chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; received improperly stored PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), with lot# S021617 with expiration date on 09-JAN-2021 for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion -14°C to -10°C degrees Celsius (-11.7C) for 2  hours 35 minutes.   There was no adverse effect reported.  This call was because of a data logger with no previous temperature excursion.
Age: 0.92
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a 11 months old patient was accidentally administered the diluent portion of the pentacel without the ActHIB and they used Pedvaxhib ( for the missing ActHIB portion)/No AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 months old patient who was accidentally administered the diluent portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot U6137AA, dose: 0.5 ml via intramuscular route in the left thigh on 31-Oct-2019 without the acthib and they used HIB VACCINE CONJ (OMPC) [PEDVAXHIB] ( for the missing acthib portion).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLUARIX).  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  Corrective action: patient was administered Pedvaxhib ( for the missing ActHIB portion).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 17 year old male patient received a dose of Flublok Quadrivalent in error/no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old male patient who received a 0.5 ml dose QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (flu Blok quadrivalent) in error lot number and expiry date not reported via intramuscular route in unknown administration site on 13-Oct-2019.  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 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 24 months old patient received a dose of flublok vaccine/No AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case: 2019SA309425 (same reporter).    This case involves a 24 months old patient (gender unknown) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: Several drops were seen rolling down the patient's arm, no AE; while pushing down on the plunger, about less than half came dripping down the patient's arm, no AE; while pushing down on the plunger, about less than half came dripping down the patient's arm, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 69 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], lot no.: UJ292AA, expiry date: 10-Jun-2020, via unknown route in the left arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to underdose.  Also a case of exposure via skin contact and syringe leakage. It was reported that Pharmacist administered the vaccine into the muscle a large amount came out maybe about less than half came dripping down patients arm. while she was pushing down on the plunger, several drops were seen rolling down the patient's arm.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: U
Vaccine: FLU4, HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 1 month old was accidentally given the Fluzone Quad instead of their Hep B vaccine, no AE; 1 month old was accidentally given the Fluzone Quad, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 month old patient who received a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) instead of HEPATITIS B VACCINE accidentally on 31-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was reported that nurse reporting on behalf of a 1-month old child that received Fluzone Quadrivalent in error and not the prescribed Hepatitis B vaccine. The nurse reported that the consumer, at the time of this report, has not received the prescribed Hepatitis B vaccine.  At the time of reporting, no adverse event was reported.   Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 16 year old female patient received a dose of Flublok Quadrivalent vaccine in error/No AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 16 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] in error lot QFAA1941 and expiration date: 30-Jun-2020, via intramuscular route in the right arm on 30-Oct-2019.  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 inappropriate age at vaccine administration.  Physician reported that Flublok Quadrivalent was given to a 16 year old patient in error.  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 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: 6.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent administered to pediatric patient/No AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA304970 same reporter.  This case involves a 6 years old patient (gender unknown) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  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 QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of 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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 5.0
Sex: M
Vaccine: FLU4, FLUN3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: drops of the vaccine had leaked onto the table at the time of vaccination due to dose less than 0.5ml also administered Flumist/NO AE; drops of the vaccine had leaked onto the table at the time of vaccination/NO AE; drops of the vaccine had leaked due to needle/ hub connection/NO AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received vaccines FLUMIST and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Oct-2019, the patient received less than 0.5mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Frequency once) lot UT6681NA, expiry date-30-06-2020 via intramuscular route in the left deltoid.  On an unknown date, the patient received a dose of suspect FLUMIST not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Incorrect dose administered and vaccine underdose.  It was also the case of syringe issue.  