chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My friend died right after getting his shot. Athletes are dying on the field after getting the vaccine; Safety information originally reported under manufacturer case 202200573641 has been nullified and re-entered under this new manufacturer report number 202400232563.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "My friend died right after getting his shot. Athletes are dying on the field after getting the vaccine". The date and cause of death for the patient were unknown. Clinical course: Reporter was asking why it was hidden that the Pfizer Covid-19 virus caused more problems than people know about. Like heart problems. Reporters friend died right after getting his shot. Athletes were dying on the field after getting the vaccine. This was being hidden from people said didn't know how this spike protein will affect organs in the long run.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow up (18Apr2022): This is a spontaneous follow-up report from a contactable consumer. This consumer reported in response to Non-HCP letter sent via telephonic in reference to cross referred case which included that  Updated information included : Primary reporter's mailing address added.  Additional information: Telephone call to obtain mailing address for reporter in slider #01 not completed due to it was already obtained in cross-reference case #. Please add the following address for reporter in slider #1 in this case as follows: Name: (name withheld) Address: (address withheld).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.  Follow-up (20May2022): Follow-up attempts are completed. No further information is expected.  Follow-up (07Aug2024): This is a follow-up report to notify that the case 202400232563 and 202200573641 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400232563.; Reported Cause(s) of Death: My friend died right after getting his shot
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: killing all the young people, the 21 year old (further not clarified who are dropping dead on sacred pillar, 'baseball field and football field'; Safety information originally reported under manufacturer case 202300118545 has been nullified and re-entered under this new manufacturer report number 202400232582.  This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 21-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killing all the young people, the 21 year old (further not clarified who are dropping dead on sacred pillar, 'baseball field and football field'". The date and cause of death for the patient were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (07Aug2024): This is a follow-up report to notify that the case 202400232582 and 202300118545 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400232582.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300118631 Same product and event, different patient;; Reported Cause(s) of Death: killing all the young people, the 21 year old (further not clarified who are dropping dead on sacred pillar, 'baseball field and football field'
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: medical assistant only administered the liquid portion of the PENTACEL and did not give the HIB portion (with no reported adverse event); Initial information received on 05-Aug-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age and unknown gender patient and reporter reported medical assistant only administered the liquid portion of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and did not give the hib portion (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 03-Jul-2024, the patient received a 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (strength: unknown) (lot: UJ93AA, expiry date: 02-Dec-2025) via unknown route in unknown administration site as Immunization and medical assistant only administered the liquid portion of the pentacel and did not give the hib portion (with no reported adverse event) (single component of a two-component product administered) (latency: same day).  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 the 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: 2.0
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: adminsitered QUADRACEL instead of his fourth dose of Pentacel, with no reported adverse event; Initial information received on 07-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old male patient who was adminsitered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of his fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], with no reported adverse event.  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) for Prophylactic vaccination.  On 31-Jul-2024, the patient received 0.5 ml TOTAL of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE Suspension for injection lot U7838AA 27-Jul-2025 via intramuscular route in the right arm for immunization (strength unknown) instead of his fourth dose of pentacel, with no reported adverse event (wrong product administered) (latency same day).   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 the 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: 60.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Mild pain and redness/pruritus at the injection site appeared day after reaction.  Mother returned to clinic the subsequent day (8/9/24) for evaluation
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Syncopal episode 10 minutes after vaccination administration.
