chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: needed that one vaccination, however she was given a second one. no adverse effects reported; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who was vaccinated with vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U5989AA and expiry date: 27-Aug-2019) via intramuscular route in the left deltoid on 26-Jul-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE).  It was actual medication error due to extra dose administered. It was reported that the patient received after the age of 16 years and only needed that one vaccination, however she was given a second one.  It was reported that the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: menactra was given early, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (with unknown demographics) who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number 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 a case of actual medication error due to inappropriate schedule of vaccine administered.  It was reported that the other product mentioned was Menactra by Sanofi and was administered to someone else; it was clarified by the transferring agent it was administered to the wrong patient. The caller explained it was not given to the wrong patient but it was actually given early.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error, Wrong product administered
Clinical narrative: patient was administered Menactra accidentally mixed with Varivax instead of diluent, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 11 years old male patient who received 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6522aa via intramuscular route in the right arm on 25-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), HPV VACCINE (HPV VACCINE), INFLUENZA VACCINE (INFLUENZA VACCINE) and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Immunisation.  It was a case of actual medication error due to product preparation error.  It was reported that a patient was administered Menactra accidentally mixed with Varivax instead of diluent. The medical assistant mistakenly thought the Menactra was the diluent for the Varicella and mixed them together and administered it to the patient.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness
Clinical narrative: He has been feeling weak.; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 65 years old male patient who received a 0.5 ml dose of vaccine INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE] via intramuscular route on 25-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Information on the batch number was requested.  It was reported on 25-Oct-2019 reporter husband is not feeling too good, since he took the shot He has been feeling weak. Today, he said that he is feeling a little better. But he is a little white again. He is functioning additionally it was reported as On Saturday, he went to the gym and he had to leave because he felt light headed. He had the shot on Friday.  The outcome of the event was recovering.
Sex: F
Vaccine: FLUR4
Symptoms: Urticaria
Clinical narrative: patient experienced hives; Initial information regarding an unsolicited valid non-serious case was received from a healthcare professional on 25-Oct-2019.  This case involves an unknown age female patient who experienced hives(Urticaria), while she 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.  Concomitant medications and concurrent conditions were unknown.   On an unknown date, the patient administerd influenza quadrivalent recombinant vaccine of an unknown dosage(Batch No: Unknown, Expiration date : Unknown) via unknown route for an unknown indication.  On an unknown date, (latency period: Unknown) after administering influenza quadrivalent recombinant vaccine, it was reported that the patient experienced hives(Urticaria).  Final diagnosis was hives.  Action taken was not applicable.  It was not reported whether corrective treatment was received.  Outcome of the event hives was unknown.  Batch number has been requested.  No further information was reported.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they administered a 16 year old patient with Flublok/no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient (60.317 kg) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Pregnancy status: negative.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  On 30-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot 2FAA1953, expiry date 30-Jun-2010 via intramuscular route in the left arm.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  It was not reported whether the patient experienced 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.
Age: 16.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 16 year old patient received a dose of Flublok QIV / no adverse event; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist via Nurse on 24-Oct-2019.  This case is linked to cases 2019SA304586, 2019SA304587, 2019SA304588, 2019SA304589, 2019SA304590, 2019SA304591, 2019SA304592 and 2019SA304588.  This case involves a 16-year-old patient (unknown gender) for who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [Flublok QIV] (Batch No: QFAA1938, Expiry date: 30-Jun-2020) (Product administered to patient of inappropriate age).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  It was not reported whether the patient experienced 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.
Age: 16.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 16 year old patient received Flublok Quadrivalent / no AE; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist and a Nurse on 24-Oct-2019.  This case is linked to cases 2019SA304586, 2019SA304580, 2019SA304588, 2019SA304589, 2019SA304590, 2019SA304591 and 2019SA304592.  This case involves a 16-year-old patient (unknown gender) for who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [Flublok QIV]) (Batch No: QFAA1938, Expiry date: 30-Jun-2020) (Product administered to patient of inappropriate age).  The patient s past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  It was not reported whether the patient experienced 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.
