chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.83
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received Pentacel and  Pediavax vaccines in error/ no AE; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 10-months-old female patient who received a dose of HIB VACCINE CONJ (OMPC) [PEDIAVAX] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (extra dose administered).  Concomitant vaccination include Pneumococcal13.  On 04-Oct-2019, the patient received a dose of suspect HIB VACCINE CONJ (OMPC) [PEDIAVAX] not produced by Sanofi Pasteur lot 3P252 (exp date: 10-Jan-2021) via unknown route in unknown administration site and a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (0.5 mL) lot UJ110AAA (exp date: 14-Oct-2020) via intramuscular route in the right thigh.  It was a case of actual medication error due to extra dose administered (patient received an extra dose of HIB).  No adverse vent reported at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.92
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered Flublok to a 23 month old patient, No AE; Initial information received on 15-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 23 months old patient who was vaccinated with vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] on an unspecified date. The lot number and expiry date not reported.  It was actual medication error due to Inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.  Information on the batch number was requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bedridden, Fatigue, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: bedridden with an extreme reaction; she could not raise her arms; was unable to dress herself or do anything; lot of pain; aches in all joints, joint throbbed; fatigue, tired; Initial information received on 15-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 65 years old female patient who experienced lot of pain (pain), bedridden with an extreme reaction (bedridden), aches in all joints, joint throbbed (arthralgia), she could not raise her arms (Movement disorder), was unable to dress herself or do anything (Loss of personal independence in daily activities) and fatigue (fatigue), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s) and family history were not provided.  On 11-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site.  On 13-Oct-2019, the patient developed a non-serious aches in all joints, joint throbbed (arthralgia) and  fatigue, tired (fatigue ) two days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious lot of pain (pain) and was bedridden with an extreme reaction (bedridden) within 10 days, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that, She was okay now, but for 10 days after the shot she had a pretty extreme reaction. On 21-Oct-2019, she went to see her doctor. During this time, she could not raise her arms (Movement disorder). Patient every joint throbbed. She was unable to dress herself or do anything (Loss of personal independence in daily activities). She was still under a doctor care.  Detail of laboratory data were not reported.  Final diagnosis was fatigue, bedridden, pain, Loss of personal independence in daily activities, Movement disorder and arthralgia.  It was not reported if the patient received a corrective treatment.  On an unknown date the patient was recovering from the events.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives were localized to the right arm; Initial information was received on 15-Jan-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (pharmacy intern).  This case involves a 36 year old male patient who experienced hives were localized to the right arm (vaccination site urticaria), while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) in left arm for immunisation; nicotine (Nicoderm); Thiamine; calcium pantothenate, folic acid, vitamins (Multi-Vitamins Vitafit); trazodone hydrochloride (Desyrel); buprenorphine hydrochloride, naloxone hydrochloride (Suboxone) 2 mg; and Prednisone.  On 19-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT66861A, expiry date - 20-Jun-2030, formulation - prefilled syringe) via intramuscular route in the right arm.  On an unknown date, the patient developed non-serious hives were localized to the right arm (vaccination site urticaria) (unknown latency), following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory data was not provided.  Final diagnosis was vaccination site urticaria.   The patient was treated with diphenhydramine.  The outcome of the event was unknown.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: pregnant patient was given Adacel  that was in freezing temperatures for 4 days with a low of -0.2F, NO AE; pregnant patient was given Adacel  that was in freezing temperatures for 4 days with a low of -0.2F, NO AE; Initial information received on 15-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 42 years old female patient who received booster dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6612AA and expiry date: 19-Mar-2020) via intramuscular route in the left arm, On 13-Jan-2020, while she was pregnant.  Data regarding this pregnancy were received prospectively.   The date of last menstrual period was reported as 20-May-2019.  The estimated due date is 24-Feb-2020. Gestation period at onset was 34 weeks.   Medical history, medical treatment, vaccination and family history were not provided.  It was the case of vaccine exposure during pregnancy.The patient was pregnant when she received vaccine.  It was also a case of actual medication error due to incorrect product storage as vaccine was in freezing temperatures for 4 days with a low of -0.2F. The product was unopened. Out of range for 4 days. The lowest temperature was negative 2 degrees Fahrenheit.  The patient did not experience any adverse effects as a result of the vaccination.   Pregnancy outcome was unknown at the time of report. Baby not delivered yet.