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 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: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: She says that she is still experiencing pain in her arm; muscle pain since the injection in her left arm; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 86 years old female patient who pain in her arm (pain in extremity)  and muscle pain since the injection in her left arm (myalgia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 04-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE in the left arm, lot number not reported via unknown route.  On an unknown date, the patient developed a non-serious event of pain in her arm (pain in extremity)  and muscle pain since the injection in her left arm following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Final diagnosis was pain in her arm and muscle pain since the injection in her left arm.   The lab data was not reported.   It was not reported if the patient received a corrective treatment.  The patient outcome is not reported for pain in her arm and muscle pain since the injection in her left arm.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: didn't notice the diluent expired 5 days before/no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and reported that didn't notice the diluent was expired (Expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not have any concomitant therapy.  It was a case of actual medication error case due to expired medical agent used.   On 30-Oct-2019, the patient received a dose of suspect Act-HIB (PRP/T) VACCINE lot U6057AA expiry date of vaccine lot- 18-Nov-2019 for vaccine and lot number U6057AA, expiry date 24/Oct/2019 diluent via unknown route in unknown administration site.  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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: Arthralgia, Back pain, Joint swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: back stiffness; mid back pain; arm was pretty sore and swollen, around 10 cm,  right knee was more swollen and sore; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demographic who experienced back stiffness (Musculoskeletal stiffness), mid back pain (Back pain) and arm was pretty sore and swollen, around 10 cm,  right knee was more swollen and sore (inflammation), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included ACL tear in 1981, Chondrectomy in 2004 and Chondrectomy in 2007. The patient's past vaccination(s) included fluzone vaccine received on unknown date of 1994 and experienced swelling. Concomitant medication not reported.  On 22-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed back stiffness (musculoskeletal stiffness), mid back pain (back pain) and arm was pretty sore and swollen, around 10 cm, right knee more swollen and sore (inflammation) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that on the evening after vaccination patient arms was pretty sore and swollen which continued into the next two days. It was more swollen than it usually is with fluzone after every year vaccination since 1994. This resolved but following Monday patient noticed right knee swollen and sore and unusual mid back pain and stiffness. It worst on following day. After taking Ibuprofen, swelling resolved. Patient visited to orthopedist on Wednesday and received Mobic and after one dose the symptoms had largely resolved. He felt that the swelling didn't suggest Lyme or RA as there was no redness or warmth and that possibly early osteoarthritis due to an increase in activity. Also reported that overuse of opposite site is a possibility.  Details of lab data not reported.  Final diagnosis was arm was pretty sore and swollen, around 10 cm, right knee was more swollen and sore, mid back pain and back stiffness.   The patient was treated with IBUPROFEN (IBUPROFEN) and MELOXICAM (MOBIC).  On an unknown date, the patient had recovered from events.  Information on the batch number was requested.
Sex: U
Vaccine: FLUR4
Symptoms: Peripheral swelling
Clinical narrative: back stiffness; mid back pain; arm was pretty sore and swollen, around 10 cm,  right knee was more swollen and sore; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demographic who experienced back stiffness (Musculoskeletal stiffness), mid back pain (Back pain) and arm was pretty sore and swollen, around 10 cm,  right knee was more swollen and sore (inflammation), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included ACL tear in 1981, Chondrectomy in 2004 and Chondrectomy in 2007. The patient's past vaccination(s) included fluzone vaccine received on unknown date of 1994 and experienced swelling. Concomitant medication not reported.  On 22-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed back stiffness (musculoskeletal stiffness), mid back pain (back pain) and arm was pretty sore and swollen, around 10 cm, right knee more swollen and sore (inflammation) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that on the evening after vaccination patient arms was pretty sore and swollen which continued into the next two days. It was more swollen than it usually is with fluzone after every year vaccination since 1994. This resolved but following Monday patient noticed right knee swollen and sore and unusual mid back pain and stiffness. It worst on following day. After taking Ibuprofen, swelling resolved. Patient visited to orthopedist on Wednesday and received Mobic and after one dose the symptoms had largely resolved. He felt that the swelling didn't suggest Lyme or RA as there was no redness or warmth and that possibly early osteoarthritis due to an increase in activity. Also reported that overuse of opposite site is a possibility.  Details of lab data not reported.  Final diagnosis was arm was pretty sore and swollen, around 10 cm, right knee was more swollen and sore, mid back pain and back stiffness.   The patient was treated with IBUPROFEN (IBUPROFEN) and MELOXICAM (MOBIC).  On an unknown date, the patient had recovered from events.  Information on the batch number was requested.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: ActHib was mixed with sterile water and given to a patient; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demography who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and reported that Act-Hib was mixed with sterile water and given to a patient (product preparation issue).