chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: CHOL
Symptoms: Vaccination error
Clinical narrative: This spontaneous case report was received from a pharmacist (PVX2019-332) on 05-Feb-2019. The report describes a 27-year-old male consumer who "had a sandwich after taking Vaxchora". The consumer was receiving Vaxchora for an unknown indication. It was reported that the consumer had a sandwich about half an hour after taking VAXCHORA. The action taken with VAXCHORA with respect to the event "had a sandwich after taking VAXCHORA" was not applicable. The clinical outcome of the event "had a sandwich after taking VAXCHORA" was unknown. Company's Comment: The causality of the event "had a sandwich after taking VAXCHORA" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "had a sandwich after taking VAXCHORA" was considered as not applicable.
Sex: U
Vaccine: CHOL
Symptoms: Exposure via skin contact
Clinical narrative: This spontaneous case report was received from a pharmacist (PVX2019-412) on 13-Feb-2019. The report describes an adult female nurse who was bare handed came in contact with the mixing stick of VAXCHORA. The consumer was receiving VAXCHORA for an unknown indication. It was reported that the nurse accidentally came in contact with the mixing stick of VAXCHORA bare handed. The action taken with VIVOTIF with respect to the event bare handed came in contact with the mixing stick of VAXCHORA was not applicable. The clinical outcome of the event bare handed came in contact with the mixing stick of VAXCHORA was unknown. Company's Comment : In this case an adult female nurse accidentally came in contact with the mixing stick of VAXCHORA bare handed.The causality of the event "bare handed came in contact with the mixing stick of VAXCHORA" was considered as not applicable.; Sender's Comments: Company's Comment : In this case an adult female nurse accidentally came in contact with the mixing stick of VAXCHORA bare handed. The causality of the event "bare handed came in contact with the mixing stick of VAXCHORA" was considered as not applicable.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-MAR-2019, the patient was vaccinated with M-M-R II therapy type rHA, intramuscularly, lot # R024906 with expiration date 30-AUG-2020 (dose and frequency) which was reconstituted with sterile diluent (manufacturer unknown) intramuscularly (dose, frequency, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Exposure via eye contact, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber), concerning a 1-year old female patient of an unknown race. The patient's medical history, concomitant medications, concurrent conditions, drug reactions/allergies or historical drugs were not reported. On 25-MAR-2019 (reported as "today"), the patient was being vaccinated with VARIVAX, subcutaneous injection, lot number: R023503 and expiration date: 16-AUG-2020 for prophylaxis (strength and dosage schedule were not reported). However, the patient only received about half of the dose as she pulled her arm away. Some of the vaccine did get on the patient's arm. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a pharmacist via a company representative, regarding to a female patient of unknown age. The patient's concurrent condition, medical history, drug allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, route of administration, anatomical location of vaccine and dose were not reported) for prophylaxis. On an unknown date, the patient developed shingles "across" her arm after vaccination. At the reporting time, the outcome of herpes zoster was unknown. The causality assessment between the event and ZOSTAVAX was not reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history and drug/allergies reactions was not provided. On 22-MAR-2019, the patient was vaccinated for prophylaxis with M-M-R II (lot #, expiration date, dosage schedule, route and anatomical location were not reported) and PROQUAD (lot #, expiration date, dosage schedule, route and anatomical location were not reported) (inappropriate schedule of vaccine administered). No adverse effects were reported.
Age: 1.25
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 15 month old patient. Information on the patient's past medical history, other concurrent conditions, drug reactions or allergies and concomitant medications were not provided. On 28-MAR-2019, the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration were not provided) with batch/lot # R028762 and expiration date for prophylaxis (product administered to patient of inappropriate age). No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication was not reported. On 28-MAR-2019, the patient was vaccinated with GARDASIL 9 (lot # R004689/expiration date: 29-NOV-2020) via intramuscular (dose, unit, frequency, anatomical location: unknown) for prophylaxis. On 28-MAR-2019, the reporter informed that the patient received two doses of GARDASIL 9 (extra dose administered). It was reported that there were no adverse effects at the time of reporting (no adverse event).