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Product administered at inappropriate site, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Qudracel instead of Pentacel was administered to a 11 week old male patient in error/no AE; Qudracel instead of Pentacel was administered to a 11 week old male patient in error/no AE; Qudracel instead of Pentacel was administered to a 11 week old male patient in error/no AE; Initial information received on 15-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11-weeks-old male patient who by mistake received 0.5 ml single dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AA via unknown route in the left thigh) instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 15-Jan-2020.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (Hepatitis B Vaccine) (dosing details not reported) on an unknown date.  It was an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration because QUADRACEL is recommended in person from age 04 years; vaccine administered at inappropriate site because QUADRACEL should be administered in deltoid muscle of the upper arm.  It was unknown whether adverse reaction was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublok QIV was given to a 6-year-old patient/no AE; Initial information received on 15-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 06 years old patient of unknown gender who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (dosing details were not reported) on an unknown date.  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was a actual medication error case due to inappropriate age at vaccine administration.  It was unknown whether any adverse reaction was observed 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.  Information on the batch number was requested.
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Decreased appetite, Nausea, Vomiting
Clinical narrative: lower back pain; nausea; vomiting; appetite loss; Initial information received on 16-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 12 years old female patient who experienced lower back pain (back pain), nausea (nausea), vomiting (vomiting) and appetite loss (decreased appetite), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a 0.5mL 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 vomiting (vomiting), lower back pain (back pain), nausea (nausea) and appetite loss (decreased appetite) (Unknown latency) 48 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient reported that she was fine for 3 days and the it happened again.  Detail of laboratory data were not reported.  Final diagnosis was decreased appetite, nausea, back pain and vomiting.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient outcome is reported as Unknown for all the events.  Information on the batch number was requested.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Seizure
Clinical narrative: seizure; Initial information received on 16-Jan-2020 regarding an unsolicited valid serious case from the consumer (office staff).  This case involves an unknown demographics patient who had seizure (seizure), when the patient received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious event seizure (seizure) (unknown latency) following after the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant.  Detail of laboratory data were not reported.  Final diagnosis was had seizure.   It was not reported if the patient received any corrective treatment.  The outcome was not reported for the event seizure.  Information on the batch number was requested.; Sender's Comments: This case involves an unknown demographics patient who presented with seizure after the administration of PENTACEL. The time to onset was unknown. Moreover, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Adacel to a patient/no AE; Initial information received on 20-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 37 years old female patient who was inadvertently administered with vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 18-Jan-2020, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5829AB, expiry date: 24-Sep-2019 via intramuscular route in the right deltoid.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive EC 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: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient said shot was fine and no issues at pharmacy. Got home and some time in the next day, arm began to hurt very badly and could hardly lift/move without being in pain. Went to her MD on 10/22/19 and she told them she thought her vaccine was given too high on her arm based on where the bandaid was placed on her arm. They did not do any test/imaging to rule anything in/out but gave the patient a steroid and said to come back in a week after finishing steroid if not better. She came back and arm was still not better. Pain with movement and decreased mobility. They set up with physical therapy and she has been going every week. She came to our pharmacy on 1/21/20 and told us about this. Said her arm is back to 50% she would say. Telling us this is to see if our pharmacy would reimburse for her physical therapy expenses. This has been escalated to our corporate team to follow up with patient on this request. Interviewed pharmacist who gave vaccine and she said there were no complaints or issues from patient or herself at the time of administration. Said nothing out of the ordinary occurred during this vaccine administration.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Rash, Rash erythematous, Sleep disorder
Clinical narrative: Patient reports on 1/13/2020 at 1130pm she awoke from her sleep in severe left arm pain. She could not raise her left arm. She then noted on Wednesday 1/15/2020 her arm was able to raise and move better but she noted a rash all over her torso from her neck to bottom of back and it was "like severe sunburn" she went to emergency room and was given oral Benadryl After she took Benadryl orally her rash had resolved and she was able to return to work on 1/16/2020 with no further concerns. Today she reported as of 1/16/2020 her symptoms had resolved.