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant gave a Fluzone High-Dose injection to 5 year old patient / no AE; Medical Assistant gave a Fluzone High-Dose injection to 5 year old patient/ no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] Prefilled syringe lot UJ274AB (Expiry date 26-May-2020) via intramuscular route in the right thigh on 01-Nov-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Vomiting; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare.  This case is linked to case 2019SA307182 (same reporter).  This case involves a patient of an unknown demographics who experienced vomiting (vomiting), while he/she received vaccine INFLUENZA QUADRIVAL A-B 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 vomiting, Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood glucose increased, Flushing, Glycosylated haemoglobin increased, Injection site urticaria
Clinical narrative: sugar levels got high; shakiness in the body; HIves, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders; the face being flushed; feeling weak; got deftly ill; Initial information received on 01-Nov-2019 and additional information 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 69 years old female patient who experienced sugar levels got high (blood glucose increased), shakiness in the body (tremor), hives, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders (urticaria), the face being flushed (flushing), feeling weak (asthenia) and got deftly ill (malaise), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ221AB, expiry date-01-Apr-2020 via intramuscular route in the right arm.  On an unknown date, the patient developed a non-serious sugar levels got high (blood glucose increased), shakiness in the body (tremor), hives, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders (urticaria), the face being flushed (flushing), feeling weak (asthenia) and got deftly ill (malaise) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, relevant laboratory test results included Glycosylated haemoglobin: 6.2 [6.2].  Final diagnosis was got deftly ill, feeling weak, the face being flushed, hives, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders, shakiness in the body and sugar levels got high.  The patient received the vaccine on 22-Oct-2019; that on 23-Oct-2019 she went to the emergency room (ER) and was given intravenous steroids and sent home with steroids; that she still was experiencing the welts; that she thinks she went back to the ER on 25-Oct-2019; that she was given IV steroids and then placed on another steroid.  On an unknown date, the patient was recovered from urticarial and outcome of the all other events was unknown.
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Tremor, Urticaria
Clinical narrative: sugar levels got high; shakiness in the body; HIves, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders; the face being flushed; feeling weak; got deftly ill; Initial information received on 01-Nov-2019 and additional information 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 69 years old female patient who experienced sugar levels got high (blood glucose increased), shakiness in the body (tremor), hives, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders (urticaria), the face being flushed (flushing), feeling weak (asthenia) and got deftly ill (malaise), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ221AB, expiry date-01-Apr-2020 via intramuscular route in the right arm.  On an unknown date, the patient developed a non-serious sugar levels got high (blood glucose increased), shakiness in the body (tremor), hives, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders (urticaria), the face being flushed (flushing), feeling weak (asthenia) and got deftly ill (malaise) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, relevant laboratory test results included Glycosylated haemoglobin: 6.2 [6.2].  Final diagnosis was got deftly ill, feeling weak, the face being flushed, hives, welt at the right arm injection site, having welts on the arms, stomach, back, and shoulders, shakiness in the body and sugar levels got high.  The patient received the vaccine on 22-Oct-2019; that on 23-Oct-2019 she went to the emergency room (ER) and was given intravenous steroids and sent home with steroids; that she still was experiencing the welts; that she thinks she went back to the ER on 25-Oct-2019; that she was given IV steroids and then placed on another steroid.  On an unknown date, the patient was recovered from urticarial and outcome of the all other events was unknown.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: reported swelling and redness to left arm and also green color to the site area of administration; pt was directed to go to ER
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient arm swell up  that night and patient thought he can just wait and the swelling will die down, but he called the pharmacy today (anout 14 days after) saying that his arm is still swollen and it starts hurting
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Tremor
Clinical narrative: 102.5 temperature after 1000 mg Tylenol, Extreme shaking
Age: 1.33
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Abscess soft tissue, Gait disturbance, Inflammatory marker increased, Injection site pain, Injection site reaction
Clinical narrative: Patient is a 16 month old male who presented with pain with weight bearing on his right leg and difficulty walking first noted the day prior to admission.  He began having subjective fevers about five days ago (1 day after vaccination) associated with mild URI symptoms (which preceded the vaccination).  Of note, he received Hep A, MMR, varicella, and influenza vaccinations on 10/31 with the Hep A and varicella vaccines administered in the right thigh.  In the ED, inflammatory markers were elevated and MRI was notable for myositis, osteomyelitis and a soft tissue abscess in the right thigh.  He was admitted for IV antibiotics and remains admitted at the time of this submission.