Sex: F
Vaccine: PPV
Symptoms: Cough, Nasopharyngitis
Clinical narrative: This spontaneous report was received from a currently 80 years old female patient via Pfizer (#2019126612). The patient's medical history, concurrent condition, concomitant medications were not reported. On an unknown date in March 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (lot# and expiry date was not reported) for prophylaxis. On an unknown date, the patient experienced cold and cough that was not gone away. The outcome of nasopharyngitis and cough was reported as not recovered. The causality for the events nasopharyngitis and cough were unknown.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reaction/allergies. On an unknown date, the patient was vaccinated with PROQUAD (rHA) via intramuscular, for prophylaxis, lot # R001543 and expiration date 15-JUL-2019 (dose was not reported). The vaccine was diluted with sterile diluent, lot # N031941 and expiration date 03-AUG-2020. The outcome of the event incorrect route of product administration was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with one improperly stored dose of PROQUAD subcutaneously, lot number R008203, expiration date 16-SEP-2019 (exact dose, frequency and site of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The administered vaccine was stored in the range of 15 Fahrenheit degrees (F) to 46 F (14.9 F) for 1 hour and 30 minutes and in the range of 6 F to 14 F (14.4 F) for 2 hours and 30 minutes. No previous temperature excursion was provided. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA001359:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, concomitant medications or concurrent conditions. On 01-APR-2019, the patient was vaccinated with an expired dose of ROTATEQ per oral, lot # N022174, expiration date:16-MAR-2019 for prophylaxis (exact dose was not provided). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with one improperly stored dose of PROQUAD subcutaneously, lot number R008203, expiration date 16-SEP-2019 (exact dose, frequency and site of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The administered vaccine was stored in the range of 15 Fahrenheit degrees (F) to 46 F (14.9 F) for 1 hour and 30 minutes and in the range of 6 F to 14 F (14.4 F) for 2 hours and 30 minutes. No previous temperature excursion was provided. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA000909:
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Pruritus, Pyrexia
Clinical narrative: This case was reported by a retired nurse via call center representative and described the occurrence of discomfort 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, unknown after receiving SHINGRIX, the patient experienced discomfort, pruritus, fever and prostration. The patient was treated with ibuprofen. On an unknown date, the outcome of the discomfort, pruritus, fever and prostration were unknown. It was unknown if the reporter considered the discomfort, pruritus, fever and prostration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine in right deltoid, and experienced continued discomfort and itching, extreme prostration. She reported after both doses of her SHINGRIX vaccines, she had a temperature of 103 degree F, even after taking ibuprofen. She did not know lot number, expiration date, and/or did not provide other details at the time of initial chat. For tolerance after 2nd dose of SHINGRIX, refer case US2018219535. Lab Comments: On unknown date, body temperature was measured.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (For tolerance refer case US2019GSK053659). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain and general body pain were unknown. It was unknown if the reporter considered the injection site pain and general body pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's son at conference, medical booth. The patient's age at vaccination was not reported. The patient received SHINGRIX (timing unknown) and experienced local pain at the site of injection that progressed throughout his body. This case has been linked to case US2019GSK053659, reported for the dose 1 of the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Pruritus, Pyrexia
Clinical narrative: This case was reported by a retired nurse via call center representative and described the occurrence of discomfort in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and an unknown time after starting ibuprofen, the patient experienced discomfort, pruritus, fever and prostration. The patient was treated with ibuprofen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the discomfort, pruritus, fever and prostration were unknown. It was unknown if the reporter considered the discomfort, pruritus, fever and prostration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine in right deltoid, and experienced continued discomfort and itching, extreme prostration. She reported after both doses of her SHINGRIX vaccines, she had a temperature of 103, even after taking ibuprofen. She did not know lot number, expiration date, and/or did not provide other details at the time of initial chat. This case has been linked with case US2019GSK056063, reported by the same reporter. Lab Comments: On unknown date, body temperature was measured.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Muscular weakness, Tendonitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle weakness upper limb in a 54-year-old female patient who received SHINGRIX (batch number ER5ZB, expiry date 6th September 2021) for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced muscle weakness upper limb, injected limb mobility decreased and tendonitis. On an unknown date, the outcome of the muscle weakness upper limb and injected limb mobility decreased were unknown and the outcome of the tendonitis was not recovered/not resolved. It was unknown if the reporter considered the muscle weakness upper limb, injected limb mobility decreased and tendonitis to be related to SHINGRIX. Additional details were reported as follows: The patient was vaccinated on left arm. The pharmacist did not provide patient's initials when asked. The reported batch number ER5ZK did not exist and was updated to ER5ZB as per sales datasheet.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hives in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received the 1st dose of SHINGRIX. On 21st March 2019, 4 hrs after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX and experienced hives and urticaria. The patient received the dose of SHINGRIX from a pharmacy, no contact details were provided. The health care professional could not provide lot number or expiration date. The day before reporting, the adverse event hives and urticaria were persisting at the time of report.
