chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old male patient who received 0.5 ml dose of suspect DAPTACEL lot C5101A via intramuscular route in the deltoid expiry date: 26 Nov 2018 instead of ADACEL (lot number and expiry date not reported) on 23-Aug-2018. 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 drug administered and inappropriate age at vaccine administration. It was unknown if any adverse event was 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. List of the documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 10 years (age at vaccination was five years) old female patient who was vaccinated with ADACEL. This is actual medication error case due to Inappropriate age at vaccine administration. It was an actual medication error due to drug administered to patient of inappropriate age. (patient received ADACEL at age 5). On 03-Jul-2012, the patient received a dose of ADACEL (batch number, expiration date, dose, route and site of administration was not reported). It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Induration, Injection site discolouration, Insomnia
Clinical narrative: Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an adult female patient who experienced cant sleep due to the discomfort and can't sleep on that side, fatigue, redness is spreading and arm pain, site is darker, local itching, not able to lift her arm up far as she usually can, hard as a rock about the and size of an olive, while she received vaccine ADACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 17-Aug-2018, the patient received a dose of suspect Diphtheria-2, Tetanus, 5 AC Pertussis Vaccine (batch no U5879AB) (expiration date 13-MAR-2020) via unknown route in the right arm. On an unknown date, following vaccination, the patient arm developed pain to the point she is not able to lift her arm up far as she usually can. States she can't sleep due to the discomfort and can't sleep on that side, has fatigue, the site is darker and "hard as a rock" about the and size of an olive with local itching. States the redness is spreading and she has contacted the doctor who told her they would get back with her. This is also an actual medication error case due to caller feels injection was given a little lower than it should have been and she thinks definitely not in the deltoid (Vaccine administered at inappropriate site). Other relevant tests included no lab data. Final diagnosis was local itching, skin discoloration, redness and arm pain, fatigue and sleep disorder. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for all reported events. 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 sender: none.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an adult female patient who experienced cant sleep due to the discomfort and can't sleep on that side, fatigue, redness is spreading and arm pain, site is darker, local itching, not able to lift her arm up far as she usually can, hard as a rock about the and size of an olive, while she received vaccine ADACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 17-Aug-2018, the patient received a dose of suspect Diphtheria-2, Tetanus, 5 AC Pertussis Vaccine (batch no U5879AB) (expiration date 13-MAR-2020) via unknown route in the right arm. On an unknown date, following vaccination, the patient arm developed pain to the point she is not able to lift her arm up far as she usually can. States she can't sleep due to the discomfort and can't sleep on that side, has fatigue, the site is darker and "hard as a rock" about the and size of an olive with local itching. States the redness is spreading and she has contacted the doctor who told her they would get back with her. This is also an actual medication error case due to caller feels injection was given a little lower than it should have been and she thinks definitely not in the deltoid (Vaccine administered at inappropriate site). Other relevant tests included no lab data. Final diagnosis was local itching, skin discoloration, redness and arm pain, fatigue and sleep disorder. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for all reported events. 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 sender: none.
Sex: U
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Product storage error
Clinical narrative: Based on information received on 24-Aug-2018, the report previously considered as non-valid became valid (as number of patient identified). Initial information received on 23-Aug-2018 regarding an unsolicited non-valid non-serious case received from a non-health care professional (office staff), This case involves 37 child patients (gender unknown) who were vaccinated with dose of PENTACEL and ADACEL (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error case due to incorrect product storage. It was reported that that there were several temperature excursion reached -0.33C for 30 minutes for PENTACEL and ADACEL and the vaccines were given to 37 children. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information received on 24-Aug-2018 from a non-health care professional (office staff). Added number of patient, as reported and confirmed validly of case. List of documents held by sender- none.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Immediate post-injection reaction, Injection site induration
Clinical narrative: Initial information received on 24-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old female patient who felt skin at the site was hard and 2/3 of the patient's arm is red, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Aug-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5979AA; expiry date:13-Jun-2022 via intramuscular route in the left arm. On an unspecified date, the patient developed a non-serious the skin at the site was hard (injection site mass), immediately following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unspecified date ¸the patient developed a nn-serious 2/3 of the patient's arm is red (localised erythema) one-week following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. No lab test reported. Final diagnosis was 2/3 of the patients arm is red and the skin at the site was hard. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for the skin at the site was hard and as Unknown for 2/3 of the patient's arm is red.
