chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 20 years old female patient who was vaccinated with 1 ml first dose of IMOVAX RABIES (Batch number: N1K30 and expiry date: 28-Oct-2019) via intramuscular route in the left deltoid on 14-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications: none. It was a case of actual medication error due to vaccine under dose because the vaccine leaked out and patient did not get full dose. Lot number reported: Vaccine vial- N1K30 expiry date: 28-Oct-2019, Diluent Syringe- Lot: M0304 Expiry date: 28-Oct-2019 and Box N1K303M expiry date: 28-Oct-2019. It was also a case of syringe leak because the liquid leaking from syringe or Luer Lock. 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 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. Documents held by the sender: none.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 17 months old female patient who was vaccinated with 0.5 ml once second dose of ACT-HIB (Batch number: UI822AAA and expiry date: 05-Jan-2019, route and site of administration were not reported) on 07-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were reported as none. It was a case of actual medication error due to expired vaccine used. No symptoms were reported. 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. Documents held by the sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 55 years old male patient who was vaccinated with a dose of  FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT Vaccine (lot number and Expiry date unknown) 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 actual medication error due to wrong vaccine administered, Inappropriate age at vaccine administration and Overdose. It was unknown whether patient experienced any adverse reaction. 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 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: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 58 years old female patient who was vaccinated with two doses of FLUBLOK QIV on 21-Sep-2018 (lot QFAA1816, expiration date: 30-Jun-2019) via unknown route in unknown administration site) and on 29-Oct-2018 (lot QFAA1834, expiration date: 30-Jun-2019) via unknown route in the right deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is an actual medication error case due to extra dose administered. It was reported that the patient received two doses of FLUBLOK QUADRIVALENT 38 days apart and stated that the patient had not complained about anything. 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: 6.0
Sex: M
Vaccine: DT
Symptoms: Abdominal discomfort, Gastrointestinal disorder, Nausea, Vomiting
Clinical narrative: Initial information received on 15-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional. This case involves a 6 years old male patient who experienced stomach/gastrointestinal problems, nauseous a lot and throws up, doesn't finish his meal and does not feel good after eating, approach to appetite has changed and vomited with milk, while he received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. In April 2018, the patient received a dose of suspect DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE (lot number: C5116AA and expiry date: 05-Jan-2019). On an unknown date, the patient developed a non-serious stomach/gastrointestinal problems, nauseous a lot and throws up,  doesn't finish his meal and does not feel good after eating approach to appetite has changed and vomited with milk following the administration of DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE. No Lab data was reported. Final diagnosis was vomited with milk, approach to appetite has changed, doesn't finish his meal and does not feel good after eating, nauseous a lot and throws up and stomach/gastrointestinal problems. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. Documents held by the sender: none.
Sex: F
Vaccine: DTAP, FLU4, HEPA, IPV, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 15-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old female patient who received an expired dose of vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE; FLUZONE QUADRIVALENT; MMR VACCINE; VARICELLA VACCINE; and IPOL. On 13-Feb-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5148AA (expiry date: 09-FEB-2019 ) in the left deltoid. It was a case of actual medication error due to expired vaccine used. It was reported that no adverse event occurred. 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: Extra dose administered
Clinical narrative: Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 47 years old male patient who experienced received vaccines INFLUENZA VACCINE on Dec-2018 and 0.5 ml single dose of FLUZONE QUADRIVALENT on 15-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if adverse event was experienced 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.