Sex: U
Vaccine: TDAP
Symptoms: Caesarean section, Developmental delay, Foetal exposure during pregnancy, Premature baby
Clinical narrative: This retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of developmental delay in a patient exposed to BOOSTRIX (batch number AH4LF, expiry date 8th July 2018) in utero. The mother received the product for prophylaxis. The parent's medical history included gestational diabetes (noted during 12th January 2016 visit) and cesarean section (C-section reported for a previous birth). On 12th February 2016, the 32-year-old mother received BOOSTRIX. The mother's last menstrual period was on an unknown date and estimated date of delivery was 17th March 2016. The patient was exposed to BOOSTRIX at week 35 of gestation and during the third trimester of pregnancy. On 13th February 2016, at [weeks gestation], the patient was born via cesarean delivery. The patient was diagnosed with premature birth. On an unknown date, the patient experienced developmental delay. On an unknown date, the outcome of the developmental delay and premature birth were unknown. The reporter considered the developmental delay to be related to BOOSTRIX. It was unknown if the reporter considered the premature birth to be related to BOOSTRIX. See case US2019055803 for details regarding the mother case. Additional details were provided as follows: The medical assistant was reporting on behalf of physician that the patient who received a BOOSTRIX vaccination has blamed her child's developmental delayed diagnosis on the BOOSTRIX vaccine. The patient's mother recently contacted doctor's office to report the patient was developmentally delayed and she feels it was because of the BOOSTRIX vaccination she received. The reporter did not specifically get permission for GSK to contact patient. The reporter gave phone number to call for patient to follow up, if she would like to.
Sex: U
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves Infant patient who broke out in a rash and hives, while he/she 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. On an unknown date, the patient developed a non-serious broke out in a rash (rash) and hives (urticaria) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data reported.) Final diagnosis was hives and broke out in a rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for broke out in a rash and as Unknown for hives.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Limb injury
Clinical narrative: Initial information received on 28-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 52 years old female patient who experienced shoulder injury, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In January 2017 (unknown date), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5686MA (reported as UT5686MA or UT5686NA) via unknown route (reported as intramuscular or intradermal) in the left deltoid. On an unknown date, the patient developed a non-serious shoulder injury (limb injury) within three weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included No lab data. Final diagnosis was shoulder injury. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for shoulder injury. List of documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 18 months old male patient who was vaccinated with an expired fourth dose of DAPTACEL (lot: C5169AA, expiry date: 16-Mar-2019) via unknown route in the left thigh on 28-Mar-2019. Concomitant medications included PREVNAR 13 for Immunisation. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. 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 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: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a five-years-old male patient who received 0.5 mL dose of vaccine DAPTACEL lot C5171AA, expiry date- 23-Mar-2019 via intramuscular route in the left arm on 29-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IPOL POLIO VACCINE; MMR; VARICELLA ZOSTER VACCINE; and TUBERSOL. It was a case of actual medication error due to Expired vaccine used. 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 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.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case is related to case- 2019SA088989, 2019SA089330 (same reporter). This case involves a 24 months old male patient who received a 0.5 mL expired dose of DAPTACEL vaccine. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR 13; and HEPATITIS B VACCINE on 27-Mar-2019. On 27-Mar-2019, the patient received a 0.5ml dose of suspect DAPTACEL (lot: C517AA, expiry date 23-Mar-2019) via unknown route in the thigh NOS. It was an actual medication error due to expired vaccine used. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Malaise, Mobility decreased, Vaccination failure