Age: 16.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 16 year old patient received a dose of Fluzone QIV with no AE; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist via Nurse on 24-Oct-2019.  This case is linked to cases 2019SA304586, 2019SA304587, 2019SA304588, 2019SA304580, 2019SA304590, 2019SA304591 and 2019SA304592.  This case involves a 16-year-old patient (unknown gender) who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [Flublok QIV]) (Batch No: QFAA1938, Expiry date: 30-Jun-2020) (Product administered to patient of inappropriate age).  The patient s past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  It was not reported whether the patient experienced 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.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Blood glucose increased, Pain in extremity, Pancreatitis
Clinical narrative: Pancratitis; Blood sugar spiked very high; Pain in hands and knees; Pain in hands and knees; This is a spontaneous case, initially received from consumer via Med Communication (reference number: SEQ19-06147) on 04-Nov-2019, concerning a 68-year-old, male patient.   The patient's relevant medical history included flu shot in 2018 after which the patient developed pancreatitis. The patient's concomitant medications included Keprom (ketoprofen) and levetiracetam, both for an unknown indication.  On 31-Aug-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: P100110154 and expiration date: not reported] for influenza prophylaxis.    On 03-Sep-2019, the patient's blood sugar spiked very high and he developed pancreatitis. The patient was hospitalised.  On an unspecified date, the patient experienced pain in hands and knees.   On an unspecified date, the patient was still having trouble with pain in his hands and knees.  The patient was recovering from the events of pancreatitis and increased blood sugar, while the outcome for the events of pain in hands and knees was not recovered, at the time of this report.  The reporter assessed the case as serious bit did not provide causality assessment to Afluria Quadrivalent.  The case was linked with 201905880 (due to same patient).  Company comment: The patient experienced pancreatitis, blood glucose increased, arthralgia and pain in extremity after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. Medical history of previous pancreatitis may have contributed to development of the events. Causality was also confounded by therapy with concomitant medications, Keprom (ketoprofen) and levetiracetam. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced pancreatitis, blood glucose increased, arthralgia and pain in extremity after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. Medical history of previous pancreatitis may have contributed to development of the events. Causality was also confounded by therapy with concomitant medications, Keprom (ketoprofen) and levetiracetam. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Nausea, Pain
Clinical narrative: Swelling, soreness, redness, shivering, headache, nausea
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling, soreness, redness, shivering, headache, nausea
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain
Clinical narrative: Patient developed vice-like headache approx 3 hours after Trumenba administration. the next day she also developed body aches. Denies fever, swelling, difficulty breathing, vomiting, rash. History of similar reaction after first dose of Trumenba resulting in ER visit. So far at the completion of this form, she has not sought care for this reaction but her mother called the office and I advised taking benadryl with ibuprofen at onset of headache and advised she could alternate the ibuprofen with tylenol every 4 hours prn. If no improvement with this, patient was instructed to go to ER for migraine cocktail, as this improved her symptoms last time.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Mental status changes, Rash
Clinical narrative: Patient received his high dose flu vaccine from another registry on 10/11/19. On 10/13/19 he was taken to ER for altered mental. status and rash. Patient spend 1 week  in hospital and 1 week in rehab with no dx  of why this happened. Pt and his wife feel that it was due to the flu vaccine and asked us to report.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Computerised tomogram head normal, Condition aggravated, Dizziness, Electrocardiogram normal