Age: 69.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Abdominal discomfort, Abdominal pain upper, Headache
Clinical narrative: Headache upset stomach ache very cramping
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Childrens Hep A vaccine was ordered, however adult HEP A vaccine was administered. Department of Health and CDC were notified immediately . Once guidance was given, parent was notified. patient did not experience any adverse reaction from adult dose hep a vaccine.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given adult dose of Hepatitis A (Havrix) by mistake.  I discovered my error after patient and caregiver had already left when inputting vaccination info
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Gave vaccine multiple times. First given on 5/9/24 and second on 7/13/24
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Erythema, Inflammation, Joint stiffness, Lymphadenopathy
Clinical narrative: Shoulder redness increasing in size followed by inflamation and lymph node involvement on that same left side. Opposite shoulder (right) became involved with similar symptoms resulting in swelling and impigment on both shoulders along with mild to moderate pain. Two years later initial symptoms have gradually lessened, however thumb joint (Carpometacarpal) on both sides became painful and stiff. Random, localied pain and some swelling has occured from time to time throughout body. (These major symptoms have resulted following the last injection. The prior injections resulted in not much more than the usual malaise and localized tissue discomfort.)
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Rotator cuff syndrome, Swelling
Clinical narrative: Shoulder redness increasing in size followed by inflamation and lymph node involvement on that same left side. Opposite shoulder (right) became involved with similar symptoms resulting in swelling and impigment on both shoulders along with mild to moderate pain. Two years later initial symptoms have gradually lessened, however thumb joint (Carpometacarpal) on both sides became painful and stiff. Random, localied pain and some swelling has occured from time to time throughout body. (These major symptoms have resulted following the last injection. The prior injections resulted in not much more than the usual malaise and localized tissue discomfort.)
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine administration error. First Shingrix given on 5/3/2024. Second dose of Shingrix was given on 5/24/2024, at 21 days after first dose (too soon based on current recommendations). Patient experienced no adverse events. Patient was informed of the vaccine being given too soon and recommended to receive another dose since the interval between dose 1 and 2 was less than 4 weeks.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: N/A none yet.  no event happened yet.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test abnormal, COVID-19, Condition aggravated, Fatigue
Clinical narrative: I received the Johnson Covid vaccine in August 2021? Got Covid in October 2021 along with my wife? My symptoms were much more severe than hers although I did not need hospitalization? About six months later I just really started to notice that I was overwhelmed with fatigue and having much more joint pain than normal? I visited my doctor and tested positive for high rheumatoid factor and inflammation? I visited a rheumatologist and was told that the combination of the vaccine and the virus likely triggered my immune system to start attacking itself? I have been on hydroxychloroquine since and that has helped a little with the fatigue? About two months ago I visited an immunology/allergy clinic to find out what foods and allergens were making me have flareups? I did blood test there and the results came back that I had high levels of the vaccine spike proteins still in my body that should not still be there after three years? I was told by the immunologist that they are seeing this every day that the vaccine is making people produce spike proteins in their body? Levels should be below .8, my levels were at about 3500? I was put on ivermectin for 30 days and returned for another blood test? My spike protein number actually increased, proof that my body is producing the spike proteins? The immunologist said that spike proteins are very bad for the body, they cause inflammation and why would they make a vaccine that causes inflammation? I am on ivermectin for another 60 days hopefully I will get some relief? He also told me that they are seeing this every day and that when people come in with levels up into the 25,000 they can hardly walk, I have heart issues and stroke issues.--
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Immunisation reaction, Inflammation, Rheumatoid factor increased
Clinical narrative: I received the Johnson Covid vaccine in August 2021? Got Covid in October 2021 along with my wife? My symptoms were much more severe than hers although I did not need hospitalization? About six months later I just really started to notice that I was overwhelmed with fatigue and having much more joint pain than normal? I visited my doctor and tested positive for high rheumatoid factor and inflammation? I visited a rheumatologist and was told that the combination of the vaccine and the virus likely triggered my immune system to start attacking itself? I have been on hydroxychloroquine since and that has helped a little with the fatigue? About two months ago I visited an immunology/allergy clinic to find out what foods and allergens were making me have flareups? I did blood test there and the results came back that I had high levels of the vaccine spike proteins still in my body that should not still be there after three years? I was told by the immunologist that they are seeing this every day that the vaccine is making people produce spike proteins in their body? Levels should be below .8, my levels were at about 3500? I was put on ivermectin for 30 days and returned for another blood test? My spike protein number actually increased, proof that my body is producing the spike proteins? The immunologist said that spike proteins are very bad for the body, they cause inflammation and why would they make a vaccine that causes inflammation? I am on ivermectin for another 60 days hopefully I will get some relief? He also told me that they are seeing this every day and that when people come in with levels up into the 25,000 they can hardly walk, I have heart issues and stroke issues.--