Clinical narrative: Seriousness criteria- Medically significant event. Initial information received on 29-Mar-2019 regarding an unsolicited valid serious case received from a non healthcare professional by phone. This case involves a 56 years old female patient who was vaccinated with 0.5 ml once dose of FLUZONE QUADRIVALENT (Batch number: UJ011AG, expiry date, dose in series, route and site of administration were not reported) on 17-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 24-Mar-2019, the patient developed a serious symptoms of flu which found to have Influenza type A (influenza) 2 months 7 days following the administration of FLUZONE QUADRIVALENT. This event was assessed as medically significant. On an unknown date, today is the first day the patient could get out of bed since falling ill (bedridden) following the administration of FLUZONE QUADRIVALENT. It was also a case of vaccination failure.These events was assessed as medically significant. It was reported that the patient went to urgent care last evening (28-Mar-2019). A rapid influenza nasal swab was done and she was found to have Influenza, type A. Corrective treatment was not reported. The patient outcome is reported as Recovering/Resolving for all the events. Documents held by the sender: none. Sender's Comments: This case involves a 56 years old female patient who developed Influenza A virus infection and was not able to get out of bed despite vaccination with FLUZONE QUADRIVALENT. Time to onset is not compatible and patient was tested positive for Influenza A, hence it was assessed as vaccination failure. The Patient's condition before vaccination or other underlying risk factors for influenza have not been reported. As with any vaccine, vaccination with Influenza vaccine may not protect 100% of susceptible individuals. Additional information regarding patient's immune status, infection status at the time of vaccination, confirmatory investigation results (details of specific strain identified in PCR) are needed to fully assess the case. Based upon the available information, the role of the vaccine or a case of vaccination failure cannot be assessed.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional via phone. This case involves a 68 years old male patient who was vaccinated with a 0.5 ml expired dose of INFLUENZA FLUZONE HIGH DOSE (Batch number: UI977AC and expiry date: 09-Mar-2019, dose in series and route of administration were not reported) in left deltoid on 28-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. 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 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 the sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional by phone. This case involves a female patient (age not reported) who exposed to vaccine ADACEL, while pregnancy on an unknown date. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient that is five weeks pregnant receive a ADACEL. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history included cut and the patient received ADACEL vaccine for tetanus protection. On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose in series, route and site of administration were not reported) for tetanus protection. It was a case of vaccine exposure during pregnancy. At time of reporting, the outcome of the pregnancy was unknown. Documents held by the sender: none.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Pruritus, Urticaria
Clinical narrative: Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 20 years old female patient who experienced broke out in hives, had red welts that had increased on her back and were spreading up to her face, itching while she received vaccine ADACEL. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported broke out in hives, had red welts that had increased on her back and were spreading up to her face, itching and a pregnant female received the ADACEL vaccine occurred at unknown gestation period and the patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 30 weeks and 2 days of pregnancy, during third pregnancy trimester for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The date of last menstrual period was reported as 20-Aug-2018. The estimated due date is 27-May-2019. The patient had no previous pregnancy. On 28-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6128AA, expiration date: 20-Nov-2020) via intramuscular in the right deltoid. On an unknown date, the patient developed a non-serious broke out in hives, had red welts that had increased on her back and were spreading up to her face, itching 2 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was also a case of exposure during pregnancy. Other relevant tests included No Lab data was reported. Final diagnosis was a pregnant female received the ADACEL vaccine, itching and broke out in hives, had red welts that had increased on her back and were spreading up to her face. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for broke out in hives, had red welts that had increased on her back and for itching. Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as Unknown and fetal outcome was reported as Unknown. Documents held by the sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves 18 years old male patient who received 0.5 mL dose of vaccine MENACTRA lot U5839AA, expiry date- 05-Mar-2019 via unknown route in the left arm on 28-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapy were not provided. It was a case of actual medication error due to Expired vaccine used. No adverse event was occurred. (reported as none symptoms). 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: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 18 years old patient (gender unknown) who received an expired dose of vaccine MENACTRA. The patients past medical history, concomitant medication and family history were not provided. On 28-Mar-2019, the patient received injection of suspect MENACTRA lot number not reported, expiry date 05-Mar-2019 via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was reported that patient received a dose of MENACTRA on 28-Mar-2019 which had expired on 05-Mar-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Pollakiuria, Pyrexia