Clinical narrative: received INJECTION ON 10/08/2019. On 10/14/2019 I woke up early, very dizzy and a little nauseated, headache in back of my head. I felt not well all week, foggy head and occipital headache. On 10/18/2019 I had my blood pressure checked and it was 220/140. My blood pressures has always been very well controlled  with Lorsartan. I contacted my PCP, who suggested that I has a systemic reaction to the flu shot and that I should double up on my medication. However, the next day my pressure was still very elevated, I went to my local emergency room. I was given IV Labatelol and sent home. On 10/21/2019 my pressure had not gotten any lower, so I called my PCP, he advised me to go back to the emergency room. I was again given IV Labatelol and IV Hydralazine and kept overnight. I was start on Norvasc, in addition to Lorsartan 50mg. Cardiac work-up was negative. CT head was negative. I am now on HCTZ 25mg in addition to those meds to keep me under control. After thinking about this, I recalled that last year approximately 1 week after receiving my flu shot, I was hospitalized with left upper and lower extremity numbness and slightly elevated blood pressure. Stroke and cardiac workup were negative and told I had a TIA, because they couldn't figure out what what was wrong with me.  So weird symptoms, 2 years in a row after a flu shot, I do not think is a coincidence.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Headache, Magnetic resonance imaging brain normal, Malaise, Myocardial necrosis marker normal
Clinical narrative: received INJECTION ON 10/08/2019. On 10/14/2019 I woke up early, very dizzy and a little nauseated, headache in back of my head. I felt not well all week, foggy head and occipital headache. On 10/18/2019 I had my blood pressure checked and it was 220/140. My blood pressures has always been very well controlled  with Lorsartan. I contacted my PCP, who suggested that I has a systemic reaction to the flu shot and that I should double up on my medication. However, the next day my pressure was still very elevated, I went to my local emergency room. I was given IV Labatelol and sent home. On 10/21/2019 my pressure had not gotten any lower, so I called my PCP, he advised me to go back to the emergency room. I was again given IV Labatelol and IV Hydralazine and kept overnight. I was start on Norvasc, in addition to Lorsartan 50mg. Cardiac work-up was negative. CT head was negative. I am now on HCTZ 25mg in addition to those meds to keep me under control. After thinking about this, I recalled that last year approximately 1 week after receiving my flu shot, I was hospitalized with left upper and lower extremity numbness and slightly elevated blood pressure. Stroke and cardiac workup were negative and told I had a TIA, because they couldn't figure out what what was wrong with me.  So weird symptoms, 2 years in a row after a flu shot, I do not think is a coincidence.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: received INJECTION ON 10/08/2019. On 10/14/2019 I woke up early, very dizzy and a little nauseated, headache in back of my head. I felt not well all week, foggy head and occipital headache. On 10/18/2019 I had my blood pressure checked and it was 220/140. My blood pressures has always been very well controlled  with Lorsartan. I contacted my PCP, who suggested that I has a systemic reaction to the flu shot and that I should double up on my medication. However, the next day my pressure was still very elevated, I went to my local emergency room. I was given IV Labatelol and sent home. On 10/21/2019 my pressure had not gotten any lower, so I called my PCP, he advised me to go back to the emergency room. I was again given IV Labatelol and IV Hydralazine and kept overnight. I was start on Norvasc, in addition to Lorsartan 50mg. Cardiac work-up was negative. CT head was negative. I am now on HCTZ 25mg in addition to those meds to keep me under control. After thinking about this, I recalled that last year approximately 1 week after receiving my flu shot, I was hospitalized with left upper and lower extremity numbness and slightly elevated blood pressure. Stroke and cardiac workup were negative and told I had a TIA, because they couldn't figure out what what was wrong with me.  So weird symptoms, 2 years in a row after a flu shot, I do not think is a coincidence.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Pallor, Presyncope
Clinical narrative: Right after giving HPV pt became light headed, pale, diaphoretic, nearly fainted.  Laid pt down and monitored x 1 hour, until she was symptom free.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: Pt was inoculated with smallpox on 06NOV2019.  On 10NOV2019 at 1200 pt got a tattoo directly below the inoculation sight.  Tattoo shows no signs of possible infection due to the inoculation.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Tattoo, Unevaluable event
Clinical narrative: Pt was inoculated with smallpox on 06NOV2019.  On 10NOV2019 at 1200 pt got a tattoo directly below the inoculation sight.  Tattoo shows no signs of possible infection due to the inoculation.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Brain natriuretic peptide, Burning sensation, Fatigue, Fibrin D dimer