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vaccination site cellulitis, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Cellulitis - swelling, redness, heat, induration at the site of the vaccines
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Product administered at inappropriate site
Clinical narrative: patient (who is RN) reported that vaccine was administered more distally than deltoid muscle and almost SQ vs IM resulting in a 'cellulitis' reaction that lasted nearly 1 week
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: patient experienced swelling and area turned blue for about 2 weeks and had pain for about 5 days and patient is fine . no symptoms now
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cholecystectomy, Chronic kidney disease, Condition aggravated, Hysterectomy
Clinical narrative: hysterectomy, gall bladder removed, chronic stage 2 kidney disease
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Thrombosis
Clinical narrative: hysterectomy, gall bladder removed, chronic stage 2 kidney disease
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 3 doses of Heplisav injection 5/13/24, 6/10/24 and 7/9/24. She has no symptoms and no signs of over vaccinated, she said she is doing fine.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia
Clinical narrative: Patient felt tingling sensation throughout her injected arm soon after the vaccine was given.  About 15 minutes later, she felt that her arm was getting better but continued to feel tingling sensation on her arm.  She was told to monitor her symptoms and go seek medical help if she felt worst.  and to call the pharmacy to give an update as to how her arms was feeling.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Pain, Periorbital swelling
Clinical narrative: Patient said she had a warm, swollen, and red area around her right eye.  She also had fever, chills, body aches, and loss of appetite. Patient thought it may have been from fever.  The reaction appeared to be getting better after 2 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient said she had a warm, swollen, and red area around her right eye.  She also had fever, chills, body aches, and loss of appetite. Patient thought it may have been from fever.  The reaction appeared to be getting better after 2 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Dysphagia, Dysphonia, Epiglottitis, Immediate post-injection reaction
Clinical narrative: Along with immediate flu like symptoms, mild swelling if throat felt early evening Aug 7, progressed to sever pain, great diffuculty swallowing or speaking by 11 pm Aug 8.  Self admitted into hospital at about midnight.  Diagnosed with epiglottitis .   Symptoms seemed under control after IV course  of  antibiotics and pain killers and steroids.  Follow up by ENT specialist  12 hours later showed no significant epiglottis swelling remained.(Aug 9 1 pm)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Laryngoscopy, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Along with immediate flu like symptoms, mild swelling if throat felt early evening Aug 7, progressed to sever pain, great diffuculty swallowing or speaking by 11 pm Aug 8.  Self admitted into hospital at about midnight.  Diagnosed with epiglottitis .   Symptoms seemed under control after IV course  of  antibiotics and pain killers and steroids.  Follow up by ENT specialist  12 hours later showed no significant epiglottis swelling remained.(Aug 9 1 pm)
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Full body hives within 18-24 hours of vaccination
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported; Improper storage of product in use; This spontaneous report has been received by other health care professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 14-JUN-2024, the vaccine HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced a temperature excursion with a temperature of 51 F during a time frame of 446 hours. However, on 28-JUN-2024, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, route of administration, site of vaccination, and vaccination scheme were not provided; lot # X019625 which has been verified to be valid, expiration date reported and validated as 23-APR-2025) as prophylaxis (product storage error). No adverse side effects were reported. ; Sender's Comments:  US-009507513-2407USA010455: US-009507513-2408USA000111:02637628 US-009507513-2407USA015892:02645759 US-009507513-2407USA016016:02645760 US-009507513-2407USA010455:02637629 US-009507513-2407USA015997:02637596 US-009507513-2407USA015998:02637623 US-009507513-2407USA015881:02645737 US-009507513-2408USA002567:02637625
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported; HCP called regarding RECOMBIVAX HB that was administered after the expiration date 11/30/2020. Product was administered on 10/1/2021. Consent to contact is yes. No adverse side effects were reported. No additional information available at this time.; This spontaneous report was received from a registered nurse and refers to a 3-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-OCT-2021, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot # T018888, expiration date reported as: 03-NOV-2020 and 30-NOV-2020, but upon internal validation determined to be: 03-NOV-2022, administered for prophylaxis (strength, dose and route of administration were not provided). No adverse side effects were reported.