Age: 55.0
Sex: M
Vaccine: TTOX
Symptoms: Rash, Tinea infection
Clinical narrative: Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 55 years old male patient who experienced rash on palms and back of hand, ringworm and would be missing his dose, while he received vaccine TETANUS TOXOID. The patient's past medical history included Allergy to animal with allergies cat and dog dander, feathers, nuts, orange juice, rabbit dander. and Eczema, allergic rhinitis, pollen allergy, moderate persistent asthma. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DUPIXENT; NASONEX; NIACIN; and PROAIR HFA and eye drops. It was reported that patient had an injury a deep cut of his arm and wrist not far from his artery, he went to hospital and they give him TETANUS TOXOID. On 23 Aug 2018, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. It was reported that patient was supposed to take his dose on 19 Aug 2018 however due to travel shipment delayed he will get it on 23 Aug 2018. On an unknown date the patient developed a non-serious rash on palms and back of hand (rash) and ringworm following the administration of TETANUS TOXOID. It was also a case of actual medication error due to Missed dose. (Other relevant tests included no lab data.) Final diagnosis was would be missing his dose and rash on palms and back of hand. An unknown corrective treatment was received. The patient outcome is reported as Unknown for would be missing his dose and as Unknown for rash on palms and back of hand. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Initial information received on 24-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three years old female patient who was administered with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI998AC, expiry date: 30-Jun-2019 and dose in series was not reported) via intramuscular route in the right thigh on 23-Aug-2018. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that patient moved so only partial dose received. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 0.75
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 24-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old female patient who was given only the hib component of PENTACEL diluted with sterile water from Merck. The patients past medical history and family history were not provided. Concomitant medications included HEPATITIS B VACCINE and PNEUMOCOCCAL CONJUGATE VACCINE (Lot number, expiry date and dose not reported on unknown date. On 16-Aug-2018, the patient received a third dose 0.5ml of suspect PENTACEL VACCINE, lot C5451AA, expiry date 07 Dec 2018 via intramuscular route in the left thigh. It was an actual medication error due to inappropriate reconstitution technique. It was reported that patient received only the Hib component of PENTACEL, diluted with sterile water from Merck. The patient had no known reported symptoms. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 3.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from an-other healthcare professional. This case was linked with the case 2018SA244411 (Siblings/ Same reporter). This case involves a 3 years old female patient who was vaccinated with a 0.5 ml dose of DAPTACEL (lot C5202BA and expiry date: 16-May-2019) via intramuscular route in the right thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient's concomitant medications included PREVENAR 13. It was a case of actual medication error due to Inappropriate schedule of vaccine administered because DAPTACEL given too early. It was unknown if any adverse reaction was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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 the sender: None.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Off label use, Product quality issue, Underdose
Clinical narrative: Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 17 years old male patient who was vaccinated with a 0.2-0.3ml dose of a single dose vial of MENACTRA (lot U6151AB; expiry date: 16-Mar-2020 via intramuscular route in the left deltoid on 25-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient didn't administer any concomitant vaccines. It was a case of actual medication error due to off label use and vaccine underdose. It was reported that physician noticed one MENACTRA single-dose vial contained between 0.2-0.3ml of product, but administered that dose. She reported the injection was delivered intramuscularly to his left deltoid. Reporter had not noticed any crack in the vial or problem with the stopper for the vial, a problem with the syringe or needle. It was reported the needle in that tray is 27g by 0.5 inch length regular needle. No signs of adverse reaction at the time of injection. This is also a case of Product packaging quantity issue. 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: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from other Health Care Professional. This case involves an unknown age and gender patient who received vaccine ACTHIB with diluent of sterile saline from Merck instead of the diluent from Sanofi. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot UI908AAB, expiry date; 10 Nov 2019 via unknown route in the unspecified deltoid. It was a case of actual medication error due to wrong solution used in drug reconstitution. It was unknown if 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. List of documents held by sender: none.