Age: 45.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Lg red swelling, hot to touch. Only Painful when touched, Pt states that it itches all the time
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Skin laceration
Clinical narrative: Pt was given vaccination ~ 5pm on Tuesday and be the next day (Wed) started experiencing dizziness - She feels her dizziness was so severe that she passed out briefly, fell, banged her head & then woke up. She had a minor cut on her head but her MD checked her out a found no other complication on 1/21/20.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt received flu shot already at Dr office already in October 2019; thus it was a duplication. No adverse effect experienced by patient per patient. Patient came to pharmacy for her Prevnar 13 shot; however flu show was typed thru and pt was given the forms to sign with flu shot label. Patient signed the forms and pharmacist administered the shot, letting her know that it was the last high dose flu shot. After the shot was given, patient notified that she was here for Prevnar not flu shot, she already had the flu shot. Patient then was administered the Prevnar. Afterward pharmacist notified the supervisor and the Dr. Staff at Dr.'s office was notified that pt got a duplication of the flu shot (1/23/2020 1:30pm). Per Staff pt had gotten the flu shot at Dr office in October. Pharmacist then called the patient to see if she had any adverse effects per patient, she is not experiencing any adverse effects. She is perfectly fine.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Herpes zoster, Influenza like illness, Lymphadenopathy
Clinical narrative: 1/20/2020, Was seen in clinic 1/17/2020 and Dxd with Shingles had broke out in the rash that day 11 days before he had gotten his Shingrix #2 shot rash feels irritated,not itching, no pain. has some pain in the shoulder joint may have some swelling in the lymph nodes no fevers started on Valtrex her for recheck, has questions at to transmission to family and time off work wife states pt has been under a lot of stress and should take time off to rest thinks it triggered the shingles. 1/17/2020, Patient is a very pleasant 58-year-old male who complains of some flulike symptoms over the last couple of days with a T-max of 101 degrees with some myalgias, cough and congestion. He took the day off work yesterday but felt better today so returned to work. While he was at work today he noticed a rash on his left chest. Patient notes that he got the shingles immunization 1 days ago. He does recall having had chickenpox in his youth. Patient had type 2 diabetes.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Rash, Respiratory tract congestion, Skin irritation
Clinical narrative: 1/20/2020, Was seen in clinic 1/17/2020 and Dxd with Shingles had broke out in the rash that day 11 days before he had gotten his Shingrix #2 shot rash feels irritated,not itching, no pain. has some pain in the shoulder joint may have some swelling in the lymph nodes no fevers started on Valtrex her for recheck, has questions at to transmission to family and time off work wife states pt has been under a lot of stress and should take time off to rest thinks it triggered the shingles. 1/17/2020, Patient is a very pleasant 58-year-old male who complains of some flulike symptoms over the last couple of days with a T-max of 101 degrees with some myalgias, cough and congestion. He took the day off work yesterday but felt better today so returned to work. While he was at work today he noticed a rash on his left chest. Patient notes that he got the shingles immunization 1 days ago. He does recall having had chickenpox in his youth. Patient had type 2 diabetes.
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Condition aggravated, Cough, Ear swelling, Rash, Rash erythematous
Clinical narrative: The night after receiving his flu shot the patient developed red spots and hives all over his body that came and went. He also had ear swelling. Already had a cough and cold, now has coughed more. No audible wheezing or blue spells. Eating and drinking well. She is concerned this is due to the flu shot. She initially was giving him Benadryl but has not had to recently though
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: The night after receiving his flu shot the patient developed red spots and hives all over his body that came and went. He also had ear swelling. Already had a cough and cold, now has coughed more. No audible wheezing or blue spells. Eating and drinking well. She is concerned this is due to the flu shot. She initially was giving him Benadryl but has not had to recently though
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling + Erythema around injection site.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: Left upper lateral arm with 4"x4" elevated, erythematous rash.
