chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arteriosclerosis, Gait inability, Scar
Clinical narrative: scar tissue, a fibro scar tissue, in his arteries, in his heart and everything else; I started having problems like my arteries closed up; couldn't walk; This spontaneous case was reported by a patient and describes the occurrence of SCAR (scar tissue, a fibro scar tissue, in his arteries, in his heart and everything else), ARTERIOSCLEROSIS (I started having problems like my arteries closed up) and GAIT INABILITY (couldn't walk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SCAR (scar tissue, a fibro scar tissue, in his arteries, in his heart and everything else), ARTERIOSCLEROSIS (I started having problems like my arteries closed up) and GAIT INABILITY (couldn't walk). At the time of the report, SCAR (scar tissue, a fibro scar tissue, in his arteries, in his heart and everything else), ARTERIOSCLEROSIS (I started having problems like my arteries closed up) and GAIT INABILITY (couldn't walk) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The reporter stated that he was curious because he took the COVID vaccine back in 2020 and he was curious about some of the documented cases of artery and vein damage.   Reporter stated he had bunch of issues; he and his wife took the vaccine and shortly after he took it, he was getting to where he could not walk, and he had to go in and have his arteries rebuilt his leg.  He started having problems like arteries closed up. He went on saying that he had got a bunch of scar tissue, a fibro scar tissue, in his arteries, in his heart and everything else. He then said that it was kind of coincidental.   Reporter had 10 stents put in, in two years. He added, he had no blood flow from knees down.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Hypercoagulation, Inflammation, Menstruation delayed
Clinical narrative: bloody nose; thicken of blood; period delayed by 3-4months; increased inflammation; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of EPISTAXIS (bloody nose), HYPERCOAGULATION (thicken of blood), MENSTRUATION DELAYED (period delayed by 3-4months) and INFLAMMATION (increased inflammation) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (bloody nose), HYPERCOAGULATION (thicken of blood), MENSTRUATION DELAYED (period delayed by 3-4months) and INFLAMMATION (increased inflammation). At the time of the report, EPISTAXIS (bloody nose), HYPERCOAGULATION (thicken of blood), MENSTRUATION DELAYED (period delayed by 3-4months) and INFLAMMATION (increased inflammation) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medications were reported. The patient had bloody nose, thicken of blood and period delayed by 3-4months and increased inflammation after vaccination started a few months after vaccination. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.
Sex: U
Vaccine: PNC20
Symptoms: Screaming, Vaccination site pain
Clinical narrative: Prevnar 20 is the most painful of all the shots they give to babies; This is a spontaneous report received from a Nurse from a sales representative.  An infant patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Prevnar 20 is the most painful of all the shots they give to babies".  Additional information: As described to me, Prevnar 20 is the most painful of all the shots they give to babies. They always have an iconic blood curdling scream when administering any dose of Prevnar 20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On 3Jun2023 I tested positive for covid at My clinic; On 3Jun2023 I tested positive for covid at My clinic; This is a spontaneous report received from a Consumer or other non HCP.  An 87-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2020 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "I had stent placed LLD", start date: 2011 (not ongoing); "I have been gluten free for about 7 years" (unspecified if ongoing); "drink about 30 oz of liquor with 7 UP in the evening" (unspecified if ongoing); "cholesterol abnormal" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jun2023, outcome "recovered" (Jun2023) and all described as "On 3Jun2023 I tested positive for covid at My clinic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2023) Positive, notes: at his clinic; (Jun2023) 10 days later, tested Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: Patient received the covid vaccine 2-3 shots in early 2020, he thought it was Moderna and all the boosters which may have been Moderna or Pfizer the Dr. prescribed Paxlovid 150 (X1) 100 mg PK (EUA) and Benzonatate 200 mg capsule 3x/ day for slight cough and stopped his cholesterol meds for 10 days. 10 days later he tested Negative and has been clear since then.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 4.0
Sex: U
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: accidentally gave a 4-year-old child an extra dose of IPV/4th dose was given (6/24) only one month after the 3rd (5/24) instead of the 6 months with no reported adverse event; Initial information received on 19-Jul-2024 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 4 years old and unknown gender patient who accidentally got an extra dose of IPV (VERO) /4th dose was given (6/24) only one month after the 3rd (5/24) instead of the 6 months with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in May- 2024, the patient received a dose 3 of suspect IPV (VERO) Suspension for injection lot number not reported via unknown route in unknown administration site. In Jun-2024 he/she also received a dose 4 of vaccine with an unknown batch number via unknown route in unknown administration site (strength and expiration date: not provided) for Immunisation (inappropriate schedule of product administration) (latency- same day).Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  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.