Age: 1.58
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; 19 month vaccine; vaccine excursion; This spontaneous report was received from an registered nurse and referred to a 19-month-old male patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 28-JUN-2024, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #X022980, expiration date: 18-MAY-2026, strength was not provided) experienced temperature excursion with 12.7 degree Fahrenheit (F) for 76 hours 50 minutes and 0 seconds (too cold for administration) according to digital data logger. On 28-JUN-2024, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #X022980, expiration date: 18-MAY-2026, administered in vastus lateralis for prophylaxis (strength, dose and route of administration were not provided) (product storage error, inappropriate schedule of product administration). No additional adverse event (no AE).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2408USA000406:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Agency called to report that a 12 year old female patient who recieved GARDASIL 9 on an unspecified date, fainted after receiving the dose.; This spontaneous report was received from registered nurse and refers to a 12-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, lot #, expiry date, anatomical location and route of administration were not provided) administered for prophylaxis.  On an unknown date, the patient fainted after receiving the dose. At the reporting time, the outcome of the event was unknown.   The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2408USA001443
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient involved has not reported any medical concerns or symptoms after the administration was completed. No additional AE; VARIVAX was administered during a temperature excursion when the product was above the recommended temperature limit; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient.  The patient's medical history, concurrent conditions previous drug reactions or allergies and concomitant therapies were not reported.  On 02-AUG-2024, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 ml, lot #Y005920, expiration date: 13-MAR-2026, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of 14.8 Fahrenheit degrees for 8 hour and 15 minutes (Improper storage of product in use). It was stated that the patient had not reported any medical concerns or symptoms after the administration was completed. No additional adverse event reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported; Improper storage of product in use; This spontaneous report has been received by other health care professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 14-JUN-2024, the vaccine HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced a temperature excursion with a temperature of 51 F during a time frame of 446 hours. However, on 28-JUN-2024, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, route of administration, site of vaccination, and vaccination scheme were not provided; lot # X019625 which has been verified to be valid, expiration date reported and validated as 23-APR-2025) as prophylaxis (product storage error). No adverse side effects were reported. ; Sender's Comments:  US-009507513-2407USA010455: US-009507513-2408USA000111:02637628 US-009507513-2407USA015892:02645759 US-009507513-2407USA016016:02645760 US-009507513-2407USA010455:02637629 US-009507513-2407USA015997:02637596 US-009507513-2407USA015998:02637623 US-009507513-2407USA015881:02645737 US-009507513-2407USA010431:02637624
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate dose schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a adult male patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero) and Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On an unknown date, the patient received the 3rd dose of Bexsero (right arm). On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate dose schedule). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-JUL-2024 Reporter was a mother calling on behalf of her son who was the patient.    The mother stated her son received his first dose of suspect vaccine in his right arm at the end of August of 2023.   The reporter did not have lot number or date of first dose.   The mother stated her son received his second dose of suspect vaccine two and a half to three months later at a walk-in pharmacy in his right arm.   Mother stated her son received a third dose of suspect vaccine 2 weeks after the second dose by mistake in his right arm, which led to shortening of vaccination schedule. Reporter could not verify any of the suspect vaccines by lot number.   Reporter would not give information of pharmacy for this agent to verify product.   Reporter also stated that her adult son, the patient, was adamant that he did not receive the third dose of suspect vaccine.   Reports stated the patient did not have any immediate AE's to report. Did not consent to follow-up.
