arm
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: LOCALIZED SWELLING, REDNESS ABOUT THE SIZE OF A HALF DOLLAR. WARM TO THE TOUCH
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Burning sensation, Chills, Fatigue, Injection site pain
Clinical narrative: ?Sunburn? sensation on skin of torso and thighs, body  aches, shivers, stomach discomfort, low-grade fever (100.2), fatigue .  The skin sensitivity began within 20 of injection and remaining symptoms were present upon awakening 12 hours later.  Low-moderate pain at site of injection and skin sensitivity continues 36 hours later.  No fever 36 hours later