Clinical narrative: Sore arm...up at night...frequent urination...headache...low-grade fever...slight nausea...aches. Took ADVIL thirty minutes ago.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Heart racing happened several times the day of and a few days following. Reported to Dr. he advised not getting second shot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Feeling cold, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Extreme upper back pain (shoulder area) radiating to shoulder & neck. Bad headache, alternating between freezing to heavy perspiration. Unable to sleep. These symptoms continued for 3 days. Nausea the first 2 days. Back/ shoulder pain still.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea, Neck pain, Pain
Clinical narrative: Extreme upper back pain (shoulder area) radiating to shoulder & neck. Bad headache, alternating between freezing to heavy perspiration. Unable to sleep. These symptoms continued for 3 days. Nausea the first 2 days. Back/ shoulder pain still.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Pain in extremity, Paraesthesia, Swelling
Clinical narrative: Normal shot pain at site and small amount of normal swelling. After six days I noticed pain in arm that I had not previously experience and spoke with pharmacist who did the injection and read listed side effects. Decided to give it a few more days. On the night of the 8th day after vaccine I had much difficulty sleeping as I was having pain in left arm from shoulder to hand. I had never experience this type of intense pain before. It was like a tingle on steroids. Arm sore to touch. This continued to a lesser extent during the 9th daytime but was more intense during the next night. I tried during the days to fine more information online but did not find good, factual information online. On Monday 4/1/19 I made an appointment with my GP, at Family Medicine. Given two prescriptions to help me sleep and with pain, Hydrocodone and Prednisone. I follow up with her today 4/3/2019.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Normal shot pain at site and small amount of normal swelling. After six days I noticed pain in arm that I had not previously experience and spoke with pharmacist who did the injection and read listed side effects. Decided to give it a few more days. On the night of the 8th day after vaccine I had much difficulty sleeping as I was having pain in left arm from shoulder to hand. I had never experience this type of intense pain before. It was like a tingle on steroids. Arm sore to touch. This continued to a lesser extent during the 9th daytime but was more intense during the next night. I tried during the days to fine more information online but did not find good, factual information online. On Monday 4/1/19 I made an appointment with my GP, at Family Medicine. Given two prescriptions to help me sleep and with pain, Hydrocodone and Prednisone. I follow up with her today 4/3/2019.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever, shivering, and fatigue.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Anal incontinence, Confusional state, Loss of consciousness, Pain, Swelling
Clinical narrative: With in 2 hours began reporting pain and swelling about 2 hours after the vaccination. She was reporting 9/10 pain at the vaccination site. Then reported body aches, vomiting, passed out, lost control of her bowel and bladder, and confusion.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: With in 2 hours began reporting pain and swelling about 2 hours after the vaccination. She was reporting 9/10 pain at the vaccination site. Then reported body aches, vomiting, passed out, lost control of her bowel and bladder, and confusion.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Malaise, Oropharyngeal pain, Throat tightness
Clinical narrative: Pt. states at 1:00 p.m. on 3/27/2019 she began experiencing soreness and tightness in her throat - she was driving a school bus at the time and did not have her albuterol inhaler so she kept sipping water until she was finished with bus route about 3:30 p.m. She was able to use her albuterol inhaler, which she left in her car, at that time and reports after using her inhaler she felt "somewhat better." At about 5:30 p.m. pt. states she "still was not feeling completely well" and took a BENADRYL LIQUIGEL and shortly after taking the BENADRYL she felt much better. She did not use her albuterol inhaler or take any other doses of BENADRYL after that.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Product preparation issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of tiredness in a 60-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2019) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In March 2019, the patient experienced tiredness and influenza-like symptoms. On an unknown date, the outcome of the tiredness, influenza-like symptoms, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the tiredness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. After vaccination with SHINGRIX, the patient felt very tired, like she was going to have the flu. The patient received only the adjuvant part of SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated the administration of just the adjuvant was already been reported. GlaxoSmithKline was previously contacted and they were instructed to wait 4 weeks before giving the patient the full vaccine. Till the time of reporting, the patient was not revaccinated yet.