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Product preparation error
Clinical narrative: Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves Infant male (age unknown) patient whom gave ACTHIB with a saline diluent not the one that comes with it, while he received vaccine ACTHIB, PREVENAR and DTAP. On 23-Aug-2018, the patient received a 0.5 ml fourth primary dose of suspect ACTHIB VACCINE (lot number: UI944AA, expiry date: 02-Dec-2019) via intramuscular route in the left thigh. Patient also received PREVENAR and DTAP on the same day. It was a case of actual medication error due to wrong solution used in drug reconstitution. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a three years old male patient who received a 0.5 mL dose of IFLUZONE QUADRIVALENT (lot number U6260AA) in the left thigh on 27-Aug-2018. 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 incorrect product storage of vaccine. It was reported that FLUZONE QUAD was delivered in the morning after it was shipped on 22-Aug-2018 and was exposed to warm temperatures for too long. It was not reported if the patient experienced 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 holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Pruritus, Swelling
Clinical narrative: Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from Other health care professional (office manager). This case involves a 70 years old female patient who experienced itching, redness and swelling way below the injection site, while she received vaccine ADACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any concomitant medication. On 24-Aug-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2, TETANUS, 5 AC PERTUSSIS VACCINE (lot no U5875AB Exp. date 14 Feb 2020) via unknown route in the left deltoid. On 25-Aug-2018, the patient developed a non-serious itching one days following the administration of DIPHTHERIA-2, TETANUS, 5 AC PERTUSSIS VACCINE. On 25-Aug-2018, the patient developed a non-serious redness and swelling way below the injection site one day following the administration of DIPHTHERIA-2, TETANUS, 5 AC PERTUSSIS VACCINE. The patient returned to office on 27 Aug 2018, and at that time, the redness, itching and swelling were noted to be way below the injection site. The patient is not able to say if symptoms began at injection site. (Other relevant tests included no lab data). Final diagnosis was itching, redness and swelling way below the injection site. The patient did not receive any corrective treatment. The patient outcome is reported as not recovered for itching, for redness and swelling way below the injection site. List of documents held by sender - none.
Sex: U
Vaccine: DTAP, DTAPIPV, DTAPIPVHIB, HIBV, IPV, MNQ, TD, TDAP
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from nurse on 28-Aug-2018. This case involves a 25 patients who was vaccinated with a dose of vaccines MENACTRA (Batch number: U5948AB, U5848AA, U5986AA and U6015AA) (expiration date : 03-Jul-2019, 11-Mar-2019, 24-Aug-2019 and 06-Oct-2019), with a dose of QUADRACEL (Batch number: C5325BA and expiration date: 14-Nov-2019), with a dose of PENTACEL (Batch number: C5432AB and C5463AA) (expiration date: 29-Oct-2018 and 26-Feb-2019) with a dose of ADACEL (Batch number: U5850AA and C5546BA (expiration date: 17-JAN-2020 and 21-NOV-2020) (route and site of administration was not reported), ACT-HIB, TENIVAC, DAPTACEL and IPOL. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was unknown whether patient experienced any adverse event following vaccination. 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.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 29-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ADACEL. On 29-Aug-2018, the patient received a dose of suspect ADACEL VACCINE lot number not reported via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. MENACTRA had been drawn up on 28-Aug-2018 at the end of the day into a syringe and placed in the refrigerator. It was unknown whether any adverse event occurred 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age, Vomiting
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to a 2 week old patient of unknown gender. There were no pre-existing physician-diagnosed allergies, births defects or medical conditions. No concomitant therapies were reported. The patient's birth weight was 13lbs 8ozs. Illness at vaccination included rash. On 06-AUG-2018, the patient was crying and was vaccinated with ROTATEQ orally, lot # R007986, expiration date 13-OCT-2019 (dose was not reported) for prophylaxis. Vaccine was inadvertently given to patient by the nurse. It was not ordered by the physician and error occurred during dispensing. The patient vomited on unknown date in August 2018. No prescription drug treatment was required. The outcome of vomiting was reported as recovered on unknown date in August 2018. The event was assessed as non-serious by the reporter. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Abdominal pain upper