Age: 18.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event
Clinical narrative: No adverse events reported by the patient. Immunization was administered IM instead of SC
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Fatigue, Myalgia
Clinical narrative: Patient reported that she had muscle pain & tiredness right after the shot. Patient came in on 1-22-20 asking for the shingrix lot number & stated that she has had an arthritic flare up since the 2nd shingrix shot an has not seen a complete recovery.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Erythema, Malaise, Mass, Swelling
Clinical narrative: redness, swelling, and a large lump within a couple of hours after the vaccination. Pt later developed vomiting & diarrhea that day & was sick for several days afterwards
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: redness, swelling, and a large lump within a couple of hours after the vaccination. Pt later developed vomiting & diarrhea that day & was sick for several days afterwards
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills, headache, slight fever (100.6 degrees), starting 3.5 hours after the vaccination and gradually lessening over the next 48 hours.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Lip swelling, Swelling face, Swollen tongue, Urticaria
Clinical narrative: multiple hives that grew in size/lips and tongue were swollen/hive welts, cheeks were bright red, hives on face, face swelling/hives on wrists and forearm, torso, back, lower back, legs; This spontaneous report has been received from the patient's mother, referring to a 15-month-old male patient. The patient had no historical condition, concurrent condition, concomitant medication and drug reaction or allergy.  On 06-JAN-2020 (reported as yesterday), at 10:30, the patient was vaccinated with the first dose of hepatitis A virus vaccine inactivated (VAQTA) (lot# S023499, expiration date not reported, but upon internal validation established as 24-AUG-2020; strength, dose, frequency and route not reported) shot in the left thigh for prophylaxis.  The patient had no welts at 13:50. However, at 15:30, the patient was noticed to have multiple hives that grew in size and the patient's lips and tongue were swollen. The patient had hives was on his face, wrists, forearm, torso, back, lower back and legs. His face was swelling, and cheeks were bright red. The patient's mother had sought for medical attention, and the patient was taken to an specified fire company and then to the emergency room by the fire company ambulance. During that time, the patient was given intramuscular diphenhydramine hydrochloride (BENADRYL) injection by ambulance workers. It was reported that diphenhydramine hydrochloride (BENADRYL) seemed to help because the swelling went down. The patient was also given prednisone by the emergency room physician. No lab diagnostics or studies were performed. On the same day, at 19:00, the patient was discharged from the emergency room. On 07-JAN-2020, the patient seemed to be ok, but the patient was given hydrochloride (BENADRYL) when small welts were returning. The patient was not given new foods or drinks. The outcome of event was reported as recovering. The causality assessment was not provided by the reporter.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; "inadvertently administered and expired dose of VAQTA; This spontaneous report was received from a nurse and refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-JAN-2020, the patient was inadvertently vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) lot # R030115, expiration date 29-DEC-2019 (exct dose and route of administration were not reported) for prophylaxis. No adverse symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No addtitional adverse effect reported.; the patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT).  On 16-DEC-2019, the patient was inadvertently administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose and route of administration were not reported) (lot # S021926, expiry date 15-JUL-2021) for prophylaxis. Storage temperature was 1.2 Celsius degrees (C) during the time frame of 3 hours 9 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect was reported.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Product administered to patient of inappropriate age, Rubella antibody negative
Clinical narrative: had negative titers for M-M-R II; one month ago the patient received a dose of mmr II; This spontaneous report as received from a pharmacy student refers to a 50-year-old female patient. The patient's medical history, current condition, concomitant medication and drug reactions/allergies were not reported.      Approximately on an unknown date in December 2019 (reported as one month ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# expiry date, strength, dosage information, route of administration and anatomical locations were unknown) negative titers for MMR (prophylaxis) (product administered to patient of inappropriate age). The patient had also received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) as a child. On an unknown date, the patient had negative titers for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (antibody test negative).   The outcome of antibody test negative and product administered to patient of inappropriate age was unknown. Causality was not reported
Sex: U
Vaccine: VARZOS
Symptoms: Drug intolerance
Clinical narrative: I was intolerant to my first Shingrix injection; This case was reported by a consumer via call center representative and described the occurrence of drug intolerance in a 73-year-old patient who received Herpes zoster (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 drug intolerance. On an unknown date, the outcome of the drug intolerance was unknown.   It was unknown if the reporter considered the drug intolerance to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was intolerant after first Shingrix injection. The patient asked whether to get the 2nd dose as the patient was intolerant to the first injection.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pyrexia