Sex: F
Vaccine: FLUX
Symptoms: Myocarditis
Clinical narrative: myocarditis; Initial information received on 19-Jul-2024 regarding an unsolicited valid serious courtesy case received from patient.  This case involves an unknown age female patient who had  myocarditis after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (immunization) (strength, dose, form, batch number and expiry date unknown).  On an unknown date the patient had myocarditis (unknown latency).  It is unknown if there were lab data/results available  Reportedly, It was bad but not as bad the time patient got it from the flu shot.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (myocarditis).  At time of reporting, the outcome was Unknown for the event myocarditis.  Seriousness criteria-Medically significant for event; Sender's Comments: Sanofi Company Comment dated 26-Jul-2024: This case involves an unknown age female patient who had  myocarditis after receiving influenza vaccine.Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACTHIB was mixed with sterile water and given to a patient with no reported adverse event; Initial information received on 18-Jul-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months and 8 days old female patient and it was reported HIB (PRP/T) vaccine [ACT-HIB] was mixed with sterile water and given to a patient 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 diphtheria vaccine toxoid, hepatitis B Vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3V (VERO), Tetanus vaccine toxoid (Pediarix); pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20); and rotavirus vaccine live reassort oral 5V (Rotateq) all for Prophylactic vaccination.  On 15-Jul-2024, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot: UJ996AA; expiry date: 31-Mar-2025; strength: standard; frequency: once) was mixed with sterile water and given to a patient with no reported adverse event (product preparation error) (latency: same day) via intramuscular route in the right vastus lateralis for Immunization.  Reportedly, caller wanted to know what to do next, and should the injection be repeated how long to wait before giving the vaccines again.  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.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion/temperature reached 9° celsius fahrenheit for 11 minutes with no reported adverse event; received the vaccine post excursion with no reported adverse event; Initial information received on 22-Jul-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves involves an unknown age and unknown gender patient IPV (VERO) [IPOL] where reporter reported temperature excursion/temperature reached 9° celsius fahrenheit for 11 minutes with no reported adverse event and received the vaccine post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml (TOTAL) dose of suspect IPV (VERO) Suspension for injection (lot- W1C751M and expiration date- 18-Nov-2025) via unknown route in unknown administration site (strength: not provided) for Immunisation and (product storage error) (unknown latency) and (poor quality 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: 0.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: inappropriate use due to administration of fourth dose of pentacel earlier than what is recommended in the PI with no reported adverse event; Initial information received on 22-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9-month-old male patient and is reported inappropriate use due to administration of fourth dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] earlier than what is recommended in the PI with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Jul-2024, the patient received a 0.5 ml dose (dose 4) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection of lot UK036AB and expiry date: 30-Jun-2025 via intramuscular route in the left thigh and On 06-May-2024 he also received a (dose 3) of vaccine and On 07-Feb-2024 he also received a (dose 2) of vaccine and On 06-Dec-2023 he also received a 0.5 ml (dose 1)of vaccine with an unknown batch number, expiry date via intramuscular route in unknown administration site for prophylactic vaccination (immunisation).  On 18-JUL-2024, inappropriate use due to administration of fourth dose of pentacel earlier than what is recommended in the PI with no reported adverse event (inappropriate schedule of product administration) (latency: on same day) was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered PENTACEL inappropriately/ administer the ActHIB component mixed with sterile water and failed to give the DTaP-IPV component of PENTACEL, with no reported adverse event; Initial information received on 22-Jul-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] inappropriately/ administer the acthib component mixed with sterile water and failed to give the dtap-ipv component of pentacel, 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 COVID-19 VACCINE PROT. SUBUNIT (NVX COV 2373) (NOVAVAX COVID-19 VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 22-Jul-2024, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Powder and suspension for suspension for injection 0.5 mlx1 lot UK036AB expiry 30-Jun-2025 via intramuscular route in Vastus lateralis for immunization (strength unknown) inappropriately/ administer the acthib component mixed with sterile water and failed to give the dtap-ipv component of pentacel, with no reported adverse event (product preparation error) (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: 0.33
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ADACEL was given to 4-month-old baby with no reported adverse event; Initial information received on 23-Jul-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves, diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was given to 4-month-old baby (unknown gender) 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 an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site as Prophylactic Vaccination (immunization) and adacel was given to 4-month-old baby with no reported adverse event (product administered to patient of inappropriate age) (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: 11.0