Clinical narrative: On 10/11/19 I went for a physical and also got the flu shot and shingles shot. That night I awoke with excruciating pain in my hand. It felt like it would burst, my heart was beating in it, it was on fire and very painful. If I tried to move it I had to use my other hand because of the pain. The next day it still hurt but it was a Saturday so I didn?t contact my doctor. On Monday I called the doctor?s office and told my symptoms and then someone called me back and said it could be normal or could be a reaction but shouldn?t last long. Today it is 1 month since I have received those shots and I am not better. My right hand is in constant pain along with the soles of my feet. I cannot grasp with my hand. I can?t open a door, I can?t cut with a knife. Also my hips and ankles are sore. I am fatigued. Before this happened I was very healthy- where I worked I usually got about 10,000 steps. This has totally changed my life.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Full blood count, Grip strength decreased, Metabolic function test, Pain in extremity
Clinical narrative: On 10/11/19 I went for a physical and also got the flu shot and shingles shot. That night I awoke with excruciating pain in my hand. It felt like it would burst, my heart was beating in it, it was on fire and very painful. If I tried to move it I had to use my other hand because of the pain. The next day it still hurt but it was a Saturday so I didn?t contact my doctor. On Monday I called the doctor?s office and told my symptoms and then someone called me back and said it could be normal or could be a reaction but shouldn?t last long. Today it is 1 month since I have received those shots and I am not better. My right hand is in constant pain along with the soles of my feet. I cannot grasp with my hand. I can?t open a door, I can?t cut with a knife. Also my hips and ankles are sore. I am fatigued. Before this happened I was very healthy- where I worked I usually got about 10,000 steps. This has totally changed my life.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: After giving Tdap, pt became pale, light headed, and vomiting.  Monitored pt x 1 hour until symptoms resolved.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: 6 days after receiving Flu vaccine has left side paralysis noticed in fac
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Adverse event
Clinical narrative: triamcinolone and Benadryl 50mg was used because had at home
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Per patient following day had joint aches, malaise, low grade fevers, nausea, and headache
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient came to the pharmacy on 11/11/19 to report throbbing arm pain that started after the vaccine was administered on 10/16/19. She stated the pain in her left arm at the injection site began the day she received the vaccine, and has continued without relief. She stated she has tried taking over the counter acetaminophen but is still experiencing pain. I referred her to her primary care provider for follow up.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: One week after vaccination, patient developed significant pain with limitation in ROM in the right arm.  No swelling or redness.  On exam 11/12/2019, TTP at the site of injection but no weakness or sensory change in the hand or arm; reflexes are normal; no swelling or skin change.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received improperly stored PEDVAX HIB; No adverse effect; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, historical drugs, drug allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (strength, dose and frequency was not reported) (lot # S000352, expiration date 17-OCT-2021) for prophylaxis. On 04-NOV-2019 or 05-NOV-2019, the patient received an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB). Exact date of administration was unknown. No adverse effects were reported. There was no previous temperature excursion reported. The call was because of data logger, with a lowest temperature below 36 degree Fahrenheit/2 degree Celsius (1.3 C) for 2 hours 18 minutes. Product quality complaint was not involved in the case.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: HPV9, MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no adverse effect; 28 week pregnant patient was vaccinated with MMR II and Gardasil 9; This spontaneous retrospective pregnancy report was received from a nurse regarding a female patient of unknown age. The patient's concurrent condition, pertinent medical history, concomitant therapies and drug reactions/allergies were unknown. The patient became pregnant with Last Menstrual Period (LMP) of 23-APR-2016. The date of conception was on 07-MAY-2016. On 05-NOV-2016, at 28 weeks of gestation, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis (Exposure during pregnancy). The Expected Delivery Date (EDD) was on 28-JAN-2017. The pregnancy outcome was unknown. The fetal outcome was unknown. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Pain, Peripheral swelling