Age: 1.33
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Magnetic resonance imaging abnormal, Myositis, Osteomyelitis, Pyrexia, Streptococcus test positive
Clinical narrative: Patient is a 16 month old male who presented with pain with weight bearing on his right leg and difficulty walking first noted the day prior to admission.  He began having subjective fevers about five days ago (1 day after vaccination) associated with mild URI symptoms (which preceded the vaccination).  Of note, he received Hep A, MMR, varicella, and influenza vaccinations on 10/31 with the Hep A and varicella vaccines administered in the right thigh.  In the ED, inflammatory markers were elevated and MRI was notable for myositis, osteomyelitis and a soft tissue abscess in the right thigh.  He was admitted for IV antibiotics and remains admitted at the time of this submission.
Age: 1.33
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Weight bearing difficulty
Clinical narrative: Patient is a 16 month old male who presented with pain with weight bearing on his right leg and difficulty walking first noted the day prior to admission.  He began having subjective fevers about five days ago (1 day after vaccination) associated with mild URI symptoms (which preceded the vaccination).  Of note, he received Hep A, MMR, varicella, and influenza vaccinations on 10/31 with the Hep A and varicella vaccines administered in the right thigh.  In the ED, inflammatory markers were elevated and MRI was notable for myositis, osteomyelitis and a soft tissue abscess in the right thigh.  He was admitted for IV antibiotics and remains admitted at the time of this submission.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: STATED SHE HAD PAIN AFTER INJ. IN ARM AT INJ. SITE.  STATES IT HAS BEEN HARD TO MOVE AND RAISE HER LEFT ARM SINCE INJECTION.  SHE HAS NOT DONE ANY TREATMENT TO RELIEVE PAIN AS IN NSAIDS, IBUPROFEN, HOT OE COLD PACKS OR EXERCISES.  SHE STATES SHE STILL HAS DIFFICULTY MOVING ARM.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: Fever, chills with intense shaking, aches - began several hours after injection - fever/chills subsided after seven hours - aches subsided after 16 hours
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Peripheral swelling, Yellow skin
Clinical narrative: Arm swelling from site to elbow and yellow bruising  at elbow
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, IPV, PNC13, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: (5/24)2 yo male here with mom who says the night after he was vaccinated (5/22), he developed redness in his leg and was irritable.  Next day leg still red, and today it seems worse.  He seems to feel itchiness at site, mom says.  Mom denies any sob, no problems breathing and no rashes or redness any where else.  He received 4 vaccines in left thigh and 3 on his right thigh.   (5/28) 2 Yrs 1 Mo Male who presents with mom for f/u L leg swelling after vaccines. On 5/22 received 7 vaccines, had fever (tactile). L sided vaccines received: flu, PCV, Hep A, Dtap.  When leaving the clinic, said leg was itchy. Mom tried to keep him from scratching. 5/23 looked more red and swollen. Was applying ice but still looked red so came to clinic on 5/24 for evaluation. Treated for cellulitis with Keflex, ibuprofen, Benadryl.  Saturday (1 day after) the leg was looking better. Now is back to normal.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain
Clinical narrative: Pt had severe lower back pain.  Pt was sent to the hospital to have it checked out.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Eye pain, Facial pain
Clinical narrative: Received first dose of Shingrix at 12:07pm, later that night experienced fever of 104F, body aches, chills, shivers, headache. Fever of 101F the following day. Day 3, experienced low grade fever and diarrhea 4-5 episodes and watery, no abdominal pain. Day 4 (today), notes erythema, redness, swelling at the injection site, pain in the arm that radiates down to the elbow, up the shoulder into the left side of the face, the left ear, and intermittently into the left eye. Feels like a needle is poking her in the eye very occasionally. No visual changes or photophobia.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Received first dose of Shingrix at 12:07pm, later that night experienced fever of 104F, body aches, chills, shivers, headache. Fever of 101F the following day. Day 3, experienced low grade fever and diarrhea 4-5 episodes and watery, no abdominal pain. Day 4 (today), notes erythema, redness, swelling at the injection site, pain in the arm that radiates down to the elbow, up the shoulder into the left side of the face, the left ear, and intermittently into the left eye. Feels like a needle is poking her in the eye very occasionally. No visual changes or photophobia.