Age: 20.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got the 1st dose of Twinrix in September 2023, and the 2nd shot in April 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 20-year-old male patient who received HAB (Twinrix) (batch number 7X224, expiry date 20-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (on September 2023 receive 1st dose).   In APR-2024, the patient received the 2nd dose of Twinrix. In APR-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient got the 1st dose of Twinrix in September 2023, and the 2nd shot in April 2024). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-JUL-2024 The pharmacist called to inform that a patient got the 1st dose of Twinrix in September 2023, and the 2nd shot in April 2024, which led to lengthening of vaccination schedule No exact dates were provided by reporter. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: they assumed 1 patient received only the liquid component,; they assumed 1 patient received only the liquid component,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A, expiry date 31-DEC-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: they assumed 1 patient received only the liquid component, ) and inappropriate dose of vaccine administered (Verbatim: they assumed 1 patient received only the liquid component, ). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 31-JUL-2024 Health Care Provider explained that they administered 5 doses of Menveo (2-vial presentation), but then they noticed 1 vial of the lyophilized component still remains, so they assumed 1 patient received only the liquid component, but it was unknown which patient received it and the date of the administration was unknown as well, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Caller did not have any patient demographics and it was unknown if this was the first dose. Consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient only receiving the liquid (MenCYW-135) portion of the Menveo 2 vial preparation; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient only receiving the liquid (MenCYW-135) portion of the Menveo 2 vial preparation) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   Additional Information: GSK receipt date: 31-JUL-2024 The reporter had a question around a patient only receiving the liquid (MenCYW-135) portion of the Menveo 2 vial preparation, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked what step they needed to ensure the patient was protected.  The reporter asked if could the vial containing MenA be reconstituted with a diluent and administered separately or if the patient needed to be revaccinated with a reconstituted 2 vial preparation.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Melanocytic naevus, Precancerous skin lesion
Clinical narrative: moles are pre-cancerous; More than 20 moles have been taken out. More moles continue to come up; immune system was against him; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Platelet disorder" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE (Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula))), for Covid-19 immunization, reaction(s): "immune system was against him", "More than 20 moles have been taken out. More moles continue to come up", "moles are pre-cancerous". The following information was reported: PRECANCEROUS SKIN LESION (medically significant), outcome "unknown", described as "moles are pre-cancerous"; MELANOCYTIC NAEVUS (non-serious), outcome "unknown", described as "More than 20 moles have been taken out. More moles continue to come up"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune system was against him".  Clinical course: The caller was called on half of her son who has a platelet disorder. She wanted to know if Zavzpret would have any platelet related reaction if her son takes it. The caller had another inquiry regarding her son who had a platelet disorder. Her son mentioned that he got two shots of the Pfizer Covid-19 vaccine and said that all problems started after that his immune system was against him. More than 20 moles have been taken out. More moles continue to come up. She said that these moles are pre-cancerous. She wanted to know any information about this. No information found on blood diseases, cancer, or mole development with the Pfizer Covid-19 vaccine.  Batch/lot number is not provided, and it cannot be obtained.