Clinical narrative: leg swelling; pain; nausea; This spontaneous report as received from a physician refers to a 15-year-old female patient. The patient had none pertinent medical history, none concomitant medications and none known drug reactions or allergies.    On an unspecified date in May 2019 (reported as 6 months ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1614898, expiration date reported as 20-SEP-2021, but upon internal validation established as 15-NOV-2021) (dose and anatomical location were not provided) intramuscularly, for prophylaxis.         On an unspecified date in May 2019 (reported as 6 months ago), the patient experienced leg swelling, nausea and pain for 2 weeks following the injection. No treatment was given for the adverse events, none lab diagnostic studies were performed and the patient did not seek medical attention. The outcome of the events was reported as recovered on an unspecified date in 2019 (reported as 2 weeks after injection).   The relatedness between the event and the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Chills; Fever; Flu like symptoms; This case was reported by a pharmacist via sales rep and described the occurrence of chills in an unspecified  patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced chills, fever and influenza-like symptoms. On an unknown date, the outcome of the chills, fever and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the chills, fever and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter reported that about 3 or 4 patients reported chills, fever, and flu like symptoms after receiving vaccine. Next day they were fine. The reporter discussed potential of if patient got flu shot, patient did not remember. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: muscle aches; fever; headache; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male 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 muscle pain, fever, headache and feeling unwell. On an unknown date, the outcome of the muscle pain, fever, headache and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fever, headache and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The caller was a consumer. The age at vaccination was not reported. The caller stated that the patient who was his personal trainer received the 1st dose of Shingrix.  After receiving the vaccine, the patient experienced muscle aches, fever, headache and did not feel well. The caller did not had time to provide any additional details regarding the patient or this event during the call. He had to get off of the phone and get to work. There is discrepancy in the reported event outcome in system and in narrative. However it is captured as per system.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: Outbreak of shingles on her back; This case was reported by a physician via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had a shingles outbreak immediately after getting the first Shingrix vaccine. The reporter asked whether the patient should get the second dose. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Echocardiogram normal, Palpitations
Clinical narrative: heart palpitations; This case was reported by a pharmacist via call center representative and described the occurrence of palpitation in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2021) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix. On 6th August 2019, less than a day after receiving Shingrix, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown.   It was unknown if the reporter considered the palpitation to be related to Shingrix.  Additional case details were reported as follows: The patient experienced heart palpitations within 24 hours of getting first Shingrix vaccination. The reporter said, she was unsure of patient's history, but stated patient told her she had no heart conditions, and did not experienced that event before.  The patient told her that she went to a cardiologist, who did an echocardiogram, and it was normal. The patient said she had only experienced one occurrence of the palpitations. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Post herpetic neuralgia
Clinical narrative: Severe burning neck pain; Post-Herpetic Neuralgia  like symptoms; This case was reported by a physician via call center representative and described the occurrence of neck pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced neck pain and post herpetic neuralgia. On an unknown date, the outcome of the neck pain and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the neck pain and post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient developed severe burning neck pain and post herpetic like symptoms after receiving Shingrix.  The reporter consented to follow up. The consult neurologist did not administer the vaccine.