Sex: M
Vaccine: FLU4
Symptoms: Fall
Clinical narrative: Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 45 years old male patient who fall, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. The patient fall (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. List of documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Initial information received on 15-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse practitioner by phone. This case involves a 3 years old (reported as 3 year and 11 months) female patient who was vaccinated with a 0.25 ml first dose once injection of FLUZONE QUADRIVALENT (Batch number: UT6262NA and expiry date: 30-Jun-2019) in right thigh (route of administration not reported) on 14-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A Vaccine. It was a case of actual medication error due to vaccine under dose because the nurse practitioner prescribed a dose of 0.5 mL, but the medical assistant who administered the dose grabbed a 0.25 mL syringe in error. It was unknown if any adverse event occurred or not following the vaccination. It was reported that PTC template was not completed because it was not realized until after the call that this would be reported also as a PTC since it is a combination drug/device product and there was a mix-up. 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. Documents held by the sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 11 years old patient who sterile water as a diluent, ACT-HIB, instead of diluent. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of medication error due to Inappropriate reconstitution technique. No ill effects have been 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: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a female patient of unknown age who received first dose (post exposure) on 17-Jan-2019, second dose on 30-Jan-2019 and third dose on 15-Feb-2019 of vaccine, IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was not reported whether adverse event was experienced by the patient. 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: 1.92
Sex: F
Vaccine: TYP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 23 months old female patient who was vaccinated with a dose of TYPHIM VI (lot P1D701M and Exp. Date 15-Sep-2020) on 16-Feb-2019 via an unknown route in unknown site. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient had any adverse reactions. 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: DTAP, FLUX, HEPA
Symptoms: Expired product administered
Clinical narrative: Initial information received on 19-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old male patient who received an expired fourth 0.5 ml dose of suspect DAPTACEL lot number C5065AA expiry date 08-Oct-2018 via intramuscular route in left leg muscle administration site on an unknown date. The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included HEPATITIS A VACCINE and INFLUENZA VACCINE. It was a case of actual medication error due to expired vaccine used. No specific adverse event information 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. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 19-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 65 years old female patient who received vaccine ADACEL after there was a delay in shipping. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was received. On 18-Feb-2019, the patient received single 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6217AA via intramuscular route in the left arm. It was a case of actual medication error due to incorrect product storage. It was unknown whether any adverse event experienced 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.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 10 years old patient who vaccinated with 0.5 ml dose of FLUBLOK QIV lot QFAA1818 and Exp. Date 30-Jun-2019 via intramuscular route in the arm, on 14-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that a 10 year old was given FLUBLOK by mistake. No adverse events were 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. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Paralysis
Clinical narrative: Initial unsolicited report received from  non healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2018343471) on 20-Feb-2019. This case involves adult patient (age and gender not reported) who was paralyzed for 24 hours, while received vaccines FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date (last year), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unspecified date, patient presented with serious paralyzed for 24 hours (paralysis) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. No Lab data was reported. Final diagnosis was paralyzed for 24 hours. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered for paralyzed for 24 hours. Documents held by the sender: none.; Sender's Comments: Patient presented with 24 hours paralysis after vaccination. Time to onset is unknown. Moreover, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Inflammation, Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: Initial information received on 20-Feb-2019 regarding an unsolicited valid serious case received from an other healthcare professional via other company (Pfizer) (MFR control number: 2018325036). This case involves a female patient of unknown age who walked off and fainted, passed out for at least 2 minutes and right arm is painful and significantly swollen, while he/she received vaccines MENACTRA and TRUMENBA. The patient had no medical history also did not take any concomitant therapy. On 08-Aug-2018, the patient received a single 0.5 ml injection of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5984AC Expiry date: 14 Aug 2019 via intramuscular route in the left deltoid. On 08-Aug-2018, the patient received a single 0.5 ml first injection of suspect TRUMENBA not produced by Sanofi Pasteur lot S58877 (Expiry date: 01 Feb 2019) via intramuscular route in the right deltoid. On 08-Aug-2018, The patient developed a serious walked off and faint (syncope) 5 minutes following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant (IME). On 09-Aug-2018, the patient's right arm was painful and significantly swollen (inflammation) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant. Lab test was not performed (The patient will come back in a week and an ultrasound will be done if the arm doesn't go down.). Final diagnosis was arm was painful and significantly swollen and faint. It was not reported if the patient received a corrective treatment. Reporter causality: causality of fainted with MENACTRA was assessed as unknown and for inflammation localized was assessed as unrelated. TRUMENBA: fainted: Unknown and inflammation localized: Related. The patient outcome is recovered for faint (duration: 2 minutes), Recovered / Resolved With Sequelae for inflammation (outcome was reported as Recovered with lasting effects). List of document held: none; Sender's Comments: A female patient experienced syncope (latency 5 minutes), swelling and painful right arm after vaccination with MENACTRA and TRUMENBA. Time to onset is compatible for syncope and unknown for other events. Patient had no medical history nor taken any concomitant therapy or done any lab test. To be noted that swelling and pain was observed at other company site hence it is considered unrelated to MENACTRA. Moreover, concomitant administration of two vaccines preceded the events. Based upon the reported information, the role of the vaccines cannot be individually assessed for syncope.