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Received first dose of Shingrix at 12:07pm, later that night experienced fever of 104F, body aches, chills, shivers, headache. Fever of 101F the following day. Day 3, experienced low grade fever and diarrhea 4-5 episodes and watery, no abdominal pain. Day 4 (today), notes erythema, redness, swelling at the injection site, pain in the arm that radiates down to the elbow, up the shoulder into the left side of the face, the left ear, and intermittently into the left eye. Feels like a needle is poking her in the eye very occasionally. No visual changes or photophobia.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza virus test negative, Muscle twitching, Streptococcus test negative
Clinical narrative: Involuntary Twitching or face and extremities. Facial twitching started 10/27/19 around 3:00pm. 10/28/19 facial and bodily involuntary twitching started around 6:30pm and lasted for about 5 minutes.  10/29/19 - 10/30/19 facial and bodily twitching throughout the whole day. (I have video's of the twitching). No previous history of these symptoms.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash developed over entire body the day after vaccine given
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Balance disorder, Chest pain, Dyspnoea, Electrocardiogram normal, Erythema
Clinical narrative: Felt suddenly hot,erythematous macular rash of chest with red ears and face, red eyes, spots in vision, chest pain, SOB, facial swelling, poor balance (nursing staff had to grab her to keep her from falling) within 2 minutes of pneumococcal 23 valent vaccine (Lot S017430, exp 2021 May18). Had pneumococcal 23 valent vaccine in 2010. Had diabetes so will need to be re-vaccinated in the future. Improving without any medication (she declined Benadryl due to wanting to be able to drive herself home). Pulse ox was 99%, bp 135/85, pulse 101. Improved greatly over 10 minutes.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Ocular hyperaemia, Rash erythematous, Rash macular, Swelling face
Clinical narrative: Felt suddenly hot,erythematous macular rash of chest with red ears and face, red eyes, spots in vision, chest pain, SOB, facial swelling, poor balance (nursing staff had to grab her to keep her from falling) within 2 minutes of pneumococcal 23 valent vaccine (Lot S017430, exp 2021 May18). Had pneumococcal 23 valent vaccine in 2010. Had diabetes so will need to be re-vaccinated in the future. Improving without any medication (she declined Benadryl due to wanting to be able to drive herself home). Pulse ox was 99%, bp 135/85, pulse 101. Improved greatly over 10 minutes.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Visual impairment
Clinical narrative: Felt suddenly hot,erythematous macular rash of chest with red ears and face, red eyes, spots in vision, chest pain, SOB, facial swelling, poor balance (nursing staff had to grab her to keep her from falling) within 2 minutes of pneumococcal 23 valent vaccine (Lot S017430, exp 2021 May18). Had pneumococcal 23 valent vaccine in 2010. Had diabetes so will need to be re-vaccinated in the future. Improving without any medication (she declined Benadryl due to wanting to be able to drive herself home). Pulse ox was 99%, bp 135/85, pulse 101. Improved greatly over 10 minutes.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Electroencephalogram, Seizure
Clinical narrative: SEIZURE- HOSPITALIZATION
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: DIZZINESS, NAUSEA, ROOM SPINNING, AND VOMITING.  GIVEN ONDANSETRON 8MG PT REFERRED TO ER
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Developed cellulitis.  PCP diagnosed and prescribed RX for Cephalexin  500mg  4X/day for 10 days.  Condition cleared with no additional adverse affects
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: For a month the patient has experienced limited range of motion in her left arm, along with soreness. She has tried icing and stretching with little results. Patient says the pain has decreased by about 50% since the shot but still has limited motions in activities such as yoga. Patient is following up with her primary car physician.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial test negative, Chills, Culture negative, Fungal test negative, Genital discomfort
Clinical narrative: Initially, fever, chills, aches for two days. Then blister-like rash along with red rash. Significant itching and irritation in genital area. I sought treatment and my doctor ran tests for bacteria and yeast but all tests were negative. Rash, blisters, tenderness, continue.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Potassium hydroxide preparation negative, Pruritus genital, Pyrexia, Rash erythematous