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: DAPTACEL was administered to an 11-year-old patient, which should have been Adacel instead with no reported adverse event; DAPTACEL was administered to an 11-year-old patient, which should have been Adacel instead with no reported adverse event; Initial information received on 23-Jul-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 11 years old and unknown gender patient who was administered with Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], which should have been Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead 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 HPV Vaccine for Prophylactic vaccination.  On 22-Jul-2024, the patient received 0.5 ml total dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot 2CA28C1) (Expiry date: 04-Nov-2024) (Strength: standard) (frequency: once) via intramuscular route in the left deltoid for immunization.  On 22-Jul-2024, the patient was administered with Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, which should have been Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine instead with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency: same day).  Reportedly, This situation is pre-assessed as a medication error/an inappropriate use due to administering DAPTACEL to a patient beyond the recommended age of use.  Nurse asked for further instructions.  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: 5.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a 5th dose of IPOL and wanted to know the product's long term and short term safety for the extra dose with no adverse event; Initial information received on 25-Jul-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 5 years old male patient who received a 5th dose of IPV (VERO) [IMOVAX POLIO] and wanted to know the product's long term and short term safety for the extra dose with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 5  of suspect IPV (VERO) (Suspension for injection) (lot number, expiry date, strength not reported) via unknown route in the thigh nos(not specified) for Immunization and patient received a 5th dose of ipol and wanted to know the product's long term and short term safety for the extra dose with no adverse event (extra dose administered) (latency: same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.   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: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: daptacel vaccine was administered, that was later noted to have expired with no reported adverse event; Initial information received on 25-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5-year-old male patient whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] vaccine was administered, that was later noted to have expired 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for polio vaccine inact (IPV); and varicella zoster vaccine (varicella vaccine) for prophylactic vaccination for Immunisation.  On 25-Jul-2024, the patient received a 0.5 ml dose (dose 5) of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot C6013AA and expiry date: 05-Jul-2024 via intramuscular route in unknown administration site for Prophylactic Vaccination (immunisation) and was reported Daptacel vaccine was administered, that was later noted to have expired with no reported adverse event (expired product administered) (latency: on 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.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: the part broken was the diluent syringe. When they attached the needle the end snapped off; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown, Expiration Date: 01Mar2025) for immunisation, Device Lot Number: HA3218, Device Expiration Date: Mar2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "the part broken was the diluent syringe. When they attached the needle the end snapped off".  The reporter considered "the part broken was the diluent syringe. when they attached the needle the end snapped off" not related to rsv vaccine prot.subunit pref 2v. Causality for "the part broken was the diluent syringe. when they attached the needle the end snapped off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400225267 same reporter/event, different device;
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient was supposed to come in for a 2nd shingles shot on 7/1/2024 I did my checks and when I hit the query button on the immunization tab it populated immunization history that has not yet been uploaded into chart. I see patient received 2 shingles shots outside of our clinic(s) in addition to the one the individual gave the patient on 4/29/2024. I called patient to let him know that our records show you already completed your series and you do not have to come in. I am not sure what happened on 4/29/2024 but I know the shot was given by a float and this was potentially the start of team rooming and the first few days of team rooming were tough and messy as we had to adjust from what our normal was to something new.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Immunisation reaction, Pruritus, Skin exfoliation, Skin warm
Clinical narrative: Months after last Covid-19 vaccination, without intervening vaccination, the area on my upper left arm where the Covid-Arm syndrome  occurred for the second or third time after injection with first Moderna version, then most recently in Fall of 2023, the Pfizer version, I've experienced similar symptoms in the same area on my upper left arm in the same area as the previous vaccine induced Covid-Arm syndrome occurred,, but without any intervening vaccination, neither Covid-19 nor Flu vaccine.  No known cause of the spontaneously occurring sympton-ms that include, itching, redness, warming and eventually scaling or sloughing off of outer skin/dermal layer.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient received the high dose influenza vaccine in error; spoke with patient and let her know of the error and what to expect and far as side effects
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus
Clinical narrative: Apparent Shingles outbreak on stomach.  Painful and itchy blisters forming lasting over 3 weeks
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Pain, Peripheral swelling
Clinical narrative: ON SUNDAY STARTED FEELING SWELLING ON THE RIGH ARM FROM SHOULDER TO WRIST, PAIN AND BURNING IN THE SKIN AND NUMBNESS IN FINGERS  AND ALOT OF PAIN
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation, Ultrasound scan
Clinical narrative: ON SUNDAY STARTED FEELING SWELLING ON THE RIGH ARM FROM SHOULDER TO WRIST, PAIN AND BURNING IN THE SKIN AND NUMBNESS IN FINGERS  AND ALOT OF PAIN
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain, swelling, redness at site; diffuse joint pain, chills, resolving now, but still some swelling, firmness, and redness at site. Itching at site, as well.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling, redness at site; diffuse joint pain, chills, resolving now, but still some swelling, firmness, and redness at site. Itching at site, as well.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: Patient had no reactions. Spoke to provider about the situation and called patient's parents right after to inform what had happened. Scheduled patient to come back in 1 month to receive vaccine.