Clinical narrative: injection site pain; aches; fever; shoulder still hurts a little from the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles, sinus congestion and headache. Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 2nd October 2019, refer case US2020007419).   On 10th January 2020, the patient received the 2nd dose of Shingrix. On 10th January 2020, 5 hrs after receiving Shingrix, the patient experienced injection site pain, pain, fever and shoulder pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and shoulder pain were not recovered/not resolved and the outcome of the pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain, fever and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient had 2nd dose of Shingrix and within 5 hours he developed injection site pain, aches, and fever. The patient stated that his shoulder still hurts at the time of reporting a little from the injection, but all other symptoms had resolved at this time. The reporter was consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: sick; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, fever and chills. On an unknown date, the outcome of the sickness, fever and chills were recovered/resolved.   It was unknown if the reporter considered the sickness, fever and chills to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient was sick, had fever and chills.  The side effects lasted for about a day or so. The reporter didn't want to provide any additional details.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number NY749, expiry date 4th December 2021) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. On 24th December 2019, 82 days after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The patient that received the first dose of Shingrix and started to experience Tinnitus two to three weeks ago. The reporter consented to follow up. The batch number for Shingrix was reported as NY747, but it was changed to NY749 as per sales data sheet.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site irritation, Injection site rash
Clinical narrative: Only received one dose; Irritation around injection site; rash around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of skin irritation in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included egg allergy.   On 20th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 22nd May 2019, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced skin irritation and rash. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with benadryl (nos) (Benadryl) and fexofenadine hydrochloride (Allegra). On 25th May 2019, the outcome of the skin irritation and rash were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the skin irritation and rash to be related to Shingrix.  Additional details were received as follows: The patient developed an irritation and rash around injection site. The reporter instructed the patient to take Benadryl then Allegra and within 3 days the symptoms were gone. Till the time of reporting patient has not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 49.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Erythema, Swelling
Clinical narrative: experience redness; swelling; shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 49-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA175A, expiry date 31st July 2020) for prophylaxis.   On 14th January 2020, the patient received Menveo. On 14th January 2020, couple of hours after receiving Menveo, the patient experienced erythema, swelling and shortness of breath. On an unknown date, the outcome of the erythema, swelling and shortness of breath were unknown.   It was unknown if the reporter considered the erythema, swelling and shortness of breath to be related to Menveo.  Additional details were received as follows: The reporter stated that the patient few hours after vaccination experienced redness, swelling, and shortness of breath and the patient was taken to the emergency room. The reporter was not aware if the patient had received previous doses of Menveo vaccine before. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: rash on the right arm / the rash was really red; the rash was swollen; the rash was itchy; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced red rash, swelling arm and itchy rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the red rash, swelling arm and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash, swelling arm and itchy rash to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient received the first dose of vaccine and experienced a rash on the right arm which required treatment with both oral and topical Benedryl. The rash was large, swollen, itchy, and really red. The reporter consented to follow up. The pharmacist did not provide further details during the call.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nausea, Pain, Rash, Vomiting
Clinical narrative: rash; pain; nausea; vomiting; Acute herpes zoster; This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number LE55F, expiry date unknown) and (batch number 3HX44, expiry date unknown) for prophylaxis.   The patient's past medical history included shingles (was located on the left buttock and was treated with famciclovir in August 2015). Previously administered products included famciclovir (received on an unknown date) and Zostavax (received on 15th August 2013). Concomitant products included Herpes zoster (Shingrix).   On 1st October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 17th October 2019, 16 days after receiving Shingrix, 84 days after receiving Shingrix and an unknown time after starting famciclovir and Calamine, the patient experienced herpes zoster. On an unknown date, the patient experienced rash, pain, nausea and vomiting. The patient was treated with famciclovir, calamine lotion (Calamine), paracetamol (Tylenol) and prochlorperazine (Compazine Suppository). On an unknown date, the outcome of the herpes zoster, rash, pain, nausea and vomiting were unknown.   It was unknown if the reporter considered the herpes zoster, rash, pain, nausea and vomiting to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but it could be 86 or 87 years. The reporter stated that patient received vaccine and had shingles on her right chest wall. The reporter consented to follow up.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given a pediatric dose of Hep b instead of an adult dose.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Erythema, Induration, Swelling