Clinical narrative: Initially, fever, chills, aches for two days. Then blister-like rash along with red rash. Significant itching and irritation in genital area. I sought treatment and my doctor ran tests for bacteria and yeast but all tests were negative. Rash, blisters, tenderness, continue.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Tenderness
Clinical narrative: Initially, fever, chills, aches for two days. Then blister-like rash along with red rash. Significant itching and irritation in genital area. I sought treatment and my doctor ran tests for bacteria and yeast but all tests were negative. Rash, blisters, tenderness, continue.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Bursitis, Injection site pain, Product administered at inappropriate site
Clinical narrative: SHOT REALLY HURT PATIENT SAID SHE GOT BURSITIS WHERE THE VACCINE WAS INJECTED PATIENT CLAIMS THE VACCINE WAS  ADMINISTERED TO HIGH ON HER RIGHT ARM ( EXTRAORDINARY PAIN)
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Patient's wife came back into the pharmacy stating that the patient was having burning in his nerves.
Age: 33.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Patient reported having a rash on his lower back starting 11/2/19 following receiving vaccines.  He stated recently he has noticed some swelling of his lymph nodes in his groin
Age: 26.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Rash macular, Urticaria
Clinical narrative: Patient reports a large, raised red welt at the injection site as well as red flat welts down her arm for about 5 inches
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site bruising, Injection site discharge, Injection site pain, Injection site swelling
Clinical narrative: Patient described a clear liquid coming out from under the Inject-Safe Barrier Bandage, after exiting out of the store (after shopping in the store as well). The liquid created a stain of approx 5 inches on her sweater. She did not report it immediately and went home. Overnight, she developed pain, swelling, bruising around the injection site (she described it as black and blue) and some more clear liquid oozed out. She called her MD and the nurse advised her to call the pharmacy. As of now, no other symptoms developed. The patient is monitoring and she will report to ER or Urgent Care if symptoms get worse. Patient states she has received this vaccine last year with no side effect, other than being a bit tired for the following 1-2 days. This time she said she only felt a bit tired for the first part of today.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Oxygen therapy, Pyrexia
Clinical narrative: Patient has had a high fever 100 to 102 for the last 2 days, SOB
Age: 45.0
Sex: F
Vaccine: FLU4, HEPAB, YF
Symptoms: Rash
Clinical narrative: Rash noticed on lower back on 11/2/19
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: arm swollen, red and feels warm "swollen like a balloon" advised ice packs, ibuprofen, get medical attention if it gets worse or shows signs of infection
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Pain was felt shortly after receiving the flu vaccine to my left arm and I continue to have pain to my left arm even a month after receiving the flu vaccine. My arm hurts with over head activities, especially when dressing, but it also hurts with certain arm movements like driving, fixing my hair, pulling or lifting etc. Pain  to my left shoulder is also felt at night and often times the pain wakes me up. I have gone to Day and Night Clinic to have my left arm examined and was initially prescribed methylprednisolone 4mg and Ibuprofen 800mg. My arm pain has not resolved and they have recommended a therapy as well as an MRI to my left shoulder however workers comp insurance is pending approval.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Shortly after getting the vaccine, that spot on my arm started to hurt quite a bit, and I felt a bit worn down and headachy. Today I have a large red blotchy area at the site of the vaccine, about 3 or 4 inches in diameter, that's hot to the touch and hurts quite a lot. I've just been taking ibuprofen for it.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Rash macular
Clinical narrative: Shortly after getting the vaccine, that spot on my arm started to hurt quite a bit, and I felt a bit worn down and headachy. Today I have a large red blotchy area at the site of the vaccine, about 3 or 4 inches in diameter, that's hot to the touch and hurts quite a lot. I've just been taking ibuprofen for it.