Age: 0.25
Sex: M
Vaccine: UNK, UNK
Symptoms: Agitation, Screaming
Clinical narrative: Patient began to scream uncontrollably for 20 minutes. He has never acted like that before, so it it very concerning. He was visibly upset the rest of the day and his demeanor is much different. He looks tired and uncomfortable.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Deafness unilateral, Sudden hearing loss
Clinical narrative: Per pt's wife via phone call: One week after receiving vaccine, pt experienced sudden hearing loss in one ear at 4pm on 7/1/24. pt wound up in hospital for stroke watch, no other symptoms of stroke, just increased blood pressure.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Headache, Immediate post-injection reaction, Oropharyngeal pain
Clinical narrative: got worse each time would have anaphylaxis with swelling in the throat and tongue had to give Epi-pen immediately after the fastest onset was the third booster it hit quickly and I almost died.  searing burning pain in my throat and head and not being able to talk and breathe was horrifying
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pharyngeal swelling, Speech disorder, Swollen tongue, Throat irritation
Clinical narrative: got worse each time would have anaphylaxis with swelling in the throat and tongue had to give Epi-pen immediately after the fastest onset was the third booster it hit quickly and I almost died.  searing burning pain in my throat and head and not being able to talk and breathe was horrifying
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunisation reaction
Clinical narrative: Reported Symptoms:  10018767:GUILLAIN-BARRE SYNDROME;     Narrative: EC 27,  2022@11:45:15 by ORIGINATOR Received influenza vaccine (FLUAD QIV PFS HIGH DOSE) and PCV 20 vaccine on 11/28/22.  Approximately 1-2 weeks after vaccines, developed numbness/tingling in bilateral toes and progressive ascending sensory loss. Also developed SOB and difficulty ambulating. Hospitalized and seen by neurology who dx'd GBS suspected 2/2 flu vaccine.  Recommended by neurology to not get future flu vaccines.    Other Relevant HX:  Other: GUILLAIN BARRE (12/27/22@11:45:15)
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia, Sensory loss
Clinical narrative: Reported Symptoms:  10018767:GUILLAIN-BARRE SYNDROME;     Narrative: EC 27,  2022@11:45:15 by ORIGINATOR Received influenza vaccine (FLUAD QIV PFS HIGH DOSE) and PCV 20 vaccine on 11/28/22.  Approximately 1-2 weeks after vaccines, developed numbness/tingling in bilateral toes and progressive ascending sensory loss. Also developed SOB and difficulty ambulating. Hospitalized and seen by neurology who dx'd GBS suspected 2/2 flu vaccine.  Recommended by neurology to not get future flu vaccines.    Other Relevant HX:  Other: GUILLAIN BARRE (12/27/22@11:45:15)
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report a temperature excursion with VAQTA. Administred after being improperly stored; This spontaneous report has been received from a medical assistant, concerning a 4-year-old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was not provided.   On 26-JUN-2024, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) dose 0.5 mL, prophylaxis, lot number X025342 and expiration date 12-MAY-2025 (strength, and route of administration was not provided). No adverse effect was reported.  It was informed that the vaccine was administered by a healthcare professional in a private doctor's office or hospital, with private funds. The vaccine was administred according to the leaflet and the operator was correctly trained. Te temperature of excursion and the time frame were not reported, however it was reported that there was a digital data logger involvement.   It was additionally reported that the current location of the vaccine was in the refrigerator.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist stated expired MMRII was administered to a patient.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT).   On 11-JUN-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (rHA), lot #X012185, expiration date: 03-JUN-2024, administered for prophylaxis (strength and route of administration were not provided) that was expired.  It was noted that the vaccine did not experience any temperature excursion through the date of administration. No adverse event was reported.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2407USA013544: US-009507513-2407USA013546:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; was administered an expired dose of MMR; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 15-JUL-2024, the patient was vaccinated with an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter, two dose series, lot # W019422, expiration date: 20-JUN-2024, Albumin status: rHA (strength and anatomical location were not provided) for prophylaxis.  It was mentioned that the patient did not experience any medical concerns or symptoms after the administration of the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