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis, lot #N029632 and expiration date 23-OCT-2019 (strength, dose, frequency and route of administration were not reported), that was reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperature of excursion was reported as 6 degree F to 14 degree F during a time frame of 14 hours. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA000590.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a company representative who is also a patient's parent and refers to a 11-year-old male patient. The patient had no pertinent medical history, concomitant medications, drug reactions and allergies. On 22-AUG-2018, the patient was vaccinated with GARDASIL 9 0.5 ml suspension for injection, intramuscularly (site of administration, lot# and expiration date were not reported) for prophylaxis. On the same day, the patient experienced pain at the vaccination (reported as injection) site. No treatment was given for the event, the patient did not seek medical attention. No lab diagnostic tests were performed. The outcome of the event was reported as not recovered. The relatedness between the event and GARDASIL 9 was not reported.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a nurse, regarding a 15 years old female patient. The patient's medical history or concurrent conditions were not reported. The patient had no any drug reaction / allergy. On 11-JUL-2018 the patient was vaccinated with 1 dose of GARDASIL 9 for prophylaxis (reported as "vaccination for HPV") (strength, anatomical location and route of administration were not reported). Lot number R000303, expiration date: 29-AUG-2020. Other suspect vaccines included Hepatitis A Vaccine, Inactivated (manufacturer unknown) (Dosage, route of administration, Lot number and expiration date were not provided). Concomitant therapies included melatonin and LEXAPRO. On 11-JUL-2018 the patient experienced syncope; it was stated from the reporter that she gave the GARDASIL 9 immediately after giving the patient Hepatitis A Vaccine, Inactivated (manufacturer unknown). Right after the patient received the GARDASIL 9 dose, the patient fainted for a couple of seconds to a minute (syncope). The patient received medical attention for the event, she layed down and recovered quickly and stayed in the office for observation for 20 to 30 minutes, but no additional side effects happened. An unspecified treatment was given for the adverse event. On 11-JUL-2018, the patient was recovered from the event. The causal relationship between the syncope and the vaccination with HPV GARDASIL 9 and Hepatitis A Vaccine, Inactivated (manufacturer unknown) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse concerning to a patient of unknown age and gender. The patient's historical conditions, concurrent condition s, drug reactions/ allergies and concomitant medications were not provided. On 27-AUG-2018,  the patient was vaccinated with PROQUAD rHA (recombinant human albumin), subcutaneous lot # R007679 and expiration date 11-SEP-2018 (dose and anatomical location were not reported) as prophylaxis. The nurse reported that the patient may have received less than the full dose of PROQUAD. No adverse effect were reported. The reporter referred to intends to revaccinate the patient after an appropriate time period.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, and refers to a 5 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 23-AUG-2018, the patient was vaccinated with a improperly stored Oka-Merck PROQUAD recombinant Human Albumin (rHA)(which had a lot # of R006750 and an expiration date of 03-SEP-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unknown date: 11.3 F for 1 hour and 11 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 19 year old patient of unspecified gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unspecified date in August 2017 (reported as: ''about a year ago''), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, frequency, lot# and expiration date were not provided) for prophylaxis. On 30-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, route, frequency, indication, lot# and expiration date were not provided) for prophylaxis. No adverse effects were being reported. No product quality complaint was filed. And no further information provided.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, and refers to a 5 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 28-AUG-2018, the patient was vaccinated with a improperly stored Oka-Merck PROQUAD recombinant Human Albumin (rHA)(which had a lot # of R006750 and an expiration date of 03-SEP-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unknown date: 11.3 F for 1 hour and 11 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA013090.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, and refers to a 4 year old patient of unknown gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 24-AUG-2018, the patient was vaccinated with a improperly stored PROQUAD recombinant Human Albumin (rHA) (which had a lot # of R006750 and an expiration date of 03-SEP-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unknown date: 11.3 F for 1 hour and 11 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA013090.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, and refers to a 4 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 23-AUG-2018, the patient was vaccinated with a improperly stored Oka-Merck PROQUAD recombinant Human Albumin (rHA)(which had a lot # of R006750 and an expiration date of 03-SEP-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unknown date: 11.3 F for 1 hour and 11 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA013090.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 24-AUG-2018, the patient was vaccinated with a improperly stored VARIVAX (which had a lot # of R002054 and an expiration date of 22-JUN-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unknown date: 11.3 F for 1 hour and 11 minutes. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA013090:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD for prophylaxis, lot #R00298 and expiration date 29-JUL-2019 (strength, dose, frequency and route of administration were not reported), that was reconstituted with a properly stored MERCK STERILE DILUENT. No adverse effects were reported. The temperature of excursion was reported as 6°F to 14°F during a time frame of 14 hours. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one of several reports received from the same source. Lot number R00298 not valid for PROQUAD Oka-Merck.