Age: 60.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Arthritis, Discomfort, Mobility decreased, Muscular weakness
Clinical narrative: On morning of Saturday July 27 I went to Medical Center ER to have sea urchin spines removed from my right ankle. The doctor removed the spines and said I should get a Tetanus vaccine because my last one was over 10 years ago. I received the injection in left shoulder, it felt a little sore but nothing unusual. The next morning the shoulder was still a little sore and felt like it was asleep (no tingling). I noticed weakness and loss of feeling in my left hand.  I was scheduled for a follow up appointment on Monday July 29.  The ankle was checked and was healing up nicely. I told the nurse about the increasing pain, discomfort, and numbness/loss of strength in my left hand. She asked a nurse practitioner to check out the symptoms. The NP said, ?it was probably some kind of reaction to the shot, and I should wait two weeks to see if it changed.? I explained that the pain was increasing and I only had partial use of my left hand. She advised me to go back to the ER. 0300 Thursday August 1 the pain and discomfort was so bad, I went to the ER. The pain was increasing and I still had numbness and weakness in left had. They advised me to ?follow up with primary care in 1 week?. They also put in the system some kind of referral, and suggested I go to the facility and have it approved. I went straight to the Medical Center Urgent Care that morning. The doctor there could not find any referrals in the system. She prescribed Diclofenac Topical gel for the pain. It had no effect on the pain, which was steadily increasing. On Monday Aug 5, I had a scheduled appointment with my Rheumatologist for Polymyalgia Rheumatica. While telling her about my pain and weakness issues since I had gotten the vaccine, another doctor (Dr. MD-Neurology) overheard the symptoms and came in. He had a pretty good idea of what may have happened. We scheduled for the earliest he can see me on Aug 19. On Aug 8, the pain was so bad I went to a hospital ER, Medical Center. They prescribed 5MG Oxycodone and 100MG Gabapentin. Nether one of these medications is helping with the pain. Today, Aug 9, the pain is still unbearable. It comes and goes in excruciating waves, it moves from my left elbow to my left shoulder. I was able to get the neurology appointment moved to Aug 15. I can?t drive, I can?t sleep, and I can?t work.
Age: 60.0
Sex: M
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: On morning of Saturday July 27 I went to Medical Center ER to have sea urchin spines removed from my right ankle. The doctor removed the spines and said I should get a Tetanus vaccine because my last one was over 10 years ago. I received the injection in left shoulder, it felt a little sore but nothing unusual. The next morning the shoulder was still a little sore and felt like it was asleep (no tingling). I noticed weakness and loss of feeling in my left hand.  I was scheduled for a follow up appointment on Monday July 29.  The ankle was checked and was healing up nicely. I told the nurse about the increasing pain, discomfort, and numbness/loss of strength in my left hand. She asked a nurse practitioner to check out the symptoms. The NP said, ?it was probably some kind of reaction to the shot, and I should wait two weeks to see if it changed.? I explained that the pain was increasing and I only had partial use of my left hand. She advised me to go back to the ER. 0300 Thursday August 1 the pain and discomfort was so bad, I went to the ER. The pain was increasing and I still had numbness and weakness in left had. They advised me to ?follow up with primary care in 1 week?. They also put in the system some kind of referral, and suggested I go to the facility and have it approved. I went straight to the Medical Center Urgent Care that morning. The doctor there could not find any referrals in the system. She prescribed Diclofenac Topical gel for the pain. It had no effect on the pain, which was steadily increasing. On Monday Aug 5, I had a scheduled appointment with my Rheumatologist for Polymyalgia