Sex: F
Vaccine: PNC15
Symptoms: Scratch, Syringe issue
Clinical narrative: Nurse administering the vaccine received a small scratch on right index finger; Nurse administering the vaccine received a small scratch on right index finger; HCP called to report finger flange on 1 VAXNEUVANCE syringe broke upon administering it to patient.  Patient received full dose.; This spontaneous report was received from a registered nurse concerning to herself.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-JUN-2024, the nurse (operator who was trained) vaccinated a patient with a full dose (reported as quantity: 1) of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, valid lot #Y002963 (batch#0001716939), expiration date reported and confirmed as 04-OCT-2026, at a private Doctor's office/hospital. No temperature excursion occurred as a result of a reading from a digital data logger. It was noted that the finger flange (along the ring of where it attaches to the syringe) on the suspect vaccine syringe broke upon administering it to the patient (syringe issue) (Captured in #2406USA009573). It was also reported that the tip of the syringe or Luer lock adaptor was not loose or broken off of the syringe tip and there was no difficulty attaching the syringe needle. In addition, the cellophane covering the syringe tray was completely sealed; the syringe carton was not damaged prior use. The syringe was broken into 3 pieces. Per the nurse, the device was returned to the manufacturer. On that day (25-JUN-2024), the nurse experienced a small scratch while administering the vaccine to the patient. The outcome of the event of scratch was reported as recovered, also reported as healed well.   The reporter considered the event of Scratch to be related to pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). ; Sender's Comments:  US-009507513-2406USA009573:
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose of Heplisav-B, and Has Not Received Second Dose Yet; Initial report received on 01-Jul-2024.  A pharmacy intern reported that a 47-year-old male patient (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 05 Jul-2023 and had not received the second dose yet.  Medical history and concomitant medications were not reported. The patient was allergic to gabapentin and tramadol (unknown reactions).  On 05-Jul-2023, the patient received the first dose of HEPLISAV-B (Lot number 941590, expiration date 31-Aug-2025, and NDC 43528-003-01) intramuscularly in the deltoid (side not specified).   As of 01-Jul-2024, the patient had not received the second dose yet. The patient did not report other side effects.   No further information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Received HEPLISAV-B while pregnant; Initial report received on 10-Jul-2024.  The report was initially received from the HEPLISAV-B Pregnancy Registry. A patient reported that she, a female (age, race, and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  Medical history, allergies, and concomitant medications were not reported.   The last menstrual period date, pregnancy history, and pregnancy risk factors were not reported.   On 13-May-2024, the patient received dose one of HEPLISAV-B (Lot number, expiration date, NDC number, route of administration, and injection site were not reported) when she was pregnant.  On 10-Jul-2024, 59 days after having been vaccinated with the first dose of HEPLISAV-B, the patient went to get the second dose of HEPLISAV-B for work but was told that it was not recommended to receive this brand in pregnancy.  The patient's estimated date of delivery is 25-Aug-2024.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose of Heplisav-B, and Second Dose Engerix; Initial report received on 19-Jul-2024.  A medical assistant reported that a patient (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then ENGERIX-B as the second dose one month later.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On 19-Jun-2024, the patient received the first dose of HEPLISAV-B (lot # 944914, expiration date 05-Sep-2026, NDC # 43528-003-01, injection site and route not provided) from a medical assistant.   On 19-Jul-2024, 31 days after having been vaccinated with HEPLISAV-B, the patient received ENGERIX-B as the second dose of hepatitis B immunization (lot#, expiration date, NDC #, injection site and route not provided). No adverse reactions were reported.  