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 67-year-old 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 66 or 67 years. About 2 months before the date of reporting, the patient received SHINGRIX and all she had was a sore arm. For tolerance to 2nd dose, refer case US2019GSK054543.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX (batch number D9474, expiry date 30th September 2021) for prophylaxis. Concurrent medical conditions included glaucoma and fruit allergy (for Avocado and Banana). Concomitant products included ALLEGRA. On 21st March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site induration and injection site discomfort. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and TYLENOL. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site induration and injection site discomfort were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site induration and injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX at left deltoid. The patient experienced redness, warmness, firmness and discomfort at the injection site. The redness was approximately 4 inches wide and 2 inches long. The pharmacist advised patient to use ice at the injection site and to take TYLENOL for discomfort.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX, the patient had pain in her arm at the injection site and felt tired. This is 1 of the 5 cases, reported by the same reporter.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Persistent shoulder and upper arm pain. Ortho consult, currently doing PT to regain range of motion.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Middle insomnia, Nausea
Clinical narrative: States he woke up in the middle of the night with a "terrible" headache, nausea and injection site pain. Was unable to return to sleep. Eventually took MOTRIN 800mg and was able to fall asleep.  Presented to the clinic this AM approx. 1000 for scheduled Primary Care appointment, states only mild injection site pain now, otherwise symptoms have resolved.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Asthenia, Fatigue, Food allergy, Gluten sensitivity
Clinical narrative: Severe migraines, inlammation, blurring vision/spots, reaction to gluten/wheat. Weakness /fatigue/aching muscles and joints.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Inflammation, Migraine, Myalgia, Vision blurred, Visual impairment
Clinical narrative: Severe migraines, inlammation, blurring vision/spots, reaction to gluten/wheat. Weakness /fatigue/aching muscles and joints.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Somnolence
Clinical narrative: Severe shivering during the night after the injection with temperature of 97.1 intermittent fatigue, dizziness, and sleepiness continuing for 5 days after the injection. Headache for 4 days after the injection.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT EXPIENCED SIGNIFICANT REDNESS (APPROXIMATELY THE SIZE OF HER PALM) AND SWELLING AT THE INJECTION SITE ABOUT 24 HOURS AFTER RECEIVING THE VACCINE. SHE ALSO REPORTED THAT IT WAS HOT TO THE TOUCH. PATIENT WAS INSTRUCTED TO MONITOR SIZE OF THE RED AREA AND REPORT TO DOCTOR OR PHARMACIST IF REDNESS INCREASED OR SPREAD TO OTHER AREAS OF THE ARM.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Patient went to Hospital. Per guardian she had a rash. She had a follow up with our office. We are the PCP and rash had resolved.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT, FEVER.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Aphasia, Asterixis, Autism spectrum disorder, Decreased eye contact, Diarrhoea
Clinical narrative: Patient developed a high fever, high pitched scream, explosive diarrhea, which persisted for a few days following vaccinations. Within a week, Patient lost all speech, lost eye contact, began banging head, began flapping hands, began tip toe walking, began having horrible meltdowns that never occurred prior to her last set of vaccinations.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Emotional disorder, Head banging, Pyrexia, Screaming, Toe walking
Clinical narrative: Patient developed a high fever, high pitched scream, explosive diarrhea, which persisted for a few days following vaccinations. Within a week, Patient lost all speech, lost eye contact, began banging head, began flapping hands, began tip toe walking, began having horrible meltdowns that never occurred prior to her last set of vaccinations.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Patient stated that she developed a rash around the injection site two to four days after vaccine administration.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Injection site mass
Clinical narrative: No adverse event or signs happened at the time of administration but a month later patient's boyfriend called and reported death of patient because of lump under the skin at site of injection.