Rheumatica. While telling her about my pain and weakness issues since I had gotten the vaccine, another doctor (Dr. MD-Neurology) overheard the symptoms and came in. He had a pretty good idea of what may have happened. We scheduled for the earliest he can see me on Aug 19. On Aug 8, the pain was so bad I went to a hospital ER, Medical Center. They prescribed 5MG Oxycodone and 100MG Gabapentin. Nether one of these medications is helping with the pain. Today, Aug 9, the pain is still unbearable. It comes and goes in excruciating waves, it moves from my left elbow to my left shoulder. I was able to get the neurology appointment moved to Aug 15. I can?t drive, I can?t sleep, and I can?t work.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Thirst
Clinical narrative: Patient stated she was very sensitive to any medications and vaccines when she completed The vaccine consent form. She rode on an electric cart into the counseling room to receive the Shingrix vaccine.  Suddenly she said she was very dizzy right after getting the vaccine. she dropped her head on the handle of the cart.  She was sweating. She was coherent and expressing how she felt.   We gave her a electric fan and a wet towel to cool her down.  She felt thirsty and hot.  Slowly she felt better. We let her sit down over 20 minutes and gave her a massage on her back. Another 20 minutes later, she gained her strength and left for house. 2 hours later, she called the pharmacy and told that she was better.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong vaccine administered. pt was a 9 yr old and received the 12+ COVID vaccine. pt was medically stable, no adverse reactions
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pyrexia, Sleep disorder
Clinical narrative: PATIENT HAD FEVER, CHILLS, UPSET STOMACH FOR ABOUT 1 DAY FOLLOWING THE VACCINE. PATIENT DESCRIBED SHE HAD INSOMNIA THAT STARTED FROM THE STEROID INJECTION THE WEEK PRIOR TO VACCINATION. PATINET SAID SHE KEPT HAVING THE INSOMNIA FOR FEW MORE DAYS AFTER THE VACCINATION.  PATIENT STATED SHE HAS RECOVERED FROM THE SIDE EFFECTS EITHER FROM SHINGLES SHOT OR THE STEROID INJECTION SHE HAD AT THE DOCTORS OFFICE.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Swelling face
Clinical narrative: Swelling on nose and underneath nose in pheltrum area of upper lip, also in the folds of my face. Tiny holds in the area.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Suture removal
Clinical narrative: Patient reported a migraine shortly after vaccination that lasted 12 days when she returned to the facility for suture removal.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and heat near injections site that is still getting redder on day 7
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Pateint had arm swelling, redness, inflammation that lasted 7 days.
Age: 69.0
Sex: M
Vaccine: HEPA
Symptoms: Sleep inertia, Somnolence
Clinical narrative: Been exceedingly groggy (sleep inertia?) every morning since vaccination.
Age: 66.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site erythema, Nausea
Clinical narrative: Fever of 101.8; shivering; nausea and vomiting; headache; stomachache; 4? red mark at the site of the Shingrix shot; sore arm
Age: 66.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever of 101.8; shivering; nausea and vomiting; headache; stomachache; 4? red mark at the site of the Shingrix shot; sore arm
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Ataxia, Bell's palsy, Conversion disorder, Guillain-Barre syndrome
Clinical narrative: Very weak and sick. Ataxia, Bells palsy. Guillaume Barre. Functional neurological disorder
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: Very weak and sick. Ataxia, Bells palsy. Guillaume Barre. Functional neurological disorder
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: seen today 8/10 - right deltoid indurated urticarial erythematous rash measuring 6cm by 6cm with swelling, tenderness, and warmth; prescribed Keflex for possible cellulitis, topical steroid, ice compress, antihistamine