No additional information was reported.    Company Comment:The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Two shots and a booster; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: Two shots and a booster). The outcome of the vaccination failure, shingles and extra dose administered were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUL-2024 This case was reported via interactive digital media. The patient received two shots and a booster still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received booster dose of Shingles vaccine, which led to extra dose administered.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Lacrimation increased, Musculoskeletal stiffness, Synaesthesia
Clinical narrative: On December 7, 2021 patient awoke with facial paralysis on the right side affecting eyebrow, eyelid, nare, glottis, cheek, and lips. Patient was unable to close eye, raise eyebrow, chew food, smile, and some drooling occured.   Patient still has some facial stiffness in right cheek and some synesthesia, and eye closes and gushes tears when chewing.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Head discomfort, Headache, Muscle spasms, Myalgia
Clinical narrative: Reported Symptoms:  10005886:BLURRED VISION;  10011285:CRAMP;  10019211:HEADACHE;  10028411:MYALGIA; 10028813:NAUSEA;  10047700:VOMITING;    Narrative:  Patient reported ntense Headache, Blurred Vision, Loss of Balance, Body Aches, Nausea, Cramps, & extreme pressure in his head.   These symptoms lasted 48 hours with the headaches lasting 2 weeks & blurred vision in his Right Eye lasted for 1 week. Other Relevant HX:  NAUSEA AND VOMITING; CRAMP; BLURRED VISION; HEADACHE
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Vision blurred, Vomiting
Clinical narrative: Reported Symptoms:  10005886:BLURRED VISION;  10011285:CRAMP;  10019211:HEADACHE;  10028411:MYALGIA; 10028813:NAUSEA;  10047700:VOMITING;    Narrative:  Patient reported ntense Headache, Blurred Vision, Loss of Balance, Body Aches, Nausea, Cramps, & extreme pressure in his head.   These symptoms lasted 48 hours with the headaches lasting 2 weeks & blurred vision in his Right Eye lasted for 1 week. Other Relevant HX:  NAUSEA AND VOMITING; CRAMP; BLURRED VISION; HEADACHE
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Tachycardia
Clinical narrative: Reported Symptoms: 10008479:CHEST PAIN; 10043071:TACHYCARDIA; Narrative: Patient reportedly is seeing a Cardiologist regarding the symptoms. Other Relevant HX: Other: chest pain
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms:  10002218:ANAPHYLAXIS;     Narrative:  Other Relevant
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms:  10037844:RASH;     Narrative:   Other Relevant HX:   Other:
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Influenza like illness, Myalgia
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; 10016797:FLU-LIKE SYMPTOMS; 10028411:MYALGIA; Narrative: Per 1/5/24 primary care f/up note, "He reports that he experienced flu-like sx w/ the COVID-19 vaccines and wants to place an ADR flag in his chart." Other Relevant HX: Other: flu-like symptoms
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Tachycardia
Clinical narrative: Reported Symptoms:  10008479:CHEST PAIN;  10043071:TACHYCARDIA;     Narrative:  Patient reportedly is seeing a Cardiologist regarding the symptoms.   Other Relevant HX:   Other:  chest pain
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypertension, Hypertensive crisis
Clinical narrative: Reported Symptoms: 10020772:HYPERTENSION; Narrative: Other Relevant HX: BP post vaccine 252/154 Hypertension Crisis Other:
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral, Rash, Urticaria
Clinical narrative: Reported Symptoms: 10014214:EDEMA ARMS; 10037844:RASH; 10046735:URTICARIA; Narrative: 60 yo F with recent vesting exam. Patient reported previous reaction to flu vaccine of itching Other Relevant HX: Other: URTICARIA; EDEMA OF ARM
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Pruritus, Rash
Clinical narrative: Reported Symptoms:  10002218:ANAPHYLAXIS;  10008493:CHEST TIGHTNESS OF;  10020197:HIVES;  10037087:PRURITUS;  10037844: RASH;  10040604:SHORTNESS OF BREATH;  10043088:TACHYPNEA;     Narrative: This was documented by Primary Care Clinical Pharmacy Practitioner - described in progress note and documented in our chart.  However, the vaccine was not administered at the clinic and additional details are not available for report. Was able to find vaccine record via vaccination record website.  Other Relevant HX:  Other: shortness of breath, chest tightness, itching/hives