Sex: U
Vaccine: PNC13, TDAP
Symptoms: Rash
Clinical narrative: Initial information received on 19-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves patient (with unknown demographic) who experienced rash, while received vaccines DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and PREVNAR 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and PREVNAR 13 (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious rash (Unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and PREVNAR 13. (Other relevant tests included No lab data.) Final diagnosis was rash. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine, Malaise
Clinical narrative: This a spontaneous case initially received from a physician, via pharmaceutical manufacturer (Pfizer), on 14-Feb-2019, concerning a female patient of an unspecified age. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication. On an unspecified date after vaccination, the patient was very ill and was hospitalized. The outcome of the event was not reported. It was considered, that the patient experienced allergy to the flu vaccination. The reporter assessed this case as serious due to hospitalization. Reporter's Comments: A female patient of unknown age was very ill and was hospitalized, on an unspecified day after administration of INN Flu Vaccine. Considering the minimal information regarding the exact onset latency between vaccination to symptoms onset, concurrent medical condition and investigations to provide alternate aetiologies, the causal role of suspect vaccine was assessed as unassessable.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Patient had SHINGRIX vaccine on 2/11/19, he had Zoster 2-3 years ago around right eye and abdomen. He developed a Zoster rash around right eye 2 days after the vaccine.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Patient reported getting flu shots every year for her job and this time, the pharmacist gave her the shot very high up on her shoulder. Immediately after, she felt pain and this pain has been lingering ever since the shot. She has to lift her injured hand with her non-injured hand to move it. She says the pain starts from her shoulder down to her elbow where she can't extend her arm and then down to her wrist as well.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient reported getting flu shots every year for her job and this time, the pharmacist gave her the shot very high up on her shoulder. Immediately after, she felt pain and this pain has been lingering ever since the shot. She has to lift her injured hand with her non-injured hand to move it. She says the pain starts from her shoulder down to her elbow where she can't extend her arm and then down to her wrist as well.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Diarrhoea, Injection site nodule, Irritability, Lethargy, Middle insomnia
Clinical narrative: Vaccines: DTP/aP, HepB, Hib, PneumoConjugate, Polio patient had her six month shots at nine months. She was lethargic and feverish the day of and days after. A couple days after shots, she had four runny feces, then started throwing up. For two weeks, she was very fussy. Prior to shots, she was always happy and sleeping most of the night. After shots, she stayed fussy any time she was awake and woke up screaming multiple times each night. One week after shots, she developed a bad rash. When we took her back to the doctor a week after the shots, he said she probably had a virus and dismissed it.  Prior to shots, she had never even had a sniffle. For months, she had a marble size knot at one of the injection sites in her left leg.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Rash, Screaming, Vomiting
Clinical narrative: Vaccines: DTP/aP, HepB, Hib, PneumoConjugate, Polio patient had her six month shots at nine months. She was lethargic and feverish the day of and days after. A couple days after shots, she had four runny feces, then started throwing up. For two weeks, she was very fussy. Prior to shots, she was always happy and sleeping most of the night. After shots, she stayed fussy any time she was awake and woke up screaming multiple times each night. One week after shots, she developed a bad rash. When we took her back to the doctor a week after the shots, he said she probably had a virus and dismissed it.  Prior to shots, she had never even had a sniffle. For months, she had a marble size knot at one of the injection sites in her left leg.