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased
Clinical narrative: after receiving a HD Vaccine his sugars have risen for 48 hrs, went up to 200; Initial information received on 14-Oct-2019  regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 78 years old male patient whose  sugars have risen for 48 hrs, his FBG (fasting blood glucose) went up to 200 (Blood glucose increased), while he was immunized with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Patient concurrent illness included TD2 (type 2 diabetes mellitus). No other vaccines were administered. No concomitant drugs, medical history or family history were reported.  On 07-Oct-2019, patient was immunized with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] at a dose of 0.5 ml (strength high dose) via intramuscular route in left deltoid (batch number and expiry date: unknown).  On 09-Oct-2019, 2 days after immunization with vaccine, his sugars have risen for 48 hours, his fasting blood glucose went up to 200 (Blood glucose increased). It was usually 115-130.   Relevant laboratory test results included: Blood glucose - On an unknown date: 200 [elevated]  Final diagnosis was after receiving a high dose vaccine his sugars have risen for 48 hrs, went up to 200.   The patient was treated with increased insulin dosing.  At the time of this report, outcome of event was recovered (His fasting blood glucose remained elevated for 2 days before returning to normal).  Information on the batch number was requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: fever; chills; arthritic-like pain moving from joint to joint; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non health care professional..  This case involves a 66 years old male patient who experienced fever (PT: Pyrexia), chills (PT: Chills) and arthritic-like pain moving from joint to joint (PT: Arthralgia), while he 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.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13).  On 04-Sep-2019, the patient received a dose  of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious fever (PT: pyrexia), chills (PT: chills ),   arthritic-like pain moving from joint to joint (PT: arthralgia) (about 3 days) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests included no lab data. Final diagnosis was arthritic-like pain moving from joint to joint, chills and fever.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as unknown for pyrexia, chills and arthralgia.  Information on batch number is requested.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 64 year old patient was given fluzone HD by mistake with no adverse event; 64 year old patient was given fluzone HD by mistake with no adverse event; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 64 years old male patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ235AB, expiry date: 04-Apr-2020), via intramuscular route in the left arm accidentally on 12-Oct-2019.  The patient past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and overdose.   It was reported that a 64 year old patient was given Fluzone HD by mistake.  At the time of reporting, the patient had no 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.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a flu shot on oct 4, and came back today to get Fluzone high dose, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 years old female patient who received a dose of INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site on 04-Oct-2019 and another dose of flu shot (INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE) (Fluzone High Dose) lot UJ251AB via intramuscular route in the right arm on 15-Oct-2019.   The patient's past vaccination(s) included a dose of PNEUMOCOCCAL VACCINE. The patient's past medical history, medical treatment(s) and family history were not provided.   It was a case of actual medication error due to the extra dose administered.   At the time of reporting, the patient had no 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.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Menactra was given every 5 years, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves female patient (reported as old woman) who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site on an unknown date in every five years.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to extra dose administered.  It was reported that she had the understanding for last 10 years that Menactra was given every 5 years like Adacel. Caller stated that now she is reading the insert and it says that it is given at ages 11, 16, and 23, and only given every 5 years if they have HIV." Indicated that this is not in our prescribing information. She states that she is an "old woman" and they get reviewed, the latest was two months ago, and no one ever called their attention to it and they never had one compliant about Menactra. She states that they have been giving Menactra every five years like Adacel.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache
Clinical narrative: headache; Dizzy; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA297782.  This case involves a 25 years old female patient who experienced headache and dizzy, while 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 17-Oct-2019, 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 headache and dizzy (dizziness) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was dizzy and headache.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for headache and dizzy.  Batch number was requested.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered Menactra that was expired, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in the left arm on 24-Oct-2019, that was already expired on 24-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: complaining of ringing in the ear/tinnitus; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 84 years old female patient who was complaining of ringing in the ear/tinnitus, after she was immunized with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2019, the patient was immunized with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  at a dose of 0.5 ml once (batch number:UJ268AA, expiry date: 10-May-2020) via intramuscular route in the left arm..  On an unknown date, latency unknown, it was reported that patient has received the vaccine and has since been complaining of ringing in the ear (tinnitus). It was going on for 1.5 to 2 weeks. One of the physician told her that tinnitus was a side effect of vaccine, but the nurse believed that physician said this just to satisfy the patient.  She was give prednisone and was sent to an ENT (ear, nose and throat).  The nurse stated that this year overall, fluzone high dose had been a good batch without many reports of side effects.  Action taken was not applicable with vaccine.  At the time of this report, outcome of event was not resolved.  No further relevant information was reported.