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: seen today 8/10 - right deltoid indurated urticarial erythematous rash measuring 6cm by 6cm with swelling, tenderness, and warmth; prescribed Keflex for possible cellulitis, topical steroid, ice compress, antihistamine
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This dose was given two (2) weeks after the initial dose on 5/5/24 when it should have been two (2) months following initial dose.  This was just discovered 8/9/24 by Pharmacy Compliance.  The patient was notified, he did not experience any adverse effects and does not have any concerns.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PATIENT WAS RETURNING FOR HIS SECOND DOSE OF MENINGITIS B (BEXSERO) BUT INSTEAD RECEIVED A SECOND DOSE OF MENINGITIS A,C,Y,W (MENQUADFI).  THE PATIENT WAS NOT AWARE OF THE INCORRECT VACCINE UNTIL 08/10/2024 WHEN I CALLED TO REPORT IT TO HIM.  HE HAD NO ADVERSE SIDE EFFECTS OR REACTIONS AND WILL BE RETURNING THE WEEK OF 08/12/2024 TO RECEIVE HIS SECOND DOSE OF BEXSERO
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Pain
Clinical narrative: Patient  got Fluzone HD and Prevnar 20 and starting complaining about pain after the Prevnar.  Pt was monitored for over 30 minutes. She denied any anaphylactic rx symptoms. she got consulted about potential side effect and seeks medical attention if symptoms were not resolved. Pt was asked if she needs any medical attention or call EMS she denied and said she  will walk in the store and contact Rx if any thing happened.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: Tinnitus in right ear that began about 1 hour following shot and still continues
Age: 29.0
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL, HEP, IPV, MMR, VARCEL
Symptoms: Heart rate increased, Tremor
Clinical narrative: PATIENT CAME IN TO THE PHARMACY AS SCHEDULED TO RECEIVE FIVE VACCINES BUT THE TDAP WHICH WAS THE FIFTH VACCINES WAS OUT OF STOCK AND I ADVISE PATIENT TO COME BACK AND RECIVE THE TDAP WHEN THE ORDER COMES IN. THE PATIENT PROCEEDED TO GET THE FOUR VACCINES THAT WAS AVAILABLE AT THE PHARMACY WHICH IS THE ENGERIX B, VARIVAX, MMR, AND POLIO VACCINES. THE PHARMACIST ADMINSTER THE ENGERIX B VACCINES, AND THE POLIO VACCINES VIA INTRAMUSCULAR ROUTE ON THE LEFT ARM AND ADMINSTER THE MMR VACCINES AND THE VARIVAX VACCINES ON THE LEFT ARM. AS SOON AS THE PATIENT GOT THE LIVE VACCINES ON THE RIGHT ARM HE SUDDENLY STARTED SHAKING WHILE HE WAS SEATED ON THE CHAIR AND I ASKED HIM IF HE WAS OKAY BUT HE KEPT HIS ARMON HIS CHEST THAT HIS CHEST WAS BEATING FAST. SO I ASKED HIM IF HE HAS HAD ANY THING TO EAT OR DRINK. AND I GAVE HIM SOME WATER TO DRINK AND CALLED 911
Age: 29.0
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL, HEP, IPV, MMR, VARCEL
Symptoms: Product administration error, Product preparation error
Clinical narrative: PATIENT CAME IN TO THE PHARMACY AS SCHEDULED TO RECEIVE FIVE VACCINES BUT THE TDAP WHICH WAS THE FIFTH VACCINES WAS OUT OF STOCK AND I ADVISE PATIENT TO COME BACK AND RECIVE THE TDAP WHEN THE ORDER COMES IN. THE PATIENT PROCEEDED TO GET THE FOUR VACCINES THAT WAS AVAILABLE AT THE PHARMACY WHICH IS THE ENGERIX B, VARIVAX, MMR, AND POLIO VACCINES. THE PHARMACIST ADMINSTER THE ENGERIX B VACCINES, AND THE POLIO VACCINES VIA INTRAMUSCULAR ROUTE ON THE LEFT ARM AND ADMINSTER THE MMR VACCINES AND THE VARIVAX VACCINES ON THE LEFT ARM. AS SOON AS THE PATIENT GOT THE LIVE VACCINES ON THE RIGHT ARM HE SUDDENLY STARTED SHAKING WHILE HE WAS SEATED ON THE CHAIR AND I ASKED HIM IF HE WAS OKAY BUT HE KEPT HIS ARMON HIS CHEST THAT HIS CHEST WAS BEATING FAST. SO I ASKED HIM IF HE HAS HAD ANY THING TO EAT OR DRINK. AND I GAVE HIM SOME WATER TO DRINK AND CALLED 911
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient did not need Tdap but was given Tdap by mistake
Age: 64.0
Sex: F
Vaccine: FLUC4, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccine admin date: 08/03/2024 (left arm- prevnar 20, right arm- flu per system) Adverse reaction reported to me in the pharmacy on 8/10/24: Symptoms started 3 days after date of administration. Left Deltoid area redness, soreness, warm to touch. No fever or other systemic symptoms. Getting worse per patient. Have not sough treatment yet but considering contacting her PCP.