Age: 44.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Headache, Immediate post-injection reaction, Nausea, Throat irritation
Clinical narrative: Client stated she had an immediate headache, nausea, and felt her throat was scratchy. This reaction occurred within five minutes after the injections. BP was 124/74 at fifteen minutes. Discussed incident with a NP who instructed to give water and comfort measures for now, return to her if her condition worsens. Returned to third floor to continue training. Checked in with her every 30 minutes. At the end of the day she stated she felt better.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Hypopnoea
Clinical narrative: I had no problem with the pain in my arm, but the dizziness and shallow breathing did concern me along with feeling incoherent. I started with the dizziness about 6 hours after the shot, followed by chills, extreme fatigue, severe muscle aches and then feeling out of it for the next 4 days. I cancelled all plans for the weekend and rested. I am concerned about whether or not to get the 2nd shot...I have never had such a horrible reaction to a vaccine before.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incoherent, Myalgia, Pain in extremity
Clinical narrative: I had no problem with the pain in my arm, but the dizziness and shallow breathing did concern me along with feeling incoherent. I started with the dizziness about 6 hours after the shot, followed by chills, extreme fatigue, severe muscle aches and then feeling out of it for the next 4 days. I cancelled all plans for the weekend and rested. I am concerned about whether or not to get the 2nd shot...I have never had such a horrible reaction to a vaccine before.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse via physician regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reaction and allergies were unknown. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ (strength, dose, frequency, route not reported) lot # R016791 and expiry date 16-APR-2020 for prophylaxis. The vaccine underwent temperature excursion of 47 degree Fahrenheit (F) /9 degree Celsius (52F) for 3 hours and 25 minutes. Previously no temperature excursion was reported. The call was due to digital data logger. No adverse symptoms reported (no adverse event). Product quality complaint was not involved.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 months old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 19-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 18-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 16-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 12-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 10-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868. US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a medical representative and described the occurrence of fatigue in a 86-year-old female patient who received SHINGRIX for prophylaxis. On 17th February 2019, the patient received the 1st dose of SHINGRIX. On 17th February 2019, less than a day after receiving SHINGRIX, the patient experienced fatigue and general body pain. On an unknown date, the outcome of the fatigue was unknown and the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the fatigue and general body pain to be related to SHINGRIX. Additional details were reported as follows: The medical representative reported case for his or her family member. The patient experienced pain, aches and pains throughout body as well as fatigue beginning the night after SHINGRIX shot. The aches improved within first 24 hours.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site reaction
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in elbow in a 56-year-old male patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a month after receiving SHINGRIX, the patient experienced pain in elbow and injection site reaction. In February 2019, the outcome of the pain in elbow was recovered/resolved. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the pain in elbow and injection site reaction to be related to SHINGRIX. The patient received SHINGRIX vaccine in left arm, on the top near the shoulder. The patient stated that he might be experiencing a reaction to the SHINGRIX vaccine which was he received two weeks ago before from the date of reporting. The patient had minimal injection site reactions except for his left elbow. The patient was having extreme pain in his elbow when it was brushed up against something. The elbow was not swollen or sore to the touch and the acute pain was went away. It was unknown if the reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter work in a doctor's office and he wanted to report an adverse event with the patient who had a small red area at the site of injection. No fever or other issues were reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of herpes zoster (received 13 years before the date of reporting, broke out with shingles on right side of neck, 1 to 2 years later).  In May 2018, the patient received SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In May 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in mid May 2018 on the left arm. Her arm became sore within a couple of hours which lasted 24 hours. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of low back pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, 5 days after receiving SHINGRIX, the patient experienced low back pain. On an unknown date, the outcome of the low back pain was not recovered/not resolved. It was unknown if the reporter considered the low back pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no history of having back pain. The patient reported that she had the 1st dose of SHINGRIX on the 11th of February. About 5 days after the injection she started having severe lower back pain. This was the 1st time that she was experiencing it. The reporter did not consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 74-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 8th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced feeling unwell, pain and product supply issue. On an unknown date, the outcome of the feeling unwell and pain were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the feeling unwell and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose, the patient did not feel well. She also experienced aches around her middle on one side. It extended from her front around to her back, but only on one side. The aches went away after a couple days. Due to the backorder of vaccine, it was expected that the patients would be late for 2nd dose. Consent to follow up was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 17th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th February 2019, less than a day after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX on left arm. The patient planned to follow up with her physician on an unknown date. Consented to follow up was provided.