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis, lot #R00298 and expiration date 29-JUL-2019 (strength, dose, frequency and route of administration were not reported), that was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The temperature of excursion was reported as 6°F to 14°F during a time frame of 14 hours. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one of several reports received from the same source. Lot number R00298 not valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 79-year-old male patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 22nd June 2018, the patient received the 1st dose of SHINGRIX. On 24th June 2018, 2 days after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The healthcare professional reported that the patient experienced injection site reactions that radiated down to his elbow. For tolerance to 2nd dose refer linked case US2018GSK159189 for the same patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Feeling hot, Headache, Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (4 to 5 years before the date of reporting). On 24th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced feeling bad. On 24th April 2018, the patient experienced headache. On 25th April 2018, the patient experienced injection site swelling, injection site pain, feeling of warmth, muscle pain, influenza, shivering, injection site erythema and injection site hives. On an unknown date, the outcome of the headache, injection site swelling, injection site pain, feeling bad, feeling of warmth, muscle pain, influenza, shivering, injection site erythema and injection site hives were recovered/resolved. It was unknown if the reporter considered the headache, injection site swelling, injection site pain, feeling bad, feeling of warmth, muscle pain, influenza, shivering, injection site erythema and injection site hives to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient received SHINGRIX into the left arm. The patient stated that, the next day after vaccination, the area of the injection was red and then she noted 3 little hive looking spots that turned into swelling in the area; they went away over the 2nd week. The patient stated that, the first week she felt bad but gradually got better. The patient had discussed the events with her physician, as she was concerned about getting the 2nd dose. Her physician only voiced allergic reaction concern of that noted in the prescribing information of anaphylaxis, which the consumer had denied. The patient stated that the general events lasted for about a week. The side effects from the clinical trials were discussed. The healthcare professional was not asked.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (4 to 5 years before the date of reporting). On 24th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced feeling bad. On 24th April 2018, the patient experienced headache. On 25th April 2018, the patient experienced injection site swelling, injection site pain, feeling of warmth, muscle pain, influenza, shivering, injection site erythema and injection site hives. On an unknown date, the outcome of the headache, injection site swelling, injection site pain, feeling bad, feeling of warmth, muscle pain, influenza, shivering, injection site erythema and injection site hives were recovered/resolved. It was unknown if the reporter considered the headache, injection site swelling, injection site pain, feeling bad, feeling of warmth, muscle pain, influenza, shivering, injection site erythema and injection site hives to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient received SHINGRIX into the left arm. The patient stated that, the next day after vaccination, the area of the injection was red and then she noted 3 little hive looking spots that turned into swelling in the area; they went away over the 2nd week. The patient stated that, the first week she felt bad but gradually got better. The patient had discussed the events with her physician, as she was concerned about getting the 2nd dose. Her physician only voiced allergic reaction concern of that noted in the prescribing information of anaphylaxis, which the consumer had denied. The patient stated that the general events lasted for about a week. The side effects from the clinical trials were discussed. The healthcare professional was not asked.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of muscle soreness in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 hrs after receiving SHINGRIX, the patient experienced muscle soreness, chills and tremor. On an unknown date, the outcome of the muscle soreness, chills and tremor were unknown. It was unknown if the reporter considered the muscle soreness, chills and tremor to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for herself. The age at vaccination was not reported. The healthcare professional reported that after receiving SHINGRIX, she developed sore muscles, shaking and chills. During this report, the healthcare professional stated two of her patients had similar symptoms after receiving SHINGRIX and would report those two separately from her adverse event. This case has been linked with case US2018154162 and US2018154163, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of muscle soreness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle soreness and fever. On an unknown date, the outcome of the muscle soreness and fever were unknown. It was unknown if the reporter considered the muscle soreness and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that after receiving SHINGRIX, two patients developed sore muscles and fever after receipt of SHINGRIX. The healthcare professional would not give patient's initials or dates of birth, did not have vaccine lot or expiry dates. This case has been linked with case US2018154161 and US2018154163, reported by same reporter.