Clinical narrative: PATIENT  RETURNED TO CLINIC WITH RED,SWOLLEN, AND FIRM LEFT ARM THE SIZE OF A SMALL BASEBALL. PATIENT STATES SHE APPLIED COOL COMPRESS TO AREA THE NIGHT BEFORE BUT AREA HAS GOTTEN WORSE SINCE THEN.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient reports redness and tenderness at injection site.  She reports to have been diagnosed with cellulitis at injection site by doctor post vaccination.  Doctor states that injection was given in wrong site in left arm.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass, Urticaria
Clinical narrative: Parent reports lump at inj site after inj that is now gone but has 1.5 inch pink mark with a few raised areas that appear hive like. No streaking, fever or pain.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NONE AT THIS TIME
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine adminsitered; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent condition were not reported. Concomitant therapies included sterile diluent. The nurse described that on 02-JAN-2020, the patient was vaccinated a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 millileter (product storage error), lot # S013712 with expiry date 01-NOV-2020, (strength, route were not reported) for prophylaxis. It was reported that sterile diluent was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was properly stored. It was reported product was stored temperature at -12.2C, for 25 minutes and there was no previous temperature excursion and digital data logger was present.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: severe headache; fever; chills; aches; This case was reported by a consumer via call center representative and described the occurrence of headache in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache, fever, chills and pain. On an unknown date, the outcome of the headache, fever, chills and pain were unknown.   It was unknown if the reporter considered the headache, fever, chills and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 81 or 82 years. The patient received Shingrix and had side effects of severe headache, chills, fever, aches. She would be scheduled for breast cancer surgery in 2 days and she wants to know should she reschedule her surgery or would the side effects be gone by then.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: had a rash since Christmas; itch; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received vaccine 4 years before the time of reporting).   In October 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 3 months after receiving Shingrix, the patient experienced red rash and itchy rash. On an unknown date, the outcome of the red rash and itchy rash were unknown.   It was unknown if the reporter considered the red rash and itchy rash to be related to Shingrix.  Additional details were received as follows: The patient had a rash that was itch and red after vaccination. The patient asked whether it was shingles. The patient asked whether the others had the same reaction after vaccination. The patient had put off seeing physician because of the flue going around and was trying to avoid crowds at the time. The GSK representative suggested to the patient be administered in the time range between now and March.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dehydration, Malaise
Clinical narrative: Very sick; Chills; Fever; Nausea; Vomiting; Inappetence; Dehydrated; Weakened; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (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 sickness, chills, fever, nausea, vomiting, inappetence, dehydration and weakness. On an unknown date, the outcome of the sickness, chills, fever, nausea, vomiting, inappetence, dehydration and weakness were unknown.   It was unknown if the reporter considered the sickness, chills, fever, nausea, vomiting, inappetence, dehydration and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had sickness, chills, fever, nausea, vomiting, inappetence, dehydration and weakness. The patient asked should get the second vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Very sick; Chills; Fever; Nausea; Vomiting; Inappetence; Dehydrated; Weakened; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (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 sickness, chills, fever, nausea, vomiting, inappetence, dehydration and weakness. On an unknown date, the outcome of the sickness, chills, fever, nausea, vomiting, inappetence, dehydration and weakness were unknown.   It was unknown if the reporter considered the sickness, chills, fever, nausea, vomiting, inappetence, dehydration and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had sickness, chills, fever, nausea, vomiting, inappetence, dehydration and weakness. The patient asked should get the second vaccination.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: developed hives on the insiden of the calf of both legs; rash on my lower legs; This case was reported by a consumer via call center representative and described the occurrence of hives in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced hives and rash. On an unknown date, the outcome of the hives was unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the hives and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed hives on the inside of the calf of both legs from knee to ankle. The patient still had a rash on my lower legs it did not itch and no blisters.